"producttype","eventid","status","recallingfirm","city","state","country","voluntarymandated","initialfirmnotificationofconsign","distributionpattern","recallnumber","classification","productdescription","codeinfo","codeinfocontinued","productquantity","reasonforrecall","recallinitiationdate","recallinitiationdatestr","reportdate","reportdatestr"
"Devices",33431,"Terminated","Oasis Medical Inc","Glendora","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland ","Z-1599-05","Class II","OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and sterilized. After sterilization, 10 pouches are loaded into a carton, the carton is labeled and heat-shrink wrapped. ","Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H ",".","9,859 cannulas for all codes","''Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators.",8/24/2005,"08/24/2005",4/2/2014,"04/02/2014"
"Devices",33431,"Terminated","Oasis Medical Inc","Glendora","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland ","Z-1601-05","Class II","OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The polybag is sealed and labeled. Typically there are 100 trays per polybag. ","Product Specification 8-4036V-NS Lot D060488 Lot D0804T Lot D0904A Lot D1004AV Lot D12048X ",".","9,859 cannulas for all codes","''Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators.",8/24/2005,"08/24/2005",4/2/2014,"04/02/2014"
"Devices",33431,"Terminated","Oasis Medical Inc","Glendora","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland ","Z-1595-05","Class II","OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight .25mm ports (four per tip).","Product Specification 4036V Lot D1201AD Lot D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y Lot D0805A8 ",".","9,859 cannulas for all codes","''Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators",8/24/2005,"08/24/2005",4/2/2014,"04/02/2014"
"Devices",33431,"Terminated","Oasis Medical Inc","Glendora","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Chile, England, Ecuador,Greece, Italy, India, Kuwait, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Spain, Sweden, and Switzerland ","Z-1600-05","Class II","OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) The MK-03V cannula is placed into a vacuum formed plastic tray and a blank Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a Tyvek pouch, heat-sealed and placed into a polybag. The polybag is sealed and labeled. Typically there are 100 pouches per polybag. ","Product Specification MK-036V Lot D0305Y",".","9,859 cannulas for all codes","''Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency''.Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators.",8/24/2005,"08/24/2005",4/2/2014,"04/02/2014"
"Biologics",34085,"Terminated","Blood Bank Of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0314-14","Class II","Platelets Pheresis Leukocytes Reduced","GS23054",,"1 unit","Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.",9/10/2002,"09/10/2002",2/5/2014,"02/05/2014"
"Biologics",38768,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","FAX","GA, SC","B-0316-14","Class II","Platelets Pheresis Leukocytes Reduced","36FM54379 (2 units)",,"2 units","Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.",6/11/2007,"06/11/2007",3/12/2014,"03/12/2014"
"Biologics",38768,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","FAX","GA, SC","B-0315-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","36FM54379",,"1 unit","Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.",6/11/2007,"06/11/2007",3/12/2014,"03/12/2014"
"Biologics",38779,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0860-14","Class II","Platelets Pheresis Leukocytes Reduced","9400513(Part A);9400513 (Part B); 9400513(Part C)","."," 3 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.",7/13/2007,"07/13/2007",9/17/2014,"09/17/2014"
"Biologics",38792,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0413-14","Class III","Red Blood Cells Leukocytes Reduced","16KP02714",".","1","Blood product,which was out of controlled storage for an indeterminable length of time, was distributed.",3/9/2007,"03/09/2007",4/2/2014,"04/02/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0513-14","Class II","Fresh Frozen Plasma ","16LT37801, 16LZ231892, 16LT37777, 16LT37798, 16LM98300, 16LT37802, 16LT37783, 16LT37803, 16LT37796, 16LT37785, 16LT37800, 16LT37788, 16LT37791, 16LT37786, 16LT37787, 16LT37784, 16LT37797",".","17 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0507-14","Class II","Cryoprecipitated AHF","16LM97945, 16LM98022, 16LM98027, 16LM98092, 16LP16059, 16LP16063, 16LP16067",".","7 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0511-14","Class II","Plasma Cryoprecipitate Reduced ","16LM97945, 16LM98079",".","2 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0508-14","Class II","Red Blood Cells Leukocytes Reduced","16LM98041, 16LM98034, 16LM98026, 16LZ31873, 16LT37791, 16LT37776, 16LT37786, 16LP16066, 16LZ31901, 16LM98096, 16LM98091, 16LT37787, 16LM98092, 16LM98022, 16LT37818, 16LT37784, 16LM98177, 16LP16148, 16LP16141, 16LT37816, 16LM98027, 16GJ50978, 16GJ50865, 16LT37797, 16LM98023, 16GJ50862, 16LT37777, 16LM98180, 16LP16063, 16LT37829, 16LM98206, 16LP16142, 16LP16064, 16LP16058, 16LP16067, 16LM98082, 16LM98025, 16LM98081, 16LT37798, 16LM98300, 16LZ31880, 16LP16048, 16LP16061, 16LM98188, 16LT37802, 16LT37827, 16LT37783, 16LP16059, 16LP16149, 16LT37803, 16LP16161, 16LZ31878, 16LM98193, 16LM98192, 16LM98205, 16LZ31874, 16LM98194, 16LT37796, 16LT37501, 16LM98087, 16LP16151, 16LZ31894, 16LZ31895, 16GJ50859, 16LP16152, 16LP16146, 16LT37785, 16LT37800, 16LT37788, 16LM98175, 16LM98179, 16LM98184, 16GJ50975, 16LM98088, 16LM98304, 16LM97941, 16LM97947, 16LM98288, 16LM98290, 16LT37801",".","80 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0510-14","Class II","Platelets Leukocytes Reduced","16LM98299, 16LT37777, 16LM98293, 16LT37798, 16LM98300, 16LZ31897, 16LT37803, 16LZ31888, 16LT37796, 16LZ31894, 16LZ31895, 16LT37785, 16LT37800, 16GJ50975, 16LT37791, 16LT37776, 16LZ31901, 16LT37784, 16GJ50865, 16GJ50978, 16LT37801",".","21 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0509-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","16LM97945, 16LZ31888, 16LZ31900, 16LZ31899",".","4 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38795,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0512-14","Class II","Cryoprecipitated AHF, Pooled ","16LM98082, 16LT37816, 16LT37827, 16LT37829 ",".","4 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/27/2007,"03/27/2007",4/9/2014,"04/09/2014"
"Biologics",38797,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","FAX","OH","B-0408-14","Class III","Blood and Blood Products for Reprocessing","16KJ35036",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/21/2007,"05/21/2007",4/2/2014,"04/02/2014"
"Biologics",38797,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","FAX","OH","B-0407-14","Class II","Platelets Leukocytes Reduced","16KJ35036",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/21/2007,"05/21/2007",4/2/2014,"04/02/2014"
"Biologics",38797,"Terminated","American National Red Cross (The)","Columbus","OH","US","Voluntary: Firm Initiated","FAX","OH","B-0406-14","Class II","Red Blood Cells Leukocytes Reduced","16KJ35036",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",5/21/2007,"05/21/2007",4/2/2014,"04/02/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0457-14","Class II","Fresh Frozen Plasma","011FL46106, 011FL46162, 011FL46165, 011FS50153, 011FS50172, 011FS50174, 011FS50234, 011FS51022, 011FS51025, 011FS51030, 011FS51032, 011FS51035, 011FS51037, 011FS51038, 011FS51039, 011FS51040, 011FT19632, 011FT19788, 011FT19798, 011FT19800, 011FT19809, 011FW36893, 011FW36917, 011FX10112, 011FX10115, 011FX10118, 011GG54667, 011GG54668, 011GG54671, 011GK98044, 011GK98049, 011GK98053, 011GK98056, 011GK98058, 011GK98065, 011GK98066, 011GK98769, 011GK98771, 011GK98775, 011GK98776, 011GQ84443, 011GQ84448, 011GQ84449, 011GQ85033, 011GQ85629, 011GQ85630, 011GQ85632, 011GQ85634, 011GQ85636, 011GQ85639, 011GQ85659, 011FJ13679, 011FS47021, 011FS47852, 011FT18717, 011FT18787, 011FT18791, 011FT18797, 011FT18903, 011FX08176, 011FX08181, 011FX08952, 011FX08963, 011FZ71115, 011FZ71118, 011FZ71122, 011FZ71127, 011FZ71138, 011FZ71650, 011FZ71691, 011FZ71703, 011FZ71710, 011GC80889, 011GC80893, 011GC80897, 011GC80899, 011GC80903, 011GC80908, 011GC80912, 011GC80919, 011GG50138, 011GG50139, 011GG50147, 011GG50148, 011GG50465, 011GG51829, 011GG51831, 011GG51850, 011GG51861, 011GG52349, 011GJ74627, 011GJ74640, 011GJ74683, 011GJ74686, 011GJ75516, 011GJ75518, 011GJ75528, 011GK94708, 011GK94717, 011GK94758, 011GK94764, 011GK94778, 011GK94798, 011GK95768, 011GK96459, 011GK96463, 011GK96467, 011GK96508, 011GN87790, 011GN87798, 011GN87800, 011GN87808, 011GN87811, 011GN87814, 011GN87824, 011GN87924, 011GN87959, 011GN87962, 011GN88384, 011GN88386, 011GN88393, 011GN88394, 011GN88397, 011GN88993, 011GQ82704, 011GQ83179, 011GQ83927, 011GQ83934, 011GQ83936, 011GQ83941, 011GQ83948, 011GQ83953, 011GR79946, 011GR79960, 011GS94355, 011GW69564, 011GW69599, 011GW69601, 011GW69604, 011KK08583, 011KK08585, 011KK08597, 011KL10569, 011KN15289, 011KN15291, 011KN16264, 011KN16266, 011KN16721, 011KN16735, 011KN16736, 011KN16739, 011KN17224, 011KX08460, 011FH05254, 011FH05349, 011FL40718, 011FL40737, 011FL40872, 011FR09640, 011FR09642, 011FS44273, 011FT16842, 011FT16843, 011FT16844, 011FT16849, 011FT16850, 011FT17633, 011FT17634, 011FT17763, 011FT17779, 011FT",".","516 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0456-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","011GR85032, 011GS96849, 011FL46158, 011FL46165, 011FL46224, 011FL47267, 011FS50157, 011FS50180, 011FW36887, 011FW36917, 011FW37198, 011FX10078, 011FX10117, 011FX10936, 011FX11204, 011GG53991, 011GN89287, 011GN89290, 011GQ85634, 011FS48758, 011FS48999, 011FS49042, 011FT19301, 011FX09399, 011FY35028, 011GC80922, 011GG49902, 011GG49905, 011GG49908, 011GG49969, 011GG51266, 011GG51278, 011GK96463, 011GK96488, 011GN87808, 011GN87811, 011GQ82752, 011GR78760, 011FW32214, 011GG48696, 011GG49445, 011GQ79911, 011GR74757, 011GS90796, 011GS90801, 011GS91560, 011GY42344, 011GY42522, 011FW31345, 011GR73686, 011FS50154, 011FX10116, 011FX10120, 011FZ68473, 011GJ73058, 011GJ73161, 011GJ73171, 011GM96837, 011GQ81054, 011GR76928, 011GS89535, 011GS89540, 011GC80923, 011FX10195, 011FT19638, 011FJ13625, 011FZ71712, 011FZ71719, 011FL40802, 011GK91395, 011GK91406, 011GQ80865, 011GR74088",".","73 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0458-14","Class II","Plasma Frozen ","011FL46149, 011FL46615, 011FL46617, 011FL46620, 011FL46622, 011FL46623, 011FW36922, 011FW37198, 011FW37201, 011FX10074, 011FX10083, 011GG52911, 011GQ84420, 011GQ84426, 011GQ84428, 011GR82779, 011GR82788, 011GR83783, 011GR83787, 011GR83791, 011GW73879, 011GW73883, 011GW73889, 011FJ13972, 011FS47824, 011FT18757, 011FT18759, 011FT18761, 011FT18913, 011FX08918, 011FX08923, 011FX08940, 011FX08942, 011FX08947, 011FX08970, 011FX09758, 011FX09759, 011FX09764, 011FZ71066, 011FZ71075, 011FZ71670, 011FZ71671, 011GC80825, 011GC80829, 011GC80838, 011GC80846, 011GC80874, 011GC80880, 011GC49898, 011GC49902, 011GG49969, 011GG49977, 011GG49984, 011GG50125, 011GG50128, 011GG50130, 011GG50131, 011GG50136, 011GK96416, 011GK96419, 011GK96427, 011GK96488, 011GQ82279, 011GR78873, 011GR78875, 011GS94351, 011GV76100, 011GY43565, 011GY43568, 011KP26544, 011KX08709, 011FL40802, 011FL40804, 011FR09613, 011FR09615, 011FR09620, 011FR09621, 011FR09623, 011FW32746, 011GQ80564, 011GQ80829, 011GQ80838, 011GV75338, 011KP25479, 011FL35533, 011FS42153, 011FS42177, 011FW29500, 011FX03281, 011FX03981, 011FX03985, 011FX03989, 011FX03990, 011GK89078, 011GK89087, 011GN85298, 011GN85307, 011GR72971, 011GR72993, 011GR72999, 011GR73086, 011GS89754, 011LQ45830, 011FL35550, 011FS42161, 011FS42170, 011FW36921, 011FX03996, 011FX10081, 011FX10085, 011FX10093, 011FY36287, 011GR73071, 011GR73092, 011GR73093, 011GR83489, 011GR83518, 011FL40787, 011FL41739, 011FR09622, 011FR09626, 011GC80868, 011GC80883, 011GG50127, 011GK89088, 011GQ80681, 011GS89765, 011KL10134, 011KN16709",".","129 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0459-14","Class II","Plasma Frozen Cryoprecipitate Reduced","011FS51244, 011FT20149, 011FT20164, 011FX10583, 011FX10930, 011FX10936, 011FX11045, 011FX11070, 011FX11077, 011FX11179, 011FX11600, 011FY36268, 011GK98780, 011GK98789, 011GK98795, 011GK98801, 011GK98803, 011GN89595, 011GN89599, 011GQ85065, 011GQ85533, 011GR83527, 011GR83530, 011GR83546, 011GR83549, 011GY44909, 011GY44911, 011GY44917, 011GY44925, 011KN17373, 011KN17730, 011KN17742, 011FS49047, 011FT18775, 011FT18780, 011FW34896, 011FW34908, 011FW34910, 011FW34953, 011FW34956, 011FY34686, 011FY34689, 011FY34690, 011FY34694, 011FY35713, 011FZ72442, 011FZ72527, 011GG49912, 011GG49913, 011GG49915, 011GG50424, 011GG51266, 011GG51267, 011GG51270, 011GG51274, 011GJ75428, 011GJ75430, 011GJ75442, 011GN87906, 011GN87907, 011GN87908, 011GN87909, 011GN87910, 011GN87912, 011GN88756, 011GQ83607, 011GR79928, 011GR79931, 011GR79935, 011GW69568, 011GW69571, 011GW69572, 011GW69573, 011GW69575, 011GY43220, 011GY43222, 011GY43225, 011KN15311, 011KN16450, 011KN16455, 011KN16457, 011KN16467, 011KN16471, 011FS44269, 011FT17303, 011FT17315, 011FW31855, 011FW31905, 011FW33385, 011FX05037, 011FX05994, 011FY34230, 011FZ69428, 011FZ69923, 011GG48512, 011GJ72616, 011GJ72627, 011GJ72999, 011GJ73044, 011GK92427, 011GK92431, 011GM97482, 011GM97948, 011GN86487, 011GQ80420, 011GQ80424, 011GQ80427, 011GQ80436, 011GQ80440, 011GQ80442, 011GQ80451, 011GQ81946, 011GQ81947, 011GQ81948, 011GQ81949, 011GQ81954, 011GQ81959, 011GQ81960, 011GR76386, 011GR76398, 011GR76419, 011GR76422, 011GR76438, 011GS90415, 011GS90819, 011GS91002, 011GY41698, 011GY41703, 011GY42230, 011GY42242, 011GY42250, 011KN12829, 011KN13078, 011KN14374, 011KN14389, 011KN14395, 011KN14400, 011KN14621, 011FS40971, 011FW28802, 011FW28807, 011FW28825, 011FW29353, 011FW31336, 011FW31342, 011FX02688, 011FX02694, 011FY32463, 011FY32470, 011FY32612, 011FZ67805, 011GG46572, 011GG46578, 011GM97350, 011GR71739, 011GR71746, 011GR71794, 011GR72211, 011GR73633, 011GR73724, 011GR73746, 011GR73769, 011GR73798, 011GR74221, 011GS89533, 011KN09753, 011KN09766, 011KN09774, 011KN10283, 011KN10288, 011KN",".","242 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0460-14","Class II","Red Blood Cells, Frozen ","011GK94709",".","1 unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0455-14","Class II","Red Blood Cells","011GJ78797, 011GJ78801, 011GJ78809, 011FL46105, 011FL46106, 011FL46117, 011FL46121, 011FL46125, 011FL46129, 011FL46130, 011FL46131, 011FL46138, 011FL46140, 011FL46141, 011FW37216, 011FX11239, 011FX11241, 011FX11243, 011FX11246, 011FX11261, 011FX11264, 011FX11266, 011GG53993, 011GG53994, 011GG53996, 011GG54004, 011GG54007, 011GG54009, 011GG54689, 011GK98769, 011GK98771, 011GK98775, 011GK98780, 011GK98786, 011GK98789, 011GK98793, 011GK98795, 011GK98801, 011GK98803, 011GK98804, 011GW73737, 011GW73740, 011GW73741, 011GW73756, 011GW73758, 011GW73760, 011GW73762, 011GW73764, 011GW73874, 011GW73876, 011GW73878, 011GW73879, 011GW73880, 011GW73881, 011GW73883, 011GW73884, 011GW73885, 011GW73886, 011GW73887, 011GW73889, 011GW73891, 011GW73892, 011GW73901, 011GW73903, 011GZ63552, 011GZ63557, 011GZ63558, 011GZ63560, 011GZ63562, 011GZ63570, 011KP29424, 011KP29426, 011KP29429, 011FW35909, 011FW35916, 011FW35918, 011FW35920, 011FW35926, 011FW35947, 011FW35949, 011FX08602, 011FX09346, 011FX09348, 011FX09366, 011FX09369, 011FX09371, 011FX09375, 011FX09380, 011FX09382, 011FX09761, 011FY34687, 011FY34689, 011FY34692, 011GC80838, 011GC80846, 011GC80874, 011GC80880, 011GG50424, 011GG52349, 011GJ74705, 011GN88379, 011GN88382, 011GN88384, 011GN88386, 011GN88394, 011GN88397, 011GN89043, 011GN89046, 011GN89053, 011GN89057, 011GS93439, 011GS93440, 011GS93443, 011GS93448, 011GS93453, 011GS93454, 011GS93459, 011GS93461, 011GS93467, 011GS93472, 011GW71457, 011GW71461, 011GW71462, 011GW71465, 011GW71466, 011GW71467, 011GW71468, 011GW71469, 011GW71470, 011GW71471, 011GW71474, 011GW71475, 011GW71477, 011GW71483, 011GY43563, 011GY43567, 011GY43568, 011GY43682, 011KC17486, 011KK08532, 011KK08538, 011KK08542, 011KK08543, 011KK08547, 011KK08549, 011KK08553, 011KK08554, 011KK08559, 011KK08573, 011KK08574, 011KK08576, 011KK08577, 011KK08578, 011KK08579, 011KK08580, 011KK08583, 011KK08585, 011KK08587, 011KK08590, 011KK08597, 011KP26544, 011KP26548, 011KX08395, 011KX08454, 011FR09613, 011FR09615, 011FR09620, 011FR09621, 011FR09625, 011FR09640, 011FR",".","365 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0453-14","Class II","Cryoprecipitated AHF","011FL48039, 011GG54687, 011GG54691, 011GG54692, 011GG54694, 011GN89879, 011GN89897, 011GN89906, 011GN89908, 011GR84727, 011FW38211, 011FW38226, 011FW38282, 011FW38285, 011FW38286, 011FW38287, 011FW38296, 011FW38297, 011FW38298, 011FW38300, 011FW38301, 011FW38302, 011GJ78797, 011GJ78800, 011GJ78801, 011GJ78803, 011GJ78809, 011GJ78810, 011GJ78813, 011FL46117, 011FL46121, 011FL46125, 011FL46129, 011FL46130, 011FL46131, 011FL46138, 011FL46140, 011FL46141, 011FL46220, 011FL46221, 011FL46222, 011FL46224, 011FL46225, 011FL46226, 011FL46229, 011FL46606, 011FL46610, 011FL47248, 011FL47267, 011FL47386, 011FL47445, 011FL47525, 011FL47905, 011FL47929, 011FL47939, 011FL47941, 011FS49729, 011FS49731, 011FS49732, 011FS49735, 011FS49738, 011FS51212, 011FS51219, 011FS51239, 011FS51244, 011FS51248, 011FS51253, 011FT19653, 011FT19655, 011FT19657, 011FT19658, 011FT19659, 011FT19660, 011FT20143, 011FT20145, 011FT20149, 011FT20157, 011FT20159, 011FT20160, 011FT20161, 011FT20164, 011FW38195, 011FX10196, 011FX10201, 011FX10580, 011FX10583, 011FX10590, 011FX10593, 011FX10595, 011FX10596, 011FX10597, 011FX10930, 011FX10936, 011FX10986, 011FX10993, 011FX11045, 011FX11055, 011FX11062, 011FX11070, 011FX11077, 011FX11175, 011FX11176, 011FX11179, 011FX11183, 011FX11184, 011FX11187, 011FX11211, 011FX11215, 011FX11219, 011FX11221, 011FX11224, 011FX11257, 011FX11261, 011FX11264, 011FX11266, 011FX11269, 011FX11273, 011FX11277, 011FX11600, 011FX11601, 011FX11603, 011FX11605, 011FY36268, 011FY36270, 011FY36440, 011FY36445, 011FY36447, 011FZ73168, 011GG52922, 011GG52925, 011GG52928, 011GG53834, 011GG53835, 011GG53838, 011GG53840, 011GG53848, 011GG53850, 011GG53941, 011GG53945, 011GG53951, 011GG53957, 011GG53969, 011GG53973, 011GG53976, 011GG53979, 011GG53993, 011GG53994, 011GG53996, 011GG53999, 011GG54004, 011GG54007, 011GG54009, 011GG54117, 011GG54118, 011GG54119, 011GG54120, 011GG54121, 011GG54124, 011GG54125, 011GG54135, 011GG54138, 011GG54139, 011GG54674, 011GG54675, 011GG54684, 011GG54689, 011GJ78649, 011GJ78657, 011GJ78672, 011GJ78675, 011GJ",".","1432 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",39127,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","FAX","MO, OK, TN, IL, MD, MA, CA, MI, Guam, GA, NC, American Samoa","B-0454-14","Class II","Red Blood Cells Leukocytes Reduced","011FL47869, 011FL47960, 011FL47967, 011FL47988, 011FL48025, 011FL48035, 011FL48133, 011GG54687, 011GG54691, 011GG54692, 011GG54694, 011GN89880, 011GN89882, 011GN89884, 011GN89885, 011GN89892, 011GN89894, 011GN89897, 011GN89904, 011GN89905, 011GR84667, 011GR84699, 011GR84727, 011GR84734, 011GR84736, 011GR84990, 011GR84995, 011GR85007, 011GR85025, 011GR85073, 011GR85086, 011GR85087, 011FW38211, 011FW38226, 011FW38282, 011FW38287, 011FW38297, 011FW38300, 011FW38302, 011GJ78800, 011GJ78803, 011GS96842, 011GS96847, 011GS96848, 011GS96850, 011GS96855, 011GS96857, 011GS96859, 011GS96862, 011GS96865, 011GS96868, 011FL46147, 011FL46149, 011FL46150, 011FL46151, 011FL46157, 011FL46160, 011FL46162, 011FL46164, 011FL46220, 011FL46221, 011FL46222, 011FL46223, 011FL46225, 011FL46226, 011FL46229, 011FL46594, 011FL46597, 011FL46604, 011FL46606, 011FL46615, 011FL46617, 011FL46619, 011FL46620, 011FL46621, 011FL46622, 011FL46625, 011FL46627, 011FL47248, 011FL47373, 011FL47386, 011FL47392, 011FL47418, 011FL47445, 011FL47525, 011FL47905, 011FL47916, 011FL47929, 011FL47939, 011FL47941, 011FL47956, 011FL48111, 011FS49729, 011FS49731, 011FS49732, 011FS49735, 011FS49738, 011FS50153, 011FS50168, 011FS50170, 011FS50172, 011FS50174, 011FS50181, 011FS50223, 011FS50225, 011FS50234, 011FS50235, 011FS50244, 011FS50246, 011FS51022, 011FS51023, 011FS51025, 011FS51027, 011FS51030, 011FS51032, 011FS51035, 011FS51037, 011FS51038, 011FS51039, 011FS51040, 011FS51042, 011FS51212, 011FS51217, 011FS51236, 011FS51239, 011FS51248, 011FS51253, 011FT19632, 011FT19634, 011FT19637, 011FT19653, 011FT19655, 011FT19657, 011FT19658, 011FT19659, 011FT19660, 011FT19786, 011FT19788, 011FT19798, 011FT19800, 011FT19804, 011FT19808, 011FT19809, 011FT20143, 011FT20145, 011FT20149, 011FT20157, 011FT20159, 011FT20160, 011FT20161, 011FT20164, 011FW36893, 011FW36905, 011FW36909, 011FW36913, 011FW36922, 011FW36925, 011FW37201, 011FW37203, 011FW37204, 011FW38195, 011FW38203, 011FW38275, 011FW38281, 011FX09927, 011FX09929, 011FX09931, 011FX09934, 011FX09941, 011FX09942, 011FX",".","2367 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",4/11/2007,"04/11/2007",3/19/2014,"03/19/2014"
"Biologics",40514,"Terminated","CSL Plasma","Lexington","KY","US","Voluntary: Firm Initiated","FAX","FL","B-0432-14","Class II","Source Plasma","0530394149; 053039394; 0530393697; 0530393535; 0530392892; 0530392693; 0530392001; 0530391617; 0530391505; 0530391141; 0530390944; 0530387218; 0530386449; 0530386279; 0530385856; 0530385694; 0530385242; 0530385039; 0530384740; 0530384530; 0530383951; 0530383876; 0530383451; 053050260; 053050252; 053050223; 053050190; 053050212; 05305146; 053050104; 053050065; 053050039; 053050022; 053041868; 053041922; 053041862; 053041843; 053041815; 053041795; 053041766; 053041746.",,"41 ","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",6/29/2013,"06/29/2013",3/26/2014,"03/26/2014"
"Biologics",40738,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0463-14","Class III","Red Blood Cells Leukocytes Reduced","106657699",,"1 unit","Blood product, not prepared in accordance with specifications was distributed.",8/6/2005,"08/06/2005",3/12/2014,"03/12/2014"
"Biologics",41330,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0466-14","Class II","Platelets Pheresis Leukocytes Reduced","107252509 (2 units), 102977169 (2 units), 101897456 (2 units), 101885085",".","7 units","Blood products, collected from a donor who was taking a medication containing aspirin at the time of donation, were distributed.",1/11/2006,"01/11/2006",3/19/2014,"03/19/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0588-14","Class III","Cryoprecipitated AHF","016GX19419, 016LC29235, 016LG79568, 016GM46776, 016GX18130, 016LG78306, 016LC28864, 016LH86961, 016GM46777, 016GR21510, 016GS27274, 016GY04855, 016KL01652, 016LC28868, 016LG78302, 016LG78305, 016LK21046, 016LK21050, 016LQ39548, 016LQ39577, 016LR77174, 016LW70975, 016GR21515, 016LR74299, 016GP26988, 016GS23835, 016LG73515, 016LG73734, 016LQ37299, 016LR74333, 016GS23895, 016GS23999, 016GW41283, 016KJ17875, 016LR74312, 016LR74410, 016LR74478, 016GW41244, 016LQ37207, 016GP26990, 016GS23981, 016LG73512, 016GX13900, 016GM47400, 016GQ25149, 016GS28603, 016LM84672, 016LM84675, 016LM84680, 016LM84682, 016LQ40078, 016LQ40084, 016LM84975, 016GQ24988, 016GR22621, 016LH87902, 016KG13986, 016GM47465, 016GX19450, 016LG79611, 016LH87886, 016LM84659, 016LM84684, 016GQ24992, 016GR22626, 016LJ25202, 016GR22635, 016GR22663, 016GX19444, 016GQ24994, 016GR22647, 016LJ25090, 016LM84666, 016LM84960, 016LM84663, 016GM47452, 016LM84983, 106GR22643, 016GR22623, 016GR22627",,"80 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0587-14","Class III","Red Blood Cells Leukocytes Reduced","016GP31723, 016GR23006, 016GR23009, 016KC33607, 016LG80024, 016LG80027, 016LG80028, 016LG80029, 016LG80031, 016LG80032, 016LM85273, 016LM85279, 016LM85280, 016LM85290, 016LM85302, 016LM85304, 016LZ27715, 016LZ27727, 016LZ27733, 016LZ27734, 016GS28568, 016GX19054, 016GX19068, 016GX19069, 016GX19077, 016GX19089, 016GX19090, 016GX19099, 016KJ21807, 016KJ21809, 016KL01879, 016LH87692, 016LH87698, 016LQ40022, 016LQ40023, 016LQ40024, 016LQ40026, 016LQ40027, 016LQ40032, 016LR77771, 016LR77774, 016LR77778, 016LR77785, 016LR77787, 016GX19081, 016GM47498, 016GQ25044, 016LW71414, 016LW71415, 016GJ37237, 016GS28463, 016GW45422, 016LX80781, 016LZ27511, 016GM47523, 016LX80770, 016GJ37210, 016GQ25047, 016GS28428, 016GS28430, 016GS28432, 016GS28461, 016GX18911, 016GX18924, 016LJ25116, 016LJ25120, 016LK21619, 016LW71408, 016LW71417, 016LW71423, 050LJ83971, 050E38686, 050LC03429, 050LC03432, 050LC03440, 050LC03450, 050LH63923, 050LH63930, 050LH63947, 050LH63951, 050LH63952, 050LH63956, 050LH63969, 050LJ83973, 050LJ83975, 050LJ83976, 050LJ83979, 050LJ83989, 050LJ83993, 050LJ83994, 050LJ84003, 050LW25826, 050LW25828, 050LW25837, 050LW25839, 050V05894, 050LH64623, 050LJ84557, 050V05913, 050LW26897, 050LW26951, 050LC05019, 050LC05050, 050LC05068, 050LC05069, 050LW26901, 016KG12309, 016LK19741, 016LQ38892, 050LC05015, 050LH64615",,"111 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0592-14","Class III","Red Blood Cells","050K41787, 050L23164, 016LT32806, 016LT32807 ",,"4 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0590-14","Class III","Platelets Pheresis, Leukocytes Reduced, Irradiated","050KP02610, 050P43602, 050KP02606, 050P43601, 050P43596, 050KP02615, 050P43599, 050KP02605, 050KP02613, 016KF48111, 016KF48100",,"11 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0591-14","Class III","Plasma, Cryoprecipitate Reduced","016GM46168, 016GR20900, 016LR76746, 016GJ35838, 016GP30057, 016GR20920, 016GS27167, 016GW44234, 016KG12897, 016LG77729, 016LH86570, 016LK20585, 016LP12080, 016LR76720",,"14 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0593-14","Class III","Fresh Frozen Plasma","016LK22501, 016LM85463, 016LR78500, 016GX20022, 016KG14368, 016KJ22339, 016LK22505, 016LK22922, 018FZ55729, 018FZ55730, 018GN44073, 018GX00359, 018FF10591, 018FS93959, 018FW66959, 018FX72618, 018GN43948, 018GR05695, 018GR05697, 018GT03768, 018GT03776, 018GX00350, 016GP31857, 016GQ25586, 016GR23070, 016GR23075, 016GS29174, 016GW45964, 016KG14367, 016KJ22330, 016LR78440, 016LR78475, 016KJ22342, 016LK22576, 016KG14369, 016LH88437, 016LK22521, 016LW71914, 016LW71218, 018GT03858, 018GT03859, 018GT03860, 018GT03863, 018GT03866, 018GT03867, 016LK21195, 016LK21210, 016GP31853, 016GR23060, 016GR23078, 016LP12562, 016LK21191, 016LK21204, 016LR77406, 016LZ27718, 016LK21184, 016LK21194, 016LH87298, 016LK21183, 016LK21185, 016LK21192, 016LK21199, 016LW71221, 016KG13661, 016KJ21547, 016KJ21549, 016LW71312, 016GS28273, 016GW45144, 016GW45148, 016KG13656, 016KG13670, 016KJ21540, 016LW71290, 016LW71292, 016LW71293, 016LW71315, 016LH87254, 016GR21955, 016GS28112, 016KG13556, 013FF51236, 013GQ88205, 013GQ88220, 013GT11643, 013GX92663, 013LH25336, 013FF51206, 013FV54817, 013GP17562, 013GT11650, 013GW50171, 013GX92610, 013GY02843, 016GR21950, 016GQ24762, 016GQ24769, 016GR21944, 016KG13530, 016KG13542, 016LH87231, 016LH87234, 016LH87260, 016LZ27436, 016GX18180, 016GM46814, 016GX17949, 016GX18179, 016LH86992, 016LW70990, 016GJ36481, 016GJ36482, 016GS27357, 016LG78418, 016GP30581, 016GX18061, 016KG13290, 016KG13297, 016KG13332, 016KG13334, 016KG13344, 016LG78329, 016LH86996, 016LH87005, 016GS27249, 016KG13358, 013FV54879, 016GX17956, 016GX17994, 016GX18165, 016GX18167, 016LW70986, 016LW70992",,"133 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41388,"Terminated","American National Red Cross","Cleveland","OH","US",,"Telephone","Nationwide","B-0589-14","Class III","Platelet, Pheresis, Leukocytes Reduced","2485050861, 2485050875, 038FX00758, 038FX00748, 038FX00757, 038FX00754 (2 units)",,"7 units","Blood products, which may have reached unacceptable temperatures during shipment, were distributed.",10/19/2005,"10/19/2005",5/7/2014,"05/07/2014"
"Biologics",41858,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated",,"OH","B-0391-14","Class II","Red Blood Cells Leukocytes Reduced","50E40490",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",2/28/2006,"02/28/2006",4/2/2014,"04/02/2014"
"Biologics",41965,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-0440-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","107215315",".","1 unit","Blood products, which were stored under unacceptable storage conditions, were distributed.",4/24/2006,"04/24/2006",3/19/2014,"03/19/2014"
"Biologics",41965,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-0441-14","Class II","Red Blood Cells Leukocytes Reduced","242463929",".","1 unit","Blood products, which were stored under unacceptable storage conditions, were distributed.",4/24/2006,"04/24/2006",3/19/2014,"03/19/2014"
"Biologics",42034,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0464-14","Class II","Platelets Pheresis Leukocytes Reduced","107228886(A) ;107228886(B)",,"2 units","Blood products, which did not meet acceptable product specifications, were distributed.",5/15/2006,"05/15/2006",3/12/2014,"03/12/2014"
"Biologics",42077,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0388-14","Class II","Red Blood Cells Leukocytes Reduced","107198792",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",5/18/2006,"05/18/2006",3/12/2014,"03/12/2014"
"Biologics",42188,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0308-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","107228280 (2 units)",,"2 units","Blood products, which did not meet the minimum requirement for volume, were distributed.",5/25/2006,"05/25/2006",2/5/2014,"02/05/2014"
"Biologics",42685,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0846-14","Class II","Red Blood Cells Leukocytes Reduced","107188134",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",8/16/2006,"08/16/2006",8/6/2014,"08/06/2014"
"Biologics",42764,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0275-14","Class II","Red Blood Cells","GS45134",,"1 unit","Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.",8/28/2006,"08/28/2006",2/5/2014,"02/05/2014"
"Biologics",42941,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","nationwide","B-0304-14","Class III","Red Blood Cells Leukocytes Reduced","107979009",,"1 unit","Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed.",9/25/2006,"09/25/2006",2/5/2014,"02/05/2014"
"Biologics",43099,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Fax","OH, MI","B-0467-14","Class III","Red Blood Cells Leukocytes Reduced","50V09551; 50V09552; 50V09556; 50V09559; 50V09560; 50V09561; 50V09562; 50V09563; 50V09566; 50V09570; 50V09571; 50V09572; 50V09573; 50V09574; 50V09575; 50V09576",".","16","Blood products, collected using trip scales for which the daily QC was not documented, were distributed. ",8/8/2006,"08/08/2006",4/2/2014,"04/02/2014"
"Biologics",43101,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated",,"MI, OH","B-0462-14","Class III","Red Blood Cells Leukocytes Reduced","50LC29458; 50LC29460; 50LC29464; 50LC29466; 50LC29467; 50LC29471; 50LC29474; 50LC29475; 50LC29476; 50LC29477; 50LC29478; 50LC29479; 50LC29480; 50LC29482; 50LC29485; 50LC29487; 50LC29488; 50LC29490",".","18","Blood products, collected using trip scales for which the daily QC was not documented, were distributed. ",8/8/2006,"08/08/2006",4/2/2014,"04/02/2014"
"Biologics",43366,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0281-14","Class III","Red Blood Cells Leukocytes Reduced","107968469",,"1 unit","Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.",11/10/2006,"11/10/2006",2/5/2014,"02/05/2014"
"Biologics",43366,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0280-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","107973991,107978084",,"2 units","Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.",11/10/2006,"11/10/2006",2/5/2014,"02/05/2014"
"Biologics",43934,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","South Carolina","B-0278-14","Class II","Platelets Pheresis Leukocytes Reduced","36FM47411",,"1 unit","Blood product, which contained an insufficient plasma volume, was distributed.",10/3/2006,"10/03/2006",2/5/2014,"02/05/2014"
"Biologics",44122,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0279-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","107980629 (2 units)",,"2 units","Blood products, collected from a donor who was taking the medication Avodart, were distributed.",2/6/2007,"02/06/2007",2/5/2014,"02/05/2014"
"Biologics",44213,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Fax","MI, OH","B-0529-14","Class III","Red Blood Cells Leukocytes Reduced","42FC23201; 50LJ98127: 50LW49978; 50LW51367; 50X33786",".","5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/15/2006,"12/15/2006",4/23/2014,"04/23/2014"
"Biologics",44213,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Fax","MI, OH","B-0531-14","Class III","Platelets Leukocytes Reduced","16GJ47521",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/15/2006,"12/15/2006",4/23/2014,"04/23/2014"
"Biologics",44213,"Terminated","American National Red Cross (The)","Toledo","OH","US","Voluntary: Firm Initiated","Fax","MI, OH","B-0530-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","16GJ47521",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/15/2006,"12/15/2006",4/23/2014,"04/23/2014"
"Biologics",44236,"Terminated","American National Red Cross","Toledo","OH","US","Voluntary: Firm Initiated","Telephone","Nationwide","B-0263-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","16LL76290",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/8/2006,"12/08/2006",2/5/2014,"02/05/2014"
"Biologics",44445,"Terminated","American National Red Cross (The)","Columbia","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-0262-14","Class II","Red Blood Cells Leukocytes Reduced","036FY39361, 036FY39367, 036FY39369 ",,"3 units","Blood products, for which there was a discrepancy in the sample tubes for viral marker testing, were distributed.",1/8/2007,"01/08/2007",2/5/2014,"02/05/2014"
"Biologics",44629,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0631-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","103642540 (2 units)",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/14/2007,"03/14/2007",5/28/2014,"05/28/2014"
"Biologics",45158,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0438-14","Class III","Red Blood Cells Leukocytes Reduced","104192654",,"1 unit","Blood product, collected from an ineligible donor, was distributed.",8/21/2007,"08/21/2007",3/12/2014,"03/12/2014"
"Biologics",45159,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-0439-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","104176388 (2 units)",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/28/2007,"08/28/2007",3/19/2014,"03/19/2014"
"Biologics",45160,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","ND, CA, MS, AL","B-0485-14","Class II","Red Blood Cells Leukocytes Reduced","300577900, 300577903, 300577905, 300577906, 305638450, 305638452, 305638457, 305638459, 305638460, 305638465, 305638466, 305638468, 305639302, 305639303, 305639306, 305639311, 305639313, 305639317, 305639318, 305639319",".","20 units","Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed.",8/28/2007,"08/28/2007",3/19/2014,"03/19/2014"
"Biologics",45160,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","ND, CA, MS, AL","B-0484-14","Class II","Red Blood Cells Apheresis Leukocytes Reduced","300577901 (2 units), 305638451 (2 units), 305638461 (2 units), 305638469 (2 units), 305638471 (2 units), 309605582 (2 units)",".","12 units","Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed.",8/28/2007,"08/28/2007",3/19/2014,"03/19/2014"
"Biologics",45163,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Montana","B-0225-14","Class II","Platelets Pheresis Leukocytes Reduced","102713647; 102713647",,"2","Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.",9/26/2007,"09/26/2007",2/26/2014,"02/26/2014"
"Biologics",45163,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Montana","B-0224-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","102713647",,"1","Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.",9/26/2007,"09/26/2007",2/26/2014,"02/26/2014"
"Biologics",45164,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0227-14","Class II","Red Blood Cells Leukocytes Reduced","104153331",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",9/26/2007,"09/26/2007",3/5/2014,"03/05/2014"
"Biologics",45360,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","California","B-0226-14","Class II","Platelets Pheresis Leukocytes Reduced","GF01233",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",9/11/2007,"09/11/2007",2/26/2014,"02/26/2014"
"Biologics",45415,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Texas","B-0331-14","Class III","Red Blood Cells Leukocytes Reduced","104199423;",".","1","Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed.",9/12/2007,"09/12/2007",3/19/2014,"03/19/2014"
"Biologics",45415,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Texas","B-0330-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","104199421;104199421",".","2","Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed.",9/12/2007,"09/12/2007",3/19/2014,"03/19/2014"
"Biologics",45415,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Texas","B-0332-14","Class III","Blood and Blood Products for Reprocessing","104192399",".","1","Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed.",9/12/2007,"09/12/2007",3/19/2014,"03/19/2014"
"Biologics",45723,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Illinois","B-0222-14","Class II","Blood and Blood Products for Reprocessing","104181146",,"1","Blood products, collected from a donor who was taking the drug Methotrexate, were distributed.",10/2/2007,"10/02/2007",2/26/2014,"02/26/2014"
"Biologics",45723,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona, Illinois","B-0223-14","Class II","Red Blood Cells Leukocytes Reduced","104181146",,"1","Blood products, collected from a donor who was taking the drug Methotrexate, were distributed.",10/2/2007,"10/02/2007",2/26/2014,"02/26/2014"
"Biologics",45726,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0335-14","Class II","Red Blood Cells Leukocytes Reduced","GY10019",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",10/29/2007,"10/29/2007",2/26/2014,"02/26/2014"
"Biologics",45726,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0336-14","Class II","Plasma","GY10019",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",10/29/2007,"10/29/2007",2/26/2014,"02/26/2014"
"Biologics",46126,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0337-14","Class III","Platelets Pheresis Leukocytes Reduced","107977875- part 1;107977875- part 2;107977882",,"3 units","Blood products, which were out of controlled storage temperatures, were distributed.",10/23/2007,"10/23/2007",2/26/2014,"02/26/2014"
"Biologics",47002,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-0486-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","103332673",".","1 unit","Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.",1/9/2008,"01/09/2008",4/2/2014,"04/02/2014"
"Biologics",47088,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0334-14","Class II","Platelets Pheresis Leukocytes Reduced","103337718",,"1 unit","Blood product, with positive bacterial detection testing, was distributed.",1/24/2008,"01/24/2008",2/26/2014,"02/26/2014"
"Biologics",47995,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0695-14","Class II","Platelets Pheresis Leukocytes Reduced","103402373",".","1 unit","Blood product, which was not tested for pH and platelet count, was distributed.",4/22/2008,"04/22/2008",5/28/2014,"05/28/2014"
"Biologics",49192,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0465-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W041008015909V, W041008017196X",".","2 units","Blood products, for which the irradiation was performed incorrectly, were distributed.",7/14/2008,"07/14/2008",3/19/2014,"03/19/2014"
"Biologics",49824,"Terminated","Blood Bank of San Bernardino and Riverside Counties","San Bernardino","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0333-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W126108008515",,"1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/13/2008,"08/13/2008",2/26/2014,"02/26/2014"
"Biologics",50560,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0443-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","103363993- part 1; 103363993- part 2; 103363994- part 1; 103363994- part 2",,"4 units","Blood products, exposed to unacceptable temperature during storage, were distributed.",12/2/2008,"12/02/2008",3/26/2014,"03/26/2014"
"Biologics",50560,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0442-14","Class III","Platelets Pheresis Leukocytes Reduced","103020207- part 1; 103020207- part 2",,"2 units","Blood products, exposed to unacceptable temperature during storage, were distributed.",12/2/2008,"12/02/2008",3/26/2014,"03/26/2014"
"Biologics",50560,"Terminated","Blood Systems, Inc.","Scottsdale","AZ","US","Voluntary: Firm Initiated","Letter","AZ","B-0444-14","Class III","Red Blood Cells Leukocytes Reduced","103363995; 103363996; 103363997; 103367002; 103367003",,"5 units","Blood products, exposed to unacceptable temperature during storage, were distributed.",12/2/2008,"12/02/2008",3/26/2014,"03/26/2014"
"Biologics",52876,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0652-14","Class II","Source Plasma","3380000447, 3380000466, 3380000462, 3380000465, 3380000461, 3380000464, 3380000463, 3380000448, 3380000454, 3380000455, 3380000458, 3380000460, 3380000450, 3380000451, 3380000452, 3380000453, 3380000467, 3380000449, 3380000456, 3380000459",".","20 units","Blood products, for which the sample tubes for NAT testing may have been stored at an unacceptable temperature, were distributed.",5/19/2009,"05/19/2009",5/28/2014,"05/28/2014"
"Biologics",53423,"Terminated","Biomat USA, Inc.","Everett","WA","US","Voluntary: Firm Initiated","Letter","Spain and California.","B-0213-14","Class II","Source Plasma","0130071123, 0130070779, 0130070193, 0130069203, 0130068928, 0130066855, 0130066466, 0130066006, 0130065657, 0130064839, 0130064410, 0130063916, 0130063618, 0130063025, 0130062778, 0130062051, 0130060955, 0130060826, 0130059008, 0130058381, 0130058146, 0130055829, 0130054113, 0130052865, 0130051573, 0130051157, 0130050694, 0130050440, 0130044617, 0130044043, 0130043718, 0130043406, 0130042801, 0130039175, 0130038761, 0130038239, 0130037815, 0130037656, ",,"38 components","Blood products, collected from a donor who reported receiving a body piercing within 12 months of donating, were distributed.",12/1/2008,"12/01/2008",2/26/2014,"02/26/2014"
"Biologics",53764,"Terminated","Biomat USA, Inc","Arlington","TX","US","Voluntary: Firm Initiated","FAX","California, Spain","B-0230-14","Class II","Source Plasma","0500281651; 0500294369; 0500294890; 0500296826; 0500299056; 0500302703; 0500304763; 0500307103; 0500309060; 0500310395; 0500322858; 0500325094; 0500351111; 0500353246; 0500353922; 0500356201; 0500357166; 0500358201; 0500359246; 0500360295; 0500361342; 0500362340; 0500379313; 0500379840; 0500384493; 0500386930; 0500388405; 0500389245; 0500392470",,"29 units","Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked",8/1/2009,"08/01/2009",2/26/2014,"02/26/2014"
"Biologics",54213,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-0029-15","Class III","Source Plasma","3440001285, 3440000085, 3440000224, 3440001391, 3440002171, 3440003422, 3440003746, 3440005747, 3440005888, 3440000862, 3440001168, 3440001276, 3440001850, 3440002106, 3440003655, 3440003748, 3440003863, 3440004139, 3440004687, 3440004963, 3440005390, 3440009247, 3440001281, 3440006905, 3440000289, 3440000711, 3440000869, 3440001752, 3440002239, 3440002374, 3440001310, 3440001412, 3440002141, 3440003449, 3440003595, 3440000697, 3440002727, 3440003063, 3440003316, 3440000019, 3440000281, 3440000476, 3440000562, 3440002766, 3440006217, 3440005210, 3440005454, 3440001609, 3440002205, 3440002980, 3440000299, 3440000588, 3440002398, 3440004360, 3440004542, 3440006813, 3440001404, 3440004781, 3440008482, 3440001166, 3440001256, 3440002207, 3440001040, 3440008370, 3440005206, 3440006251, 3440007577, 3440007888, 3440005761, 3440005883, 3440000009, 3440002906, 3440009322, 3440000032, 3440000132, 3440000160, 3440007486, 3440008534, 3440008853, 3440003067, 3440003145, 3440003210, 3440003569, 3440004140, 3440004713, 3440009256, 3440003528, 3440008686, 3440001420, 3440001978, 3440008876, 3440006925, 3440004074, 3440005896, 3440002777, 3440000013, 3440000805, 3440000886, 3440001222, 3440001606, 3440002344, 3440002848, 3440003022, 3440003193, 3440003507, 3440003758, 3440004096, 3440004125, 3440004320, 3440004697, 3440004866, 3440004959, 3440005734, 3440005913, 3440006427, 3440006534, 3440005457, 3440001052, 3440000785, 3440001315, 3440001402, 3440002949, 3440004177, 3440004552, 3440004682, 3440009455, 3440002112, 3440003594, 3440002237, 3440003671, 3440004195, 3440004526, 3440005731, 3440006101, 3440008360, 3440006914, 3440007604, 3440007905, 3440001512, 3440004894, 3440004970, 3440005543, 3440007845, 3440003562, 3440008701, 3440003644, 3440003635, 3440004090, 3440004185, 3440001789, 3440002372, 3440002899, 3440005400, 3440005655, 3440006958, 3440000189, 3440001849, 3440003873, 3440003182, 3440004863, 3440005392, 3440005638, 3440005732, 3440006594, 3440002196, 3440001400, 3440001746, 3440002001, 3440002230, 3440002405, 34400",".","187 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",11/25/2009,"11/25/2009",11/5/2014,"11/05/2014"
"Biologics",55401,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-0696-14","Class II","Source Plasma","3390027291, 3390026997, 3390034901, 3390034613, 3390034177, 3390033892, 3390033469, 3390033180, 3390032797, 3390032529, 3390032271, 3390031693, 3390031410, 3390031031, 3390029276, 3390028939, 3390028671, 3390012919, 3390012722, 3390030301, 3390029888, 3390029304, 3390028888, 3390028585, 3390028144, 3390027839, 3390027478, 3390027200, 3390026795, 3390026532, 3390026022, 3390025464, 3390025215, 3390024882, 3390024316, 3390024051, 3390023876, 3390023612, 3390023015, 3390022664, 3390022459, 3390022147, 3390021905, 3390021626, 3390019372, 3390019174, 3390018812, 3390018481, 3390018240, 3390017846, 3390017612, 3390017216, 3390016985, 3390016654, 3390016420, 3390016106, 3390015849, 3390015489, 3390015259, 3390014959, 3390014685, 3390014384, 3390014163, 3390013933, 3390013733, 3390013439, 3390013224, 3390012946, 3390012751, 3390012496, 3390012103, 3390011903, 3390011682, 3390011462, 3390011210, 3390010971, 3390010750, 3390003006, 3390002682, 3390002337, 3390002045, 3390021152, 3390020917, 3390020618, 3390020404, 3390020051, 3390019867, 3390019539, 3390018923, 3390018752, 3390018194, 3390017706, 3390017561, 3390017127, 3390016973, 3390016583, 3390016403, 3390016009, 3390015815, 3390015402, 3390015217, 3390014798, 3390014667, 3390014308, 3390019301, 3390018546, 3390018197, 3390017940, 3390017520, 3390017318, 3390016944, 3390016722, 3390016374, 3390016162, 3390036116, 3390031303, 3390031155, 3390029200, 3390029014, 3390036586, 3390036446, 3390007066, 3390004328, 3390004253, 3390003906, 3390003853, 3390003481, 3390003270, 3390003136, 3390001924, 3390001865, 3390001651, 3390001566, 3390014569, 3390014401, 3390026741, 3390026095, 3390025709, 3390025082, 3390024857, 3390024485, 3390024287, 3390023891, 3390023238, 3390022907, 3390022358, 3390022127, 3390021606, 3390021266, 3390020711, 3390020484, 3390020126, 3390019573, 3390019354, 3390019028, 3390018815, 3390018493, 3390018259, 3390017879, 3390017618, 3390021969, 3390021741, 3390021435, 3390021243, 3390020890, 3390020690, 3390020350, 3390020113, 3390019558, 3390019214, 33900",".","308 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",3/2/2010,"03/02/2010",6/18/2014,"06/18/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0676-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","022GJ24195 (2 units)",".","2 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0679-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","022FN15436, 022FZ83294, 022FZ83380, 022FZ83466, 022LC74607",".","5 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0673-14","Class II","Red Blood Cells Leukocytes Reduced ","022FS93673, 022FG83722, 022FL08670, 022FL08692, 022FL08701, 022FP17540, 022FQ86931, 022FQ86938, 022FQ86945, 022FZ83162, 022FZ83166, 022FZ83172, 022FZ83176, 022FZ83287, 022FZ83304, 022FZ83339, 022FZ83371, 022FZ83377, 022FZ83391, 022FZ83400, 022FZ83454, 022GJ26949, 022GT40909, 022GT40921, 022GT40927, 022GT40941, 022GT40945, 022KE80962, 022KE80970, 022KE80979, 022KE80982, 022KE80988, 022LC74593, 022LC74598, 022LC74603, 022LC74768, 022LC74781, 022LC74785, 022LC74821, 022FL08688, 022KE81220, 022LC74822, 022LC74824, 022LZ49041, 022GK39785, 022FN15363, 022FN15365, 022FN15382, 022GQ51845, 022GQ51649, 022KH53831, 022KH53839, 022KH53827, 022KH53836, 022FN15361, 022GQ51850, 022GQ51847, 022GP36543, 022FZ83350, 022FN15432, 022FZ83360, 022GP36563, 022KE81341, 022KE81333, 022GP36534, 022GP36553, 022LZ49044, 022KH53820, 022GP36557, 022FN15377, 022GQ51636, 022KH53846, 022GP36530, 022GP36541, 022GP36545, 022FN15428",".","76 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0674-14","Class II","Fresh Frozen Plasma ","022FG83722, 022FL08071, 022FL08086, 022FL08670, 022FL08701, 022FN15377, 022FP17540, 022FQ88491, 022FS93695, 022FZ82230, 022FZ82479, 022FZ82635, 022FZ82730, 022FZ82734, 022FZ82878, 022FZ82910, 022FZ82992, 022FZ83162, 022FZ83294, 022FZ83304, 022FZ83339, 022FZ83454, 022GK38673, 022GM65828, 022GP36534, 022GP36541, 022GQ51845, 022GQ51847, 022GQ51850, 022GT40921, 022GT40941, 022GT40945, 022GY40823, 022KE80672, 022KE80707, 022KE80962, 022KE80979, 022KH53831, 022KL79196, 022KL79258, 022LC73637, 022LC73696, 022LC74821, 022LZ49038, 022LZ49041, 022LZ49044, 022FZ82885, 022KE81215, 022LC74822, 022LC74824",".","50 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0675-14","Class II","Plasma Frozen within 24 hours (FP24) ","022GQ51643, 022FL08688, 022FN15361, 022FN15424, 022FN15428, 022FN15432, 022FN15436, 022FQ86501, 022FQ86528, 022FQ86541, 022FQ88408, 022FQ88437, 022FS93673, 022FZ82472, 022FZ82606, 022FZ82953, 022FZ83360, 022GK38531, 022GK39776, 022GK39785, 022GP36563, 022GQ51649, 022GT40463, 022GV41774, 022GY40839, 022KE80677, 022KE80683, 022KH53827, 022LC74593, 022LC74598, 022LC74603, 022LC74781",".","32 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0678-14","Class II","Platelets Leukocytes Reduced","022GL83277",".","1 unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55691,"Completed","American National Red Cross (The)","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, NJ, Washington D.C.","B-0677-14","Class II","Red Blood Cells ","022FN15375, 022FS93687",".","2 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",3/17/2010,"03/17/2010",5/28/2014,"05/28/2014"
"Biologics",55917,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","NC","B-0018-15","Class III","Source Plasma","3990047292, 3990046660, 3990048201, 3990047075, 3990046607, 3990046943, 3990047230, 3990048493, 3990047568, 3990047144, 3990048142, 3990048037, 3990046803, 3990046550, 3990047273, 3990047016, 3990047731, 3990046912, 3990046834, 3990047756, 3990047388, 3990047904, 3990047507, 3990047563, 3990046825, 3990046645, 3990047685, 3990048047, 3990047216, 3990046612, 3990047742, 3990047372, 3990048411, 3990047564, 3990047418, 3990048382, 3990047104, 3990048364, 3990047625, 3990047475, 3990047203, 3990046617, 3990047534, 3990047148, 3990048150, 3990047238, 3990048187, 3990047658, 3990048399, 3990048379, 3990047707, 3990047621, 3990047613, 3990046914, 3990048428, 3990046917, 3990048191, 3990046990, 3990046779, 3990047503, 3990047255, 3990047261, 3990046976, 3990047668, 3990046924, 3990046653",".","66 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",3/23/2010,"03/23/2010",11/5/2014,"11/05/2014"
"Biologics",56288,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0697-14","Class II","Source Plasma","3440027170, 3440026953, 3440026567, 3440026309, 3440026110, 3440025821, 3440025612, 3440025322, 3440025128, 3440024872, 3440024697, 3440024460, 3440024272, 3440024007, 3440023735, 3440023460, 3440023271, 3440023025, 3440022849, 3440022512, 3440022367, 3440022259, 3440021975, 3440020798, 3440020621, 3440020435, 3440020184, 3440019945, 3440019807, 3440019560, 3440019436, 3440019076, 3440018876, 3440018612, 3440018397, 3440018139, 3440017939, 3440017715, 3440017537, 3440017337, 3440017136, 3440016957, 3440016804, 3440016284, 3440016065, 3440015801, 3440015606, 3440015369, 3440015230, 3440014751, 3440014537, 3440014303, 3440014133, 3440013853",".","54 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",7/7/2010,"07/07/2010",5/28/2014,"05/28/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0159-2015","Class II","Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.","Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.",,"Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units","Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0157-2015","Class II","Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity ","Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.",,"165 units","Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0161-2015","Class II","Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector'' that is the subject of this correction/removal activity ","Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.",,"24 units","Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0158-2015","Class II","Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. ","Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.",,"777 units","Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0156-2015","Class II","Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity","Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0",,"596 units; 876 units","Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Devices",58185,"Terminated","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.","Z-0160-2015","Class II","Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity. ","Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0",,"Catalog: 16579 ; Catalog 6375: 3256 units","Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line",3/1/2011,"03/01/2011",11/12/2014,"11/12/2014"
"Biologics",58500,"Completed","Department of the Navy","Washington","DC","US","Voluntary: Firm Initiated","FAX","Maryland, New Jersey","B-0078-15","Class II","Fresh Frozen Plasma","W020011100414, W020011100416, W020011100442, W020011100446, W020011100448, W020011100451, W020011100452, W020011100456, W020011100462, W020011100482, W020011100485",".","11 units","Blood products, for which CMV testing was performed incorrectly, were distributed.",2/22/2011,"02/22/2011",12/2/2014,"12/02/2014"
"Biologics",58500,"Completed","Department of the Navy","Washington","DC","US","Voluntary: Firm Initiated","FAX","Maryland, New Jersey","B-0076-15","Class II","Cryoprecipitated AHF","W020011100405, W020011100443, W020011100455, W020011100457, W020011100493, W020011100502, W020011100513",".","7 units","Blood products, for which CMV testing was performed incorrectly, were distributed.",2/22/2011,"02/22/2011",12/2/2014,"12/02/2014"
"Biologics",58500,"Completed","Department of the Navy","Washington","DC","US","Voluntary: Firm Initiated","FAX","Maryland, New Jersey","B-0077-15","Class II","Red Blood Cells","W020011100405, W020011100407, W020011100416, W020011100432, W020011100437, W020011100442, W020011100455, W020011100457, W020011100460, W020011100485, W020011100486, W020011100488, W020011100489, W020011100491, W020011100493, W020011100502, W020011100503, W020011100510, W020011100513, W020011100518, W020011100520",".","21 units","Blood products, for which CMV testing was performed incorrectly, were distributed.",2/22/2011,"02/22/2011",12/2/2014,"12/02/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0850-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W050911002349; W050910094520; W050911002320; W050911002348; W050911002629; W050911005031; W050910089932; W050910094327; W050911001841; W050911002000; W050911002327; W050911000802; W050911003114; W050911004123; W050911002004",,"15 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0849-14","Class II","Platelets Pheresis Leukocytes Reduced","W050911000138; W050911000478; W050911000716; W050911001093; W050911001807-part1; W050911001807-part2; W050911001830; W050911001996; W050911005037; W050911000179; W050911002043; W050911000155; W050911001021; W050911001879; W050911000133-part1; W050911005033-part2; W050911005043; W050911001732; W050911002002; W050911000132-part1; W050911000132-part2; W050911000133; W050911000134-part1;W050911000134;part2;W050911000170;W050911000178-part1; W050911000178-part2; W050911000190; W050911000193; W050911000224; W050911000735; W050911000742-part1; W050911000742-part2; W050911000745; W050911001020; W050911001250-part1; W050911001250-part2; W050911001289; W050911001734; W050911001803-part1; W050911001803-part2; W050911001821; W050911001866-part1; W050911001866-part2; W050911001867-part1; W050911001867-part2; W050911001872; W050911001993; W050911002005-part1; W050911002005-part2; W050911002016; W050911002024; W050911002027-part1; W050911002027-part2 ;W050911005056; W050911005059; W050911000495; W050911000730-part1; W050911001130-part2; W050911001879; W050911001885;W050911001898; W050911005044; W050911000151; W050911000192; W050911001102; W050911001286; W050911001408; W050911001799; W050911001883; W050911005043; W050911000221; W050911000716; W050911001870; W050911000735; W050911001206; W050911001414; W050911002016; W050911000148; W050911001835; W050911001883; W050911001124; W050911001874; W050911001876; W050911000219; W050911000225; W050911000748; W050911001133; W050911001826; W050911000495; W050911000730; W050911000751; W050911001294; W050911001732",,"94 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0855-14","Class II","Red Blood Cells Irradiated","W050911001092; W05091001113 ",,"2 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0854-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050911000478; W050911001280; W050911001993; W050911000169; W050911000727; W050911000151; W050911000152; W050911000217; W050911000727; W050911001240; W050911001855; W050911000193; W050911000224; W050911002002; W050911002013; W050911000216; W050911000212; W050911000752; W050911002013",,"19 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0848-14","Class II","Red Blood Cells Leukocytes Reduced","W050910090401; W050910090745; W050910094326; W050911000731; W050911001126; W050911001129; W050911001238; W050911001241; W050911001809; W050911001857; W050911001888; W050911002317; W050911003036; W050911005301; W050911000208; W050911001105; W050910090448; W050911000301; W050911000303; W050911000307; W050911000311; W050911000316; W050911000324; W050911000325; W050911000714; W050911000721; W050911000777; W050911001243; W050911001254; W050911001850; W050911001897; W050911002009; W050911002333; W050911003043; W050911003291; W050911004508; W050911005088; W050910089939; W050910092725; W050910093657; W050911000327; W050911000628; W050911000646; W050911000725; W050911000769; W050911001109; W050911001119; W050911001237; W050911001849; W050911001851; W050911001869; W050911002335; W050911002658; W050911003245; W050911003262; W050911003996; W050911000203; W050911001236; W050911001839; W050911000343; W050911000629; W050911001087; W050911001122; W050911001135; W050911001142; W050911001247; W050911001253; W050911001873; W050911001877; W050911001894; W050911002342; W050911002393; W050911003040; W050911003052; W050911003056; W050911003059; W050911000792; W050910084180; W050911001862; W050911002346; W050911002802; W050911003038; W050911004124; W050911000207; W050911002017; W050911002331; W050911002339; W050911004122 ",,"88 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0851-14","Class II","Red Blood Cells (Apheresis)","W050911000152; W050911005043; W050911005044; W050911005059; W050911001280; W050911002024; W050911000133; W050911000134; W050911000155; W050911000193; W050911000216; W050911000217; W050911000219; W050911000478; W050911000727; W050911000745; W050911000752; W050911001021; W050911001250; W050911001294; W050911001874; W050911001876; W050911001879; W050911002002; W050911002013; W050911002016; W050911001093; W050911001408; W050911002027; W050911000178; W050911001826; W050911001835; W050911001102; W050911000225; W050911000495; W050911000730; W050911001206; W050911001996; W050911000151; W050911000148; W050911000212; W050911001020; W050911001240; W050911001803",,"44 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0853-14","Class II","Fresh Frozen Plasma","W050910093657; W050911001841; W050911001142; W050911002335; W050911001236; W050910090448; W050911002346; W050910089932; W050910089939; W050910094327; W050911000203; W050911000628; W050911001135; W050911002327; W050911003036; W050911003040; W050911002331; W050910094326; W050910094520; W050911002317; W050911001119; W050911001243",,"22 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",58606,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","PA, MD, NJ","B-0852-14","Class II","Fresh Frozen Plasma (Apheresis)","W050911000138; W050911001021; W050911001206 W050911001732; W050911000224; W050911000132 W050911000219; W050911001830; W050911001993 W050911005056; W050911000152; W050911001855 ",,"12 units","Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. ",4/10/2011,"04/10/2011",9/24/2014,"09/24/2014"
"Biologics",59256,"Terminated","CSL Plasma, Inc.","Columbus","OH","US","Voluntary: Firm Initiated","Fax","IN","B-0461-14","Class II","Source Plasma","40900748636; 40900733901 ;40900905179; 40900912627; 40900833187; 40900764257; 40900702857; 40900774922; 40900820044; 40900484458; 40900492546; 40900617994; 40900525539; 40900547391; 40900616473; 40900530442; 40900416295; 40900446320; 40900587895; 40900569080; 40900224103; 40900288350; 40900315072; 40900280009; 40900291200; 40900245192; 40900367040; 40900383569; 40900381352; 40900165502; 40900181334; 40900118095; 40900088543; 40900090467; 40900077810; 40900072912; 40900039821; 40900053199; 40900033075; 40900033895; 40900021437; ",".","41","Blood products, collected from donors whose physical exams were not adequately performed, were distributed.",5/12/2011,"05/12/2011",4/2/2014,"04/02/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-119-2015","Class I","MAZURI CU TX RODENT 6F 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG3 ITEM NO.0063538 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-078-2015","Class I","MAZURI FLAMINGO COMPLETE 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5644 ITEM NO.0005480 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-068-2015","Class I","MAZURI PARROT MAINTENANCE 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56A8 ITEM NO.0001454 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-056-2015","Class I","MAZ KOI POND NUGGETS 20 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5M78 ITEM NO.0001489",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-100-2015","Class I","AUTOCLAVABLE RODENT BREEDER DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5013 ITEM NO.0042048 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-015-2015","Class I","MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5038 ITEM NO. 0001333",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-042-2015","Class I","NIA GERIATRIC PRIMATE DIET 22 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L1F ITEM NO.0049716",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-086-2015","Class I","MAZURI FLAMINGO BREEDER 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5645 ITEM NO. 0006593 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-024-2015","Class I","GUINEA PIG DIET 33 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5025 ITEM NO.0006544",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-027-2015","Class I","PMI CERTIFIED HI FIBER PRIMATE JUMBO 22 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5K91 ITEM NO.0006684",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-095-2015","Class I","AQUAMAX POND PLUS 3000 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D08 ITEM NO.0007685 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-118-2015","Class I","MAZURI CROCODILIAN DIET - LARGE 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG2 ITEM NO.0062645 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-076-2015","Class I","MAZURI KANGAROO & WALLABY DIET 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z88 ITEM NO.0001500 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-080-2015","Class I","MAZURI CRANE DIET 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5646 ITEM NO.0005484 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-043-2015","Class I","PROLAB RMH 1800 33 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LL2 ITEM NO.0051209",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-058-2015","Class I","MAZURI RATITE DIET 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5647 ITEM NO.0001437",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-106-2015","Class I","MAZURI FRESH WATER TURTLE DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M87 ITEM NO.0047362 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-035-2015","Class I","PMI LAB FIBERPLUS MONKEY 20JUMBO 40 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L0K ITEM NO.0007532",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-066-2015","Class I","Purina GAME FISH CHOW 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.52C1 ITEM NO.0001363 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-101-2015","Class I","AQUAMAX CUSTOM 41/12 3/16 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D2L ITEM NO.0042091 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-019-2015","Class I","CERTIFIED GUINEA PIG DIET 33 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5026 ITEM NO. 0002032",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-044-2015","Class I","GUINEA PIG DIET 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5025 ITEM NO.0057230",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-050-2015","Class I","CU JUVENILE FROG DIET 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z49 ITEM NO.0006848",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-104-2015","Class I","MAZURI TIMOTHY RABBIT DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.530Q ITEM NO.0043945 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-071-2015","Class I","MAZURI LEAF EATER PRIMATE DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M02 ITEM NO.0001472 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-127-2015","Class I","MAZURI CALLITRICHID GEL DIET, PLUS (SIZE VARIES) ","12MAY11RTD1 One Lot Only FORMULA NO.5B33 ITEM NO.1815097 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-012-2015","Class I","MAZURI PRIMATE BASIX, FOR PRIMATES ~ CAUTION: USE ONLY AS DIRECTED, PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 631446812 Net. Weight 25 Ib (11.33 kg) ","APR20122PMI FORMULA NO. 5M68 ITEM NO. 0006758 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-011-2015","Class I"," Mazuri Mouse Breeder 9F, FOR BREEDING RODENTS CAUTION: USE AS DIRECTED, PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 631446812 Net. Weight 50 Ib (22.67 kg) ","APR20122PMI Formula No. 5M68 Item No. 0006758 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-038-2015","Class I","MONKEY DIET 15% 40 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LE0 ITEM NO.0015349",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-124-2015","Class I","AQUAMAX LARGEMOUTH 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5DA1 ITEM NO.0066904 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-125-2015","Class I","MAZURI CALLITRICHID GEL HEAT STABLE (SIZE VARIES) ","12MAY14RTD1 One Lot Only FORMULA NO.57R0 ITEM NO.1810111 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-111-2015","Class I","KOI KICHI WHEAT GERM FOOD 40# 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D58 ITEM NO.0051044 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-079-2015","Class I","MAZURI FLAMINGO BREEDER 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5645 ITEM NO.0005482 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-097-2015","Class I","EH GUINEA PIG DIET 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5L1P ITEM NO.0037461 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-032-2015","Class I","PROLAB RMH 2500 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P14 ITEM NO.0006788",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-017-2015","Class I","HIGH PROTEIN MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5045 ITEM NO. 0001335",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-067-2015","Class I","MAZURI LEAF EATER PRIMATE DIET MINI-BISCUIT 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5672 ITEM NO.0001448 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-096-2015","Class I","MAZURI KOI PLAT OGATA 20 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MC8 ITEM NO.0007687 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-040-2015","Class I","ISOPRO RHM 2500 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LN6 ITEM NO.0047063",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-072-2015","Class I","MAZURI MONKEY CRUNCH 20 20 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M29 ITEM NO.0001476 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-037-2015","Class I","TAD PRIMATE DIET 40 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L0P ITEM NO.0011746",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-120-2015","Class I","CU CARNIVORE TURTLE 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.L539 ITEM NO.0063712 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-025-2015","Class I","HIGH PROTEIN MONKEY DIET JUMBO 25LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5047 ITEM NO.0006554",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-094-2015","Class I","AQUAMAX FRY POWDER 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D00 ITEM NO. 0007684 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-046-2015","Class I","FIBERBALANCED MONKEY JUMBO 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5000 ITEM NO.0062306",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-073-2015","Class I","MAZURI RODENT 6F 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M30 ITEM NO.0001477 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-113-2015","Class I","AQUAMAX GROWER NAB 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D23 ITEM NO.0053713 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-126-2015","Class I","MAZURI BROOKFIELD ZOO CALLITRICHID DIET (SIZE VARIES) ","12MAY10RTD1 One Lot Only FORMULA NO.5TAF ITEM NO.1810536 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-063-2015","Class I","AQUAMAX GROWER 400 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D04 ITEM NO.0001466",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-114-2015","Class I","GUINEA PIG DIET 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5025 ITEM NO.0057230 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-016-2015","Class I","NEW WORLD PRIMATE DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5040 ITEM NO. 0001334",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-110-2015","Class I","MAZURI INSECTIVORE DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MK8 ITEM NO.0050819 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-029-2015","Class I","RODENT LAB DIET EQ 44.1 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L37 ITEM NO.0006705",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-108-2015","Class I","MAZURI CALLITRICHID GEL NO ADD SUGAR (SIZE VARIES) ","12MAY04RTD1 One Lot Only FORMULA NO.592Y ITEM NO.0047797 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-122-2015","Class I","MAZURI BEAR DIET 40 LB ","APR 09 12 3 One lot Only FORMULA NO.5ZH6 ITEM NO.0064966 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-036-2015","Class I","FIBER ENHANCER 40 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 56DJ ITEM NO.0010748",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-061-2015","Class I","Purina WELLSOLVE W/C 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.35TD ITEM NO.0066925",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-069-2015","Class I","MAZURI PARROT BREEDER 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56A9 ITEM NO.0001455 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-055-2015","Class I","Purina CATFISH CHOW SR 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5136 ITEM NO.0007136",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-021-2015","Class I","LAB FIBERPLUS MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5049 ITEM NO. 0005326",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-028-2015","Class I","PMI LAB FIBERPLUS MONKEY DIET 15% 40 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L07 ITEM NO.0006690",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-102-2015","Class I","AQUAMAX CUSTOM 41/12 1/8 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D2N ITEM NO.0042092 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-039-2015","Class I","PROLAB RMH 1800 AUTOCLAVABLE 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5013 ITEM NO.0029432",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-087-2015","Class I","MAZURI MOUSE 11F 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M99 ITEM NO. 0006763 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-074-2015","Class I","MAZURI RATITE STARTER 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M32 ITEM NO.0001480 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-098-2015","Class I","ORNAMENTAL FISH GROWER 3/16 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D18 ITEM NO.0038282 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-109-2015","Class I","ORNAMENTAL FISH GROWER 1/8 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D57 ITEM NO.0049312 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-115-2015","Class I","HIGH PROTEIN MONKEY DIET 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5045 ITEM NO.0057231 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-026-2015","Class I","LAB FIBER PLUS MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5K63 ITEM NO.0006669",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-075-2015","Class I","MAZURI PLATINUM KOI BITS 20 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M81 ITEM NO.0001492 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-062-2015","Class I","MAZURI KOI PLATINUM NUGGETS 20 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5M80 ITEM NO.0001491",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-059-2015","Class I","MAZURI WATERFOWL MAINT. 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5642 ITEM NO.0001435",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-092-2015","Class I","MAZURI NEW WORLD PRIMATE 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA5 ITEM NO. 0007320 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-054-2015","Class I","Purina CATFISH 32 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.51J2 ITEM NO.0040967",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-064-2015","Class I","AQUAMAX GROWER 500 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D05 ITEM NO.0045303",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-070-2015","Class I","AQUAMAX DENSE 4000 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D09 ITEM NO.0001470 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-014-2015","Class I","MONKEY DIET JUMBO 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5037 ITEM NO. 0001332",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-051-2015","Class I","Mazuri CRL GUINEA PIG AUTO, W/O VIT C 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5KG0 ITEM NO.0066196",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-034-2015","Class I","PROLAB GUINEA PIG 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P18 ITEM NO.0006791",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-020-2015","Class I","CERTIFIED PRIMATE DIET 22 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5048 ITEM NO. 0005325",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-090-2015","Class I","MAZURI HIGH FIBER STICKS 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA3 ITEM NO. 0007316 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-121-2015","Class I","MAZURI FLAMINGO COMPLETE 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG6 ITEM NO.0064874 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-018-2015","Class I","HIGH PROTEIN MONKEY DIET JUMBO 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5047 ITEM NO. 0001336",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-084-2015","Class I","AQUAMAX FINGERLING 300 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D03 ITEM NO. 0005555 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-047-2015","Class I","HF PRIMATE 5K91 12G 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5K9J ITEM NO.0065046",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-099-2015","Class I","AQUAMAX GROWER 5/8 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D1D ITEM NO.0038854 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-123-2015","Class I","MAZURI CU RODENT BRDR GA 9F 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5LU2 ITEM NO.0065748 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-033-2015","Class I","PROLAB RMH 2500 15 KG","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P14 ITEM NO.0055648",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-085-2015","Class I","Purina Minnow Chow 50# 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5115 ITEM NO. 0006569 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-093-2015","Class I","MAZURI GROWTH & REPRO PRIMATE BISCUIT 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA1 ITEM NO. 0007321 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-103-2015","Class I","MAZURI PRIMATE L/S BANANA 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M1G ITEM NO.0043252 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-023-2015","Class I","AUTOCLAVABLE RODENT BREEDER DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5013 ITEM NO. 0006529",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-057-2015","Class I","MAZURI GUINEA PIG DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5664 ITEM NO.0001444",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-105-2015","Class I","Purina WellSolve W/G 25# (bucket) 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.35SU ITEM NO.0046451 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-048-2015","Class I","MONKEY DIET JUMBO 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5LFD ITEM NO.0066782",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-107-2015","Class I","KOI KICHI COLOR ENHANCER 40# 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D55 ITEM NO.0047481 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-052-2015","Class I","5LK7 / 20000 IU/KG VIT D3 (Weight VARIES)","12APR24RTD1 One Lot Only FORMULA NO.9G4P ITEM NO.1815328",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-010-2015","Class I","Mazuri Primate Maintenance Biscuit PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 631446812 Net Weight 251b (11.33 kg) "," APR11123 Formula No. 5MA2 Item No. 0040996 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-041-2015","Class I","LAB FIBERPLUS MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5CAM ITEM NO.0047230",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-116-2015","Class I","MAZURI KOI PLATINUM - WHEAT NUGGETS 20 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.50D0 ITEM NO.0060561 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-091-2015","Class I","MAZURI PRIMATE BROWSE BISCUIT 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA4 ITEM NO. 0007317 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-128-2015","Class I","MAZ CU FRZ CALL HI D (SIZE VARIES) ","12APR20RTD1 One Lot Only FORMULA NO.5BOU ITEM NO.1815310 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-088-2015","Class I","MAZURI GUINEA PIG BREEDER 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z19 ITEM NO. 0006842 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-031-2015","Class I","FIBER PLUS MONKEYPNT 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LB2 ITEM NO.0006746",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-009-2015","Class I","MAZURI SMALL BIRD MAINTENANCE PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 631446812 Net Weight 251b (11.33 kg)","APR15123, Formula No. 56A6, Item No. 0001452.",,"420-25 LB BAGS","Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X)",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-007-2015","Class I","Guinea Pig Diet PMI NUTRITION INTL., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144 Net Weight 50 Ib (22.67 kg) ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive Formula No. 5025 Item Number. 0001330",,"476- 50 lb bags","Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X)",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-022-2015","Class I","LAB FIBERPLUS MONKEY DIET JUMBO 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5050 ITEM NO. 0005328",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-065-2015","Class I","AQUAMAX POND 2000 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D07 ITEM NO.0001469",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-013-2015","Class I","MAZURI EX GAMEBIRD STARTER 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5637 ITEM NO. 0001430 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-045-2015","Class I","HIGH PROTEIN MONKEY DIET 25 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5045 ITEM NO.0057231",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-117-2015","Class I","EVANS FIBER NUTRIENTS 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56CC ITEM NO.0061020 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-053-2015","Class I","AQUAMAX GROWER 600 50 LB","All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D06 ITEM NO.0001468",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-030-2015","Class I","RODENT LAB AUTO DIET EQ 20 KG","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L65 ITEM NO.0006712",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-060-2015","Class I","NUTRISOURCE KOI POND 4.25 LB","Best If Used By 04/25/14 FORMULA NO.5ZC9 ITEM NO.0049071",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-083-2015","Class I","AQUAMAX FRY STARTER 200 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D02 ITEM NO. 0005554 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-082-2015","Class I","MAZURI ZEBRA PELLETS 50 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5662 ITEM NO.0005506 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-081-2015","Class I","MAZURI MOOSE MAINTENANCE 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5658 ITEM NO.0005501 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-089-2015","Class I","MAZURI HERBIVORE BOOST 25 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z0D ITEM NO. 0006992 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-008-2015","Class I","MAZURI MANED WOLF DIET THE RICHMOND STANDARD PMI NUTRITION INT'l., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144-6812 15kg","APR21122, Formula No. 5MD9, Item No. 0011482.",,"89-33LB BAGS","Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X)",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-049-2015","Class I","CU ADULT FROG DIET 50 LB","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z18 ITEM NO.0006841",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-112-2015","Class I","MAZURI PARROT BREEDER 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MI8 ITEM NO.0052901 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62479,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and worldwide: USA and Japan","V-077-2015","Class I","MAZURI PETTING ZOO 40 LB ","All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z95 ITEM NO.0001504 ",,,"Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). ",7/3/2012,"07/03/2012",10/15/2014,"10/15/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-143-2015","Class I","ADVANCED PROTOCOL SMALL AVIAN DIET 11 LB ","Lot codes: APR11122, APR15123 Formula Item number 5LP50055567",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-131-2015","Class I","HIGH PROTEIN MONKEY DIET REGRIND MEAL 25 LB ","Lot code:APR24122 Formula Item Number 5045M0006552",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-130-2015","Class I","HIGH PROTEIN MONKEY DIET REGRIND MEAL 50 LB ","Lot code:APR09122 Formula Item Number 5045M0006551 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-146-2015","Class I","MAZ CROCODILLIAN DIET 50 LB ","Lot code:APR03121 Formula Item Number 5MG10062615",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-145-2015","Class I","CERTIFIED GUINEA PIG - IRR 25 LB ","Lot code:APR12122A, APR17122A Formula Item Number 50E60060296",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-140-2015","Class I","FIBER BALANCED MONKEY DIET MEAL 25 LB ","Lot code:APR29122 Formula Item Number 5000M0046064",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-144-2015","Class I","ADVANCED PROTOCOL LARGE AVIAN 5 KG ","Lot number: APR15122 Formula Item number 5LP60055568",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-153-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 45 MG RASPBERRY (BAG SIZE VARIES) ","Lot code:12JUN07RTD1 Formula Item Number 5TUR1811466",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-160-2015","Class I","LABDIET 5025W/0.5%CHOLESTEROL FROM EGGS/5%LARD (BAG SIZE VARIES) ","Lot code:12MAY10RTD1 Formula Item Number 9G0Y1815142-209",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-152-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 190 MG FRUIT PUNCH (BAG SIZE VARIES) ","Lot code:12JUN15RTD1 Formula Item Number 5TUR1811441",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-142-2015","Class I","ADVANCED PROTOCOL FROG DIET 11 LB ","lot codes: APR15123, APR28123 Formula: Item number: 5LP30055545 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-154-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 97 MG RASPBERRY (BAG SIZE VARIES) ","Lot code:12MAY09RTD1 Formula Item Number 5TUR1811467",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-147-2015","Class I","MAZ FRESH WATER TURTLE 1 LB ","Lot code:BEST BY 06/04/14 AND 06/05/14 Formula Item Number 5.00E+080065162",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-137-2015","Class I","MONKEY 1-HIGGINS 25 LB","Lot code:MAY07122 Formula Item Number 5ME60025433 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-155-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABALET 97 MG GRAPE (BAG SIZE VARIES) ","Lot code:12MAY09RTD1 Formula Item Number 5TUR1811473",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-141-2015","Class I","MAZURI CALLITRIC GEL DIET, NO SUGAR ADDED (BAG SIZE VARIES) ","Lot code:12JUN08RTD1 Formula Item Number 592Y0047797",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-149-2015","Class I","MAZ MINIPACK KOI PLATINUM WHEAT NUGGETS 2.5 LB ","Lot code:APR04123 Formula Item Number 5MM40065238",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-151-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 1 GM BANANA (BAG SIZE VARIES) ","Lot code:12APR26RTD1, 12JUN11RTD1, 12MAY11RTD1, 12MAY16RTD1 Formula Item Number 5TUR1811182",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-136-2015","Class I","MAZURI CALLITRICHID HIGH FIBER DIET SIZE VARIES ","Lot code:12JUN12RTD1, 12MAY21RTD1 Formula Item Number 5MI60008108",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-148-2015","Class I","MAZURI MINI PACK INSECTIVORE DIET 3 LB ","Lot code:APR03121, APR27121, MAY07121 Formula Item Number 5MM30065236",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-129-2015","Class I","NEW WORLD PRIMATE 10 KG ","Lot code: APR04121 Formula Item Number 50400006549 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-135-2015","Class I","MAZURI CALLITRICHID DIET SIZE VARIES ","Lot code:12JUN05RTD1 Formula Item Number 5MI50008107",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-157-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 1 GM FRUIT PUNCH (BAG SIZE VARIES) ","Lot code:12JUN07RTD1 Formula Item Number 5TUR1811482",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-133-2015","Class I","NUTRAZU INSECTIVORE DIET 50 LB ","Lot code:APR27121 Formula Item Number 500A0007429 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-139-2015","Class I","ADVANCED PROTOCOL OLD WORLD PRIMATE WITH DENTAGUARD 25 LB ","Lot code:MAY04123 Formula Item Number 5LG10033078 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-159-2015","Class I","LABDIET 5037 GEL DIET (BAG SIZE VARIES) ","Lot code:12APR10RTD1 Formula Item Number 9G021815113-409",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-132-2015","Class I","FISH CHOW MEAL 50 LB ","Lot code:MAY05121 Formula Item Number 51200006570",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-150-2015","Class I","MAZURI BZ CALLITRICHID DIET (BAG SIZE VARIES) ","Lot code:12JUN14RTD1, 12MAY17RTD1, 12MAY24RTD1 Formula Item Number 5TAF1810536",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-138-2015","Class I","ORNAMENTAL FISH FINGERLING 3/64 50 LB ","Lot code:MAY07121 Formula Item Number 51V20032876 ",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-156-2015","Class I","GRAIN-BASED NON-HUMAN PRIMATE TABLET 97 MG FRUIT PUNCH (BAG SIZE VARIES) ","Lot code:12MAY09RTD1 Formula Item Number 5TUR1811479",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-158-2015","Class I","MAZURI CALLITRICHID GEL DIET, HIGH VITAMIN D (BAG SIZE VARIES) ","Lot code:12MAY21RDT1 Formula Item Number 5B341815098",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Veterinary",62614,"Terminated","PMI Nutrition International","Richmond","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.","V-134-2015","Class I","MAZURI ALPACA ULTIMATE 40 LB ","Lot code:2MAY11MFI3, 2MAY24MFI3, 2MAY29MFI1, 2JUN14MFI1, 2JUN21MFI3, and 2JUL06MFI1. Formula Item Number 560B0007864",".",,"This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).",7/20/2012,"07/20/2012",10/22/2014,"10/22/2014"
"Devices",63071,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.","Z-0718-2014","Class II","Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only ","A-CRN B123005578 LHD-6AC 8123005628 Q08-4B 311838 5-6R 333195 A-CRN B143006072 LH0-6AC 8393012282 QD8-4B 312583 S-6R 333458 A-CRN B183006882 LHD-6AC (463028357 Q08-4B 315793 S-6R 333793 A-CRN B213007929 LHD-6AC 8423013160 QD8-4B 316956 S-6R 333982 A-CRN 8313010424 LHD-6AC (253022922 QD8-48 317934 S-6R 334093 A-CRN 8373011925 LHD-6AC B073004408 008-48 318394 S-6R 334236 A-CRN 8393012268 LHD-6AC B373011840 Q08-48 319435 S-6R 334455 A-CRN 8393012369 LHD-6AC 093020161 Q08-48 319991 5-6R 334640 A-CRN 8393012486 LHD-6AC (243022710 008-48 330615 S-6R 334925 A-CRN 8433013376 LHD-6AC (303024122 Q08-4B 331283 S-6R 335148 A-CRN 8493014144 LHD-6AC 8243008895 Q08-4B 50220710 S-6R 335723 A-CRN 8513015111 LHD-6AC (423027109 Q08-4B 50244135 S-6R 335922 A-CRN B513015587 LHD-6AC 8283009782 Q08-4B 50288181 S-6R 336059 A-CRN 8533015857 LHD-6AC 8473013675 QD8-4B 50335706 S-6R 336180 A-CRN (083017208 LHD-6AC 023018999 Q08-48 50416854 S-6R 336 A-CRN-S-4 C353025392 M-2DC 611433 Q08-58 621855 5-9AC 621199 ADG-10 8233008614 M-2DC 611434 Q08-58 621856 5-9AC 621898 ADG-10 8283009851 M-2DC 611435 Q08-58 621857 5-9AC 621899 ADG-10 8513014221 M-2DC 611436 QD8-58 621858 5-9AC 621900 ADG-10 C123019873 M-2DC 611437 QD8-58 621859 S-9AC 621901 ADG-10 8113005441 M-2DC 611438 QD8-58 621860 5-98 314753 ADG-10 8103005121 M-2DC 611439 Q08-58 621861 5-98 317985 ADG-10 C453027963 M-2DC 616669 QD8-58 622850 5-98 332848 ADG-10 C033015647 M-2DC 616670 Q08-58 622851 5-98 50417033 ADG-10 A483000896 M-2DC 616671 Q08-58 622852 5-98 50430130 ADG-10 8453014133 M-2DC 616672 Q08-58 622853 5-98 50463416 ADG-10 C253022551 M-2DC 616673 Q08-58 622854 5-98 C213021763 ADG-10 A513001807 M-2DC 619860 QDS-58 622855 5-98 C393026383 ADG-10 C353024460 M-2DC 619861 Q08-58 622856 5-98 C413027012 ADG-10 8403012560 M-2DC 619862 Q08-58 622857 5-98 0353038977 ADG-10 320195 M-2DC 619863 Q08-58 622858 5-98 (143019969 ADG-10 331336 M-20C 622494 QD8-58 622859 5-98 C443027778 ADG-10 332219 M-20C 622495 Q08-58A 8163006509 S-98 8043003077 ,A.DG-10 332714 M-20C 622496 Q08-58A 8243007994 5"," M-20 332002 Q08-58 607674 5-9AC 50417032 A-CRN-5 608256 M-20 332335 Q08-58 607675 5-9AC 50463415 A-CRN-5 608257 M-20 332584 Q08-58 607676 5-9AC A483000810 A-CRN-5 608258 M-20 332977 Q08-58 607677 5-9AC 8213008124 A-CRN-5 608259 M-20 333417 Q08-58 607678 5-9AC 8393012512 A-CRN-5 608260 M-20 333830 Q08-58 607679 5-9AC C163017691 A-CRN-5 608261 M-20 334045 Q08-58 607680 5-9AC (243022544 A-CRN-5 608262 M-20 334438 Q08-58 607681 5-9AC (293023566 A-CRN-5 608263 M-20 335045 Q08-58 607682 5-9AC 0343038740 A-CRN-5 608264 M-20 602917 Q08-58 607683 5-9AC 0473042254 A-CRN-5 608265 M-20 614427 Q08-58 607684 5-9AC E113047375 A-CRN-5 608266 M-20 614428 Q08-58 607685 5-9AC 309188 A-CRN-5 608267 M-20 614429 Q08-58 607686 5-9AC 318699 A-CRN-5 608268 M-20 614430 Q08-58 607687 5-9AC 336343 A-CRN-5 608269 M-20 614431 Q08-58 607688 5-9AC A483001063 A-CRN-5 608270 M-20 614432 QOS-58 613829 5-9AC 8043003002 A-CRN-5 608271 M-20 614433 Q08-58 613830 5-9AC 8073004224 A-CRN-5 608272 M-20 614434 Q08-58 613831 5-9AC (043015180 A-CRN-5 608273 M-20 614435 Q08-58 613832 5-9AC (323024883 A-CRN-5 608274 M-20 614436 Q08-58 613833 5-9AC (373024900 A-CRN-5 608275 M-20 614437 Q08-58 613834 S-9AC (433027419 A-CRN-5 608276 M-20 614438 Q08-58 613835 5-9AC 0103032429 A-CRN-5 608277 M-20 614439 Q08-58 613836 S-9AC 0263036651 A-CRN-5 608278 M-20 614440 Q08-58 613837 5-9AC 0493042602 A-CRN-5 608279 M-20 614441 Q08-58 613838 S-9AC E043045088 A-CRN-5 608280 M-20 614442 Q08-58 613839 5-9AC A513001784 A-CRN-5 608968 M-20 614443 Q08-58 613840 5-9AC 0063031528 A-CRN-5 608969 M-20 614444 Q08-58 613841 5-9AC E213050936 A-CRN-5 608970 M-20 614445 Q08-58 613842 5-9AC E253052029 A-CRN-5 608971 M-20 614446 Q08-58 613843 S-9AC E193049972 A-CRN-5 608972 M-20 620752 Q08-58 613844 5-9AC 300679 A-CRN-5 608973 M-20 620753 Q08-58 613845 5-9AC 319284 A-CRN-5 610916 M-20 620754 Q08-58 613846 5-9AC 330058 A-CRN-5 610917 M-20 620755 Q08-58 613847 5-9AC 330309 A-CRN-5 610918 M-20 620756 Q08-58 613848 S-9AC 330800 A-CRN-5 610919 M-20 620757 Q08-58 613849 5-9AC 331172 A-CRN-5 610","1,805,022 cutting burs and 55,026 irrigation clips ","Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier. ",9/9/2011,"09/09/2011",1/22/2014,"01/22/2014"
"Devices",63145,"Completed","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO","Z-1565-2014","Class II","SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000. ","S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701",".","30 devices","It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the mating SI50002 Implant Holder can shear off under high-impact force during insertion and removal.",12/23/2011,"12/23/2011",5/14/2014,"05/14/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0492-2015","Class I","Fortified Chocolate Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0484-2015","Class I","Endurance In Race Coconut Dietary Supplement Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), and 30 gram sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergens: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0491-2015","Class I","Fortified Vanilla Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0477-2015","Class I","Recovery Vanilla (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that the label fails to declare the allergens: milk, shellfish ",".","19668 units","Protein supplement fails to declare allergens: milk, shellfish ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0488-2015","Class I","Daily Balance Natural Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergens: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0490-2015","Class I","Hunger and Weight Chocolate Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0479-2015","Class I","Recovery Natural (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Pack Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that fail to declare the allergens: milk, shellfish an",".","3112 units","Protein supplement fails to declare allergens: milk, shellfish ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0481-2015","Class I","Endurance Daily Chocolate Dietary Supplement Packaged under the label: Stronger Faster Healthier Coconut, Lime Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that fail to declare the allergens milk",".","803 units","Protein supplement fails to declare allergens milk",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0478-2015","Class I","Recovery Chocolate (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that fail to declare the allergens: milk, shellfish ",".","2218 units","Protein supplement fails to declare allergens: milk, shellfish ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0494-2015","Class I","Rejuvenate Natural Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergen milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0489-2015","Class I","Hunger and Weight Vanilla Dietary Supplement Packaged under the labels Stronger Faster Healthier Whey: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0482-2015","Class I","Endurance Pre Race Lime , Dietary Supplement Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), and 30 gram sizes","All lots codes that fail to declare the allergens: milk & shellfish ",".",,"Protein supplement fails to declare allergens: milk, shellfish ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0486-2015","Class I","Daily Balance Vanilla Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0476-2015","Class I","Pure Whey Natural Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz","All lots codes that the label fails to declare the allergen milk",".","4276 units","Protein supplement fails to declare allergen milk",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0483-2015","Class I","Endurance Pre Race Pina Colada, Dietary Supplement Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), and 30 gram sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergens: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0485-2015","Class I","Endurance In Race Lime Dietary Supplement Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), and 30 gram sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergens: milk and coconut ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0474-2015","Class I","Pure Whey Vanilla , Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that the label fails to declare the allergen milk",".","24742 units","Protein supplement fails to declare allergen: milk",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0475-2015","Class I","Pure Whey Chocolate, Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz.","All lots codes that the label fails to declare the allergen milk, ",".","5377 units","Protein supplement fails to declare allergen milk",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0487-2015","Class I","Daily Balance Chocolate Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0493-2015","Class I","Rejuvenate Vanilla Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz), and 10 oz sizes","All lots codes that fail to declare the allergens: milk ",".",,"Protein supplement fails to declare allergen: milk ",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Food",63260,"Ongoing","Maine Natural Health, Inc.","Warren","ME","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-0480-2015","Class I","Endurance Daily Vanilla Dietary Supplement Packaged under the label: Stronger Faster Healthier and Mainer Whey Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes","All lots codes that fail to declare the allergen milk",".","1032 units","Protein supplement fails to declare allergen milk",9/21/2012,"09/21/2012",11/19/2014,"11/19/2014"
"Drugs",63451,"Terminated","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide Including Puerto Rico","D-0297-2015","Class II","CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01. ","Lot 6003853, exp. date 04/2014",".","240,550 Vials","Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",9/27/2012,"09/27/2012",12/17/2014,"12/17/2014"
"Drugs",63451,"Terminated","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide Including Puerto Rico","D-0296-2015","Class II","ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02","Lot 6003930, exp. date 04/2014",".","184,550 Vials","Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",9/27/2012,"09/27/2012",12/17/2014,"12/17/2014"
"Drugs",63451,"Terminated","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide Including Puerto Rico","D-0295-2015","Class II","MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.","Lot 6003827, Exp. Date 04/2015",".","101,200 Vials","Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",9/27/2012,"09/27/2012",12/17/2014,"12/17/2014"
"Devices",63486,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.","Z-1867-2014","Class II","Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.","All serial numbers",".","317","Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.",10/11/2012,"10/11/2012",7/2/2014,"07/02/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0759-2014","Class II","MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0754-2014","Class II","MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"68","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0766-2014","Class II","MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0749-2014","Class II","Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots ",,"163","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0753-2014","Class II","MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"175","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0767-2014","Class II","MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0761-2014","Class II","MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0752-2014","Class II","MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"87","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0751-2014","Class II","MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots ",,"57","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0756-2014","Class II","MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"76","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0769-2014","Class II","MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots ",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0765-2014","Class II","MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0763-2014","Class II","MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0758-2014","Class II","MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0760-2014","Class II","MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0764-2014","Class II","MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0750-2014","Class II","MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots ",,"212","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0755-2014","Class II","MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"574","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0757-2014","Class II","MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0768-2014","Class II","MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",63624,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.","Z-0762-2014","Class II","MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.","All lots are included in recall",,"6439 total","The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decided to recall the cutting burrs along with the dissection tools.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Biologics",63919,"Terminated","St Joseph'S Medical Ctr Blbank","Brainerd","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota","B-0277-14","Class III","Platelets Pheresis","17FE84919",,"1 unit","Blood product, which may have reached an unacceptable temperature during storage, was distributed.",10/9/2012,"10/09/2012",2/5/2014,"02/05/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1912-2014","Class II","ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4603-00; Serial Numbers: 200280, 200281, 200279, 200095.",".","40","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1907-2014","Class II","ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.",".","130","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1881-2014","Class II","ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems","Part Numbers: 98-0002, 98-0004, 98-0007, 98-0030, 98-0036; Serial Numbers: 200245, 20032601, 20032602 20032603, 20032604, 20032504, 20032508, 20032502, 20032503, 20032506, 20032702, 20032701, 20032507, 20032501, 20032505, 200027203, 200027201, 200027202, 200064104.",".","21","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1906-2014","Class II","ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.",".","113","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1910-2014","Class II","ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4601-00; Serial Number: 200093",".","10","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1891-2014","Class II","ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0024; Serial Number: 2000100",".","12","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1879-2014","Class II","ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems","Part Numbers: 98-0049, 98-0051; Serial Numbers: 2000729, 2000761",".","20","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1909-2014","Class II","ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-3101-00; Serial Number: 200045",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1876-2014","Class II","ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems","Part Number 98-0020, Serial Number: 200423",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1884-2014","Class II","ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0008; Serial Numbers: 20033001, 20033002.",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1900-2014","Class II","ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0044; Serial Number: E16200088601.",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1882-2014","Class II","ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Number 98-0003; Serial Numbers: 20030101, 20030102.",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1895-2014","Class II","ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0035; Serial Numbers: B51301262004, B51301262001, 2000487.",".","9","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1911-2014","Class II","ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4602-00; Serial Numbers: 200278, 200094",".","20","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1878-2014","Class II","ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems","Part Number 98-0029; Serial Number: 20000263",".","10","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1896-2014","Class II","ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0037; Serial Number: 2000940.",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1904-2014","Class II","ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0062; Serial Number: E15200088401.",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1888-2014","Class II","ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0019; Serial Number: 200422",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1901-2014","Class II","ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0048; Serial Number: 200073101.",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1880-2014","Class II","ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0001; Serial Numbers: 20028601, 20028602 ",".","3","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1916-2014","Class II","ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-5000-00; Serial Numbers: 200174, 200173, 200161.",".","30","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1902-2014","Class II","ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0054, 98-0055; Serial Numbers: 2000782, 2000783, D51200085101.",".","3","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1885-2014","Class II","ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0010; Serial Number: 200341",".","10","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1903-2014","Class II","ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0056; Serial Number: 30978704",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1894-2014","Class II","ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0034; Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304.",".","16","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1908-2014","Class II","ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-3100-00; Serial Numbers: 200276, 200277, 200156, 200275, 310008.",".","50","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1917-2014","Class II","ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-5001-00; Serial Number: 200252",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1905-2014","Class II","ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-3012-00; Serial Number: 200294",".","5","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1897-2014","Class II","ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.",".","45","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1893-2014","Class II","ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0031; Serial Numbers: 200056702, 200030002, 200056701, 200030001.",".","4","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1892-2014","Class II","ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0025; Serial Number: 2000220",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1887-2014","Class II","ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0016; Serial Numbers: 200008201, 200008202, 200008203, 200008204, 200008205, 200008206.",".","6","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1875-2014","Class II","ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.",".","4","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1877-2014","Class II","ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems","Part Number 98-0022. Serial Number: 2000040",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1919-2014","Class II","ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0033; Serial Number: 200055701",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1898-2014","Class II","ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0042; Serial Numbers: 20069801. 20069802.",".","3","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1899-2014","Class II","ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0043; Serial Numbers: D41200080101, D41200080102.",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1883-2014","Class II","ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Numbers: 98-0005, 98-0011; Serial Numbers: 200390, 200379, 20030001, 20030002, 20035201, 20035202.",".","6","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1913-2014","Class II","ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4604-00; Serial Numbers: 200282, 200299, 200096.",".","19","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1918-2014","Class II","ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0012; Serial Number: 201421",".","1","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1886-2014","Class II","ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems","Part Numbers: 98-0013, 98-0014; 98-0018. Serial Numbers: 20039501, 20039502, 20039601, 20039602, 20039701, 20039702.",".","6","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1890-2014","Class II","ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0023; Serial Number: 2000288",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1915-2014","Class II","ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4606-00; SP-5002-00. Serial Numbers: 200251, 200243, 200223, 200218, 200215, 200200, 200190, 200252, 200244, 200222.",".","100","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1889-2014","Class II","ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: 98-0021; Serial Numbers: A46200000001, 20042601",".","2","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64247,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .","Z-1914-2014","Class II","ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems","Part Number: SP-4605-00; Serial Numbers: 200199, 200166, 200160, 200158, 200134, 200132, 200133, 200103.",".","68","The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.",11/28/2012,"11/28/2012",7/2/2014,"07/02/2014"
"Devices",64273,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.","Z-1784-2014","Class II","Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.","Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08",".","80 units","Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.",2/5/2013,"02/05/2013",6/18/2014,"06/18/2014"
"Devices",64507,"Ongoing","Philips Healthcare Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and country of: Canada.","Z-1783-2014","Class II","Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.","All iX versions with A.01 software",".","899","If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.",3/5/2013,"03/05/2013",6/18/2014,"06/18/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-088-2014","Class I","Cargill Cattle Grazers AP Mineral (MOS) (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-CM MH 1103 MOS Manufactured at the McPherson, KS firm.","Lot Code: 523014. No expiration dates",,"78/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-117-2014","Class I","Cargill Right Now Emerald (P) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-P MH 1203, Manufactured at the McPherson, KS firm.","Lot Code: 523039, 523035, 523044, 523047 and 523056. No expiration dates.",,"531/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-123-2014","Class I","Cargill Stocker Wheat Mineral (M720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-L MH 1105, Manufactured at the McPherson, KS firm.","Lot Code: 522347, 522352, 522362, 523002, 523009 and 523015. No expiration dates.",,"1545/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-078-2014","Class I","Cargill Right Now Emerald (C650) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-A5 MC 1301 Manufactured at the Montgomery City, MO firm.","Lot Code: 613045. No expiration dates",,"78/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label.",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-119-2014","Class I","Cargill Stocker Summer Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92111 MH 1301, Manufactured at the McPherson, KS firm.","Lot Code: 523010. No expiration dates.",,"79/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-099-2014","Class I","Cargill Right Now Emerald (C2.0) MOS (MH) Medicated, Active Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N3 MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523044. No expiration dates",,"2215/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-112-2014","Class I","Cargill Right Now Emerald (P) (CHLT) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-CH MH 1203, Manufactured at the McPherson, KS firm.","Lot Code: 523038. No expiration dates.",,"82/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-085-2014","Class I","Cargill Cattle Grazers APC Mineral (C2800) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C MH 1103 Manufactured at the McPherson, KS firm.","Lot Code: 523028 and 523038. No expiration dates",,"443/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-108-2014","Class I","Cargill Stocker Summer Mineral (B720) (MH), Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92111-L MH 0807 Manufactured at the McPherson, KS firm.","Lot Code: 523037 and 523039. No expiration dates",,"120/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-076-2014","Class I","Cargill Right Now Emerald Anaplas Fly Control (C2.4/Meth) (GY) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-C4 GY 0802 Manufactured at the Montgomery City, MO firm.","Lot Code: 613039. No expiration dates",,"79/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label.",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-087-2014","Class I","Cargill Cattle Grazers ALL Purpose (C2.0/IGR) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C6 MH 1205 Manufactured at the McPherson, KS firm.","Lot Code: 523015. No expiration dates",,"77/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-081-2014","Class I","Cargill Right Now Emerald (MC) Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103 MC 1301 Manufactured at the Montgomery City, MO firm.","Lot Code: 613038, 613039, 613043 and 613050. No expiration dates",,"1220/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-120-2014","Class I","Cargill Stocker Summer Mineral (M610) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92111-R MH 1212, Manufactured at the McPherson, KS firm.","Lot Code: 523015. No expiration dates.",,"80/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-075-2014","Class I","Cargill Right Now Onyx (MC), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104 Manufactured at the Montgomery City, MO firm. Cargill Right Now Onyx (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104 MH -0802 Manufactured at the McPherson, KS firm.","Lot Codes at Montgomery City, MO firm: 522345; 522349; 522353; 523018; 523032; 613039; 613044; 612356; 612362; 612363; 613009; 613014; 613024; and 613046. No expiration dates Lot Codes at McPherson, KS firm: Lot Code: 5222345, 522349, 522353, 523018, 523032, 613039, 613044, 612356, 612362, 612363, 613009, 613014, 613024 and 613046. No expiration dates",,"3193/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label.",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-090-2014","Class I","Cargill Cattle Grazers APC Fescue Mineral (C1.4) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-FT MH 1206 Manufactured at the McPherson, KS firm.","Lot Code: 523008. No expiration dates",,"121/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-096-2014","Class I","Cargill Right Now Emerald (Altosid IGR) Active Ingredient: S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-GR MH Manufactured at the McPherson, KS firm.","Lot Code: 2MK3045 and 2MK3051. No expiration dates",,"695/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-101-2014","Class I","Cargill Right Now Emerald (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523042 and 523050. No expiration dates",,"681/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-102-2014","Class I","Cargill Breeding Herd Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92428 MH 1206 Manufactured at the McPherson, KS firm.","Lot Code: 523047. No expiration dates",,"553/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-107-2014","Class I","Cargill Right Now Onyx Min (P) (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-CC MH 1112 Manufactured at the McPherson, KS firm.","Lot Code: 522348 and 523036. No expiration dates",,"159/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-118-2014","Class I","Cargill Right Now Emerald (C3.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline. Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-WK MH 1207, Manufactured at the McPherson, KS firm.","Lot Code: 523046. No expiration dates.",,"78/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-105-2014","Class I","Cargill Right Now Onyx (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-N MH 1210 Manufactured at the McPherson, KS firm.","Lot Code: 523044. No expiration dates",,"153/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-114-2014","Class I","Cargill Right Now Emerald Fescue (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-FT MH 1201, Manufactured at the McPherson, KS firm.","Lot Code: 523038, 523047 and 523058. No expiration dates.",,"45/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-113-2014","Class I","Cargill Right Now Emerald (P) (C2.0) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-CH MH 1203, Manufactured at the McPherson, KS firm.","Lot Code: 523038. No expiration dates.",,"279/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-079-2014","Class I","Cargill Right Now Emerald (C1.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-CS MC 1301 Manufactured at the Montgomery City, MO firm.","Lot Code: 613058, 613037 and 613044. No expiration dates",,"310/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label.",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-097-2014","Class I","Cargill Right Now Emerald (PNW) Complex (MH), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N1 MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523039. No expiration dates",,"193/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-121-2014","Class I","Cargill Stocker Wheat Mineral W/THIA (B720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-L3 MH 1201, Manufactured at the McPherson, KS firm.","Lot Code: 522361. No expiration dates.",,"870/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-077-2014","Class I","Cargill Right Now Onyx Fly (C1.4) (GY) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methaprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-C2 GY 0802 Manufactured at the Montgomery City, MO firm.","Lot Code: 613036. No expiration dates",,"116/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label.",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-104-2014","Class I","Cargill Right Now Emerald (C2.0) (W) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-WS MH 1202 Manufactured at the McPherson, KS firm.","Lot Code: 523046. No expiration dates",,"80/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-095-2014","Class I","Cargill Right Now Emerald (PNW) (AVL) (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-NH MN 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523039. No expiration dates",,"236/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-106-2014","Class I","Cargill Nutrebeef Stocker Summer Mineral (C1.4) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 92111-C MH 0707 Manufactured at the McPherson, KS firm.","Lot Code: 523046. No expiration dates",,"153/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-092-2014","Class I","Cargill Cattle Grazers APC Mineral CFLY (C1.4) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-CE MH 1302 Manufactured at the McPherson, KS firm.","Lot Code: 523058. No expiration dates",,"78/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-100-2014","Class I","Cargill Right Now Emerald (PNW) (MOS) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N8 MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523039. No expiration dates",,"10/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-116-2014","Class I","Cargill Right Now Emerald (M1200) (UMW) MOS (MH), Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-RZ MH 1203, Manufactured at the McPherson, KS firm.","Lot Code: 523038. No expiration dates.",,"159/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-103-2014","Class I","Cargill Winter Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 80678 MH 1207 Manufactured at the McPherson, KS firm.","Lot Code: 523010, 523021 and 523039. No expiration dates",,"308/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-084-2014","Class I","Cargill Cattle Grazers APC Mineral (C3500) (MH) Medicated, Active Drug Ingredient: Chlortetracycline , mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C5 MH 1103 Manufactured at the McPherson, KS firm.","Lot Code: 523052. No expiration dates",,"123/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-115-2014","Class I","Cargill Right Now Emerald (M600) (UMW) (MH), Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-PH MH 1301, Manufactured at the McPherson, KS firm.","Lot Code: 523038. No expiration dates.",,"158/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-110-2014","Class I","Cargill Cattle Grazers APC Mineral (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144 MH 1103 Manufactured at the McPherson, KS firm.","Lot Code: 523008, 523023, 523030, 523035 and 523052. No expiration dates.",,"1,509/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-111-2014","Class I","Cargill Cattle Grazers All Purpose Fescue Mineral (UMW) (M800) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 7144-P3 MH 1302, Manufactured at the McPherson, KS firm.","Lot Code: 523037. No expiration dates.",,"158/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-080-2014","Class I","Cargill Right Now Emerald Fly (C1.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-AL MC 1301 Manufactured at the Montgomery City, MO firm.","Lot Code: 613050, 613045, 613056, 613057 and 613058. No expiration dates",,"3440/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-094-2014","Class I","Cargill Right Now Emerald (C2.0) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-N2 MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523044 and 523056. No expiration dates",,"60/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-109-2014","Class I","Cargill Right Now Onyx (P) (MH), Mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55104-P MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 522347, 522356, 523008, 523023, 523028, 523030, 523036, 523044, 523047 and 523058. No expiration dates.",,"1599/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-091-2014","Class I","Cargill Right Now Emerald (P) (C2.0/IGR) (MH) Medicated, Active Drug Ingredients: Chlortetracycline and S-Methoprene, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-GG MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523058. No expiration dates",,"420/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-089-2014","Class I","Cargill Cattle Grazers APC Mineral (C4000) (MH) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-C3 MH 1103 Manufactured at the McPherson, KS firm.","Lot Code: 523002, 523015 and 523046. No expiration dates",,"316/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-122-2014","Class I","Cargill Stocker Wheat Mineral (M600) (MH) Medicated, Active Drug Ingredient: Monensin, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 92113-R MH 1208, Manufactured at the McPherson, KS firm.","Lot Code: 522352 and 523015. No expiration dates.",,"194/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-098-2014","Class I","Cargill Right Now Emerald (B1440) MOS CHEL (MH) Medicated, Active Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-NF MH 1201 Manufactured at the McPherson, KS firm.","Lot Code: 523044. No expiration dates",,"236/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-086-2014","Class I","Cargill Cattle Grazer AP (B720) (MH) Medicated, Active Drug Ingredient: Lasalocid, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 7144-B MH 1301 Manufactured at the McPherson, KS firm.","Lot Code: 523030. No expiration dates",,"159/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-083-2014","Class I","Cargill Right Now Emerald (C2.0) (BIOMS) (UMW) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-P5 MC 1202 Manufactured at the Montgomery City, MO firm. Cargill Right Now Emerald (C2.0) (BIOMS) (UMW) (MH), Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition, Minneapolis, MN. Product Code: 55103-P5 MH 1203, Manufactured at the McPherson, KS firm.","Lot Code: 523024, 523038, 523049, 523051, 523056, 613039 and 613057. No expiration dates (same for both facilities)",,"1776/50-lb","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-082-2014","Class I","Cargill Right Now Emerald Anaplas (C2.4) (MC) Medicated, Active Drug Ingredient: Chlortetracycline, mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-C1 MC 1301 Manufactured at the Montgomery City, MO firm.","Lot Code: 613037. No expiration dates",,"162/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Veterinary",64532,"Completed","Cargill, Inc","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AL, AR, CO, FL, IA, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, OH, OK, PA, SD, TN, TX, UT, VA, WI, WV, and WY. There was no known foreign/military/government distribution.","V-093-2014","Class I","Cargill Right Now Emerald (W) (MH), mineral mix with added Vitamin A, Vitamin D3 and Vitamin E. Packaged in a 50-lb/poly bag. Cargill Animal Nutrition General Office, Minneapolis, MN. Product Code: 55103-W MH 1203 Manufactured at the McPherson, KS firm.","Lot Code: 523050. No expiration dates",,"78/50-lb bags","The product does not contain Vitamins A, D, and E as indicated on the label. ",3/4/2013,"03/04/2013",6/25/2014,"06/25/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1447-2014","Class I","Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36 ","Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36 ",,"55/1 mL/20mg/mL syringe","Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1451-2014","Class II","Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 ","Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60 ",,"99/240 mg softgel caps","Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1450-2014","Class II","Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01","Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01",,"284/800 mg tablets","Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1448-2014","Class I","metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 ","Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01 ",,"88/5 mg tablets","Labeling: Label Mix up; product labeled did not indicated Extended Release ",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1449-2014","Class II","Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01","Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01",,"99/500 mg tablets","Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Drugs",64611,"Completed","Shamrock Medical Solutions Group LLC","Lewis Center","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: CO, MA, OH, TX & WY.","D-1446-2014","Class I","Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90"," Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90",,"89/120 mg tablets","Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules ",9/27/2011,"09/27/2011",7/30/2014,"07/30/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0013-15","Class II","Platelets Pheresis","W286812024558; W286812026300; W286812029459; W286812029461; W286812029467; W286812029471; W286812029476; W286812029950 ",,"8 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0007-15","Class II","Cryoprecipitated AHF","W286812007416; W286812007418; W286812007421; W286812007424; W286812007425; W286812007426; W286812007427; W286812007708; W286812007431; W286812007432; W286812007436; W286812007437; W286812007438; W286812007439; W286812000675; W286812000679; W286812000680; W286812000684; W286812001061; W286812007723; W286812007733; W286812007806; W286812007811; W286812007813; W286812007814; W286812007815; W286812008951; W286812011840; W286812016195; W286812016210; W286812016213; W286812019728; W286812020332; W286812024550; W286812024552; W286812024760; W286812024771; W286812026300; W286812026952; W286812026959; W286812026964; W286812026966; W286812026968; W286812026971; W286812027075; W286812027960; W286812027971; W286812029421; W286812029422; W286812029427; W286812029432; W286812029433; W286812029440; W286812029441; W286812029442; W286812029443; W286812029444; W286812029448; W286812029449; W286812029450; W286812029453; W286812029454; W286812029455; W286812029458; W286812029459; W286812029461; W286812029462; W286812029463; W286812029464; W286812029466; W286812029469; W286812029470; W286812029471; W286812029476; W286812029950; W286812029953; W286812029958; W286812029959; W286812029961; W286812029962; W286812029963; W286812031504; W286812042473; W286812042474; W286812044319; W286812045379; W286812045381; W286812045382; W286812045387; W286812045389; W286812045391; W286812045413; W286812045417; W286812052715; W286812052720; W286812052729; W286812052732; W286812054007; W286812065603; W286812075275; W286812086549; W286812086552; W286812088845; W286812090387; W286812090399; W286812103138; W286812103220; W286812103831; W287612005664; W288212000466; W288212000596; W288212001155; W288212001280; W288212001281; W288212001294; W288212001610; W288212001746; W288212002066; W288412004695; W288512003708",,"120 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0008-15","Class II","Blood and Blood Products for Reprocessing","W286812007756 W286812007784 W286812008916 W286812008918 W286812008919 W286812008922 W286812008928 W286812008932 W286812008933 W286812008934 W286812008935 W286812008937 W286812008938 W286812008943 W286812008946 W286812008949 W286812010334 W286812010368 W286812011785 W286812011786 W286812011789 W286812011794 W286812011796 W286812011797 W286812011803 W286812011816 W286812011824 W286812011838 W286812011839 W286812011845 W286812011850 W286812011851 W286812013115 W286812013118 W286812013119 W286812015624 W286812015809 W286812015824 W286812015855 W286812016186 W286812016187 W286812016190 W286812016191 W286812016193 W286812016197 W286812016198 W286812016199 W286812016204 W286812016205 W286812016219 W286812016221 W286812016223 W286812016225 W286812018164 W286812018265 W286812018266 W286812018267 W286812018274 W286812018275 W286812018276 W286812018377 W286812018379 W286812018968 W286812019198 W286812021239 W286812023599 W286812024566 W286812024567 W286812024573 W286812024576 W286812024751 W286812024752 W286812024756 W286812024922 W286812026933 W286812026937 W286812026942 W286812026943 W286812026944 W286812026946 W286812026947 W286812026949 W286812026951 W286812027942 W286812027952 W286812027953 W286812027956 W286812027963 W286812027966 W286812027969 W286812029384 W286812029385 W286812029386 W286812029388 W286812029392 W286812029393 W286812029396 W286812029398 W286812029400 W286812029401 W286812029403 W286812029405 W286812029409 W286812029412 W286812029418 W286812029419 W286812029456 W286812032682 W286812032792 W286812032796 W286812035315 W286812035318 W286812035323 W286812035349 W286812036894 W286812044211 W286812044214 W286812044215 W286812044217 W286812044219 W286812052709 W286812052725 W286812052859 W286812053174 W286812053182 W286812053183 W286812053185 W286812053199 W286812053985 W286812054002 W286812056832 W286812065541 W286812065543 W286812065554 W286812065556 W286812065566 W286812065573 W286812065576 W286812065605 W286812065606 W286812065607 W286812065612 W286812066249 W286812066264 W286812067413 W286812067417 W",,"1227 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0009-15","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W286813000292 W286813000292 W286813000320 W286813000320 W286813001209 W286813001209 W286813001237 W286813001237 W286813001248 W286813001248 W286813001269 W286813001271 W286813001271 W288212003672 W288212003672 ",,"15 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0006-15","Class II","Fresh Frozen Plasma","W286812007434 W286812011822 W286812013183 W286812016214 W286812016218 W286812024764 W286812029439 W286812029446 W286812029452 W286812029952 W286812035363 W286812075312 W286813008423 W287912004596 ",,"14 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0014-15","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W286812125916; W286812125942",,"2 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0005-15","Class II","Plasma Frozen within 24 hours (FP24)","W286812007756 W286812007784 W286812008916 W286812008918 W286812008919 W286812008922 W286812008928 W286812008932 W286812008933 W286812008934 W286812008935 W286812008937 W286812008938 W286812008943 W286812008946 W286812008949 W286812010334 W286812010368 W286812011785 W286812011786 W286812011789 W286812011794 W286812011796 W286812011797 W286812011803 W286812011816 W286812011824 W286812011838 W286812011839 W286812011845 W286812011850 W286812011851 W286812013115 W286812013118 W286812013119 W286812015624 W286812015809 W286812015824 W286812015855 W286812016186 W286812016187 W286812016190 W286812016191 W286812016193 W286812016197 W286812016198 W286812016199 W286812016204 W286812016205 W286812016219 W286812016221 W286812016223 W286812016225 W286812018164 W286812018265 W286812018266 W286812018267 W286812018274 W286812018275 W286812018276 W286812018377 W286812018379 W286812018968 W286812019198 W286812021239 W286812023599 W286812024566 W286812024567 W286812024573 W286812024576 W286812024751 W286812024752 W286812024756 W286812024922 W286812026933 W286812026937 W286812026942 W286812026943 W286812026944 W286812026946 W286812026947 W286812026949 W286812026951 W286812027942 W286812027952 W286812027953 W286812027956 W286812027963 W286812027966 W286812027969 W286812029384 W286812029385 W286812029386 W286812029388 W286812029392 W286812029393 W286812029396 W286812029398 W286812029400 W286812029401 W286812029403 W286812029405 W286812029409 W286812029412 W286812029418 W286812029419 W286812029456 W286812032682 W286812032792 W286812032796 W286812035315 W286812035318 W286812035323 W286812035349 W286812036894 W286812044211 W286812044214 W286812044215 W286812044217 W286812044219 W286812052709 W286812052725 W286812052859 W286812053174 W286812053182 W286812053183 W286812053185 W286812053199 W286812053985 W286812054002 W286812056832 W286812065541 W286812065543 W286812065554 W286812065556 W286812065566 W286812065573 W286812065576 W286812065605 W286812065606 W286812065607 W286812065612 W286812066249 W286812066264 W286812067413 W286812067417 W",,"396 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0012-15","Class II","Cryoprecipitated AHF, Pooled","W383812000010 W383812000118 W383812000126 W383812000183 W383812000184 W383812000185 W383812000189 W383812000256 W383812000262 W383812000269 W383812000270 W383812000271 W383812000272 W383812000425 W383812000463 W383812000464 W383812000474 W383812000605 W383812000716 W383812000727 W383812000738 W383812000745 W383812000749 W383812000762 W383812000774 W383812000775 W383812000777 W383812000831 W383812000839 W383812000840 W383812000879 W383812001022 W383812001061 W383812001279 W383812001335 W383812001336 W383812001371 W383812001519 W383812001534 W383812001600 W383812001643 W383812001646 W383812001656 W383812001798 W383812001799 W383812001894 W383812002089 W383812002129 W383812002264 W383812002332 W383812002333 W383812002334 W383812002335 W383812002365 W383812002600 W383812002864 W383812002898 W383812003065 W383812003152 W383812003186 W383812003189 W383812003614 W383812003615 W383812003650 W383812003656 W383812003657 W383812004240 W383812004241 W383812004249 W383812004433 W383812004434 W383812004743 W383812004822 W383812004823 W383812004833 W383812004860 W383812004861 W383812004862 W383812004863 W383812004864 W383812004865 W383812004882 W383812004883 W383812004892 W383812004893 W383812004914 W383812004917 W383812004926 W383812004957 W383812004963 W383812007270 W383812007332 W383812007338 W383812007500 W383812007501 W383812007535 ",,"96 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0011-15","Class II","Red Blood Cells (Human) Leukocytes Removed (Blood and Blood Derivatives)","W286812079933 W286812079934 W286812079939 W286812079941 W286812079943 W286812079947 W286812079951 W286812079961 W286812079962 W286812113496 W286812113499 W286812113518 W286812113522 W286812116297 W286812116303 W286812116310 W286812116318 W286812120423 W286812120445 W286812120863 W286812125909 W286812125910 W286812125911 W286812125912 W286812125914 W286812125915 W286812125917 W286812125921 W286812125923 W286812125924 W286812125925 W286812125927 W286812125928 W286812125930 W286812125935 W286812125936 W286812125937 W286812125940 W286812125943 W286812125945 W286812125946 W286812125949 W286812125950 W286812125951 W286812125953 W286812125954 W286812125958 W286812125960 W286812125961 W286812125962 W286812125963 W286812127196 W286813000269 W286813000302 W286813000313 W286813000316 W286813000317 W286813000318 W286813000319 W286813000322 W286813000324 W286813000326 W286813000328 W286813000332 W286813001202 W286813001203 W286813001204 W286813001208 W286813001211 W286813001212 W286813001213 W286813001216 W286813001217 W286813001218 W286813001219 W286813001220 W286813001221 W286813001224 W286813001228 W286813001230 W286813001231 W286813001232 W286813001235 W286813001236 W286813001239 W286813001240 W286813001243 W286813001245 W286813001246 W286813001250 W286813001253 W286813001255 W286813001257 W286813001260 W286813001266 W286813001273 W286813001275 W286813003284 W286813008401 W286813008402 W286813008413 W286813008414 W286813008417 W286813008420 W286813008425 W286813008426 W286813008428 W286813008432 W288212003661 W288212003918 W288412008352 W288412008677 W288513000025 W288513000063 ",,"114 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Biologics",64616,"Completed","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide","B-0010-15","Class II","Red Blood Cells (Human) (Blood and Blood Derivatives)","W286812079936 W286812082981 W286812084316 W286812084331 W286812084345 W286812084347 W286812084350 W286812084400 W286812084401 W286812112123 W286812113492 W286812113519 W286812113521 W286812116301 W286812116319 W286812120414 W286812120418 W286812120442 W286812120447 W286812125931 W286812125934 W286812127094 W286812127103 W286812127107 W286812127200 W286813000275 W286813000287 W286813000295 W286813000305 W286813000307 W286813000310 W286813000323 W286813000325 W286813000329 W286813001201 W286813001205 W286813001206 W286813001214 W286813001215 W286813001229 W286813001233 W286813001241 W286813001251 W286813001258 W286813001259 W286813001265 W286813001274 W286813001276 W286813001425 W286813003279 W286813003285 W286813008406 W286813008410 W286813008415 W286813008418 W286813008422 W286813008423 W286813008424 W286813008430 W286813008433 W286813008434 W286813010408 W286813010409 W287612006222 W287613000135 W288212003678 W288212003772 W288212003869 W288212003877 W288212003882 W288212003901 W288213000008 W288412008187 W288512007635 ",,"74 units","Blood products, collected from unsuitable donors, were distributed. ",1/31/2013,"01/31/2013",10/15/2014,"10/15/2014"
"Devices",64724,"Ongoing","Ge Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.","Z-0731-2014","Class II","Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. ","GE Centricity Software versions 3.X and higher and 4.X and higher",,"748 units","There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once terminated, the transfer service skips the image being sent, and continues to send the image in the exam.",9/15/2012,"09/15/2012",1/22/2014,"01/22/2014"
"Drugs",64727,"Ongoing","Mutual Pharmaceutical Company, Inc.","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-400-2014","Class III","Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA","lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16 ",,,"Labeling: Incorrect Instructions: The product is being recalled due to a labeling error which provides incorrect medical advice. ",2/27/2013,"02/27/2013",1/15/2014,"01/15/2014"
"Drugs",64727,"Ongoing","Mutual Pharmaceutical Company, Inc.","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-398-2014","Class III","FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA ","Lots 6504705, 6504706 exp. 05/14",,,"Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read ''If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.'' The labeling for the recalled lots omits the work ''not'' in that sentence.",2/27/2013,"02/27/2013",1/15/2014,"01/15/2014"
"Drugs",64727,"Ongoing","Mutual Pharmaceutical Company, Inc.","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-399-2014","Class III","Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07 ","Lot 6561703, exp. 03/14",,,"The reason for this recall is an error in section 5.11 of the labeling that results in incorrect medical advice. Specifically, the labeling should read ''If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.'' The labeling for the recalled lots omits the work ''not'' in that sentence.",2/27/2013,"02/27/2013",1/15/2014,"01/15/2014"
"Devices",64740,"Ongoing","Ge Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.","Z-0773-2014","Class II","Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA. ","Imagecast PACS versions prior to 3.6.51.01",,"43 units","In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. Because the estimated magnification factor is not used, distance measurements may not be calculated accurately if both the Pixel Spacing and Imager Pixel Spacing tags are not supplied.",3/4/2011,"03/04/2011",1/22/2014,"01/22/2014"
"Devices",64774,"Ongoing","Briggs Medical Service Company d.b.a. Mabis","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of:US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; and country of : Canada.","Z-0142-2015","Class II","DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4''; Overall Width: 23 1/2''; Seat Height: 21 1/4''; Seat Size: 14'' x 12 3/4''; Handle Height: 31'' - 36''; Width Between Handles: 18''; Weight: 19 Lbs; Walking assistance device.","A) Model Number: 501-1018-0700; UPC Code: 0-41298-10187-1; Lot Numbers: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211; B) Model Number: 501-1018-2100; UPC Code: 0-41298-10182-6; Lots: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211 ",".","1,869 units","There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.",6/5/2014,"06/05/2014",11/5/2014,"11/05/2014"
"Devices",64791,"Ongoing","Abbott Molecular","Des Plaines","IL","US","Voluntary: Firm Initiated","Letter","Nationwide (CA, CO, CT, FL, HI, IL, IN, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI); Canada","Z-1491-2014","Class III","The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.","List Number: 06J37-018; Lot Number: 440023",,"20 kits","20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.",3/28/2013,"03/28/2013",4/30/2014,"04/30/2014"
"Devices",64795,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.","Z-0865-2014","Class III","The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users ","Software Versions: 3.3, 4.0, 4.1",,"7 units","GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are truncated if significant figures are defined.",11/20/2012,"11/20/2012",2/5/2014,"02/05/2014"
"Devices",64807,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.","Z-0620-2014","Class II","The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users ","Software Versions: 3.3, 4.0, 4.1",,"5 units","GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).",3/12/2013,"03/12/2013",1/8/2014,"01/08/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0375-14","Class III","Bone","UDM0057690797; UDM0057690798; UDM0057690799; UDM0087290053; UDM0087290054; UDM0087290055; UDM0087290056; UDM0087290057; UDM0087290058; UDM0087320044; UDM0087320045; UDM0087320046; UDM0087320047; UDM0087360025; UDM0087360026; UDM0087360027; UDM0087360028; UDM0087360029; UDM0087800071; UDM0087800072; UDM0087800073; UDM0087800074; UDM0087800075; UDM0087800076; UDM0089200029; UDM0089200030; UDM0089540144; UDM0089540145; UDM0089540146; UDM0089540147; UDM0089540148; UDM0089570035; UDM0089570036; UDM0089570037; UDM0089570038; UDM0089570039; UDM0089940333; UDM0089940334; UDM0089940335; UDM0089940336; UDM0089940337; UDM0089940338; UDM0090030075; UDM0090030076; UDM0090320241; UDM0090320242; UDM0090470125; UDM0090470126; UDM0090470128; UDM0090470129; UDM0091060096; UDM0092130072; UDM0092130073. ",,"53 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0378-14","Class III","Bone","UBO0094860174 ",,"1 allograft","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0376-14","Class III","Bone","UPO0090560006; UPO0090810029; UPO0091060004; UPO0091070030. ",,"4 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0377-14","Class III","Bone","010150351; UBO0010150352; UBO0010150353; UBO0010150354; UBO0010150355; UBO0010150356; UBO0010150357; UBO0010150358; UBO0010150359; UBO0010150360; UBO0010150361; UBO0010150362; UBO0010150363; UBO0010150364; UBO0010150365; UBO0010150366; UBO0010150367; UBO0010150368; UBO0010150369; UBO0010150370; UBO0010150371; UBO0010150372; UBO0010150373; UBO0010150374; UBO0010150375; UBO0010150376; UBO0010150377; UBO0010150378; UBO0010150379; UBO0010150380; UBO0010150381; UBO0010150382; UBO0010150383; UBO0010150384; UBO0010150385; UBO0010150386; UBO0010150387; UBO0010150388; UBO0010150389; UBO0010150390; UBO0010150391; UBO0010150392; UBO0010150393; UBO0010150394; UBO0010150395; UBO0010150396; UBO0010150397; UBO0010150398; UBO0010150399; UBO0010150400; UBO0010150401; UBO0010150402; UBO0010150403; UBO0010150404; UBO0010150405; UBO0010150406; UBO0010150407; UBO0010150408; UBO0010150409; UBO0010150410; UBO0010150411; UBO0010150412; UBO0010150414; UBO0010150415; UBO0010150416; UBO0010150417; UBO0010150418; UBO0010150419; UBO0010150420; UBO0010150421; UBO0010150422; UBO0010150423; UBO0010150424; UBO0010150425; UBO0010150426; UBO0010150427; UBO0010150428; UBO0010150429; UBO0010150430; UBO0010150431; UBO0010150432; UBO0010150433; UBO0010150434; UBO0010150435; UBO0010150436; UBO0010150437; UBO0010150438; UBO0010150439; UBO0010150440; UBO0010150441; UBO0010150442; UBO0010150443; UBO0010150444; UBO0010150445; UBO0010150446; UBO0010150447; UBO0010150448; UBO0010150449; UBO0010150450; UBO0010150451; UBO0010150452; UBO0010150453; UBO0010150454; UBO0010150455; UBO0010150456; UBO0010150457; UBO0010150458; UBO0010150459; UBO0010150460; UBO0010150461; UBO0010150462; UBO0010150463; UBO0010150464; UBO0010150465; UBO0010150466; UBO0010150467; UBO0010150468; UBO0010150469; UBO0010150470; UBO0010150471; UBO0010150473; UBO0010150474; UBO0010150475; UBO0010150476; UBO0010150477; UBO0010150478; UBO0010150479; UBO0010150480; UBO0010150481; UBO0010150482; UBO0010150483; UBO0010150484; UBO0010150485; UBO0010150486; UBO0010",,"30,661 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0371-14","Class III","Bone","UBO0057420184; UBO0057420185; UBO0057560679; UBO0057560680; UBO0057850605; UBO0057850606; UBO0058550052; UBO0058550053; UBO0060520331; UBO0060520332; UBO0061290057; UBO0061290058; UBO0061630062; UBO0082020034; UBO0082020068; UBO0082020069; UBO0082020237; UBO0082020238; UBO0082020352; UBO0082020370; UBO0082020371; UBO0082740060; UBO0082740061; UBO0082740064; UBO0082740065; UBO0082950526; UBO0083160032; UBO0083160033; UBO0085100022; UBO0085920072; UBO0085920072; UBO0087380081; UBO0087430065; UBO0087800054; UBO0087800058; UBO0087890040; UBO0087890041; UBO0088540053; UBO0088540054; UBO0089140130; UBO0089200034; UBO0089200035; UBO0089310068; UBO0089310070; UBO0089540118; UBO0089540119; UBO0089650078; UBO0089650079; UBO0089720073; UBO0089720074; UBO0089720074; UBO0090050064; UBO0090460074; UBO0090710039; UBO0090720063; UBO0090720064; UBO0090720065; UBO0090720066; UBO0090810077; UBO0090810078; UBO0090880048; UBO0090980073; UBO0090980074; UBO0091060078; UBO0091370041; UBO0091410064; UBO0091800070; UBO0091800071; UBO0092340021; UBO0092690029; UBO0092890057; UBO0092890058; UBO0094010030; UBO0094010030; UBO0094050027; UBO0094230031; UBO0094260027; UBO0094260027; UBO0094270019; UBO0094270019; UBO0094340029; UBO0094340029; UBO0094730030; UBO0094730030; UBO0095270035. ",,"85 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0373-14","Class III","Bone","082360041; UBO0082360044; UBO0082740008; UBO0082740009; UBO0082740011; UBO0082740013; UBO0082740014; UBO0082740015; UBO0082740016; UBO0082740018; UBO0082740019; UBO0082740020; UBO0082740021; UBO0082820001; UBO0082820002; UBO0082820003; UBO0082820004; UBO0082820006; UBO0082820009; UBO0082820010; UBO0082820011; UBO0083120001; UBO0083120002; UBO0083120009; UBO0083120010; UBO0083120012; UBO0083120014; UBO0083120015; UBO0083120016; UBO0083120017; UBO0083120018; UBO0083120019; UBO0085490049; UBO0085490050; UBO0085490051; UBO0085490052; UBO0085490053; UBO0085490054; UBO0085490055; UBO0085490056; UBO0085490061; UBO0085920058; UBO0085920059; UBO0085920060; UBO0085920061; UBO0085920063; UBO0085920064; UBO0085920065; UBO0085920066; UBO0085920067; UBO0085920074; UBO0085920075; UBO0085920076; UBO0085920077; UBO0085920078; UBO0085920079; UBO0085920080; UBO0086490047; UBO0086490048; UBO0086490051; UBO0086490052; UBO0086490053; UBO0086490054; UBO0086490055; UBO0086490056; UBO0086640041; UBO0086640042; UBO0086640043; UBO0086640046; UBO0086640047; UBO0086640050; UBO0086640051; UBO0086790048; UBO0086790049; UBO0086790050; UBO0086790055; UBO0086790056; UBO0086790057; UBO0086790058; UBO0086790059; UBO0086790062; UBO0086790063; UBO0087000064; UBO0087000065; UBO0087000066; UBO0087000067; UBO0087000070; UBO0087000071; UBO0087000072; UBO0087000073; UBO0087000074; UBO0087000075; UBO0087000076; UBO0087000077; UBO0087150053; UBO0087150054; UBO0087150055; UBO0087150056; UBO0087150057; UBO0087150058; UBO0087150059; UBO0087150060; UBO0087150061; UBO0087150062; UBO0087150063; UBO0087230047; UBO0087230048; UBO0087230049; UBO0087230050; UBO0087230051; UBO0087230052; UBO0087230053; UBO0087230054; UBO0087230055; UBO0087230056; UBO0087230057; UBO0087230058; UBO0087230090; UBO0087230090; UBO0087230099; UBO0087240051; UBO0087240052; UBO0087240053; UBO0087240054; UBO0087240059; UBO0087240060; UBO0087240061; UBO0087240062; UBO0087240063; UBO0087240064; UBO0087240064; UBO0087240067; UBO0087240068; UBO0087240095; UBO008",,"1,079 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0372-14","Class III","Bone","UBI0082020002; UBI0087020084; UBI0087020093; UBI0089290068; UBI0089290069; UBI0090560104; UBI0090560111; UBI0090730079; UBI0090730087; UBO0044660073; UBO0044660129; UBO0045350099; UBO0045580201; UBO0046310001; UBO0046310195; UBO0046830061; UBO0056670143; UBO0056670218; UBO0058270003; UBO0058550015; UBO0059900093; UBO0059900095; UBO0059900153; UBO0060520095; UBO0061290033; UBO0061630003; UBO0061630058; UBO0061640005; UBO0085490057; UBO0085490060; UBO0086790053; UBO0086790054; UBO0086790060; UBO0086790061; UBO0087000068; UBO0087000069; UBO0087000078; UBO0087000079; UBO0087240055; UBO0087240058; UBO0087240065; UBO0087240066; UBO0088080076; UBO0088080077; UBO0088080083; UBO0088080084; UBO0089190053; UBO0089190060; UBO0089310056; UBO0089310057; UBO0089310064; UBO0089310065; UBO0089500062; UBO0089500071; UBO0089560065; UBO0089560066; UBO0089940080; UBO0091070037; UBO0091070038; UBO0091070044; UBO0091070045; UBO0091800058; UBO0091800066; UBO0091800067; UBO0093260037; UBO0093260040; UBO0094860055; UBO0094860056; UBO0094860064; UBO0094860065; UBO0095010042. ",,"71 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Biologics",64823,"Terminated","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, including Puerto Rico and St. Thomas, Virgin Island. Coutries: South Korea, Venezuela, Canada, Netherland, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.","B-0374-14","Class III","Bone","USK0044570001; USK0044570002; USK0044570003; USK0044570004; USK0044570005; USK0044570006; USK0057690769; USK0057690770; USK0057690771; USK0057690772; USK0057690773; USK0057690774; USK0057690775; USK0057690776; USK0057690777; USK0057690778; USK0057690779; USK0057690780; USK0057690781; USK0057690782; USK0057690783; USK0057690784; USK0057690785; USK0057690786; USK0057690787; USK0057690788; USK0057690789; USK0057690790; USK0057690791; USK0081870630; USK0081870631; USK0081870632; USK0081870633; USK0081870634; USK0081870635; USK0081870636; USK0081870637; USK0081870638; USK0081870639; USK0081870640; USK0081870641; USK0081870642; USK0081870643; USK0081870644; USK0082020618; USK0082020619; USK0082020620; USK0082020621; USK0082020622; USK0082020623; USK0082020624; USK0082020625; USK0082020626; USK0082020627; USK0087320035; USK0087320036; USK0087320037; USK0087320038; USK0087320039; USK0087320040; USK0087320041; USK0087320042; USK0087320043; USK0087380036; USK0087380037; USK0087380038; USK0087380039; USK0087380040; USK0087380041; USK0087380042; USK0087380043; USK0089650038; USK0089650039; USK0089650040; USK0089650041; USK0089650042; USK0089650043; USK0089650044; USK0089650045; USK0089710078; USK0089710079; USK0089710080; USK0089710081; USK0089710082; USK0089710083; USK0089710084; USK0089710085; USK0089710086; USK0089710087; USK0089940039; USK0089940040; USK0089940041; USK0089940042; USK0089940043; USK0089940044; USK0089940045; USK0089940046; USK0089940047; USK0090320035; USK0090320036; USK0090320037; USK0090320038; USK0090320039; USK0090320040; USK0090320041; USK0090320042; USK0090320043; USK0090320044; USK0090320045; USK0090370035; USK0090370036; USK0090370037; USK0090370038; USK0090370039; USK0090370040; USK0090730045; USK0090730046; USK0090730047; USK0090810036; USK0090810037; USK0090810038; USK0090810039; USK0090810040; USK0090810041; USK0090810042; USK0090810043; USK0090810044; USK0090880023; USK0090880024; USK0090880025; USK0090880026; USK0090880027; USK0090880028; USK0090880029; USK",,"148 allografts","Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/24/2013,"03/24/2013",2/5/2014,"02/05/2014"
"Drugs",64921,"Ongoing","Apothecure, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1066-2014","Class II","The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.","All Lots",,,"Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.",4/15/2013,"04/15/2013",2/12/2014,"02/12/2014"
"Drugs",64922,"Ongoing","NuVision Pharmacy, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1052-2014","Class I","Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244","Lot #:N10172012@11, Exp 10/17/2013",,"122 vials","Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.",4/15/2013,"04/15/2013",2/5/2014,"02/05/2014"
"Drugs",64922,"Ongoing","NuVision Pharmacy, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1051-2014","Class I","HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244","Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15",,"285 vials","Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.",4/15/2013,"04/15/2013",2/5/2014,"02/05/2014"
"Devices",64966,"Ongoing","Ziemer Usa Inc","Alton","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.","Z-0811-2014","Class II","1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.","Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817",,"5 units","A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.",4/16/2013,"04/16/2013",1/29/2014,"01/29/2014"
"Devices",65007,"Ongoing","Synthes USA HQ, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .","Z-0615-2014","Class II","Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.","Part Number 05.001.012, lot number AV18166",,"290","Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The ''on'' and ''lock'' labels were interchanged.",4/15/2013,"04/15/2013",1/8/2014,"01/08/2014"
"Drugs",65095,"Ongoing","American Lifestyle.Com","Pittsford","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.","D-1223-2014","Class I","Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.","All lots, UPC 893490820087",".","13 boxes distributed domestically & 50 boxes distributed internationally to consumers ","Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.",4/30/2013,"04/30/2013",4/16/2014,"04/16/2014"
"Drugs",65095,"Ongoing","American Lifestyle.Com","Pittsford","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.","D-1224-2014","Class I","Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging).","All lots, UPC 4026666142546.",".","3 boxes distributed domestically & 4 boxes distributed internationally to consumers.","Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.",4/30/2013,"04/30/2013",4/16/2014,"04/16/2014"
"Drugs",65107,"Ongoing","Insight Instruments, Inc.","Stuart","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1056-2014","Class II","Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.","Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.",,"316,464 kits","Marketed without an Approved NDA/ANDA.",4/24/2013,"04/24/2013",2/12/2014,"02/12/2014"
"Devices",65131,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","US Nationwide and OUS.","Z-0561-2014","Class II","Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module","Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11",,"17,719","Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected lot of Chemistry Wash is placed on the instrument following an unaffected lot, a negative bias will be seen on CTN1, LTN1, TSH, PBNP and LPBN. A positive bias will be seen on FT4; 2 - If any of these assays are calibrated using an affected lot of Chemistry Wash, QC should return within range; but when a subsequent unaffected Chemistry Wash lot is placed into use, a positive bias will be seen on CTN1, LTN1, TSH, PBNP and LPBN. A negative bias will be seen on FT4.",5/6/2013,"05/06/2013",1/1/2014,"01/01/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0862-2014","Class II","Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CMBC2Y CMDCN9 CMJC48 CMLC6D CNCCLB CNCCZ4 CNDBRG CNDCNB CNHC8M CNJC4P CNKCL4 CNLCL1 CNMB8Y CNMDM0 CNNDHY CNPCLZ CPBC99 CPCC27 CPDBYJ CMNBFF CMNCDY CNCB6M CPBCRZ CPDCKL ",,"369 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0861-2014","Class II","Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CNKBTR CNKCL0 CNKCL2 CNLBR2 CNLBZD CNMCDV CNMDM3 CNNCWC CNPB1W CNPBRJ CNPCLP CPBB39 CPBBGN CPBC98 CPBCKR CPBCKT CPCBG7 CPCCBG CPDBYH CPDC09 CPDCC4 CNBB13 CNCB6L CNDB8B CNDBVZ CNDCM9 CNHC8J CNHCKG CNJC39 CNJC4H CNJC4J CNJCB0 CNDCM8 CNKB42 CNFCVH CNHCZH CNJB98 CNLCW4 CNMBFK CNMCDW CNMDNH CNNCWH CNNDH2 CNNDH3 CNPB1V CPBB3H CPBCR0 CPCBG6 CPCCBD CPCCBF CPDBYG CPDCC6 CMMB1L CMBC2W CMDBHB CMDDJP CMDDJR CMKB22 CMLCKR CMMCR5 CMNBFD CMNCVP CMNCYM CMPB95 CMPBMD CNBBCZ CNCB4R CNCB61 CNMCDR CPCCMW ",,"1481 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0864-2014","Class II","Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL ",,"746 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0859-2014","Class II","Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CMBBP2 CMCBLG CMDBHG CMFBB8 CMHDFW CMJCPY CMLBLW CMLCKP CMMBCY CMMC3F CMNBFC CMNCDW CMPB96 CNCCLK CNJBW0 CNJC4B CNJC4W CNKBWN CNKCL1 CNLBR3 CNLBZF CNMDM1 CNNCPL CNNDH4 CNPBRM CPBBGP CPBC97 CPBCRW CPCBHB CPCCMP CPDBYF CPBCVD CPDBYD CPDBM1 CMBCB2 CMCBLH CMDBHF CMGBL5 CMJCMC CMLBLY CMNBZK CNDCV1 CNHC8N CNKB41 CNLBR5 CNMB2Z CNMDNN CNNCWG CNPB1Y CNPCLT CPBCRY CPFBK1 CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2 ",,"895 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0860-2014","Class II","Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2 ",,"431 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0863-2014","Class II","Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CMJCMD CMBC2Z CMDB7C CMJC49 CMBCPR CMCC2T CMDBHC CMLBLZ CMMB14 CNDBCY CNDCV2 CNJCFT CNKBH6 CNLB57 CNMDNL CNNCWD CNPB1Z CPBB3J CPBDBB CPCCM0 CPDBYK ",,"409 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Devices",65179,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of: Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy ,Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Solvenia, Solvakia, Turkey, South Africa, and UK.","Z-0858-2014","Class II","Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting. ","Lot Codes: CLNCB1 CMBBP1 CMBCPN CMCBWG CMCC2V CMDCN8 CMDDJN CMGB8H CMJCL8 CMJCPW CMKB21 CMMCGR CMNBFB CMNBZJ CMNC8T CMNCYL CMPB4V CNCCPF CNDBCW CNDBRH CNDCJ2 CNFCK7 CNGBG0 CNGBK2 CNHCKH CNHCZN CNJBW5 CNJBWZ CNJC38 CNJC4K CNJCD3 CNJCFR CNJCMN CNKBWP CNKCC8 CNKCL3 CNLBR6 CNLCL3 CNLCW3 CNNCWF CNPB1R CNPBRH CNPCLR CPBC96 CPBCCR CPBCRV CPCBG9 CPCCMK CPDBYC CPDC07 CPDCC7 CNBBCV CNCB6W CNGBRY CNHB95 CNNDCK CNPB1T CNPBML CPBB3G CPCBG8 CPCCBH CPCCM1 CPCCMZ CPFBKP ",,"1460 units","Codman Certas Programmable Valves used for hydrocephalus may not operate properly",5/16/2013,"05/16/2013",2/5/2014,"02/05/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-744-2014","Class III","Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02. ","Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13 ",,"2,978,000/2-caplet packages","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-743-2014","Class III","Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.","a) 08 caplets: Lot# 10121222 exp 07/13. b) 24 caplets: Lot# 10117231 exp 06/13 Lot# 10117814 exp 06/13 Lot# 10119341 exp 07/13 Lot# 10123425 exp 08/13 Lot# 10124156 exp 10/13 ",,"3,768/8-caplet packages and 300,580/24-caplet packages","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-738-2014","Class III","Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.","Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13 ",,"104,328/32-caplet packages","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-741-2014","Class III","Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24","Lot# 10117247 06/13 Lot# 10119336 07/13 ",,"167,712/24-caplet packages ","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-739-2014","Class III","Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24. ","Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13 ",,"32,256/24-caplet packages","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-742-2014","Class III","Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.","a) 08 caplets: Lot# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lot# 10117811 exp 06/13 Lot# 10119338 exp 07/13 Lot# 10121470 exp 07/13 Lot# 10123892 exp 09/13 Lot# 10124161 exp 10/13 ",," 98,024/8-caplet packages and 557,548/24-caplet packages","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Drugs",65181,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.","D-740-2014","Class III","Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24. ","Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13 ",,"38,856/24-caplet package","Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.",5/15/2013,"05/15/2013",1/22/2014,"01/22/2014"
"Devices",65184,"Terminated","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","E-Mail","Distribution was nationwide, as well as to Puerto Rico. There was also military distribution, but no foreign distribution.","Z-0794-2014","Class II","Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes","Lot 1215912, Exp. 31Jul2015",,"80 packs","Cartridges may contain individual discs which were not impregnated with antibiotic.",4/9/2013,"04/09/2013",1/29/2014,"01/29/2014"
"Devices",65184,"Terminated","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution: US including Puerto Rico.","Z-0792-2014","Class II","Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes","Lot 1275353, Exp. 31Dec2015",,"9 packs","Cartridges may contain individual discs which were not impregnated with antibiotic.",4/9/2013,"04/09/2013",1/29/2014,"01/29/2014"
"Devices",65184,"Terminated","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution: US including Puerto Rico.","Z-0795-2014","Class II","Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.","Lot 1227786, Exp. 31AUG2013",,"30 packs","Cartridges may contain individual discs which were not impregnated with antibiotic.",4/9/2013,"04/09/2013",1/29/2014,"01/29/2014"
"Devices",65184,"Terminated","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","E-Mail","Distribution was nationwide, as well as to Puerto Rico. There was also military distribution, but no foreign distribution.","Z-0793-2014","Class II","Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.","Lot 1192177, Exp. Exp. 31May2015",,"10 packs","Cartridges may contain individual discs which were not impregnated with antibiotic.",4/9/2013,"04/09/2013",1/29/2014,"01/29/2014"
"Devices",65214,"Ongoing","Sysmex America, Inc.","Mundelein","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.","Z-0949-2014","Class II","The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. ","Software versions 1.0, 1.01, 1.1.1, 1.1.2",".","214 units","The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system performance issues. ",3/31/2013,"03/31/2013",2/19/2014,"02/19/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1391-2014","Class II","Low salt, vacuum packaged, Hot Smoked Salmon (may include any of the following varieties Coho, Keta, King, Sockeye). Jensen's product is labeled in part ''*** JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON JENESN'S SMOKEHOUSE, INC. *** Keep Refrigerated Below 38 F*** INGREDIENTS: WILD PACIFIC KING SALMON, SALT, BROWN SUGAR, HARDWOOD SMOKE ***'' Lusamerica Keta or Sockey product is shipped with the ''Keep Frozen'' sticker on individual units. No label was provided. ALCHEMIST SEAFOOD King or Coho product is labeled parts: ''***Get Wild ALCHEMIST SEAFOODS***wwww.AlchemistSeafoods.com Wild Alaskan Salmon***INGREDIENTS (smoked product): Wild Alaskan Salmon, Salt, Brown Sugar, Natural Wood Smoke***Thaw Under Refrigeration Just Prior to Consumption***Product of Alaska, U.S.A.***.","lot numbers with the first four numbers starting with 1104 through 3104.",,"14,628 lbs","Jensen's Old Fashioned Smokehouse, Inc. is recalling Lusamerica, Jensen's and ALCHEMIST SEAFOODs Hot Smoked Salmon products may not labeled ''KEEP FROZEN'' and products are potentially contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1396-2014","Class II","Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker and ''KEEP FROZEN'' sticker on individual units. The customer applies their own label upon receipt. Rolf's Choice Sockeye hot smoked salmon is labeled in part: ''***ROLF'S CHOICE***SMOKED ALASKAN KING SALMON*** Ingredients: salmon, salt, brown sugar, hardwood smoke***Important: Keep frozen. Thaw under refrigeration immediately before use***''. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"5,125 lbs","Jensen's Old Fashioned Smokehouse, Inc. is recalling Great Ruby Fish Co., Rolf's Choice Hot Smoked Keta or King Salmon products that are not labeled ''KEEP FROZEN''. The recall does NOT include Salmon Candy or any products bearing the Jensen's Smokehouse brand.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1394-2014","Class II","Hot Smoked Pink Salmon is Low salt, vacuum packaged. Clippership Hot Smoked Pink Salmon does not have any labels. Lummi Island Co-Op product's label is read in parts: ''***WILD SMOKED PINK SALMON***LUMMI ISLANDWILD.COM***KEEP FROZEN***Thawing Instructions: Remove all packaging Thaw under refrigeration; Maintain below 38 F (30 C)***LUMMI ISLAND WILD***Wild Caught*** Product of U.S.A.*** Important. Keep Frozen. Thaw Under Refrigeration Immediately Before Use***Ingredients: Pacific Salmon, Salt,Sugar, Natural Alder Smoke.***''.","lot numbers with the first four numbers starting with 1104 through 3104.",,"20,271 lbs","Jensen's Old Fashioned Smokehouse, Inc. is recalling Hot Smoked Pink Salmon that is not labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum. ",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1388-2014","Class II","Low salt, vacuum packaged, Hot Smoked Black Cod sold under Clippership. No label was provided.","lot numbers with the first four numbers starting with 1104 through 3104.",,"Unknown","Jensen's Old Fashioned Smokehouse, Inc. is recalling Clippership Hot Smoked Black Cod because it may not labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1387-2014","Class II","Low salt, vacuum packaged, Hot Smoked Farmed Raised Salmon (Atlantic, Coho, Keta, King, Steelhead, and Sockeye). AKS (Alaska King Seafoods) products such as Sockeye Traditional, Coho Traditional, Keta Traditional, Farmed Atlantic Traditional are labeled in parts: ''***IMPORTANT KEEP FROZEN***THAW UNDER REFRIGERATION (BELOW 38 F) IMMEDIATELY BEFORE USE***. Jack's Fish Spot products such as Coho, Keta, King, Sockeye are labeled in parts: ''***Important: Keep Frozen. Thaw under refrigeration immediately before use***'' Clippership products such as Steelhead, Coho, King, and Sockeye are labeled in parts: ''***Important: Keep Frozen. Thaw under refrigeration immediately before use***''. Anthony's products such as Keta Traditional and Coho Traditional have no labels.","lot numbers with the first four numbers starting with 1104 through 3104.",,"Estimated total 45,436 lbs","Jensen's Old Fashioned Smokehouse, Inc. is recalling hot smoked salmon because it is not consistenly labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1390-2014","Class II","Low salt, vacuum packaged, Hot Smoked Sturgeon Clippership product is labeled in parts: ''***Keep Frozen. Thaw under refrigeration immediately before use***''. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"Unknown","Jensen's Old Fashioned Smokehouse, Inc. is recalling Hot Smoked Sturgeon because it is not consistently labeled ''KEEP FROZEN'' and it has the potential to be contaminated with Clostrididum botulinum",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1337-2014","Class II","Savory Hot Smoked Salmon is Farmed Raised product, Low salt, vacuum packaged. Savory Smoked Salmon produced by Jensen's Smokehouse is not sold as a vacuum packaged product to the consumer. Products are shipped with ''Keep Frozen'' sticker on a case label. The case label states ***HOT SMOKED SAVORY SALMON 3/3# Packages***Ingredients: Salmon, Salt, Brown Sugar, Seasonings, Dehydrated Vegetables, Spices, Hydrolyzed Soy Protein, Natural Smoke***KEEP FROZEN*** Net Wt. 9 lb.***. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"10,971 lbs","Jensen's Old Fashioned Smokehouse, Inc. is recalling Savory Hot Smoked Salmon because it is not consistently labeled ''KEEP FROZEN'' and it has the potential to be contaminated with Clostridium botulinum",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1392-2014","Class II","Short Strips Teriyaki is a low salt, vacuum packaged, Hot Smoked Salmon, and it is sold under Alaska King Seafoods brand. The labels contain the following statement above or below the product name and/or ingredient statement: ''***IMPORTANT KEEP FROZEN***THAW UNDER REFRIGERATION (BELOW 38 F) IMMEDIATELY BEFORE USE***DIST OR DISTRIBUTED BY: ALASKA KING SEAFOODS, PO BOX 1826 TACOMA, WA 98401***'' ''***Short Strips Teriyaki***INGREDIENTS: SALMON, MOLASSES, SOY SAUCE (WATER, WHEAT, SOYBEANS, SALT, SODIUM BENZOATE), RUM, GARLIC, ONION, GINGER, BROWN SUGAR, SPICES, ORGANIC DEXTROSE, NATURAL FLAVORS, NATURAL WOOD SMOKE (CONTAINS SOY)***''.","lot numbers with the first four numbers starting with 1104 through 3104.",,"5,615 lbs ","Jensen's Old Fashioned Smokehouse, Inc. is recalling Alaska King Seafoods Short Strips Teriyaki because it is not labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1397-2014","Class II","Low salt, vacuum packaged, Garlic Pepper Hot Smoked Salmon with Hardwood. AKS (Alaska King Salmon) product is labeled in parts: ''***Garlic Pepper Smoked Salmon product ***GARLIC PEPPER SMOKED SALMON ***INGREDIENTS: SALMON, SALT, BROWN SUGAR, GARLIC, PEPPER, HARDWOOD SMOKE***''. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"Unknown","Jensen's Old Fashioned Smokehouse, Inc. is recalling Alaska King Salmon Garlic Pepper Hot Smoked Salmon because it may not be labeled ''KEEP FROZEN'' and it has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1389-2014","Class II","Low salt, vacuum packaged, Hot Smoked Halibut was sold under brand Clippership. No product labeling was provided.","lot numbers with the first four numbers starting with 1104 through 3104.",,"171 lbs.","Jensen's Old Fashioned Smokehouse, Inc. is recalling Hot Smoked Halibut because it may not be labeled ''KEEP FROZEN'' and the pdoduct has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1393-2014","Class II","Low salt, vacuum packaged, Hot Smoked King Nova Salmon. The following is information on the individual products for Alaska King Seafoods brand: All AKS stands for Alaska King Seafoods product labels contain the following statement above or below the product name and/or ingredient statement: ''***IMPORTANT KEEP FROZEN***THAW UNDER REFRIGERATION (BELOW 38 F) IMMEDIATELY BEFORE USE***DIST OR DISTRIBUTED BY: ALASKA KING SEAFOODS, PO BOX 1826 TACOMA, WA 98401***'' ''***AKS***Hot Smoked King Nova Short Strips*** 4oz***''.","lot numbers with the first four numbers starting with 1104 through 3104.",,"See information under Product #3 -unknown if wild or farmed","Jensen's Old Fashioned Smokehouse, Inc. is recalling ALL low salt, vacuum packaged, smoked salmon/seafood products that are not labeled ''KEEP FROZEN''. The recall does NOT include Salmon Candy or any products bearing the Jensen's Smokehouse brand.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1399-2014","Class II","Jack's Fish Spot Hot Smoked Cajun Atlantic is a low salt, vacuum packaged, Hot Smoked Salmon. This product is labeled in parts: ''***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlantic Salmon, Salt, Brown Sugar, Spices and Natural Wood Smoke***Important: Keep Frozen. Thaw under refrigeration immediately before use***''. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"Total 36,105 lbs. for both Cajun Atlantic & Atlantic Garlic & Pepper Chunks","Jensen's Old Fashioned Smokehouse, Inc. is recalling Jack's Fish Spot Hot Smoked Cajun Atlantic because it may not be labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1395-2014","Class II","Hot Smoked Alaskan Sockeye Salmon is a low salt, vacuum packaged. Great Ruby Fish Co Sockeye Hot smoked salmon has no labels. ROLF'S Choice Sockeye Salmon is labeled in parts: ''***ROLF'S CHOICE***SMOKED ALASKAN SOCKEYE SALMON*** Ingredients: salmon, salt, brown sugar, hardwood smoke***Important: Keep frozen. Thaw under refrigeration immediately before use***''. ROLF'S Choice Sockeye Salmon also contains a white sticker stating ''***Important Keep Frozen Thaw under refrigeration Prior to consumption***'' and ''Keep Frozen'' sticker on individual units. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"3,446 lbs.","Jensen's Old Fashioned Smokehouse, Inc. is recalling Hot Smoked Sockeye Salmon because it may not be labeled ''KEEP FROZEN'' and it has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1338-2014","Class II","Low salt, vacuum packaged, Hot Smoked Trout and Arctic Char. Clippership products are labeled in parts: ''***IMPORTANT. Keep Frozen. Thaw under refrigeration immediately before use***''. ","lot numbers with the first four numbers starting with 1104 through 3104.",,"Unknown","Jensen's Old Fashioned Smokehouse, Inc. is recalling Clippership Hot Smoked Trout and Arctic Char because they may not be labeled ''KEEP FROZEN'' and it has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Food",65264,"Ongoing","Jensens Old Fashioned Smokehouse Inc","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Washington","F-1398-2014","Class II","Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks is a low salt, vacuum packaged, hot smoked salmon. The product is labeled in parts: ''***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlantic Salmon, Salt, Brown Sugar, Spices and Natural Wood Smoke***Important: Keep Frozen. Thaw under refrigeration immediately before use***''.","lot numbers with the first four numbers starting with 1104 through 3104.",,"Total 36,105 lbs. for both Cajun Atlantic & Atlantic Garlic & Pepper Chunks","Jensen's Old Fashioned Smokehouse, Inc. is recalling Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks because it may not be labeled ''KEEP FROZEN'' and the product has the potential to be contaminated with Clostridium botulinum.",4/29/2013,"04/29/2013",1/22/2014,"01/22/2014"
"Drugs",65273,"Ongoing","Health & Beyond","Pompano Beach","FL","US","Voluntary: Firm Initiated","Telephone","Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.","D-1067-2014","Class II","HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.","All lots. Expiration date 09/2015.",,"46 bottles","Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) ",5/15/2013,"05/15/2013",2/12/2014,"02/12/2014"
"Devices",65274,"Ongoing","Nipro Medical Corporation","Miami","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.","Z-1834-2014","Class II","''***NIPRO Safe Touch Safety Scalp Vein Set STERILIZED WITH ETO GAS Intended to be used for insertion into a patient's vascular system as an indwelling device to administer fluids intravenously or to sample blood. ","Product Code: PR+25G19; Lot #12H31H (7,000) Product Code: PR+25G19; Lot #12l14H (2,000) Product Code: PR+25G19; Lot #12Hl24 (10,000) Product Code: PR+25G19; Lot #12J11 (9,000) Product Code: PR+25G19; Lot #12H27H (150,000) Product Code: PR+25G19; Lot #12l12H (100,000) ",,"176,000 pieces","There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids. ",5/4/2013,"05/04/2013",6/25/2014,"06/25/2014"
"Devices",65309,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA","Z-0978-2014","Class II","DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible. ","Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046",,"35 units","It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems",5/1/2013,"05/01/2013",3/5/2014,"03/05/2014"
"Devices",65366,"Ongoing","GE Healthcare It","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, CA, IA, ID, IL, MI, MS, MT, NJ, NV, NY, OR, PA, SC, TN, WI and Internationally to Israel, Mexico, and Spain.","Z-0748-2014","Class II","Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modal softcopy image including the use of prosthetic template overlays, and including mammography. Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography. ","Software version 8.0.2",,"28 units","There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in a missed intervention or mis-diagnosis.",8/26/2013,"08/26/2013",1/22/2014,"01/22/2014"
"Food",65373,"Terminated","Creole & Company, LLC","new orleans","LA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","LA","F-1645-2013","Class I","Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869","None, the product is not lot coded",,"22 cases of 20 units","Product which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence.",6/6/2013,"06/06/2013",1/15/2014,"01/15/2014"
"Drugs",65383,"Ongoing","Dolphin Intertrade Corporation","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1250-2014","Class I","XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box","All Lots",,"8 bottles","Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",5/20/2013,"05/20/2013",4/30/2014,"04/30/2014"
"Drugs",65383,"Ongoing","Dolphin Intertrade Corporation","Miami","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1249-2014","Class I","JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle ","Manufacturing Codes: 10.06.2011 Exp. 09.06.2013 ",,"998 boxes","Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",5/20/2013,"05/20/2013",4/30/2014,"04/30/2014"
"Devices",65409,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.","Z-0625-2014","Class II","HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. ","Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13.",,"11006 Total","Positive bias on the lots listed compared to alternate methods and a higher frequency of ''Above Assay Range'' flags with the lots listed.",4/22/2013,"04/22/2013",1/15/2014,"01/15/2014"
"Devices",65409,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.","Z-0626-2014","Class II","HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. ","Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13. ",,"11006 Total","Positive bias on the lots listed compared to alternate methods and a higher frequency of ''Above Assay Range'' flags with the lots listed.",4/22/2013,"04/22/2013",1/15/2014,"01/15/2014"
"Devices",65450,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.","Z-1064-2014","Class II","SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.","105285, 105445, 105305, 105532, 105366, 105403, 105265, 105492, 105273, 105186, 105494, 105481, 105395, 105326, 105467, 105392, 105204, 105382, 105093, 105521, 105154, 105387, 105228, 105126, 105514, 105359, 105279, 105518, 105528, 105210, 105482, 105213, 105466, 105284, 105544, 105260, 105194, 105195, 105515, 105386, 105199, 105475, 105117, 105325, 105127, 105498, 105233, 105187, 105478, 105261, 105166, 105321, 105369, 105363, 105437, 105119, 151370, 151889, 151177, 152420, 152003, 151693, 105664, 151211, 105480, 105570, 105501, 105652, 105608, 105792, 105570, 152188, 151483, 105491, 105801, 151746, 151248, 151052, 152195, 151562, 152354, 105338, 152142, 105316, 152213, 152272, 152434, 151354, 151711, 151685, 151201, 151200, 105376, 151822, 151821, 152389, 105373, 151610, 151651, 151876, 151937, 152020, 151105, 151633, 105684, 151372, 151244, 152283, 152317, 152509, 152516, 152590, 151023, 105810, 153165, 152097, 152286, 105793, 151670, 151153, 105427, 105733, 105223, 105281, 105689, 151065, 105970, 151344, 151859, 105346, 105748, 105760, 105680, 151383, 151417, 151797, 105446, 105870, 105292, 105737, 105714, 151158, 151172, 152216, 152557, 152581, 105920, 151536, 105988, 151028, 151174, 151597, 105229, 151600, 105724, 105301, 105422, 105308, 105535, 151494, 151518, 151586, 151814, 151894, 151723, 105613, 151914, 105752, 152284, 105394, 105674, 151183, 105525, 105531, 105634, 105993, 105620, 152575, 152011, 105592, 105450, 151921, 105896, 152092, 105314, 151701, 151922, 151852, 105595, 105361, 105850, 105923, 105554, 105867, 105353, 105934, 105807, 151996, 152224, 151452, 152869, 152065, 105677, 151034, 151891, 105538, 105602, 105778, 105765, 105903, 151719, 151909, 152002, 152083, 151930, 105687, 105711, 151316, 151318, 151088, 105833, 105946, 151378, 151212, 151596, 151658, 151837, 151762, 151815, 105669, 105966, 105795, 105978, 152398, 152032, 151280, 151150, 151984, 151682, 151656, 151045, 151231, 105504, 151017, 151115, 105975, 105974, 105600, 105414, 105429, 105937, 105838, 105758, 151140, 151101, 10591",,"449","Customers are resetting the default values outside recommended factory settings.",5/28/2013,"05/28/2013",3/26/2014,"03/26/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-758-2014","Class II","NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).","Lot #: a) 10112236, Exp 4/30/2014 and 10122295, Exp 9/30/2014; b) 10093319, Exp 6/30/2013 and 10100417, Exp 9/30/2013. ",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-760-2014","Class II","NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9. ","Lot #: 10122293, Exp 8/31/2013.",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-761-2014","Class II","NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product)","Lot #: 10116030, Exp 6/30/2013. Korea product: 10112972, Exp 5/31/2013 and 10116032, Exp 7/31/2013. ",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-750-2014","Class II","Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.","Lot #: a) 25777303, 25777304, Exp 5/31/2013; 25777501, 25777502, Exp 6/30/2013; 25777801, 25777802, Exp 7/31/2013; 25777803, 25981801, 25981802, Exp 8/31/2013; 25981803, 26088801, 26088802, Exp 9/30/2013; b) 25596201, 25596202, 25596203, 25596204, 25596205, 25596206, Exp 5/31/2013; 25596207, 25767001, 25767101, 25767102, 25767103, Exp 6/30/2013; 25767002, 25767104, 25767105, 25767106, 25767201, Exp 7/31/2013; 25767202, 25767203, 25767204, 25767205, 25767206, 25981602, 25981603, 25981604, 25981605, Exp 8/31/2013; 25981601, Exp 9/30/2013",,"917,400 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-759-2014","Class II","NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product); ","Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013. Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp 5/31/2013; 10116051, 10116053, 10116055, 10116057, 10116059, 10116061,10117302, 10117304, Exp 7/31/2013; 10119732, 10119735, Exp 9/30/2013; 10124276, 10124281, 10125922, 10126539, 10126540, 10126541, 10126542, 10126543, Exp 10/31/2013; Korea product: 10112969, Exp 5/31/2013; 10116034, Exp 7/31/2013; 10120027, Exp 9/30/2013. ",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-762-2014","Class II","Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.","Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-748-2014","Class II","Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2. ","Lot #: 10115121, 10115832, Exp 5/31/2013; 10119854, 10119856, Exp 7/31/2013; 10122257, 8/31/2013; 10124286, 10124289, 10124292, Exp 9/30/2013; 10128103, 10128105, 10128108, 10128110, Exp 10/31/2013. NeoCitran Cold & Flu: 10115118, Exp 5/31/2013 and 10122252, Exp 9/30/2013.",,"1,614,564 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-752-2014","Class II","Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.","Lot #: a) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013",,"1,202,960 cartons and cards","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-753-2014","Class II","Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1. ","Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014.",,"868,104 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-754-2014","Class II","Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.","Lot #: 10116040, Exp 6/30/2013; 10119871, Exp 7/31/2013; 10122275, Exp 9/30/2013.",,"292,320 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-757-2014","Class II","NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5). ","Lot #: a) 10094895, Exp 7/31/2013; 10098586, Exp 9/30/2013; 10104820, Exp 12/31/2013; 10109982, Exp 2/28/2014; 10110876, Exp 3/31/2014; 10114393, Exp 5/31/2014; 10119851, Exp 7/31/2014; 10122313, Exp 9/30/2014; b) 10097661, Exp 8/31/2013; 10099912, Exp 9/30/2013; 10105539, Exp 12/31/2013; 10109980, Exp 2/28/2014; 10114396, Exp 5/31/2014; 10119849, Exp 7/31/2014; 10122312, Exp 9/30/2014.",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-763-2014","Class II","Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)","Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.",,,"Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-751-2014","Class II","Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico","Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.",,"1,140,564 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-755-2014","Class II","Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.","Lot #: 10115134, Exp 5/31/2013; 10119862, Exp 7/31/2013; 10122276, 10124325, Exp 10/31/2013.",,"398,208 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-756-2014","Class II","Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.","Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013. ",,"3,753,348 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Drugs",65490,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.","D-749-2014","Class II","Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2. ","Lot #: 10115840, 10115888, Exp 5/31/2013; 10118946, 10118948, 10119864, 10119867, Exp 7/31/2013; 10122271, 10122297, 10124374, Exp 8/31/2013; 10122300, Exp 9/30/2013; 10124493, 10125910, 10128097, 10128099, 10128101, Exp 10/31/2013. NeoCitran Extra Strength Total 7 symptom relief: 10115129, Exp 5/31/2013; 10124152, Exp 8/31/2013; and 10124488, Exp 10/31/2013. ",,"1,871,122 cartons","Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",6/18/2013,"06/18/2013",1/29/2014,"01/29/2014"
"Devices",65562,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican","Z-1960-2014","Class II","ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.","Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013",,"51 units","ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).",6/25/2013,"06/25/2013",7/9/2014,"07/09/2014"
"Food",65580,"Completed","Purely Pomegranate, Inc","Dana Point","CA","US","Voluntary: Firm Initiated","E-Mail","CA, MI, NJ, and OR.","F-1673-2014","Class I","GOKNUR Organic Frozen/IQF Pomegranate Arils. Packed in 10 kg cases. Labeling is bilingual and in English, reads in part:''goknur***Product of Turkey***ORGANIC FROZEN/IQF POMEGRANATE ARILS***Production Date 17.10.2012***Lot No 12-15-13-2-1-O***Net Weight (kg) 10***Crop Year 2012***Expiry Date 17.10.2014***Carton No 8721***''.","Lot Code 12-15-13-2-1-O Production Date 17.10.2012 Crop Year 2012 Carton No. 8721",,"13,785 cases","Purely Pomegranate, Inc. is voluntarily recalling certain lots of a pomegranate arils due to public concerns about the Hepatitis A Virus.",6/27/2013,"06/27/2013",3/26/2014,"03/26/2014"
"Food",65585,"Ongoing","Beta Labs","Memphis","TN","US","Voluntary: Firm Initiated","Press Release","nationwide and UK","F-2400-2014","Class II","PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802 ","Lot # 1205129, Exp 12/16",".","743 units","The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.",6/20/2013,"06/20/2013",9/3/2014,"09/03/2014"
"Food",65585,"Ongoing","Beta Labs","Memphis","TN","US","Voluntary: Firm Initiated","Press Release","nationwide and UK","F-2398-2014","Class II","Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747","Lot #s 200910 and 200911, Exp 10/16",".","5951 units","The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.",6/20/2013,"06/20/2013",9/3/2014,"09/03/2014"
"Food",65585,"Ongoing","Beta Labs","Memphis","TN","US","Voluntary: Firm Initiated","Press Release","nationwide and UK","F-2401-2014","Class II","RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559819","Lot # 1205128 (90ct Bottle) Expires 12/16",".","743 units","The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.",6/20/2013,"06/20/2013",9/3/2014,"09/03/2014"
"Food",65585,"Ongoing","Beta Labs","Memphis","TN","US","Voluntary: Firm Initiated","Press Release","nationwide and UK","F-2399-2014","Class I","PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822","Lot # 58800512, Exp 05/16",".","2154 units","The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.",6/20/2013,"06/20/2013",9/3/2014,"09/03/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0948-2014","Class II","Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois","Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961",".","6,000 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0946-2014","Class II","MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5'' x 98'', (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702","Lot Numbers: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671",".","2,102 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0944-2014","Class II","MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702","Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371, D121511, D121661, D121681, D122141, D122431, D122561, D122991, D130581, D81701, D81711, D82661, D83041, D83501, D90691, D90701, D91611, D92011, D92021, D92121, D92431, D92601, D92991, D93061, DA100051, DA100061, DA100341, DA100951, DA100971, DA101511, DA101521, DA102011, DA81931, DA82451, DA83011, DA83031, DA83241, DA91131,DA91141, DA91601, and DA92881",".","210, 560 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0947-2014","Class II","MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702","Lot Numbers: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161",".","6,040 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0943-2014","Class II","MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702. ","Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891",".","1800 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Devices",65667,"Ongoing","Ecolab Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.","Z-0945-2014","Class II","MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5'' x 96'', REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702","Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V",".","12,546 individual units","Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.",7/2/2013,"07/02/2013",2/19/2014,"02/19/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-726-2014","Class II","amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316 ","amLODIPine BESYLATE, Tablet, 10 mg has the following code Pedigree: AD62846_4, EXP: 5/24/2014. ",,"90 Tablets","Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-526-2014","Class II","hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401 ","hydrALAZINE HCl Tablet, 100 mg has the following codes Pedigree: AD46312_13, EXP: 5/16/2014; Pedigree: AD73652_4, EXP: 5/29/2014; Pedigree: AD30197_7, EXP: 5/9/2014. ",,"400 Tablets","Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-635-2014","Class II","CRANBERRY Tablet, 450 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896084501 ","CRANBERRY, Tablet, 450 mg has the following code Pedigree: AD73640_1, EXP: 5/30/2014. ",,"100 Tablets","Labeling:Label Mixup; CRANBERRY Tablet, 450 mg may be potentially mislabeled as METOPROLOL SUCCINATE ER, Tablet, 200 mg, NDC 62037083301, Pedigree: AD73652_13, EXP: 5/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-591-2014","Class II","hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801 ","hydrALAZINE HCl, Tablet, 50 mg has the following code Pedigree: AD52778_28, EXP: 5/20/2014. ",,"100 Tablets","Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree: AD52778_16, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-464-2014","Class II","CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392. ","CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units has the following codes: Pedigree: W002610, EXP: 6/4/2014; Pedigree: AD54576_1, EXP: 5/20/2014. ",,"10,819 tablets","Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-673-2014","Class II","OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018388 ","OXcarbazepine, Tablet, 150 mg has the following code Pedigree: AD54562_4, EXP: 5/20/2014. ",,"100 Tablets","Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-640-2014","Class II","ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913 ","ARIPiprazole Tablet, 15 mg has the following codes Pedigree: AD21965_1, EXP: 5/1/2014; Pedigree: AD28322_1, EXP: 5/6/2014. ",,"150 Tablets","Labeling:Label Mixup; ARIPiprazole, Tablet, 15 mg may be potentially mislabeled as ATOMOXETINE HCL, Capsule, 40 mg, NDC 00002322930, Pedigree: AD21790_82, EXP: 5/1/2014; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, NDC 13668009190, Pedigree: AD25264_10, EXP: 5/3/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-684-2014","Class II","guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850 ","guaiFENesin ER, Tablet, 600 mg has the following code Pedigree: W003244, EXP: 6/17/2014. ",,"500 Tablets","Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-678-2014","Class II","METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304057901 ","METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD21790_67, EXP: 5/1/2014; Pedigree: AD73525_52, EXP: 5/30/2014. ",,"420 Tablets","Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4/30/2014; LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD73525_49, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-616-2014","Class II","GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54458010022 ","GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/400 mg has the following code Pedigree: AD60240_33, EXP: 5/22/2014. ",,"60 Capsules","Labeling:Label Mixup; GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg may be potentially mislabeled as FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD60240_30, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-666-2014","Class II","ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61570007301 ","ESTERIFIED ESTROGENS, Tablet, 0.625 mg has the following code Pedigree: W003736, EXP: 6/26/2014. ",,"100 Tablets","Labeling:Label Mixup; ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ETODOLAC, Tablet, 400 mg, NDC 51672401801, Pedigree: W003734, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-659-2014","Class II","CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201 ","CILOSTAZOL, Tablet, 100 mg has the following code Pedigree: AD65475_4, EXP: 5/28/2014. ",,"60 Tablets","Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-621-2014","Class II","tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915 ","tiZANidine HCl, Tablet, 2 mg has the following codes Pedigree: AD21790_40, EXP: 5/1/2014; Pedigree: AD46265_16, EXP: 5/15/2014; Pedigree: W002663, EXP: 6/5/2014; Pedigree: AD73525_31, EXP: 5/30/2014. ",,"600 Tablets","Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014; NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree: AD73525_19, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-598-2014","Class II","SOLIFENACIN SUCCINATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51248015001 ","SOLIFENACIN SUCCINATE, Tablet, 5 mg has the following code Pedigree: W003755, EXP: 6/26/2014. ",,"30 Tablets","Labeling: Label Mixup; SOLIFENACIN SUCCINATE Tablet, 5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010601, Pedigree: W003754, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-633-2014","Class II","PIMOZIDE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701 ","PIMOZIDE, Tablet, 2 mg has the following code Pedigree: AD30140_43, EXP: 5/7/2014. ",,"100 Tablets","Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD30140_31, EXP: 5/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-483-2014","Class II","diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159 ","diphenhydrAMINE HCl, Tablet, 25 mg has the following codes Pedigree: AD33897_13, EXP: 5/9/2014; Pedigree: W002775, EXP: 6/6/2014; Pedigree: W003513, EXP: 6/21/2014; Pedigree: AD67992_4, EXP: 5/28/2014. ",,"901 Tablets","Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg, NDC 16714031101, Pedigree: AD67989_4, EXP: 11/30/2013. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-474-2014","Class II","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260 ","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) has the following code Pedigree: AD46257_43, EXP: 5/15/2014. ",,"200 Tablets","Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-564-2014","Class II","MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012 ","MISOPROSTOL, Tablet, 100 mcg has the following code Pedigree: AD42611_7, EXP: 5/14/2014. ",,"120 Tablets","Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-545-2014","Class II","TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722053001 ","TORSEMIDE Tablet, 10 mg has the following code Pedigree: AD25264_13, EXP: 5/3/2014. ",,"100 Tablets","Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-592-2014","Class II","traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043301 ","traZODone HCl, Tablet, 50 mg has the following codes Pedigree: AD37088_4, EXP: 5/9/2014; Pedigree: AD54562_1, EXP: 5/20/2014; Pedigree: AD39611_4, EXP: 5/14/2014. ",,"400 Tablets","Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-614-2014","Class II","MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092019112 ","MESALAMINE CR, Capsule, 500 mg has the following code Pedigree: AD21965_16, EXP: 5/1/2014. ",,"111 Capsules","Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-656-2014","Class II","SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001 ","SENNOSIDES, Tablet, 8.6 mg has the following code Pedigree: AD37063_17, EXP: 5/13/2014. ",,"300 Tablets","Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD37063_7, EXP: 5/13/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-629-2014","Class II","METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652 ","METOPROLOL TARTRATE, Tablet, 25 mg has the following codes Pedigree: W003843, EXP: 6/27/2014; Pedigree: W002841, EXP: 6/7/2014. ",,"300 Tablets","Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014; amLODIPine BESYLATE, Tablet, 5 mg, NDC 00093716798, Pedigree: W002840, EXP: 6/7/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-494-2014","Class II","MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466 ","MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD21846_17, EXP: 5/1/2014; Pedigree: AD73521_19, EXP: 5/30/2014. ",,"359 Tablets","Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG (1/2 of 25 MG), NDC 47335090288, Pedigree: AD21790_79, EXP: 5/1/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD73521_13, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-722-2014","Class II","buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130 ","buPROPion HCl ER (XL), Tablet, 150 mg has the following code Pedigree: AD52412_4, EXP: 4/30/2014. ",,"60 Tablets","Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-589-2014","Class II","DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109 ","DILTIAZEM HCL ER, Capsule, 240 mg has the following codes Pedigree: AD52375_1, EXP: 5/17/2014; Pedigree: AD56917_1, EXP: 5/21/2014. ",,"180 Capsules","Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-622-2014","Class II","GLIMEPIRIDE Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111032001 ","GLIMEPIRIDE, Tablet, 1 mg has the following code Pedigree: AD73525_10, EXP: 5/30/2014. ",,"100 Tablets","Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD73525_4, EXP: 5/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-701-2014","Class II","CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001 ","CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg has the following codes Pedigree: W002581, EXP: 6/3/2014; Pedigree: AD32345_1, EXP: 5/14/2014. ",,"509 Tablets","Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-615-2014","Class II","LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290 ","LANTHANUM CARBONATE, Chew Tablet, 500 mg has the following codes Pedigree: AD32764_5, EXP: 5/13/2014; Pedigree: AD32764_8, EXP: 5/14/2014; Pedigree: W002790, EXP: 6/6/2014; Pedigree: W003410, EXP: 6/19/2014. ",,"405 Chew Tablets","Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_31, EXP: 5/13/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD32757_53, EXP: 5/14/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W002712, EXP: 6/6/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W003359, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-619-2014","Class II","OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530 ","OLANZapine, Tablet, 7.5 mg has the following codes Pedigree: AD46265_46, EXP: 5/15/2014; Pedigree: AD60272_79, EXP: 5/22/2014; Pedigree: AD73525_58, EXP: 5/30/2014. ",,"210 Tablets","Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: AD46265_37, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD60272_73, EXP: 5/22/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: AD73525_55, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-536-2014","Class II","ERYTHROMYCIN DR EC Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24338012213 ","ERYTHROMYCIN DR EC Tablet, 250 mg has the following code Pedigree: AD46426_13, EXP: 5/15/2014. ",,"100 Tablets","Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD46426_10, EXP: 5/15/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-594-2014","Class II","traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101 ","traZODone HCl, Tablet, 150 mg has the following codes Pedigree: AD21858_7, EXP: 5/1/2014; Pedigree: W003245, EXP: 6/17/2014. ",,"300 Tablets","Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-497-2014","Class II","MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813 ","MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD46257_56, EXP: 5/15/2014; Pedigree: W003022, EXP: 6/12/2014; Pedigree: W003723, EXP: 6/26/2014; Pedigree: AD21846_34, EXP: 5/1/2014; Pedigree: AD30028_28, EXP: 5/7/2014; Pedigree: AD60240_39, EXP: 5/22/2014; Pedigree: AD73521_31, EXP: 5/30/2014; Pedigree: W002701, EXP: 6/5/2014; Pedigree: W003320, EXP: 6/19/2014. ",,"3,710 Tablets","Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, NDC 00904548152, Pedigree: AD21846_14, EXP: 5/1/2014; OXcarbazepine, Tablet, 600 mg, NDC 62756018588, Pedigree: AD30140_46, EXP: 5/7/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD60240_36, EXP: 5/22/2014; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: AD73521_28, EXP: 5/30/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002691, EXP: 6/5/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003333, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-667-2014","Class II","RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301 ","RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014; Pedigree: AD62995_7, EXP: 5/29/2014; Pedigree: W002857, EXP: 6/7/2014; Pedigree: W003538, EXP: 6/21/2014; Pedigree: W003741, EXP: 6/26/2014; Pedigree: AD32757_47, EXP: 5/13/2014; Pedigree: W003648, EXP: 6/25/2014; Pedigree: AD60272_40, EXP: 5/22/2014. ",,"840 Tablets","Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: W003535, EXP: 6/21/2014; NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003740, EXP: 6/26/2014; LANTHANUM CARBONATE, Chew Tablet, 500 mg, NDC 54092025290, Pedigree: AD32764_5, EXP: 5/13/2014; VITAMIN B COMPLEX, Tablet, NDC 43292055540, Pedigree: W003628, EXP: 6/25/2014; PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD60272_82, EXP: 5/22/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-507-2014","Class II","PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430 ","PARoxetine HCl, Tablet, 10 mg has the following code Pedigree: AD52778_67, EXP: 5/20/2014. ",,"30 Tablets","Labeling: Label Mixup; PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 62175018046, Pedigree: AD52778_64, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-561-2014","Class II","VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055540 ","VITAMIN B COMPLEX, Tablet has the following codes Pedigree: W003820, EXP: 6/27/2014; Pedigree: W003628, EXP: 6/25/2014. ",,"200 Tablets","Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003789, EXP: 6/27/2014; prednisoLONE, Tablet, 5 mg, NDC 16477050501, Pedigree: W003627, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-503-2014","Class II","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 ","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg has the following code Pedigree: AD42584_15, EXP: 5/14/2014. ",,"84 Capsules","Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-533-2014","Class II","ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155014701 ","ACARBOSE Tablet, 25 mg has the following code Pedigree: AD32757_1, EXP: 5/13/2014. ",,"100 Tablets","Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-530-2014","Class II","PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001 ","PROPRANOLOL HCL, Tablet, 5 mg (1/2 of 10 mg) has the following code Pedigree: AD73525_25, EXP: 5/30/2014. ",,"198 Tablets","Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-520-2014","Class II","LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058102 ","LOSARTAN POTASSIUM Tablet, 25 mg has the following codes Pedigree: AD67989_7, EXP: 5/28/2014; Pedigree: W003845, EXP: 6/27/2014; Pedigree: W003899, EXP: 6/27/2014; Pedigree: AD22616_7, EXP: 5/2/2014. ",,"448 Tablets","Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014; LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD22616_4, EXP: 5/2/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-478-2014","Class II","PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904531360 ","PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet has the following codes Pedigree: AD62986_22, EXP: 5/23/2014; Pedigree: W003098, EXP: 6/13/2014; Pedigree: W003479, EXP: 6/20/2014; Pedigree: W003480, EXP: 6/20/2014; Pedigree: AD52993_13, EXP: 5/20/2014; Pedigree: AD60428_7, EXP: 5/22/2014; Pedigree: AD73652_16, EXP: 5/30/2014; Pedigree: W003706, 6/25/2014. ",,"1,501 Tablets","Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904531360, Pedigree: W003479, EXP: 6/20/2014; NIACIN, Tablet, 500 mg, NDC 00904227260, Pedigree: AD52993_10, EXP: 5/20/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD60240_39, EXP: 5/22/2014; MINOCYCLINE HCL, Capsule, 100 mg, NDC 00591569550, Pedigree: AD73611_10, EXP: 5/30/2014; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, NDC 13668009190, Pedigree: W003683, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-647-2014","Class II","medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762374202 ","medroxyPROGESTERone ACETATE, Tablet, 10 mg has the following code Pedigree: AD46312_19, EXP: 5/16/2014. ",,"100 Tablets","Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD46312_13, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-719-2014","Class II","carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832 ","carBAMazepine ER, Capsule, 200 mg has the following code Pedigree: AD32764_14, EXP: 5/14/2014. ",,"229 Capsules","Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-648-2014","Class II","sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001 ","sulfaSALAzine, Tablet, 500 mg has the following code Pedigree: AD46265_13, EXP: 5/15/2014. ",,"100 Tablets","Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-493-2014","Class II","BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760 ","BISACODYL EC, Tablet, 5 mg has the following code Pedigree: AD34931_1, EXP: 5/9/2014. ",,"100 Tablets","Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD37056_13, EXP: 5/10/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-702-2014","Class II","aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101 ","aMILoride HC, Tablet, 5 mg has the following codes Pedigree: AD60272_55, EXP: 5/22/2014; Pedigree: W003686, EXP: 6/26/2014. ",,"200 Tablets","Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003764, EXP: 6/26/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-551-2014","Class II","VITAMIN B COMPLEX PROLONGED RELEASE Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251 ","VITAMIN B COMPLEX PROLONGED RELEASE Tablet has the following codes Pedigree: AD73627_26, EXP: 5/30/2014; Pedigree: AD76686_1, EXP: 5/31/2014. ",,"120 Tablets","Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE Tablet may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD73627_23, EXP: 5/30/2014; TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD73686_1, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-512-2014","Class II","PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 13811051410 ","PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet has the following code Pedigree: AD65314_1, EXP: 5/24/2014. ",,"2,400 Tablets","Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 100 mcg, NDC 00536354201, Pedigree: AD62840_1, EXP: 5/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-475-2014","Class II","PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559 ","PSEUDOEPHEDRINE HCL, Tablet, 60 mg has the following code Pedigree: W002856, EXP: 6/7/2014. ",,"100 Tablets","Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-509-2014","Class II","PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009190 ","PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg has the following codes Pedigree: AD25264_10, EXP: 5/3/2014; Pedigree: W003683, EXP: 6/25/2014. ",,"359 Tablets","Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013; PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W003682, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-699-2014","Class II","PHOSPHORUS Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980010401 ","PHOSPHORUS Tablet, 250 mg has the following codes Pedigree: AD56916_1, EXP: 5/21/2014; Pedigree: W002534, EXP: 6/3/2014; Pedigree: AD25452_7, EXP: 5/3/2014; Pedigree: AD54498_1, EXP: 5/20/2014; Pedigree: W003997, EXP: 7/1/2014; Pedigree: AD46300_8, EXP: 5/15/2014; Pedigree: AD70639_10, EXP: 5/29/2014. ",,"1,000 Tablets","Labeling: Label Mixup; PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: AD56921_1, EXP: 5/21/2014; VENLAFAXINE HCL, Tablet, 75 mg, NDC 00093738201, Pedigree: W002533, EXP: 2/28/2014; NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg, NDC 47781030701, Pedigree: AD25452_4, EXP: 5/3/2014; traZODone HCl, Tablet, 50 mg, NDC 50111043303, Pedigree: AD54475_7, EXP: 5/20/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003996, EXP: 7/1/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD46297_1, EXP: 5/15/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70655_1, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-653-2014","Class II","VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001 ","VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet has the following codes Pedigree: AD73652_19, EXP: 5/30/2014; Pedigree: W003591, EXP: 6/24/2014; Pedigree: AD70655_17, EXP: 5/28/2014; Pedigree: W003361, EXP: 6/19/2014.",,"600 Tablets","Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003320, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-492-2014","Class II","MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904791152 ","MAGNESIUM CHLORIDE DR, Tablet, 64 mg has the following codes Pedigree: AD54510_1, EXP: 2/28/2014; Pedigree: AD70615_1, EXP: 2/28/2014. ",,"180 Tablets","Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5 mg, NDC 67253070006, Pedigree: AD54549_19, EXP: 5/20/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD70639_10, EXP: 5/29/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-549-2014","Class II","COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065 ","COENZYME Q-10, Capsule, 100 mg has the following codes Pedigree: AD30180_16, EXP: 5/9/2014; Pedigree: AD32325_4, EXP: 5/9/2014; Pedigree: AD37056_4, EXP: 5/10/2014; Pedigree: AD70655_11, EXP: 5/28/2014; Pedigree: W002711, EXP: 6/6/2014; Pedigree: W003871, EXP: 6/27/2014; Pedigree: W003998, EXP: 7/1/2014; Pedigree: AD68019_4, EXP: 5/28/2014. ",,"341 Capsules","Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD30180_13, EXP: 5/9/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: AD33897_1, EXP: 5/9/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD37056_1, EXP: 5/10/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_17, EXP: 5/28/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002710, EXP: 6/6/2014; SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003866, EXP: 6/27/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: W003997, EXP: 7/1/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD68019_1, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-707-2014","Class II","PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110 ","PROMETHAZINE HCL, Tablet, 25 mg has the following code Pedigree: W002578, EXP: 6/3/2014. ",,"100 Tablets","Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-560-2014","Class II","LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292050022 ","LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU has the following codes Pedigree: AD46257_28, EXP: 5/15/2014; Pedigree: AD30028_10, EXP: 5/7/2014; Pedigree: AD60240_20, EXP: 5/22/2014. ",,"700 Capsules","Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-694-2014","Class II","METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110 ","METAXALONE Tablet, 800 mg has the following code Pedigree: W003738, EXP: 6/26/2014. ",,"100 Tablets","Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-660-2014","Class II","CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201 ","CILOSTAZOL Tablet, 100 mg has the following code Pedigree: AD65475_4, EXP: 5/28/2014. ",,"60 Tablets","Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-471-2014","Class II","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260 ","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) has the following codes Pedigree: W002699, EXP: 6/5/2014; Pedigree: AD60240_27, EXP: 5/22/2014; Pedigree: AD73521_28, EXP: 5/30/2014. ",,"900 Tablets","Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-681-2014","Class II","LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230 ","LURASIDONE HCL, Tablet, 120 mg has the following code Pedigree: W003487, EXP: 6/20/2014. ",,"60 Tablets","Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-518-2014","Class II","FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104 ","FAMOTIDINE Tablet, 20 mg has the following codes Pedigree: W003226, EXP: 6/17/2014; Pedigree: W003507, EXP: 6/21/2014; Pedigree: W003508, EXP: 6/21/2014; Pedigree: W003764, EXP: 6/26/2014; Pedigree: W003406, EXP: 6/19/2014. ",,"700 Tablets","Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00378225001, Pedigree: W003763, EXP: 6/26/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 49348085216, Pedigree: W003393, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-668-2014","Class II","METOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62037083301 ","METOPROLOL SUCCINATE ER Tablet, 200 mg",,"100 Tablets","Labeling:Label Mixup; METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as Pedigree: AD73652_13, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-697-2014","Class II","LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060 ","LUBIPROSTONE Capsule, 24 mcg has the following codes Pedigree: AD21790_46, EXP: 5/1/2014; Pedigree: AD21811_1, EXP: 5/1/2014; Pedigree: AD46312_1, EXP: 5/16/2014. ",,"180 Capsules","Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-469-2014","Class II","PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360 ","PSEUDOEPHEDRINE HCL, Tablet, 30 mg has the following code Pedigree: AD52993_37, EXP: 5/20/2014. ",,"100 Tablets","Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-645-2014","Class II","MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503 ","MIRTAZAPINE, Tablet, 7.5 mg has the following codes Pedigree: AD73525_55, EXP: 5/30/2014; Pedigree: W003012, EXP: 6/11/2014; Pedigree: W003334, EXP: 6/18/2014.",,"91 Tablets","Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-535-2014","Class II","MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24208063210 ","MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule has the following codes Pedigree: AD21846_40, EXP: 5/2/2014; Pedigree: AD60240_45, EXP: 5/22/2014; Pedigree: W003025, EXP: 6/12/2014; Pedigree: AD73521_37, EXP: 5/30/2014. ",,"204 Capsules","Labeling: Label Mixup; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule may be potentially mislabeled as CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD21846_37, EXP: 5/1/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD60240_42, EXP: 5/22/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003024, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD73521_31, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-511-2014","Class II","LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668011390 ","LOSARTAN POTASSIUM, Tablet, 25 mg has the following code Pedigree: AD65323_10, EXP: 5/29/2014. ",,"180 Tablets","Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, NDC 00093312901, Pedigree: AD65323_4, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-695-2014","Class II","HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105 ","HYDROCORTISONE Tablet, 5 mg has the following codes Pedigree: W002966, EXP: 6/11/2014; Pedigree: W003046, EXP: 6/12/2014. ",,"100 Tablets","Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-734-2014","Class II","MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 74312002832 ","MELATONIN, Tablet, 1 mg has the following code Pedigree: W003717, EXP: 6/26/2014. ",,"360 Tablets","Labeling:Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003711, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-686-2014","Class II","BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116 ","BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg has the following code Pedigree: AD42592_4, EXP: 5/14/2014. ",,"32 Lozenges","Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-470-2014","Class II","CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260 ","CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium has the following code Pedigree: AD28333_1, EXP: 5/8/2014. ",,"100 Tablets","Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-728-2014","Class II","FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130 ","FLUCONAZOLE, Tablet, 50 mg has the following code Pedigree: W003066, EXP: 6/12/2014. ",,"29 Tablets","Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-725-2014","Class II","RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901 ","RAMIPRIL, Capsule, 2.5 mg, Rx only has the following codes Pedigree: AD54549_16, EXP: 5/20/2014; Pedigree: AD76639_1, EXP: 5/31/2014. ",,"200 Capsules","Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree: AD54549_13, EXP: 5/20/2014; CALCIUM POLYCARBOPHIL, Tablet, 625 mg, NDC 00536430611, Pedigree: AD73592_11, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-714-2014","Class II","COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118 ","COLESEVELAM HCL Tablet, 625 mg has the following code Pedigree: AD46426_19, EXP: 5/15/2014 ",,"180 Tablets","Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: AD46265_31, EXP: 5/15/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-711-2014","Class II","guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310 ","guanFACINE HCl Tablet, 2 mg has the following codes Pedigree: AD21790_13, EXP: 5/1/2014; Pedigree: W002999, EXP: 6/11/2014; Pedigree: W003678, EXP: 6/25/2014; Pedigree: AD60272_10, EXP: 5/22/2014. ",,"501 Tablets","Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014; ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60272_4, EXP: 5/22/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-463-2014","Class II","ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160. ","ZINC GLUCONATE, Tablet, 50 mg has the following codes: Pedigree: AD60240_57, EXP: 5/22/2014; Pedigree: W003028, EXP: 6/12/2014. ",,"200 Tablets","Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-703-2014","Class II","DISULFIRAM Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980017101 ","DISULFIRAM Tablet, 250 mg has the following code Pedigree: AD22609_1, EXP: 5/2/2014. ",,"100 Tablets","Labeling: Label Mixup; DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_22, EXP: 5/2/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-524-2014","Class II","SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303 ","SIMVASTATIN, Tablet, 20 mg has the following code Pedigree: W003580, EXP: 6/24/2014. ",,"1,000 Tablets","Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, EXP: 6/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-473-2014","Class II","CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260 ","CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) has the following code Pedigree: AD21846_24, EXP: 5/1/2014. ",,"200 Tablets","Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially mislabeled as TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD21858_10, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-577-2014","Class II","NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030301 ","NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg has the following code Pedigree: AD52778_58, EXP: 5/20/2014. ",,"100 Capsules","Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-532-2014","Class II","PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011401 ","PROPRANOLOL HCL, Tablet, 80 mg has the following code Pedigree: AD42566_4, EXP: 5/14/2014. ",,"100 Tablets","Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-693-2014","Class II","ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001 ","ZONISAMIDE Capsule, 100 mg has the following code Pedigree: W003786, EXP: 6/27/2014. ",,"100 Capsules","Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-689-2014","Class II","PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304 ","PANTOPRAZOLE SODIUM DR Tablet, 20 mg has the following codes Pedigree: AD70690_4, EXP: 5/29/2014. ",,"90 Tablets","Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-569-2014","Class II","guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878 ","guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21790_58, EXP: 5/1/2014; Pedigree: W002734, EXP: 6/6/2014; Pedigree: W003689, EXP: 6/26/2014; Pedigree: AD30140_37, EXP: 5/7/2014; Pedigree: W003006, EXP: 6/11/2014. ",,"500 Tablets","Labeling: Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP: 5/1/2014; FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: W002733, EXP: 6/6/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: W003688, EXP: 5/31/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD30140_34, EXP: 5/7/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: W003012, EXP: 6/11/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-488-2014","Class II","CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760 ","CHOLECALCIFEROL, Tablet, 2000 units has the following codes Pedigree: AD46312_37, EXP: 5/16/2014; Pedigree: AD65311_1, EXP: 5/24/2014; Pedigree: W003539, EXP: 6/21/2014; Pedigree: W003744, EXP: 6/26/2014; Pedigree: AD54586_10, EXP: 5/21/2014. ",,"2,998 Tablets","Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00074707090, Pedigree: W003743, EXP: 6/26/2014; NICOTINE POLACRILEX, GUM, 2 mg, NDC 24385059471, Pedigree: AD54586_7, EXP: 3/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-607-2014","Class II","NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51991073801 ","NEOMYCIN SULFATE, Tablet, 500 mg has the following code Pedigree: AD49448_17, EXP: 5/17/2014. ",,"100 Tablets","Labeling: Label Mixup; NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPRAMINE HCL, Tablet, 25 mg, NDC 00781176401, Pedigree: AD49448_10, EXP: 5/17/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-679-2014","Class II","ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101 ","ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD73525_1, EXP: 5/30/2014; Pedigree: AD30140_1, EXP: 5/7/2014. ",,"398 Tablets","Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014; PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-522-2014","Class II","PRAMIPEXOLE DI-HCL Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058701 ","PRAMIPEXOLE DI-HCL Tablet, 1 mg has the following code Pedigree: W003150, EXP: 6/13/2014. ",,"90 Tablets","Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: W003117, EXP: 6/13/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-613-2014","Class II","MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981 ","MESALAMINE CR, Capsule, 250 mg has the following code Pedigree: AD52412_1, EXP: 5/17/2014. ",,"240 Capsules","Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-674-2014","Class II","OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588 ","OXcarbazepine, Tablet, 600 mg has the following code Pedigree: AD30140_46, EXP: 5/7/2014. ",,"100 Tablets","Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-664-2014","Class II","QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313001 ","QUEtiapine FUMARATE, Tablet, 25 mg has the following codes Pedigree: AD33897_25, EXP: 5/9/2014; Pedigree: W003099, EXP: 6/13/2014. ",,"400 Tablets","Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014; ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-498-2014","Class II","GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103 ","GALANTAMINE HBr ER, Capsule, 8 mg has the following code Pedigree: W003509, EXP: 6/21/2014. ",,"30 Capsules","Labeling: Label Mixup; GALANTAMINE HBr ER, Capsule, 8 mg may be potentially mislabeled as FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003508, EXP: 6/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-644-2014","Class II","NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401 ","NIFEdipine, Capsule, 10 mg has the following code Pedigree: AD52778_55, EXP: 5/20/2014. ",,"100 Capsules","Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-713-2014","Class II","BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075410 ","BENAZEPRIL HCL Tablet, 40 mg has the following codes Pedigree: AD49423_1, EXP: 5/16/2014; Pedigree: W003918, EXP: 6/28/2014; Pedigree: AD32757_7, EXP: 5/13/2014; Pedigree: AD68010_1, EXP: 5/28/2014. ",,"799 Tablets","Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP: 5/16/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003931, EXP: 6/28/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD42592_1, EXP: 5/14/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 00904513559, Pedigree: AD68022_4, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-716-2014","Class II","QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862048901 ","QUEtiapine FUMARATE, Tablet, 25 mg has the following code Pedigree: AD49582_22, EXP: 4/30/2014. ",,"400 Tablets","Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-733-2014","Class II","MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 68585000575 ","MAGNESIUM CHLORIDE, Tablet, 64 mg has the following codes Pedigree: AD52993_4, EXP: 5/17/2014; Pedigree: W003527, EXP: 6/21/2014; Pedigree: W002712, EXP: 6/6/2014; Pedigree: W003359, EXP: 6/19/2014; Pedigree: W003923, EXP: 6/28/2014. ",,"720 Tablets","Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: W003408, EXP: 6/19/2014; FIDAXOMICIN, Tablet, 200 mg, NDC 52015008001, Pedigree: W003920, EXP: 6/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-496-2014","Class II","OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 05445800022 ","OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following code Pedigree: AD21858_4, EXP: 5/1/2014. ",,"90 Capsules","Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD21790_70, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-580-2014","Class II","LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374 ","LACTOBACILLUS GG, Capsule, 10 Billion Cells has the following code Pedigree: AD21965_19, EXP: 5/1/2014. ",,"300 Cells","Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD21965_22, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-515-2014","Class II","ALLOPURINOL Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714004204 ","ALLOPURINOL Tablet, 300 mg has the following code Pedigree: AD52778_1, EXP: 5/20/2014. ",,"100 Tablets","Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-636-2014","Class II","SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101 ","SEVELAMER HCl Tablet, 800 mg has the following code Pedigree: W002858, EXP: 6/7/2014. ",,"180 Tablets","Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP: 6/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-558-2014","Class II","PANCRELIPASE DR Capsule, Rx only, Distributed by: AidaPak Service, LLC, NDC 42865010302 ","PANCRELIPASE DR, Capsule has the following codes Pedigree: W003354, EXP: 6/19/2014; Pedigree: W003171, EXP: 6/13/2014. ",,"200 Capsules","Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014; VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-704-2014","Class II","SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980018210 ","SODIUM BICARBONATE Tablet, 650 mg has the following code Pedigree: W002970, EXP: 6/11/2014. ",,"1,013 Tablets","Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: W002974, EXP: 6/11/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-676-2014","Class II","CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001 ","CALCITRIOL, Capsule, 0.5 mcg has the following codes Pedigree: W003730, EXP: 6/26/2014; Pedigree: AD32757_10, EXP: 5/14/2014. ",,"500 Capsules","Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-682-2014","Class II","guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815 ","guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21965_22, EXP: 5/1/2014; Pedigree: AD56917_13, EXP: 5/21/2014; Pedigree: AD73627_23, EXP: 5/30/2014; Pedigree: W003218, EXP: 6/17/2014; Pedigree: W003360, EXP: 6/19/2014; Pedigree: W002660, EXP: 6/5/2014. ",,"600 Tablets","Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216, EXP: 6/14/2014; LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003357, EXP: 6/19/2014; LEFLUNOMIDE, Tablet, 10 mg, NDC 23155004303, Pedigree: W002659, EXP: 6/5/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-688-2014","Class II","MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081601 ","MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet has the following codes Pedigree: AD60272_31, EXP: 5/22/2014; Pedigree: AD73627_8, EXP: 5/30/2014; Pedigree: W002507, EXP: 6/3/2014. ",,"400 Tablets","Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00527134601, Pedigree: AD60272_22, EXP: 5/22/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD73627_1, EXP: 5/30/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: W002513, EXP: 6/3/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-468-2014","Class II","COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546 ","COENZYME Q-10, Capsule, 30 mg has the following code Pedigree: W002814, EXP: 6/7/2014. ",,"60 Capsules","Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-654-2014","Class II","MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258017201 ","MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium) has the following code Pedigree: AD30197_16, EXP: 5/9/2014. ",,"100 Tablets","Labeling:Label Mixup; MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD30197_7, EXP: 5/9/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-642-2014","Class II","methylPREDNISolone Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59746000103 ","methylPREDNISolone, Tablet, 4 mg has the following code Pedigree: AD21811_17, EXP: 5/1/2014. ",,"21 Tablets","Labeling:Label Mixup; methylPREDNISolone Tablet, 4 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00781519192, Pedigree: AD22616_10, EXP: 5/2/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-612-2014","Class II","TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601 ","TRIMETHOBENZAMIDE HCl, Capsule, 300 mg has the following codes Pedigree: AD21858_10, EXP: 5/1/2014; Pedigree: AD70625_1, EXP: 5/29/2014; Pedigree: W002976, EXP: 6/11/2014. ",,"300 Capsules","Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-665-2014","Class II","QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301 ","QUEtiapine FUMARATE, Tablet, 100 mg has the following codes Pedigree: W002777, EXP: 6/6/2014; Pedigree: W003825, EXP: 6/27/2014; Pedigree: AD73623_13, EXP: 5/30/2014. ",,"1,300 Tablets","Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-687-2014","Class II","MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081501 ","MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) has the following code Pedigree: AD22609_7, EXP: 5/2/2014. ",,"100 Chew Tablets","Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-487-2014","Class II","CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660 ","CHOLECALCIFEROL, Capsule, 5000 units has the following codes Pedigree: AD70629_19, EXP: 5/29/2014; Pedigree: W003541, EXP: 6/21/2014; Pedigree: AD52993_22, EXP: 5/20/2014. ",,"300 Capsules","Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-631-2014","Class II","ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088 ","ISOSORBIDE DINITRATE ER, Tablet, 40 mg has the following code Pedigree: AD23082_4, EXP: 5/3/2014. ",,"100 Tablets","Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-721-2014","Class II","DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060 ","DOCUSATE SODIUM, Capsule, 50 mg has the following codes Pedigree: AD60211_8, EXP: 5/21/2014; Pedigree: AD62865_10, EXP: 5/23/2014; Pedigree: AD65457_13, EXP: 5/24/2014. ",,"181 Capsules","Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-641-2014","Class II","DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630 ","DARUNAVIR, Tablet, 800 mg has the following code Pedigree: W003929, EXP: 7/1/2014. ",,"90 Tablets","Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-650-2014","Class II","QUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762502001 ","QUINAPRIL HCL, Tablet, 10 mg has the following code Pedigree: AD42611_4, EXP: 5/14/2014. ",,"90 Tablets","Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-570-2014","Class II","LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802065078 ","LORATADINE, Tablet, 10 mg has the following codes Pedigree: W002652, EXP: 6/5/2014; Pedigree: AD22865_7, EXP: 5/2/2014; Pedigree: W003253, EXP: 6/17/2014. ",,"799 Tablets","Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-508-2014","Class II","lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701 ","lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg) has the following codes Pedigree: ADWA00002116, EXP: 5/31/2014; Pedigree: AD46265_31, EXP: 5/15/2014. ",,"600 Tablets","Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-542-2014","Class II","BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 29300012601 ","BISOPROLOL FUMARATE Tablet, 5 mg has the following code Pedigree: AD34934_7, EXP: 5/10/2014. ",,"299 Tablets","Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-605-2014","Class II","MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991001406 ","MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD25452_16, EXP: 5/3/2014; Pedigree: AD28322_7, EXP: 5/6/2014; Pedigree: AD70655_14, EXP: 5/28/2014; Pedigree: W003999, EXP: 7/1/2014; Pedigree: AD32325_7, EXP: 5/9/2014; Pedigree: AD68019_7, EXP: 5/28/2014. ",,"718 Tablets","Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W003998, EXP: 7/1/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD30140_1, EXP: 5/7/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD68019_4, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-565-2014","Class II","NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024 ","NIFEDIPINE, Capsule, 10 mg has the following codes Pedigree: AD23082_7, EXP: 9/23/2013; Pedigree: AD23082_10, EXP: 9/23/2013. ",,"202 Capsules","Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-634-2014","Class II","DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110 ","DOCUSATE SODIUM, Capsule, 100 mg has the following codes Pedigree: AD37063_1, EXP: 5/13/2014; Pedigree: W002977, EXP: 6/11/2014. ",,"1,998 Capsules","Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4, EXP: 5/13/2014; tiZANidine HCl, Tablet, 2 mg, NDC 00378072219, Pedigree: W002975, EXP: 6/11/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-732-2014","Class II","RASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256 ","RASAGILINE MESYLATE, Tablet, 0.5 mg has the following code Pedigree: W002929, EXP: 6/10/2014. ",,"30 Tablets","Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-554-2014","Class II","FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 41167412003 ","FEXOFENADINE HCL, Tablet, 180 mg has the following code Pedigree: AD62834_1, EXP: 5/23/2014. ",,"30 Tablets","Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-683-2014","Class II","guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834 ","guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD62834_4, EXP: 5/24/2014; Pedigree: AD62834_7, EXP: 5/24/2014; Pedigree: W003514, EXP: 6/21/2014; Pedigree: W003574, EXP: 6/24/2014; Pedigree: W003850, EXP: 6/27/2014; Pedigree: W003931, EXP: 6/28/2014; Pedigree: AD46429_1, EXP: 5/15/2014; Pedigree: AD73592_1, EXP: 5/31/2014. ",,"480 Tablets","Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003558, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003845, EXP: 6/27/2014; TERAZOSIN HCL, Capsule, 5 mg, NDC 00781205301, Pedigree: W003913, EXP: 6/28/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD46300_1, EXP: 5/15/2014; IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: AD73686_7, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-623-2014","Class II","MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130 ","MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) has the following code Pedigree: AD21787_4, EXP: 5/1/2014. ",,"60 Tablets","Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-506-2014","Class II","CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901 ","CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg has the following code Pedigree: AD34928_1, EXP: 5/9/2014. ",,"135 Tablets","Labeling: Label Mixup; CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD37088_4, EXP: 5/9/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-720-2014","Class II","SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006 ","SELEGILINE HCL, Capsule, 5 mg has the following code Pedigree: AD54549_19, EXP: 5/20/2014. ",,"60 Capsules","Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZOLE, Capsule, 100 mg, NDC 10147170003, Pedigree: AD54549_10, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-672-2014","Class II","PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046 ","PANTOPRAZOLE SODIUM DR Tablet, 20 mg has the following code Pedigree: AD52778_64, EXP: 5/20/2014. ",,"90 Tablets","Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-550-2014","Class II","NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769 ","NICOTINE POLACRILEX Lozenge, 2 mg has the following codes Pedigree: AD52433_4, EXP: 5/17/2014; Pedigree: AD70700_4, EXP: 5/29/2014; Pedigree: AD73623_7, EXP: 5/30/2014; Pedigree: W003823, EXP: 6/27/2014; Pedigree: W003463, EXP: 6/20/2014. ",,"1,582 Lozenges","Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: AD52433_1, EXP: 5/17/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70700_1, EXP: 5/29/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD73623_1, EXP: 5/30/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003822, EXP: 6/27/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003440, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-595-2014","Class II","TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111091601 ","TORSEMIDE, Tablet, 10 mg has the following code Pedigree: AD30197_25, EXP: 5/9/2014. ",,"100 Tablets","Labeling: Label Mixup; TORSEMIDE, Tablet, 10 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD30197_22, EXP: 5/9/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-495-2014","Class II","NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901 ","NAPROXEN, Tablet, 500 mg has the following codes Pedigree: AD54516_1, EXP: 5/20/2014; Pedigree: AD68025_8, EXP: 5/28/2014. ",,"200 Tablets","Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-552-2014","Class II","VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022251 ","VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg has the following codes Pedigree: AD30180_19, EXP: 5/9/2014; Pedigree: AD60211_20, EXP: 5/21/2014; Pedigree: AD39588_10, EXP: 5/13/2014. ",,"182 Tablets","Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD30180_16, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD60211_8, EXP: 5/21/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD39588_1, EXP: 5/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-584-2014","Class II","NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49348085216 ","NICOTINE POLACRILEX, Lozenge, 2 mg has the following code Pedigree: W003393, EXP: 6/19/2014. ",,"70 Lozenges","Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003361, EXP: 6/19/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-637-2014","Class II","SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001 ","SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014. ",,"3,238 Tablets","Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002851, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 100 mg, NDC 57896040110, Pedigree: W002977, EXP: 6/11/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD56917_1, EXP: 5/21/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD73627_8, EXP: 5/30/2014; MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W002695, EXP: 6/5/2014; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: W002610, EXP: 6/4/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003492, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-611-2014","Class II","DOXYCYCLINE HYCLATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489012002 ","DOXYCYCLINE HYCLATE Tablet, 100 mg has the following code Pedigree: AD30993_8, EXP: 5/9/2014. ",,"50 Tablets","Labeling: Label Mixup; DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DESLORATADINE, Tablet, 5 mg, NDC 00085126401, Pedigree: AD30993_5, EXP: 2/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-692-2014","Class II","LISINOPRIL Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679092701 ","LISINOPRIL Tablet, 2.5 mg has the following codes Pedigree: AD25264_4, EXP: 5/3/2014; Pedigree: W003365, EXP: 6/19/2014. ",,"300 Tablets","Labeling: Label Mixup; LISINOPRIL Tablet, 2.5 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD23087_1, EXP: 5/2/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003358, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-646-2014","Class II","MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141509 ","MIRTAZAPINE, Tablet, 7.5 mg has the following code Pedigree: W003693, EXP: 4/30/2014. ",,"90 Tablets","Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-543-2014","Class II","CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271 ","CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg has the following codes Pedigree: W002692, EXP: 6/5/2014; Pedigree: W003715, EXP: 6/26/2014; Pedigree: W003716, EXP: 6/26/2014; Pedigree: AD60240_11, EXP: 5/22/2014; Pedigree: W002693, EXP: 6/5/2014; Pedigree: AD46257_13, EXP: 5/15/2014. ",,"546 Capsules","Labeling: Label Mixup; CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: W002653, EXP: 6/5/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W003779, EXP: 6/26/2014; NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003739, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/400 mg, NDC 54458010022, Pedigree: AD60240_33, EXP: 5/22/2014; LEFLUNOMIDE, Tablet, 10 mg, NDC 23155004303, Pedigree: W002658, EXP: 6/4/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD46300_14, EXP: 5/15/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-583-2014","Class II","D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348041010 ","D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units has the following code Pedigree: AD52993_28, EXP: 5/20/2014. ",,"107 Capsules","Labeling: Label Mixup; D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD52993_19, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-705-2014","Class II","RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106 ","RILUZOLE Tablet, 50 mg has the following code Pedigree: W003255, EXP: 6/17/2014. ",,"240 Tablets","Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-708-2014","Class II","FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110 ","FLECAINIDE ACETATE Tablet, 50 mg has the following code Pedigree: AD46414_16, EXP: 5/16/2014. ",,"100 Tablets","Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-638-2014","Class II","MULTIVITAMIN/MULTIMINERAL Chew Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 58914001460 ","MULTIVITAMIN/MULTIMINERAL, Chew Tablet has the following codes Pedigree: AD30180_10, EXP: 5/9/2014; Pedigree: AD32325_1, EXP: 5/9/2014. ",,"180 Chew Tablets","Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Chew Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD30140_40, EXP: 5/7/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU, NDC 43292050022, Pedigree: AD30028_10, EXP: 5/7/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-723-2014","Class II","IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67877029401 ","IBUPROFEN, Tablet, 400 mg has the following code Pedigree: W002577, EXP: 6/3/2014. ",,"200 Tablets","Labeling:Label Mixup; IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002573, EXP: 6/3/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-527-2014","Class II","LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303 ","LEFLUNOMIDE Tablet, 10 mg has the following codes Pedigree: W002659, EXP: 6/5/2014; Pedigree: W002658, EXP: 6/4/2014.",,"60 Tablets","Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-657-2014","Class II","FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251002 ","FOSINOPRIL SODIUM, Tablet, 10 mg has the following code Pedigree: AD46414_19, EXP: 5/16/2014. ",,"90 Tablets","Labeling:Label Mixup; FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD46414_10, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-476-2014","Class II","ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559 ","ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg has the following code Pedigree: AD68022_4, EXP: 5/28/2014. ",,"100 Tablets","Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-706-2014","Class II","FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110 ","FOLIC ACID, Tablet, 1 mg has the following codes Pedigree: AD33897_22, EXP: 5/9/2014; Pedigree: W003822, EXP: 6/27/2014; Pedigree: W003097, EXP: 6/13/2014. ",,"1,000 Tablets","Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014; DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-559-2014","Class II","HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401 ","HYOSCYAMINE SULFATE ER Tablet, 0.375 mg has the following code Pedigree: W003576, EXP: 6/24/2014. ",,"99 Tablets","Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-700-2014","Class II","LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950 ","LACTOBACILLUS Tablet has the following codes Pedigree: AD62986_10, EXP: 5/23/2014; Pedigree: AD62992_1, EXP: 5/23/2014; Pedigree: AD22865_1, EXP: 5/2/2014; Pedigree: W003624, EXP: 1/31/2014; Pedigree: W003622, EXP: 6/25/2014; Pedigree: W003623, EXP: 10/31/2013. ",,"1,249 Tablets","Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003462, EXP: 6/20/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003648, EXP: 6/25/2014; LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003622, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-537-2014","Class II","LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385014976 ","LACTASE ENZYME Tablet, 3000 units has the following codes Pedigree: AD21846_31, EXP: 5/1/2014; Pedigree: W003721, EXP: 6/26/2014; Pedigree: AD30028_25, EXP: 5/7/2014; Pedigree: AD60240_36, EXP: 5/22/2014; Pedigree: W002700, EXP: 6/5/2014; Pedigree: AD46257_53, EXP: 5/15/2014; Pedigree: W003021, EXP: 6/12/2014. ",,"2,872 Tablets","Labeling: Label Mixup; LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: AD21811_4, EXP: 5/1/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 46122010478, Pedigree: W003722, EXP: 4/30/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD30140_37, EXP: 5/7/2014; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: AD60240_27, EXP: 5/22/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: W002696, EXP: 6/5/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD46257_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: W003009, EXP: 6/11/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-519-2014","Class II","FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714052201 ","FINASTERIDE Tablet, 5 mg has the following codes Pedigree: AD62846_1, EXP: 2/28/2014; Pedigree: W003031, EXP: 2/28/2014. ",,"120 Tablets","Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP: 5/23/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003061, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-709-2014","Class II","MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066810 ","MULTIVITAMIN/MULTIMINERAL Tablet has the following code Pedigree: AD73646_13, EXP: 5/30/2014. ",,"200 Tablets","Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as PRENATAL MULTIVITAMIN/MULTIMINERAL Tablet, NDC 00904531360, Pedigree: AD73652_16, EXP: 5/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-585-2014","Class II","ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015 ","ASPIRIN EC DR, Tablet, 81 mg has the following codes Pedigree: AD28349_1, EXP: 2/28/2014; Pedigree: W003672, EXP: 2/28/2014. ",,"544 Tablets","Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-643-2014","Class II","COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762045001 ","COLESTIPOL HCL MICRONIZED, Tablet, 1 g has the following code Pedigree: AD56847_1, EXP: 5/21/2014. ",,"120 Tablets","Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as rifAXIMin, Tablet, 200 mg, NDC 65649030103, Pedigree: AD54587_10, EXP: 4/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-597-2014","Class II","TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50742020801 ","TACROLIMUS, Capsule, 1 mg has the following code Pedigree: AD60590_1, EXP: 5/29/2014. ",,"100 Capsules","Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890, Pedigree: AD70633_4, EXP: 5/23/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-690-2014","Class II","PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043402 ","PANTOPRAZOLE SODIUM DR Tablet, 40 mg has the following code Pedigree: AD37063_10, EXP: 5/13/2014. ",,"1,001 Tablets","Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-663-2014","Class II","OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203 ","OLANZAPINE, Tablet, 7.5 mg has the following code Pedigree: AD21790_76, EXP: 5/1/2014. ",,"60 Tablets","Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: AD21790_73, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-603-2014","Class II","WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701 ","WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg) has the following code Pedigree: AD60590_4, EXP: 5/29/2014. ",,"200 Tablets","Labeling: Label Mixup; WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-517-2014","Class II","FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103 ","FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014. ",,"100 Capsules","Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-538-2014","Class II","NICOTINE POLACRILEX Gum, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 24385059471 ","NICOTINE POLACRILEX Gum, 2 mg has the following code Pedigree: AD54586_7, EXP: 3/31/2014. ",,"50 Pieces of Gum","Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-479-2014","Class II","ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260 ","ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) has the following code Pedigree: AD57624_1, EXP: 5/9/2014. ",,"99 Capsules","Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-541-2014","Class II","PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515 ","PHYTONADIONE Tablet, 5 mg has the following codes Pedigree: AD46312_22, EXP: 4/30/2014; Pedigree: W003061, EXP: 5/31/2014; Pedigree: W003737, EXP: 5/31/2014; Pedigree: AD25452_1, EXP: 4/30/2014; Pedigree: W003440, EXP: 5/31/2014. ",,"500 Tablets","Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001, Pedigree: AD25264_13, EXP: 5/3/2014; VENLAFAXINE HCL ER, Capsule, 150 mg, NDC 00093738656, Pedigree: W003414, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-593-2014","Class II","traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303 ","traZODone HCl, Tablet, 50 mg has the following code Pedigree: AD54475_7, EXP: 5/20/2014. ",,"2,000 Tablets","Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-662-2014","Class II","ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505267109 ","ATORVASTATIN CALCIUM, Tablet, 80 mg has the following code Pedigree: AD21965_4, EXP: 5/1/2014. ",,"90 Tablets","Labeling:Label Mixup; ATORVASTATIN CALCIUM, Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, 10 Billion Cells, NDC 49100036374, Pedigree: AD21965_19, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-630-2014","Class II","CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050788 ","CITALOPRAM, Tablet, 10 mg has the following codes Pedigree: AD56921_1, EXP: 5/21/2014; Pedigree: W002844, EXP: 6/7/2014. ",,"299 Tablets","Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014; COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-571-2014","Class II","DESIPRAMINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45963034302 ","DESIPRAMINE HCL, Tablet, 50 mg has the following code Pedigree: AD30140_7, EXP: 5/7/2014. ",,"98 Tablets","Labeling: Label Mixup; DESIPRAMINE HCL Tablet, 50 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD30140_4, EXP: 5/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-731-2014","Class II","PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490 ","PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg has the following code Pedigree: AD68010_20, EXP: 5/28/2014. ",,"90 Tablets","Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD68010_11, EXP: 5/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-547-2014","Class II","MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000391 ","MELATONIN Tablet, 1 mg has the following codes Pedigree: W002695, EXP: 6/5/2014; Pedigree: W003317, EXP: 6/18/2014. ",,"200 Tablets","Labeling: Label Mixup; MELATONIN Tablet, 1 mg may be potentially mislabeled as CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002692, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W003252, EXP: 6/17/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-624-2014","Class II","CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330 ","CINACALCET HCL, Tablet, 30 mg has the following codes Pedigree: W003168, EXP: 6/13/2014; Pedigree: AD54516_4, EXP: 5/20/2014; Pedigree: AD32757_50, EXP: 5/14/2014; Pedigree: W003615, EXP: 6/25/2014; Pedigree: AD52778_82, EXP: 5/21/2014; Pedigree: AD73597_13, EXP: 5/31/2014; Pedigree: W003481, EXP: 6/20/2014; Pedigree: W003492, EXP: 6/20/2014. ",,"600 Tablets","Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003113, EXP: 6/13/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), NDC 00904759160, Pedigree: AD54553_1, EXP: 5/20/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD32757_40, EXP: 5/14/2014; COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: W003612, EXP: 6/25/2014; quiNIDine SULFATE, Tablet, 200 mg, NDC 00591543801, Pedigree: AD52778_79, EXP: 5/21/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD73597_10, EXP: 5/31/2014; EXEMESTANE, Tablet, 25 mg, NDC 00054008013, Pedigree: W003471, EXP: 6/20/2014; LURASIDONE HCL, Tablet, 120 mg, NDC 63402031230, Pedigree: W003487, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-466-2014","Class II","CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713 ","CYANOCOBALAMIN, Tablet, 1000 mcg has the following codes Pedigree: AD21846_46, EXP: 5/1/2014; Pedigree: AD46257_59, EXP: 5/15/2014; Pedigree: AD32582_3, EXP: 5/9/2014; Pedigree: AD60240_51, EXP: 5/22/2014; Pedigree: W002839, EXP: 6/7/2014; Pedigree: W003026, EXP: 6/12/2014; Pedigree: W003075, EXP: 6/12/2014; Pedigree: W003322, EXP: 6/19/2014. ",,"1,821 Tablets","Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904531360, Pedigree: AD60428_7, EXP: 5/22/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002826, EXP: 6/7/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003011, EXP: 6/12/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003053, EXP: 6/12/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003326, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-604-2014","Class II","carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672412401 ","carBAMazepine ER, Tablet, 200 mg has the following code Pedigree: AD60272_7, EXP: 5/22/2014. ",,"200 Tablets","Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: AD60272_1, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-491-2014","Class II","DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159 ","DOCUSATE SODIUM, Capsule, 250 mg has the following codes Pedigree: AD68028_1, EXP: 5/28/2014; Pedigree: AD68022_1, EXP: 5/28/2014; Pedigree: AD37072_1, EXP: 5/13/2014; Pedigree: AD37072_4, EXP: 5/13/2014; Pedigree: AD56924_1, EXP: 5/21/2014; Pedigree: W003671, EXP: 6/25/2014; Pedigree: W002920, EXP: 6/10/2014. ",,"4,318 Capsules","Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_1, EXP: 5/13/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: AD56882_1, EXP: 5/21/2014; LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003623, EXP: 10/31/2013; NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: W002930, EXP: 6/10/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-521-2014","Class II","PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501 ","PRAMIPEXOLE DI-HCL Tablet, 0.25 mg has the following code Pedigree: W003761, EXP: 6/26/2014. ",,"90 Tablets","Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-573-2014","Class II","buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886 ","buPROPion HCl ER, Tablet, 200 mg has the following code Pedigree: W002727, EXP: 6/6/2014. ",,"60 Tablets","Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-658-2014","Class II","FOSINOPRIL SODIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251102 ","FOSINOPRIL SODIUM, Tablet, 20 mg has the following code Pedigree: AD70690_1, EXP: 5/29/2014. ",,"90 Tablets","Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: AD65478_1, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-480-2014","Class II","ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260 ","ZINC SULFATE, Capsule, 50 mg has the following code Pedigree: AD30994_8, EXP: 5/9/2014. ",,"100 Capsules","Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-618-2014","Class II","LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629011101 ","LACTOBACILLUS ACIDOPHILUS, Capsule has the following codes Pedigree: AD65311_7, EXP: 5/24/2014; Pedigree: AD65311_4, EXP: 5/24/2014. ",,"2,392 Capsules","Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD65311_1, EXP: 5/24/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD65457_4, EXP: 5/24/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-710-2014","Class II","MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066850 ","MULTIVITAMIN/MULTIMINERAL Tablet has the following codes Pedigree: AD62979_1, EXP: 5/23/2014; Pedigree: W003553, EXP: 6/24/2014. ",,"1,000 Tablets","Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD62865_13, EXP: 5/23/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003514, EXP: 6/21/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-572-2014","Class II","ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 46122010478 ","ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg has the following code Pedigree: W003722, EXP: 4/30/2014. ",,"100 Tablets","Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: W003714, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-724-2014","Class II","QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180055809 ","QUINAPRIL HCL, Tablet, 20 mg has the following code Pedigree: W003556, EXP: 6/24/2014. ",,"90 Tablets","Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-652-2014","Class II","ASCORBIC ACID Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258014101 ","ASCORBIC ACID Tablet, 500 mg has the following code Pedigree: AD23082_19, EXP: 5/6/2014. ",,"300 Tablets","Labeling:Label Mixup; ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree: AD23082_16, EXP: 11/1/2013.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-617-2014","Class II","VITAMIN B COMPLEX W/C Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629008001 ","VITAMIN B COMPLEX W/C, Capsule has the following code Pedigree: AD39560_4, EXP: 5/13/2014. ",,"2,398 Capsules","Labeling:Label Mixup; VITAMIN B COMPLEX W/C Capsule may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD39560_1, EXP: 5/13/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-516-2014","Class II","VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101 ","VENLAFAXINE Tablet, 25 mg has the following code Pedigree: AD67989_4, EXP: 11/30/2013. ",,"100 Tablets","Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD65457_22, EXP: 5/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-504-2014","Class II","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 ","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg has the following codes Pedigree: AD70655_20, EXP: 5/29/2014; Pedigree: AD73627_35, EXP: 5/30/2014. ",,"210 Capsules","Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-625-2014","Class II","CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430 ","CINACALCET HCL, Tablet, 60 mg has the following code Pedigree: W003742, EXP: 6/26/2014. ",,"60 Tablets","Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-715-2014","Class II"," rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103 ","rifAXIMin Tablet, 200 mg has the following code Pedigree: AD54587_10, EXP: 4/30/2014. ",,"30 Tablets","Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-579-2014","Class II","LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374 ","LACTOBACILLUS GG, Capsule has the following codes Pedigree: AD39588_4, EXP: 5/13/2014 Pedigree: AD65457_16, EXP: 5/24/2014 Pedigree: AD70655_8, EXP: 5/29/2014 Pedigree: AD73627_17, EXP: 5/30/2014 Pedigree: W003051, EXP: 6/12/2014 Pedigree: W003216, EXP: 6/14/2014 Pedigree: AD42584_12, EXP: 5/14/2014 Pedigree: AD46300_11, EXP: 5/15/2014 Pedigree: W002968, EXP: 6/11/2014 Pedigree: AD68019_1, EXP: 5/28/2014 Pedigree: W003172, EXP: 6/13/2014 Pedigree: W003173, EXP: 6/13/2014 ",,"1,970 Capsules","Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD73627_14, EXP: 5/30/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003047, EXP: 6/12/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: W003215, EXP: 6/14/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD42970_1, EXP: 5/14/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD46300_8, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W002967, EXP: 6/11/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD62829_1, EXP: 5/22/2014; PANCRELIPASE DR, Capsule, NDC 42865010302, Pedigree: W003171, EXP: 6/13/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003172, EXP: 6/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-544-2014","Class II","QUINAPRIL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722027090 ","QUINAPRIL Tablet, 40 mg has the following code Pedigree: AD52778_76, EXP: 5/21/2014. ",,"90 Tablets","Labeling: Label Mixup; QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 16714002104, Pedigree: AD52778_73, EXP: 5/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-467-2014","Class II","NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260 ","NIACIN TR, Tablet, 500 mg has the following code Pedigree: W002969, EXP: 6/11/2014. ",,"103 Tablets","Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-620-2014","Class II","tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915 ","tiZANidine HCl, Tablet, 1 mg (1/2 of 2 mg) has the following code Pedigree: AD60272_52, EXP: 5/22/2014. ",,"299 Tablets","Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-534-2014","Class II","VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155024801 ","VENLAFAXINE HCL Tablet, 50 mg has the following code Pedigree: AD65475_22, EXP; 5/28/2014. ",,"100 Tablets","Labeling: Label Mixup; VENLAFAXINE HCL Tablet, 50 mg may be potentially mislabeled as sulfaSALAzine, Tablet, 500 mg, NDC 00603580121, Pedigree: AD65475_19, EXP: 5/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-481-2014","Class II","GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152 ","GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg has the following codes Pedigree: AD21846_14, EXP: 5/1/2014; Pedigree: W003316, EXP: 6/18/2014; Pedigree: AD73521_16, EXP: 5/30/2014. ",,"180 Capsules","Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014; PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-578-2014","Class II","NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701 ","NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg has the following code Pedigree: AD25452_4, EXP: 5/3/2014. ",,"102 Capsules","Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD25452_1, EXP: 4/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-655-2014","Class II","CYPROHEPTADINE HCL Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60258085001 ","CYPROHEPTADINE HCL, Tablet, 4 mg has the following codes Pedigree: W003676, EXP: 6/25/2014; Pedigree: W003324, EXP: 6/18/2014. ",,"203 Tablets","Labeling:Label Mixup; CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W003673, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003323, EXP: 6/18/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-627-2014","Class II","tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289 ","tiZANidine HCL, Tablet, 2 mg has the following codes Pedigree: AD70700_10, EXP: 5/29/2014; Pedigree: W003750, EXP: 6/26/2014. ",,"299 Tablets","Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-563-2014","Class II","METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028 ","METHYLERGONOVINE MALEATE, Tablet, 0.2 mg has the following codes Pedigree: AD52778_40, EXP: 5/20/2014; Pedigree: W003477, EXP: 6/20/2014. ",,"112 Tablets","Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-626-2014","Class II","traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664037708 ","traMADol HCl, Tablet, 25 mg (1/2 of 50 mg) has the following code Pedigree: AD60272_92, EXP: 5/22/2014. ",,"200 Tablets","Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00527163801, Pedigree: AD60272_76, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-590-2014","Class II","HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701 ","HYDRALAZINE HCL, Tablet, 25 mg has the following code Pedigree: AD49610_4, EXP: 5/16/2014. ",,"100 Tablets","Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD49582_16, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-575-2014","Class II","QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 47335090288 ","QUETIAPINE FUMARATE, Tablet, 12.5 mg (1/2 of 25 mg) has the following code Pedigree: AD21790_79, EXP: 5/1/2014. ",,"200 Tablets","Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-581-2014","Class II","LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374 ","LACTOBACILLUS GG, Capsule, 15 Billion Cells has the following codes Pedigree: W003357, EXP: 6/19/2014; Pedigree: W003787, EXP: 6/27/2014; Pedigree: W003869, EXP: 6/27/2014. ",,"630 Cells","Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-628-2014","Class II","METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652 ","METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD68010_14, EXP: 5/28/2014; Pedigree: AD68010_17, EXP: 5/28/2014. ",,"402 Tablets","Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68022_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_14, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-566-2014","Class II","ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024 ","ORPHENADRINE CITRATE ER, Tablet, 100 mg has the folowing code Pedigree: W002962, EXP: 6/11/2014. ",,"100 Tablets","Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-601-2014","Class II","ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801 ","ETODOLAC, Tablet, 400 mg has the following code Pedigree: W003734, EXP: 6/26/2014. ",,"101 Tablets","Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W003731, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-685-2014","Class II","BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016 ","BENZOCAINE/MENTHOL, Lozenge, 15 mg/3.6 mg has the following codes Pedigree: AD21811_4, EXP: 5/1/2014; Pedigree: W003273, EXP: 6/17/2014. ",,"80 Lozenges","Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-696-2014","Class II","COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907 ","COLCHICINE Tablet, 0.6 mg has the following codes Pedigree: AD46419_1, EXP: 5/16/2014; Pedigree: AD52778_22, EXP: 5/20/2014; Pedigree: AD65457_1, EXP: 5/23/2014; Pedigree: W003612, EXP: 6/25/2014; Pedigree: W002961, EXP: 6/11/2014. ",,"150 Tablets","Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003626, EXP: 6/25/2014; NIACIN, Tablet, 500 mg, NDC 00904227260, Pedigree: W002957, EXP: 6/10/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-525-2014","Class II","HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16729018201 ","HYDROCHLOROTHIAZIDE Tablet, 12.5 mg has the following code Pedigree: AD46414_25, EXP: 5/16/2014. ",,"100 Tablets","Labeling: Label Mixup; HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD46333_4, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-539-2014","Class II","PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515 ","PHYTONADIONE Tablet, 5 mg has the following codes Pedigree: AD46312_22, EXP: 4/30/2014; Pedigree: W003061, EXP: 5/31/2014; Pedigree: W003737, EXP: 5/31/2014; Pedigree: AD25452_1, EXP: 4/30/2014; Pedigree: W003440, EXP: 5/31/2014. ",,"500 Tablets","Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001, Pedigree: AD25264_13, EXP: 5/3/2014; VENLAFAXINE HCL ER, Capsule, 150 mg, NDC 00093738656, Pedigree: W003414, EXP: 6/19/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-472-2014","Class II","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260 ","CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) has the following code Pedigree: W003720, EXP: 6/26/2014. ",,"298 Tablets","Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-717-2014","Class II","IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830 ","IRBESARTAN, Tablet, 150 mg has the following codes Pedigree: W003649, EXP: 6/25/2014; Pedigree: AD73686_7, EXP: 5/31/2014. ",,"60 Tablets","Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-610-2014","Class II","CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 53191036201 ","CHOLECALCIFEROL, Capsule, 50000 units has the following code Pedigree: AD60268_4, EXP: 5/22/2014. ",,"100 Capsules","Labeling: Label Mixup; CHOLECALCIFEROL Capsule, 50000 units may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD60272_64, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-557-2014","Class II","LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001902 ","LIOTHYRONINE SODIUM Tablet, 25 mcg has the following codes Pedigree: AD46414_35, EXP: 5/16/2014; Pedigree: AD68010_11, EXP: 5/28/2014. ",,"200 Tablets","Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-513-2014","Class II","prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 16477050501 ","prednisoLONE, Tablet, 5 mg has the following code Pedigree: W003627, EXP: 6/25/2014. ",,"100 Tablets","Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-649-2014","Class II","MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801 ","MISOPROSTOL, Tablet, 200 mcg has the following codes Pedigree: AD21965_13, EXP: 5/1/2014; Pedigree: W003117, EXP: 6/13/2014. ",,"120 Tablets","Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-609-2014","Class II","HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201 ","HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014. ",,"100 Tablets","Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-562-2014","Class II","LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292055746 ","LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU has the following code Pedigree: W002698, EXP: 6/5/2014. ",,"999 Capsules","Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-556-2014","Class II","LIOTHYRONINE SODIUM, Tablet, 5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001802 ","LIOTHYRONINE SODIUM Tablet, 5 mcg has the following code Pedigree: AD46414_38, EXP: 5/16/2014. ",,"100 Tablets","Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 5 mcg may be potentially mislabeled as HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 16729018201, Pedigree: AD46414_25, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-632-2014","Class II","PIMOZIDE Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701 ","PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg) has the following code Pedigree: AD73525_61, EXP: 5/30/2014. ",,"200 Tablets","Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD73525_52, EXP: 5/30/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-727-2014","Class II","RIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382026007 ","RIBAVIRIN, Capsule, 200 mg has the following codes Pedigree: AD21790_37, EXP: 4/30/2014; Pedigree: AD30140_13, EXP: 4/30/2014. ",,"168 Capsules","Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014; DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-608-2014","Class II","FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001 ","FIDAXOMICIN, Tablet, 200 mg has the following code Pedigree: W003920, EXP: 6/28/2014. ",,"120 Tablets","Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-735-2014","Class II","HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910 ","HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg has the following codes Pedigree: AD54501_1, EXP: 5/21/2014; Pedigree: W003438, EXP: 6/20/2014. ",,"200 Tablets","Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-606-2014","Class II","PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51991056601 ","PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet has the following codes Pedigree: AD62829_18, EXP: 5/24/2014; Pedigree: W003511, EXP: 6/21/2014; Pedigree: AD32579_4, EXP: 5/9/2014; Pedigree: AD73597_16, EXP: 5/31/2014; Pedigree: W003086, EXP: 6/12/2014; Pedigree: W003034, EXP: 6/12/2014. ",,"1,399 Tablets","Labeling: Label Mixup; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD65457_1, EXP: 5/23/2014; GALANTAMINE HBr ER, Capsule, 8 mg, NDC 10147089103, Pedigree: W003509, EXP: 6/21/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00781532531, Pedigree: AD32579_7, EXP: 5/9/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD73597_13, EXP: 5/31/2014; VENLAFAXINE HCL ER, Capsule, 150 mg, NDC 00093738656, Pedigree: W003084, EXP: 6/12/2014; SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003033, EXP: 6/12/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-712-2014","Class II","BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162075110 ","BENAZEPRIL HCL Tablet, 5 mg has the following code Pedigree: AD52778_7, EXP: 5/20/2014. ",,"100 Tablets","Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-677-2014","Class II","HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304029601 ","HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg has the following code Pedigree: AD70629_10, EXP: 5/29/2014. ",,"200 Tablets","Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-546-2014","Class II","MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 35046000322 ","MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) has the following code Pedigree: W002687, EXP: 6/5/2014. ",,"90 Tablets","Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-675-2014","Class II","LETROZOLE Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756051183 ","LETROZOLE, Tablet, 2.5 mg has the following code Pedigree: W003868, EXP: 6/27/2014. ",,"30 Tablets","Labeling:Label Mixup; LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003848, EXP: 6/27/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-482-2014","Class II","MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904549213 ","MULTIVITAMIN/MULTIMINERAL, Tablet has the following code Pedigree: AD23082_13, EXP: 11/1/2013. ",,"520 Tablets","Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LISINOPRIL, Tablet, 2.5 mg, NDC 64679092701, Pedigree: AD25264_4, EXP: 5/3/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-661-2014","Class II","ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909 ","ATORVASTATIN CALCIUM, Tablet, 20 mg has the following code Pedigree: W003846, EXP: 6/27/2014. ",,"90 Tablets","Labeling:Label Mixup; ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003850, EXP: 6/27/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-540-2014","Class II","CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173 ","CAFFEINE Tablet, 200 mg has the following codes Pedigree: AD21846_37, EXP: 5/1/2014; Pedigree: AD60240_42, EXP: 5/22/2014; Pedigree: W003024, EXP: 6/12/2014; Pedigree: W003725, EXP: 6/26/2014. ",,"128 Tablets","Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003723, EXP: 6/26/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-600-2014","Class II","clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205 ","clomiPRAMINE HCl, Capsule, 50 mg has the following codes Pedigree: AD46265_1, EXP: 5/15/2014; Pedigree: W002998, EXP: 6/11/2014; Pedigree: W003675, EXP: 6/25/2014; Pedigree: AD30140_4, EXP: 5/7/2014; Pedigree: AD73525_4, EXP: 5/30/2014. ",,"450 Capsules","Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25, EXP: 5/15/2014; CHLORTHALIDONE, Tablet, 50 mg, NDC 00378021301, Pedigree: W002988, EXP: 6/11/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003674, EXP: 6/25/2014; ISOSORBIDE MONONITRATE, Tablet, 10 mg, NDC 62175010601, Pedigree: AD28352_1, EXP: 5/7/2014; EFAVIRENZ, Tablet, 600 mg, NDC 00056051030, Pedigree: AD73646_16, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-531-2014","Class II","PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011010 ","PROPRANOLOL HCL Tablet, 10 mg has the following code Pedigree: AD65317_1, EXP: 5/24/2014. ",,"1,999 Tablets","Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS, Capsule, NDC 54629011101, Pedigree: AD65311_4, EXP: 5/24/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-529-2014","Class II","PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001 ","PROPRANOLOL HCL Tablet, 10 mg has the following codes Pedigree: AD21790_34, EXP: 5/1/2014; Pedigree: AD52390_1, EXP: 5/17/2014; Pedigree: AD60272_37, EXP: 5/22/2014; Pedigree: W002732, EXP: 6/6/2014; Pedigree: W003229, EXP: 6/17/2014; Pedigree: AD60272_34, EXP: 5/22/2014; Pedigree: W003684, EXP: 6/25/2014; Pedigree: W002618, EXP: 6/4/2014; Pedigree: W003002, EXP: 6/11/2014; Pedigree: W003068, EXP: 6/12/2014; Pedigree: W003545, EXP: 6/21/2014. ",,"2,299 Tablets","Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W002731, EXP: 6/6/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003226, EXP: 6/17/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree: AD60272_28, EXP: 5/22/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003681, EXP: 6/25/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: W002616, EXP: 6/4/2014; LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003001, EXP: 4/30/2014; FLUCONAZOLE, Tablet, 50 mg, NDC 68462010130, Pedigree: W003066, EXP: 6/12/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W003491, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-528-2014","Class II","metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155010201 ","metFORMIN HCl, Tablet 500 mg has the following code Pedigree: AD46312_25, EXP: 5/16/2014. ",,"100 Tablets","Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-671-2014","Class II","ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837 ","ISOSORBIDE MONONITRATE ER Tablet, 30 mg has the following codes Pedigree: W003996, EXP: 7/1/2014; Pedigree: AD46297_1, EXP: 5/15/2014; Pedigree: W003350, EXP: 6/18/2014; Pedigree: AD21790_64, EXP: 5/1/2014; Pedigree: AD32757_37, EXP: 5/14/2014. ",,"700 Tablets","Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD21790_55, EXP: 5/1/2014; traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD39611_4, EXP: 5/14/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-548-2014","Class II","MULTIVITAMIN/MULTIMINERAL Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205018581 ","MULTIVITAMIN/MULTIMINERAL Tablet has the following codes Pedigree: AD32328_8, EXP: 5/9/2014; Pedigree: W002513, EXP: 6/3/2014. ",,"1,045 Tablets","Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as QUEtiapine FUMARATE, Tablet, 25 mg, NDC 60505313001, Pedigree: AD33897_25, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002512, EXP: 6/3/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-718-2014","Class II","PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510 ","PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg has the following code Pedigree: W003640, EXP: 6/25/2014. ",,"100 Tablets","Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-486-2014","Class II","CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460 ","CHOLECALCIFEROL, Tablet, 1000 units has the following codes Pedigree: W003464, EXP: 6/20/2014; Pedigree: AD33897_37, EXP: 5/9/2014; Pedigree: W002779, EXP: 6/6/2014; Pedigree: W003626, EXP: 6/25/2014; Pedigree: W003827, EXP: 6/27/2014; Pedigree: AD33897_34, EXP: 5/9/2014. ",,"2,399 Tablets","Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601, Pedigree: W003625, EXP: 6/25/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: W003824, EXP: 6/27/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD33897_31, EXP: 5/9/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-680-2014","Class II","ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310 ","ESZOPICLONE, Tablet, 3 mg has the following code Pedigree: W002765, EXP: 6/6/2014. ",,"100 Tablets","Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-639-2014","Class II","ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613 ","ARIPiprazole, Tablet, 2 mg has the following codes Pedigree: AD21790_43, EXP: 5/1/2014; Pedigree: AD30140_25, EXP: 5/7/2014; Pedigree: AD46265_19, EXP: 5/15/2014; Pedigree: AD46414_1, EXP: 5/16/2014; Pedigree: W003004, EXP: 6/11/2014. ",,"180 Tablets","Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD46419_4, EXP: 5/16/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: W003003, EXP: 6/11/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-555-2014","Class II","LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901 ","LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19, EXP: 3/31/2014. ",,"102 Tablets","Labeling: Label Mixup; LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg may be potentially mislabeled as MAGNESIUM GLUCONATE DIHYDRATE, Tablet, 500 mg (27 mg Elemental Magnesium), NDC 60258017201, Pedigree: AD30197_16, EXP: 5/9/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-596-2014","Class II","RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50458057930 ","RIVAROXABAN, Tablet, 20 mg has the following code Pedigree: W002620, EXP: 6/4/2014. ",,"30 Tablets","Labeling: Label Mixup; RIVAROXABAN Tablet, 20 mg may be potentially mislabeled as VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: W002619, EXP: 6/4/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-514-2014","Class II","PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714002104 ","PROPRANOLOL HCL, Tablet, 10 mg has the following code Pedigree: AD52778_73, EXP: 5/21/2014. ",,"100 Tablets","Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: AD52778_70, EXP: 5/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-568-2014","Class II","FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578 ","FEXOFENADINE HCL Tablet, 60 mg has the following codes Pedigree: W003020, EXP: 6/12/2014; Pedigree: AD60240_30, EXP: 5/22/2014; Pedigree: AD46257_50, EXP: 5/15/2014. ",,"300 Tablets","Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-599-2014","Class II","PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901 ","PYRIDOXINE HCL, Tablet, 50 mg has the following codes Pedigree: W002697, EXP: 6/5/2014; Pedigree: W003019, EXP: 6/12/2014; Pedigree: W003718, EXP: 6/26/2014; Pedigree: AD46257_25, EXP: 5/15/2014; Pedigree: AD73521_25, EXP: 5/30/2014. ",,"600 Tablets","Labeling: Label Mixup; PYRIDOXINE HCL Tablet, 50 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: W002699, EXP: 6/5/2014; MULTIVITAMIN/MULTIMINERAL W/IRON, Chew Tablet, NDC 00536781601, Pedigree: W003018, EXP: 6/12/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003705, EXP: 6/25/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD46257_53, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 04746900466, Pedigree: AD73521_19, EXP: 5/30/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-729-2014","Class II","FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230 ","FLUCONAZOLE, Tablet, 100 mg has the following code Pedigree: W003064, EXP: 6/12/2014. ",,"30 Tablets","Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-465-2014","Class II","OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360 ","OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following codes: Pedigree: AD33897_19, EXP: 5/9/2014; Pedigree: AD32328_5, EXP: 5/9/2014; Pedigree: W002852, EXP: 6/7/2014; Pedigree: AD62865_13, EXP: 5/23/2014; Pedigree: W002509, EXP: 6/3/2014; Pedigree: W003705, EXP: 6/25/2014; Pedigree: AD22845_7, EXP: 5/2/2014; Pedigree: AD39588_7, EXP:5/13/2014; Pedigree: AD73627_20, EXP: 5/30/2014; Pedigree: W003870, EXP: 6/27/2014; Pedigree: AD46300_14, EXP: 5/15/2014; Pedigree: AD60211_14, EXP: 5/22/2014; Pedigree: W003052, EXP: 6/12/2014; Pedigree: W003217, EXP: 6/14/2014; Pedigree: AD73623_4, EXP: 5/30/2014; Pedigree: W003462, EXP: 6/20/2014; Pedigree: W003195, EXP: 6/13/2014; Pedigree: W003473, EXP: 6/20/2014.",,"2,799 Capsules","Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD62865_10, EXP: 5/23/2014; PHENobarbital, Tablet, 97.2 mg, NDC 00603516821, Pedigree: AD73518_10, EXP: 5/31/2014; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), NDC 00904506260, Pedigree: W003720, EXP: 6/26/2014; DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD22609_4, EXP: 4/30/2014; ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD32757_34, EXP: 5/14/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD73652_7, EXP: 5/29/2014; LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003869, EXP: 6/27/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD46257_10, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD56917_10, EXP: 5/21/2014; ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003050, EXP: 6/12/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003242, EXP: 6/17/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD73627_20, EXP: 5/30/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00536342408, Pedigree: W003461, EXP: 6/20/2014; chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: W003194, EXP: 6/13/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003463, EXP: 6/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-691-2014","Class II","ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401 ","ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) has the following code Pedigree: AD28355_1, EXP: 5/8/2014. ",,"402 Tablets","Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-505-2014","Class II","OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11845014882 ","OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following code Pedigree: AD70700_7, EXP: 5/29/2014. ",,"116 Capsules","Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: AD70700_10, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-567-2014","Class II","ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001 ","ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg has the following codes Pedigree: W003596, EXP: 5/31/2014; Pedigree: AD22858_1, EXP: 3/31/2014. ",,"200 Capsules","Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-502-2014","Class II","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 ","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg has the following codes Pedigree: AD49399_4, EXP: 5/16/2014; Pedigree: AD46300_17, EXP: 5/15/2014; Pedigree: AD65457_22, EXP: 5/24/2014. ",,"294 Capsules","Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-698-2014","Class II","FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830 ","FEBUXOSTAT Tablet, 40 mg has the following codes Pedigree: AD23082_16, EXP: 11/1/2013; Pedigree: W002664, EXP: 6/5/2014; Pedigree: W003927, EXP: 7/1/2014. ",,"300 Tablets","Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014; tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014; SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-553-2014","Class II","OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921 ","OMEGA-3 FATTY ACID Capsule, 1000 mg has the following codes Pedigree: AD21846_1, EXP: 5/1/2014; Pedigree: AD30028_4, EXP: 5/8/2014; Pedigree: W003015, EXP: 6/12/2014; Pedigree: W003710, EXP: 6/26/2014; Pedigree: W003711, EXP: 6/26/2014; Pedigree: AD46257_1, EXP: 5/15/2014; Pedigree: W002965, EXP: 6/10/2014; Pedigree: W003312, EXP: 6/18/2014; Pedigree: AD30028_1, EXP: 5/8/2014; Pedigree: AD46257_4, EXP: 5/15/2014; Pedigree: AD32742_1, EXP: 5/1/2014; Pedigree: AD60240_1, EXP: 5/22/2014; Pedigree: ADWA00002135, EXP: 5/31/2014; Pedigree: W002690, EXP: 6/5/2014; Pedigree: W003313, EXP: 6/18/2014. ",,"36,840 Capsules","Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003712, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003715, EXP: 6/26/2014; CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, NDC 00093029401, Pedigree: AD46426_28, EXP: 5/15/2014; SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W002917, EXP: 6/10/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, NDC 00904548152, Pedigree: W003316, EXP: 6/18/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD32325_7, EXP: 5/9/2014; BUMETANIDE, Tablet, 0.5 mg, NDC 00093423201, Pedigree: AD46426_25, EXP: 5/15/2014; COLESEVELAM HCL, Tablet, 625 mg, NDC 65597070118, Pedigree: AD46426_19, EXP: 5/15/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD60211_14, EXP: 5/22/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: AD73521_37, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W002701, EXP: 6/5/2014; BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: W003273, EXP: 6/17/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-501-2014","Class II","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 ","OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg has the following codes Pedigree: W003789, EXP: 6/27/2014; Pedigree: W003873, EXP: 6/27/2014. ",,"210 Capsules","Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-500-2014","Class II","NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533 ","NIACIN TR, Tablet, 250 mg has the following code Pedigree: W003756, EXP: 5/31/2014. ",,"101 Tablets","Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-499-2014","Class II","ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003 ","ITRACONAZOLE, Capsule, 100 mg has the following code Pedigree: AD54549_10, EXP: 5/20/2014. ",,"30 Capsules","Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-588-2014","Class II","DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703 ","DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg has the following codes Pedigree: AD65323_7, EXP: 5/28/2014; Pedigree: AD52778_25, EXP: 5/20/2014. ",,"799 Capsules","Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-582-2014","Class II","ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348000123 ","ASPIRIN, Tablet, 325 mg has the following code Pedigree: W002640, EXP: 6/4/2014. ",,"300 Tablets","Labeling: Label Mixup; ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002642, EXP: 6/4/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-490-2014","Class II","FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160 ","FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) has the following code Pedigree: AD54553_1, EXP: 5/20/2014. ",,"100 Tablets","Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-602-2014","Class II","WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701 ","WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) has the following code Pedigree: AD60590_4, EXP: 5/29/2014. ",,"200 Tablets","Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-489-2014","Class II","FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160 ","FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) has the following codes Pedigree: W002717, EXP: 6/6/2014; Pedigree: W002826, EXP: 6/7/2014; Pedigree: AD60268_1, EXP: 5/22/2014. ",,"402 Tablets","Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-730-2014","Class II","VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001 ","VERAPAMIL HCL ER, Tablet, 240 mg has the following code Pedigree: AD52778_94, EXP: 5/21/2014. ",,"100 Tablets","Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1 mg, NDC 00781103001, Pedigree: AD52778_91, EXP: 5/21/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-669-2014","Class II","ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010601 ","ISOSORBIDE MONONITRATE Tablet, 10 mg has the following code Pedigree: AD28352_1, EXP: 5/7/2014. ",,"100 Tablets","Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-523-2014","Class II","SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204 ","SERTRALINE HCL Tablet, 50 mg has the following codes Pedigree: AD70585_7, EXP: 5/29/2014; Pedigree: W003575, EXP: 6/24/2014; Pedigree: AD46426_1, EXP: 5/15/2014; Pedigree: AD30993_14, EXP: 5/9/2014; Pedigree: W003033, EXP: 6/12/2014. ",,"500 Tablets","Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: AD33897_34, EXP: 5/9/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: W003032, EXP: 6/12/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-510-2014","Class II","PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690 ","PANTOPRAZOLE SODIUM DR, Tablet, 20 mg has the following code Pedigree: W003695, EXP: 6/26/2014. ",,"90 Tablets","Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-477-2014","Class II","GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460 ","GUAIFENESIN, Tablet, 200 mg has the following code Pedigree: W002853, EXP: 6/7/2014. ",,"100 Tablets","Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-576-2014","Class II","MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 47469000466 ","MELATONIN, Tablet, 1 mg has the following codes Pedigree: AD46257_19, EXP: 5/15/2014; Pedigree: AD60240_14, EXP: 5/22/2014. ",,"360 Tablets","Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: AD46265_28, EXP: 5/15/2014; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, NDC 00904559293, Pedigree: AD60211_17, EXP: 5/22/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-484-2014","Class II","GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904559293 ","GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg has the following code Pedigree: AD60211_17, EXP: 5/22/2014. ",,"180 Tablets","Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD60211_11, EXP: 5/22/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-651-2014","Class II","ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101 ","ZINC SULFATE, Capsule, 220 mg has the following codes Pedigree: AD52993_34, EXP: 5/20/2014; Pedigree: W003641, EXP: 6/25/2014. ",,"200 Capsules","Labeling:Label Mixup; ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014; CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-670-2014","Class II","ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701 ","ISOSORBIDE MONONITRATE, Tablet, 20 mg has the following codes Pedigree: AD52778_31, EXP: 5/20/2014; Pedigree: AD67989_10, EXP: 5/28/2014; Pedigree: W002656, EXP: 6/4/2014.",,"300 Tablets","Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-587-2014","Class II","DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884022201 ","DOXEPIN HCL, Capsule, 150 mg has the following code Pedigree: AD46312_10, EXP: 5/16/2014. ",,"100 Capsules","Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD46312_7, EXP: 5/16/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-586-2014","Class II","GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601 ","GLYCOPYRROLATE, Tablet, 2 mg has the following code Pedigree: W003625, EXP: 6/25/2014. ",,"100 Tablets","Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624, EXP: 1/31/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-485-2014","Class II","CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360 ","CHOLECALCIFEROL, Tablet, 400 units has the following codes Pedigree: AD37056_13, EXP: 5/10/2014; Pedigree: W002574, EXP: 6/3/2014; Pedigree: AD76686_7, EXP: 5/31/2014; Pedigree: AD60578_27, EXP: 5/29/2014; Pedigree: W003540, EXP: 6/21/2014; Pedigree: AD52993_25, EXP: 5/20/2014; Pedigree: W002715, EXP: 6/5/2014; Pedigree: AD30197_31, EXP: 5/9/2014; Pedigree: AD73592_8, EXP: 5/31/2014; Pedigree: W002642, EXP: 6/4/2014. ",,"1,199 Tablets","Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD60578_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003539, EXP: 6/21/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904531360, Pedigree: AD52993_13, EXP: 5/20/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W002703, EXP: 6/5/2014; PYRIDOXINE HCL, Tablet, 25 mg, NDC 00536440601, Pedigree: AD30197_28, EXP: 5/9/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD73592_1, EXP: 5/31/2014; ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002624, EXP: 6/4/2014. ",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Drugs",65707,"Ongoing","Aidapak Services, LLC","Vancouver","WA","US","Voluntary: Firm Initiated","Telephone","Repacked drugs were distributed in Arizona, California, Oregon, and Washington.","D-574-2014","Class II","GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335083783 ","GALANTAMINE HBR ER, Capsule, 24 mg has the following code Pedigree: W003735, EXP: 5/31/2014. ",,"30 Capsules","Labeling: Label Mixup; GALANTAMINE HBR ER, Capsule, 24 mg may be potentially mislabeled as ESCITALOPRAM, Tablet, 5 mg, NDC 00093585001, Pedigree: W003733, EXP: 6/26/2014.",7/2/2013,"07/02/2013",1/22/2014,"01/22/2014"
"Food",65733,"Ongoing","Healthmaxx Global Inc.","Hacienda Heights","CA","US","Voluntary: Firm Initiated","Letter","CA, MD, and NY","F-1924-2013","Class III","MAX Brand BRAZILIAN BEE PROPOLIS, 180 Count Softgels Product labeling reads in part:''MAX***BRAZILIAN BEE PROPOLIS DIETARY SUPPLEMENT 180 Softgels***6 65176 31465 0***Manufactured For:HealthMax Products Co. Altadena, CA 91001***''. ","Lot # BP0417 UPC 6 65176 31465 0",,"2318 bottles","In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.",6/10/2013,"06/10/2013",8/6/2014,"08/06/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1358-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Original flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. ","Pull Dates of AUG 1 2013 to OCT 6 2013",,"73/4 oz. packages; unknown amount for 2.5 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Original flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1362-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. Sticker is placed on the package to identify the ''LEMON PEPPER'' flavor. ","Pull Dates of AUG 1 2013 to OCT 6 2013",,"98/4 oz. packages; unknown amount for 2.5 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1363-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Peppered flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. Sticker is placed on the package to identify the ''PEPPERED'' flavor.","Pull Dates of AUG 1 2013 to OCT 6 2013",,"95/4 oz. packages; unknown amount for 2.5 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Peppered flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1361-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Habanero flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. Sticker is placed on the package to identify the ''HABANERO'' flavor.","Pull Dates of AUG 1 2013 to OCT 6 2013",,"98/4 oz. packages; unknown amount for 2.5 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Habanero flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1359-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. Sticker is placed on the package to identify the ''GARLIC PEPPER'' flavor.","Pull Dates of AUG 1 2013 to OCT 6 2013",,"103/ 4 oz. packages; Unknown amount of 2 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65735,"Ongoing","T And S Oyster Farm","Tillamook","OR","US","Voluntary: Firm Initiated","Visit","products are distributed in Oregon.","F-1360-2014","Class II","The refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part ''***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***''. Sticker is placed on the package to identify the ''TERIYAKI'' flavor.","Pull Dates of AUG 1 2013 to OCT 6 2013",,"103/4 oz. packages; unknown amount for 2.5 oz. packages","T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is recalled due to the potential contamination with Clostridium botulinum. ",7/12/2013,"07/12/2013",1/8/2014,"01/08/2014"
"Food",65741,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","Letter","MD, PA, MN, NY, OH,& PA","F-1944-2014","Class II","Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709","UPC 3585600709 September 7 2013",,"11 BOXES (12 tins each)","Kaija Ivasi lightly salted herring does not meet water phase salt standard of five percent for processed fish.",4/26/2013,"04/26/2013",5/21/2014,"05/21/2014"
"Devices",65753,"Ongoing","Custom Medical Specialties, Inc.","Pine Level","NC","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.","Z-0974-2014","Class II","5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover","Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521 - Custom Medical Lot Nos. 15831-0906, Exp. 6/2012; 17181-0910, Exp. 1/2012; 17926-1001, Exp. 1/2013; 18672-1003, Exp. 3/2013; 19067-104, Exp. 4/2013; 19683-1005, Exp. 5/2013; 19771-1006, Exp. 6/2013; 19931-1006, Exp. 6/2013; 21886-1010, Exp. 10/2013; 23233-1103, Exp. 3/2014; 24926-1108, Exp. 8/2014; 25201-1109, Exp. 9/2014; 26150-1112, Exp. 12/2014; 26502-1201, Exp. 1/2015; 27522-1204, Exp. 4/2015; 28161-1206, Exp. 6/2015; 28999-1208, Exp. 8/2015; 29153-1208, Exp. 8/2015; 31811-1304, Exp. 4/2016; 32056-1305, Exp. 5/2016; 32391-1306, Exp. 6/2016 ",".","2,610","No endotoxin (LAL) testing to proper level.",7/12/2013,"07/12/2013",2/19/2014,"02/19/2014"
"Drugs",65772,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1150-2014","Class I","Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433. ","lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown",,"11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)","Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug",7/22/2013,"07/22/2013",3/12/2014,"03/12/2014"
"Drugs",65772,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1151-2014","Class I","METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL","lot number: L54Q",,"5,555 bottles ","Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug",7/22/2013,"07/22/2013",3/12/2014,"03/12/2014"
"Drugs",65772,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1149-2014","Class I","B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735","Lot numbers: C02R and F03Q ",,"unknown ","Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug",7/22/2013,"07/22/2013",3/12/2014,"03/12/2014"
"Drugs",65774,"Ongoing","Herbal Give Care Llc","Grand Prairie","TX","US","Voluntary: Firm Initiated","Press Release","Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.","D-1331-2014","Class I","Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268","All lots",".","54 bottles of 30 capsules each","Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",7/19/2013,"07/19/2013",5/28/2014,"05/28/2014"
"Drugs",65774,"Ongoing","Herbal Give Care Llc","Grand Prairie","TX","US","Voluntary: Firm Initiated","Press Release","Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.","D-1332-2014","Class I","Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275","All lots",".","195 bottles of 30 capsules each","Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",7/19/2013,"07/19/2013",5/28/2014,"05/28/2014"
"Drugs",65774,"Ongoing","Herbal Give Care Llc","Grand Prairie","TX","US","Voluntary: Firm Initiated","Press Release","Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.","D-1330-2014","Class I","Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553","All lots",".","311 pouches","Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",7/19/2013,"07/19/2013",5/28/2014,"05/28/2014"
"Drugs",65774,"Ongoing","Herbal Give Care Llc","Grand Prairie","TX","US","Voluntary: Firm Initiated","Press Release","Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.","D-1333-2014","Class I","Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251","All lots",".","347 bottles of 30 capsules each","Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",7/19/2013,"07/19/2013",5/28/2014,"05/28/2014"
"Drugs",65774,"Ongoing","Herbal Give Care Llc","Grand Prairie","TX","US","Voluntary: Firm Initiated","Press Release","Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.","D-1329-2014","Class I","Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060","All lots",".","1053 bottles of 30 capsules each","Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.",7/19/2013,"07/19/2013",5/28/2014,"05/28/2014"
"Food",65791,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA","F-1473-2014","Class II","Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).","lot J53Q",".","unknown (firm did not maintain accurrate consistent logs)","Mira Health Products Ltd. recalled products marked as Dietary Supplements due to the use of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract in their raw materials.",7/23/2013,"07/23/2013",2/19/2014,"02/19/2014"
"Food",65827,"Ongoing","Nicomex Inc.","Passaic","NJ","US","Voluntary: Firm Initiated","Telephone","NY and NJ","F-1648-2014","Class II","Nicomex Color Para Tamal Net Wt 1/8 oz (3.54gms) Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062.","UPC 8 84678 10369 6",".","93 lbs.UPC ","Nicomex Inc. is recalling Camaron Entero for undeclared sulfites and Color Para Tamal for unapproved color based on NYSDAM Laboratory analysis.",12/7/2013,"12/07/2013",3/19/2014,"03/19/2014"
"Food",65827,"Ongoing","Nicomex Inc.","Passaic","NJ","US","Voluntary: Firm Initiated","Telephone","NY and NJ","F-1647-2014","Class II","Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9.","UPC 8 84678 10173 9.",".","230 lbs ","Nicomex Inc. is recalling Camaron Entero for undeclared sulfites and Color Para Tamal for unapproved color based on NYSDAM Laboratory analysis.",12/7/2013,"12/07/2013",3/19/2014,"03/19/2014"
"Veterinary",65870,"Terminated","BARF World Inc","Danville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","V-064-2014","Class I","BARF World Brand Juicy Lamb Recipe 12 patties packed into a 6 lb bag. UPC 3752800104 Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506","Lot S220 Use by 8/7/13.",".","14 cases (24 lb case contains 4 x 6 lb bags)","Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health.",8/1/2013,"08/01/2013",6/18/2014,"06/18/2014"
"Veterinary",65870,"Terminated","BARF World Inc","Danville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","V-065-2014","Class I","BARF World Brand Juicy Combination Recipe 12 patties packed into a 6 lb bag. UPC 3752800106 Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506","Lot S220 Use by 8/7/13.",".","9 cases, 24 lb. case contains 4 x 6 lb bags.","Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health.",8/1/2013,"08/01/2013",6/18/2014,"06/18/2014"
"Veterinary",65870,"Terminated","BARF World Inc","Danville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","V-066-2014","Class I","BARF World Brand Variety Pack; 12 patties packed into a 6 lb bag- one each of Chicken, Beef, Lamb, Combination. No UPC - contains individual UPC for each variety. Distributed by: BARF World, Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506","Lot S220 Use by 8/7/13.",".","200 cases (24 lb case contains 4 x 6 lb bags.)","Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health.",8/1/2013,"08/01/2013",6/18/2014,"06/18/2014"
"Veterinary",65870,"Terminated","BARF World Inc","Danville","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","V-063-2014","Class I","BARF World Brand Juicy Chicken Recipe 12 patties packed into a 6 lb bag. UPC 3752800101 Distributed by: BARF World Inc. 3840 Blackhawk Road, Suite 100 Danville, CA 94506","Lot T220, S220 Use by 8/7/13.",".","11 cases lot S220, 58 cases lot T220. 24 lb cases contains 4 x 6 lb bags.","Product was manufactured on the same equipment as product that tested positive for Salmonella by the Minnesota Dept of Public Health.",8/1/2013,"08/01/2013",6/18/2014,"06/18/2014"
"Drugs",65892,"Ongoing","Fabscout Entertainment, Inc","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and France","D-1169-2014","Class I","Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)","All lots",,,"Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.",6/27/2013,"06/27/2013",3/26/2014,"03/26/2014"
"Drugs",65892,"Ongoing","Fabscout Entertainment, Inc","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and France","D-1170-2014","Class I","Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)","All lots ",,,"Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.",6/27/2013,"06/27/2013",3/26/2014,"03/26/2014"
"Drugs",65900,"Ongoing","CTV Best Group","Duluth","GA","US","Voluntary: Firm Initiated","Letter","Nationwide and Australia, Canada.","D-1154-2014","Class I","BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.","All lots (lot 109400, Exp 12/31/2016)",".","593 bottles","Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.",8/1/2013,"08/01/2013",3/19/2014,"03/19/2014"
"Veterinary",65903,"Ongoing","Land O Lakes Purina LLC","Shoreview","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Shipped to Distributor, Lab Supply, Fort Worth Warehouse, Fort Worth, Texas who shippedproduct to the Oklahoma City Zoo.","V-058-2014","Class I","PURINA TEST DIET: Mod PicoLab Mouse w/12 PPM Ivermectin Route of Administration: Oral; Name and Address: Richmond Indiana Test Diet, 1050 Progress Drive, Richmond, IN 47374; Product Code 5D5R","Lot number:13JUL19RTD1",,"3.065 kg","A single lot (one 3.065 kg lot) test diet product Mod PicoLab Mouse w/12 ppm Ivermectin was manufactured incorrectly. The Test Diet facility was advised by their customer of a rodent mortality incident and the on-site veterinarian diagnosed Ivermectin toxicity. Investigation confirmed that an employee manufacturing error resulted in a significantly elevated level of Ivermectin in this feed. ",8/5/2013,"08/05/2013",3/26/2014,"03/26/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1296-2014","Class II","Nisha Libigrow capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1280-2014","Class II","Nature Science M-Sten capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1283-2014","Class II","Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1285-2014","Class II","CoQ10 capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1287-2014","Class II","L-Serine capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1309-2014","Class II","Biogenix USA Equibolix capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1316-2014","Class II","Biogenix USA Bolasterol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1292-2014","Class II","Mineral Complex, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (200 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"at minimum 2000 bottles","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1288-2014","Class II","Vitamin C, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1298-2014","Class II","New Age Solutions Uri-Flow capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1273-2014","Class II","Nature Science Serenity capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1321-2014","Class II","Biogenix USA Halo capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1308-2014","Class II","Biogenix USA Energize capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1293-2014","Class II","Nisha Male Pill capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1258-2014","Class II","Nature Science Super DMZ capsules packaged in plastic bottle with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1263-2014","Class II","Nature Science Formex capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1303-2014","Class II","Swiss Labs Rem Tyme capsules packaged in a plastic bottle with 30 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1323-2014","Class II","Biogenix USA Serenity capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1274-2014","Class II","Nature Science Yohimbe capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1268-2014","Class II","Nature Science E-Control capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1325-2014","Class II","Biogenix USA Male Pill capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1328-2014","Class II","Biogenix USA Prematif Male capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1333-2014","Class II","Biogenix USA Methadrol capsules, packaged in plastic bottles with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1326-2014","Class II","Biogenix USA Vitalikor capsules, packaged in plastic bottles with 40 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1304-2014","Class II","Nature Bee Bee Pollen capsules packaged in a plastic bottle with containing: 1) 360 capsules per bottle, 2) 180 capsules per bottle and 3) 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1275-2014","Class II","Nature Science Male Pill capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1290-2014","Class II","L-Carnitine, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (90 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1257-2014","Class II","Nature Science Super Drol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1284-2014","Class II","Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1301-2014","Class II","Park Labs Reparagen Pro capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1322-2014","Class II","Biogenix USA Sports A-Acid capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1277-2014","Class II","Nature Science Tendex capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1260-2014","Class II","Nature Science Equibolix capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1324-2014","Class II","Biogenix USA Yohimbe capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1320-2014","Class II","Biogenix USA Halostane capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1310-2014","Class II","Biogenix USA ADT capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1278-2014","Class II","Nature Science Prematif Male capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1313-2014","Class II","Biogenix USA Estro Fuze capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1262-2014","Class II","Nature Science M1 capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1289-2014","Class II","B Complex, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (180 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1272-2014","Class II","Nature Science Sports A-Acid capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1281-2014","Class II","Nature Science 4 Andro capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1311-2014","Class II","Biogenix USA M1 capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1312-2014","Class II","Biogenix USA Formex capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1279-2014","Class II","Nature Science HAM capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1291-2014","Class II","B-50, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"at minimum 1036 bottles","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1286-2014","Class II","L-Glutamine capsules, labeled in part as ''Healthy Life Chemistry'' By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1267-2014","Class II","Nature Science Cyanostane capsules, packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1270-2014","Class II","Nature Science Halostane capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1300-2014","Class II","Park Labs Reparagen + Glucosamine capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1305-2014","Class II","Biogenix USA Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1318-2014","Class II","Biogenix USA E-Control capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1256-2014","Class II","Nature Science Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1315-2014","Class II","Biogenix USA Alpha Male capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1299-2014","Class II","Park Labs Reparagen EX capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1297-2014","Class II","Nisha Power Pill capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1306-2014","Class II","Biogenix USA Super Drol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1329-2014","Class II","Biogenix USA HAM capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1265-2014","Class II","Nature Science Alpha Male capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1307-2014","Class II","Biogenix USA Super DMZ capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1331-2014","Class II","Biogenix USA 4 Andro capsules, packaged in plastic bottles with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1282-2014","Class II","Nature Science 1 Andro capsules packaged in a plastic bottle with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1332-2014","Class II","Biogenix USA 1 Andro capsules, packaged in plastic bottles with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1264-2014","Class II","Nature Science Estro Fuze capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1330-2014","Class II","Biogenix USA M-Sten capsules, packaged in plastic bottles with 60 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1295-2014","Class II","Nisha Mojo Nights capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1259-2014","Class II","Nature Science Energize capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1317-2014","Class II","Biogenix USA Cyanostane capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1266-2014","Class II","Nature Science Bolasterol capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1269-2014","Class II","Nature Science Decadrol capsules packed in plastic bottles with 90 capsules per bottle and packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1302-2014","Class II","Park Labs Vinicol capsules packaged in a plastic bottle with 30 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1294-2014","Class II","Nisha Blue Diamond capsules packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1314-2014","Class II","Biogenix USA Estro Fuse capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1276-2014","Class II","Nature Science Vitalikor capsules packaged in a plastic bottle with 40 capsules per bottle.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1334-2014","Class II","Biogenix USA Green Coffee Bean capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1271-2014","Class II","Nature Science Halo capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1327-2014","Class II","Biogenix USA Tendex capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1261-2014","Class II","Nature Science ADT capsules, packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,"unknown","The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Food",65916,"Ongoing","Mira Health Products Ltd.","Farmingdale","NY","US","Voluntary: Firm Initiated","Letter","GA, FL, NC, possibly NJ and New Zealand","F-1319-2014","Class II","Biogenix USA Decadrol capsules, packaged in plastic bottles with 90 capsules per bottle and also packaged as a bulk product in clear plastic bags.","All lots within expiry and distributed prior to August 2013",,,"The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs.",9/4/2013,"09/04/2013",1/8/2014,"01/08/2014"
"Drugs",65953,"Ongoing","Specialty Compounding, LLC","Cedar Park","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-0231-2015","Class II","All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613 ","ALL lots of product on the market as of August 9, 2013.",".","Undetermined","Lack of Assurance of Sterility",8/9/2013,"08/09/2013",11/5/2014,"11/05/2014"
"Drugs",65953,"Ongoing","Specialty Compounding, LLC","Cedar Park","TX","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-0230-2015","Class I","CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613","Lot #: 07092013M16; Exp 09/13",".","Undetermined","Non Sterility: Microbial contamination ",8/9/2013,"08/09/2013",11/5/2014,"11/05/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-192-2015","Class I","Iams Cat Food ProActive Health Chicken Kitten, 3.2 lb (UPC: 19014612628), 5.7 lb (UPC: 19014612505), 17.4 lb bags (UPC: 19014611867)","Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3.2 lb) & Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best By Date: 14Nov14 (5.7 lb) and Lot Code: 31904177, Best by Date: 9Nov14 (17.4 lb).",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-181-2015","Class I","Eukanuba Dog Food Weight Control Large Breed Adult, 30 lb bags, UPC: 19014269303","Lot Code: 31894177, Best by Date: 8Nov14, Lot Code: 31924177, Best by Date: 11Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-202-2015","Class I","Iams Dog Food ProActive Health Large Breed Mature Adult, 30 lb. bags (UPC 19014611331)","Lot Code: 31884177, Best by Date: 7Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-196-2015","Class I","Iams Cat Food ProActive Health Weight Control & Hairball Adult, 2.9 lb, (UPCs: 19014700240 and 19014700257), 5 lb (UPC: 19014612789), 5.5 lb (UPC: 19014611652), 9.8 lb (UPC: 19014612130) and 16 lb bags (UPC: 19014612147)","Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14, Lot Code: 31944177, Best by Date: 13Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (2.9 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (5 lbs); Lot Code: 31924177, Best by Date: 11Nov14 (5.5 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (9.8 lbs); Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by Date: 11Nov14, Lot Code: 31934177, Best by Date: 12Nov14 and Lot Code: 31944177, Best by Date: 13Nov14 (16 lbs). ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-175-2015","Class I","Eukanuba Dog Food Base Maintenance Mature Adult, 30 lb bag, UPC: 19014149308","Lot Code: 31954177, Best by Date: 14Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-186-2015","Class I","Iams Dog Food ProActive Health Large Chunks Adult, 15 lb bags, UPC: 19014610815","Lot Code: 31944177, Best by Date: 13Nov14",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-199-2015","Class I","Eukanuba Dog Food Base Maintenance Puppy, 5 lb. (UPC 19014039852), 16.5 lb. (UPC 19014042234), and 33 lb. (UPC 19014609468) bags","Lot Code: 31884177, Best by Date: 7Nov14 ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-187-2015","Class I","Iams Dog Food ProActive Health Small Breed Adult, 3.1 lb (UPC: 19014700110), 13.3 lb (UPC: 19014610990) and 5 lb bags (UPC: 19014612055)","Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31894177, Best by Date: 8Nov14 (3.1 lb), Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31894177, Best by Date: 8Nov14 & Lot Code: 31924177, Best by Date: 11Nov14: (5 lb), and Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31894177, Best by Date: 8Nov14 and Lot Code: 31924177, Best bt Date: 11Nov14 (13.3 lb).",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-177-2015","Class I","Eukanuba Dog Food Breed Specific Chihuahua Adult, 4 lb bags, UPC: 19014607037","Lot Code: 31884177, Best by Date: 7Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-182-2015","Class I","Iams Dog Food Healthy Naturals Chicken Adult, 2.9 lb (UPC: 19014700165), 5 lb (UPC: 19014612635), 13.3 lb (UPC: 19014612017) and 25.7 lb bags (UPC: 19014700646)","Lot Code: 31944177, Best by Date: 13Nov14 (2.9 lb.); Lot Code: 31904177, Best by date: 9Nov14 and Lot Code: 31914177, Best by Date: 10Nov14 (5 lb); Lot Code: 31884177, Best by Date: 7Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31924177, Best by Date: 11Nov14; Lot Code: 31934177, Best by Date: 12Nov14 and Lot Code: 31944177, Best by Date: 13Nov14 (13.3 lb) and Lot Code: 31884177, Best by Date: 7Nov14; Lot Code: 31894177, Best by Date: 8Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31914177, Best by Date: 10Nov14; and Lot Code: 31934177, Best by Date: 12Nov14 (25.7 lb). ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-174-2015","Class I","Eukanuba Dog Food Base Large Breed Mature Adult, 15 lb. (UPC: 19014270156), and 30 lb. (UPC: 19014270309) bags","Lot Code: 31874177, Best by Date: 6Nov14.",,"211,161 bags total","Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-178-2015","Class I","Eukanuba Dog Food Breed Specific Labrador Retriever Adult, 36 lb bags, UPC: 19014019564","Lot Code: 31954177, Best by Date: 14Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-191-2015","Class I","Iams Cat Food ProActive Health Chicken Adult, 3.2 lb (UPC: 19014612659), 5.7 lb (UPC: 19014612499), 6.3 lb (UPC: 19014611621), 10.8 lb (UPC: 19014612086) and 17.4 lb bags (UPC: 19014611836)","Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31924177, Best by Date: 11Nov14; Lot Code: 31934177, Best by Date: 12Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (3.2 lb); Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (5.7 lb); Lot Code: 31944177, Best by Date: 13Nov14 (6.3 lb); Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (10.8 lb) and Lot Code: 31864177, Best by Date: 5Nov14; Lot Code: 31914177, Best by Date: 10Nov14; Lot Code: 31924177, Best by Date: 11Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (17.4 lb).",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-184-2015","Class I","Iams Dog Food Premium Protection Chicken Adult, 12.1 lb bags, UPC: 19014611362","Lot Code: 31894177, Best by Date: 8Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-201-2015","Class I","Eukanuba Dog Food Breed Specific Boxer Adult, 36 lb. bags (UPC 19014019588)","Lot Code: 31944177, Best by Date: 13Nov14 and Lot Code: 31954177, Best by Date 14Nov14 .",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-197-2015","Class I","Iams Cat Food ProActive Health Weight Control Adult, 5 lb (UPC: 19014612680), 9.8 lb (UPC: 19014612123) and 16 lb bags (UPC: 19014612178)","Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31934177, Best by Date: 12Nov14 (5 lbs); Lot Code: 31874177, Best by Date: 6Nov14 (9.8 lbs) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31934177, Best by Date: 12Nov14 (16 lbs). ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-198-2015","Class I","Iams Cat Food Professional Feeding Bag Chicken Adult, 33 lb bags, UPC: 19014105458","Lot Code: 31914177, Best by Date: 10Nov14 and Lot Code: 31944177, Best by Date: 13Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-195-2015","Class I","Iams Cat Food ProActive Health Hairball Mature Adult, 5 lb bags, UPC: 19014612604","Lot Code: 31954177, Best by Date: 14Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-176-2015","Class I","Eukanuba Dog Food Base Small Breed Adult, 4 lb (UPC: 19014039722) and 16 lb (UPC: 19014010516) bags","Lot Code: 31904177, Best by Date: 9Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-200-2015","Class I","Eukanuba Dog Food Base Small Breed Puppy, 4 lb. (UPC 19014039678), 16 lb. (UPC 19014010509), and 40 lb. (UPC 19014011070) bags","Lot Code: 31874177, Best by Date: 6Nov14 (4 lb); Lot Code: 31944177, Best by Date 13Nov14 (16 lb) and Lot Code: 31874177, Best by Date 6Nov14 & Lot Code: 31944177, Best by Date 13Nov14 (40 lb).",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-180-2015","Class I","Eukanuba Dog Food Professional Feeding Bag Small Breed Puppy, 44 lb bags, UPC: 19014113194","Lot Code: 31874177, Best by Date: 6Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-189-2015","Class I","Iams Cat Food Healthy Naturals Chicken Adult, 5 lb (UPC: 19014612697) and 16 lb bags (UPC: 19014611881)","Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (5 lb) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (16 lb).",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-193-2015","Class I","Iams Cat Food ProActive Health Digestive Care Adult, 3 lb (UPC: 19014700202), 5 lb (UPC: 19014612451) and 16 lb bags (UPC: 19014611904)","Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3 lb); Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (5 lb) and Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best by Date: 14Nov14 (16 lb). ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-179-2015","Class I","Eukanuba Dog Food Premium Performance 30/20 Adult, 33 lb bags, UPC: 19014609475","Lot Code: 31884177, Best by Date: 7Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-190-2015","Class I","Iams Cat Food Healthy Naturals Weight Control Adult, 5 lb bags, UPC: 19014612703","Lot Code: 31894177, Best by Date: 8Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-185-2015","Class I","Iams Dog Food ProActive Health Large Breed Senior Plus, 13.3 lb (UPC: 19014612000) and 26.2 lb bags (UPC: 19014700615)","Lot Code: 31934177, Best by Date: 12Nov14 (both sizes)",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-194-2015","Class I","Iams Cat Food ProActive Health Hairball Adult, 3.1 lb (UPC: 19014700219), 5 lb (UPC: 19014612420), 9.8 lb (UPC: 19014612161) and 16 lb bags (UPC: 19014611911)","Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3.1 lbs); Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31934177, Best by Date: 12Nov14, Lot Code: 31954177, Best by Date: 14Nov14 (5 lbs); Lot Code: 31894177, Best by Date: 8Nov14, and 31914177, Best by Date: 10Nov14 (9.8 lbs.); Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (16 lb). ",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-183-2015","Class I","Iams Dog Food Healthy Naturals Weight Control Adult, 13.3 lb bags, UPC: 19014612024","Lot Code: 31894177, Best by Date: 8Nov14",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Veterinary",66009,"Completed","Procter & Gamble Co","Mason","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CT, FL, DE, GA, LA, MA, MD, ME, MS, NC, NH, NJ, NY, SC, PA and VA.","V-188-2015","Class I","Iams Dog Food ProActive Health Small Breed Puppy, 5 lb bags UPC: 19014700943","Lot Code: 31904177, Best by Date: 9Nov14.",,,"Product has the potential to be contaminated with Salmonella.",8/13/2013,"08/13/2013",11/12/2014,"11/12/2014"
"Devices",66030,"Ongoing","Leica Biosystems Newcastle Ltd.","Newcastle Upon Tyne",,"GB","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV); and Internationally to Chile, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, Poland, Romania, Singapore, South Korea, and the United Kingdom.","Z-0717-2014","Class II","Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed. ","*** 1 ) Catalog Number: DS9390; Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541; *** 2) Catalog Number: DS9477; Lot Number: 22250 ",,"1) 2,304 units; 2) 37 units","The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.",7/31/2013,"07/31/2013",1/22/2014,"01/22/2014"
"Drugs",66041,"Ongoing","Cubist Pharmaceuticals, Inc.","Lexington","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-764-2014","Class I","Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA","Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015 ",,"179,870 vials","Presence of Particulate Matter; Glass particulates observed in vials",8/29/2013,"08/29/2013",1/29/2014,"01/29/2014"
"Biologics",66045,"Ongoing","Musculoskeletal Transplant Foundation","Edison","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide; Spain Portugal","B-0103-14","Class I","Cascade Autologous Platelet System Rx Distributed by ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Manufactured by: MTF Musculoskeletal Transplant Foundation 125 May Street Edison, NJ www.mtf.org","Product Code 910046 Lot number 107692",,"1 unit","A single lot of CASCADE Autologous Platelet System, containing a component (yellow tube) that may have higher than normal endotoxin levels, was distributed. ",7/30/2013,"07/30/2013",1/22/2014,"01/22/2014"
"Devices",66055,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.","Z-0867-2014","Class II","T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.","Lot Numbers 353, 354",,"2201 kits in total","Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.",8/27/2013,"08/27/2013",2/5/2014,"02/05/2014"
"Devices",66055,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.","Z-0868-2014","Class II","T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.","Lot Numbers 737, 738, 739, 740, 741, 742, 743",,"4695 kits in total","Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.",8/27/2013,"08/27/2013",2/5/2014,"02/05/2014"
"Devices",66064,"Ongoing","Trans American Medical, Inc.","Lindon","UT","US","Voluntary: Firm Initiated","Letter","US Distribution: including states of: WA and UT.","Z-0532-2014","Class II","Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number","Serial numbers NS 10324 through NS 10392",,"68","TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.",8/22/2013,"08/22/2013",1/15/2014,"01/15/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-158-2014","Class I","Goldenfeast Petite Hookbill Bulk Foil 32 lb. Bag, Foil Mini Bulk Bag 12 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag. ","Goldenfeast Petite Hookbill Bulk Bag UPC 741919167605, 32 lb., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Mini Bulk Bag UPC 741919165601, 12 lb., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Super Size Jar, UPC 741919163607, 64 oz., best if used by June 30, 2013 through October 31, 2013 Goldenfeast Petite Hookbill Barrier Bag UPC 741919164604, 25 oz., best if used by June 30, 2013 through October 31, 2013 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-156-2014","Class I","Goldenfeast Caribbean Bounty Foil 32 lb. Bulk Bag Foil, 11 lb. Mini Bulk 64 oz. Super Size Plastic Jar, 25 oz. Barrier Film Bag. ","Caribbean Bounty Bulk Bag, UPC 741919167728, 32 lb., best if used by July 31, 2013 through September 30, 2013 Caribbean Bounty Mini Bulk UPC 741919165724, 11 lb., best if used by July 31,2013 through September 30, 2013 Caribbean Bounty Super Size UPC 741919163720, 64 oz., best if used by July 31, 2013 through September 30,2013 Caribbean Bounty Barrier Bag UPC 741919164727, 25 oz., best if used by July 31,2013 through September 30, 2013 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-154-2014","Class I","Goldenfeast Australian Blend packaged in 32 lb foil Bulk Bags, 13 lb. foil mini bulk bags, 64 oz super size plastic jars, and 25 oz barrier film bags. ","Goldenfeast Australian Blend Bulk Bag, UPC741919167629, 32 lb. best if used by May 31, 2013 through October 31, 2013 Australian Blend Mini Bulk Bag UPC 741919165625, 13 lb. bag best if used by May 31, 2013 through October 31, 2013 Australian Blend Super Size Plastic Jar, UPC 741919163621, 64 oz. best if used by May 31, 2013 through October 31, 2013 Australian Blend Barrier Bag, UPC 741919164628, 25 oz. best if used by May 31, 2013 through October 31, 2013 ",,"87864 lbs","Goldenfeast Inc. is recalling several bird seed blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-157-2014","Class I","Goldenfeast Gardenflora Foil 12 lb. Bulk Bag, Foil 4 lb. Mini Bulk Foil Bag, Super Size 23 oz Plastic Jar, and Barrier Film 9 oz. Bag. ","Goldenfeast Gardenflora Bulk Bag UPC 741919167681, 12 lb., best if used by July 31, 2013 through February 28, 2014 Gardenflora Mini Bulk Bag UPC 741919165687, 4 lb., best if used by July 31, 2013 through February 28, 2014 Gardenflora Super Size UPC 741919163683, 23 oz., best if used by July 31, 2013 through February 28, 2014 Gardenflora Barrier Bag UPC 741919164680, 9 oz., best if used by July 31, 2013 through February 28, 2014 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-159-2014","Class I","Goldenfeast Schmitts Original Bulk Foil 32 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag. ","Goldenfeast Schmitts Original Bulk Bag UPC 741919167865, 32 lb., best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Mini Bulk Bag UPC 741919165861, 13 lb. best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Super Size UPC 741919163867, 64 oz, best if used by July 31, 2013 through August 31, 2013 Goldenfeast Schmitts Original Barrier Bag UPC 741919164864, 25 oz., best if used by July 31, 2013 through August 31, 2013 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-155-2014","Class I","Goldenfeast Bean Supreme in 32 lbs.Foil Bulk Bag, 10 lb. Foil Mini Bulk Bags, 64 oz. Super Size Plastic Jars, and 23 oz. Barrier Film Bag. ","Bean Supreme Bulk Bag, UPC 741919167759, 32 lb., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Mini Bulk UPC 741919165755, 10 lb., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Super Size UPC 741919163751, 64 oz., best if used by July 31, 2013 through December 31, 2013 Bean Supreme Barrier Bag, UPC 741919164758, 23 oz., best if used by July 31, 2013 through December 31, 2013 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-161-2014","Class I","Goldenfeast Basics Plus Parakeet Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size Plastic Jar 72 oz, and Barrier Film 32 oz. Bag. ","Goldenfeast Basics Plus Parakeet Bulk Bag UPC 741919167933, 40 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Mini Bulk Bag UPC 741919165939, 13 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Super Size Jar UPC 741919163935, 72 oz., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Barrier Bag UPC 741919164932, 32 oz., best if used by August 31, 2013 through February 28, 2014 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Veterinary",66068,"Ongoing","Goldenfeast","Phoenixville","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and China.","V-160-2014","Class I","Goldenfeast Basics Plus Finch Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 80 oz. Plastic Jar, Barrier Film 32 oz. Bag. ","Goldenfeast Basics Plus Finch Bulk Bag, UPC 741919167926, 40 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Finch Mini Bulk Bag 741919165922, 13 lb., best if used by August 31,2013 through February 28, 2014 Goldenfeast Basics Plus Finch Super Size Jar UPC 741919163928, 80 oz., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Finch Barrier Bag UPC 741919164925, 32 oz., best if used by August 31, 2013 through February 28, 2014 ",,,"Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. ",8/26/2013,"08/26/2013",9/24/2014,"09/24/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1053-2014","Class I","STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.","Pack Number: SAMP0213; Lot: 13CD1774",,"10 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1051-2014","Class I","CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ41103; Lots: 13GB5484, 13GB9975",,"120 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1055-2014","Class I","CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.","Pack Number: DYNJ40851; Lot: 13FB8753",,"50 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1050-2014","Class I","CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ41101; Lot: 13FB5744",,"304 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1049-2014","Class I","CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ40926; Lot: 13FB4759",,"120 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1054-2014","Class I","STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.","Pack Number: SAMP0147; Lot: 13CD2146",,"5 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1056-2014","Class I","CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.","Pack Number: DYNJ40904; Lot: 13GB9975",,"112 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1048-2014","Class I","HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692",,"160 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1047-2014","Class I","ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ39185; Lots: 13EB2046, 13FB1553, 13GB2605",,"768 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1046-2014","Class I","ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.","Pack Number: DYNJ26855D; Lots: 13EB2046, 13EB8965",,"1,194 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66080,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.","Z-1052-2014","Class I","STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..","Pack Number: SAMP0144; Lots: 13CD2145, 13CD2146",,"10 units","Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.",8/14/2013,"08/14/2013",3/5/2014,"03/05/2014"
"Devices",66119,"Completed","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, and UNITED KINGDOM.","Z-1148-2014","Class II","GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system","Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2 00000171121GE7 00000171120GE9 00000186991GE6 00000186695GE7 00000171129GE0 00000207772GE5 00000211999GE8 00000194705GE0 00000175339GE1 00000171944GE2 00000198439GE2 00000187430GE4 00000183133HP8 00000171643GE0 00000L10106002 00000N10127001 00000V10334001 000000Z9309005 000000Z9309002 00000F10090001 00000H10153001 00000K10130001 000000G9337003 000000G9337002 00000W10230001 00000W10230002 00000H11083001 00000Y10245001 00000G10161002 00000M10162001 000000G9337001 00000180602GE5 00000187436GE1 00000171943GE4 00000194704GE3 00000194703GE5 00000194702GE7 00000175342GE5 00000187435GE3 00000172680GE1 00000171127GE4 00002UAO430KJL 00002UA04307KD 0000CZC9450FKS 0000CZC944B57J 0000CZC9385MCH 0000CZC94602P9 0000CZC94583RB 0000CZC1128HGN 0000CZC1128HGR 0000CZC1100YF8 0000CZC1128HGJ 00002UA04307L2 00002UA0430KL4 00002UA04307KV 00002UA04211JK 00002UA04307K5 0000CZC942647P 0000CZC9441VF1 00000V10245007 00000D10252002 0000CZC94602PY 0000CZC94602PC 00000185759HP8 0000CZC9406S71 0000CZC9412L3G 00000185734HP1 00000018579HP0 0000AB10235005 0000CZC9445HLZ 0000CZC9425PPQ 00000E10011004 00000E10011005 00000S11019009 00000S11019010 00000H11027003 00000Q11060006 000000G9337004 0000AB10126002 00000T10123004 00000E10336009 00000E10336005 00000E10336006 00000E10336008 00000E10011001 00000E10011002 00000T10123002 00000T10123001 00000H10028003 00000J10208004 ",,"283 (59 US, 224 OUS)","When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.",3/25/2011,"03/25/2011",3/12/2014,"03/12/2014"
"Food",66135,"Ongoing","Atlantic Pro Nutrients, Inc. dba XYMOGEN","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Alaska Canada and China","F-0815-2014","Class III","XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metabolic P Manufactured for Integrated Medical Center, Mesa AZ. *3. AstaMega-3 Balance Medical Food Distributed by: Lifestyle Research, Cheyenne, WY. *4.Body Balance H.E.M.M.L.A. Manufactured for: Health Masters, Auburndale, FL. *5. Cardio Protect Manufactured for: Shop The Care Group, LLC, Aurora, CO *6. Cardio-Krill Manufactured for: Whole Health Center, Lone Tree, CO. *7. CardiOmega Distributed by: Vail Valley Pharmacy, Edwards, CO. *8. CholeCare Manufactured for: Dr. Christina M. Tondora Scottsdale, AZ. *9. CHOLESTO-BUST Manufactured for: Clear Sky Medical, Centennial, CO. *10. Manufactured for: Arne Chiropractic & Wellness Center PC, Littleton, CO. *11. Dr. Elkin's CardioBlend Manufactured for: Medical Advocated Inc. Whittier, CA. *12. FaB Fats Manufactured for:Bukovina, Auburn, CA. *13. FEM Lipid Support Manufactured for:FEM Centre, Fort Worth, TX. *14.InflmmaChol Distributed By: INNER SCIENCE, Denver, CO. *15. Integrative Bio-Omega Distributed By: Center for Integrative Bio-Energetics, Santa Monica, CA. *16. ItisControl Distributed By: The 2nd Opinion Inc.Chattanooga, OK. *17. Killer Krill Manufactured for: Integrated Medical Care, Littleton, CO. *18. 360 Medicine Krill Pills Manufactured for: Russ Canfield, MD Santa Fe, NM. *19. Krill Supreme Manufactured for: Health Bridge, Great Neck, NY. *20. Krill-Xanthin Manufactured for: Envita Lifestyle, Scottsdale, AZ. *21. '' Li-Chol Manufactured for: Pierce Integrative Medical Center, West Bloomfield, MI. *22. Antarctic Omega Cholesterol Free Distributed By: Villa Park Medical , Villa Park, CA. *23.Lipechol Manufactured For: Women's View Medical Group Holistic Center for Integrated Family Health Care, Upland, CA. *24. Lipical Manufactured For: Ruben Ruiz, M.D.,Montebello, CA. *25. Lipicare Ma","UPC # 8 71149 00375 3 and UPC # 8 71149 00891 8 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015",,"25,852 bottles (All brands)","Product was labeled as a medical food as opposed to a dietary supplement.",8/16/2013,"08/16/2013",1/8/2014,"01/08/2014"
"Food",66135,"Ongoing","Atlantic Pro Nutrients, Inc. dba XYMOGEN","Orlando","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Alaska Canada and China","F-0816-2014","Class III","LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida","UPC # N3 53731-001-06 9 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015",,"25,852 bottles (All Brands)","Product was labeled as a medical food as opposed to a dietary supplement.",8/16/2013,"08/16/2013",1/8/2014,"01/08/2014"
"Drugs",66139,"Terminated","Fusion Pharmaceuticals, LLC","Camarillo","CA","US","Voluntary: Firm Initiated","Letter","CA","D-1055-2014","Class II","Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML","Lots: PL520, PL521, PL522 and PL523",,"1,200 kits","Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.",5/8/2013,"05/08/2013",2/12/2014,"02/12/2014"
"Drugs",66147,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-461-2014","Class I","Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.","Lot# 26-138-JT; Exp. 08/14",,"17,256 containers","Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.",8/30/2013,"08/30/2013",1/22/2014,"01/22/2014"
"Veterinary",66149,"Completed","Nestle Purina PetCare Co","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","Distributon was made to AL, AR, AZ, CA, CO, FL, GA, KS, LA, MO, MS, NV, OK. OR, SC, SD, TN, TX, UT and WA. No foreign or military distribution was made.","V-165-2015","Class I","Purina ONE beyond, White Meat Chicken & Barley, dry dog food, packaged in a 3.5 lb bag. UPC 1780012679.","Production Code: 31071083, Best By date: OCT 2014",".","29,610/3.5-lb bags","The product is being recalled due to contamination with Salmonella.",8/30/2013,"08/30/2013",10/22/2014,"10/22/2014"
"Veterinary",66183,"Terminated","Hubbard Feeds, Inc","Mankato","MN","US","Voluntary: Firm Initiated","Telephone","Michigan, Illinois, and Indiana","V-153-2014","Class I","34739-2, HOMESTEAD, FASTGROW AM.0125 NAP/NAB, MEDICATED Complete Chicken Starter/Grower/Finisher/Broiler Feed, Complete Turkey Grower/Finisher, Aid in prevention of coccidiosis. ACTIVE DRUG INGREDIENT AMPROLIUM 0.0125 % GUARANTEED ANALYSIS ... CALCIUM, min 0.8 % CALCIUM, max 1.3 % PHOSPHORUS, min 0.65 % ... Net Weight 50 lb (22.68 kg) or bulk invoice","Item 34739-2, Lot B00578594, B00582621, B00584526 ",,"42,550 lbs","Hubbard Feeds has initiated a voluntary recall of three additional lots of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of elevated calcium levels that may be harmful to chickens and turkeys. This voluntary recall is the result of identification of additional lot numbers through assays by the FDA related to a voluntary recall of the same product on July 2, 2013. Although no adverse events or complaints have been reported to date for the three additional lots, chickens and turkeys exposed to these lots may exhibit decreased feed intake, decreased growth rate or death",9/4/2013,"09/04/2013",9/24/2014,"09/24/2014"
"Devices",66197,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV., and the countries of Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.","Z-0831-2014","Class II","Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories","Model # 728306 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100028, 100031, 100032, 100037, 100038, 100039, 100040, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100077, 100078, 100079, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100155, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100194, 100195, 100196, 100197, 100198, 100199, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100234, 100235, 100236, 100238, 100240, 100241, 100242, 100243, 100244, 100245, 100246, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100255, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100267, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100277, 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287",,"506","An artifact that resembles thrombus may appear on the image.",7/16/2013,"07/16/2013",2/5/2014,"02/05/2014"
"Devices",66202,"Ongoing","Vital Diagnostics, Inc.","Lincoln","RI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0732-2014","Class II","Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum","All lots",,"395 units","High positive calcium bias on plasma sample versus results on serum",8/29/2013,"08/29/2013",1/22/2014,"01/22/2014"
"Devices",66202,"Ongoing","Vital Diagnostics, Inc.","Lincoln","RI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0733-2014","Class II","Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum","All lots",,"213 units","High positive calcium bias on plasma sample versus results on serum",8/29/2013,"08/29/2013",1/22/2014,"01/22/2014"
"Drugs",66261,"Ongoing","Janssen Pharmaceuticals, Inc.","Titusville","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1514-2014","Class II","Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11","Vial - 4212AAP1, Kit - 309316, Exp. 07/15",".","70,495 kits","Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample ",9/11/2013,"09/11/2013",8/13/2014,"08/13/2014"
"Devices",66273,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution: including states of: TX and VA.","Z-0624-2014","Class II","PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.","Lot: 012212-001",,"13 devices","Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. ",9/11/2013,"09/11/2013",1/15/2014,"01/15/2014"
"Devices",66274,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.","Z-1725-2014","Class II","Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.","Leica Ceiling Mount MSF-1; Article Numbers: 10446781, 10446782",".","103 total","The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).",9/11/2013,"09/11/2013",6/18/2014,"06/18/2014"
"Devices",66274,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.","Z-1726-2014","Class II","Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination.","Leica Ceiling Mounts MS-1F, MC-1F; Article Numbers: 10446657, 10446658",".","103 total","The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).",9/11/2013,"09/11/2013",6/18/2014,"06/18/2014"
"Devices",66287,"Ongoing","MCKESSON TECHNOLOGIES INC.","Durham","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.","Z-1060-2014","Class I","McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.","MAC 14.3.1/MAC 14.3.1.1",,"10","There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case.",3/15/2013,"03/15/2013",3/12/2014,"03/12/2014"
"Food",66292,"Ongoing","Hahn, Harry O Seafood Inc","West Lawn","PA","US","Voluntary: Firm Initiated","Telephone","PA, MD.","F-1355-2014","Class III","Adelphia Seafood Shrimp Salad, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA, Ingredients: shrimp, celery, mayonnaise, onion, green pepper, relish, sweet pickle, chili sauce (sugar, water, picked red chili, vinegar, garlic, salt, stabilizer, xanthan gum), gum cellulose. Allergens: Soybeans, egg, shellfish, wheat. ","Use by: 9/19/13 ",,"55lbs","Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads.",9/5/2013,"09/05/2013",1/8/2014,"01/08/2014"
"Food",66292,"Ongoing","Hahn, Harry O Seafood Inc","West Lawn","PA","US","Voluntary: Firm Initiated","Telephone","PA, MD.","F-1354-2014","Class III","Gold Label Shrimp Dip in 7 oz plastic containers, Manufactured by Adelphia Seafood, ingredients: cream cheese (pasteurized milk & cream, cheese culture, salt, stabilizers (carob bean and/or xanthan gums), water, shrimp, surimi (fish protein (pollock, cod and/or pacific whiting), water, wheat/corn starch, natural crab extract, soy oil), shrimp base (shrimp, salt, monosodium glutamate, spices), contains 2% or less of the following: spices, natural preservative (inactive dry yeast, lactic acid, cultured dextrose, maltodextrin, sodium diacetate, egg white lysozyme, nisin preparation) Allergens: milk, fish, crustacean shellfish, egg, wheat, soy.","Use by 11/04/13 ",,"89.25lbs","Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads.",9/5/2013,"09/05/2013",1/8/2014,"01/08/2014"
"Food",66292,"Ongoing","Hahn, Harry O Seafood Inc","West Lawn","PA","US","Voluntary: Firm Initiated","Telephone","PA, MD.","F-1357-2014","Class III","Adelphia Seafood Mermaid Salad in a 5 lb. plastic tub. Ingredients: surimi (alaska pollock, water, wheat flour, soybean oil, natural and artificial flavor), shrimp, pasta shell, mayonnaise (vegetable oil (soybean, canola), egg yolk, water, corn syrup, vinegar), lemon juice, spices, peppers, (diced green), natural and artificial flavors, natural preservatives. Allergens: Soybeans, milk, egg, fish, shellfish, wheat Adelphia Seafood, West Lawn, PA","Use by: 9/17/13 ",,"35 lbs","Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads.",9/5/2013,"09/05/2013",1/8/2014,"01/08/2014"
"Food",66292,"Ongoing","Hahn, Harry O Seafood Inc","West Lawn","PA","US","Voluntary: Firm Initiated","Telephone","PA, MD.","F-1356-2014","Class III","Adelphia Seafood Shrimp & Scallop Rotini, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA. Ingredients: pasta, oil (soybean and olive), cider vinegar, water, shrimp, scallops, red & green peppers, red onion, food starch, salt, spices, natural preservatives. Allergens: soybeans, shellfish, wheat ","Use by 9/21/13",,"30-lbs","Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads.",9/5/2013,"09/05/2013",1/8/2014,"01/08/2014"
"Devices",66298,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution: VA only.","Z-0776-2014","Class II","Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure. ","CT128047, CT128048, 2572401, 2572402, 2572405, 05172, 2572403, 2572404, 05171, 2572501, 2572502, 2572503",,"23 devices in total","Handles and heads may not be compatible. ",9/24/2013,"09/24/2013",1/22/2014,"01/22/2014"
"Devices",66298,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution: VA only.","Z-0777-2014","Class II","Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure. ","CT128047, CT128048, 2572401, 2572402, 2572405, 05172, 2572403, 2572404,05171, 2572501, 2572502, 2572503",,"23 devices in total","Handles and heads may not be compatible. ",9/24/2013,"09/24/2013",1/22/2014,"01/22/2014"
"Devices",66298,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution: VA only.","Z-0778-2014","Class II","Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure","CT128047, CT128048, 2572401, 2572402, 2572405, 05172, 2572403, 2572404,05171, 2572501, 2572502, 2572503",,"23 devices in total","Handles and heads may not be compatible. ",9/24/2013,"09/24/2013",1/22/2014,"01/22/2014"
"Veterinary",66307,"Terminated","CHS Nutrition","Hermiston","OR","US","Voluntary: Firm Initiated","Telephone","ID, OR and WA","V-060-2014","Class I","''CHAMPION LAMB TEXTURIZED B30 MEDICATED For GROWING AND FINISHING SHEEP***'' Product Code 6701","LOT88021813 M392190",".","200/50 lb sacks","A high level of Copper was discovered in the feed.",5/21/2013,"05/21/2013",4/16/2014,"04/16/2014"
"Devices",66311,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.","Z-0791-2014","Class II","Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349. ",,"23","The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect. ",3/7/2011,"03/07/2011",2/5/2014,"02/05/2014"
"Drugs",66313,"Terminated","Central Shared Services dba Parallon","Nashville","TN","US","Voluntary: Firm Initiated","E-Mail","GA, KY, TN","D-1062-2014","Class II","CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH"," 600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14",,"3764 cups","CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.",8/23/2013,"08/23/2013",2/12/2014,"02/12/2014"
"Devices",66323,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.","Z-0654-2014","Class II","***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. ","Serial Number 31496602",,"2,785","The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..",4/25/2013,"04/25/2013",1/15/2014,"01/15/2014"
"Devices",66323,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.","Z-0657-2014","Class II","***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. ","Serial Number F37306977201",,"12","The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..",4/25/2013,"04/25/2013",1/15/2014,"01/15/2014"
"Devices",66323,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.","Z-0656-2014","Class II","***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. ","Serial Number MM900",,"1,224","The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..",4/25/2013,"04/25/2013",1/15/2014,"01/15/2014"
"Devices",66323,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.","Z-0655-2014","Class II","***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126** Intended for cutting and shaping bone. ","Serial Number G11307654403",,"976","The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..",4/25/2013,"04/25/2013",1/15/2014,"01/15/2014"
"Food",66327,"Ongoing","El Tampiqueno Food Products, LLC","Schulenburg","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-2417-2014","Class I","El Tampiqueno Original Queso Fresco White Soft Cheese, Manufactured and distributed by El Tampiqueno Cheese Products, 1210 Summit St. Schulenberg, Texas 78956","Lot codes: 07312013-1, 07312013-2, 07312013-3, and 07312013-4",".","354 cases of white soft cheese","The product has the potential to be contaminated with Salmonella.",9/18/2013,"09/18/2013",9/17/2014,"09/17/2014"
"Drugs",66345,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-409-2014","Class II","Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09","Lot 3110358 Exp. 12/13",,"22, 896 bottles","Failed Impurity/Degradation Specification: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval",9/17/2013,"09/17/2013",1/22/2014,"01/22/2014"
"Drugs",66345,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-408-2014","Class II","Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09","Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13",,"30,264 bottles","Failed Impurity/Degradation Specification: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval",9/17/2013,"09/17/2013",1/22/2014,"01/22/2014"
"Food",66358,"Ongoing","Industrias Alimenticias Kern's y Cia. S.C.A.","Guatemala",,"GT","Voluntary: Firm Initiated","Letter","Distribution was retail outlets in TX, OK, LA, CO, and TN","F-2193-2014","Class II","Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was shipped in cases each of which included 4 paperboard cartons. Each paper board carton held 12-4 oz pouches.","27 LOTE-05-2014 or 22 LOTE-05-2014",".","84 cases distributed from Goya Foods of Texas","Lab analysis detected the pH to be greater than 4.4",8/20/2013,"08/20/2013",7/23/2014,"07/23/2014"
"Devices",66364,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico","Z-1926-2014","Class II","Siemens Dimension LOCI TNI Troponin I Calibrator The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module. RC621.","Lot Number - 3DD007 ",".","1625","Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration. ",9/17/2013,"09/17/2013",7/2/2014,"07/02/2014"
"Drugs",66380,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1060-2014","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)","Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015",,"6,540 bottles","Failed Tablet/Capsule Specifications: Broken tablets",3/22/2013,"03/22/2013",2/12/2014,"02/12/2014"
"Devices",66398,"Ongoing","Nova Biomedical Corporation","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0650-2014","Class II","Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood. ","All serial numbers",,"est. 200,000","Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage",10/10/2013,"10/10/2013",1/15/2014,"01/15/2014"
"Drugs",66406,"Ongoing","Haute Health, LLC","Williamstown","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide and internationally via internet sales.","D-1235-2014","Class I","Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com. ","All lot codes and expiration dates.",".","172,800 capsules","Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. ",9/27/2013,"09/27/2013",4/23/2014,"04/23/2014"
"Drugs",66406,"Ongoing","Haute Health, LLC","Williamstown","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide and internationally via internet sales.","D-1236-2014","Class I","PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com. ","All lot codes and expiration dates.",".","172,800 capsules","Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. ",9/27/2013,"09/27/2013",4/23/2014,"04/23/2014"
"Drugs",66406,"Ongoing","Haute Health, LLC","Williamstown","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide and internationally via internet sales.","D-1237-2014","Class I","Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com ","All lot codes and expiration dates.",".","82,944 capsules","Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. ",9/27/2013,"09/27/2013",4/23/2014,"04/23/2014"
"Food",66427,"Completed","Mandy Star Trading Inc","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City (NY)","F-1937-2014","Class I","GOOD TASTE brand Plum, 10.5 OZ, PRODUCT OF CHINA, UPC 3 867320 507650 --- AMERICA MANDY STAR TRADING","2013.01.18",,"9 cases (50 x 10.5 oz. bags per case)","The product contained undeclared sulfites (440 ppm), undeclared FD&C Yellow # 6, and unapproved color Ponceau 4R, based on sampling and analysis by New York State Department of Agriculture & Markets. ",9/27/2013,"09/27/2013",5/21/2014,"05/21/2014"
"Veterinary",66429,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to manufacturers and distributors nationwide and to Canada and Taiwan.","V-056-2014","Class II","Xylanase Enzyme Blends, bulk, custom blended formulations identified as Synerzyme-ae, Brizyme, Cellulase Special Blend OMRI, Xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws, Alkacel 20x, BC-XR, Enzyme blend #2237, CHX blend, and EB-7 multi-enzyme blend, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, and labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: synae-vw18 bri-xw16 csbomri-xw20 xab-vw21 bcr-yw14 fbws-uw04 alc20-ww05 bcxr-tw04 eb2237-vw14 chxb-uw27 eb7-xw08 ",,"57,000 kg total","Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",3/5/2014,"03/05/2014"
"Veterinary",66429,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to manufacturers and distributors nationwide and to Canada and Taiwan.","V-055-2014","Class II","Pectinase Enzyme Blends, bulk, custom blended formulations identified as Synerzyme-AE, Brizyme, EB-7 Multi-Enzyme Blend, Enzyme 7x, Pectinase 3,000 ENDO PG/GM, and Enzyme Blend Y2X, in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: BRI-XW16 EB7-XW08 E7X-TW03 PE003-UW21 EBY2X-UW22 ",,"57,000 kg total","Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",3/5/2014,"03/05/2014"
"Veterinary",66429,"Ongoing","Bio-Cat Inc","Troy","VA","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to manufacturers and distributors nationwide and to Canada and Taiwan.","V-054-2014","Class II","Cellulase Enzyme Blends, bulk, custom blended formulations identified as Feed Sources blend and P-one blend, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** ","Lots: fsb-vw08 pob-tw31 ",,"57,000 kg total ","Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol.",9/26/2013,"09/26/2013",3/5/2014,"03/05/2014"
"Devices",66430,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Other","Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.","Z-1079-2014","Class II","Trabecular Metal'' Reverse Shoulder System","61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880, 60855532, 60852815, 60855529, 60846158, 60846157, 60840619, 60834839, 60806512, 60824952, 60820211, 60814537, 60785523, 60795705, 60792083, 60761203, 60752933, 60781096, 60776583, 60765951, 60768804, 60757206, 60747093, 60741590, 60747092, 60741589, 60738183, 60727960, 60738184, 60730072, 60730073, 60723302, 60723277, 60718989, 60712568, 60683321, 60675599, 60669310, 60674468, 105533, 60605155, 105588, 60577323, 60580942, 60572796, 60564704, 60572798, 60568536, 60568535, 60578677, 60568468, 60568467, 60568466, 60564623, 60564639, 60564628, 60564641, 60564638, 60564636, 60568470, 60564642, 60564635, 60564625, 60564621, and 60564633. ",,"73,002 units","As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate. ",10/17/2013,"10/17/2013",3/5/2014,"03/05/2014"
"Food",66440,"Ongoing","Ontime Distribution Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-2224-2014","Class I","PRAN brand Spice Powder TURMERIC, Net Wt. 14.1 oz./400g, UPC 8 46656 00209 4, and Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in clear plastic jars with yellow plastic lids.","BEST BEFORE: 26 OCT 14 and BEST BEFORE: 15 JAN 15",,"18 - 250 gram jars and 23 - 400 gram jars","The product was found to contain excessive levels of lead based on sampling by New York State Department of Health, private laboratory analysis, and FDA sampling and analysis. ",10/3/2013,"10/03/2013",7/30/2014,"07/30/2014"
"Drugs",66441,"Ongoing","Hospira, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1234-2014","Class I","1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.","Lot #25090DK; Exp 01/15",".","374,500 vials","Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.",9/16/2013,"09/16/2013",4/23/2014,"04/23/2014"
"Drugs",66454,"Ongoing","G & W Laboratories Inc","South Plainfield","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-391-2014","Class III","G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 ","15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002.",,"187,368 metal tubes","Failed Content Uniformity Specifications; at the 18 month time point.",9/30/2013,"09/30/2013",1/8/2014,"01/08/2014"
"Food",66455,"Ongoing","Asia Cash & Carry Inc.","Maspeth","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Massachusetts, Pennsylvania, Virginia, Florida, and Illinois.","F-2225-2014","Class I","PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in a clear plastic jar with a yellow plastic lid.","DATE CODE: BEST BEFORE: 02 SEP 14",,"10 cartons ","The product was found to contain 28 ppm lead based on sampling by New York State Department of Health and private laboratory analysis",10/8/2013,"10/08/2013",7/30/2014,"07/30/2014"
"Devices",66467,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK","Z-0941-2014","Class II","enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.","Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0",".","8 units","Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.",10/8/2013,"10/08/2013",2/19/2014,"02/19/2014"
"Devices",66467,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK","Z-0942-2014","Class II","enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.","Custom v3.2.2 & Below Configuration Files",".","20 units","Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.",10/8/2013,"10/08/2013",2/19/2014,"02/19/2014"
"Devices",66468,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.","Z-0618-2014","Class II","S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.","Models: 3002 S3 EX, 3002 S3 PATRIOT, 3002 S3 CUSTOM, 3002 S3 ZOOM, and 3002 S3 SIGNATURE. And Serial Numbers:080615942, 080715062, 080916706, 080916707, 080916708, 080916709, 080916710, 080916711, 080916712, 080916713, 080916714, 080916715, 080916716, 080916717, 090415690, 100215206, 100215207, 100215208, 100215209, 100215210, 100215211, 100215212, 100215213, 100215214, 100215215, 100215216, 100215217, 100215218, 100215219, 100215220, 100215221, 100215222, 100215223, 100215224, 100215225, 100215804, 100215805, 100215806, 100215807, 100215808, 100215809, 100215810, 100315078, 100315079, 100315080, 100315081, 100315082, 100315083, 100315084, 100315085, 100315086, 100315087, 100315088, 100315089, 100315090, 100315091, 100315092, 100315670, 100315671, 100315672, 100315673, 100315674, 100315675, 100315676, 100315677, 100315678, 100315679, 080815116, 091215376, 091215377, 091215378, 110215808, 110215809, 100815273, 100815274, 100815275, 100815276, 100815277, 100815278, 100815279, 100815280, 100815281, 100815282, 100815283, 100815284, 100815285, 100815286, 100815287, 100815288, 100815289, 100815290, 100815291, 100815292, 100815293, 100815294, 100815295, 101116017, 110215554, 100815726, 100815727, 100815728, 100815729, 100815730, 100815731, 100815732, 100815733, 100815734, 100815735, 100815736, 100815737, 100815738, 100815739, 100815740, 100815741, 100815742, 100815743, 100815744, 100815745, 100815746, 100815747, 100815748, 100815749, 100815750, 100815751, 100815752, 100815753, 100815754, 100815755, 100815756, 100815757, 100815758, 100815759, 100815760, 100815761, 100815884, 100815885, 100815886, 100815887, 100815888, 100815889, 100815890, 100815891, 100815892, 100815893, 100815894, 100815895, 100815896, 100815897, 100815898, 100815899, 100815900, 100815901, 100815902, 100815903, 100815904, 100815905, 100815906, 100815907, 100815908, 100815909, 100815910, 100815911, 100815912, 100815913, 100815914, 100815915, 100815916, 100815917, 100815918, 080815227, 090616274, 090616275, 090616276, 090616277, 090616278, 090616279, "," 110316823, 110316824, 110316825, 110316826, 110316827, 110316828, 110316829, 110316830, 110316831, 110316832, 110316833, 110316834, 110316835, 110316836, 110316837, 110317181, 110317182, 110317183, 110317184, 110317185, 110317186, 110317187, 110317188, 110317189, 110317190, 110317191, 110317192, 110317193, 110317194, 110317195, 110317196, 110317197, 110317198, 110317199, 110317200, 110317201, 110317202, 110317203, 110317204, 110317205, 110415126, 110415127, 110415128, 110415129, 110415130, 110415131, 110415132, 110415133, 110415134, 110415135, 110415136, 110415137, 110415138, 110415139, 110415140, 110415141, 080915857, 080915858, 080915859, 080915860, 080915861, 080915862, 080915863, 080915864, 080915865, 080915866, 080915867, 080915868, 080915869, 080915870, 080915871, 080915872, 080915873, 080915874, 080915875, 080915876, 080915877, 080915878, 080915879, 080915880, 080915881, 080915882, 080915883, 080915884, 100115547, 100115548, 100115549, 100115550, 100115551, 100115552, 100115553, 100115554, 100115555, 100115556, 100115557, 100115558, 100115589, 110116271, 110116272, 110116273, 110116274, 110116275, 110116276, 110116277, 110116278, 110116279, 110116280, 110117191, 110117192, 100215248, 100215249, 100215250, 100215251, 100215252, 100215253, 100215254, 100215255, 100215256, 100215257, 100215258, 110316147, 110316148, 110316149, 110316150, 110316151, 110316152, 110316154, 100515811, 100515812, 100515813, 100515814, 100515815, 100515816, 100515817, 100515818, 100515819, 100515820, 100515821, 100515822, 100515823, 100515824, 100515825, 100515826, 100515827, 100515828, 100515829, 100515830, 100515831, 100515832, 100515833, 100515834, 100515835, 100515836, 100515837, 100515838, 100515839, 100515840, 100515841, 100515842, 100515843, 100515844, 100515845, 100515846, 100515847, 100515848, 090916777, 090916778, 090916779, 090916780, 090916781, 090916782, 090916783, 090916784, 090916785, 090916786, 090916787, 090916788, 090916789, 090916790, 090916791, 090916792, 090916793, 090916794, 090916795, 090916796, 090916797","108,769 Total","Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.",11/26/2013,"11/26/2013",1/8/2014,"01/08/2014"
"Devices",66468,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.","Z-0617-2014","Class II","Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.","Models: 3002 EX, 3002 KCI, 3002 CUSTOM, 3002 ZOOM, 3002000000, and 3002 ZX-SB. And Serial Numbers: 060215711 , 060215712 , 060215713 , 060215714 , 060215715 , 060215716 , 060215717 , 060215718 , 060215719 , 060215720 , 060215721 , 060215722 , 060215723 , 060215724 , 060215725 , 060215726 , 060215727 , 060215728 , 060215729 , 060215730 , 060215731 , 060215732 , 060215733 , 060215734 , 060215735 , 060215736 , 060215737 , 060215738 , 060215739 , 060215740 , 060215741 , 060215742 , 060215743 , 060215744 , 060215761 , 060215762 , 060215763 , 060215764 , 060215765 , 060215766 , 060215767 , 060215768 , 060215769 , 060215770 , 060215771 , 060215772 , 060215773 , 060215774 , 060215775 , 060215776 , 060215777 , 060215778 , 060215779 , 060215780 , 060215781 , 060215782 , 060215783 , 060215784 , 060215785 , 060215786 , 050916199 , 060515187 , 080615291 , 080615292 , 080615293 , 080615294 , 080615295 , 080615296 , 080615297 , 080615298 , 080615299 , 080615300 , 080615301 , 080615302 , 080615303 , 080615304 , 080615305 , 080615306 , 080615307 , 080615308 , 080615309 , 080615310 , 080615311 , 080615312 , 050815989 , 050815990 , 050815991 , 050815992 , 050815993 , 050816164 , 050816165 , 050816166 , 050816167 , 050816168 , 050816169 , 050816170 , 050816171 , 050816172 , 050816173 , 050816174 , 050816175 , 050816176 , 050816177 , 050816178 , 050816179 , 050816180 , 050816181 , 050816182 , 050816183 , 050816184 , 050816185 , 050816186 , 050816187 , 050816188 , 050816189 , 050816190 , 050816191 , 050816192 , 050816193 , 050816194 , 050816195 , 050816196 , 050816197 , 050816198 , 050816199 , 050816200 , 050816201 , 050816202 , 050816203 , 050816204 , 050816205 , 050816206 , 050816207 , 050816208 , 050816443 , 050816444 , 050816445 , 050816446 , 050816447 , 050816448 , 050816449 , 050816450 , 050816451 , 050816452 , 050816453 , 050816454 , 050816455 , 050816456 , 050816457 , 050816458 , 050816460 , 050816461 , 050816462 , 050816463 , 050816464 , 050816465 , 050816466 , 050816467 , 051015830 , 051015831 , 051015832 , 051015833 , 05"," 080215334 , 080215335 , 080215336 , 080215337 , 080215338 , 080215339 , 080215340 , 080215341 , 080215417 , 080215418 , 080215419 , 080215420 , 080215421 , 080215422 , 080215423 , 080215424 , 080215425 , 080215426 , 080215427 , 080215428 , 080215429 , 080215430 , 080215431 , 080215432 , 080215433 , 080215434 , 080215435 , 080215436 , 080215437 , 080215438 , 080215439 , 080215440 , 080215441 , 080215442 , 080215443 , 080215444 , 080215445 , 080215446 , 080215553 , 080215554 , 080215555 , 080215556 , 080215557 , 080215558 , 080215559 , 080215560 , 080215561 , 080215562 , 080215563 , 080215564 , 080215565 , 080215716 , 080215717 , 080215718 , 080215719 , 080215720 , 080215721 , 080215722 , 080215723 , 080215724 , 080215725 , 080215726 , 080215727 , 080215728 , 080215729 , 080215730 , 071015444 , 071015445 , 071015446 , 071015447 , 080116717 , 080116718 , 080116719 , 080116720 , 080116721 , 080116722 , 080116723 , 080116724 , 080116725 , 080116726 , 080116727 , 080116728 , 080116729 , 080116730 , 080116731 , 080116732 , 080116733 , 080116734 , 080116735 , 080116736 , 080116737 , 080116738 , 080116739 , 080116740 , 080116741 , 080116742 , 060316691 , 060316692 , 060616341 , 060616658 , 060616691 , 060616870 , 060616897 , 060715191 , 060715208 , 060715211 , 060715233 , 070616980 , 080615958 , 080615959 , 080615960 , 080615961 , 080615962 , 060616306 , 060715084 , 060715194 , 070616041 , 070616042 , 070616043 , 070616044 , 070616045 , 070616853 , 070616854 , 070616855 , 070616856 , 070616857 , 070616858 , 070616859 , 070616860 , 070616861 , 070616862 , 070616863 , 070616864 , 070616865 , 070616866 , 070616867 , 070616868 , 070616869 , 070616870 , 070616871 , 070616872 , 070616873 , 070616874 , 070616875 , 070616876 , 070616877 , 070616878 , 070616879 , 070616880 , 070616881 , 070616882 , 070616883 , 070616884 , 070616885 , 070616886 , 070616887 , 070616888 , 070616889 , 070616890 , 070616891 , 070616892 , 070616893 , 070616894 , 070616895 , 070616896 , 070616897 , 070715710 , 070715711 , 070715712 , 070715713 , 0707","108,769 Total","Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.",11/26/2013,"11/26/2013",1/8/2014,"01/08/2014"
"Drugs",66469,"Ongoing","B @ B Trade Inc.","North Miami Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1233-2014","Class I","Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.","ALL LOTS",".","10 bottles","Marketed Without an Approved NDA/ANDA; undeclared Sibutramine",10/7/2013,"10/07/2013",4/23/2014,"04/23/2014"
"Drugs",66469,"Ongoing","B @ B Trade Inc.","North Miami Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1231-2014","Class I","Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.","ALL LOTS",".","10 bottles","Marketed Without an Approved NDA/ANDA; undeclared Sibutramine",10/7/2013,"10/07/2013",4/23/2014,"04/23/2014"
"Drugs",66469,"Ongoing","B @ B Trade Inc.","North Miami Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1232-2014","Class I","Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.","ALL LOTS",".","10 bottles","Marketed Without an Approved NDA/ANDA; undeclared Sibutramine",10/7/2013,"10/07/2013",4/23/2014,"04/23/2014"
"Devices",66474,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico; and Internationally to: Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.","Z-0817-2014","Class II","VITROS Chemistry Products COCM Reagent","Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014",,"3,342 units","Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Chemistry Products COCM Reagent due to inaccurate quality control results.",10/4/2013,"10/04/2013",1/29/2014,"01/29/2014"
"Food",66486,"Completed","Best Value Inc","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","in and around Hamtramck, Michigan","F-2222-2014","Class I","PRAN TURMERIC POWDER 400 GM plastic bag","MFG:27 OCT 12; and Best Buy 26 OCT 14 UPC 8-31730-00502-3",,"12 boxes (20 bags/box)","Best Value Inc imported PRAN Spice Powder TURMERIC and distributed to retail stores. FDA sample was found to contain excessive levels of Lead above 53.7ppm.",10/11/2013,"10/11/2013",7/30/2014,"07/30/2014"
"Devices",66493,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.","Z-0789-2014","Class I","TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery. ","All lot codes",,"7,983","Incorrect instructions for use (IFU). ",10/11/2013,"10/11/2013",1/29/2014,"01/29/2014"
"Devices",66493,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.","Z-0788-2014","Class I","TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. ","All lot codes ",,"3,860","Incorrect instructions for use (IFU). ",10/11/2013,"10/11/2013",1/29/2014,"01/29/2014"
"Drugs",66497,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1054-2014","Class I","Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 ","Lot H3A744, Exp 01/15",,"18,936 Containers","Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.",10/15/2013,"10/15/2013",2/12/2014,"02/12/2014"
"Devices",66498,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain","Z-0968-2014","Class II","VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides. ","1) VITROS 250 (Product Code 8132086; Model # 3332); 2) VITROS 350 (Product Code 6802153; Model # 3330); 3) Mixing Cup Arrays (Product Code 1631779; Model # n/a)",".","6380 units (each unit contains 48 arrays with 10 microcups)","Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.",10/10/2013,"10/10/2013",2/19/2014,"02/19/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0589-2014","Class II","ITST THREADED GUIDE PIN","Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0591-2014","Class II","FEM COND BUTTRESS PLT, LT","Item #'s: 00-2347-002-12 00-2347-002-14 00-2347-002-16 00-2347-002-18 Lot #s: All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0587-2014","Class II","DIST LAT FEM LOCK PLT, LT","Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0588-2014","Class II","DIST LAT FEM LOCK PLT, RT","Item Numbers: 47-2357-101-14 47-2357-101-18 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0585-2014","Class II","FEM COND BUTTRESS PLT, RT.","Item #'s: 00-2347-001-12 00-2347-001-14 00-2347-001-16 00-2347-001-18 Lot #s: All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0590-2014","Class II","NGK Stem Ext 24 x 245mm","Item Numbers: 32-5988-012-24 All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0586-2014","Class II","TIBIO FEM/FEM NAIL.","Item Numbers 32-8553-311-11 32-8553-311-13 32-8553-311-15 32-8553-311-17 All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66499,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.","Z-0592-2014","Class II","TIB NAIL","Item #'s: 32-8553-311-59 32-8553-311-61 32-8553-311-63 32-8553-311-65 Lot #s: All lots with an expiration date prior to July 24, 2023",,"42, 065 units total","Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. ",11/5/2013,"11/05/2013",1/8/2014,"01/08/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1005-2014","Class II","VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941","366026 60252546 60386429 60387234 60387236 60664570 60746113 60820564 368890 60131310 60161887 60208595 60337755 60386430 60387237 60674436 60674437 60746114 60820565 62063880 60674437R 366027 60165190 60351204 60406618 60598293 60699479 60714970 60820566 61753280 366028 368891 60189692 60510769 60699480 60714938 60820568 60189692R 366029 368892 60154515 60413139 60740818 60812406 62161712 366030 60844072 60868450 60844072R 368894 60154516 60173867 60175580 60206848 60292114 60366271 60379893 60424741 60452501 60476633 60523009 60523011 60568292 60598291 60598292 60610993 60619081 60646238 60726314 60746117 60911330 60931155 60944509 61076064 61169404 61505367 61523575 61640872 62098503 60082818 60082819 60119113 60129285 60144960 60147708 60175581 60182119 60241838 60278773 60328084 60410030 60435440 60476635 60510770 60539704 60581931 60619076 60664573 60726313 60763191 60787023 60877481 60890087 60890088 60900735 60911331 60928243 60931156 60932380 60938399 60943332 60944510 61140151 61163257 61264711 61294823 61374274 61505374 61505375 61558652 61590985 61640873 61748725 62045196 62063886 368896 60127957 60129286 60156372 60189693 60215781 60252548 60292116 60353487 60383970 60405451 60452504 60502812 60539715 60539717 60568287 60581933 60619073 60646239 60726315 60726316 60726317 60726318 60890089 60911332 60918552 61114103 61120930 61344223 61505376 61558653 61596975 61602061 61677240 62050758 62057618 366505 60129287 60175582 60260273 60410031 60433745 60482396 60510771 60619078 60726319 60763195 60959966 61031789 61128189 61527193 61558654 61602062 61748726 61753014 62045197 368373 369962 60402976 60424743 60445069 60510772 60619079 60968719 61118961 61198403 61264715 61693779 62045195 62063881 368898 370907 60812398 61577082 62279718 00368898R 60165193 60482973 60527776 60533011 368916 60598295 60746132 60820576 60598295R 60746132R 60699481 61895937 60074372R 60699481R 368960 60136494 60189695 60266339 60353489 60370812 60383972 60416018 60473692 60489349 60510773 60548437 60699482 60746134 60746137 6",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1040-2014","Class II","PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT SCR X 20MM 3.5MM CORT SCR X 22MM 3.5MM CORT SCR X 24MM 3.5MM CORT SCR X 26MM 3.5MM CORT SCR X 28MM 3.5MM CORT SCR X 30MM 3.5MM CORT SCR X 32MM 3.5MM CORT SCR X 34MM 3.5MM CORT SCR X 36MM 3.5MM CORT SCR X 38MM 3.5MM CORT SCR X 40MM 3.5MM CORT SCR X 42MM 3.5MM CORT SCR X 44MM 3.5MM CORT SCR X 46MM 3.5MM CORT SCR X 48MM 3.5MM CORT SCR X 50MM 3.5MM CORT SCR X 52MM 3.5MM CORT SCR X 54MM 3.5MM CORT SCR X 56MM 3.5MM CORT SCR X 58MM 3.5MM CORT SCR X 60MM 3.5MM CORT SCR X 65MM 3.5MM CORT SCR X 70MM 3.5MM CORT SCR X 75MM 3.5MM CORT SCR X 80MM 3.5MM CORT SCR X 85MM 3.5MM CORT SCR X 90MM 3.5MM CORT SCR X 100MM 3.5MM CORT SCR X 105MM 3.5MM CORT SCR X 110MM CANC SCR 4.0MM X 10MM CANC SCR 4.0MM X 10MM FUL CANC SCR 4.0MM X 12MM CANC SCR 4.0MM X 12MM FUL CANC SCR 4.0MM X 14MM CANC SCR 4.0MM X 14MM FUL CANC SCR 4.0MM X 16MM CANC SCR 4.0MM X 16MM FUL CANC SCR 4.0MM X 18MM CANC SCR 4.0MM X 18MM FUL CANC SCR 4.0MM X 20MM CANC SCR 4.0MM X 20MM FUL CANC SCR 4.0MM X 22MM CANC SCR 4.0MM X 22MM FUL CANC SCR 4.0MM X 24MM CANC SCR 4.0MM X 24MM FUL CANC SCR 4.0MM X 26MM CANC SCR 4.0MM X 26MM FUL CANC SCR 4.0MM X 28MM CANC SCR 4.0MM X 28MM FUL CANC SCR 4.0MM X 30MM CANC SCR 4.0MM X 30MM FUL CANC SCR 4.0MM X 32MM CANC SCR 4.0MM X 32MM FUL CANC SCR 4.0MM X 34MM CANC SCR 4.0MM X 34MM FUL CANC SCR 4.0MM X 36MM CANC SCR 4.0MM X 36MM FUL CANC SCR 4.0MM X 38MM CANC SCR 4.0MM X 38MM FUL CANC SCR 4.0MM X 40MM","61337161 61251498 61251499 61220432 61553288 61966252 61966257 60856802 60871924 60871946 60837236 61168818 61168821 61251340 61168823 61251341 61168825 61216588 61247526 61168827 61216589 61247527 61168829 61216590 61247528 61168830 61216591 61247529 61168831 61247530 61168833 61216593 61247531 61168835 61247532 61168837 61216596 61247533 61168839 61168841 61168842 61168843 61168845 61247536 61168847 61223705 61168849 61168850 61168852 61168854 61168856 61168858 61168859 61168860 61168861 61168862 61567437 61411579 61678383 61678382 61835910 61835909 61214649 61216599 61214650 61216602 61251346 61216605 61591005 61190532 61190535 61740546 61190538 61190539 61401997 61190540 61190543 61560426 61823977 61190544 61190546 61740547 61190547 61190549 61740548 61190551 61190552 61560430 61190554 61190555 61560431 61190618 61190619 61740550 61190620 61190627 61560427 61190628 61190629 61401998 61190630 61190632 61740551 61190633 61190634 61740552 61190635 61190636 61740553 61190638 61190639 61190640 61190641 61190642 61740554 61190643 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1027-2014","Class II","PRESSFIT FEM ST FX 16 X 1","60621428 60667768 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1009-2014","Class II","INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534","60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817 60387525 60569948 60602446 60620341 60630482 60711126 60714151 60735643 60808002 60819266 60864018 60864019 60876889 60876890 60956565 61104687 61112613 61133165 61266235 61422229 61458906 61489975 60690743 60711143 60714152 60728336 60735644 60747675 60757046 60789824 60808003 60817590 60838120 60838121 60876892 60876893 60937495 60937496 61031038 61112614 61112651 61158629 61161384 60466661 60615939 60735645 60817572 60847807 61120278 61221431 61263174 61333468 60152966 60196077 60196079 60750994 60806391 60847809 60979630 61226089 61263175 61408290 61504079 60753364 60806396 60817586 60829585 60876926 60931129 61331079 60120568 60140390 60150071 60152967 60165627 60177186 60185172 60190843 60195440 60195442 60243126 60253766 60279638 60279639 60279640 60338431 60349085 60387526 60393389 60422609 60438317 60444815 60472686 60528779 60569949 60602447 60602448 60620342 60653343 60690744 60714153 60735646 60735647 60735648 60811023 60819429 60819430 60864026 60864029 60876928 60937499 60937501 60979623 60985453 61079807 61079808 61086366 61100812 61104688 61140198 61143244 61150035 61161407 61173560 61194688 61231196 61244342 61280079 61293775 61303278 61319424 61383085 61428464 61453389 61516672 61564740 61613173 61657631 61709056 61709069 61763484 60103523 60127531 60130218 60140391 60152968 60172506 60179290 60201128 60201130 60229987 60242009 60265708 60279641 60323303 60323305 60338432 60349086 60387527 60393390 60407650 60438318 60444317 60491698 60569950 60602207 60620343 60653345 60653346 60690745 60714154 60735649 60735650 60808004 60819270 60819273 60864032 60864034 60956555 60956558 60956566 60956567 61064852 61075702 61086367 61100813 61104689 61120279 61143245 61158631 61164107 61173035 61173562 61173564 61173565 61512411 61729530 61763487 60349309 60602449 60674160 60"," 60979612 60979613 60991171 60991172 60991173 60991176 61040644 61040645 61040646 61040647 61059932 61059933 61071463 61071464 61075730 61091749 61112678 61112679 61112680 61112681 61120301 61120303 61133901 61140220 61143285 61178961 61190334 61190340 61211659 61221457 61242349 61249881 61263193 61267744 61280092 61303336 61388931 61396185 61414398 61421250 61453395 61475195 61484489 61504101 61516697 61516698 61555836 61613192 61621180 61709160 60393248 60757134 60807411 61226105 61331080 61383109 61467827 61631409 60132574 60338611 60468392 60620458 60691543 60747666 60814271 60889690 61226106 61325067 60253811 60513286 60513287 60550420 60550421 60573738 60620459 60819462 60858007 60877717 61009865 61091751 61125235 61131936 61186068 61256018 61263194 61280094 61293782 61319684 61325068 61358804 61383110 61414401 61489993 61530550 61719709 60101719 60117058 60127542 60135238 60140404 60154233 60157588 60167199 60175772 60186889 60196147 60196149 60242208 60259330 60265753 60288636 60288637 60288639 60323397 60338612 60338613 60338614 60363835 60380507 60385528 60387537 60410623 60422669 60429171 60431524 60431525 60444324 60444828 60461627 60461628 60506052 60506054 60506056 60506057 60537373 60550422 60550423 60575746 60602635 60620460 60620461 60654047 60691544 60714274 60735789 60757136 60757137 60808036 60808037 60819451 60819452 60819453 60877718 60877719 60877720 60931195 60985540 60985541 61040681 61040682 61040684 61109144 61112682 61120304 61120981 61131937 61190343 61211661 61267746 61271273 61286469 61306562 61420296 61420297 61446342 61464971 61484490 61523821 61547953 61650561 61729661 61729663 61763514 61763515 62262082 60099573 60099574 60099585 60124870 60129688 60135240 60140405 60145218 60145219 60154234 60154235 60154237 60157589 60165672 60167201 60167202 60172525 60177208 60186890 60187396 60196178 60196181 60201147 60201149 60218886 60218887 60230030 60242035 60242036 60259331 60265754 60265755 60288640 60288641 60288648 60288649 60310719 60310720 60323398 60323399 60338615 60338619 6","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1028-2014","Class II","VERSYS HERITAGE FEM STEM ","60888636 60953044 60953045 60990022 60990023 61037925 61101347 61190038 61199991 61216692 61231958 61337105 61337106 61337108 61337109 61380551 61393846 61395480 61395481 61395482 61457789 61488608 61501472 61528642 61607607 61613260 61631108 61636270 61640544 61658343 61727080 61795011 61803866 61830030 61841636 61841637 61859438 61860472 61878469 61880368 61903233 61936199 61980174 62001339 62024623 62055989 62055991 62097061 62106808 62143853 62147329 62147330 62199398 62199399 62213245 62232590 62240777 62257146 62268582 62268583 62281833 62298293 62305944 369871 61282966 61727082 61962092 369672 61189806 61266267 61294351 369898 61293625 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1011-2014","Class II","M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543. ","367948 60314382 60630218 60691787 61053255 61064495 61117719 61303810 61367343 61434774 368764 369138 60219125 60391605 60468238 60645301 61040164 61040166 61092425 61271218 61298490 61332788 61415337 61565527 61711271 61748698 61565527R 368397 60136443 60269633 60393450 60894576 61031591 61079877 61191197 61242951 61294517 61490690 61578055 367232 367951 369139 60518287 60747414 61026918 61092426 61191198 61244794 61275552 61332789 61413348 61490691 00367232R 367735 367952 60205391 60439856 60917345 61049665 61117720 61191199 61260863 61328159 61394802 61428545 367953 368447 369593 60797052 60917346 61069777 61172854 61290214 61382432 61413349 367725 367954 369141 60820229 60969982 60970713 61290216 61382436 00367725R 367955 60222667 60231603 60977563 61191201 61382437 61445338 60231603R 367956 60205392 60969976 60999538 61275553 61344244 61512881 367933 369142 60165691 60269651 60583693 60622432 60973767 61092427 61266204 61298505 61446672 61453160 61631388 61667272 61747816 61747817 367957 60175558 60278617 60426189 60487390 60622433 60630460 60931489 61031586 61069779 61092428 61226794 61242943 61275555 61285979 61415338 61468148 61711274 367361 60154629 60175559 60684985 60973773 61069780 61113627 61155638 61290219 61458957 61632569 60175559R 60973773R 367934 368448 60139737 60208383 60377209 60426190 60472556 60922833 61069782 61113628 61191202 61413350 61584830 367928 369144 60913694 61159195 61313806 61328160 61415339 60913694R 61159195R 61328160R 367935 368449 369145 61053248 61097069 61191203 61415340 367959 368450 60205393 61231968 61233990 61341152 61395129 61584831 60205393R 61395129R 367960 369146 60685553 60735612 60999519 61117721 61338942 367726 367936 368192 60104823 60119139 60136445 60173954 60216381 60260479 60266612 60454980 60468259 60645310 60897830 60897855 61040167 61117722 61172853 61191230 61223093 61313802 61458958 61597136 61667273 61700135 61747820 61747821 367923 60098284 60136446 60150750 60173955 60208385 60241721 60258736 60310279 60415176 60437847 60454981 60463316 60468260 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1030-2014","Class II","ZIMTRON 6 DEG 22 HEADS","61841123 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1018-2014","Class II","MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001","365614 369469 60101996 60101997 60156488 60156489 60178356 60187896 60202868 60202869 60257213 60261647 60266457 60273995 60273996 60324337 60411690 60411691 60428980 60457742 60474620 60474621 60474622 60646263 60646264 60646265 60708475 60797297 60822088 60867060 60899017 60899018 60945798 61104294 61199990 61222220 61282924 61293845 61320383 61336983 61336985 61522992 61550876 61555656 61664260 365612 369617 370353 370412 60065984 60113194 60135098 60135109 60156491 60179688 60242116 60242117 60273997 60294371 60345749 60457743 60600426 60646268 60708476 60803408 60846356 60899019 60945799 60979573 61172283 61199988 61282925 61320379 61339628 61460816 61550877 61664258 60242118 60324338 60428996 60474623 61222221 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1008-2014","Class II","RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.","60177183 60185167 60358113 60497829 60497830 60505959 60537292 60537294 60575711 60620308 60714139 60725700 60817575 60863968 60876909 61031020 61075699 61140183 61178962 61286463 61475180 61530431 60099578 60152959 60185168 60265704 60279629 60358114 60461498 60497831 60505960 60537296 60550315 60575712 60602426 60615919 60690735 60714140 60735634 60857991 60863973 60950791 60966531 61104682 61175267 61194460 61453383 61489974 60099579 60185169 60195438 60265705 60279630 60358115 60380439 60450626 60497832 60505961 60537298 60569917 60575713 60602428 60615938 60711131 60735635 60819473 60857992 60863980 61024758 61066603 61075700 61133155 61158610 61175268 61178939 61242313 61258929 61280067 61303205 61446260 61484472 61604368 61664930 60152960 60177184 60185170 60208612 60279631 60323289 60450628 60461502 60461503 60505962 60537299 60537301 60569919 60602430 60615936 60714142 60735636 60819454 60857994 60863981 60876912 61041742 61071417 61120273 61143242 61158614 61175269 61178942 61256011 61303206 61414385 61439695 61446261 61512407 61530432 61551620 62296412 60095053 60117030 60123298 60137565 60152961 60167141 60185171 60208614 60279632 60301507 60367530 60450630 60451182 60461504 60461505 60497835 60497836 60550316 60561121 60569927 60575715 60620326 60620327 60711137 60714143 60735637 60757038 60819450 60853602 60863982 61004026 61064849 61071418 61104683 61109127 61120958 61158616 61164106 61175270 61190330 61303207 61425887 61453384 61516664 61538686 61607673 61657614 60129672 60140389 60152323 60152962 60179286 60201124 60208616 60279633 60288489 60338428 60358117 60367533 60387524 60422606 60438312 60461506 60461508 60497837 60505963 60505964 60537303 60550317 60569928 60575716 60615937 60653330 60690737 60714144 60735638 60819460 60857995 60863983 60863986 60979593 61041738 61071419 61104684 61120960 61138172 61143243 61147777 61175271 61178947 61211621 61221429 61263171 61286467 61303220 61425889 61453385 61512408 61516671 61560199 61607674 61621137 61746795 62262050 60095055 60117033 60135208 60",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1038-2014","Class II","HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S","60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382 60318917 60367391 60451947 60491785 60589767 60665682 60665683 60757015 60810891 60926378 60930484 60953937 60953938 61045584 61109124 61135014 61144262 61428498 61437196 60096548 60109535 60111962 60126279 60132072 60135124 60142531 60152397 60165150 60169711 60196507 60208415 60218735 60235187 60244038 60247673 60291570 60303879 60308478 60308479 60323219 60429155 60435646 60451952 60472779 60487172 60491786 60501138 60501139 60603149 60629958 60652968 60665904 60714756 60714757 60735916 60757016 60810892 60818328 60953942 61008526 61012463 61012464 61012465 61012466 61045586 61045587 61045588 61144264 61428502 61437198 61490670 61754462 60096549 60101706 60109537 60112829 60123232 60126280 60132073 60140244 60141574 60152398 60155288 60172485 60190827 60194301 60195422 60222272 60231258 60247674 60257483 60257484 60270650 60274974 60279001 60291572 60291574 60323220 60336408 60343703 60429156 60435650 60451953 60472780 60491790 60501140 60501141 60529889 60544298 60557791 60589768 60652972 60671883 60683409 60714758 60735917 60810894 60810895 60818329 60818330 60818331 60944477 60990430 61001693 61045590 61045591 61045592 61080404 61083225 61117670 61135015 61144266 61273769 61357130 61374874 61382949 61382950 61434454 61473777 61523647 369406 60096550 60101707 60109539 60112830 60117016 60126281 60130233 60132074 60140245 60141576 60148204 60152399 60155289 60162144 60169712 60172486 60178898 60189031 60190828 60194302 60195425 60228106 60235188 60244039 60247675 60253689 60257485 60270651 60274975 60279002 60291576 60291577 60303880 60308480 60323221 60336409 60343704 60372743 60380525 60425090 60429157 60435653 60451954 60472781 60478986 60501142 60501143 60529890 60544299 60544301 60557795 60652974 60667006 60675136 60677483 60677485 60683412 60757018 60810896 60810897 6081",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1026-2014","Class II","HGP II ACETABULAR CUP MOD","60035657 60035663 60163301 60078959 60163345 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1002-2014","Class II","HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.","60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650 60845570 60885012 61156076 61290771 60097888 60126180 60155283 60235175 60270647 60278995 60393280 60425089 60472771 60538426 60555772 60557775 60588046 60591903 60603145 60715075 60845571 60885014 61316528 61616158 61749182 60111959 60140238 60162141 60175614 60208384 60218727 60278996 60285802 60291544 60406046 60435612 60487168 60550156 60555773 60557774 60576766 60591904 60603146 60859714 60885015 61075639 61103192 61166254 61290772 61650519 61750812 60093352 60101703 60115126 60140239 60141562 60186799 60195341 60253673 60265299 60270648 60291547 60380281 60393281 60406047 60472772 60478980 60536890 60555774 60557776 60588047 60591905 60708627 60845573 60845574 60859715 61019223 61103193 61117518 61144243 61434451 61473776 61635184 61650520 61750818 60094821 60115127 60123222 60126182 60135115 60142528 60169707 60189030 60195345 60208386 60222271 60231248 60240379 60265301 60278998 60318916 60323216 60380282 60422419 60429154 60435617 60451941 60536891 60550158 60557777 60576768 60603147 60603150 60671881 60708628 60756056 60756071 60756072 60788112 60845575 60845576 60859716 60885016 61080555 61103194 61141227 61156079 61266929 61287003 61420555 61434452 61487520 61564719 61640830 61660576 61729755 61753841 60101704 60123223 60142529 60169708 60195352 60195392 60195393 60195394 60195395 60291561 60367373 60401265 60435620 60472773 60514749 60557778 60576769 60588048 60598747 60708630 60845577 60845578 60868431 61019224 61061013 61076451 61080556 61144244 61224620 61290773 61538664 61729756 62304810 60097889 60140240 60165147 60195353 60253674 60270649 60278999 60291562 60367380 60435623 60491779 60550161 60671882 60709315 60713651 60845579 60859730 61076452 61111263 61166257 61179536 61206335 61316530 61487522 61616159 60152391 60190823 60231245 60240380 60285801 60323217 60406048 60435626 60478981 60514751 60538427 60598749 60603151 60708631 60788113 60845581 60885017 61019225 61061014 61075640 61",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1032-2014","Class II","CPT 12/14 COCR (various sizes)","60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761 60261763 60776227 60776234 60846362 60916726 60952935 60979483 61162865 61189800 61356814 61460831 61523005 61739387 61748949 61829563 61996730 60310780 60335521 60412478 60457571 60533531 60776287 60776288 60823773 60990055 61045309 61351320 61500146 61727738 61727739 61957411 60217292 60245136 60330281 60448728 60491098 60648441 60704737 60748770 60776312 60797325 60916737 60952946 61261797 61293863 61307997 61733348 61758312 61868121 61881187 61885896 61991679 62001331 60245153 60245154 60323912 60372490 60589471 60704749 60723802 60748790 60921196 60957269 61045290 61061843 61104280 61114610 61733350 61987756 61991676 60217518 60310793 60330358 60589477 60789763 60829712 60957183 60957252 61010390 61047782 61356826 61484547 61589156 61650372 61696379 61747548 61762055 61774068 61783714 61878465 61930415 61991684 61999776 62003973 62006549 62006552 62014206 60509163 61130729 61460829 61613256 61711999 62097052 60600577 60704770 60898905 61035924 61045315 61114612 61237346 61243405 61516824 61596779 61744474 61833302 61878466 61930418 61964629 60310799 60352497 60600588 60615058 60748834 60797333 60823790 60889814 60889815 60952953 60957186 60979502 61045316 61325399 61336846 61351344 61522157 61694927 61762060 61815831 62001327 60261985 60261986 60326340 60330332 60510215 60574913 60685247 60748844 60748850 60797335 60799614 60822508 60916748 60916749 60921201 60944305 61075599 61114637 61460856 61472388 61731627 61762053 61833303 61840602 61884450 61957405 62001329 60380023 60443946 60491173 60685261 60809480 61024361 61104288 61516832 61607601 60378595 60723862 60748854 607488",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1001-2014","Class II","Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.","60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830 60962064 61107953 61144212 61291484 62326539 60137568 60381037 60452034 60678940 60725699 60861044 60885486 61030192 61064420 61107954 61144213 61291485 61627268 62320020 60099553 60124830 60155276 60210916 60279193 60293173 60406084 60678941 60735831 60772796 60820105 60914273 60932397 60962068 61100754 61107955 61141540 61383124 61542613 60099554 60123327 60151759 60165563 60186810 60218909 60323277 60337989 60392818 60641792 60700524 60776686 60861046 60885488 60914275 60932398 61041383 61064421 61107956 61122465 61383125 61523983 61549785 60097901 60151760 60167122 60231230 60242175 60338000 60374541 60678943 60690724 60700525 60820107 60863688 60962072 60997213 61041385 61099269 61107957 61122466 61162278 61185825 60097903 60151761 60186811 60231231 60338011 60374542 60502481 60735832 60776688 60787138 60997215 61099270 61115884 61180535 61282213 62294111 60154180 60172533 60242176 60309839 60381041 60452035 60502489 60735833 60938330 61062712 61064422 61107958 61122467 61141541 61549786 61699534 60099555 60165564 60201193 60242177 60356457 60502490 60735834 60820109 61041387 61099271 61115885 61180536 60137569 60172535 60218167 60264360 60274085 60538627 60569295 60585920 60749370 60861047 60868423 61099273 61122468 61141542 61180537 61466708 61542615 61721886 60279194 60293174 60545074 60588248 60735835 60755954 60820110 61067734 61107959 61122469 61162279 61185824 61513918 61542616 61699535 61707903 60127526 60167124 60264361 60274087 60452036 60569296 60678944 60749371 60820111 60863690 60868424 60962076 61030196 61031914 61107960 61141543 61141544 61286988 61",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1037-2014","Class II","FEM HD ION (various sizes)","61401713 60282649 60291491 60362702 60586125 60977398 61089134 62051714 60530561 60759915 60939995 61275826 60169621 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1041-2014","Class II","2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT ","61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1004-2014","Class II","Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM ","61484349 62124275 62157179 61077209 61337135 61484350 60555611 60747379 60874833 61142854 61142854R 60325552 60293083 60879683 61284330 61286943 60085527 60436025 60513856 60879684 61284331 61286947 60145167 60186855 60210921 60815940 60879685 60152929 60293084 60483144 60523344 60483145 60523345 60483145R 60440756 60483146 60523346 61142856 60483147 60523347 60536820 60483148 60523350 60483149 60523353 60483150 60523355 60536821 60483151 60483152 60523360 60483153 60523364 60483154 60523365 61067755 60483155 60523369 60132504 60165597 60206470 60293086 60387521 60452004 60488952 60572992 60653075 60671959 60812149 60984699 61004201 61040107 61092997 61099399 61104820 61142860 61224794 61283207 60127012 60140321 60152930 60208488 60265677 60281409 60293087 60323242 60425131 60452005 60488953 60523371 60561146 60653078 60671960 60812150 60848590 61002194 61002195 61026422 61026423 61026424 61083094 61092998 61099402 61142861 61144218 61195105 61195106 61002194R 61002195R 60096566 60118985 60127013 60137590 60165601 60172576 60234054 60254715 60264345 60317521 60385457 60393375 60436028 60483156 60488954 60513859 60538635 60572993 60576792 60585224 60621346 60653083 60671961 60714813 60736759 60848591 60848592 60973703 61004197 61004199 61083095 61092999 61099403 61142862 61144219 61195108 61275457 61616168 61737706 61774929 62116937 60127013R 60106616 60112849 60127014 60132507 60137591 60140322 60145168 60150159 60165604 60172578 60181949 60195046 60234055 60254716 60258448 60258449 60281411 60281412 60293088 60293089 60317522 60319984 60329109 60425132 60430657 60448001 60452006 60528727 60538637 60572994 60585225 60621347 60653085 60653088 60671962 60671963 60702010 60736760 60794263 60830601 60848593 60848594 60970191 60970192 60970193 61026416 61026417 61026418 61037609 61037611 61099405 61117601 61133098 61136511 61142863 61142864 61195109 61224796 61224797 61224798 61296709 61296710 61562050 61578287 61616170 61737707 61774932 62116938 60106617 60132509 60135161 60137592 60145169 60150161 60159613 601725",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1006-2014","Class II","VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980, 001981, 0011990 and 0011991","60053473 60528659 60807849 60855076 365855 60807850 60855077 365856 60143351 60384033 60403721 60452546 60543211 60632720 60807851 368913 369123 60219007 60740783 60993433 365857 369559 371074 60539739 60807852 365859 60098398 60119108 60241936 60625494 60082810 60625506 365860 365861 60222477 60109715 60187232 366023 60161891 60116180 60175536 365749 60082811 60109716 60123966 60175537 60231394 60097992 60119110 60123967 60143352 60154511 60165702 60175538 60231395 365740 366424 60109717 60112053 60112054 60116181 60116182 60119111 60119112 60129316 60129317 60154512 60154513 60165703 60175539 60187233 60187234 60206858 60206859 60241934 60161892 365739 60109718 365738 60123968 366024 366025 60136407 365752 365751 60123969 60154514 60082812 60109719 365753 365743 60163222 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1044-2014","Class II","3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X 34 CORT SCREW SELFT 3.5 X 36 CORT SCREW SELFT 3.5 X 38 CORT SCREW SELFT 3.5 X 40 CORT SCREW SELFT 3.5 X 45 CORT SCREW SELFT 3.5 X 50 CORT SCREW SELFT 3.5 X 55 CORT SCREW SELFT 3.5 X 60 CORT SCREW SELFT 3.5 X 75 CORT SCREW SELFT ","61173204 61173205 61173206 61804309 61173207 61804310 61173208 61117130 61173210 61173212 61173213 61173214 61173215 61173216 61173218 61173219 61173220 61173221 61173223 61173224 61173226 61173228 61173231 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1016-2014","Class II","MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.","60484301 60536380 60565715 60753818 60817438 60864746 61003323 61059514 61081364 61121949 61135827 61387138 61783644 365466 60096346 60097010 60259990 60422473 60459752 60515365 60674982 60715057 60768520 60787821 60799626 60799627 61012710 61029791 61029797 61075345 61103552 61103553 61121950 61121951 61135828 61883369 61901575 61938344 369678 369843 60242811 60260004 60317143 60370104 60411929 60411932 60441611 60501819 60501820 60501821 60540465 60553615 60715059 60759283 60759284 60759285 60787991 60799628 60979642 61003325 61012729 61059519 61121952 61121954 61222215 61339786 61398793 61528632 61541580 61565702 61589080 61613237 61921999 61938346 60085561 60096349 60097011 60124640 60134157 60148294 60154764 60154765 60169374 60169375 60187551 60187552 60242814 60260197 60274423 60301862 60313429 60335338 60395245 60395246 60422533 60442559 60484312 60501825 60511856 60553618 60574472 60600313 60609939 60753835 60768538 60768539 60768541 60768542 60787295 60799629 60799630 60990033 61003326 61003327 61012713 61029792 61042227 61059521 61059540 61059541 61121955 61121958 61286077 61293836 61336916 61356578 61365617 61427119 61506293 61550873 61567517 61685104 61708167 61744439 61803839 61846938 61886948 61987166 365462 366297 367557 370033 60091185 60110058 60110136 60110138 60124644 60124646 60134158 60134159 60141863 60148295 60166638 60169376 60169383 60204468 60242818 60242819 60242820 60260206 60274450 60274453 60274486 60293234 60293235 60293236 60293237 60313507 60326529 60395249 60395250 60411943 60411944 60422535 60441625 60459776 60484317 60501827 60523550 60552243 60552244 60565799 60574476 60574477 60574478 60609942 60609943 60646735 60700464 60700465 60743733 60743734 60768553 60787311 60787313 60842140 60900070 60919566 61003328 61029793 61029794 61033867 61033868 61075309 61103522 61103523 61103525 61121959 61166175 61183999 61197657 61218568 61218569 61356579 61365618 61369497 61435961 61468751 61484505 61490076 61541589 61550869 61565703 61579856 61651260 61658293 61736305 61806778 6181209",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1017-2014","Class II","MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem","60204970 60242926 60877896 61059555 60148524 60162051 60187879 61178682 365451 60097214 60097216 60313377 60395244 60441594 60484309 60540466 60609930 60768532 60979646 61003342 61029820 61135862 61307977 61575440 369866 60087317 60097220 60172931 60187880 60242928 60242933 60293228 60335340 60395248 60422523 60484314 60540516 60609935 60743728 60864758 60877921 60919578 61102981 61135863 61262147 61262148 61336941 61575443 61575444 367763 60120648 60124981 60172935 60187881 60326524 60335353 60370152 60411948 60441627 60532104 60581829 60726774 60787322 60900086 60960054 61003345 61122115 61179463 61262149 61387146 61575446 61596750 365457 366212 369774 60064812 60095554 60095560 60134404 60154918 60187882 60204978 60242941 60242942 60260213 60335392 60335393 60370158 60395262 60411955 60411956 60484366 60484367 60501914 60532123 60540536 60609996 60678493 60727909 60727910 60743735 60787899 60887298 60900087 61003347 61012722 61081371 61122116 61158989 61179459 61262150 61304671 61318408 61329737 61339783 61387149 61501412 61565711 61575452 60095693 60095694 60204979 60260220 60293281 60395267 60423089 60484383 60532144 60574503 61003348 61003349 61029828 61118583 61122119 61153010 61282911 61324219 61356603 61453524 61575460 61575462 60085706 60095713 60095714 60169604 60204981 60242974 60242975 60260221 60293303 60326540 60370208 60370209 60411976 60423093 60484384 60506722 60540820 60581932 60727952 60808903 60900088 61003350 61012732 61042240 61122120 61122121 61183998 61273012 61286073 61336942 61468754 61575468 61708166 366432 60095748 60095756 60095778 60139193 60317118 60484702 60506730 61012733 61042241 61059557 61135866 61260563 61336943 61592242 61607581 365471 366358 366990 367755 369775 60095777 60095783 60154919 60260446 60317117 60370238 60383173 60423125 60484712 60506746 60540828 60582009 60610179 60610180 60835007 60864759 61045178 61164596 61178681 61575470 61708163 365479 60081485 60095784 60095805 60412007 60484715 60553895 60727999 61012758 61036131 61122123 61339897 61592243 61696347 3",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1021-2014","Class II","I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST","61069810 61239668 60817848 60859538 61069808 60564425 60629462 61098322 60586662 60119138 60125003 60138865 60138866 60144492 60144493 60160818 60160819 60160820 60177055 60177056 60190191 60190192 60194090 60194091 60210614 60210615 60210616 60244036 60244045 60254555 60254559 60262556 60266099 60280552 60294695 60310003 60310009 60310017 60337897 60350850 60359183 60367447 60382117 60403684 60403685 60420502 60441357 60461431 60475823 60494867 60507637 60507638 60535476 60541148 60579568 60627444 60652013 60656130 60671226 60681755 60713063 60721666 60746532 60769330 60786197 60805886 60875806 60884324 60897175 60931950 60965132 60990158 61002035 61035915 61070777 61077276 61137977 61197943 61227779 61249364 61249365 61287995 61319958 61357847 61422276 61454665 61458496 61504823 61548591 61593075 61770510 61895892 62016765 62079773 62090497 60097574 60097576 60097579 60097580 60125006 60134489 60134492 60138867 60149449 60149450 60160821 60160822 60166063 60166936 60177057 60177058 60190193 60190194 60190195 60194092 60194093 60209183 60209190 60213787 60213788 60230913 60244037 60244046 60254556 60254560 60254561 60262558 60266101 60266108 60280549 60294696 60294697 60309999 60310004 60310010 60310018 60310020 60337898 60337899 60359186 60367435 60367448 60382119 60396003 60396004 60410775 60420496 60420499 60441359 60441360 60461429 60461434 60475824 60494868 60527379 60535465 60535466 60535467 60541149 60588177 60621584 60627445 60652015 60652016 60656131 60667723 60676021 60687736 60713064 60713066 60721667 60740450 60756648 60769332 60780581 60796099 60808882 60817474 60829580 60847405 60854395 60884325 60897176 60906707 60909008 60931951 60952859 60970285 60990160 61002034 61018582 61056173 61070783 61077277 61103028 61126010 61137978 61160761 61171951 61197945 61197946 61227782 61242481 61249368 61249369 61283850 61307741 61323831 61341880 61371974 61400196 61422277 61454671 61454672 61474936 61497084 61521995 61573721 61573722 61593076 61593077 61626678 61708924 61764280 61917452 61917453 62021043 62",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1003-2014","Class II","FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.","60879678 61278171 61625237 60564708 61026414 60564708R 60564710 60915347 61141512 61142759 60639474 60782037 62046409 60155294 60206463 62120939 60206463R 60108502 60152927 60206464 60862361 60862362 60862361R 60142899 60165580 60206466 60487350 60671954 60736748 61491355 62120941 60208478 60815946 61278172 61502705 60142901 60172569 60281392 60538633 60705043 60736749 60830649 61026415 60162132 60639475 60781210 61110037 60782040 60782041 61345993 61399023 61045321 61400219 60817011 61268917 60782042 60931208 61400222 61400223 61393376 60782043 61141513 61278174 61284322 61026411 61286935 60106612 60572988 61286938 61491356 60071404 60099545 60107375 60218931 60218932 60653031 60782044 61026409 61195093 61420626 61502706 61616173 60080046 60109509 60115145 60126996 60154170 60195018 60208481 60234047 60275162 60472815 60536817 60653032 60781212 60879681 61026406 61141514 61195094 61274845 61284324 61345995 61629793 61700052 60111966 60112840 60123244 60126997 60142902 60165583 60175627 60189035 60190841 60218933 60218934 60222827 60222828 60234048 60275163 60281396 60290741 60293063 60323238 60653043 60701995 60705044 60782045 60812141 60862367 61037587 61037588 61141515 61195095 61209053 61251129 61278175 61284325 61420628 61466805 61614765 61663369 61278175R 60097895 60103441 60106613 60112843 60123245 60126998 60132497 60142903 60154171 60157576 60172572 60181946 60186847 60195020 60208482 60215946 60222829 60222830 60234049 60242264 60242265 60254701 60275164 60281399 60290742 60293064 60293065 60323239 60572989 60621339 60653053 60671955 60701998 60736750 60782046 60812142 60931209 61026403 61026404 61077251 61110038 61120992 61141516 61171562 61184409 61195096 61209054 61251130 61428485 61534196 61609887 61644214 61663371 61195096R 60088618 60097896 60099546 60103442 60107376 60107377 60123246 60126999 60135159 60142904 60150153 60155295 60165584 60172573 60186849 60195021 60208483 60215947 60222831 60222832 60234050 60236419 60242267 60242269 60254706 60275165 60281401 60290743 60293066 60323240 603810",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1042-2014","Class II","X 65 PART THD CANC SC 4.0 X 70 CANCELL. SCREW 4.0 X 70 PART THD CANC SC 4.0 X 75 CANCELL. SCREW 4.0 X 80 CANCELL. SCREW 4.5 X 16 CORT SCREW SELF 4.5 X 22 CORT SCREW SELF 4.5 X 24 CORT SCREW SELF 4.5 X 26 CORT SCREW SELF 4.5 X 28 CORT SCREW SELF 4.5 X 30 CORT SCREW SELF 4.5X30 MALLEOLAR SCREW 4.5 X 32 CORT SCREW SELF 4.5 X 34 CORT SCREW SELF 4.5 X 36 CORT SCREW SELF 4.5 X 38 CORT SCREW SELF 4.5 X 40 CORT SCREW SELF 4.5X40 MALLEOLAR SCREW 4.5 X 42 CORT SCREW SELF 4.5 X 44 CORT SCREW SELF 4.5 X 46 CORT SCREW SELF 4.5 X 48 CORT SCREW SELF 4.5 X 50 CORT SCREW SELF 4.5 X 52 CORT SCREW SELF 4.5 X 54 CORT SCREW SELF 4.5 X 56 CORT SCREW SELF 4.5 X 58 CORT SCREW SELF 4.5 X 60 CORT SCREW SELF 4.5 X 62 CORT SCREW SELF 4.5 X 64 CORT SCREW SELF 4.5 X 70 CORT SCREW SELF 6.5 X 50 CANC SCREW, 32MM 6.5 X 55 CANC SCREW, FULL 6.5 X 60 CANC SCREW, FULL ","61267037 61195515 61233513 61255911 61196113 61255912 61255913 61196115 61233517 61255914 61255915 61255916 61196121 61196122 61759822 61196123 61582530 61605810 61196124 61582531 61196125 61196126 61582532 61196127 61759823 61196128 61196129 61196131 61196132 61196133 61196134 61196460 61196461 61168863 61234474 61196462 61196463 61234476 61247538 61196464 61225322 61234477 61196465 61234479 61168867 61196466 61234480 61196467 61234481 61196468 61234482 61196469 61234484 61168870 61196470 61168871 61196471 61196472 61168873 61196473 61168874 61196474 61196475 61168875 61196476 61168876 61196477 60654904 61168877 61196478 61196479 60654906 61196480 61168878 61196482 61196483 61196484 61168880 61196485 61256597 61256599 61256600 61256601 61256603 61310792 61344225 61530374 61654821 61256605 61256606 61216613 61247253 61557215 61881416 61216616 61247255 61263780 61585001 61247492 61247493 61251362 61251363 61322883 61326924 61473762 61873515 61247496 61247272 61247273 61247275 61775835 61835769 61196225 61247504 61247505 61241617 61337168 61339774 61775836 61196226 61247277 61263781 61263782 61263783 61196227 61234462 61247278 61263784 61196228 61263785 61196229 61247280 61263786 61196230 61234465 61263787 61640844 61775837 61196231 60619377 61216644 61234466 61196232 61216646 61234467 61196233 61585002 61196234 61216649 61296496 61196235 60619404 61216651 61635840 61196236 61234469 61420532 61614769 61196237 61216653 61234470 61585003 61640846 61234471 61640847 61196239 60619379 61216656 60619382 60564048 60619380 61216659 61234473 60564052 60553867 60564055 60619373 60564056 60619372 61196212 61196213 61196214 61196215 61196216 61196217 61196218 61196219 61196220 61196221 61196222 61196223 61196224 61251335 61378853 61296498 61359796 61553346 61574969 61216664 61234486 61296499 61420534 61234487 61234488 61247467 61263788 61234489 61234491 61567476 61247468 61378854 61447036 61553315 61565530 61567477 61234505 61241624 61234494 61420533 61473763 61557223 61268670 61268671 61557234 61251336 61553318 61593247 61",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1039-2014","Class II","COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)","60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078 60451935 60491775 60504962 60538423 60569271 60629869 60629870 60671868 60690620 60735901 60790633 60828403 60859841 60885052 60910023 60926381 60938165 60997341 61008512 61045578 61049489 61063879 61085581 61087377 61120002 61160484 61160485 61179531 61276833 61441956 61457387 61513903 61626104 61660625 61664773 61677697 61677702 61705589 61707801 61729145 61729146 61729745 61750828 62109253 60049193 60096554 60101711 60102587 60102588 60123238 60130244 60139604 60140249 60140250 60141583 60142539 60145093 60165156 60165157 60169713 60169714 60175619 60177171 60193845 60195824 60195825 60218748 60222629 60222631 60231265 60231266 60240376 60249923 60249924 60257490 60257491 60265333 60275014 60275015 60297515 60307915 60307916 60316668 60316669 60322678 60330555 60332252 60338176 60370097 60380274 60391503 60391504 60393274 60393275 60401261 60405226 60471147 60491776 60491777 60514747 60536910 60536915 60538424 60550151 60557766 60563823 60585131 60591894 60610147 60629871 60629873 60629876 60639748 60639754 60646706 60652934 60652937 60671869 60671870 60698228 60714739 60735902 60735903 60756001 60790637 60794404 60843741 60868448 60885053 60885055 60926383 60930495 60932378 60938166 60938167 60938168 60944479 60997342 60997343 61008514 61012474 61045579 61063880 61063881 61063882 61085583 61120003 61120004 61140029 61140030 61140031 61160486 61160487 61160488 61179533 61206340 61233884 61245938 61262515 61276834 61276835 61296488 61305259 61313619 61316547 61354692 61354693 61354694 61359714 61359715 61420257 61425119 61425120 61457388 61461974 61468652 61523661 61584920 61620163 61634702 61657584 61660646 61707798 61707799 61713678 61713679 61729746 61729747 61740684 61750832 62118597 62304910 60044879 60086616 60086618 60096556 60097892 60097893 60097894 60101712 60101713 60101714 60102590 60102594 60102595 60105526 60105527 60108360 60108362 60109554 60109556 60109558 60111964 60111965 60112836 60",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1025-2014","Class II","HGP II ACETABULAR CUP BON","60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499 61830570 62081013 62130755 62204493 60358198 60456662 60676065 60740508 60793418 60847420 60906711 60970346 61018601 61089082 61114463 61197927 61265392 61336977 61405285 61445415 61504347 61560488 61612779 61717244 61770502 61830571 61953544 62017892 62081014 62126660 62161132 62194338 62286121 60096604 60191638 60231058 60310154 60403566 60541147 60614769 60652079 60713588 60771842 60809040 60906712 60965173 61013603 61077260 61120020 61191847 61197928 61288037 61336979 61405286 61445416 61504866 61548952 61612780 61649225 61738511 61770503 61830572 61902195 61902196 62017893 62048834 62090584 62204494 62286108 60134456 60196503 60254570 60310198 60400186 60604759 60642280 60687794 60749489 60793419 60838387 60914317 60965174 61018602 61070794 61114467 61180328 61191849 61226932 61296291 61362816 61378482 61405287 61458844 61504348 61548956 61612781 61649239 61687332 61738512 61770504 61801685 61830573 61902198 61902199 62061747 62104331 62130756 62194340 62211466 62315402 60307754 60358199 60537583 60745919 60817921 60884347 60932061 61013580 61077263 61135531 61197929 61283948 61354050 61445417 61458847 61573708 61612782 61649249 61738514 61770505 61830569 61906698 61948762 62104332 62130758 62227608 62308540 60391769 60537584 60614771 60732352 60780619 60838388 60906713 60965175 61013604 61056224 61120060 61180329 61226933 61283949 61336980 61405288 61445418 61479405 61504351 61573709 61623853 61674477 61717245 61760696 61770506 61830575 61902204 62017896 62074012 62104333 62143479 62227609 62308549 60354639 60400189 60503574 60535463 60604758 60616222 60642282 60687795 607566",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1012-2014","Class II","ASIA ONE-PIECE LAG SCREW ","61671102 62142296 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1031-2014","Class II","12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)","365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 60138381 60138382 60157045 60157046 60157047 60173107 60173557 60178493 60189233 60190544 60196799 60205060 60205062 60215717 60232508 60232571 60236680 60238555 60239170 60239172 60239173 60249946 60250022 60250024 60262696 60262703 60274914 60274915 60274916 60275490 60275491 60275492 60346324 60346325 60349076 60349077 60349078 60349079 60349080 60389118 60392706 60425077 60431157 60431160 60431161 60458471 60466704 60475849 60484210 60499766 60508292 60517078 60524278 60535550 60535551 60541380 60541381 60568674 60579071 60587849 60597445 60597446 60610372 60610373 60623786 60627203 60656086 60664595 60670142 60677138 60687291 60687418 60687419 60718653 60722394 60732757 60746715 60758427 60758430 60769368 60780501 60796169 60806142 60816001 60821870 60823970 60838548 60847561 60857285 60902859 60926643 60932110 60946189 60960585 60985058 60985059 60985060 60991401 61005341 61022599 61035615 61035616 61052152 61070012 61070013 61070014 61089088 61089090 61092840 61092841 61111756 61135439 61135440 61138014 61138016 61167124 61178515 61178688 61184545 61203739 61203740 61223370 61223371 61245055 61245056 61256831 61261936 61261937 61261938 61269109 61288320 61304610 61304612 61338105 61338107 61338108 61343023 61350054 61368478 61371507 61373326 61383291 61383292 61401624 61401626 61450665 61450666 61450667 61469240 61469241 61469242 61488251 61488252 61488253 61502828 61502829 61502830 61548470 61548474 61548476 61548479 61548480 61548481 61600727 61600731 61600733 61600736 61600738 61634945 61659973 61659975 61674846 61686460 61686461 61686462 61720170 61727773 61736757 61743025 61743026 61744785 61760260 61769457 61769458 61769459 61777541 61780566 61780567 61803288 61803289 61803290 61826627 61826628 61826629 61826630 61826631 61829226 61847059 61847060 61855260 61870131 61870132 61870133 61870134 61887176 61904394 61904395 61938358 61938359 61938360 61982248 61982249 61982250 61982252 61982254 620054"," 60759884 60759885 60763109 60763110 60769383 60769384 60769385 60769386 60769387 60780509 60780510 60780511 60783707 60783708 60783709 60783810 60783811 60785475 60800902 60800903 60806148 60806149 60810280 60810281 60816009 60816010 60818371 60818372 60823981 60823982 60823984 60829293 60838558 60838559 60838560 60846847 60846870 60846871 60846872 60847575 60847577 60847578 60857299 60858873 60867339 60884503 60884522 60884523 60892278 60892279 60897057 60899389 60902868 60902869 60902870 60906729 60906730 60906731 60912614 60914296 60926664 60926665 60932124 60939980 60946203 60946205 60946206 60946207 60960607 60960608 60960609 60960610 60960611 60975928 60975930 60991420 60991423 60991425 61001946 61001950 61001951 61005351 61005352 61019162 61019163 61022619 61022621 61022622 61029613 61029614 61029615 61029616 61029617 61029620 61035629 61035630 61038602 61038603 61041474 61041476 61064914 61064915 61064916 61064917 61064919 61064920 61070020 61070023 61070024 61070025 61077814 61081260 61089114 61089115 61089116 61089119 61089120 61089121 61092851 61092852 61099121 61099122 61099123 61099124 61109537 61109538 61109543 61109545 61111795 61131703 61131704 61131705 61131707 61131708 61135455 61135456 61138029 61138030 61156930 61156931 61156932 61156933 61167144 61175561 61175562 61175563 61178702 61179838 61179839 61179840 61203755 61203758 61218492 61218493 61218495 61218496 61218498 61218501 61218502 61218503 61223380 61223416 61223418 61232599 61232601 61238158 61240141 61247033 61247034 61252259 61261953 61261955 61261957 61269073 61269104 61275853 61288329 61288459 61292738 61313725 61322955 61328189 61328190 61331630 61331631 61331632 61338126 61338143 61338144 61342447 61352578 61352579 61356688 61363401 61382321 61382322 61382323 61383306 61383307 61394008 61401638 61401639 61409506 61409507 61409508 61424817 61424818 61424819 61424820 61424821 61454745 61454746 61454749 61454751 61454755 61454756 61454757 61488277 61513584 61513585 61513586 61513588 61513590 61513591 61513592 61513593 61513594 6","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1007-2014","Class II","M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400","368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248 61332792 61727932 368490 60158049 60506370 60741224 60960320 61111054 61120925 61143374 61220140 61298509 61143374R 368281 60114142 60232597 60518286 60960628 60960818 61220141 61266215 61281313 61317747 60175525 60281124 60958453 60960815 61140792 61159204 61275565 61317749 60960815R 61275565R 368311 368493 60082894 60281333 61075889 61111055 61159205 61220142 61290251 61338952 368112 368494 60186975 60253467 60703526 60994877 61075890 61111056 61143376 61220143 61275566 60186975R 60253467R 60703526R 368284 368285 368948 60082895 60186976 60305055 60958452 60960816 61140794 61271223 61281317 61313785 367853 368496 60376357 60506371 60725289 61075891 61140795 61237562 61281322 61298511 61468151 60506371R 60725289R 368324 368497 60082896 60484441 61020656 61075892 61117767 61220144 61294524 61501046 00368497R 60082896R 368286 368498 60158050 60484442 60718439 61237563 61266214 61294525 61367353 00368498R 60158050R 60484442R 60718439R 61266214R 368287 60186977 61140796 61267607 61290253 61341154 00368287R 60186977R 61140796R 368288 60186978 61178912 61307949 61501047 00368500R 60186978R 61178912R 61501047R 368312 61178913 61317751 61328162 61317751R 368313 60186979 61143378 61211142 61228027 61290256 61328163 00368313R 61211142R 61290256R 368289 60158051 60919031 61275568 00368289R 60158051R 368113 60165694 60677567 60919032 61117768 61140797 61317753 61338953 61428547 367341 368114 60591981 61075893 61117769 61140799 61155653 61237564 61249763 61281323 61453188 61501049 61249763R 61501049R 368115 60591982 61049751 61075894 61114076 61140801 61206020 61214454 61220913 61290257 61501052 61049751R 367183 367833 60214950 60338296 60771516 60931843 61075895 61114077 61117770 61140802 61155654 61214458 61220922 60771516R 368116 60114143 60136484 60186980 60422981 60553621 60640168 60",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1022-2014","Class II","NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLUTED STEM EXT, 2 NEXGEN CEMENTED STEM EXT ","61424993 61507222 61543969 61442278 61497511 61518148 61518149 61627190 61454951 61454952 61507223 61558358 61627192 61627198 61627202 61643930 61721669 61442310 61459958 61475125 61543975 61567342 61627206 61678232 61678233 61442319 61454955 61459970 61475130 61518182 61543977 61567344 61627260 61658886 61414605 61451226 61479488 61479489 61479490 61518197 61518198 61592093 61643938 61682157 61685470 61721675 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61424999 61543980 60877120 60893096 60903660 60917693 60917702 60917706 60917708 60917709 60917710 60917711 60917712 60917713 60918890 60918891 60918895 60918896 60918898 60918899 60922337 60922338 60922340 60922341 60922342 60922343 60922345 60922347 60922348 60927295 60927296 60927297 60927299 60927301 60927302 60927303 60927304 60927305 60927307 60927310 60927311 60931982 60931984 60936965 60936970 60936971 60936972 60936975 60936977 60936978 60947334 60947335 60954602 60966905 60966909 60966911 60966916 60966917 60966918 60973395 60973396 60973397 60973412 60973414 60983508 60983509 60983511 60983518 60983519 60983537 60983538 60983541 60983543 60983546 60994064 60994065 60995223 60995226 60995227 60998606 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61852882 61852883 61852885 61852886 61852888 61852889 61852892 61852893 61852894 61874150 61874497 61874498 61874500 61875035 61879905 61879907 61879908 61879910 61879911 61881529 61881530 61885111 61891993 61891994 61892858 61892860 61892861 61895824 61895827 61901107 61901108 61903387 61903391 61905926 61905928 61905929 61914161 61914162 61915686 61915689 61919775 61919776 61932231 61932233 61932235 61932238 61932239 61932240 61932242 61932245 61935537 61935538 61935541 61935542 61935543 61941682 61941683 61941684 61941686 61941692 61941695 61947282 61947284 61947285 61956254 61956255 61963008 61980334 61980335 61980336 61980337 61980338 61981208 61981210 61985182 61985185 61988470 61988472 61988473 61988477 61988482 61999439 61999440 62017863 62017864 62017868 62017873 62017875 62017876 62027348 62034473 62034475 62034476 62034478 62034481 62037943 62037946 62037947 62037948 62037949 62037950 62037951 62037952 62037953 62037954 62037955 62058696 62058697 62058698 62058699 62058701 62058702 62060789 62060791 62060793 62060794 62060795 62060796 62064018 62064019 62074485 62074487 62074488 62074489 62074491 62074493 62074495 62081113 62081114 62081116 62081117 62081118 62081121 62081122 62081123 62081124 62081125 62081126 62081127 62081129 62087176 62087179 62093756 62093757 62093759 62096757 62096759 62096760 62109778 62109779 62109780 62109781 62118613 62118615 62121749 62121752 62121753 62121754 62121755 62121756 62129219 62129221 62131538 62131539 62137429 62137430 62137431 62145058 62145059 62145061 62145064 62145065 62148849 62148852 62154756 62154757 62154759 62154760 62154762 62157029 62157030 62157031 62157032 62157033 62157034 62157035 62157036 62160771 62160774 62160775 62160776 62160777 62160779 62164928 62164930 62164932 62164933 62164934 62164935 62164936 62164937 62164939 62164940 62168410 62168416 62174920 62180201 62180202 62180203 62180206 6","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1020-2014","Class II","NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500","60114195 60595579 61077273 60187380 60610778 60796106 61137985 61249340 60105628 60595582 60919090 61277444 60330148 60732231 60945764 61283889 60219129 60579389 60756650 60965136 61207433 61242494 60244944 60579385 60756651 60965137 61233951 61593013 61887830 60105629 60166064 60224275 60244943 60337906 60461446 60586318 60595606 60696728 60808905 60906705 61018586 61103031 61180337 61249355 61341882 61422286 61526208 61636571 61717191 61770492 61887831 61929703 62048813 60213807 60331257 60579387 60941524 61233952 61687333 60099537 60139269 60194156 60244942 60330150 60436638 60614725 60681999 60838357 60945765 61089048 61207434 61378442 61585149 61770493 60105630 60191625 60200995 60610790 60858860 61180338 61770494 60139270 60209213 60310131 60579392 60713474 60906706 61089049 61378443 61902190 60503470 60678795 60897195 61233953 61770495 60124943 60230948 60420518 60676026 61056150 61445351 60177068 60330149 60504976 60671244 60897209 61146352 61770496 60294720 60503550 61018587 61585151 60233993 60501971 60834361 61160767 60105632 60503494 60586320 60595609 61238563 60125012 60504978 60844061 61265359 60266112 60503499 60860053 61207435 60209212 60382121 60491633 60671248 60847409 61070792 61238565 61497083 61911709 60099538 60395058 60503554 60682001 61228341 61266850 60160832 60367469 60503479 60858861 61207436 60310132 60491634 60671251 60991375 60105634 60139271 60213808 60330152 60461447 60652031 60861035 61180339 61422287 60135104 60194157 60266113 60334482 60436657 60503483 60667751 60834366 61146353 61445352 62143506 60125013 60213809 60330153 60503489 60965138 61504824 60177432 60263493 60503552 60858859 61331581 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1034-2014","Class II","6 DEGREE COCR FEM HEAD 36","369934 60308845 60508319 60588077 60670902 60701935 60779840 60790101 60810357 60847644 60906703 61077837 61077838 61191243 61191244 61247015 61304729 61340542 61401735 61485227 61530679 61551614 61555020 61670831 61720512 61774878 61790557 61837158 62025229 62124070 62176438 369935 60339031 60407279 60586160 60658085 60701954 60701967 60779852 60779856 60779863 60806208 60821916 60847645 60900931 61002276 61052833 61077839 61077840 61191246 61304732 61401736 61448090 61502826 61530680 61570271 61618471 61618472 61713710 61734540 61837159 61837160 61896789 62025230 62091051 62176441 62284369 60339030 60392901 60440343 60508338 60656885 60669433 60779864 60779866 60779867 60790102 60806209 60821917 60847646 61002277 61052834 61077841 61144531 61191245 61304736 61401737 61485225 61530678 61551616 61551617 61670830 61713709 61734539 61774872 61779845 61790554 61896791 61896792 62025231 62025232 62124069 62176444 62218172 60323824 60439671 60508340 60536879 60611544 60652728 60684197 60779872 60790103 60847647 60906704 61002278 61077842 61191242 61224848 61304741 61340544 61424894 61485226 61618473 61676503 61713708 61774879 61779846 61790560 61896793 62025233 62093451 62176446 62218173 60439652 60515401 60593679 60701996 60884548 60940020 61018982 61077843 61081687 61191241 61224849 61304743 61459434 61535709 61618470 61683763 61720514 61774871 61779847 61837161 61896795 62025234 62098854 62099285 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1024-2014","Class II","TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY ACET SHELL 56MM O TRILOGY ACET SHELL 58MM O TRILOGY ACET SHELL 60MM O TRILOGY ACET SHELL 62MM O TRILOGY ACET SHELL 64MM O TRILOGY ACET SHELL 66MM O TRILOGY ACET SHELL 68MM O TRILOGY ACET SHELL 70MM O TRILOGY ACET SHELL 72MM O TRILOGY ACET SHELL 74MM O TRILOGY ACET SHELL 76MM O TRILOGY ACET SHELL 78MM O TRILOGY ACET SHELL 80MM O BONE SCREW 4.5X15 SELF-TA BONE SCREW 4.5X20 SELF-TA BONE SCREW 4.5X25 SELF-TA BONE SCREW 4.5X30 SELF-TA BONE SCREW 4.5X35 SELF-TA BONE SCREW 4.5X40 SELF-TA BONE SCREW 4.5X50 SELF-TA BONE SCREW 4.5X60 SELF-TA BONE SCREW 6.5X15 SELF-TA BONE SCREW 6.5X20 SELF-TA BONE SCREW 6.5X25 SELF-TA BONE SCREW 6.5X30 SELF-TA BONE SCREW 6.5X35 SELF-TA BONE SCREW 6.5X40 SELF-TA BONE SCREW 6.5X50 SELF-TA BONE SCREW 6.5X60 SELF-TA BONE SCREW 6.5X70 SELF-TA BONE SCREW 6.5X80 SELF-TA ","366971 60384272 60838522 61558081 60159292 60690384 60926262 61215883 61559843 61567731 61611793 60069675 60160804 60225912 60427290 60690394 60813602 60926263 61050686 61095381 61292658 61459870 61564135 61783434 61930401 62268587 60069675R 61157229 60042677 62243630 367119 60077122 60254935 60331076 60402575 60479496 60601302 60690396 60824152 60877128 61128097 61201897 61263144 61471012 61580824 61906180 61921675 60481374 369642 60675755 366453 367366 367898 369730 370449 60068486 60121239 60126675 60126676 60146168 60181426 60200570 60202526 60216477 60225913 60237051 60294477 60365231 60368737 60431168 60479084 60482633 60550826 60550828 60568252 60586275 60601305 60601306 60653796 60653797 60661219 60690399 60704848 60704849 60724503 60750887 60750888 60813603 60813604 60824170 60838528 60845664 60890073 60926264 60926265 60950165 60954659 60955591 60982888 60998689 61008548 61050687 61050689 61076195 61080146 61080147 61126792 61142157 61150949 61150950 61168263 61199815 61201845 61263145 61263146 61281167 61283615 61292660 61309774 61321048 61329084 61374925 61403503 61412019 61412020 61452210 61470969 61471011 61486653 61486654 61528582 61533558 61533559 61580825 61580826 61580827 61638696 61638698 61734419 61758219 61783436 61809006 61817461 61825846 61837767 61906445 61911378 61930403 61945055 61957085 62052788 62055820 62099618 62102507 62158151 62183129 62189393 62281814 62291870 60358224 60513008 60890113 61176450 60513008R 367528 369648 60897498 60950229 365711 366188 370606 60068487 60082444 60099809 60109102 60109103 60109104 60109106 60121241 60121243 60121244 60126802 60126803 60126804 60126807 60146170 60146171 60146172 60160807 60181430 60188266 60188267 60202529 60237055 60237056 60254946 60254948 60287158 60287160 60287165 60294481 60331083 60331086 60348931 60365236 60365239 60382059 60382060 60427293 60427294 60429610 60431172 60446282 60479532 60479533 60479534 60479535 60528763 60550835 60601312 60653805 60653807 60690415 60704852 60704853 60708778 60708780 60724508 60750889 60750893"," 60295108 60295109 60300416 60301511 60301516 60301989 60310012 60310954 60312703 60317124 60319120 60326447 60327279 60328646 60330460 60330461 60330463 60330464 60330466 60330468 60330469 60330470 60330471 60330472 60330473 60330475 60330476 60330477 60330478 60330479 60330480 60330481 60330482 60330483 60330485 60330486 60330487 60330488 60336272 60336274 60346532 60365042 60365043 60365044 60365046 60365047 60365048 60365049 60368806 60368813 60368818 60368824 60378799 60378801 60378802 60378804 60378805 60378806 60378807 60378808 60378809 60378810 60378811 60378812 60378814 60378815 60382423 60382425 60390291 60392666 60395358 60396390 60398438 60399275 60399374 60399375 60399377 60399378 60402046 60402611 60407768 60407769 60407770 60407771 60407772 60407773 60411578 60411581 60411582 60411583 60411584 60411585 60411586 60416337 60419697 60419698 60419701 60419703 60419704 60419706 60419708 60427342 60427343 60428648 60439450 60439451 60439453 60439455 60439456 60439458 60439459 60439460 60439461 60448545 60448868 60448870 60448874 60448877 60448879 60448881 60460715 60463884 60469984 60469985 60469987 60469989 60481779 60481782 60481783 60481784 60481787 60481788 60481793 60481794 60481795 60481798 60481799 60514007 60514008 60514010 60514011 60514013 60514014 60514015 60514017 60514018 60515764 60519482 60537437 60545215 60545498 60545499 60545501 60545503 60545504 60545505 60552308 60552319 60552320 60552321 60552323 60552325 60552326 60552327 60552328 60552329 60552330 60552331 60552332 60552337 60552341 60552342 60564439 60565252 60577378 60579110 60588117 60588118 60588119 60588121 60590965 60598017 60601474 60601476 60601477 60601478 60601483 60601484 60613884 60616358 60616598 60616599 60616601 60616602 60622446 60622447 60638363 60638365 60638373 60638376 60638377 60638417 60641626 60641633 60646593 60646594 60649936 60654988 60654990 60654993 60654994 60654996 60654998 60654999 60655001 60657116 60675637 60675639 60675640 60675641 60675642 60690549 60690551 60690553 60690556 60697830 60724740 6","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1033-2014","Class II","6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE","60248716 61500239 60124919 60193878 60227863 60305825 60451065 60796836 61144521 60227864 61144525 61887185 62054654 366155 60227791 60300577 60607124 60671459 60774007 60758129 60807553 60973105 60807553R 60227802 60892289 61462907 61586239 60900891 366160 369922 60114470 60153496 60177429 60197992 60227792 60265896 60308809 60382234 60499745 60552245 60737193 60929071 61052827 61203376 61713707 61864130 61866007 60265896R 369929 370590 60107297 60125487 60192043 60266060 60541831 60724231 60743135 61099150 61589279 61666186 61743037 62005415 369930 60114471 60130005 60134697 60134698 60150444 60162851 60173086 60173087 60192044 60197993 60215876 60225025 60246461 60247733 60266062 60294572 60308811 60323678 60362748 60423131 60476815 60535978 60623842 60671476 60728078 60774008 60929072 61002145 61099151 61160409 61203377 61304707 61401714 61587536 61652334 61670828 61732726 61751518 61837152 61911472 62005416 60114471R 369923 60153497 60197994 60308812 60541835 60608604 60747329 60940009 61780614 62005414 60153497R 366158 369931 60107298 60114472 60125488 60147971 60169666 60191454 60222124 60240111 60247734 60282817 60362750 60423132 60499746 60605096 60671478 60732860 60810352 60940010 61052828 61160410 61401715 61645997 61666187 61732727 61751519 61887182 60114473 60128960 60184947 60222125 60265894 60294574 60340822 60403879 60440338 60529671 60566374 60597607 60623844 60699106 60728079 60774009 60800969 60847639 60929073 60929075 61052829 61052830 61099152 61160411 61179796 61224840 61281512 61462909 61530673 61543470 61589278 61603830 61618474 61713704 61732725 61758468 61801238 61808407 61833352 61864131 61866008 61906271 61957512 61977935 62038434 62094968 60099535 60124920 60192050 60233947 60265898 60294573 60323679 60359305 60392803 60440339 60476817 60529670 60541839 60586138 60623849 60699107 60740543 60774010 60806205 60821878 60900890 60929076 60940011 60977427 61002171 61052831 61099153 61099154 61160412 61179797 61224841 61322982 61350125 61401716 61401717 61462911 61462913 61530676 6157027",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1043-2014","Class II","3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE ","61270590 61270591 61450581 61270594 61270595 61270596 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1010-2014","Class II","INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530","60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782 60867785 61071422 61150075 61173568 61319435 61319436 61379514 60748952 60762088 60806399 60876899 60876901 60876902 61248174 61325065 60123303 60130220 60135214 60142918 60150073 60218846 60243102 60279663 60309141 60323311 60338439 60349093 60387528 60393392 60407659 60422612 60422615 60422617 60422618 60505967 60505968 60569960 60597683 60597684 60602462 60620369 60620371 60690750 60690751 60714161 60714162 60735662 60735663 60757051 60757052 60808010 60808011 60814567 60814568 60829596 60829597 60867787 60867788 60867789 60867790 60867792 60956540 60956547 61003994 61004003 61004006 61004010 61035979 61035980 61064854 61066610 61066611 61071425 61071426 61084123 61100815 61158640 61211625 61211626 61221436 61249859 61271267 61286461 61421225 61496669 61509881 61535667 61564743 61664934 61729550 61729552 61746802 61746803 62262065 60123304 60132558 60142920 60152971 60253769 60253770 60280195 60288490 60310563 60310564 60310565 60323343 60338521 60367544 60393393 60393395 60407661 60410614 60438323 60451198 60472688 60487155 60487156 60491717 60491718 60505969 60602464 60602465 60602466 60602467 60620387 60653365 60690752 60690753 60714165 60735665 60735666 60757057 60757058 60757059 60817613 60829604 60867807 60867809 60867811 60867813 60956553 60979622 60985458 60985459 60985460 61024754 61024757 61031015 61031016 61035968 61035972 61041707 61041709 61041713 61064855 61066614 61066615 61067796 61073739 61091734 61096524 61104693 61133860 61133862 61150093 61153543 61199894 61210272 61224276 61269415 61295067 61362462 61382019 61489978 61504080 61504081 61564747 61",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1013-2014","Class II","ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)","60587172 60642426 60674247 60691374 60749915 60813568 60897964 60897965 60897966 60966659 60090438 60092202 60092203 60620584 60642427 60654140 60691390 60749916 60813570 60915915 60915916 60915917 60087121 60092204 60092205 60642428 60654141 60674248 60714649 60747680 60749917 60813572 60831102 60915929 60915930 60915931 60915932 60092206 60092207 60630503 60642429 60654142 60674249 60691392 60714651 60789796 60789797 60889685 60931200 61031022 61031023 60092208 60092209 60532938 60561134 60570051 60587174 60630504 60642430 60654144 60674250 60691399 60749918 60789811 60813573 60831103 60915853 60915859 60915881 60915882 60966668 61031028 61420306 61432404 60087123 60090440 60092210 60092211 60535276 60562837 60654146 60691414 60749919 60813595 60813596 60813597 60831104 60915940 60915943 61031024 61031025 61120332 61432405 60090442 60092212 60092213 60552204 60620589 60654147 60654148 60714654 60749920 60813598 60832686 60889687 60915918 60915919 60915921 61004060 61031029 61100833 61120333 60090443 60092215 60615944 60630505 60654149 60674251 60691416 60749921 60789807 60813599 60831105 60915884 60915885 60915887 61031027 61100835 60090444 60253827 60620591 60654151 60714656 60749922 60789794 60853697 60897968 60897969 60958487 60966666 60092220 60092221 60642432 60674252 60691436 60749923 60789793 60897961 60897962 60897963 60966667 60085615 60087126 60552203 60554585 60654153 60747681 60749924 60813601 60915937 60915938 60915939 60079503 60079505 60103543 60103544 60103545 60119931 60124048 60131328 60131329 60136433 60136434 60139743 60143336 60143337 60155221 60155222 60169687 60169688 60173964 60173966 60219063 60219064 60225895 60236611 60236621 60278602 60293977 60310068 60324201 60338316 60338317 60361131 60361132 60361133 60363705 60368193 60368194 60398160 60451902 60451903 60472738 60487398 60489887 60515451 60515452 60536773 60537997 60550819 60550820 60568228 60568231 60583769 60583771 60583772 60603370 60603371 60612896 60612897 60630467 60641825 60641826 60654212 60654213 60654214 60672037 60",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1019-2014","Class II","Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD","369276 369524 60291473 60310301 60342024 60357090 60399558 60425903 60452829 60558758 60570479 60584084 60590812 60599272 60611906 60620113 60657785 60682169 60687824 60708283 60711104 60821371 60841560 60907093 60984963 61022804 61070950 61077603 61134756 61154119 61175581 61209547 61228859 61270001 61287201 61368475 61368477 61530412 61533227 61533467 61692052 61732327 61774928 61783774 61824402 61870194 61873807 61879216 61910402 61977973 62063907 62075334 62106829 62146121 62150826 62240863 62291985 60563149 60566878 60600179 60630361 60815719 60828775 61066145 61144414 61162703 61213636 61261189 61313751 61408337 61461416 61504803 61522363 61756178 61783396 61847265 61923132 61998438 62133204 62298309 369341 370194 60222129 60353227 60368431 60373709 60399559 60466343 60507563 60554703 60579220 60584085 60599273 60623449 60656522 60661145 60662839 60687825 60708286 60709627 60709632 60711101 60841591 60867231 60884747 60976986 60976987 61008062 61036699 61070953 61115030 61135548 61135550 61175582 61200729 61200730 61260738 61279518 61283870 61283871 61345873 61382663 61401473 61453030 61504719 61549273 61549274 61549275 61549276 61677022 61692027 61722491 61742558 61779295 61810839 61824403 61859392 61882807 61887464 61895659 61977974 61993270 62002515 62118749 62148588 62183205 62262698 62291986 60581741 60581742 60612133 60643129 60670842 60885034 61006076 61017248 61135870 61151284 61151285 61162712 61191580 61191582 61213637 61296090 61313753 61388431 61408356 61461420 61554436 61695657 61728055 61751742 61803721 61847257 61899761 61985050 62046280 62103973 62182475 62275050 62311689 369521 370193 370858 370945 60222133 60266021 60291474 60310305 60325143 60325144 60333414 60342026 60353228 60357681 60361328 60368433 60383211 60392168 60392169 60421527 60439918 60439919 60452834 60452835 60472566 60499470 60507564 60515205 60537020 60557545 60563123 60575106 60581719 60584086 60595310 60599274 60611914 60630347 60630619 60643072 60643073 60656529 60661146 60666934 60674054 60687826 60702902 60704516 "," 61767894 61772441 61772443 61772444 61772445 61776710 61776711 61776722 61778305 61778306 61778307 61778308 61778309 61782462 61782463 61782464 61794268 61798242 61798243 61798244 61798245 61799675 61799676 61803730 61815231 61815232 61815234 61815235 61815236 61819698 61819699 61819702 61819703 61823605 61823606 61823607 61828296 61828297 61833478 61833479 61835066 61835069 61837191 61837193 61837194 61839830 61839831 61841930 61841931 61847269 61852609 61852610 61855322 61855323 61858160 61858161 61861717 61861719 61864141 61864143 61864145 61867401 61867402 61867403 61867404 61871959 61871961 61871968 61873847 61873848 61873849 61879323 61879324 61881272 61881273 61882648 61884437 61891268 61895570 61895574 61902103 61902104 61902105 61902108 61908944 61908945 61912460 61920541 61925655 61925656 61928947 61928948 61928949 61931759 61931760 61934544 61939324 61939325 61945138 61945139 61945142 61948390 61948393 61952520 61952524 61953154 61953155 61953156 61957673 61957675 61957676 61957681 61968326 61980224 61985052 61985054 61985055 61992555 61992557 61993184 61993185 61993187 61993188 62002356 62002357 62007738 62007739 62007740 62007741 62020940 62020941 62020945 62027858 62033254 62033255 62036980 62036981 62040504 62040505 62042792 62042793 62042794 62042795 62050788 62065575 62065576 62065577 62065578 62069023 62069024 62069025 62069026 62071955 62071956 62071957 62071959 62071961 62071962 62071963 62080199 62080200 62080201 62080202 62080204 62080205 62091037 62091038 62091039 62091040 62097273 62097275 62097276 62097279 62097280 62098890 62098891 62099681 62099682 62103590 62103591 62103592 62109977 62115180 62115181 62126449 62126450 62126451 62126452 62127604 62127605 62127606 62127607 62127608 62127609 62127610 62134053 62135129 62135130 62137178 62141839 62143885 62143886 62143887 62154599 62161573 62161575 62162182 62162183 62164627 62164628 62164645 62170702 62170703 62172064 62175376 62175377 62175379 62175380 62180240 62180241 62180242 62181553 62188398 62188399 62191275 62191276 62191277 6","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1036-2014","Class II","CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)","60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227 ",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1035-2014","Class II","MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID ","60169597 365445 60096116 60096117 60134409 60845244 61059560 61613250 366221 60096118 60553617 60743729 60990038 61298521 365622 60096119 60411949 60501830 60540531 60609946 60700469 61657255 365458 60110443 60154855 60187556 60301871 60484369 60590160 60716272 60768572 60887301 61118584 61211680 61304669 61589078 61619986 366386 60096121 60124827 60169413 60242838 60301886 60411970 60484390 60540735 60565849 60610009 61122126 61401537 61694181 61878452 61934378 61992515 365461 366387 367572 60109037 60110290 60124913 60169470 60204787 60242845 60326542 60395275 60423101 60474918 60484409 60768593 60845456 61199171 61298517 61613251 61817985 61992516 365499 367548 369841 60096125 60110448 60148883 60242895 60293315 60484704 60540826 60581312 60737211 61103540 61324218 61619209 61659604 61758278 61817987 366388 369882 60109039 60124924 60134410 60169479 60187599 60242901 60293321 60335415 60442118 60506747 60993378 60993379 61118585 61276626 61398796 61651794 61756168 61758280 60096126 60187653 60412010 60537009 60574597 60787916 61118586 61932403 366389 369842 60124934 60187682 60274760 60423134 60980807 61231910 61651793 61837093 365464 365604 60096127 60355236 60540889 60565935 61662668 61976171 365444 60085816 60148884 60484813 61042186 61290074 61528630 61744433 60301911 60541000 61059561 61555631 61658313 366382 60154916 60395295 60900095 61324217 60096128 60541001 61370524 365448 60096186 60553915 61496597 60096187 60096188 366307 60096189 60096190 60166763 367542 60110458 60301876 60906529 60169412 60326978 60484392 61895487 60099418 60242846 60506729 60096192 60096193 365496 60523403 60331362 365481 366300 61222214 365500 60906530 61886563 366301 60096195 60484817 61886564 365449 366304 60423158 60906531 60096202 60331367 365616 366578 367657 369317 60101998 60101999 60113196 60113197 60145797 60",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1014-2014","Class II","ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.","60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303 60172595 60203125 60208505 60293052 60293053 60385452 60435952 60451975 60513716 60550121 60569137 60621316 60653000 60671936 60690725 60700503 60783464 60820534 60860511 60860513 60860514 60922581 60931393 61057541 61057542 61091712 61144231 61144232 61175725 61179682 61213680 61213685 61226623 61458924 61496585 61496586 61516718 61652312 61987298 60931393R 60068461 60085970 60112862 60137583 60167084 60177165 60203127 60208506 60230633 60254680 60263992 60281385 60293054 60323227 60323228 60338339 60351950 60363732 60381044 60381045 60429147 60451979 60472802 60488988 60513720 60536838 60544315 60550122 60550123 60569139 60585209 60604065 60604067 60646729 60671937 60671938 60700504 60705398 60736738 60736739 60783465 60804583 60804584 60820535 60820536 60879653 60879654 60879655 60922582 60973810 61004373 61057265 61057267 61057528 61083833 61083835 61086989 61110816 61133147 61133148 61133149 61144233 61144234 61168198 61168199 61179683 61196070 61209047 61213689 61226624 61226625 61251155 61346007 61352916 61359836 61371148 61392581 61466852 61508368 61524260 61524261 61584950 61612575 61639615 61657718 61746169 61781850 61890428 61930475 61987301 62070014 62070016 62133640 60569139R 60700504R 61144234R 60063005 60106621 60111972 60132528 60137584 60155304 60167085 60172596 60177167 60186862 60198526 60198637 60218946 60218947 60218948 60242254 60245527 60254681 60263994 60263995 60281387 60293055 60293056 60309898 60309899 60323229 60323230 60338340 60338341 60363733 60367337 60367338 60381046 60381047 60385453 60393368 60423609 60425113 60435972 60435975 60451981 60451982 60472803 60479109 60487347 60488989 60513721 60528722 60536839 60536840 60550124 60569140 60569141 60576790 60585211 60585212 60597782 60604069 60604071 60621318 60621319 60621320 60646732 60646733 6064673",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1029-2014","Class II","12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19X ","365717 366402 367390 368994 369213 369214 369215 369319 370354 370750 371011 60109630 60142945 60235507 60273068 60339025 60448362 60554135 60784634 60800920 60819863 60884374 60902584 60943291 60971162 60988528 61070891 61100359 61100360 61176577 61176578 61176579 61632276 61765960 61814863 365718 367382 368346 368981 369034 369220 369221 369268 369269 369320 370432 370439 370542 370733 60114244 60206094 60222003 60282832 60334506 60448361 60554138 60651808 60697870 60737518 60784635 60800012 60819864 60819866 60843493 60866926 60884376 60884377 60928161 60943290 60988523 60997305 60997308 61013936 61013938 61171992 61171994 61171995 61176581 61176582 62124063 62256027 365719 367386 368347 369032 369209 369212 369216 369321 369425 369777 369793 370009 370139 370355 370440 370543 370747 371010 60105214 60105215 60118794 60134658 60150050 60191183 60197679 60217131 60222017 60262516 60280674 60322647 60339026 60362643 60407176 60451001 60535945 60559829 60587995 60597421 60691785 60713743 60756664 60784637 60797521 60810339 60838414 60854443 60866927 60902585 60909206 60928153 60943284 60961115 60961116 60997298 60997302 61013941 61070892 61100361 61100362 61176583 61176587 61284588 61330548 61565671 61633857 61748978 61758460 62010702 62079124 62109109 62200261 62251993 62287497 365720 367387 368348 368993 369033 369266 369267 369322 369426 369794 370011 370147 370356 370441 370544 370734 371009 60118795 60134659 60134660 60150052 60176098 60176099 60191978 60197704 60215816 60218181 60224979 60239685 60262517 60265792 60278841 60294265 60322588 60322648 60339027 60356036 60381913 60381933 60407169 60429439 60446325 60476575 60508194 60529659 60535946 60559830 60574968 60597422 60619977 60645475 60651960 60691790 60709222 60727029 60752694 60758477 60785503 60810318 60822017 60822018 60838415 60862041 60866929 60866930 60909208 60943285 60943288 60943289 60988552 60997310 61019080 61022707 61066053 61066055 61100363 61100364 61135473 61176591 61176592 61206721 61245068 61256746 61256747 61266194 61284589 61284"," 61996756 61996757 61996758 62010697 62010698 62017706 62026438 62035457 62036910 62039624 62051004 62089746 62094961 62100691 62112175 62126354 62142874 62154558 62183163 62187425 62198824 62199420 62203218 62222768 62226922 62235721 62252003 62260134 62270715 62277511 62284341 62299111 62308265 62315879 365731 367317 367486 368584 369026 369436 369776 370391 370447 370553 371008 60098533 60098536 60105468 60105973 60105974 60105975 60105976 60105977 60105978 60105979 60105980 60134599 60135091 60138465 60138466 60150154 60150157 60150158 60159563 60159564 60159565 60169635 60173103 60183057 60184645 60184886 60192016 60192018 60192020 60197531 60206111 60209236 60209243 60217126 60217127 60224839 60224840 60224847 60246330 60246357 60255236 60262405 60262744 60265526 60265529 60278827 60294226 60300551 60322577 60337470 60355059 60362585 60392716 60404427 60423076 60442258 60442275 60457052 60476516 60512358 60535831 60566368 60571027 60574937 60588002 60610536 60619827 60645454 60656923 60670376 60691696 60691697 60709215 60726992 60732778 60758570 60785487 60806161 60822009 60822010 60844090 60861913 60866967 60866968 60902579 60928133 60928134 60943294 60943295 60988447 60988448 61019112 61019113 61035757 61064765 61101589 61101590 61111905 61134839 61176548 61176549 61202009 61206719 61206720 61222437 61222438 61245062 61256739 61273826 61284623 61284624 61286567 61304581 61330598 61357212 61382332 61401656 61425877 61425878 61459569 61469272 61469273 61508258 61522116 61522117 61545826 61575674 61598504 61658073 61679885 61683760 61713688 61748998 61748999 61749001 61758454 61769230 61769231 61785394 61803943 61814872 61817436 61819346 61825737 61833345 61847129 61896777 61896778 61901651 61910389 61918042 61928518 61947597 61952497 61957523 61987199 61999778 62006572 62006573 62019795 62019799 62030059 62042605 62042607 62057445 62073524 62079119 62094962 62106822 62112176 62140348 62140349 62140352 62187426 62195521 62226923 62270716 62277513 62284342 62284344 62299112 62308258 62311677 62325622 62334","7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1015-2014","Class II","DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.","60123273 60132377 60140219 60141550 60142733 60148179 60155310 60165544 60186827 60195674 60200835 60216184 60220271 60220273 60226819 60252510 60252511 60259230 60262844 60264178 60281557 60291992 60311248 60336996 60351041 60366235 60379861 60389521 60445063 60463387 60517290 60517292 60530516 60564287 60581857 60581858 60581859 60581860 60674481 60674482 60714213 60714223 60714225 60714226 60857024 60857027 61019442 61516750 61616190 61635188 61685368 61771896 61899228 60094966 60098072 60123274 60124846 60145183 60150097 60155311 60167108 60175653 60185178 60194989 60199687 60207679 60216185 60220275 60223990 60226822 60230043 60242725 60252513 60255762 60262845 60264179 60281558 60281559 60311250 60322259 60336998 60351042 60373290 60377460 60385381 60463388 60517295 60539760 60564286 60564288 60581861 60581862 60581863 60581865 60592821 60609737 60642868 60653869 60714227 60714228 60714229 60714230 60714231 60741925 60857033 61129810 61186464 61473793 61730300 61771898 61842787 62025436 62029387 60094967 60103382 60132379 60135136 60141552 60167110 60175655 60179248 60195675 60220276 60252514 60281560 60281561 60311251 60353652 60391406 60440767 60452547 60564290 60581866 60592822 60592823 60642869 60653871 60674484 60674485 60714232 60714237 60857035 60857036 61730306 61866479 62043246 60141553 60142748 60142755 60145184 60148180 60150099 60165545 60169762 60179249 60194990 60200836 60207680 60218493 60223991 60230047 60235515 60255763 60272031 60275498 60284176 60351044 60379862 60383893 60385383 60395991 60398449 60435432 60452548 60523197 60530517 60570076 60609738 60625566 60653875 60674486 60674487 60714250 60714253 60714255 60714259 60741924 60857039 60857040 60857042 60857044 61313819 61551161 61584912 61685369 61730307 62056813 62152980 365643 60098251 60123276 60124849 60135139 60142756 60145185 60152916 60165546 60177174 60185179 60193962 60198630 60202768 60206116 60207681 60226824 60230048 60241412 60255764 60264181 60264182 60272033 60275499 60307920 60322262 60337001 60337643 60351045 6035",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",66500,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.","Z-1023-2014","Class II","MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI ","61547919 61954158 61241463 61821673 62188365 61564304 60919205 61666604 60928241 62086340 62296755 60611445 60841757 60863748 61187640 61224727 61261826 62062929 62173370 60550153 60588810 60828784 61018862 61110916 61159634 62296754 60576173 61209715 61564309 60575226 60595581 60623653 60749578 62316407 60611447 61255394 61364450 61382532 60611244 60817929 60863723 60563186 62268497 61547941 62137191 61892712 61901662 60668061 61584777 61059234 61403759 60497031 61303608 61875716 62087621 62138394 61906179 61919744 61853252 60945780 61403762 61868301 62123088 62330868 61552276 60973584 61159666 61209871 61491267 61731038 61906430 62154608 60806194 60940002 61092880 62304925 61598585 61698771 61712665 61902214 62148657 60612251 60658071 60980492 61072064 61160052 61261860 61642713 61722445 62296659 60715034 61018915 61036921 61136634 61179946 61377132 61504792 61564330 61598593 61652828 61662223 61746897 61885964 61902215 62062927 62166311 62166312 62167440 60664534 60611465 61121730 61491274 61542625 62170707 62296657 62304924 61138050 61392960 61509276 61591304 61662225 61751908 61875723 61885967 61902216 62113239 62183216 62308937 62322488 60715040 60715041 62134061 62292055 61407093 61509275 61564339 61598601 61751904 61928945 62183217 62292053 62330877 61575699 61403906 60699177 61591302 62127617 62301528 60545115 61504789 61698789 61863756 62109142 62296661 61261880 61403757 62123083 62296662 60595588 61407096 61633829 61788072 62296663 60593824 60841777 61424558 62268509 61509269 61580668 61631807 62330880 61234865 61286973 61521041 62049367 61241564 61542576 61751903 62147386 61478541 60588818 62118728 61403756 61598607 62044858 62329122 61547934 62147387 61478392 61575705 61788071 62329128 61712669 61005950 60945793 60595589 61765738 61036924 61668359 61478415 62330884 61110936 61675948 61138057 623015",,"7,044,680 total","Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Food",66501,"Ongoing","Innovative Labs, LLC","Hauppauge","NY","US","Voluntary: Firm Initiated","E-Mail","CA","F-1381-2014","Class II","Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.","Lot # 130401",,"1256 bottles","Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.",10/14/2013,"10/14/2013",1/15/2014,"01/15/2014"
"Food",66501,"Ongoing","Innovative Labs, LLC","Hauppauge","NY","US","Voluntary: Firm Initiated","E-Mail","CA","F-1382-2014","Class II","Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.","Lot # 130444",,"579 bottles","Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.",10/14/2013,"10/14/2013",1/15/2014,"01/15/2014"
"Drugs",66503,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1161-2014","Class I","Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.","Lot 25-220-DD, Exp 1JAN2015",,"40,360 vials","Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. ",10/18/2013,"10/18/2013",3/26/2014,"03/26/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1409-2014","Class II","Smoked King Salmon Bellies is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Smoked King Salmon Bellies***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1410-2014","Class II","Smoked Coho Salmon Bellies is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Smoked Coho Salmon Bellies***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1407-2014","Class II","Hickory Smoked King Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Hickory Smoked King Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-2012-2014","Class II","Pepper Smoked Coho Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Pepper Smoked Coho Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, Soy Sauce, & Pepper***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1413-2014","Class II","Teriyaki Smoked Coho Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Teriyaki Smoked Coho Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1416-2014","Class II","Variety Smoked Pack is sold in vacuum packed plastic packages, net weight 1.5 lbs., with label located on the front that include the pack date and AK 604. No label was provided.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1406-2014","Class II","Pepper Smoked King Salmon. Product sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Pepper Smoked King Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, Soy Sauce, & Pepper***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-2011-2014","Class II","Hickory Smoked Coho Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Hickory Smoked Coho Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1408-2014","Class II","Teriyaki Smoked King Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Teriyaki Smoked King Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1414-2014","Class II","Smoked Wild Silver (Coho) Salmon Filet is sold in vacuum packed plastic packages, net weight from 1 lb. to 2.5 lbs., with label located on the front that include the pack date and AK 604. NO label was provided.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66507,"Ongoing","Big Blue Fisheries","Sitka","AK","US","Voluntary: Firm Initiated","Press Release","distributed nationwide and sold online via the website Alaskasmokedfish.com","F-1415-2014","Class II","Hickory Smoked Black Cod is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: ''***BIG BLUE FISHERIES, LLC***Hickory Smoked Black Cod***Ingredients: Wild Alaskan Black Cod, Water, Sugar, Salt, & Soy Sauce***AK 604***Order online @ alaskasmokedfish.com***''.","All lots, packed between 09/24/11 to 09/24/13.",,"unknown","Big Blue Fisheries, LLC. is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum. Because the products may not have been fully processed, product contamination by spoilage organisms or pathogens could lead to illness if consumed.",9/27/2013,"09/27/2013",1/22/2014,"01/22/2014"
"Food",66523,"Ongoing","Fahman Enterprises, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Dallas, Texas area","F-2223-2014","Class I","Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3","Best Before 25 JAN 15",,"4 cases","Elevated levels of lead.",10/17/2013,"10/17/2013",7/30/2014,"07/30/2014"
"Devices",66527,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1113-2014","Class II","TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.","SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238, JDA1162239, JDA1182240, JDA1182241, JDA1182242, JDA1182243, JDA1182244, JDA11X2245, JDA11X2246, JDA11X2247, JDA11Z2249, JDA11Z2250, JDA11Z2252, JDA11Z2253, JDA11Z2254, JDA11Z2255, JDA1222257, JDA1222258, JDA1222259, JDA1222260, JDA1222261, JDA1242264, JDA1252265, JDA1252266, JDA1252267, JDA12Z2271, JDA1312272, JGA1062178, JGA1062181, JGA1062182, JGA1112220, JGA1112228, JGA11Z2256, JGA1222262, JGA12X2269, JLA1062179, JLA1062180, JLA1072185, JLA10Z2208, JLA1122232, JLA1122233, JLA1132235, JLA11Y2248, JLA11Z2251, JLA1232263, JLA1262268, JLA12Y2270, KDA1062080, KDA1072081, KDA1072082, KDA1072083, KDA1072085, KDA1072086, KDA1072088, KDA1082090, KDA1082091, KDA1082092, KDA1092093, KDA10X2094, KDA10X2095, KDA10X2096, KDA10X2097, KDA10X2098, KDA10X2099, KDA10Y2100, KDA10Y2101, KDA10Y2102, KDA10Z2104, KDA1112107, KDA1122110, KDA1122111, KDA1132113, KDA1142114, KDA1152115, KDA1152116, KDA1152117, KDA1152118, KDA1162119, KDA1162120, KDA1162121, KDA1162122, KDA1162123, KDA1162124, KDA1172125, KDA1182126, KDA1182127, KDA1182128, KDA1182129, KDA1192130, KDA1192131, KDA11X2132, KDA11X2133, KDA11Y2134, KDA11Z2136, KDA11Z2137, KDA11Z2138, KDA11Z2139, KDA11Z2140, KDA1222141, KDA1222142, KDA1222143, KDA1232144, KDA1242145, KDA1242146, KDA1252147, KDA1272148, KDA1282149, KDA1292151, KDA12X2152, KDA12Y2153, KDA12Z2154, KDA1322155, KGA1082089, KGA10Z2103, KGA10Z2105, KGA1112106, KGA1112108, KGA1122109, KGA1122112, KGA11Z2135, KLA1072084, KLA1072087, KLA",,"338 units","Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.",10/1/2013,"10/01/2013",3/12/2014,"03/12/2014"
"Drugs",66531,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-383-2014","Class II","Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx Only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01","Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14 ",,"12,521 bottles","Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Devices",66535,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including Puerto Rico.","Z-0559-2014","Class II","B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.","lot no. 3C30258317",,"55,200 units","One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries. ",9/27/2013,"09/27/2013",1/1/2014,"01/01/2014"
"Devices",66541,"Ongoing","Intra Pump Infusion Systems","Grapevine","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.","Z-0099-2015","Class II","CRN Crono Syringe CRN20 with 19G x 1 ''Steel Needle''","Product Code CRN20, lot numbers 14N02, 15E01, 15A02",," 25,440 pieces","Product has the potential to have a clear debris on the tip of the needle.",10/18/2013,"10/18/2013",10/29/2014,"10/29/2014"
"Food",66549,"Ongoing","North Pacific Seafoods, Inc.","Sitka","AK","US","Voluntary: Firm Initiated","Letter","distributed nationwide","F-1405-2014","Class II","Sitka Sound Seafoods Hickory Smoked Salmon (Coho, King, or Sockeye) is hot smoked salmon, vacuum packaged, random net weight. The product is labeled in parts: ''***Sitka Sound Seafoods***329 Katlian St. Sitka, Ak. 99835***Hickory Smoked***Salmon***Ingredients: Wild Alaskan Coho Salmon, Water, Sugar, Salt, & Soysauce***Keep Frozen***Thaw Under Refrigeration***Refrigerated After Opening/Thawing***Processed by Big Blue Fisheries LLC***AK604***.","packed dates between 09/24/2011 and 09/25/2013.",,"estimated 1084 lbs. total","Sitka Sound Seafoods Hickory Smoked Salmon products are recalled due to the potential contamination with Clostridium botulinum and a contract manufacturer does not have HACCP Plan and does not keep any records for thermal processing.",9/26/2013,"09/26/2013",1/22/2014,"01/22/2014"
"Drugs",66554,"Ongoing","Sandoz Inc","Wilson","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-393-2014","Class II","Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01, ","Lot CU0856",,"2,491 bottles of 100 tablets each","Subpotent; Hydrochlorothiazide at the 9 month time point.",10/11/2013,"10/11/2013",1/8/2014,"01/08/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1234-2014","Class I","The Deli Counter Four Bean Salad, Formula VE.55, packaged in 2/8-lb (UPC 071117060089) carton cases. Distributed by Safeway, Inc., Pleasanton, CA.","Use by dates 11/21/13 - 01/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0264-2014","Class I","Country Potato Salad, Formula PO.15, packaged under these labels: - Cross Valley Farms Country Style Potato Salad with Egg, in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. UPC 758108301511 -Reser's Country Potato Salad, in 3/8-lb carton cases. . Reser's Fine Foods, Beaverton, OR. UPC 071117001891 -Sysco Classic Country Potato Salad, in 3/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865209113","Use by dates 10/21/13-12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1242-2014","Class II","Reser's Chicken Salad Dressing, Formula DR.49B64, packaged in 5/4-lb (UPC 071117060355) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed onto the bags at the facility. As such, it is not for retail sale.","Use by dates 10/26/13 - 12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0311-2014","Class I","Pasta Twist Base Formula PA.103, packaged under these labels: Resers Baked Potato Salad in 2/2.5 lb containers. Resers Fine Foods, Inc. Beaverton, OR ","Use by dates 10/07/13-11/22/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0257-2014","Class I","Reser's Fine Foods Ranch Potato Salad, Formula PO.156, packaged in 2/8-lb (UPC071117004854), 6/16-oz (UPC 071117190472) and 6/3-lb (UPC 071117193183) carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/11/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0300-2014","Class I","Red Potato Salad, Formula PO.62, packaged under the following labels: -Cross Valley Farms Red Royal Potato Salad packaged in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. -Reser's Deluxe Red Skin Potato Salad packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Block & Barrel Deluxe Red Skinned Potato Salad packaged in 2/5-lb carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/10/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1200-2014","Class I","Amish Macaroni Salad, Formula MA.8 packaged under the following labels: -Reser's Amish Macaroni packaged in 3/8-lb (UPC 071117004410), 6/16-oz (UPC 071117190441) and 6/3-lb (UPC 071117193152) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Yoder's Amish Macaroni Salad in 6/32-oz (UPC 073474010455) and 2/5-lb (UPC 073474887293) carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/23/13 - 12/10/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0332-2014","Class I","Coleslaw, Formula CS.38, packaged under the following labels: -Sysco Classic Homestyle Shredded White Cole Slaw packaged in 2/7-lb carton cases. Distributed by Sysco Corporation, Houston, TX. -US Food Service Cross Valley Farms Cole Slaw packaged in 2/7-lb carton cases. Distributed by Cross Valley Farms, Columbia, MD. -Reser's Homestyle Cole Slaw packaged in 2/7-lb, 6/30-oz, 12/11-oz, 12/15-oz, and 6/2.75-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/05/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1238-2014","Class I","Reser's Pea Salad, Formula VE.69, packaged in 2/5-lb (UPC 071117142198) carton cases. Reser's Fine Foods, Inc., Beaverton, OR","Use by dates 10/13/13 - 11/30/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1190-2014","Class I","Reser's German Chocolate Mousse Kit, Formula KI.36, packaged in 2/4.25-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 11/25/2013.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0244-2014","Class I","Reser's Originial Potato Salad (Sam's), Formula PO.20, packaged in 6/5-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117616507 ","Use by dates 20131126.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1182-2014","Class I","Reser's Loaded Antipasto Pasta Kit, Formula KI.10, packaged in 3/6.13-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 09/30/13 - 11/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1219-2014","Class I","Reser's Meatloaf Glaze, Formula SA.19B36 packaged in 6/36-oz carton cases UPC 071117615012. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 11/15/13 - 12/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0256-2014","Class I","Potato Salad, Formula PO.15, packaged under these labels: - Cross Valley Farms Potato Salad packaged in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. UPC 758108301511 -Reser's Potato Salad, packaged in 3/8-lb carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117001891 -Classic Sysco Country Potato Salad, packaged in 3/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865209113","Use by dates 10/21/13-12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0329-2014","Class I","Reser's Homestyle Cole Slaw, Formula CS.104, packaged in 6/4.5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/10/13-11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0334-2014","Class I","Safeway The Deli Counter Southern Style Cole Slaw, Formula CS.46, packaged in 6/2.75-lb carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/11/13-11/14/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0247-2014","Class I","The Deli Counter Deviled Egg Potato Salad (Safeway Brand), Formula PO.51, packaged in 12/16-oz (UPC 021130066889), 6/32-oz (UPC 021130069835) and 3/8-lb (UPC 071117060195 ) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/13/13-11/15/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1177-2014","Class I","Reser's Crunchy Chinese Salad Kit, Formula DR.59B12, packaged in 2/1.25-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 7111711469 ","Use by dates 10/20/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1239-2014","Class I","Reser's Four Bean Salad, Formula VE.79, packaged in 2/8-lb (UPC 071117141375) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/03/13 - 12/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1245-2014","Class II","Reser's Italian Dressing, Formula DR.97B32, packaged in 12/32-oz (UPC 071117061017) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed onto the bags at the facility. As such, it is not for retail sale.","Use by dates 11/08/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0290-2014","Class I","Dillons Mustard Potato Salad, Formula PO.86, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.","Use by dates 10/20/13-12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1235-2014","Class I","Millers Bar-B-Que Beans, Formula VE.33, packaged in 6/3-lb (UPC 071117141771) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/16/13 - 12/02/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1221-2014","Class II","Jewel Chef's Kitchen Salsa Medium, Formula SA.28 packaged in 6/16-oz carton cases UPC 041280011263. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1157-2014","Class I","Safeway The Deli Counter Ambrosia Dessert, Formula DE.50, packaged in 2/6-lb carton cases. Distributed by Safeway, Inc., Pleasanton, CA.","Use by dates 10/24/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1230-2014","Class I","Carrot Raisin Salad, Formula VE.11 packaged under the following labels: -Cross Valley Farms Carrot Raisin Salad packaged in 2/8-lb (758108301627) carton cases. US Foodservice, Inc., Rosemont, IL. -Reser's Carrot & Raisin Salad packaged in 2/8-lb (UPC 071117142105) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco Classic Carrot & Raisin Salad packaged in 2/8-lb (UPC 074865101516) carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/17/13 - 12/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1158-2014","Class I","Pistachio Dessert, Formula DE.72, packaged under the following labels: -Cross Valley Farms Pistachio Creme packaged in 2/6-lb carton cases. Distributed by Cross Valley Farms, Columbia, MD. - Reser's Pistachio Delight packaged in 2/6-lb and 6/11-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/12/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0232-2014","Class I","Reser's Fine Foods, Cheesy Macaroni Salad, Formula MA.66 packaged in 12/454-gm carton cases (UPC 071117182415) and 6/1.25-KG carton cases (UPC 071117612271) plastic containers. Reser's Fine Foods, Inc., Beaverton, OR.","Use by date 10/20/13 and 12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1161-2014","Class I","Jewel Chef's Kitchen The Ultimate French Onion Dip, Formula DI.100, packaged in 6/12-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0238-2014","Class I","Red Potato Salad, Formula PO.37, packaged under these labels: -Reser's Red Potato Salad, packaged in 6/16-oz (UPC 071117190052), 6/3-lb (UPC 071117004816) carton cases. -Stonemill Kitchens, Country Red Potato Salad, packaged in 6/4-lb (UPC 071117616842) carton cases. Reser's Fine Foods, Beaverton, OR.","Use by dates 10/16/13-11/18/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0231-2014","Class I","Macaroni Reg CAD, Formula MA.50, Macaroni Salad, packaged: -7-Eleven Fresh to Go Macaroni Salad, 12/7-oz carton cases. Distributed by 7-11, Inc., Dallas, TX. UPC 052548517571 -Reser's Fine Foods Macaroni Salad, 6/4-lb (UPC 071117001631) Party Pack, 3/8-lb (UPC 071117002164) and 6/1.25-KG (UPC 071117613223) carton cases. -King Soopers City Market Regular Macaroni Salad, 12/16-oz container cases. Distributed by King Soopers, Inc, Denver, CO. UPC 071117646078 -Sysco Classic Macaroni Salad, 3/8-lb container cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865208369 ","Use by dates: 10/21/13-12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1180-2014","Class I","Reser's Honey Chicken Salad Kit, Formula DR.105B32, packaged in 6/40-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 7111711428","Use by dates 10/22/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1217-2014","Class I","The Deli Counter Premium Tuna Salad, Formula PT.61 packaged in 6/15-oz (UPC 021130067428) and 2/3-lb (UPC 071117060362) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/11/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1208-2014","Class I","Reser's Tuna Salad, Formula PT.151 packaged in 6/12-oz (UPC 071117190120) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/22/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0321-2014","Class I","Reser's Fine Foods Seafood Salad Kit, Formula MO.54C15, packaged in 2/4.47-kg container cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/06/13-11/22/2013.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0251-2014","Class I","Reser's Chef's Choice Baked Potato Salad, Formula PO.113, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117111507","Use by dates 10/10/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0266-2014","Class I","Stonemill Kitchens Southern Style Potato Salad, Formula PO.173, packaged in 6/4-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117615869 ","Use by dates 10/20/13-12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1222-2014","Class II","Jewel Chef's Kitchen Salsa Hot, Formula SA.29 packaged in 6/16-oz carton cases UPC 041280095539. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1229-2014","Class I","Stonemill Tabouli Salad, Formula VE.105 packaged in 2/5-lb (UPC 071117114966) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/16/13 - 11/15/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0254-2014","Class I","Essential Everyday Homestyle Potato Salad, Formula PO.137, packaged in 6/16-oz (UPC 041303820148) and 6/3-lb (UPC 041303820179) carton cases. Distributed by Supervalu Inc., Eden Prairie, MN.","Use by dates 10/13/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0330-2014","Class I","Reser's Traditional Cole Slaw with Oil & Vinegar, Formula CS.11, packaged in 6/425-g carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/10/13-11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1214-2014","Class I","The Deli Counter Seafood with Shrimp Salad, Formula PT.44 packaged in 6/5-oz (UPC 021130067442) carton cases. Distributed by Safeway Inc., Pleasanton, CA","Use by dates 10/12/13 - 11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0261-2014","Class I","Reser's Creole Potato Salad, Formula PO.01, packaged in 2/8-lb carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117070101","Use by dates 10/13/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1193-2014","Class I","Walmart Deli Amish Macaroni Salad, Formula MA.11, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed By Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/20/13 - 12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0249-2014","Class I","Mustard Potato Salad, Formula PO.58, packaged under these labels: -Reser's Mustard Potato Salad, packaged in 3/8-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117002584 -Sysco Classic Mustard Potato Salad, packaged in 3/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865208352 ","Use by dates 10/23/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0319-2014","Class I","Orval Kent Signature Italian Style Ziti Salad, Formula PA.132, packaged in 2/4.5-lb container cases. Orval Kent Foods, Wheeling, IL.","Use by dates 10/11/13-11/27/2013.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0303-2014","Class I","Pasta Artichoke, Formula PA.04, packaged under these labels: Resers Pasta Salad in 2/8 lb carton cases. Resers Fine Foods, Inc. Beaverton, OR. ","Use by dates 10/09/13-11/20/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1186-2014","Class I","Stonemill Tuna Salad, Formula KI.25, packaged in 2/5.25-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/16/13 - 11/20/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1176-2014","Class I","Reser's Curry Chicken Recovery Kit, Formula DR.14B20, packaged in 6/25-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117114935 ","Use by dates 10/22/13 - 12/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0342-2014","Class I","Mrs. Giles Amish Cole Slaw, Formula CSG.10, packaged in 2/5-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/17/13-12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0337-2014","Class I","Wal-Mart Deli Cole Slaw, Formula CS.75, packaged in 12/15-oz and 6/30-oz carton cases. Distributed by Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/08/13-11/22/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1205-2014","Class I","Safeway Kitchens Seafood Salad, Formula PT.154 packaged in 6/12-oz carton cases. Distributed by Safeway Inc., Pleasanton, CA. UPC 021130124121 ","Use by dates 10/20/13 - 12/04/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0324-2014","Class I","Pimento Spread, Formula CH.95, packaged under these labels: -Homehill Pimento Salad packaged in 12/12-oz carton cases. Distributed by: Save-A-Lot Food Stores, Ltd., Earth City, MO. -Cross Valley Farms Pimento Spread packaged in 2/5-lb carton cases. Distributed by Cross Valley Farms, Columbia, MD. -Mrs. Weaver's Pimento Spread packaged in 12/7-oz , 12/12-oz and Family Pack 6/24 oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. -Reser's Pimento Cheese Spread packaged in 2/5lb and 6/16-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR","Use by dates 01/03/14-02/22/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0306-2014","Class I","Italian Pasta Salad Formula PA.42, packaged under these labels: Independent Marketing Alliance Italian Pasta Salad in 2/8 lb containers. Marketed by Independent Marketing Alliance Houston, TX. Cross Valley Farms Fresh Salad in 2/8 lb containers. Distributed by U.S. Foodservice, Inc. Rosemont, IL. Resers Pasta Salad in 2/8 lb containers. Resers Fine Foods, Inc. Beaverton, OR SYSCO Classic Italian Pasta Salad in 2/8 lb containers. Distributed by Sysco Corporation, Houston, TX. ","Use by dates 10/05/13-11/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0339-2014","Class I","Cole Slaw, Formula CS.81, packaged under these labels: -Sysco Classic Cole Shredded Slaw Salad packaged in 2/7-lb carton cases. Distributed by Sysco Corporation, Houston, TX. -Reser's Shredded Cole Slaw packaged in 2/7-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/08/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0301-2014","Class I","Potato Salad, Formula PO.65, packaged under the following labels: -The Deli Counter Picnic Potato Salad packaged in 12/16-oz carton cases. Distributed by Safeway Inc., Pleasanton, CA. -The Deli Counter Old Fashioned Potato Salad packaged in 3/8-lb carton cases. Prepared for Safeway Inc., Pleasanton, CA.","Use by dates 10/14/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1203-2014","Class I","Seafood Salad, Formula PT.130 packaged under labels: -Essential Everyday Seafood Salad packaged in 6/12-oz carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. UPC 041303820377 -Reser's Fine Foods Seafood Salad packaged in 6/12-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117190106 ","Use by dates 10/12/13 - 11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0323-2014","Class I","Mrs. Weaver's Jalapeno Pimento Spread, Formula CH.72, packaged in 12/7-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 01/15/14-02/15/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0294-2014","Class I","Yoder's My Premier Potato Salad, Formula PO.179, packaged in 6/3-lb carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/18/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1159-2014","Class I","Mrs. Giles Spiced Apples, Formula DEG01, packaged in 2/5-lb and 6/11-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/23/13-12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0234-2014","Class I","Potato Salad with Egg, Formula PO.71, packaged under these labels: -Reser's Fine Foods, Potato Salad with Egg, in 12/454-gm carton cases UPC 071117182439, 6/1.25-KG carton cases UPC 071117613216 and 3/8-lb container cases UPC 071117651355. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco, Potato W/ Egg Salad, in 3/8-lb container cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865745291 -Little Salad Bar Potato Salad (Aldi), packaged in 6/32-oz carton cases. Distributed by ALDI Inc., Batavia, IL. UPC 041498128661 -Independent Marketing Alliance Diced Potato Salad with Egg, in 3/8-lb container cases. Marketed by Independent Marketing Alliance, Houston, TX. UPC 822486158859 -Cross Valley Farms, Potato Salad, in 2/8-lb container cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. UPC 758108301467 ","Use by date 10/20/13 - 12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1218-2014","Class I","Tuna Salad, Formula PT.88 packaged under the following labels: -Cobblestreet Market Tuna Salad packaged in 2/5-lb carton cases UPC 822486158866. Marketed by Independent Marketing Alliance. -Cross Valley Farms Tuna Salad packaged in 2/5-lb carton cases UPC 758108301450. Distributed by Cross Valley Farms, Columbia, MD. -Reser's Tuna Salad packaged in 2/5-lb carton cases UPC 071117114058. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco Classic Tuna Salad packaged in 2/5-lb (UPC 074865800389) carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/10/13 - 12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1233-2014","Class I","Four Bean Salad, Formula VE.28, packaged under these labels: -Reser's Four Bean in 2/8-lb (UPC 071117002669 & 071117612813) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Cross Valley Farms Four Bean Salad packaged in 2/8-lb carton cases. Distributed by Cross Valley Farms, Columbia, MD. UPC 758108301610 -Sysco Classic 4 Bean Salad packaged in 2/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865101165 ","Use by dates 11/24/13 - 01/05/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1196-2014","Class I","Macaroni & Cheddar Salad, Formula MA.33, packaged under the following labels: -Essential Everyday Macaroni & Cheese Salad packaged in 6/16-oz carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -Cross Valley Farms Sour Cream & Cheddar Macaroni Salad packaged in 2/8-lb carton cases. Distributed by US Foods, Rosemont, IL. -Reser's Gourmet Macaroni & Cheese Salad packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco Block & Barrel Gourmet Pasta Salad with Cheddar Cheese packaged in 2/5-lb carton cases. Distributed By Sysco Corporation, Houston, TX. ","Use by dates 10/23/13 - 12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0307-2014","Class I","BLT Pasta Salad Formula PA.43, packaged under these labels: Resers BLT Pasta Base in 2/3.25 lb containers. Resers Fine Foods, Inc. Beaverton, OR. ","Use by dates 10/06/13-11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0263-2014","Class I","Walmart Deli Red Skin Potato Salad, Formula PO.184, packaged in 12/16-oz (UPC 681131916813), 6/32-oz (UPC 681131916875) and 6/4-lb (UPC 081131916934) carton cases. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. ","Use by dates 10/15/13-12/02/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1228-2014","Class I","Reser's Roasted Corn & Black Bean Salad, Formula VE.104 packaged in 2/5-lb (UPC 071117141955) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/10/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1178-2014","Class I","Reser's Rotisserie Chicken Salad Base, Formula DR.62, packaged in 6/2-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147438 ","Use by dates 10/24/13 - 12/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1179-2014","Class I","Reser's Seafood Salad Base, Formula DR.71B48, packaged in 2/6-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 7111711464 ","Use by dates 11/10/13 - 11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0313-2014","Class I","Pasta Mexican Formula PA.129, packaged under these labels: 7-11 Fresh to Go Mexican Pasta Salad in 12/7 oz containers. Distributed by 7-Eleven Inc. Dallas, TX.","Use by dates 10/20/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1160-2014","Class I","Reser's Creamy Spinach Dip, Formula DI.23, packaged in 2/8-lb and 12/454-gm carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/17/13-12/03/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0299-2014","Class I","Reser's Texas Redskin Potato Salad, Formula PO.60, packaged in 3/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/12/13-11/30/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1204-2014","Class I","Reser's Tuna Salad Supreme, Formula PT.137 packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117141382","Use by dates 10/12/13 - 11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1187-2014","Class I","Stonemill Mandarin Wheatberry Salad, Formula KI.28, packaged in 2/5.188-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/16/13 - 11/4/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0280-2014","Class I","Reser's Deluxe Baked Potato Salad, Formula PO.31, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/09/13-11/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0326-2014","Class I","Coleslaw, Formula CS.08, packaged under these labels: -Aldi Little Salad Bar Creamy Coleslaw packaged in 6/30-oz carton cases. Distributed by: ALDI Inc., Batavia, IL. -Reser's Amish Cole Slaw packaged in 2/7-lb carton cases. Reser's Fine Foods, Beaverton, OR. -Yoder's Cole Slaw packaged in 6/30-oz and 12/15-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OI&K Distributors, Delphos, OH.","Use by dates 10/12/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1246-2014","Class I","Market Pantry Macaroni Salad, Formula MA.102, packaged in 12/454-gm container/cases. Distributed by Target Canada, Mississauga, ON L4W 0C4. UPC 628919002399","Use by dates 10/20/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0237-2014","Class I","Walmart Mustard Potato Salad, Formula PO.105, packaged in 12/16-oz (UPC 681131916790), 6/32-oz (UPC 681131916851) and 6/4-lb (UPC 681131916912) carton cases. Distributed by Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/21/13-11/22/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0318-2014","Class I","Stonemill Kitchens Curry Ginger Couscous, Formula PA.144, packaged in 2/5-lb container cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 11/15/2013.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0236-2014","Class I","Potato Salad, Formula PO.70, packaged under these labels: -Reser's Fine Foods, Original Potato Salad, in 12/12-oz (UPC 071117182200), 6/32-oz (UPC 071117181500), 3/4-lb (UPC 071117002232), 3/8-lb (UPC 071117002157), 12/3.5-oz (UPC 071117170009), 12/5.5-oz (UPC 071117171006) and 2/10-lb (UPC 071117002782) container cases. Also distributed in a 6/4-lb party pack (UPC 071117001624). Distributed by: Reser's Fine-Foods, Beaverton, OR. -Yoder's American Potato Salad, in 6/32-oz (UPC 073474010462), 2/5-lb (UPC 073474550098), 6/3-lb (UPC 073474010219) and 12/16-oz (UPC 073474887385) carton cases. -West Creek, Original Potato Salad, in 2/5-lb carton cases. (UPC 806795286793) Distributed by Performance Food Group, Richmond, VA. -Essential Everday Original Potato Salad packaged in 6/16-oz (UPC 041303820131) and 6/3-lb (UPC 041303820209) carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -7-11 Potato Salad, in 12/7-oz carton cases. (UPC 052548517526) Distributed by 7-Eleven, Inc., Dallas, TX. -Cross Valley Farms Family Style Potato Salad packaged in 2/8-lb carton cases. Distributed by US Foodservice, Inc., Rosemont, IL. UPC 758108373877 -Sysco Classic Potato Salad, in 3/8-lb carton cases. (UPC 074865100915) ","Use by date 10/13/2013 - 11/15/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0262-2014","Class I","Yum Two Mustard Potato Salad, Formula PO.04, packaged in 3/8-lb carton cases. Packaged Exclusively for use by: Yum! Brands Global Restaurants, Louisville, KY. UPC 885251033225","Use by dates 10/21/13-12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1165-2014","Class I","Stonemill Kitchens Creamy Spinach Dip, Formula DI.46, packaged in 6/11-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. ","Use by dates 10/22/13 - 12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1167-2014","Class I","Reser's Ranch Dip, Formula DI.78, packaged in 12/4-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR..","Use by dates 12/27/13 - 1/24/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","f-1220-2014","Class II","Jewel Chef's Kitchen Salsa Mild, Formula SA.27 packaged in 6/16-oz carton cases UPC 041280095560. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0338-2014","Class I","Cole Slaw, Formula CS.76, packaged under these labels: -Sysco Classic Cole Slaw Salad packaged in 2/7-lb carton cases. Distributed by Sysco Corporation, Houston, TX. -Reser's Cole Slaw packaged in 2/7-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/08/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0265-2014","Class I","Dickey's Original Potato Salad, Formula PO.141, packaged in 3/8-lb carton cases. Distributed by Dickey's Barbecue Restaurants, Inc. UPC 071117115888","Use by dates 10/12/13-11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0344-2014","Class I","Reser's Strawberries and Cream Desserts, Formula DE.05, packaged in 2/6-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/14/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1207-2014","Class I","Reser's Classic Tuna Salad, Formula PT.142 packaged in 2/5-lb (UPC 071117141337) carton cases.Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/11/13 - 11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1215-2014","Class I","Seafood Salad, Formula PT.48 packaged under these labels: -Cross Valley Farms Seafood Salad packaged in 2/8-lb (UPC 758108301566) carton cases. Distributed by US Foodservice, Inc., Rosemont, IL. -Reser's Seafood Salad Base packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117114157 ","Use by dates 10/10/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0277-2014","Class I","Mustard Potato Salad, Formula PO.23, packaged under these labels: -Yoder's Mustard Potato Salad, packaged in 6/3-lb, 6/32-oz and 2/5-lb carton cases. Distributed by Lipari Foods, Warren, MI. -Sysco Classic Gourmet Mustard Potato Salad, packaged in 3/8-lb carton cases. Distribued by Sysco Corporation, Houston, TX.","Use by dates 10/21/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1185-2014","Class I","Stonemill Pesto Feta Orzo Salad, Formula KI.29, packaged in 2/5.18-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/24/13 - 11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1209-2014","Class II","Krab Dip, Formula PT.152 packaged under these labels: -Reser's Cajun Krab Dip packaged in 2/5-lb (UPC 071117169010) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Safeway Cajun Krab Dip packaged in 6/7-oz (UPC 021130124183) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/20/13 - 12/04/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1227-2014","Class I","-The Deli Counter BBQ Beans, Formula VE.103 packaged in 6/32-oz (UPC 021130069842) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/22/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1164-2014","Class I","Jewel Chef's Kitchen Spinach Dip, Formula DI.39, packaged in 12/16-oz and 6/12-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. (16-oz package distributed by Jewel Food Stores, Inc., Melrose Park, IL.","Use by dates 10/27/13 - 12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0333-2014","Class I","Sysco Dixie Chopped Cole Slaw, Formula CS.39, packaged in 2/7-lb carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/08/13-11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0315-2014","Class I","Thai Noodle Salad Formula PA.141, packaged under these labels: Thai Noodle Salad in 2/5 lb containers.","Use by dates 11/06/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1191-2014","Class I","Orval Kent Signature Refried Beans with Picante, Formula KI.70, packaged in 1/16-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/30/13 - 12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0285-2014","Class I","Southern Style Mustard Potato Salad, Formula PO.56, packaged under these labels: The Deli Counter Southern Style Mustard Potato Salad packaged in 6/3-lb carton cases. Distributed by Safeway Inc., Pleasanton, CA. -Cobblestreet Market Southern Style Mustard Potato Salad packaged in 3/8-lb carton cases. Marketed by Independent Marketing Alliance, Houston, TX. -Cross Valley Farms Southern Style Mustard Potato Salad packaged in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. -Reser's Southern Mustard Potato Salad packaged in 3/8-lb carton cases. Reser's Fine Foods Inc., Beaverton, OR.","Use by dates 10/20/13-12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1237-2014","Class I","Yoder's Amish Baked Beans, Formula VE.61, packaged in 2/5-lb (UPC 7347488727) carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/21/13 - 12/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1184-2014","Class I","Reser's Buffalo Dressing and Pasta Kit, Formula KI.21, packaged in 1/4.75-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/10/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0322-2014","Class I","Orval Kent Signature Pimento Spread, Formula CH.07, packaged in 2/5-lb container cases. Orval Kent Foods, Wheeling, IL.","Use by dates 1/14/14-2/7/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1170-2014","Class I","Stonemill Kitchens Spinach & Artichoke Dip, Formula DIS.05, packaged in 6/10-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/30/13 - 12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1171-2014","Class I","Reser's Beet & Onion Salad, Formula DR.09, packaged in 2/9-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 07111700268","Use by dates 11/5/13 - 12/16/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1240-2014","Class I","Reser's Smokehouse BBQ Beans, Formula VE.99, packaged in 2/8-lb (UPC 071117141726) and 6/16-oz (UPC 71117183399) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/23/13 - 12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0260-2014","Class I"," Deviled Egg Potato Salad, Formula PO.169, packaged under these labels: -Essential Everyday Deviled Egg Potato Salad, packaged in 6/16-oz (UPC 41303820346) and 6/3-lb (UPC 041303820353) carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -Reser's Fine Foods Deviled Egg Potato Salad, packaged in 2/8-lb carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117005578","Use by dates 10/11/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0291-2014","Class I","Dillons Red Potato Salad, Formula PO.87, packaged in 12/16-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.","Use by dates 10/10/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0336-2014","Class I","The Deli Counter Classic Cole Slaw, Formula CS.52, packaged in 12/15-oz carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/09/13-11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0242-2014","Class I","Stonemill Kitchens Red Potato Salad, Formula PO.07, packaged in 6/2.27 kg carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117616293","Use by dates 10/18/13 - 11/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0272-2014","Class I","Farmstyle Potato Salad, Formula PO.27, packaged in 3/8-lb carton cases. Packaged Exclusively for use by: Yum! Brands Global Restaurants, Louisville, KY. UPC 885251252626","Use by dates 10/21/13-12/02/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1195-2014","Class I","Elbow Macaroni Salad, Formula MA.22, packaged under the following labels: -West Creek Elbow Macaroni Salad packaged in 2/5-lb carton cases. Distributed by Performance Food Group, Richmond, VA. -Cobblestreet Market Elbow Macaroni Salad packaged in 3/8-lb carton cases. Marketed by Independent Marketing Alliance, Houston, TX. -Essential Everyday Classic Macaroni Salad packaged in 6/16-oz and 6/3-lb carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -Little Salad Bar Macaroni Salad packaged in 3/32-oz carton cases. Distributed by ALDI Inc., Batavia, IL. -Cross Valley Farms Elbow Macaroni Salad packaged in 2/8-lb carton cases. Distributed by US Foods, Rosemont, IL. -Reser's Elbow Macaroni Salad packaged in 3/8-lb, 3/4-lb, 12/3.5-oz, 6/32-oz, 12/12-oz, 12/454 grams, 12/16-oz, 6/32-oz and 6/3-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -King Soopers City Market Regular Macaroni Salad packaged in 3/4-lb carton cases. Distributed by King Soopers Inc., Denver, CO. -Yoder's Macaroni Salad Original Recipe packaged in 6/32-oz, 6/3-lb, 2/5-lb and 12/16-oz carton cases. Distributed By Lipari Foods, Warren, MI. -Sysco Classic Elbow Macaroni Salad packaged in 3/8-lb carton cases. Distributed By Sysco Corporation, Houston, TX. ","Use by dates 10/21/13 - 12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1189-2014","Class I","Reser's Turkey Salad Dressing Kit, Formula KI.33, packaged in 6/3.375-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 12/01/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1198-2014","Class I","Reser's Homestyle Seashell Macaroni Salad, Formula MA.36 packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/27/13 - 12/10/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0309-2014","Class I","Bow Tie Pasta Formula PA.71, packaged under these labels Cross Valley Farms Bow Tie Pasta in 2/4.5 lb containers. Distributed by Cross Valley Farms, Columbia, MD. Resers Bow Tie Florentine in 2/4.5 lb containers. Resers Fine Foods, Inc. Beaverton, OR. Block and Barrel Bow Tie Florentine Pasta Salad in 2/4.5 lb containers. Distributed by Sysco Corporation, Houston, TX. ","Use by dates 10/06/13-11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0239-2014","Class I","Reser's Gourmet Red Potato Salad, Formula PO.40, packaged in 6/1.8 kg (UPC 071117001648) and 12/340-g (UPC 071117612097) carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/12/13 - 10/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0343-2014","Class I","Reser's Ambrosia Delight, Formula DE.03, packaged in 2/8-lb and 6/11-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/23/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1168-2014","Class I","Stonemill Kitchens Artichoke & Parmesan Dip, Formula DIS.01, packaged in 6/10-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR..","Use by dates 12/08/13 - 1/21/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0316-2014","Class I","Reser's Fine Foods Desserts, Raspberry Parfait, Formula PF.78, packaged in 2/8-lb container cases. ","Use by dates 11/06/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0310-2014","Class I","Zesty Rotini with Mushrooms Formula PA.99, packaged under these labels: Resers Pasta Salad in 2/8 lb containers. Resers Fine Foods, Inc. Beaverton, OR.","Use by dates 10/09/13-11/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0298-2014","Class I","Reser's Baked Potato Salad, Formula PO.06, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/13/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0308-2-14","Class I","Tri-color Rotini Pasta Formula PA.54, packaged under these labels: Resers Tr-Color Rotini Pasta in 6/3.1875 lb containers. Resers Fine Foods, Inc. Beaverton, OR. ","Use by dates 10/15/13-12/03/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1175-2014","Class II","Reser's Cole Slaw Dressing, Formula DR.14, packaged in 2/4-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147520 pH: 2.86 +/- 0.2","Use by dates 12/22/13 - 2/01/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1199-2014","Class I","Classic Macaroni Salad, Formula MA.55 packaged under the following labels: The Deli Counter Classic Macaroni Salad packaged in 12/16-oz, 12/5.5-oz and 6/2.75-lb carton cases. Distributed By Safeway Inc., Pleasanton, CA. -(Reser's) The Deli Counter Classic Macaroni Salad in 3/8-lb carton cases. Prepared for Safeway Inc., Pleasanton, CA. ","Use by dates 10/23/13 - 12/10/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1174-2014","Class I","Reser's Broccoli Salad Kit, Formula DR.14B16, packaged in 2/1.75-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 7111714820 ","Use by dates 10/19/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0325-2014","Class I","Dixie Coleslaw, Formula CS.04, packaged under these labels: -Cobblestreet Market Dixie Coleslaw packaged in 2/7-lb carton cases. Marketed by: Independent Marketing Alliance, Houston, TX. -Yoder's Chopped Cole Slaw packaged in 2/4.5-lb carton cases. Reser's Fine Foods, Beaverton, OR. -Reser's Pimento Dixie Fine Chopped Cole Slaw packaged in 2/7-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR","Use by dates 10/13/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0331-2014","Class I","Coleslaw, Formula CS.29, packaged under the following labels: -Essential Everyday Cole Slaw packaged in 6/15-oz and 6/44-oz carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -US Food Service Cross Valley Farms Cole Slaw packaged in 2/7-lb carton cases. Distributed by Cross Valley Farms, Columbia, MD. -Reser's Homestyle Cole Slaw packaged in 2/7-lb, 6/15-oz and 6/2.75-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/05/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0297-2014","Class I","Classic Mustard Potato Salad, Formula PO.58, packaged under the following labels: -Reser's Classic Mustard Potato Salad, in 3/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Classic Sysco Mustard Potato Salad, in 3/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX. ","Use by dates 10/24/13-12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1172-2014","Class I","Reser's Honey Chicken Salad Kit, Formula DR.107B32, packaged in 6/32-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147292 ","Use by dates 10/20/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0252-2014","Class I","Walmart Deli Potato Salad, Formula PO.121, packaged in 12/16-oz (UPC 681131916783), 6/32-oz (UPC 681131916844) and 6/4-lb (UPC 681131916905) carton cases. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/21/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1169-2014","Class I","Stonemill Kitchens Artichoke & Jalapeno Dip, Formula DIS.03, packaged in 6/10-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR..","Use by dates 10/20/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1188-2014","Class I","Stonemill Tomato Mozzarella Pasta Salad, Formula KI.31, packaged in 2/4.64-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 11/07/13 - 11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1241-2014","Class I","Walmart Marketside Spinach Artichoke Dip, Formula DI.68, packaged in 6/16-oz (UPC 681131457804) carton cases. Manufactured for Marketside, a division of Walmart Stores, Inc., Bentonville, AR.","Use by dates 10/23/13 - 12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0270-2014","Class I","FD's Potato Salad, Formula PO.182, packaged in 3/8-lb (UPC 071117116045) carton cases. Reser's Fine Foods, Beaverton, OR.","Use by dates 10/21/13-12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0293-2014","Class I","Reser's Loaded Baked Potato Salad Base, Formula PO.161, packaged in 2/5.5-lb carton cases. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/11/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0282-2014","Class I","Red Skin Potato Salad, Formula PO.39, packaged under these labels: West Creek Diced Red Skin Potato Salad packaged in 2/5-lb carton cases. Distributed by Performance Food Group, Richmond, VA. -Reser's Red Skin Potato Salad packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco Classic Red Potato Salad packaged in 2/8-lb carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/11/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1250-2014","Class II","Reser's Baja Cafe Mango Salsa, Formula SA.10, packaged in 2/5-lb (UPC 071117002829) carton/cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/10/13 - 11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0275-2014","Class I","Market Pantry Potato Salad, Formula PO.191, packaged in 12/454 gm carton cases. Distributed by Target Canada, Mississauga, ON.","Use by dates 10/20/13-12/02/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0255-2014","Class I","Dickey's Barbecue Pit Old Fashioned Dill Potato Salad, Formula PO.142, packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117115871","Use by dates 10/12/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1225-2014","Class II","-Reser's Baja Cafe Original Salsa, Formula SA.83 packaged in 2/5-lb carton cases UPC 071117001518. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/11/13 - 12/30/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0340-2014","Class I","Dillon's Cole Slaw, Formula CS.86, packaged in 12/14-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.","Use by dates 10/05/13-11/20/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1202-2014","Class I","Seafood Salad, Formula PT.05 packaged under the following labels: -Reser's Deluxe Seafood Salad packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117113969 -Block & Barrel Deluxe Seafood Salad packaged in 2/5-lb carton cases. Distributed by Sysco Corporation, Houston, TX. UPC 074865797368 ","Use by dates 10/06/13 - 11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0281-2014","Class I","Stone Mill Foods Potato Salad, Formula PO.32, packaged in 3/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/25/13-11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0286-2014","Class I","Dillons Potato Salad, Formula PO.76, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.","Use by dates 10/20/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1216-2014","Class I","Tuna Salad, Formula PT.60 packaged under these labels: -Essentail Everyday Tuna Salad packaged in 6/12-oz (UPC 041303820285) carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -Reser's Gourmet Tuna Salad packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117855067 ","Use by dates 10/10/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0312-2014","Class I","Pasta Spinachi with Cavatappi Formula PA.111, packaged under these labels: Resers Pasta Spinachi with Cavatappi in 2/4.5 lb containers. Resers Fine Foods, Inc. Beaverton, OR. ","Use by dates 10/11/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0241-2014","Class I","The Deli Counter Classic Potato Salad (Safeway brand), Formula PO.50, packaged in 12/5.5-oz (UPC 021130067169), 12/16-oz (UPC 021130066858), 6/3-lb (UPC 021130066902) and 3/8-lb (UPC 071117060058) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/18/13 - 11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1181-2014","Class I","Cranberry Orange Relish, Formula GE.14, packaged under the following labels: -Reser's Cranberry Orange Relish packaged in 6/12--oz (UPC 071117280029) and 2/8-lb (UPC 071117804003) carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. -Yoder's Cranberry Relish packaged in 2/5-lb carton cases. Orval Kent Foods, Wheeling, IL. UPC 073474681143","Use by dates 10/22/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1156-2014","Class I","Reser's Apple Salad Base, Formula DE.44, packaged in 2/40-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/18/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0278-2014","Class I","King Soopers City Market Old Fashioned Potato Salad, Formula PO.29, packaged in 3/4-lb and 12/1-lb carton cases. Distributed by King Soopers Inc., Denver, CO.","Use by dates 10/31/13-12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0233-2014","Class I","Reser's Fine Foods, Potato Salad, Formula PO.98, packaged in 12/454-gm carton cases (UPC 071117182422) and 6/1.25-KG carton cases (UPC 071117613209). Reser's Fine Foods, Inc., Beaverton, OR.","Use by date 10/23/13-12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1154-2014","Class I","Reser's Cranberry Ambrosia, Formula DE.27, packaged in 2/4-lb and 6/9-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 11/14/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0279-2014","Class I","Reser's New England Potato Salad, Formula PO.03, packaged in 2/8-lb carton cases. Reser's Fine Foods, Beaverton, OR.","Use by dates 10/15/13-12/03/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1153-2014","Class I","Reser's Pistachio Delight, Formula DE.26, packaged in 2/5-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/11/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0246-2014","Class I","Homestyle Potato Salad, Formula PO.38, packaged under the following labels: -Deluxe Homestyle Potato Salad, packaged in 3/8-lb carton cases (carton states Cobblestreet Market, Marketed by Independent Marketing Alliance, Houston, TX. UPC 822486158835 -Reser's Fine Foods, Homestyle Potato Salad, packaged in 12/16-oz (UPC 071117183023), 2/5-lb (UPC 071117002119), 3/8-lb (UPC 071117004830)and 1/30-lb (UPC 7111700221) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco, Homestyle Potato Salad, packaged in 1/30-lb (UPC 7486575475) and 3/8-lb (UPC 074865188449) carton cases. -West Creek, Homestyle Potato Salad, packaged in 2/5-lb carton cases. UPC 806795286786","Use by dates 10/21/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0302-2014","Class I","Reser's Three Potato Salad, Formula PO.68, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/09/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0271-2014","Class I","Reser's Fine Foods Homestyle Potato Salad, Formula PO.198, packaged in 6/454gm carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117612516","Use by dates 10/10/13-11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1232-2014","Class I","Reser's American Harvest BBQ Beans, Formula VE.18, packaged in 2/8-lb (UPC 071117141757) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/14/13 - 11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0235-2014","Class I","Potato Salad with Deviled Egg, Formula PO.16, packaged under these labels: -Reser's Fine Foods, Deviled Egg Potato Salad, in 6/454-gm UPC 071117612523, 6/16-oz UPC 071117190380 and 2/8-lb UPC 071117002256 container cases. Reser's Fine Foods, Inc., Beaverton, OR. -Dillons Deviled Egg Potato Salad, in 12/16-oz UPC 71117182576 and 6/32-oz UPC 071117182576 carton cases. Distributed by: Dillons Stores, Hutchinson, KS. -Stonemill Kitchens (Sam's Club) Potato Salad with Deviled Egg, packaged in 6/4-lb carton cases. UPC 071117615876 ","Use by date 10/13/2013 - 11/15/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0267-2014","Class I","Orval Kent Loaded Baked Potato Salad, Formula PO.174, packaged in 2/5-lb carton cases. Orval Kent Foods, Wheeling, IL. UPC 079453519223","Use by dates 10/12/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0327-2014","Class I","West Creek Classic Coleslaw, Formula CS.100, packaged in 2/4.75-lb carton cases. Distributed by: Performance Food Group, Richmond, VA.","Use by dates 10/12/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1210-2014","Class I","Safeway Kitchens Krab & Cheese Dip, Formula PT.153 packaged in 6/7-oz (UPC 021130125197) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/17/13 - 11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0243-2014","Class I","Walmart Deli Amish Potato Salad, Formula PO.120, packaged in 6/32-oz (UPC 681131917445), 12/16-oz (UPC 681131917469)and 6/4-lb (UPC 681131917049) carton cases. Distributed by Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/20/13-11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0341-2014","Class I","Cobblestreet Market Short Shredded Coleslaw, Formula CS.91, packaged in 12/14-oz carton cases. Marketed by Independent Marketing Alliance, Houston, TX.","Use by dates 10/07/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0317-2014","Class I","Reser's Fine Foods Desserts, Strawberry Parfait, Formula PF.83, packaged in 2/8-lb container cases. ","Use by dates 02/20/14-04/20/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0245-2014","Class I","Stonemill Kitchens Southern Style Potato Salad (Sam's), Formula PO.173, packaged in 6/4-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117615869","Use by dates 20131020.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1197-2014","Class I","Homestyle Macaroni Salad, Formula MA.35, packaged under the following labels: -Reser's Hommestyle Elbos Macaroni Salad packaged in 3/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Sysco Classic Homestyle Macaroni Salad packaged in 3/8-lb carton cases. Distributed By Sysco Corporation, Houston, TX. ","Use by dates 10/21/13 - 12/05/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0253-2014","Class I","Reser's Classic Potato Salad, Formula PO.126, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. UPC 071117002102","Use by dates 10/10/13-11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1155-2014","Class I","Reser's Ambrosia Delight (Hawaiian Delight), Formula DE.36, packaged in 2/4-lb and 6/9-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/25/13-12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0335-2014","Class I","Reser's Oil & Vinegar Cole Slaw, Formula CS.50, packaged in 2/9-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/13/13-11/23/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1231-2014","Class I","Reser's Baja Cafe Black Bean Salsa, Formula VE.16, packaged in 2/5-lb (UPC 071117001587) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/23/13 - 12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1223-2014","Class II","-Reser's Baja Cafe Margarita Salsa, Formula SA.40 packaged in 2/5-lb carton cases UPC 071117001327. Reser's Fine Foods, Inc., Beaverton, OR. Also labeled: Casa Solana Margarita Salsa packaged in 2/5-lb carton cases UPC 074865776394. Distributed by Sysco Corporation, Houston, TX.","Use by dates 12/09/13 - 1/19/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1163-2014","Class I","Stonemill Kitchens Three Cheese Peperoncini Dip, Formula DI.38, packaged in 6/10-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/27/13 - 12/02/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1152-2014","Class I","Reser's Cookies and Cream Desserts, Formula DE.09, packaged in 2/6-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 10/12/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0250-2014","Class I","Mustard Potato Salad, Formula PO.57, packaged under these labels: -Reser's Mustard Potato Salad, packaged in 12/16-oz (UPC 071117190038 & 071117183344), 6/32-oz (UPC 071117181531 ), 6/3-lb (UPC 071117193039), 3/4-lb (UPC 071117002270 ) and 3/8-lb carton cases. Also Reser's Deli Salads packaged in 6/3-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. -Essentail Everyday Mustard Potato Salad, packaged in 6/16-oz (UPC 041303820162 ) and 6/3-lb (UPC 041303820193) carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -Cross Valley Farms Potato Salad, packaged in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. UPC 758108301597 -King Sooper's Mustard Potato Salad, packaged in 12/1-lb (UPC 071117654752) and 3/4-lb (UPC 071117646405) carton cases. -West Creek Mustard Potato Salad, packaged in 2/5-lb carton cases. Distributed by Performance Food Group, Richmond, VA. UPC 806795286809 -Little Salad Bar Mustard Potato Salad (Aldi brand), packaged in 6/32-oz carton cases. Distributed by ALDI Inc., Batavia, IL. UPC 041498182915 ","Use by dates 10/21/13-11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1243-2014","Class II","Reser's Broccoli Salad Dressing, Formula DR.92B18, packaged in 18/18-oz (UPC 071117061024) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed onto the bags at the facility. As such, it is not for retail sale.","Use by dates 12/06/13 - 01/14/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0258-2014","Class I","The Deli Counter Loaded Baked Potato Salad, Formula PO.163, packaged in 12/16-oz carton cases. Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA. UPC 021130068463","Use by dates 10/11/13-11/28/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1183-2014","Class I","Reser's Buffalo Style Pasta & Chicken Kit, Formula KI.11, packaged in 1/4.75-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 09/26/13 - 11/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1194-2014","Class I","Walmart Deli Macaroni Salad, Formula MA.12, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed By Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/21/13 - 12/09/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1192-2014","Class I","Yum Creamy Macaroni Salad, Formula MA.05, packaged in 3/8-lb carton cases. YUM! Brands, Louisville, KY. ","Use by dates 10/20/13 - 12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0283-2014","Class I","The Deli Counter Mustard Potato Salad, Formula PO.52, packaged in 2/5-lb carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/24/13-12/10/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1249-2014","Class I","Cucumber & Onion Salad, Formula VE.17, packaged under the following labels: Reser's Fine Foods Cucumber & Onion Salad packaged in 2/8-lb (UPC 071117142839) carton/cases. Reser's Fine Foods, Inc., Beaverton, OR. Cross Valley Farms Cucumber Salad packaged in 2/8-lb carton cases (UPC 758108301580) carton/cases. Distributed by Cross Valley Farms, Columbia, MD. ","Use by dates 10/22/13 - 12/04/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0288-2014","Class I","Reser's Homestyle Recipe Potato Salad with Egg, Formula PO.81, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/11/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0320-2014","Class I","Orval Kent Signature Italian Style Ziti Salad, Formula PA.132, packaged in 2/4.5-lb container cases. Orval Kent Foods, Wheeling, IL.","Use by dates 10/11/13-11/27/2013.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1244-2014","Class II","Reser's Cole Slaw Dressing, Formula DR.93B20, packaged in 18/20-oz (UPC 071117061031) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed onto the bags at the facility. As such, it is not for retail sale.","Use by dates 11/05/13 - 12/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0328-2014","Class I","Yoder's Shredded Cole Slaw, Formula CS.103, packaged in 6/2.75-lb and 2/4.5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/21/13-11/22/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1236-2014","Class I","Yoder's Kidney Bean Salad, Formula VE.58, packaged in 2/5-lb (UPC 7347499042) carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/14/13 - 11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0295-2014","Class I","Yoder's Mustard Potato Salad, Formula PO.185, packaged in 2/5-lb carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/11/13-11/22/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0248-2014","Class I","Amish Potato Salad, Formula PO.08, packaged under these labels: -Reser's Fine Foods Amish Potato Salad, packaged in 6/16-oz (UPC 071117190458), 6/3-lb (UPC 071117193169) and 3/8-lb (UPC 071117004380) carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. -Yoder's Amish Potato Salad, Original Recipe, packaged in 6/32-oz (073474010394), 6/3-lb (UPC 073474681631) and 2/5-lb (UPC 073474887286) carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/23/13-11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1247-2014","Class I","Egg Salad, Formula PT.21, packaged under the following labels: Cross Valley Farms Egg Salad packaged in 2/5-lb carton/cases. Distributed by Cross Valley Farms, Columbia, MD. USPC 758108301634 Dreser's Egg Salad packaged in 2/5-lb carton/cases. Distributed by Dreser's Fine Foods, Beaver ton, OR. USPC 071117114126 ","Use by dates 10/06/13 - 11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0289-2014","Class I","Reser's Red Potato with Blue Cheese and Bacon Salad Kit, Formula PO.90, packaged in 2/5.5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/12/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0276-2014","Class I","Market Pantry Potato & Egg Salad, Formula PO.192, packaged in 12/454 gm carton cases. Distributed by Target Canada, Mississauga, ON.","Use by dates 11/03/13-12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0269-2014","Class I","Yoder's Potato Salad, Formula PO.179, packaged in 2/5-lb (UPC 7347455031) and 6/3-lb (UPC 7347410067) carton cases. Distributed by Lipari Foods, Warren, MI.","Use by dates 10/10/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0296-2014","Class I","Mrs. Giles Homestyle Potato Salad, Formula POG16, packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/17/13-12/03/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0287-2014","Class I","Red Potato Salad with Sour Cream & Dill, Formula PO.80, packaged under these labels: -Reser's Red Potato Salad with Sour Cream & Dill packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Block & Barrel Red Skinned Potato Salad with Sour Cream & Dill packaged in 2/5-lb carton cases. Distributed by Sysco Corporation, Houston, TX.","Use by dates 10/12/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0268-2014","Class I","Red Potato Salad with Bacon & Chives, Formula PO.176, packaged in 2/5-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 079453214722 ","Use by dates 10/12/13-11/27/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1173-2014","Class II","Reser's Chicken Salad Dressing, Formula DR.12, packaged in 2/8-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147612 ","Use by dates 10/24/13 - 12/11/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0240-2014","Class I","Reser's Chef's Choice Baked Potato Salad, Formula PO.103 (UPC 071117005561), packaged in 2/5-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. Also labeled under: -Supervalu Everday Essential Potato Salad, packaged 6/16-oz carton cases. UPC 041303820360 Distributed by Supervalu Inc., Eden Prairie, MN.","Use by dates 10/07/13 - 11/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1248-2014","Class I","Safeway Kitchens Cajun Krab Dip, Formula PT.152, packaged in 6/7-oz (UPC 021130124183) and 2/5-lb (UPC 071117169010) carton/cases. Distributed by Safeway Inc., Pleasanton, CA. UPC ","Use by dates 10/22/13 - 12/04/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1201-2014","Class I","Dillons Macaroni with Cheese, Formula MA.86 packaged in 12/16-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS. UPC 071117182330 ","Use by dates 10/20/13 - 12/07/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1206-2014","Class I","Reser's Classic Egg Salad, Formula PT.141 packaged in 2/3-lb (UPC 071117060492) and 2/5-lb (UPC 071117141344) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. ","Use by dates 10/14/13 - 11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0259-2014","Class I","Stonemill Kitchens Texas Potato Salad, Formula PO.167, packaged in 6/5-lb, carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117615586","Use by dates 10/11/13-11/21/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0305-2014","Class I","Roma Feta Pasta Salad, Formula PA.13, packaged under these labels: Reser's Roma Feta Pasta Salad in 2/5 lb containers. Reser's Fine Foods, Inc. Beaverton, OR ","Use by dates 10/16/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1226-2014","Class I","-Reser's Pumpkin Mousse Dessert, Formula SE.71 packaged in 2/6-lb (UPC 071117157697) and 6/12-oz (UPC 071117182736) carton cases UPC 071117001518. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/11/13 - 12/30/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1162-2014","Class I","Jewel Chef's Kitchen Dill Dip, Formula DI.101, packaged in 6/12-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.","Use by dates 12/06/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1166-2014","Class I","Marketside Jalapeno & Artichoke Dip, Formula DI.52, packaged in 6/16-oz carton cases. Manufactured for Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 11/06/13 - 12/20/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0284-2014","Class I","Reser's Loaded Baked Potato Salad, Formula PO.54, packaged in 2/5-lb carton cases. Reser's Fine Foods Inc., Beaverton, OR.","Use by dates 10/08/13-11/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0304-2014","Class I","California Pasta Salad PA.12, packaged under these labels: West Creek California Pasta Salad in 2/5 lb containers. Distributed by Performance Food Group Richmond, VA. Cross Valley Farms California Style Pasta Salad in 2/5 lb containers. Distributed by Cross Valley Farms Columbia, MD. Resers California Pasta Salad in 2/5 lb containers. Resers Fine Foods, Inc. Beaverton, OR Block and Barrel California Pasta Salad in 2/5 lb containers. Distributed by Sysco Corporation, Houston, TX. ","Use by dates 10/05/13-11/24/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0292-2014","Class I","Stonemill Kitchens Red Potato with Blue Cheese and Bacon Salad Kit, Formula PO.95, packaged in 12/16-oz carton cases. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 10/16/13-12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1212-2014","Class I","Walmart Deli Tuna Salad, Formula PT.159 packaged in 12/12-oz (UPC 081131917559) carton cases. Distributed by Wal-Mart Stores, Inc., Bentonville, AR.","Use by dates 10/10/13 - 11/26/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0314-2014","Class I","Bacon Ranch Pasta Salad Formula PA.140, packaged under these labels: Resers Bacon Ranch Pasta Salad in 2/8 lb, 6/16 oz, 6/3 lb containers. Resers Fine Foods, Inc. Beaverton, OR.","Use by dates 10/11/13-11/29/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0274-2014","Class I","Orval Kent Sliced Steakhouse Potato Salad, Formula PO.177, packaged in 2/5-lb carton cases. Orval Kent Foods, Wheeling, IL. UPC 079453469252","Use by dates 10/25/13-12/08/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1213-2014","Class I","Egg Salad, Formula PT.21 packaged under the following labels: -Cross Valley Farms Egg Salad packaged in 2/5-lb (UPC 758108301634) carton cases. Distributed by Cross Valley Farms, Columbia, MD. -Reser's Fine Foods Egg Salad packaged in 2/5-lb carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117114126 ","Use by dates 10/06/13 - 11/25/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-0273-2014","Class I","Reser's German Potato Salad, Formula PO.28, packaged in 2/8-lb carton cases. Reser's Fine Foods, Beaverton, OR. UPC 071117141016","Use by dates 10/25/13-12/12/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1224-2014","Class II","-Reser's Baja Cafe Pico De Gallo Salsa, Formula SA.70 packaged in 2/5-lb carton cases UPC 071117001341. Reser's Fine Foods, Inc., Beaverton, OR.","Use by dates 12/15/13 - 1/23/14.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Food",66563,"Ongoing","Reser's Fine Foods, Inc.","Beaverton","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WI, WV AND WY. Distribution was also made to Canada.","F-1211-2014","Class I","Safeway Kitchens Smoked Salmon Dip, Formula PT.155 packaged in 6/7-oz (UPC 021130124145) carton cases. Distributed by Safeway Inc., Pleasanton, CA.","Use by dates 10/17/13 - 12/01/13.",,"1,320,899 cases total for all products","The recalled products are potentially contaminated with Listeria monocytogenes.",10/22/2013,"10/22/2013",1/1/2014,"01/01/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-433-2014","Class II","NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08292013@10",,"120 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-419-2014","Class II","EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10082013@7, 10152013@2, t10102013@1, t10092013@7, t10092013@6, t10142013@60, t10142013@61 ",,"157.08 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-413-2014","Class II","Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@3 ",,"44.44 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-430-2014","Class II","METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@1",,"20 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-429-2014","Class II","Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07312013@41, 07312013@42, 07312013@43, 07312013@44, 07312013@45, 08012013@1, 08012013@2, 08012013@4, 08012013@6, 08012013@11, 08012013@3, 08012013@5, 08012013@7, 08012013@8, 08012013@9, 08012013@10 ",,"19200 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-446-2014","Class II","Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10022013@6, 10162013@3, t10172013@10 ",,"180 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-441-2014","Class II","POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10032013@2, 10032013@1 ",,"600 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-448-2014","Class II","QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08262013@5",,"15 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-432-2014","Class II","Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1 ",,"186 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-414-2014","Class II","Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@4, 10162013@1",,"38 doses","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-447-2014","Class II","HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07122013@1, 09162013@6 ",,"420 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-423-2014","Class II","Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1",,"126 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-450-2014","Class II","TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08192013@34, t08272013@34, t10012013@28 ",,"17.5 ml","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-451-2014","Class II","TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08282013@8, 09192013@9, 10142013@2 ",,"3000 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-422-2014","Class II","Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@5, 10162013@2 ",,"38 doses","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-417-2014","Class II","DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09112013@1, 09232013@40, t09252013@26",,"70 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-455-2014","Class II","VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10012013@23, 10012013@24, 10012013@25, 10012013@9, 10012013@12, 10012013@13, 10012013@15, 10012013@16, 10012013@17, 10012013@19, 10012013@20, 10012013@22 ",,"204 doses","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-424-2014","Class II","GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2 ",,"210 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-452-2014","Class II","TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10142013@30",,"5.5 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-445-2014","Class II","Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08302013@12",,"100 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-457-2014","Class II","Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09202013@1, 09202013@2, 09202013@3, 09202013@4, 09202013@5, 09202013@6, 09202013@7, 09202013@8, 10102013@7, 10102013@3, 10102013@8 ",,"8090.8 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-410-2014","Class II","Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10152013@22",,"20 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-415-2014","Class II","Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t08162013@15 ",,"180 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-428-2014","Class II","LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08142013@39, t09052013@40, t09122013@3, t09122013@25 ",,"65 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-434-2014","Class II","NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@3",,"100 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-425-2014","Class II","Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, 10152013@1 ",,"148.075 ml","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-453-2014","Class II","TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t09032013@48, t09252013@37, 09162013@38 ",,"44 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-442-2014","Class II","Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@8",,"6 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-454-2014","Class II","VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2",,"50 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-439-2014","Class II","Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6",,"6 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-420-2014","Class II","FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7",,"700 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-458-2014","Class II","0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8 ",,"a) Injectable 800 mL; b) Topical 600 mL ","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-435-2014","Class II","Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@8, 09242013@3, 09242013@4, 09242013@6, 09242013@7, 09242013@9, 10012013@1, 10012013@2, 10012013@3, 10012013@4, 10012013@5, 10012013@6, 10032013@6, 10142013@1 ",,"5582.6 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-427-2014","Class II","HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09192013@10, 10152013@19 ",,"53 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-421-2014","Class II","FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09242013@1",,"4.4 mL ","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-438-2014","Class II","Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 07232013@41",,"11 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-449-2014","Class II","TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09182013@42, t09172013@31, t09182013@4 ",,"33 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-444-2014","Class II","SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@11, 09242013@12, 10022013@1, 10022013@2, 10082013@1, 10082013@2, 10082013@3, 10092013@1, 10092013@2, 10092013@3, 10152013@15, 09192013@1, 09192013@2, 09192013@3, 09192013@4, 09192013@6, 09192013@7, 09192013@8, 09202013@28, 09202013@29, 10032013@3, 10032013@4, 10152013@3, 10152013@4 ",,"9200 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-426-2014","Class II","HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08122013@18, t09232013@8 ",,"70 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-443-2014","Class II","QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12 ",,"86 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-437-2014","Class II","Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08212013@13, 09112013@2, 09172013@17, 09232013@1, 09242013@13, 10022013@7, 09242013@14, 10022013@9, 10032013@5, 10072013@2 ",,"1351 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-416-2014","Class II","CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@1 ",,"5 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-436-2014","Class II","Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@20, t09162013@43, t08282013@18, t08292013@11 ",,"35.5 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-459-2014","Class II","DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@10, 09302013@1, 10152013@5, ; b) Topical 09252013@11, 09302013@3, 10152013@7 ",,"a) Injectable 600 mL; b) Topical 800 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-456-2014","Class II","WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20 ",,"a) 1900 injectable; b) 1900 mL topical","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-412-2014","Class II","Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: for both sizes: 08072013@26, 08282013@52, 09112013@31, 09162013@33, 10072013@33, 07242013@47, 08082013@42, 09172013@52, 10162013@35, 07242013@55, 07242013@56, 09122013@36, 09122013@35, 10042013@8, 10042013@9, 07262013@12, 07262013@13, 07262013@14, 07262013@16, 08082013@35, 08082013@41, 08152013@44, 08162013@21, 08292013@53, 08302013@24, 08302013@25, 08302013@35, 09062013@20, 09132013@26, 09132013@12, 09132013@13, 09202013@34, 09202013@35, 09202013@36, 09262013@24, 10092013@36, 10092013@39, 10102013@37, 10112013@34, 10162013@44, 10172013@26, 10172013@27 ",,"2801 doses","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-411-2014","Class II","Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08132013@1, 08162013@5 ",,"160 grams","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-440-2014","Class II","Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t07312013@28",,"10 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-418-2014","Class II","EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@36, t09182013@5 ",,"30 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-431-2014","Class II","METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 ","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10072013@4, 10192013@1, 07112013@3, 09052013@6, 09262013@2, 09272013@35, 10012013@26, 08282013@35, t08282013@17, t10092013@30, t10102013@18, t08222013@11, t08292013@21, t08302013@5, t09162013@30, 09162013@46, 09172013@23, t09242013@33, t09302013@25, t10022013@15, t10112013@21, t10162013@4, t08222013@21, t10092013@29 ",,"726.45 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66566,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-460-2014","Class II","SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10152013@20 ",,"10 mL","Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.",10/19/2013,"10/19/2013",1/22/2014,"01/22/2014"
"Drugs",66568,"Ongoing","Compounding Centre At Blue Ridge","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-401-2014","Class II","Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.","All Lots",,"92 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ",10/18/2013,"10/18/2013",1/15/2014,"01/15/2014"
"Drugs",66568,"Ongoing","Compounding Centre At Blue Ridge","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-405-2014","Class II","Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.","All Lots",,,"Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ",10/18/2013,"10/18/2013",1/15/2014,"01/15/2014"
"Drugs",66568,"Ongoing","Compounding Centre At Blue Ridge","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-403-2014","Class II","Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.","All Lots",,"3 Vials","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ",10/18/2013,"10/18/2013",1/15/2014,"01/15/2014"
"Drugs",66568,"Ongoing","Compounding Centre At Blue Ridge","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-402-2014","Class II","PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.","All Lots",,"11 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ",10/18/2013,"10/18/2013",1/15/2014,"01/15/2014"
"Drugs",66568,"Ongoing","Compounding Centre At Blue Ridge","Raleigh","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-404-2014","Class II","Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.","All Lots",,"1 unit","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. ",10/18/2013,"10/18/2013",1/15/2014,"01/15/2014"
"Devices",66585,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution including Puerto Rico.","Z-0851-2014","Class II","User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. ","Material numbers 10284473, 10488224, 10444801, and 10444802.",,"2038","When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.",10/7/2013,"10/07/2013",2/5/2014,"02/05/2014"
"Devices",66591,"Ongoing","Civco Medical Instruments Inc","Kalona","IA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.","Z-0802-2014","Class II","Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.","Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570",,"138 belly boards","Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.",10/25/2013,"10/25/2013",1/29/2014,"01/29/2014"
"Devices",66591,"Ongoing","Civco Medical Instruments Inc","Kalona","IA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.","Z-0803-2014","Class II","Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.","Lot#'s: M551490 and M550150",,"2 belly board","Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.",10/25/2013,"10/25/2013",1/29/2014,"01/29/2014"
"Drugs",66593,"Ongoing","Amedra Pharmaceuticals LLC","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-385-2014","Class II","Dexedrine (Dextroamphetamine Sulfate) Spansules Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09 ","Lot# 243459; Exp. 01/14 ",,"10,992 bottles","Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.",10/7/2013,"10/07/2013",1/1/2014,"01/01/2014"
"Drugs",66594,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-392-2014","Class II","Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)","Lot number EXP 31314801B, 2/2014; 31314990B, 2/2014; 31314991B, 2/2014; 31315014B, 2/2014; 31315155B, 6/2014; 31315279B, 6/2014; 31315837B, 10/2014; 31315921B, 10/2014; 31316029D, 12/2014; and 31316029C, 12/2014",,"13520 vials","Presence of Precipitate; precipitation of drug product",10/11/2013,"10/11/2013",1/8/2014,"01/08/2014"
"Devices",66603,"Ongoing","Midmark Corp dba Progeny Inc","Lincolnshire","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, CA, CO, CT, FL, GA, IL, KS, MA, NC, NH, NJ, OH, OK, PA, SC, TN, TX, VA, and WI, and the countries of Australia, Canada, and Russia.","Z-0651-2014","Class II","The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800","Vantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3. Vantage Panoramic X-Ray System Catalog Numbers and Serial Numbers: Catalog Number V5000, Serial Numbers ZM81025, ZM81026, ZM81030, ZZ08005, ZZ08006, ZZ08007, ZZ08008, ZZ08009, ZZ08010, ZZ08011, ZZ08012, ZZ08013, ZZ08015, ZZ08016, ZZ08017, Z08018, ZZ08019, ZZ08020, ZZ08021, ZZ08022, ZZ08023, ZB51001, ZB51002, ZB51006, ZB51007, ZT18018, ZY49014, ZK58019, ZS54011, ZP01043, ZV78016, ZE09006, ZN44018, ZS59007, ZS59001, ZW15007, ZW34003, ZW34012, ZW34018, ZY49012, ZY49015, ZZ02010, ZM81022, ZS54012, ZE09019, ZM81017, ZT18004, ZT18015, ZN44020, ZE09012, ZM81023, ZT27012; Catalog Number V5050, Serial Number ZZ08014; Catalog Number V5100, Serial Numbers ZM81027, ZM81028, ZZ08003; Catalog Number V5150, Serial Number ZZ08002; Catalog Number V5150C, Serial Number ZM81016",,"58 units","An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop'').",9/20/2013,"09/20/2013",1/15/2014,"01/15/2014"
"Drugs",66604,"Ongoing","Ferring Pharmaceuticals Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1426-2014","Class III","ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3","Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15 ",,"72,046 cartons","Discoloration; due to prolonged heat exposure.",9/19/2013,"09/19/2013",7/16/2014,"07/16/2014"
"Biologics",66620,"Terminated","American National Red Cross (The)","Portland","OR","US","Voluntary: Firm Initiated","FAX","AZ, GA, MD, MT, NV, NY, OR, PA, PA, UT, WA, and Washington DC","B-0369-14","Class II","Cryoprecipitated AHF, Pooled","021L48171, 021L48172, 021L48173, 021L48174, 021L48175, 021L48176, 021L48177, 021L48178, 021L48179, 021L48180, 021L48181, 021L48182, 021L48183, 021L48201, 021L48202, 021L48203, 021L48204, 021L48205, 021L48206, 021L48207, 021L48208, 021L48209, 021L48210, 021L48211, 021L48212, 021L48213, 021L48214, 021L48215, 021L48216, 021L48221, 021L48222, 021L48223, 021L48224, 021L48225, 021L48226, 021L48227, 021L48228, 021L48232, 021L48233, 021L48234, 021L48235, 021L48236, 021L48237, 021L48238, 021L48239, 021L48240, 021L48251, 021L48252, 021L48253, 021L48254, 021L48255, 021L48256, 021L48257, 021L48258, 021L48259, 021L48260, 021L48261, 021L48263, 021L48279, 021L48280, 021L48285, 021L48287, 021L48288, 021L48289, 021L48290, 021L48291, 021L48292, 021L48293, 021L48294, 021L48295, 021L48296, 021L48317, 021L48318, 021L48319, 021L48320, 021L48321, 021L48322, 021L48323, 021L48324, 021L48325, 021L48326, 021L48327, 021L48328, 021L48347, 021L48348, 021L48349, 021L48350, 021L48352, 021L48358, 021L48359, 021L48360, 021L48361, 021L48362, 021L48363, 021L48396, 021L48397, 021L48398, 021L48399, 021L48400, 021L48401, 021L48402, 021L48403, 021L48404, 021L48405, 021L48406, 021L48407, 021L48409, 021L48410, 021L48411, 021L48412, 021L48438, 021L48439, 021L48440, 021L48444, 021L48446, 021L48462, 021L48463, 021L48464, 021L48465, 021L48466, 021L48467, 021L48468, 021L48469, 021L48470, 021L48471, 021L48472, 021L48473, 021L48474, 021L48475, 021L48477, 021L48479",,"131 units","Blood products, which failed the monthly quality control testing for Factor VIII level, were distributed.",9/9/2013,"09/09/2013",3/12/2014,"03/12/2014"
"Devices",66622,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.","Z-0629-2014","Class II","Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.","All serial numbers",,"111,504 units US and 3,638 Canada and Mexico-","2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Food",66628,"Ongoing","Fresh Foods Manufacturing Co.","Freedom","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD, OH, PA, WV","F-1148-2014","Class II","Diced Summer Slaw Salad Kit Fresh Food Manufacturing Company 10.5 lbs","UPC 815712010960 Lot # VG-2456574: Exp. 10/17/2013 Lot# VG-2456576: Exp. 10/19/2013 Lot # VG-2456579: Exp. 10/21/2013 Lot # VG-2456581: Exp. 10/24/2013 Lot# VG-2456583: Exp. 10/26/2013 Lot# VG-2456586: Exp. 10/28/2013 Lot# VG-2456588: Exp. 10/31/2013 Lot# VG-2456590: Exp. 11/2/2013 Lot# VG-2456595 Exp. 11/7/2013 Lot# VG-2456595a Exp, 11/4/2013 Lot# VG-2456597 Exp. 11/9/2013 Lot# VG-2456600 Exp. 11/11/2013 ",,"714 cases","Diced Summer Slaw Salad kit included a package of dressing currently under recall by US Foods for possible Listeria monocytogenes contamination.",10/26/2013,"10/26/2013",1/1/2014,"01/01/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-052-2014","Class II","XYLAZINE* (VET) 100MG/ML INJECTABLE ","t08212013@17 Best By11/20/2013 ",,"100 mls","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-042-2014","Class II","AMIKACIN SULFATE*-PF 250MG/ML INJECTABLE ","Lot t10162013@20 Best By 10/30/2013 ",,"20.166 mls","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-048-2014","Class II","PHENOBARBITAL SODIUM* 65MG/ML INJECTABLE ","Lot 08192013@28 Best By11/17/2013 ",,"10 ml","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-051-2014","Class II","TACROLIMUS* (VET) MCT 0.02% OPHTH SOL ","t07092013@24 Best By 9/7/2013 ",,"10 ml","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-049-2014","Class II","TACROLIMUS (VET)* 0.03% OPHTH SOL TACROLIMUS* (VET) 0.02% OPHTH SOL ","0.03% : Lot 08222013@17, Best By10/21/2013 t09052013@14 11/4/2013 0.02%: Lot t08272013@17, Best By10/26/2013 t09162013@20 11/15/2013 t09262013@6 11/25/2013 t09302013@31 11/29/2013 t10092013@14 12/8/2013 ",,"70.5 mls","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-047-2014","Class II","IDOXURIDINE* OPHTHALMIC 0.1% SOLUTION L ","Lot t08022013@17 Best By 9/1/2013 ",,"15 ml","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-046-2014","Class II","DOXYCYCLINE-OS 100MG/ML VET LIQUID ","Lot 08092013@23 Best By 2/5/2014 ",,,"Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-050-2014","Class II","TACROLIMUS OINTMENT 0.03% OPHTHALMIC ","08122013@39 2/8/2014 t10092013@15 4/7/2014 ",,"8.5 ml","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-043-2014","Class II","BUPRENORPHINE* HCL 0.6MG/ML INJECTABLE ","Lot 10112013@2 Best By11/10/2013 ",,"10 ml","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-044-2014","Class II","CYCLOSPORIN* MCT 0.2% OPHTHALMIC CYCLOSPORIN* MCT 1% OPHTHALMIC CYCLOSPORIN* MCT 2% OPHTHALMIC ","0.2%: Lot t08142013@42 Best By 2/10/2014 1%: Lot t07022013@29 Best By 12/29/2013; Lot t07242013@27 Best By 1/20/2014; Lot t08282013@28 Best By 2/24/2014; Lot t10032013@10 Best By 4/1/2014 2%: Lot t08142013@36 Best By 2/10/2014 ",,"140 mls","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Veterinary",66636,"Ongoing","Specialty Medicine Compounding Pharmacy","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Vet clinics and individual pet owners in Michigan","V-045-2014","Class II","DESMOPRESSIN ACETATE* (0.01%) 0.1MG/ML SOLUTION DESMOPRESSIN ACETATE* (0.0125%) 0.125MG/ML DESMOPRESSIN ACETATE* (0.02%) 0.2MG/ML SOLUTION ","Lot 09132013@4 Best By 12/12/2013 Lot t09182013@39 Best By 12/17/2013 Lot t09032013@21 Best By 12/2/2013 Lot t07242013@22 Best By 10/22/2013 ",,"48 mls ","Unexpired sterile compounded human and veterinary products distributed July 1, 2013 to October 19, 2013 are being recalled after particulate matter, later identified as mold, was found floating in a sterile 50% dextrose product. The recalled products were distributed in Michigan. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.",10/19/2013,"10/19/2013",2/12/2014,"02/12/2014"
"Food",66651,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1441-2014","Class III","Bread Filled with Jam, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton. ","lot no: 4400",,"1050 cartons","LSG Food World Inc., has recalled Bread Filled with Jam and Bean Paste Bread due to a misbranded product label (lacks english translation).",10/23/2013,"10/23/2013",2/5/2014,"02/05/2014"
"Food",66651,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1440-2014","Class III","Bean Paste Bread, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton. ","lot no: 4400",,"1050 cartons","LSG Food World Inc., has recalled Bread Filled with Jam and Bean Paste Bread due to a misbranded product label (lacks english translation).",10/23/2013,"10/23/2013",2/5/2014,"02/05/2014"
"Devices",66660,"Ongoing","Orthofix, Inc","Lewisville","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and the country of Germany.","Z-1089-2014","Class II","Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., 3451 Plano Pkwy, Lewisville, TX 75056 USA. Tel: 1-888-298-5700/1-214-937-2000, RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.","86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date",,"4,172 units","There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. ",10/29/2013,"10/29/2013",3/5/2014,"03/05/2014"
"Food",66661,"Ongoing","Lsg Food World Inc","Bayonne","NJ","US","Voluntary: Firm Initiated","Letter","New York","F-1442-2014","Class III","Lam Sheng Kee Fu Zhou Vermicell, Net Wt. 4.4 LB (2000 g), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6949682 803360; Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED RM3. 8/F, YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI HK; Distributed by: S&M INT'L INC 100 Pulaski Street, Bayonne, NJ 07002, Product of China.","Item no: 803360, Best Before 10/06/2014",,"541 cartons","LSG Food World Inc., has recalled Fu Zhou Vermicelli due to filth subject to Import Alert 02-02 and the product is misbranded in that it does not have English translation.",10/23/2013,"10/23/2013",2/5/2014,"02/05/2014"
"Biologics",66668,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0178-14","Class II","Platelets Pheresis Leukocytes Reduced","W041013129463O; W041013129463O; ",,"2","Blood products, with insufficient plasma to support the platelet concentrations, were distributed.",8/29/2013,"08/29/2013",2/12/2014,"02/12/2014"
"Biologics",66669,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri; Arkansas","B-0185-14","Class II","Blood and Blood Products for Reprocessing","W045112402808; W045112358415; ",,"2","Blood products, collected from a donor who resided with a person who has hepatitis B, were distributed.",9/19/2013,"09/19/2013",1/22/2014,"01/22/2014"
"Biologics",66669,"Terminated","Community Blood Center of the Ozarks","Springfield","MO","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri; Arkansas","B-0184-14","Class II","Red Blood Cells Leukocytes Reduced","W045112402808; W045112358415; ",,"2","Blood products, collected from a donor who resided with a person who has hepatitis B, were distributed.",9/19/2013,"09/19/2013",1/22/2014,"01/22/2014"
"Drugs",66675,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-389-2014","Class II","Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.","Batch no: 1) 614463 (exp. 03/2014), 2) 612905 (exp. 12/2013), 3) 614923 (exp. 03/2014), 4) 615852 (exp. 05/2014), 5) 615855 (exp. 05/2014), 6) 616689 (exp. 07/2014), 7) 616692 (exp. 07/2014).",,"51.948 bottles","Failed Stability Specification; product viscosity and or pH are below specification.",10/28/2013,"10/28/2013",1/1/2014,"01/01/2014"
"Drugs",66678,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide","D-1034-2014","Class II","Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.","National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014) NDC: 14789-500-10; 122911 (12/2013), 123011 (12/2013)",,"121,456 vials","Presence of particulate matter consistent with delamination of the glass vial container.",10/31/2013,"10/31/2013",1/29/2014,"01/29/2014"
"Biologics",66680,"Terminated","Houchin Community Blood bank","Bakersfield","CA","US","Voluntary: Firm Initiated","FAX","California","B-0182-14","Class III","Fresh Frozen Plasma","W224313506898; ",,"1","Blood product, frozen more than 8 hours after collection, was distributed.",9/13/2013,"09/13/2013",1/22/2014,"01/22/2014"
"Biologics",66681,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Other","California","B-0172-14","Class III","Blood and Blood Products for Reprocessing","FP113302016; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",9/26/2013,"09/26/2013",1/22/2014,"01/22/2014"
"Biologics",66682,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0181-14","Class II","Cryoprecipitated AHF","W047013030598; W047013030617; W047013033865; W047013034565; W047013033529; W047013037580; W047013031648; ",,"7","Blood products, not re-frozen within the appropriate time frame, were distributed.",10/8/2013,"10/08/2013",1/22/2014,"01/22/2014"
"Biologics",66683,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0180-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W047013442274; W047013442274; W047013442269; ",,"3","Blood products, tested by NAT for communicable diseases using unsuitable samples, were distributed.",9/30/2013,"09/30/2013",1/22/2014,"01/22/2014"
"Biologics",66683,"Terminated","New York Blood Center, Inc.","Westbury","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0179-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W047013442274; ",,"1","Blood products, tested by NAT for communicable diseases using unsuitable samples, were distributed.",9/30/2013,"09/30/2013",1/22/2014,"01/22/2014"
"Biologics",66684,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0183-14","Class III","Red Blood Cells Leukocytes Reduced","W115913025007; W115913025008; W115913025009; W115913025010; W115913025017; W115913025077; W115913025078; W115913025080; ",,"8","Blood products, collected using a trip scale for which daily QC was not properly recorded, were distributed.",9/20/2013,"09/20/2013",1/22/2014,"01/22/2014"
"Biologics",66686,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri; Indiana","B-0197-14","Class II","Red Blood Cells Leukocytes Reduced","W040709644316; W040709425218; ",,"2","Blood products, collected from a donor who reported high risk behavior, were distributed.",9/20/2013,"09/20/2013",1/22/2014,"01/22/2014"
"Biologics",66686,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Switzerland; Missouri; Indiana","B-0198-14","Class II","Blood and Blood Products for Reprocessing","W040709425218; ",,"1","Blood products, collected from a donor who reported high risk behavior, were distributed.",9/20/2013,"09/20/2013",1/22/2014,"01/22/2014"
"Biologics",66687,"Terminated","Csl Plasma","Columbus","OH","US","Voluntary: Firm Initiated","Other","Illinois; Germany","B-0177-14","Class II","Source Plasma","40904030630; 40905673274; 40905744669; 40905538662; 40905484289; 40905324891; 40905363532; 40904396720; 40904298863; 40904292883; 40904301719; 40903880050; 40904056012; 40903936202; 40903930417; 40903917044; 40903747436; 40903743902; 40903580488; 40903069380; 40903809289; 40903818601; 40903675495; 40903811979; 40903609412; 40903731143; 40903727742; 40902939698; 40902923557; 40903654483; 40903531061; 40903018073; 40903048029; 40902959509; 40903021504; 40903110478; 40902965319; ",,"37","Blood products, collected from a donor whose annual physical examination was incomplete, were distributed. ",8/29/2013,"08/29/2013",1/22/2014,"01/22/2014"
"Veterinary",66690,"Completed","Renaissance Nutrition, Inc.","Roaring Spring","PA","US","Voluntary: Firm Initiated","Letter","WI","V-164-2014","Class I","Dan Nelson Dairy Pre-mix R Dairy mineral pre-mix with Monensin at 509g/ton Product #WIK361 Lot #21413J","On product tag - WIK361 Lot #21413J",,"39 bags","Custom blend of mineral pre-mix was found with high levels of monensin up from 800 g/ton to 26,000 g/ton",10/31/2013,"10/31/2013",10/1/2014,"10/01/2014"
"Drugs",66695,"Ongoing","Airgas Medical Services","Radnor","PA","US","Voluntary: Firm Initiated","Telephone","To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.","D-386-2014","Class II","Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009","Lot # HS05A266E , size ''E'' and ''D'', NDC # 11054-009-XX Number and Part Numbers = USPE, USPEAC, USPDAC",,"145 cylinders","Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.",10/10/2013,"10/10/2013",1/1/2014,"01/01/2014"
"Drugs",66696,"Ongoing","Greenstone LLC","Peapack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-746-2014","Class II","sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1","Lot SASA12001-A, exp. date 06/2015; Lot SASA12001-B, exp. date 06/2015; Lot SASA13001-A, exp. date 02/2016; Lot SASA13002-A, exp. date 02/2016",,"585,096 bottles","Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life",11/5/2013,"11/05/2013",1/29/2014,"01/29/2014"
"Biologics",66699,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Utah","B-0176-14","Class II","Platelets Pheresis Leukocytes Reduced","W1165132060143; ",,"1","Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.",10/11/2013,"10/11/2013",1/22/2014,"01/22/2014"
"Biologics",66700,"Terminated","Ogden Medical Center, Inc.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Utah","B-0175-14","Class II","Platelets Pheresis Leukocytes Reduced","W1165132058833; W1165132058833; ",,"2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",10/11/2013,"10/11/2013",1/22/2014,"01/22/2014"
"Biologics",66701,"Terminated","Arup Laboratories, Inc.","Sandy","UT","US","Voluntary: Firm Initiated","Telephone","Utah","B-0174-14","Class II","Platelets Pheresis","W158013702296; W158013702296; ",,"2","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",9/27/2013,"09/27/2013",2/12/2014,"02/12/2014"
"Biologics",66702,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","Other","Switzerland","B-0173-14","Class II","Blood and Blood Products for Reprocessing","W120613007643; W120613003349; W120612021000; W120612043666; W120612008549; W120612004742; W120612001120; W120611017111; W120611012999; W120611009153; ",,"10","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",9/12/2013,"09/12/2013",1/22/2014,"01/22/2014"
"Food",66706,"Ongoing","Taylor Farms Florida, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-1149-2014","Class II","BROCCOLI, SLAW CRUNCH KIT, 390260, 1/6.55#","TTFLD285A11, BEST IF USED BY: 10/23/13; TTFLD288A11, BEST IF USED BY: 10/26/13; TFFLD289A11, BEST IF USED BY: 10/27/13; TTFLD 289A11, BEST IF USED BY: 10/28/13; TTFLD 290A11, BEST IF USED BY: 10/28/13; TTFLD294A11, BEST IF USED BY: 11/1/13; TTFLD295A11, BEST IF USED BY: 11/2/13; TTFLD296A11, BEST IF USED BY: 11/3/13",,"35 units","The firm manufactured and distributed one salad kit which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/28/2013,"10/28/2013",1/1/2014,"01/01/2014"
"Food",66708,"Ongoing","Taylor Farms Texas, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","F-1150-2014","Class II","CabG Coleslaw Kit with Dressing TF 12.56#, 1400265, Net Weight: 12.5 Lbs, Ingredients: Green Cabbage, Carrots, Dressing; Distributed by Taylor Farms Texas, Dallas, TX 75211 ","Codes: TFD285, Use by: 10/24/2013; TFD288, Use by: 10/27/2013; TFD290, Use by: 10/29/2013; TFD292, Use by: 10/31/2013; TFD295, Use by: 11/3/2013",,"218 units ","The firm manufactured and distributed two salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/28/2013,"10/28/2013",1/1/2014,"01/01/2014"
"Food",66708,"Ongoing","Taylor Farms Texas, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","F-1151-2014","Class II","Kit, Salad Italian Pasta PPC SWY 1/5.67#, 2900070, Net Weight: 5.67Lbs, Distributed by Taylor Farms Texas, Dallas, TX 75211","TFD288AU5, Use by: 10/25/2013; TFD290AU5, Use by: 10/27/2013; TFD292AU5, Use by: 10/29/2013; TFD295AU5, Use by: 11/01/2013",,"211 units","The firm manufactured and distributed two salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/28/2013,"10/28/2013",1/1/2014,"01/01/2014"
"Food",66709,"Ongoing","Taylor Farms Maryland-Assateague Drive","Jessup","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, MA, MO, MA","F-0396-2014","Class II","KIT COLE SLAW, 310160, TAYLOR FARMS 12.5#, NET WT: 12, TAYLOR FARMS, MD","TFMDAA287A, MIX THRU 10/24/2013; TFMDAA288A, MIX THRU 10/25/2013; TFMDAA289A, MIX THRU 10/26/2013; TFMDAA290A, MIX THRU 10/27/2013; TFMDAA291A, MIX THRU 10/28/2013; TFMDAA294A, MIX THRU 11/01/2013; TFMDAA295A, MIX THRU 11/01/2013; TFMDAA296A, MIX THRU 11/02/2013; TFMDAA297A, MIX THRU 11/03/2013",,"1312 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Food",66709,"Ongoing","Taylor Farms Maryland-Assateague Drive","Jessup","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, MA, MO, MA","F-0394-2014","Class II","DICED SUMMER SLAW, 310140, TAYLOR FARMS 1/5.25, NET WT: 5 lbs; 2 PK, 310138, TAYLOR FARMS 2/1.25, NET WT: 10.5, TAYLOR FARMS, MD","TFMDAA287A, MIX THRU 10/24/2013; TFMDAA288A, MIX THRU 10/25/2013; TFMDAA289A, MIX THRU 10/26/2013; TFMDAA290A, MIX THRU 10/27/2013; TFMDAA291A, MIX THRU 10/28/2013; TFMDAA294A, MIX THRU 11/01/2013; TFMDAA295A, MIX THRU 11/01/2013; TFMDAA296A, MIX THRU 11/02/2013; TFMDAA297A, MIX THRU 11/03/2013",,"3396","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Food",66709,"Ongoing","Taylor Farms Maryland-Assateague Drive","Jessup","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, MA, MO, MA","F-0395-2014","Class II","KINGS SUMMER SLAW, 310161, TAYLOR FARMS 4.75#, NET WT: 4, TAYLOR FARMS, MD","TFMDAA290A, MIX THRU 10/27/2013; TFMDAA291A, MIX THRU 10/28/2013; TFMDAA297A, MIX THRU 11/03/2013",,"136 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Food",66709,"Ongoing","Taylor Farms Maryland-Assateague Drive","Jessup","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, MA, MO, MA","F-0397-2014","Class II","KIT BROCCOLI CHEDDAR PASTA, 310087, TAYLOR FARMS 8.56#, NET WT: 8.56, TAYLOR FARMS, MD","TFMDAA287A, MIX THRU 10/24/2013; TFMDAA288A, MIX THRU 10/25/2013; TFMDAA289A, MIX THRU 10/26/2013; TFMDAA290A, MIX THRU 10/27/2013; TFMDAA291A, MIX THRU 10/28/2013; TFMDAA294A, MIX THRU 11/01/2013; TFMDAA295A, MIX THRU 11/01/2013; TFMDAA296A, MIX THRU 11/02/2013; TFMDAA297A, MIX THRU 11/03/2013",,"281 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Food",66709,"Ongoing","Taylor Farms Maryland-Assateague Drive","Jessup","MD","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, PA, MA, MO, MA","F-0398-2014","Class II","ITALIA PASTA KIT, 310168 SAFEWAY 1/5.69#, NET WT: 5.69, S2560, DISTRIBUTED BY LUCERNE FOODS, INC. PO BOX 99, PLEASANTON, CA945, 95466-009, 1-877-232-4271","TFMDAA288A, BEST IF USED BY: 10/25/2013; TFMDAA289A, BEST IF USED BY: 10/26/2013; TFMDAA290A, BEST IF USED BY: 10/27/2013; TFMDAA291A, BEST IF USED BY: 10/28/2013; TFMDAA295A, BEST IF USED BY: 11/01/2013; TFMDAA296A, BEST IF USED BY: 11/02/2013; TFMDAA297A, BEST IF USED BY: 11/03/2013",,"240 units","The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Devices",66713,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.","Z-0569-2014","Class II","IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.","Kit Lots 335, 336, and 337",,"Domestic: 442 kits; Foreign: 680 kits","potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.",11/6/2013,"11/06/2013",1/1/2014,"01/01/2014"
"Biologics",66715,"Terminated","American National Red Cross, Northeastern","Ashley","PA","US","Voluntary: Firm Initiated","Other","California","B-0171-14","Class III","Blood and Blood Products for Reprocessing","030GY87884; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",10/9/2013,"10/09/2013",1/22/2014,"01/22/2014"
"Biologics",66716,"Terminated","Central Texas Regional Blood & Tissue Center","Austin","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0169-14","Class II","Platelets Pheresis Leukocytes Reduced","W221613611398; W221613611398; W221613611398; ",,"3","Blood products, collected from a donor who had taken aspirin prior to donating, were distributed. ",10/2/2013,"10/02/2013",1/22/2014,"01/22/2014"
"Biologics",66728,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0170-14","Class II","Red Blood Cells","W036809182595; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",10/25/2013,"10/25/2013",1/22/2014,"01/22/2014"
"Biologics",66729,"Terminated","American Natl Red Cross Mid Atlantic Region","Norfolk","VA","US","Voluntary: Firm Initiated","Letter","Virginia","B-0238-14","Class II","Red Blood Cells Leukocytes Reduced","029KG11680; ",,"1","Blood product, incorrectly determined to be negative for the E and c antigens, was distributed.",10/4/2013,"10/04/2013",1/22/2014,"01/22/2014"
"Biologics",66731,"Terminated","Talecris Plasma Resources","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0168-14","Class II","Source Plasma","4200227848; 4200227435; 4200226574; 4200226153; ",,"4","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",8/28/2013,"08/28/2013",1/22/2014,"01/22/2014"
"Biologics",66732,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0167-14","Class II","Source Plasma","3550176369; ",,"1","Blood product, collected from a donor who did not appropriately answer questions regarding risk factors for CJD, was distributed.",8/13/2013,"08/13/2013",1/22/2014,"01/22/2014"
"Drugs",66741,"Ongoing","Sigma-Tau Pharmaceuticals, Inc.","Gaithersburg","MD","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-736-2014","Class II","PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01","Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13 ",,"7479 vials ","Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak. ",11/1/2013,"11/01/2013",1/22/2014,"01/22/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0838-2014","Class II","DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.","Lot Number: 32871812",,"2 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0836-2014","Class II","DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.","Lot Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413",,"409 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0837-2014","Class II","DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.","Lot Numbers: 32871775, 32980891, 33132755, 33141184, 33217572, 33329945 ",,"48 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0835-2014","Class II","DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.","Lot Numbers: 32871821, 32976471, 33105247",,"121 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0839-2014","Class II","DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.","Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239",,"25 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66742,"Ongoing","DeRoyal Industries Inc","New Tazewell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0834-2014","Class II","Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.","Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911",,"738 units","The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.",9/17/2013,"09/17/2013",2/5/2014,"02/05/2014"
"Devices",66744,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","Z-0491-2014","Class II","Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.","DRX Revolution Mobile X-Ray Systems manufactured from June 2012 through October 2013: Serial Numbers DRXR00690, 111, 114, 119, 121, 122, 123, 125, 126, 134, 142, 143, 151, 152, 153, 154, 155, 161, 162, 163, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 181, 182, 183, 188, 189, 190, 191, 192, 196, 197, 198, 199, 201, 202, 203, 205, 206, 207, 208, 209, 211, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 331, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 363, 364, 365, 372, 373, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 405, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442, 443, 444, 451, 452, 454, 455, 456, 457, 458, 459, 460, 461, 464, 466, 467, 487, 488, 489, 490, 495, 506, 510, 511, 512, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523, 524, 530, 538, 541, 542, 543, 544, 545, 546, 547, 548, 549, 555, 557, 560, 561, 562, 563, 564, 581, 583, 584, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 601, 602, 603, 609, 610, 611, 612, 613, 614, 616, 619, 620, 621, 622, 626, 627, 628, 629, 631, 632, 633, 634, 635, 636, 637, 639, 644, 645, 649, 650, 651, 656, 657, 658, 659, 660, 661, 663, 664, 665, 676, 677, 682, 685, 686, 687, 688, 689, 691, 692, 694, 696, 697, 698, 699, 700, 702, 703, 704, 705, 706, 707, 718, 723, 724. ",,"310 systerms domestically","It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.",8/29/2013,"08/29/2013",1/15/2014,"01/15/2014"
"Biologics",66748,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia","B-0166-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W043211042830; W043211042830; W043209014042; W043209014042; ",,"4","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",10/11/2013,"10/11/2013",1/22/2014,"01/22/2014"
"Biologics",66749,"Terminated","American National Red Cross (The)","Oakland","CA","US","Voluntary: Firm Initiated","Other","California","B-0165-14","Class III","Blood and Blood Products for Reprocessing","084FC37434; ",,"1","Blood product, collected from a donor whose health history screening was not adequately performed, was distributed. ",9/19/2013,"09/19/2013",1/22/2014,"01/22/2014"
"Biologics",66752,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","GA","B-0253-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113288748A; W115113288746E",,"2 units","Blood products, with a low platelet counts, were distributed.",10/2/2013,"10/02/2013",1/29/2014,"01/29/2014"
"Devices",66754,"Ongoing","Data Innovations, Inc.","South Burlington","VT","US","Voluntary: Firm Initiated","E-Mail","Nationwide Canada and Britain","Z-0571-2014","Class II","Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004","Software alll versions prior to: v7.00.0006 and v8.00. Includes: v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004",,"24 systems","When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option ''Strip Zeros from Result'' set to ''Yes'' may result in sample error",11/6/2013,"11/06/2013",1/1/2014,"01/01/2014"
"Drugs",66760,"Ongoing","Greenstone Llc","Peapack","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-737-2014","Class II","Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8","V110079",,"21600 tablets","Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months. ",11/1/2013,"11/01/2013",1/22/2014,"01/22/2014"
"Food",66762,"Ongoing","NOW Foods","Bloomingdale","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia; FOREIGN: Bulgaria, China, Germany, Greece, Romania, Singapore, Slovakia, United Kingdom","F-1537-2014","Class II","Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules.","*** 1) Product Code 2965; Lot Numbers: 1660276, 1653504, 1634330, 1618025, 1606053, 1587905, 1539085, 1518136, 1497964, 1476818. *** 2) Product Code 2968; Lot Numbers: 1645219, 1630289, 1616607, 1607295, 1593903, 1549088, 1536759, 1528258, 1516482, 1511273, 1483789, 1470001, 1458643. *** 3) Product Code 102965; Lot Numbers: 1649254, 1643889, 1632228, 1630192, 1622153, 1618074, 1606601, 1599557, 1599554, 1571142. 1564422, 1554121, 1554086, 1548791, 1538088, 1538078, 1522374, 1520852, 1510332, 1498999, 1492855, 1479602, 1475604, 1459330. *** 4) Product Code: 102968; Lot Numbers 1620846, 1534791. *** 5) Product Code 3C212965; Lot Number: 1602054",,"31,344 bottles","Digestive enzyme capsules manufactured by NOW Foods may contain the antibiotic chloramphenicol.",11/7/2013,"11/07/2013",2/26/2014,"02/26/2014"
"Biologics",66769,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","GA","B-0219-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113260468X",,"1 unit","Blood Product, which did not meet specifications, were distributed.",9/18/2013,"09/18/2013",1/29/2014,"01/29/2014"
"Biologics",66770,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Florida; New York","B-0124-14","Class I","Bone","0108090073; 0108090075; 0108090076; 0108090077; 0108090078; 0108090106; 0108090107; 01080900108; 0108090109; 0108090074",,"10 allografts","Tissue allografts, associated with positive pre-processing cultures for Clostridium, were distributed. ",7/24/2013,"07/24/2013",1/22/2014,"01/22/2014"
"Drugs",66771,"Ongoing","Alexion Pharmaceuticals, Inc.","Cheshire","CT","US","Voluntary: Firm Initiated","E-Mail","Nationwide, Puerto Rico, Jamaica, and Grenada.","D-1049-2014","Class I","Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.","Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15",,"21,661 vials","Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.",11/4/2013,"11/04/2013",2/5/2014,"02/05/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1141-2014","Class II","Vega Sport Performance Protein Dietary Supplement Vanilla Powder. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 829 g and 1.2oz/33g containers.","Lots: 47047700, 47047701, 47047702, 47047704, 47047705, 47048400, 47048401, 47043001, 47043002, 47050100 ",,"32,662 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1147-2014","Class II","Vega All-In-One Nutritional Shake Berry. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30 oz./850g, 425g, 38.6g containers.","Lots: 47046600, 47041900, 47043100, 47042000, 47047800, 47048500 and 47047100",,"22,969","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1140-2014","Class II","Vega Sport Performance Protein Dietary Supplement Chocolate Powder. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 29oz/822g, 1.3 oz/36g, 17x1.3oz/36g pouches.","Lots: 47042900, 47047600, 47043500, 47047602, 47048290, 47048291 ",,"28,149 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1145-2014","Class II","Vega ONE Nutritional Shake French Vanilla. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 414 g, 827 g, and 37.6 g containers.","Lots: 47042700, 47042701, 47042702, 47042703, 47042800, 47042801, 47042802, 47046500, 47047000, 47047500, 47047501, 47047502, 47048200, 47048201, 47048700, 47049300, 47049800, 47050600, 47051400, 47051800, 47052100, 47055200, 47055300 ",,"62,809 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1144-2014","Class II","Vega ONE Nutritional Shake Natural. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.4oz/862g, 35.9g, and 431g containers.","Lots: 47042100, 47042200, 47043400, 47046700, 47047200, 47047900, 47049000, 47049001, 47049500, 47050300 ",,"21,598 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1143-2014","Class II","Vega ONE Nutritional Shake Vanilla Chai. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.8 oz./874 g, 38g, 437g units containers.","Lots: 47042500, 47042600, 47042601, 47042602, 47043300, 47046900, 47047400, 47047401, 47048100, 47048101, 47049200, 47049201, 47049700, 47050500, 47051600 ",,"36,629 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1142-2014","Class II","Vega One Starter Kit. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 7oz/197.2g containers.","Lots: 12SE13PP1, 13SE13PP1, 16SE13PP1, 17SE13PP1, 23OC13PP1, 24OC13PP1 ",,"2,759 units","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Food",66772,"Ongoing","Vega / Sequel Naturals","Burnaby",,"CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No military/govt/VA.","F-1146-2014","Class II","Vega ONE Nutritional Shake Chocolate. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.9oz/876 g, 41.7 g, and 438 g, containers.","Lots: 47042400, 47042401, 47042402, 47042403, 47043200, 47046801, 47046802, 47047300,47048000,47048001, 47048600, 47049101, 47049601 ",,"47,565","Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol.",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Devices",66774,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.","Z-1087-2014","Class II","VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Product Code 8379034; Affected Generations (GENs)/Lots: GENs 7 - 13; Expiry Dates: 2013-11-01 thru 2015-01-01",,"548,663 units","Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.",10/17/2013,"10/17/2013",3/5/2014,"03/05/2014"
"Devices",66774,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.","Z-1088-2014","Class II","VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.","Product Code 1662659; Lots: 1) 212 and 2) 292; Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28.",,"19,368 units total (10,328 for lot 212 and 9,040 for lot 292)","Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.",10/17/2013,"10/17/2013",3/5/2014,"03/05/2014"
"Devices",66775,"Ongoing","Medline Industries Inc","Mundelein","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.","Z-1612-2014","Class II","Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.","Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929",,"1,610 mucus specimen traps","There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.",11/4/2013,"11/04/2013",5/21/2014,"05/21/2014"
"Veterinary",66776,"Ongoing","Bailey's Choice","Cumming","GA","US","Voluntary: Firm Initiated","Telephone","DE, GA, NC, SC, TN and VA.","V-069-2014","Class I","Bailey's Choice 100% Teriyaki Chicken Treat, Made in Waleska, GA","Lot number: 132881",".",,"Possible Salmonella contamination.",10/28/2013,"10/28/2013",6/18/2014,"06/18/2014"
"Veterinary",66776,"Ongoing","Bailey's Choice","Cumming","GA","US","Voluntary: Firm Initiated","Telephone","DE, GA, NC, SC, TN and VA.","V-067-2014","Class I","Bailey's Choice 100% Chicken Treat, Net wt. 5oz, Made in Waleska, GA .","Lot numbers: Jun 2 2013, Jun 3, 2013, Jun 15, 2013, Jul 8, 2013 and Jul 11, 2013",".","200 units","Possible Salmonella contamination.",10/28/2013,"10/28/2013",6/18/2014,"06/18/2014"
"Veterinary",66776,"Ongoing","Bailey's Choice","Cumming","GA","US","Voluntary: Firm Initiated","Telephone","DE, GA, NC, SC, TN and VA.","V-068-2014","Class I","Bailey's Choice 100% Chicken Breast Treat, Made in Waleska, GA","Lot number: Jun 4, 2013",".",,"Possible Salmonella contamination.",10/28/2013,"10/28/2013",6/18/2014,"06/18/2014"
"Devices",66777,"Completed","Merit Medical Systems, Inc.","Chester","VA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV.","Z-0980-2014","Class I","Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.","Tray/Kit SPPT-5F-10/D, Lot # T491273 , Exp. 31-Dec-2014, SPPT-5F-10/D, Lot # T512967, Exp.31-Dec-2014, K12T-04453, Lot # T472220, Exp. 31-Dec-2014, K12T-04454, Lot # T487452, Exp. 31-Dec-2014, K12T-04455B, Lot # T479169, Exp. 31-Dec-2014, K12T-04455B, Lot # T502497, Exp. 31-Jul-2014, K12T04455B, Lot #T479169, Exp. 31-Dec-2014, K12T-03650C, Lot #T483624, Exp. 31-Oct-2014, K12T-04082B, Lot #T479165, Exp. 31-Oct-2014, K12T-06488, Lot #T475046, Exp. 30-Nov-2014, SPPT-5F-10/D, Lot #T51296, Exp. 31-Dec-2014, SPPT-5F-10/D, Lot #T491273, Exp. 31-Dec-2014, TAPS-5F-10LT, Lot #T486378, 31-Dec-2014, TAPS-5F-10T, Lot#T486379, 31-Dec-2014, SPPT-5F-10L/B, Lot #T486376, 31-Dec-2014, K12T-06292, Lot #T502623, 31-Dec-2014, SPPT-5F-7L/B, Lot #T486377, 31-Dec-2014, SPPT-5F-7L/B, Lot #489467, 31-Dec-2014, K12T-03502A, Lot #T506171, 31-Dec-2014, K12T-04021D, Lot #T450842, 31-Dec-2014, K12T-04021D, Lot #T521882, 31-Dec-2014, K12T-04174A, Lot #T489860, 31-Dec-2014, K12T-04174A, Lot# T496696, 31-Dec-2014, SPPT-5F-10/D, Lot #T491273, 31-Dec-2014, PPT-5F-10/D, Lot #T485986, 31-Dec-2014, TAPS-5F-10LT, Lot #T466554, 31-Dec-2014, TAPS-5F-10LT, Lot #T486378, 31-Dec-2014, TAPS-5F-10LT, Lot #T489468, 31-Dec-2014, K12T-03347, Lot #T478804, 31-Dec-2014, K12T-03425C, Lot #489341, 31-Dec-2014, K12T-05704, Lot #T492544, 31-Dec-2014, SPPT-5F-7/D, Lot #T489466, 31-Dec-2014, K12T-06493A, Lot #T48492, 30-Apr-2014, K09T-11022C. Lot #T483912, 31-Dec-2014, K12T-04001, Lot #T463981, 31-Dec-2014, K12T-05568A, Lot #481071, 30-Nov-2014, SPPT-5F-10S, Lot #T468623, 31-Oct-2014, K10T-04655A, Lot #T484345, 31-Dec-2014, SPPT-100/D, Lot #T478020, 31-Dec-2014, TAPS-5F-10T, Lot #T489469, 31-Dec-2014, K12T-05115A, Lot #T479730, 31-Dec-2014, K12T-03903A, Lot #T468576, 31-Dec-2014, K09T-10692B, Lot #T483949, 31-Dec-2014, K12T-02098, Lot #T483019, 31-Dec-2014, K12T-05386, Lot #T520848, 31-Dec-2014, K10T-04192G, Lot #T472284, 31-Dec-2014, SPPT-5F-7S, Lot #T485990, 31-Oct-2014, K12T-05329D, Lot #T499996, 31-Dec-2014, K10T-04359C, Lot #T491197, 31-Dec-2014, K12T-05060A, Lo",,"20, 872 trays","Custom Procedural Trays/Kits which contain 1% Lidocaine HCl injectio were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodge through the tissue and could possibly cause a pneumothorax or hemothorax.",9/30/2013,"09/30/2013",2/26/2014,"02/26/2014"
"Devices",66778,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.","Z-0115-2015","Class II","Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.","*** 1) Part Number 10275879; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1026 , 1027 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1050 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1093 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1105 , 1106 , 1107 , 1108 , 1109 , 1110 , 1111 , 1112 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1124 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1134 , 1135 , 1136 , 1137 , 1138 , 1139 , 1140 , 1141 , 1142 , 1143 , 1144 , 1145 , 1146 , 1147 , 1148 , 1149 , 1150 , 1151 , 1152 , 1153 , 1154 , 1155 , 1156 , 1157 , 1158 , 1159 , 1160 , 1161 , 1162 , 1163 , 1164 , 1165 , 1166 , 1167 , 1168 , 1169 , 1170 , 1171 , 1172 , 1173 , 1174 , 1175 , 1176 , 1177 , 1178 , 1179 , 1180 , 1181 , 1182 , 1183 , 1184 , 1185 , 1186 , 1187 , 1188 , 1189 , 1190 , 1191 , 1192 , 1193 , 1194 , 1195 , 1196 , 1197 , 1198 , 1199 , 1200 , 1201 , 1202 , 1203 , 1204 , 1205 , 1206 , 1207 , 1208 , 1209 , 1210 , 1211 , 1212 , 1213 , 1214 , 1215 , 1216 , 1217 , 1218 , 1219 , 1220 , 1221 , 1222 , 1223 , 1224 , 1225 , 1226 , 1227 , 1228 , 1229 , 1230 , 1231 , 1232 , 1233 , 1234 , 1235 , 1236 , 1237 , 1238 , 1239 , 1240 , 1241 , 1242 , 1243 , 1244 , 1245 , 1246 , 1247 , 1248 , 1249 , 1250 , 1251 , 1252 , 1253 , 1254 , 1255 , 1256 , 1257 , 1258 , 1259 , 1260 , 1261 , 1262 , 1263 , 1264 , 1265 , 1266 , 1267 , 1268 , 1269 , 1270 , 1271 , 1273 , 1274 , 1275 , 1276 , 1277 , 1278 , 1279 , 1280 , 1281 , 1282 , 1283 , 1284 , 1285 , 1286 , 1287 ",,"562 devices","Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.",10/28/2013,"10/28/2013",10/29/2014,"10/29/2014"
"Devices",66778,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.","Z-0116-2015","Class II","e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.","*** 1) Part Number: 10151531; Serial Numbers: 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1026 , 1027 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1050 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 11128 , 11131 , 11144 , 70001 , 70002 ; *** 2) Part Number: 10151532; Serial Numbers: 1001 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1026 , 1027 , 1028 , 1029 , 1030 , 1031 , 10319 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1047 , 1048 , 1049 , 1050 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1093 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1105 , 1106 , 1107 , 1108 , 1109 , 1110 , 1111 , 1112 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1124 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1134 , 1135 , 1136 , 1137 , 1138 , 1139 , 1140 , 1141 , 1142 , 1143 , 1144 , 1145 , 1146 , 1147 , 1148 , 1149 , 1150 , 1151 , 1152 , 1153 , 1154 , 1155 , 1156 , 1157 , 1158 , 1159 , 1160 , 1161 , 1162 , 1163 , 1164 , 1165 , 1166 , 1167 , 1168 , 1169 , 1170 , 1171 , 1172 , 1173 , 1174 , 1175 , 1176 , 1177 , 1178 , 1179 , 1180 , 1181 , 1182 , 1183 , 1184 , 1185 , 1186 , 1187 , 1188 , 1189 , 1190 , 1191 , 1"," 5389 , 5517 , 5764 , 6481 , 7778 , 7853 , 7883 , 7990 , 8484 , 8490 , 9001 , 9002 , 9003 , 9004 , 9005 , 9006 , 9007 , 9008 , 9009 , 9010 , 9011 , 9012 , 9013 , 9014 , 9015 , 9016 , 9017 , 9018 , 9019 , 9020 , 9021 , 9022 , 9023 , 9024 , 9025 , 9026 , 9027 , 9028 , 9029 , 9030 , 9031 , 9032 , 9033 , 9034 , 9035 , 9036 , 9037 , 9038 , 9039 , 9040 , 9041 , 9042 , 9043 , 9044 , 9045 , 9046 , 9047 , 9048 , 9049 , 9050 , 9051 , 9052 , 9053 , 9054 , 9055 , 9056 , 9057 , 9058 , 9059 , 9060 , 9061 , 9062 , 9063 , 9064 , 9065 , 9066 , 9067 , 9068 , 9069 , 9070 , 9071 , 9072 , 9073 , 9074 , 9075 , 9076 , 9077 , 9078 , 9079 , 9080 , 9081 , 9082 , 9083 , 9084 , 9085 , 9086 , 9087 , 9088 , 9089 , 9090 , 9091 , 9092 , 9093 , 9094 , 9095 , 9096 , 9097 , 9098 , 9099 , 9100 , 9101 , 9102 , 9103 , 9104 , 9105 , 9106 , 9107 , 9108 , 9109 , 9110 , 9111 , 9112 , 9113 , 9114 , 9115 , 9116 , 9117 , 9118 , 9119 , 9120 , 9121 , 9122 , 9123 , 9124 , 9125 , 9126 , 9127 , 9128 , 9129 , 9130 , 9131 , 9132 , 9133 , 9134 , 9135 , 9136 , 9137 , 9138 , 9139 , 9140 , 9141 , 9142 , 9143 , 9144 , 9145 , 9146 , 9147 , 9148 , 9149 , 9150 , 9151 , 9152 , 9153 , 9154 , 9155 , 9156 , 9157 , 9158 , 9159 , 9160 , 9161 , 9162 , 9163 , 9164 , 9165 , 9166 , 9167 , 9168 , 9169 , 9170 , 9171 , 9172 , 9173 , 9174 , 9175 , 9176 , 9177 , 9178 , 9179 , 9180 , 9181 , 9182 , 9183 , 9184 , 9185 , 9186 , 9187 , 9188 , 9189 , 9190 , 9191 , 9192 , 9193 , 9194 , 9195 , 9196 , 9197 , 9198 , 9199 , 9200 , 9201 , 9202 , 9203 , 9204 , 9205 , 9206 , 9207 , 9208 , 9209 , 9210 , 9211 , 9212 , 9213 , 9214 , 9215 , 9216 , 9217 , 9218 , 9219 , 9220 , 9221 , 9222 , 9223 , 9224 , 9225 , 9226 , 9227 , 9228 , 9229 , 9230 , 9231 , 9232 , 9233 , 9234 , 9235 , 9236 , 9237 , 9238 , 9239 , 9240 , 9241 , 9242 , 9243 , 9244 , 9245 , 9246 , 9247 , 9248 , 9249 , 9250 , 9251 , 9252 , 9253 , 9254 , 9255 , 9256 , 9257 , 9259 , 9260 , 9261 , 9262 , 9263 , 9264 , 9265 , 9266 , 9267 , 9268 , 9269 , 9270 , 9271 , 9272 , 9273 , 9274 , 9275 , 9276 , 9277 , 9278 , 9279 , 9280 , 9281 , 9282 , 9283 , ","4,862 devices","Reports of loose bolts in the detector support structure of Symbia and e.cam systems.",10/28/2013,"10/28/2013",10/29/2014,"10/29/2014"
"Biologics",66783,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","TN","B-0256-14","Class II","Red Blood Cells","W227713042574",,"1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",9/26/2013,"09/26/2013",1/29/2014,"01/29/2014"
"Devices",66787,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of: Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.","Z-1215-2014","Class II","Dental Abutment labeled in part: ''4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.","All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx",,"10,454","Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. ",8/26/2013,"08/26/2013",3/26/2014,"03/26/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0743-2014","Class II","Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)",,"1,944 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0742-2014","Class II","Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)",,"7,274 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0738-2014","Class II","Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)",,"361 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0739-2014","Class II","Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346. ( All units in between and including these two numbers)",,"1,002 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0735-2014","Class II","Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum. ","Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)",,"10,448 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0740-2014","Class II","Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)",,"42,699 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0741-2014","Class II","Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346. All units in between and including these two numbers.",,"954 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0737-2014","Class II","Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.","Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)",,"6,684 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Devices",66788,"Ongoing","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.","Z-0736-2014","Class II","Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum. ","Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.",,"624 units","Chest Drain tubing of of the ATS Blood recovery may leak or disconnect",11/19/2013,"11/19/2013",1/22/2014,"01/22/2014"
"Biologics",66797,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-0259-14","Class III","Plasma Frozen within 24 hours (FP24)","W038113125686; W038113174337; W038113162647; W038113113880; W038113161099; W038113165125; W038113165121; W038113165124; W038113161103; W038113161663; W038113125688; W038113146701; W038113125689",,"13 units","Blood Products, in which component preparation/component were not prepared in accordance with specifications, were distributed.",9/27/2013,"09/27/2013",1/29/2014,"01/29/2014"
"Biologics",66799,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","E-Mail","HI and Austria","B-0258-14","Class II","Blood and Blood Products for Reprocessing","W088413529943",,"1 unit","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",10/25/2013,"10/25/2013",1/29/2014,"01/29/2014"
"Biologics",66800,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","E-Mail","CA","B-0250-14","Class III","Blood and Blood Products for Reprocessing","004FC72018",,"1 unit","Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.",9/13/2013,"09/13/2013",1/29/2014,"01/29/2014"
"Biologics",66801,"Terminated","PlasmaCare, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","E-Mail","Spain","B-0255-14","Class II","Source Plasma","2010363701; 2010363208; 2010362156; 2010361554; 2010361279",,"5 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/19/2013,"09/19/2013",1/29/2014,"01/29/2014"
"Biologics",66802,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","IA","B-0254-14","Class II","Platelets Pooled Leukocytes Reduced","W037913564403",,"1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",9/23/2013,"09/23/2013",1/29/2014,"01/29/2014"
"Biologics",66804,"Terminated","Community Blood Center","Dayton","OH","US","Voluntary: Firm Initiated","FAX","Austria","B-0252-14","Class II","Blood and Blood Products for Reprocessing","W035410046738; 8550379",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/15/2013,"10/15/2013",1/29/2014,"01/29/2014"
"Biologics",66805,"Terminated","Csl Plasma, Inc.","Lansing","MI","US","Voluntary: Firm Initiated","Other","Illinois","B-0215-14","Class II","Source Plasma","04204108231; ",,"1","Blood product collected from a donor whose physical examination was incomplete, was distributed.",9/25/2013,"09/25/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1421-2014","Class II","Trader Joe's Classic Greek Salad with Feta Cheese, Cucumber Kalamata olives and Greek Dressing; (9 oz) (255 g) in plastic clam shell container. Packaged for Trader Joe's Manufactured by Glass Onion Catering, Richmond, CA","UPC 40083 5794; Best by Dates of 9-23-13 to 11-14-13.",,"588.94 pounds","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1419-2014","Class II","Delish Asian Style Noodle Salad, Tender noodles, crisp snowpeas, carrots and red bell peppers tossed with a zesty sesame dressing. 6 oz (170g) in clam shell plastic container. Packaged for Walgreens Manufactured by Glass Onion Catering, Richmond, CA.","UPC 49022-74628; Best by Dates of 9-23-13 to 11-14-13.",,"322.5 pounds","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1418-2014","Class II","Delish Greek Style Orzo Salad; Traditional orzo, cucumber, red bell peppers, green onion and Kalamata olives tossed with a creamy Greek Style yogurt and feta dressing. 6 oz (170g) in clam shell plastic container. Packaged for Walgreens Manufactured by Glass Onion Catering, Richmond, CA.","UPC 49022-74630; Best by Dates of 9-23-13 to 11-14-13.",,"244.13 lbs.","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1423-2014","Class II","Wheat Berry Salad kit (20 lb box). Contents in package: Cooked Wheat Berry Zucchini Cherry Tomatoes Red Bell Pepper Artichoke Pieces Shallots Almonds Dressing. Packaged for Whole Foods Manufactured by Glass Onion Catering, Richmond, CA","UPC NA Best by Dates of 9-23-13 to 11-14-13.",,"1080 pounds","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1420-2014","Class II","Delish Vegetarian Wrap, Fire Roasted red bell pepper tortilla with tender mixed greens, fresh carrots, cucumber, Jicama, sundried tomatoes, couscous & ages asiago cheese with a side of sweet basil dressing. 11.3 oz, (322 g)) wrapped in cellophane. Packaged for Walgreens Manufactured by Glass Onion Catering, Richmond, CA.","UPC 49022-55349; Best by Dates of 9-23-13 to 11-14-13.",,"1599.66 pounds","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66811,"Terminated","Atherstone Foods Inc dba Glass Onion Catering","Richmond","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA and Northern NV","F-1422-2014","Class II","Southwestern Salad kit (20 lb box). Contents in individual Bags: Cooked Soo Foo Roasted Corn Red and Yellow Bell Peppers Jalapenos Cilantro Pepitas Dressing. Packaged for Whole Foods Manufactured by Glass Onion Catering, Richmond, CA","UPC NA Best by Dates of 9-23-13 to 11-14-13.",,"1080 pounds","Investigation into an outbreak of e-coli 0157:H7 found that Glass Onion Catering was the supplier of the products. All FDA regulated products were made with similar ingredients.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1372-2014","Class I","USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz","Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487",,"645,826 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1376-2014","Class I","USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) RASPBERRY LEMONADE Manufactured for USPlabs, LLC (Dallas, TX 75220)"," UPC #094922447494",,"10,278 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1371-2014","Class I","USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.","3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869",,"1,065,783 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1370-2014","Class I","USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.","2 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules ''Pink Label'', UPC # 094922447906; 180 count capsules, UPC # 094922447852",,"2,166,328 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1375-2014","Class I","USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GREEN APPLE Manufactured for USPlabs, LLC (Dallas, TX 75220)"," UPC #094922426499",,"21,325 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1374-2014","Class I","USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220)"," UPC #094922447500",,"10,306 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Food",66813,"Ongoing","USPlabs, LLC","Dallas","TX","US",,"Press Release","Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.","F-1373-2014","Class I","USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)"," UPC #094922426376",,"71,499 units","USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.",11/9/2013,"11/09/2013",1/22/2014,"01/22/2014"
"Drugs",66814,"Ongoing","Greenstone Llc","Peapack","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide (including PR)","D-1059-2014","Class III","Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2","lot V112000, EXP Jun 2016",,"22,529 bottles","Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval",11/4/2013,"11/04/2013",2/12/2014,"02/12/2014"
"Drugs",66816,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","US nationwide (including PR)","D-1058-2014","Class III","Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66","Lot V120131",,"14,357 bottles","Failed Dissolution Specification; 8 hr stability timepoint",11/4/2013,"11/04/2013",2/12/2014,"02/12/2014"
"Drugs",66817,"Ongoing","Deseo Rebajar","Fajardo","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1277-2014","Class I","Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.","Lot #: 052012, Exp 10/2015",,"1,146 bottles","Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.",11/7/2013,"11/07/2013",5/7/2014,"05/07/2014"
"Food",66825,"Terminated","Whole Foods Market","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA only","F-1424-2014","Class II","Artichoke Wheatberry Salad: sold in prepackaged pint and half pint containers in the Prepared Foods Dept. as well as sold fresh from the Deli case and salad bar.","UPC 28563300000 or 28563400000; Expiration dates of Nov 9 to Nov 13, 2013.",,,"Salad ingredients supplied are now under recall for potential e-coli 0157:H7.",11/12/2013,"11/12/2013",1/22/2014,"01/22/2014"
"Food",66825,"Terminated","Whole Foods Market","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Northern CA only","F-1425-2014","Class II","Southwest SooFoo Salad: sold in prepackaged pint and half pint containers in the Prepared Foods Dept. as well as sold fresh from the Deli case and salad bar.","UPC 28563700000 or 28563800000; Expiration dates of Nov 9 to Nov 13, 2013.",,,"Salad ingredients supplied are now under recall for potential e-coli 0157:H7.",11/12/2013,"11/12/2013",1/22/2014,"01/22/2014"
"Devices",66832,"Ongoing","Kimberly-Clark Corporation","Roswell","GA","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.","Z-0850-2014","Class II","Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.","Lot M3085K301 and M2327K301",,"55 cases (10 units per case = 550 units)","Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.",10/29/2013,"10/29/2013",2/5/2014,"02/05/2014"
"Devices",66833,"Ongoing","EOS Imaging","Paris France",,"FR","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0529-2014","Class II","EOS System X- ray beam Digital radiography system used in general radiographic examinations.","EOS System",,"22 EOS systems are installed in US","EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition. ",11/7/2013,"11/07/2013",1/15/2014,"01/15/2014"
"Devices",66835,"Completed","Medtronic Advanced Energy, LLC","Portsmouth","NH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.","Z-0905-2014","Class II","Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.","lowest serial number is GN001141; the highest is GN001704 (non-consecutive)",,"242 devices","The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.",11/12/2013,"11/12/2013",2/12/2014,"02/12/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1190-2014","Class II","G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2483968 2492596 2496746 2500736 2505477 2514016 2524048 2529356 2536681 2541173 2554034 2475168",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1186-2014","Class II","4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1192-2014","Class II","G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2548332 ",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1189-2014","Class II","G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2530465 2530465",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1185-2014","Class II","4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2459795 2476328 2503425 2521590 2529540 2533322 2551265 2560930 2569055 2574218",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1183-2014","Class II","4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2489881 2503429 2513713 2525788 2555872 2472514",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1184-2014","Class II","4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection."," 2485116 2489882 2498071 2503431 2506818 2511214 2521593 2533326 2542764 2547293 2555873 2560933 2569066 2578565 2459802 2472515",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1187-2014","Class II","4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1191-2014","Class II","G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2491431 ",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1181-2014","Class II","4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2463876 2472511 2476324 2476325 2480609 2485108 2489875 2493965 2503422 2503423 2506814 2511211 2513709 2521588 2529536 2533320 2536817 2547283 2551262 2551263 2560919 2560920 2569052 2569053 2574217 2463876",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1182-2014","Class II","4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2459798 2472512 2472513 2476329 2480613 2480614 2489880 2493968 2498070 2503427 2506816 2511212 2513711 2521591 2521592 2525786 2529541 2533323 2547290 2547291 2551266 2555870 2560932 2569056 2569057 2569058 2463882 2467732 2574219",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1180-2014","Class II","4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Devices",66837,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.","Z-1188-2014","Class II","G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.","2467804 2480661 2503528 2503529 2521653 2529597 2529598 2551329 2572218 2572220 2467805",".",,"issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes",11/22/2013,"11/22/2013",3/19/2014,"03/19/2014"
"Drugs",66838,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1064-2014","Class III","Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29. ","Lot 1113661 Exp. 01/15",,"3,950 packs","Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.",11/13/2013,"11/13/2013",2/12/2014,"02/12/2014"
"Drugs",66838,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1063-2014","Class III","Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33","Lot 1111291 Exp. 02/16",,"156 bottles","Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.",11/13/2013,"11/13/2013",2/12/2014,"02/12/2014"
"Drugs",66838,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1065-2014","Class III","Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05. ","Lot 1112467 Exp. 02/15",,"111,384 sample packs","Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.",11/13/2013,"11/13/2013",2/12/2014,"02/12/2014"
"Drugs",66839,"Terminated","Vitality Research Labs LLC","Las Vegas","NV","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1364-2014","Class I","vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148. ","LOT K58Q Exp 01/16 LOT F50Q Exp 07/16 ",".","11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q","Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules",11/19/2013,"11/19/2013",6/18/2014,"06/18/2014"
"Drugs",66840,"Ongoing","SS Wholesale Inc. dba Jobbers Wholesale","Paramount ","CA","US","Voluntary: Firm Initiated","Press Release","CA","D-1047-2014","Class I","eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.","Lot #: KWAKPMC03050517, Exp 12/16",,"2,395 blister packs total for all products","Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by the FDA.",11/18/2013,"11/18/2013",2/5/2014,"02/05/2014"
"Drugs",66840,"Ongoing","SS Wholesale Inc. dba Jobbers Wholesale","Paramount ","CA","US","Voluntary: Firm Initiated","Press Release","CA","D-1046-2014","Class I","MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.","Lot #: JBP-L-1270-70, Exp 12/16",,"2,395 blister packs total for all products","Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by the FDA.",11/18/2013,"11/18/2013",2/5/2014,"02/05/2014"
"Drugs",66840,"Ongoing","SS Wholesale Inc. dba Jobbers Wholesale","Paramount ","CA","US","Voluntary: Firm Initiated","Press Release","CA","D-1045-2014","Class I","Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.","Lot #: KWAKPMC030505175957019, Exp 12/16",,"2,395 blister packs total for all products","Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by the FDA.",11/18/2013,"11/18/2013",2/5/2014,"02/05/2014"
"Devices",66841,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - all states including DC and Puerto Rico.","Z-1525-2014","Class II","Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.","The first released affected product was released to the market in April, 2005.",,"170,286 US, 73,921 OUS for all devices","Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. ",2/27/2014,"02/27/2014",5/7/2014,"05/07/2014"
"Devices",66841,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - all states including DC and Puerto Rico.","Z-1526-2014","Class II","Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.","The first released affected product was released to the market in April, 2005.",,"170,286 USa, 73,921 OUS for all devices.","Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. ",2/27/2014,"02/27/2014",5/7/2014,"05/07/2014"
"Devices",66841,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - all states including DC and Puerto Rico.","Z-1524-2014","Class II","Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.","The first released affected product was released to the market in April, 2005.",,"170,286 USa, 73,921 OUS for all devices.","Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios; however Medtronic has identified that in some situations the use of cycling can reduce the device battery longevity or recharge interval. The only impact to patients is the potential for earlier than expected replacement or recharging at a greater than expected frequency. The issue doesn't impact the device end of service alarms. ",2/27/2014,"02/27/2014",5/7/2014,"05/07/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1459-2014","Class II","Enzyme Formula, dietary supplement, 100 capsules or 250 capsules per bottles, sold unlabeled to Rich Distributing.","LOT# 1319603, EXP 07/15",,"200 bottles (100 ct); 367 bottles (250 ct)","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1457-2014","Class II","Zinc Plus, Mineral/Enzyme supplement, 90 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.","LOT# 1228603, EXP 10/15 (means October 2015); LOT# 1134004, EXP 12/14 (means December 2014);",,"1914 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1453-2014","Class II","Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules per bottle, or 270 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life.","Digestive (90 count): LOT #1206801, EXP 03/15 (means March 2015); Digestive (135 count): LOT # 1108103, EXP 03/14 (means March 2014); LOT# 1234006, EXP 12/15 (means December 2015) for Empower Life Nutrition brand. Digestive (270 count): LOT# 1127002, EXP 09/14 (means September 2014); LOT# 1120606, EXP 07/14 (means July 2014); LOT# 1113201, EXP 05/14 (means May 2014); LOT# 1029104, EXP 10/13 (means October 2013); LOT# 1215601, EXP 06/15 (means June 2015); LOT# 1234006, EXP 12/15 (means December 2015).",,"1199 bottles of 90 ct; 2081 bottles of 135 ct; 9799 bottles of 270 ct; ","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1454-2014","Class II","B-Complex with Enzymes, Vitamin/Enzyme Supplement. Packaged 60 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.","LOT# 1224405, EXP 08/15 (means August 2015)",,"991 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1461-2014","Class II","Digest Ultra, dietary supplement, packaged 56 capsules per bottle or distributed in bulk, sold under brand YOR. Product distributed OUTSIDE the US has Spanish label.","LOT Numbers: 1207408; MFG -03/12; 1217703; MFG -06/12; 10190112; MFG -01/12; 10190112; MFG -01/12; 10190312; MFG-03/12; 10190313; MFG -03/13; 10191112; MFG -11/12; 20190313; EXP- 2/2015; 20190612; EXP- 06/14; 20191012; EXP -10/14; 1019A0811; EXP- 08/13 ;",,"82,906 bottles and 1,552,319 capsules (bulk) in US and 62766 bottles OUTSIDE the US","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1460-2014","Class II","XymoZyme, dietary supplement, packaged 60 capsules per bottte, 120 capsules per bottle, sold under brand ZYMOGEN.","60 count bottle: LOT# 1207301D, EXP 03/14 (means March 2014); LOT# 1221501D, EXP 08/14 (means August 2014); LOT# 1229205D, EXP 10/14 (means October 2014); 120 count bottle: LOT# 1207301H; EXP 03/14 (means March 2014); LOT# 1221501H, EXP 08/14 (means August 2014); LOT# 1229205H, EXP 10/14 (means October 2014); ",,"7890 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1455-2014","Class II","B-Complex Plus. They are sold under brand Enzyme Research Products","LOT# 1108001, EXP 03/14 (means March 2014)",,"1033 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1456-2014","Class II","Glucosamine, Chondroitin, MSM Plus, dietary supplement, 60 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life Vital Joints brand.","LOT# 1125804, EXP 09/14 (means September 2014); LOT# 1214301, EXP 05/15 (means May 2015); LOT# 1308601; EXP 03/16 (means March 2016); ",,"3127 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Food",66843,"Ongoing","Health Wright Products Inc","Clackamas","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to California, Florida, Oregon, Utah, and Mexico","F-1458-2014","Class II","Digestaze, dietary supplement, 90 vegetable capsules per bottle. They are sold under brand DESBIO","LOT# 1215904, EXP 06/14 (means June 2014).",,"1137 bottles","Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.",10/25/2013,"10/25/2013",2/5/2014,"02/05/2014"
"Devices",66846,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and Internationally to: Eschbach, Germany and Europe.","Z-0784-2014","Class II","Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.","Part numbers 00-5850-013-95 ",,"5305 distribution events","After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. ",12/19/2013,"12/19/2013",1/29/2014,"01/29/2014"
"Devices",66846,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and Internationally to: Eschbach, Germany and Europe.","Z-0783-2014","Class II","Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty. ","Part numbers 00-5850-012-95 ",,"5305 distribution events","After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. ",12/19/2013,"12/19/2013",1/29/2014,"01/29/2014"
"Biologics",66847,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","Nebraska; Iowa; New Jersey","B-0318-14","Class II","Red Blood Cells Leukocytes Reduced","W037912141508; ",,"1","Blood products,collected from donors who did not meet the re-entry criteria following invalid NAT testing, were distributed.",9/19/2013,"09/19/2013",2/12/2014,"02/12/2014"
"Biologics",66847,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","Nebraska; Iowa; New Jersey","B-0317-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W037912135464; W037912135464;",,"2","Blood products,collected from donors who did not meet the re-entry criteria following invalid NAT testing, were distributed.",9/19/2013,"09/19/2013",2/12/2014,"02/12/2014"
"Biologics",66848,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","E-Mail","Iowa","B-0214-14","Class II","Red Blood Cells Leukocytes Reduced","W037913105997; ",,"1","Blood product, collected from a donor with a history of Hepatitis A, was distributed.",9/10/2013,"09/10/2013",1/22/2014,"01/22/2014"
"Biologics",66850,"Terminated","Community Blood Bank of Lancaster County Medical Society","Lincoln","NE","US","Voluntary: Firm Initiated","FAX","Nebraska; Florida; New Jersey","B-0212-14","Class II","Red Blood Cells Leukocytes Reduced","W087910605473; W087910607115; W087911601257; W087911602631; ",,"4","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed",10/3/2013,"10/03/2013",1/22/2014,"01/22/2014"
"Biologics",66851,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","Letter","Hawaii","B-0232-14","Class II","Red Blood Cells Leukocytes Reduced","W088413516295; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",10/30/2013,"10/30/2013",1/22/2014,"01/22/2014"
"Biologics",66853,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","Illinois; New Jersey; New York","B-0233-14","Class II","Red Blood Cells Leukocytes Reduced","W333613055964; W333613041330; W333613016833; ",,"3","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",10/18/2013,"10/18/2013",1/22/2014,"01/22/2014"
"Biologics",66854,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0241-14","Class III","Red Blood Cells Leukocytes Reduced","W333613072746; ",,"1","Blood product, which contained anti-Fya but was not labeled as positive for an unexpected antibody, was distributed.",9/26/2013,"09/26/2013",1/22/2014,"01/22/2014"
"Biologics",66855,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","Telephone","South Korea; Texas","B-0239-14","Class III","Blood and Blood Products for Reprocessing","W067312024055; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/16/2013,"08/16/2013",1/22/2014,"01/22/2014"
"Biologics",66855,"Terminated","Coffee Memorial Blood Center","Amarillo","TX","US","Voluntary: Firm Initiated","Telephone","South Korea; Texas","B-0240-14","Class II","Red Blood Cells Leukocytes Reduced","W067312024055; W067313009450; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",8/16/2013,"08/16/2013",1/22/2014,"01/22/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1139-2014","Class II","Triamcinolone Acetonide 3mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1098-2014","Class II","Lidocaine 4% Urethral Gel","Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14",,"104 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1133-2014","Class II","Tetracaine 0.5% ophth.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1108-2014","Class II","Dexamethasone phosphate 24mg/ml inj.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1111-2014","Class II","EDTA 3% ophthalmic","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1143-2014","Class II","Voriconazole 1% opthal","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1101-2014","Class II","Bladder Instillation","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1138-2014","Class II","Testosterone Cypionate 200mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1135-2014","Class II","Tacrolimus 0.02% opth. (H20-based)","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1116-2014","Class II","L-Glutathione inhalation","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1120-2014","Class II","Hydroxocobalamin inj.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1128-2014","Class II","Prostaglandin all combinations","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1124-2014","Class II","Methylcobalamin","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1137-2014","Class II","Testosterone Cypionate 100mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1110-2014","Class II","Ethanol 20% ophthal.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1129-2014","Class II","Pyridoxine (p-f) 100mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1134-2014","Class II","Tacrolimus (H20-based) 0.03% ophth.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1103-2014","Class II","Cyanocobalamin 100mcg/ml injection","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1132-2014","Class II","Scopolamine 0.25 opth.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1145-2014","Class II","Voriconazole 0.5mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1144-2014","Class II","Voriconazole 0.5mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1112-2014","Class II","5-Fluorouracil pf in methocel 1% opthal","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1109-2014","Class II","Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1117-2014","Class II","Glutathione 6%/ascorbic 1%/DMSO 6.25%","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1104-2014","Class II","Cyano B-12 p-f 1000mcg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1130-2014","Class II","Renacidin Irrigation","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1121-2014","Class II","Hydroxyprogesterone Caproate","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1113-2014","Class II","5-Fluorouracil 1% ophthal","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1105-2014","Class II","Cyano B-12 (Cmpd) 1000mcg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1142-2014","Class II","Vitamin D (Ergocalciferol) 800 u/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1126-2014","Class II","Papaverine 1nj 30mg/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1114-2014","Class II","Folic acid (pf) 10mg/cc inj","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1099-2014","Class II","Acetylcysteine 10% ophthalmic","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1127-2014","Class II","Papaverine 12mg/phent 1mg/Pros 9mcq/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1106-2014","Class II","Dexamethasone (pf) 0.05 % opth.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1102-2014","Class II","Bleomycin Sulfate 1unit/ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1100-2014","Class II","AMP/M-B12/Pyridox/Methionine Inositol","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1141-2014","Class II","Vit A (olive oil) 0.1% opth.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1123-2014","Class II","Methotrexate Intraocular 400mcg 0.1cc","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1136-2014","Class II","Terbutaline/Ipratropium 0.5mg/2.5ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1125-2014","Class II","Novarel (IM)","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1122-2014","Class II","Idoxuridine 0.1% Ophthalmic","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1140-2014","Class II","Vancomycin (fortified) 25mg/ml opth","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1131-2014","Class II","Sodium Bicarbonate 8.4% inj.","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1107-2014","Class II","Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1118-2014","Class II","Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1115-2014","Class II","Gentamycin 80mg/1000cc 0.9% NS","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Drugs",66856,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","NC","D-1119-2014","Class II","Glutathione Inhalation 200mg/5ml","All lot numbers within expiry.",,,"Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/1/2013,"11/01/2013",3/12/2014,"03/12/2014"
"Veterinary",66857,"Ongoing","Natures Pharmacy & Compounding Center","Asheville","NC","US","Voluntary: Firm Initiated","Telephone","FL and NC","V-040-2014","Class III","Cyclosporine Opthalmic (vet use)","All lot numbers within expiry.",,"40 units","Sterility could not be assured.",11/1/2013,"11/01/2013",2/12/2014,"02/12/2014"
"Food",66858,"Completed","Atlapac Trading Company Inc","Commerce","CA","US","Voluntary: Firm Initiated","Letter","CA","F-1439-2014","Class II","California Girl canned Peach Halves in Juice, 6 cans per case. UPC 52391 72992","Code: 3700/01182 OCT.-08-2012 OCT.-08-2015 ",,"881 units","Atlapac Trading Co. is recalling California Girl canned Peach Halves because they were reported to be swollen.",11/14/2013,"11/14/2013",2/5/2014,"02/05/2014"
"Devices",66861,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","nationwide and worldwide","Z-0933-2014","Class II","The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.","Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 MTA7900I90027 MTA7900E90031 MTA7900I90031 MTA7900I90041 MTA7900H90004 MTA7900B80004 MTA7900A80028 MTA7900E80054 MTA7900E01042 MTA7900D80001 MTA7900C01012 MTA7900J90018 MTA7900A01028 MTA7900E80046 MTA7900J70023 MTA7900J70024 MTA7900J70025 MTA7900J70026 MTA7900J70027 MTA7900J70031 MTA7900J70032 MTA7900E80011 MTA7900E80035 MTA7900H80014 MTA7900H80018 MTA7900H80019 MTA7900A90017 MTA7900K80010 MTA7900K80011 MTA7900K80012 MTA7900K80013 MTA7900L80001 MTA7900L80004 MTA7900L80013 MTA7900E80059 MTA7900A01014 MTA7900H90019 MTA7900H90020 MTA7900H90021 MTA7900H90022 MTA7900H90023 MTA7900D80055 MTA7900J90035 MTA7900J70028 MTA7900H80023 MTA7900A80032 MTA7900J70029 MTA7900I80029 MTA7900C80001 MTA7900C80002 MTA7900C80003 MTA7900J90027 MTA7900D80006 MTA7900E80029 MTA7900E80040 MTA7900E80065 MTA7900D01022 MTA7900E01022 MTA7900B01036 MTA7900F01010 MTA7900D90030 MTA7900K90003 MTA7900C01009 MTA7900C01025 MTA7900J60008 MTA7900A01032 MTA7900K90004 MTA7900E01029 MTA7900E90017 MTA7900J70022 MTA7900K90019 MTA7900B01040 MTA7900B01043 MTA7900B01024 MTA7900A90001 MTA7900A90005 MTA7900A90008 MTA7900E80022 MTA7900G80009 MTA7900G80011 MTA7900H80002 MTA7900H80003 MTA7900H80006 MTA7900H80007 MTA7900H80008 MTA7900H80010 MTA7900H80011 MTA7900H80012 MTA7900H80013 MTA7900L70008 MTA7900L70009 MTA7900G60063 MTA7900K40071 MTA7900B01019 MTA7900F01014 MTA7900C90010 MTA7900J80039 MTA7900K90053 MTA7900K90054 MTA7900A90012 MTA7900A90016 MTA7900A90020 MTA7900J90036 MTA7900K80005 MTA7900H80026 MTA7900L90017 MTA7900I90003 MTA79",,"1002 units","Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to Auto mode, the therapy will be reset, and may potentially cause patients to reach the set point earlier. The rate of controlled rewarming is a set slope controlled by the Medi-therm unit. There is a potential that the patients passive rate of rewarming is greater than the rate-controlled rewarming. If switched out of Auto mode, the patients passive rewarming is no longer controlled by the machine, which allows the patient to rewarm at their passive rate. Once switched back into Auto mode, the machine will use the patients current temperature as the new starting temperature. The Medi-therm unit will take back control of the rate of warming. However, the patients temperature may potentially have been raised to a higher point while outside of Auto mode due to the patients passive rewarming ability. Consequently, this may result in the patient reaching the target temperature earlier than if modes had not been.",12/27/2013,"12/27/2013",2/12/2014,"02/12/2014"
"Devices",66865,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.","Z-0534-2014","Class I","Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.","not available",,"4824 total units (4242 units in US)","CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.",12/5/2013,"12/05/2013",1/1/2014,"01/01/2014"
"Cosmetics",66867,"Ongoing","NEW RELIANCE TRADERS, INC.","Maspeth","NY","US","Voluntary: Firm Initiated","Letter","CT, PA, MD and RI","F-1139-2014","Class II","HASHMI SURMA SPECIAL Eyeliner, Net Wt. 12 GM, product is held within a gold bottle with blue wrapping, packaged in a small blue carton with 12 units per carton. Manufactured by MOHD. HASHIM TAJIR SURMA M.A. JINNAH ROAD, KARACHI-PAKISTAN G.P.O. BOX 692. Product of Pakistan.","all lots",,"6 cartons (12 units per carton)","New Reliance Traders, Inc. has recalled Hashmi Surma Special Eyeliner due to Elevated Lead Levels.",9/10/2013,"09/10/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1132-2014","Class II","MegaFood High Active Enzymes - 30 count (Formula 10216) ","Lot Numbers: 10804 10971 11510 11968 12752 12753 12794 12795 13344 14072 15729 15947 16025 ",,"6356 botles","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1135-2014","Class II","Innate Response Digestive Enzymes Clinical Strength 90ct. (40126) and '' Innate Response Digestive Enzymes Clinical Strength 10 Ct. Sample (90037) ","Lot Numbers: 10841 11040 11057 11184 11185 11639 11690 12105 12106 12202 12445 12547 13546 14626 14627 14767 14981 15650 D239 ",,"20661","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1137-2014","Class II","KARIKAS ORTHOMOLECULAR NUTRITION MegaZymes Plus (High Concentration) (LK10528) ","Lot Numbers: 11619, 15808, K131",,"1,005 units","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1133-2014","Class II","MegaFood Vegan-Ease 30 ct. (12002) and MegaFood Vegan-Ease 2 ct. Sample Pack (S12002) ","Lot Numbers:30 count): 10910 10911 11114 12010 12347 12348 12385 12386 12387 12388 12389 14149 14304 B242 Lot Number: 2 ct sample: E231",,"49,560 units","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1136-2014","Class II","Innate Response Gluten and Dairy Ultra Shield Enzymes 60ct. (40127) ","Lot Numbers: 10517 10518 11186 11429 12107 12087 ",,"3,105","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Food",66868,"Ongoing","FoodState (Nutrient Manufacturing)","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","Nationwide Foreign:","F-1134-2014","Class II","MegaFood Gluten & Dairy Megazymes 30ct. (10218) and MegaFood Gluten & Dairy Megazymes 60ct. (10219) ","Lot Numbers:30 count 10554 11908 11909 11972 12362 12613 12798 14239 Lot Numbers 60 count 10543 11910 11973 12144 12799 14242 D240 ",,"6590 units","Potential for Chloramphenicol contamination. ",11/12/2013,"11/12/2013",1/1/2014,"01/01/2014"
"Devices",66869,"Ongoing","King Systems Corp.","Noblesville","IN","US","Voluntary: Firm Initiated","E-Mail","Distributed in the states of CA, KS, MS, NY, and TX.","Z-0709-2014","Class II","King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration. ","Lot Number(s): I15LB",,"108 cases( 540 products)","KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube. ",12/10/2013,"12/10/0013",1/22/2014,"01/22/2014"
"Devices",66870,"Completed","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution: including states of: AL, CA, PA, and VA.","Z-0653-2014","Class II","Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert'' Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.","Lot/Unit Codes: DSD-765-011 (Alere PN 4012350099) DOA2100709, DOA2110198, DOA2120093, DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420. DSD-765-011 (Alere PN 4080350099) DOA2100672, DOA2120094, DOA2120095, DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565, DOA3020557. DSF-765-031 (Alere PN 4584150099) DOA2100438, DOA2100667, DOA2110073, DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004, DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183. DSF-765-011 (Alere PN 4582290164) DOA2100250, DOA2110316 , DOA2110317 , DOA2120502, DOA2120503, DOA3010236. DSF-765-011 (Alere PN 4028220211) DOA2100614. Expiration date, or Expected shelf life: 10/31/14 to 2/28/15. Expected shelf life: 24 months.",,"280,710","Alere initiated this recall of certain lots of the Oral Fluid Drug Scrren Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. ",6/3/2013,"06/03/2013",1/15/2014,"01/15/2014"
"Drugs",66872,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1061-2014","Class II","Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56","Lot W22042 ",,"7,020 bottles","Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. ",11/8/2013,"11/08/2013",2/12/2014,"02/12/2014"
"Devices",66873,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .","Z-0555-2014","Class II","PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.","VM13222- 34489",,"13","Screw inserters may not mate properly with hex interface of the screws. ",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66873,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .","Z-0554-2014","Class II","PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.","VM 13194-34457",,"25","Screw inserters may not mate properly with hex interface of the screws. ",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66873,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .","Z-0553-2014","Class II","PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.","VM13221-34457",,"4","Screw inserters may not mate properly with hex interface of the screws. ",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66875,"Ongoing","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.","Z-0816-2014","Class II","ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. ","Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010",,"Total 3414 (US 524, CA 31, ROW 2859)","RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.",10/15/2013,"10/15/2013",1/29/2014,"01/29/2014"
"Drugs",66878,"Ongoing","Fossil Fuel Products, LLC","Dallas","GA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-1248-2014","Class I","RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309","Lots QL110408B046, QL110714A102 Exp. 11/13",," 50,300 capsules","Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.",11/18/2013,"11/18/2013",4/30/2014,"04/30/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1347-2014","Class II","Chewable EnZym-Complete/DPPIV with Isogest, Kirkman brand. Item # 0934-090.","Lot 54112001 ",,"114 bottles (87 bottles in US and 27 bottles outside US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1348-2014","Class II","Chewable Maximum Spectrum EnZym-Complete/DPPIV with Isogest, Kirkmand brand. Item # 0893-090","Lot number: 54255000",,"79 bottles (43 bottles in US and 36 bottles outside US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1353-2014","Class II","Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.","LOT numbers: 53666006, 53666007, 53666008, 53666009,",,"6099 bottles (5489 bottles in US and 610 outside the US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1349-2014","Class II","EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090.","Lot numbers: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, 53852016, ",,"9486 bottles (5584 bottles in the US and 3902 bottles outside US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1351-2014","Class II","Maximum Spectrum EnZym-Complete/DPP-IV Fruit Free w/Isogest, Kirkman brand, Item # 0869A-120 and 0932-120. ","LOT number: 53854008, 53854010, 53854012, 53854014, ",,"2273 bottles (1735 bottles in the US and 538 bottles outside the US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1352-2014","Class II","Phenol Assist, Kirkman brand, Item # 0835-090","LOT numbers: 52640015, 53855003, 53855004. ",,"1774 bottles (1313 bottles in the US and 461 outside of the US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",66879,"Ongoing","Kirkman Group Inc.","Lake Oswego","OR","US","Voluntary: Firm Initiated","E-Mail","distributed worldwide","F-1350-2014","Class II","Enzym-Complete/DPP-IV, Kirkman brand. Item numbers 0234-060, 0234-120, 0234-200, 5234-200","LOT numbers: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 53853006, 53853007, 53853008, 53853009, 53853010, 54956000, 52588051, ",,"11944 bottles (5956 bottles in the US and 5988 bottles outside the US)","Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Drugs",66880,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Saudi Arabia and Colombia","D-1057-2014","Class I","50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02","G105197, Exp. 02/14",,"49,932 glass containers","Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.",11/18/2013,"11/18/2013",2/12/2014,"02/12/2014"
"Drugs",66881,"Ongoing","Fougera Pharmaceuticals Inc.","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1044-2014","Class III","KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.","Lot #: 495P, Exp 07/14",,"31,122 tubes","Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. ",11/18/2013,"11/18/2013",2/5/2014,"02/05/2014"
"Food",66883,"Ongoing","Blount Fine Foods Corporation","Fall River","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, PA, NJ, MD, MA","F-1340-2014","Class II","Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup. ","Lot: 10313-8J UPC 77890 27864 Use By Date: 01/08/2014",,"140 cases (1680 units)","May contain undeclared shellfish (crab). ",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Drugs",66889,"Ongoing","Tower Pharmacy and Compounding ","Mission Viejo","CA","US","Voluntary: Firm Initiated","Letter","CA","D-384-2014","Class II","Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691","Lot # 13603, Exp 12/13",,"2 Bottles","Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Biologics",66890,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0234-14","Class II","Red Blood Cells Leukocytes Reduced","W227013023512; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",10/15/2013,"10/15/2013",1/22/2014,"01/22/2014"
"Biologics",66891,"Terminated","The American National Red Cross South Carolina Region","Columbia","SC","US","Voluntary: Firm Initiated","FAX","South Carolina","B-0242-14","Class II","Plasma Frozen within 24 hours (FP24)","036FY60123; ",,"1","Blood product, collected from a donor who reported post donation diagnosis of a sexually transmitted disease, was distributed.",8/23/2013,"08/23/2013",1/22/2014,"01/22/2014"
"Cosmetics",66892,"Ongoing","Millenium Productions, LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Houston, TX","F-1344-2014","Class II","Labeled to be Antibacterial Sea Spa Tablet, packaged in five gallon buckets. Firm name on the label is La Palm Products, Wichita, KS.","8121Gcr",,"10 buckets","Labels on the recalled product do not match the product.",10/28/2013,"10/28/2013",1/8/2014,"01/08/2014"
"Cosmetics",66892,"Ongoing","Millenium Productions, LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Houston, TX","F-1343-2014","Class II","Labeled to be Antiseptic Skin Freshener, packaged in one gallon containers. The product is shipped in boxes containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS."," 061115Gcr",,"10 cases","Labels on the recalled product do not match the product.",10/28/2013,"10/28/2013",1/8/2014,"01/08/2014"
"Cosmetics",66892,"Ongoing","Millenium Productions, LLC","Wichita","KS","US","Voluntary: Firm Initiated","Telephone","Houston, TX","F-1345-2014","Class II","Labeled to be Antibacterial Ocean Fresh Super Dark Green Antiseptic, packaged in one gallon containers. The product is shipped in cases containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS.","7251GCR",,"18 cases","Labels on the recalled product do not match the product.",10/28/2013,"10/28/2013",1/8/2014,"01/08/2014"
"Devices",66893,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, Hawaii and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spian, Finland, France, IK, Greece, Israel, Italy, Malta, Netherland,s, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.","Z-1068-2014","Class II","''Renasys EZ PLUS'' a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System","Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299",,"6,871,375 canisters","Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters, which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems, communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling.",11/14/2013,"11/14/2013",3/5/2014,"03/05/2014"
"Devices",66893,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, Hawaii and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spian, Finland, France, IK, Greece, Israel, Italy, Malta, Netherland,s, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.","Z-1067-2014","Class II","''Renasys EZ'' a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System","Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299",,"6,799,140 canisters EZ & EZ PLUS","Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters, which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems, communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling.",11/14/2013,"11/14/2013",3/5/2014,"03/05/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0600-2014","Class II","Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.","Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers: 0230128 5005803 5030168.",,"454 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0598-2014","Class II","Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.","Asante Catalog number: FG-4226-5, G-4147T; Unomedical Item number:43-060-5266; Lot numbers: 0230126 5005801 5030167. ",,"1392 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0599-2014","Class II","Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.","Asante Catalog number:FG-4229-5 FG-4229T; Unomedical Item number:43-060-5269; Lot numbers: 0230127 5005802 5038313. ",,"1979 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0594-2014","Class II","Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark","Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994 ",,"834 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0597-2014","Class II","Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark","Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227. ",,"352","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0596-2014","Class II","Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark","Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108. ",,"635 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0601-2014","Class II","Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.","Asante Catalog number:FG-4249-5, FG-4249T; Unomedical Item number: 43-110-5269; Lot numbers: 0230129 5005804 5040412.",,"1085 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Devices",66895,"Ongoing","Asante Solutions, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0595-2014","Class II","Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark","Asante Catalog number: FG-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106 ",,"246 kits","Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.",11/19/2013,"11/19/2013",1/8/2014,"01/08/2014"
"Drugs",66897,"Ongoing","Tendex","Beverly Hills","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-1345-2014","Class I"," P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 ","Lot # F51Q. EXP: 07/16 The UPC Codes for P-Boost are: 1ct - 862545101013 5ct - 862545101051 10ct - 862545101105 20ct - 862545101204 40ct - 862545101402 ",".","unknown","Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.",11/19/2013,"11/19/2013",5/28/2014,"05/28/2014"
"Drugs",66897,"Ongoing","Tendex","Beverly Hills","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-1346-2014","Class I","NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 ","Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402 ",".","unknown","Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.",11/19/2013,"11/19/2013",5/28/2014,"05/28/2014"
"Drugs",66899,"Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-747-2014","Class III","Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.","Lot: (Exp); V10316 (11/13), V10317 (11/13), V10320 (11/13), V10321 (11/13), V20086 (2/14), V20087 (2/14), V20089 (2/14), V20093 (2/14), V20094 (2/14), V20086 (2/14), V20118 (3/14), V20119 (3/14), V20147 (3/14), V20148 (3/14), V20152 (4/14), V20154 (4/14), V20155 (4/14), V20180 (4/14), V20181 (4/14), V20182 (4/14), V20203 (5/14), V20204 (5/14), V20233 (5/14), V20234 (5/14), V20273 (6/14), V20274 (6/14), V20275 (6/14), V20293 (8/14), V20294 (8/14), V20321 (9/14), V20322 (9/14), V20323 (9/14), V20324 (9/14), V20325 (9/14), V20326 (9/14), V20327 (9/14), V20369 (10/14), V20370 (10/14), V20410 (11/14), V20411 (11/14), V20412 (11/14), V30009 (12/14), V30010 (12/14), V30011 (12/14), V30056 (01/15), V30120 (2/15), V30122 (2/15), V30123 (2/15), V30163 (3/15), V30164 (3/15), V30165 (3/15), V30190 (3/15), V30249 (5/15), V30250 (5/15). ",,"234,242 bottles","Failed stability testing; this product is below specification for preservative content.",11/14/2013,"11/14/2013",1/29/2014,"01/29/2014"
"Devices",66900,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide distribution - all states.","Z-0557-2014","Class II","VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs","Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013",,"1,920 kits","Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.",10/25/2013,"10/25/2013",1/1/2014,"01/01/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1432-2014","Class II","Snowball Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"1 lbs metal tins: 5 tins","The labels do not declare milk, soy, and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1428-2014","Class II","Shortbread Almond Crescent cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"10 oz packages: 80 bags","The labels do not declare milk, soy, and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1431-2014","Class II","Lemon Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"10 oz packages: 342 bags; 7 lbs bulk packages: 1 bag","The labels do not declare milk and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1434-2014","Class II","Raspberry Swirl Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"3 loaves","The labels do not declare soy allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1433-2014","Class II","Cheerful Cookie Combo containing an assortment of Lemon Butter Cookies and Famous Butter Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"1 lbs. metal tins: 34 tins","The labels do not declare milk and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1429-2014","Class II","Double Chocolate Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"10 oz packages: 111 bags; 7 lbs bulk packages: 1 bag","The labels do not declare milk and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1430-2014","Class II","Famous Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"10 oz packages: 491 bags; 7 lbs bulk packages: 1","The labels do not declare milk and wheat allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1435-2014","Class II","Banana Nut Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"3 loaves","The labels do not declare soy allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66901,"Ongoing","The Lambs Farm, Inc.","Libertyville","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide (FL, IL, IN, MN, PA, WI)","F-1436-2014","Class II","Blueberry Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.","All batches coded with dates 7/1/2013 through 11/14/2013.",,"3 loaves","The labels do not declare soy allergens.",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Devices",66902,"Ongoing","Instrumentation Industries Inc","Bethel Park","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0606-2014","Class II","RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. ","multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013.",,"220 ","Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. ",11/13/2013,"11/13/2013",1/8/2014,"01/08/2014"
"Biologics",66903,"Terminated","Central Texas Regional Blood & Tissue Center","Austin","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0235-14","Class II","Red Blood Cells Leukocytes Reduced","W221613610749; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",10/14/2013,"10/14/2013",1/22/2014,"01/22/2014"
"Biologics",66904,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-0236-14","Class II","Red Blood Cells Leukocytes Reduced","W071212035733; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",10/16/2013,"10/16/2013",1/22/2014,"01/22/2014"
"Biologics",66905,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0261-14","Class II","Red Blood Cells Leukocytes Reduced","13C42347",,"1 unit","Blood product, which was incorrectly labeled with respect to the red cell antigens, was distributed.",9/6/2013,"09/06/2013",2/5/2014,"02/05/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0722-2014","Class II","Boston Scientific PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13062402, H13071302, H13082603",,"253 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0723-2014","Class II","Boston Scientific PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13082603",,"620 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0724-2014","Class II","Boston Scientific PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561422. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061102, H13061104, H13062401, H13062402, H13071302, H13082603",,"3,300 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0720-2014","Class II","Boston Scientific TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061101, H13062403, H13062404, H13071301",,"425 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0719-2014","Class II","Boston Scientific TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061101, H13062403, H13062404, H13071301",,"0 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Devices",66907,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.","Z-0721-2014","Class II","Boston Scientific PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.","Lot Numbers: H13061101, H13062403, H13062404, H13071301",,"740 eaches","Sterility of device may be compromised due to lack of pouch seal integrity",11/20/2013,"11/20/2013",1/22/2014,"01/22/2014"
"Food",66910,"Ongoing","Marina's German Bakery","El Paso","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to commissaries at Fort Bliss (El Paso, TX) and Holloman Air Force Base (Alamogordo, NM).","F-1472-2014","Class I","Marina's German Bakery; Assorted Pastries; 2 pieces, Minimum Wt. 6 oz. 170 g; UPC# 010801003018; 2033 Trawood Dr., El Paso, Texas 79935","All ''Sell By'' dates, prior to 11/23/2013",,"Unknown","The assorted pastry products may contain undeclared hazelnuts, walnuts or almonds. These tree nuts can cause life-threatening, allergic reactions for some individuals.",11/20/2013,"11/20/2013",2/12/2014,"02/12/2014"
"Devices",66912,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide)","Z-0904-2014","Class II","ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. ","Lot No. 1300801",,"698 units total (80 units in US)","Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.",11/21/2013,"11/21/2013",2/12/2014,"02/12/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1267-2014","Class I","Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11","Lot# H2L712, Exp 09/14",,"22,248 units ","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1271-2014","Class I","6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55","Lot# J2H002, Exp 06/14; J2S018, Exp 12/14",,"4614 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1265-2014","Class I","0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31","Lot# J2P912, Exp 02/14",,"53,592 units ","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1270-2014","Class I","0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55 ","Lot# J0B003, Exp 02/14",,"1302 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1272-2014","Class I","15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55","Lot# J2J012, Exp 01/14; J3B002, Exp 08/14",,"18,288 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1266-2014","Class I","Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895","Lot# H3B702, Exp 02/15",,"32,376 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1275-2014","Class I","Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311","Lot# J3B007, Exp 08/14",,"5,592 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1264-2014","Class I","Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11","Lot# H3E507, Exp 11/14",,"22,584 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1273-2014","Class I","TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55","Lot# J3A028, Exp 07/14",,"17,544 units ","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1274-2014","Class I","ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07","Lot# J2K023, Exp 02/14",,"18,090 units ","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1268-2014","Class I","Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11","Lot# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14; Lot# H3H507, Exp 01/15",,"136,392 units","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Drugs",66913,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Spain","D-1269-2014","Class I","Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11","Lot# H2S723, Exp 07/14; H3H711, Exp 01/15",,"42,576 units ","Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.",11/21/2013,"11/21/2013",5/7/2014,"05/07/2014"
"Devices",66914,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.","Z-0574-2014","Class II","Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.","Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M",,"922","Mismarked and unmarked screws",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66914,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.","Z-0576-2014","Class II","Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.","Lot/Serial Number: IM71013-01: Lot 0000",,,"Mismarked and unmarked screws",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66914,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.","Z-0575-2014","Class II","Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.","Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1",,,"Mismarked and unmarked screws",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66914,"Ongoing","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.","Z-0573-2014","Class II","Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.","Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000",,"993","Mismarked and unmarked screws",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Food",66915,"Ongoing","Del Monaco Specialty Foods Inc.","Morgan Hill","CA","US","Voluntary: Firm Initiated","Telephone","CA","F-1385-2014","Class II","Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and 3 lb. pouches 4 x 3 lb. pouches per case for food service use UPC - 10 oz. samples: 10041622 002635 UPC 3 lb. pouch: 10041622 019428 Distributed by Armanino Foods, Hayward, CA; Manufactured by Del Monaco Specialty Foods, Walnut Creek, CA","Three lots of the 10 oz. pacakges, and 2 lots of the 3 lb. packages are under recall. The codes for these are as follows: 10 oz. sample size: Product code: 41622 263AS: DSF Code: 960110 Package code: A26713, Packaging Date: 09/24/13 Case code: 0924139438; Package code: A26913 Packaging Date: 09/26/13 Case code: 0926139569; Package code: A31113 Packaging Date: 11/07/13 Case code: 1107131625 4 x 3 lb. pouch size: Product code 41622-1942F; DSF Code 941270 Package code: Use by 9-25-14 Packaging Date:9/25/13 Case code:0925139543 Package code: Use by 11/06/14 Packaging Date: 11/06/13 Case code: 1106131577 ",,"196 cases of 12. x 10 oz, sample size; 1470 lbs; 550 cases of 4 x 3 lb. ","The product was not labeled with ingredients nor with an allergen declaration; the carton only contained one label which states the product identity by the second label with ingredients and allergen information was inadvertently left off. The product is for food service and is sold in cartons of 4 x 3 lb. individual pouches and samples, not for retail sales.",11/21/2013,"11/21/2013",1/15/2014,"01/15/2014"
"Devices",66916,"Ongoing","Clark Laboratories, Inc. (dba,Trinity Biotech USA)","Jamestown","NY","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the state of WA","Z-0572-2014","Class II","Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.","Product Code: 800-960, Lot number: 082, Model: 10 - plate kit",,"38 kits","Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.",8/27/2013,"08/27/2013",1/1/2014,"01/01/2014"
"Devices",66917,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.","Z-0840-2014","Class II","GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes."," Mfg Lot or Serial # System ID 00000311096HM2 561747CT2 00000317657HM5 859313TCCT 00000318100HM5 765447CDICT 00000320796HM6 317569CDINE 00000322703HM0 317846CDINCT 00000323060HM4 651294OPT 00000325273HM1 317890CDIS 00000325782HM1 317890CDIW 00000325783HM9 INSIGHTCT2013 00000326335HM7 Unknown 00000328883HM4 606573O540 00000330505HM9 972596CT540 00000331902HM7 651294OPT 00000333256HM6 Unknown 00000336763HM8 620384CT 00000337348HM7 850325OPT540 00000338324HM7 251275GHCTOP540 00000338344HM5 419ARROWCT 00000339268HM5 817465PORT 00000339269HM3 571367OP540 00000339708HM0 980212CT 00000340245HM0 704403NCRC 00000340698HM0 TMCACT540 00000341570HM0 620257CT540 00000341573HM4 Unknown 00000342027HM0 620234CT 00000342972HM7 Unknown 00000343769HM6 Unknown 00000344605HM1 419PERRYCT 00000300762HM2 DZ1061CT02 00000308967HM9 DZ1460CT01 00000310027HM8 DZ1466CT01 00000310562HM4 DZ1070CT03 00000311872HM6 DZ1481CT01 00000311873HM4 DZ1255CT01 00000313494HM7 DZ1476CT01 00000318960HM2 DZ1551CT01 00000326325HM8 DZ1482CT02 00000326888HM5 DZ1404CT01 00000332418HM3 DZ1526CT01 00000304142HM3 0910213163 00000307762HM5 0910213164 00000318131HM0 0910212230 00000320782HM6 0910212233 00000328111HM0 0910212233 00000328289HM4 Unknown 00000329547HM4 Unknown 00000333910HM8 83094749135 00000336762HM0 83093534693 00000340201HM3 83093282036 00000340648HM5 Unknown 00000344608HM5 Unknown 00000345259HM6 Unknown 00000304667HM9 030079CT01 00000326872HM9 030173CT04 00000314578HM6 BG4646CT01 00000336118HM5 BG4657CT01 00000332406HM8 416756BSCT 00000335739HM9 Unknown 00000339713HM0 Unknown 00000308344HM1 CI1048CT02 00000310563HM2 CI1065CT01 00000327491HM7 CI1070CT01 00000313495HM4 EG1924CT01 00000333231HM9 EG1925CT01 00000304668HM7 X180869704 00000304669HM5 M6044523 00000306538HM0 M9164621 00000307761HM7 M4216031 00000310043HM5 P4200409 00000310044HM3 M171587014 00000310045HM0 M1118326 00000314580HM2 M156048204 00000315893HM8 M4472517 00000316785HM5 X4180101 00000319320HM8 M4465308 00000319974HM2 Unknown 00000327492HM5 Unknown 00000330901HM0 X25010006 0000",,"272 (29 US; 243 OUS)","There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen and the color image cannot be printed.",10/9/2013,"10/09/2013",2/5/2014,"02/05/2014"
"Devices",66919,"Ongoing","Welch Allyn Protocol, Inc","Beaverton","OR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.","Z-0633-2014","Class II","The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.","SERIAL NUMBERS OF DEVICES DISTRIBUTED IN THE US: KA008788, KA009581, KA009685, KA009776, KA009917, KA010079, KA010193, KA010996, KA011141, KA011192, KA011227, KA011228, KA011231, KA011249, KA011303, KA011307, KA011311, KA011314, KA011327, KA011355, KA011356, KA011609, KA011610, KA011611, KA011667, KA011671, KA011672, KA011673, KA011674, KA011675, KA011676, KA011677, KA011678, KA011682, KA011731, KA011758, KA020006, KA020007, KA020008, KA020009, KA020010, KA020011, KA020012, KA020013, KA020014, KA020015, KA020016, KA020018, KA020023, KA020088, KA020091, KA020092, KA020093, KA020116, KA020135, KA020140, KA020149, KA020150, KA020151, KA020192, KA020200, KA020206, KA020207, KA020208, KA020209, KA020210, KA020211, KA020212, KA020213, KA020214, KA020215, KA020262, KA020264, KA020265, KA020266, KA020269, KA020270, KA020273, KA020295, KA020299, KA020304, KA020310, KA020311, KA020313, KA020314, KA020321, KA020381, KA020385, KA020386, KA020387, KA020388, KA020389, KA020390, KA020391, KA020392, KA020393, KA020394, KA020405, KA020406, KA020407, KA020408, KA020409, KA020410, KA020411, KA020412, KA020413, KA020414, KA020417, KA020422, KA020423, KA020424, KA020425, KA020426, KA020427, KA020429, KA020430, KA020432, KA020433, KA020435, KA020436, KA020437, KA020438, KA020439, KA020442, KA020443, KA020444, KA020445, KA020446, KA020447, KA020448, KA020449, KA020450, KA020451, KA020452, KA020453, KA020454, KA020455, KA020456, KA020457, KA020458, KA020459, KA020460, KA020461, KA020462, KA020463, KA020464, KA020465, KA020466, KA020467, KA020468, KA020469, KA020470, KA020471, KA020472, KA020473, KA020474, KA020475, KA020477, KA020478, KA020479, KA020480, KA020481, KA020482, KA020483, KA020526, KA020529, KA020532, KA020533, KA020534, KA020535, KA020536, KA020537, KA020538, KA020540, KA020541, KA020542, KA020543, KA020545, KA020546, KA020547, KA020548, KA020549, KA020550, KA020551, KA020552, KA020553, KA020554, KA020555, KA020556, KA020557, KA020558, KA020559, KA020560, KA020561, KA020562, KA020563, KA020564, KA020575, KA020576, KA0205"," KA022264, KA022265, KA022266, KA022267, KA022268, KA022269, KA022270, KA022271, KA022272, KA022273, KA022274, KA022275, KA022276, KA022278, KA022280, KA022281, KA022282, KA022284, KA022285, KA022287, KA022288, KA022289, KA022290, KA022291, KA022292, KA022293, KA022294, KA022295, KA022296, KA022297, KA022298, KA022299, KA022300, KA022301, KA022302, KA022303, KA022304, KA022305, KA022306, KA022307, KA022308, KA022309, KA022316, KA022317, KA022318, KA022319, KA022320, KA022321, KA022322, KA022323, KA022324, KA022325, KA022326, KA022327, KA022328, KA022329, KA022330, KA022331, KA022332, KA022333, KA022334, KA022335, KA022336, KA022337, KA022338, KA022339, KA022340, KA022341, KA022342, KA022343, KA022344, KA022345, KA022346, KA022347, KA022348, KA022349, KA022350, KA022351, KA022352, KA022353, KA022354, KA022357, KA022359, KA022360, KA022361, KA022362, KA022363, KA022364, KA022365, KA022366, KA022367, KA022402, KA022403, KA022404, KA022405, KA022406, KA022407, KA022408, KA022409, KA022410, KA022411, KA022412, KA022413, KA022414, KA022415, KA022416, KA022417, KA022418, KA022419, KA022420, KA022421, KA022422, KA022423, KA022424, KA022425, KA022426, KA022427, KA022428, KA022429, KA022430, KA022431, KA022432, KA022433, KA022434, KA022435, KA022436, KA022437, KA022438, KA022439, KA022440, KA022441, KA022442, KA022443, KA022444, KA022445, KA022446, KA022447, KA022448, KA022449, KA022450, KA022451, KA022452, KA022453, KA022454, KA022455, KA022456, KA022457, KA022458, KA022459, KA022460, KA022461, KA022462, KA022463, KA022464, KA022465, KA022466, KA022467, KA022469, KA022470, KA022471, KA022472, KA022473, KA022475, KA022476, KA022477, KA022478, KA022479, KA022480, KA022483, KA022487, KA022490, KA022491, KA022492, KA022493, KA022494, KA022495, KA022497, KA022498, KA022499, KA022500, KA022501, KA022502, KA022503, KA022504, KA022505, KA022506, KA022507, KA022508, KA022509, KA022510, KA022511, KA022519, KA022521, KA022523, KA022525, KA022526, KA022529, KA022530, KA022531, KA022532, KA022533, KA022534, KA022535, KA022536, KA02","6003 units total (1715 units in the US and 4288 outside the US)","Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.",11/21/2013,"11/21/2013",1/15/2014,"01/15/2014"
"Biologics",66922,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","Nevada","B-0237-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W042213044816*; W042213044816*; ",,"2","Blood products, collected in a way that may have compromised their sterility, were distributed. ",10/18/2013,"10/18/2013",1/22/2014,"01/22/2014"
"Biologics",66923,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0231-14","Class II","Red Blood Cells Leukocytes Reduced","W0415130204545; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",11/22/2013,"11/22/2013",1/22/2014,"01/22/2014"
"Biologics",66924,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","Montana","B-0245-14","Class II","Red Blood Cells Leukocytes Reduced","W0423130405491",,"1 unit","Blood products, which tested negative for West Nile Virus (WNV) using pooled testing, but were not tested for WNV by individual donor testing, were distributed.",9/8/2013,"09/08/2013",2/5/2014,"02/05/2014"
"Biologics",66924,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","FAX","Montana","B-0246-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W042313040551D (2 units), W0423130405555 (2 units), ",,"4 units","Blood products, which tested negative for West Nile Virus (WNV) using pooled testing, but were not tested for WNV by individual donor testing, were distributed.",9/8/2013,"09/08/2013",2/5/2014,"02/05/2014"
"Biologics",66925,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-0306-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W041513030506I",,"1 unit","Blood product, for which the additive solution was not added during manufacturing, was distributed.",9/10/2013,"09/10/2013",2/5/2014,"02/05/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1122-2014","Class II","UPC Name 6000050617 French Toast Whole Wheat (bulk)","none",,"19,890 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1117-2014","Class II","Whole Wheat Bread packaged under the following names and sizes: UPC Name, size 41498-18997 L'Oven Fresh, Wheat Sandwich, 20 OZ 24126-01170 Healthy Life Soft Style, 100% Whole Wheat, 12 OZ 24126-33001 Roman Meal Sandwich, 24 OZ 24126-01134 Healthy Life Soft Style, 100% Whole Wheat, 20 OZ 78742-36690 Great Value, 100% Whole Wheat, 20 OZ 41290-01118 Piggly Wiggly, 100% Whole Wheat, 20 OZ 71025-00646 Hart's, Wheat Bread, 20 OZ 40700-60015 Bonnie Bread, Wheat Bread, 20 OZ 41498-11343 L'Oven Fresh, 100% Whole Wheat, 20 OZ ","Best by NOV 22 through NOV 26",,"111,807 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1120-2014","Class II","UPC Name 6000283495 Cinnamon Bread (bulk)","none",,"18,360 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1121-2014","Class II","UPC Name 6000050623 French Toast Yellow Bread (bulk)","none",,"62,220 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1118-2014","Class II","Honey Wheat Bread packaged under the following names and sizes: UPC Name, size 24126-01435 Bunny, Honey Wheat, 20 OZ 71025-00443 Holsum, Honey Wheat, 20 OZ 78742-03639 Honey Wheat Great Value, Honey Wheat, 20 OZ 24126-01511 Honey Wheat Schnucks Select, Honey Wheat, 20 OZ 41498-11344 Honey Wheat L'Oven Fresh, Honey Wheat, 20 OZ 71302-05715 Sunbeam, Honey Grain Sandwich, 24 OZ ","Best by NOV 22 through NOV 26",,"89,471 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1119-2014","Class II","UPC Name 6000283494 Yellow bread (bulk)","none",,"87,210 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1115-2014","Class II","White bread packaged under the following names and sizes: UPC Name, size 71025-00269 Holsum, Sof-Twist, Giant, 24 OZ 24126-01025 Bunny, Thin Sandwich, 24 OZ 71302-04738 Sunbeam, KING, 24 OZ 71025-00512 Harts, HOME STYLE, 24 OZ 71025-00040 Lewis, CIRCLE B, Texas Toast, 24 OZ 71302-04745 Sunbeam, Texas Toast, 24 OZ 78742-03616 Great Value, Texas Toast, 24 OZ 71025-00253 Aunt Hatties, Thin Sandwich, 24 OZ 41270-39928 IGA, Sandwich, 24 OZ 71025-00279 IDEAL, Sandwich, 24 OZ 71025-00336 Fluffy, GIANT Sandwich, 24 OZ 71025-00232 Sandwich, 24 OZ 78742-28542 Great Value, Sandwich, 24 OZ 24126-01291 James Family KITCHEN, Sandwich, 1 1/2 lb. 41130-36622 FOODLAND, GIANT, 24 OZ 70038-31119 Best Choice, Sandwich, 24 OZ 71025-00272 Holsum, Sof-Twist, 20 OZ 41498-11871 LOven Fresh, CLASSIC WHITE, 20 OZ 71025-00647 Harts, BIG, 20 OZ 71025-00281 IDEAL, WHITE, 1LB. 71025-00290 Fluffy, SOFT & FLUFFY, 16 OZ 70038-31152 Best Choice, CLASSIC WHITE, 16 OZ 71025-00255 Aunt Hatties, 16 OZ 41270-39848 IGA, WHITE, 16 OZ 71025-00234 Food GIANT, White, 1 lb 78742-28540 Great Value, White, Round Top, 16 OZ 41290-01111 Piggly Wiggly, ROUND TOP WHITE, 16 OZ 24126-00800 Fluffy, THIN Sandwich, 20 OZ 41290-01135 Piggly Wiggly, SANDWICH, 20 OZ 41498-19121 LOven Fresh, Sandwich, 20 OZ 71302-04547 Sunbeam, OLD FASHION, 20 OZ 71025-00085 IDEAL, WHITE, 1LB 1/4 lb 40700-60075 Bonnie, LARGE, 20 OZ 78742-28544 Great Value, Round Top, 20 OZ 24126-01294 James Family KITCHEN, 20 OZ 24126-01028 Bunny, Large, 20 OZ 71302-04331 Sunbeam, WHITE 16 OZ 24126-01027 Bunny, Soft-Twist, 16 OZ 71025-00511 Harts, HOME STYLE, 16 OZ 24126-01119 Holsum, Sof-Twist, 12 OZ 24126-01169 White Baby BUNNY, 1/2 Loaf, 12 OZ 71302-04186 Sunbeam, HALF LOAF WHITE, 12 OZ 41498-12011 LOven Fresh, Whole Grain White, 20 OZ ","Best by NOV 22 through NOV 26",,"365,847 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Food",66926,"Ongoing","Lewis Bakeries-Evansville","Evansville","IN","US","Voluntary: Firm Initiated","Letter","nationwide","F-1116-2014","Class II","Whole Grain White Bread packaged under the following names and sizes: UPC Name, size 24126-01449 Bunny, Whole Grain White, 20 OZ 24126-01450 Holsum, Whole Grain White, 20 OZ 78742-03638 Great Value, Whole Grain White, 20 OZ 24126-01557 Healthy Life Soft Style, Whole Grain White, 20 OZ ","Best by NOV 22 through NOV 26",,"40,741 loaves","The firm found two small food-grade stainless steel fragments in two slices of bread.",11/16/2013,"11/16/2013",1/1/2014,"01/01/2014"
"Drugs",66927,"Ongoing","Humco Holding Group, Inc","Texarkana","TX","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1048-2014","Class II","Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501.","a) Good Neighbor Pharmacy Mercuroclear 2 fl. oz, Lots: ALL LOTS b) Quality Choice Mercuroclear 2 fl. oz, Lots: ALL LOTS c) Select Brand Mercuroclear 2 fl. oz, Lots: ALL LOTS d) Premier Value Mercuroclear 2 fl. oz, Lot: ALL LOTS e) Rite Aid Mercuroclear 2 fl. oz, Lots: ALL LOTS f) Top Care Mercuroclear 2 fl. oz , Lots: ALL LOTS g) Vida Mia Mercuroclear, 2 fl. oz. Lots: ALL LOTS h) HUMCO Mercuroclear 2 fl oz. sold to WalMart Lots: ALL LOTS i) HUMCO Mercuroclear 3 fl. oz. Lots: ALL LOTS ",,,"Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.",11/26/2013,"11/26/2013",2/5/2014,"02/05/2014"
"Food",66928,"Ongoing","CSM Bakery Products North America","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","Illinois and Wisconsin","F-1681-2014","Class II","10'' Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use.","Lot #1328702013 All cases stamped with Lot #1328702013 and also showing a USE BY date of JUL/14/14 along with a 24-hour time stamp between 15:00 and 24:00. For example, a case showing ''1328702013 17:36 USE BY JUL/14/14'' is subject to the recall while ''1328702013 02:14 USE BY JUL/14/14'' is not subject to the recall. Also NOT included in the recall would be a case showing an earlier USE BY date along with Lot # 1328702013. For example, ''1328702013 15:36 USE BY JUL/13/14'' is not subject to the recall.",,"576 cases each containing 12 - 20 oz. cake layers","Foreign Material - specifically the product has the potential to contain pieces of a red plastic scoop.",11/20/2013,"11/20/2013",3/26/2014,"03/26/2014"
"Devices",66930,"Ongoing","C.L.R. Medicals International, Inc.","Pomona","CA","US","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.","Z-0531-2014","Class I","Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment. ","All lots manufactured September 01, 2011 to September 19, 2013.",,"249,592 units","CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the Quality System Regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a possible public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products. ",11/25/2013,"11/25/2013",1/1/2014,"01/01/2014"
"Devices",66931,"Ongoing","Biomerieux France Chemin De L'Or","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe","Z-0841-2014","Class II","ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. ","Lot numbers: 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.",,"39439 kits (includes ZYM B reagents, API Listeria * API NH kits)","bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.",11/8/2013,"11/08/2013",2/5/2014,"02/05/2014"
"Devices",66931,"Ongoing","Biomerieux France Chemin De L'Or","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe","Z-0843-2014","Class II","API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.","Lot numbers: 1001896203, 1001957530, 1001957531, 1002112170, 1002112171, 1002112172, 1002279351, 1002340500, 1002112173, 1002171111, 1002171110, 1002279350, 1002279352, 1002340501, 1002340502, 1002340503, 1002412550, 1002412551, 1002485910, 1002485911, 1002455912.",,"39439 kits (includes ZYM B reagents, API Listeria * API NH kits)","bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.",11/8/2013,"11/08/2013",2/5/2014,"02/05/2014"
"Devices",66931,"Ongoing","Biomerieux France Chemin De L'Or","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe","Z-0842-2014","Class II","API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.","Lot numbers: 1002210010, 1002210011, 1002287930, 1002287931, 1002350760, 1002390940, 1002390941, 1002518070, 1002518071, 1002518072, 1001915090, 1001915091, 1001915092, 1001932340, 1001998120 and 1002129350.",,"39439 kits (includes ZYM B reagents, API Listeria * API NH kits)","bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.",11/8/2013,"11/08/2013",2/5/2014,"02/05/2014"
"Devices",66933,"Completed","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.","Z-0790-2014","Class II","BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm'' Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.","Lot 08T13108 Exp Dec 24 2013",,"33 kits","An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples. ",10/11/2013,"10/11/2013",1/29/2014,"01/29/2014"
"Devices",66934,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Distributed to 3 customers in FL only.","Z-0560-2014","Class III","Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.","Lot Number: 11211566.1, Exp. Date: 09/01/2017.",,"3","Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect. ",11/20/2013,"11/20/2013",1/1/2014,"01/01/2014"
"Devices",66935,"Completed","Materialise USA LLC","Plymouth","MI","US","Voluntary: Firm Initiated","E-Mail","Distributed in Canada.","Z-0577-2014","Class II","ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.","Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01",,"1 ","Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. ",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Devices",66935,"Completed","Materialise USA LLC","Plymouth","MI","US","Voluntary: Firm Initiated","E-Mail","Distributed in Canada.","Z-0578-2014","Class II","ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. ."," Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2",,"1 ","Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. ",11/8/2013,"11/08/2013",1/1/2014,"01/01/2014"
"Biologics",66936,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0305-14","Class II","Platelets Pheresis Leukocytes Reduced","W039413489620 (2 units)",,"2 units","Blood products, for which the platelet yield was not sufficient to support the products being split into two parts, were distributed.",10/18/2013,"10/18/2013",2/5/2014,"02/05/2014"
"Biologics",66937,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0260-14","Class II","Red Blood Cells Frozen Leukocytes Reduced","W039713746412J",,"1 unit","Blood product, which was incorrectly labeled as negative for the S red cell antigen, was distributed.",10/8/2013,"10/08/2013",2/5/2014,"02/05/2014"
"Biologics",66938,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","Telephone","Indiana","B-0276-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","038FS27049 (2 units)",,"2 units","Blood products, collected from a donor with a history of Hepatitis A exposure, were distributed.",10/9/2013,"10/09/2013",2/5/2014,"02/05/2014"
"Biologics",66939,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0249-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113269757J",,"1 unit","Blood product, with a low platelet count, was distributed.",9/27/2013,"09/27/2013",2/5/2014,"02/05/2014"
"Biologics",66940,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","Telephone","Arizona, Colorado","B-0248-14","Class II","Platelets Pheresis Leukocytes Reduced","W0423130201412",,"1 unit","Blood products, which tested negative for West Nile Virus (WNV) using pooled testing, but were not tested for WNV by individual donor testing, were distributed.",8/20/2013,"08/20/2013",2/5/2014,"02/05/2014"
"Biologics",66940,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","Telephone","Arizona, Colorado","B-0247-14","Class II","Red Blood Cells Leukocytes Reduced","W0423130201404",,"1 unit","Blood products, which tested negative for West Nile Virus (WNV) using pooled testing, but were not tested for WNV by individual donor testing, were distributed.",8/20/2013,"08/20/2013",2/5/2014,"02/05/2014"
"Biologics",66941,"Terminated","Blood Systems, Inc","Billings","MT","US","Voluntary: Firm Initiated","Telephone","Montana","B-0244-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W042313038777T",,"1 unit","Blood product, which did not meet the minimum requirement for Red Blood Cell recovery following leukoreduction, was distributed.",8/13/2013,"08/13/2013",2/5/2014,"02/05/2014"
"Biologics",66942,"Terminated","Blood Systems, Inc. DBA United Blood Services","Lafayette","LA","US","Voluntary: Firm Initiated","Telephone","Mississippi","B-0243-14","Class III","Red Blood Cells Leukocytes Reduced","W041613034464M",,"1 unit","Blood product, for which the quality control testing for the Hemoflow shaker was not documented, was distributed.",8/13/2013,"08/13/2013",2/5/2014,"02/05/2014"
"Food",66943,"Ongoing","Perrigo of SC","Greenville","SC","US","Voluntary: Firm Initiated","Letter","FL, IL, MI, MN, OR, PA & TX","F-1384-2014","Class II","EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28 Caplets; TopCare Maximum Strength Estroplus Dietary Supplement, 28 Caplets; Sunmark Estroplus Extra Strength, Dietary Supplement, 56 Caplets; Health Mart Pharmacy Extra Strength Estroplus, 56 Caplets Dietary Supplement; Up&Up Estroplus Dietary Supplement Maximum Strength 28 Caplets; CareOne Extra Strength Estroplus 56 Caplets/Dietary Supplement; Western Family Extra Strength Estroplus 56 Caplets, Meijer Extra Strength Estroplus Dietary Supplement 56 Caplets; Publix Extra Strength Estroplus 56 Caplets, Dietary Supplement; and TopCare Extra Strength Estroplus Dietary Supplement 56 Caplets. ","3FN0981 (Exp 04/15), 3FN1338 (Exp 04/15), 3FN1116 (Exp 04/15), 3EN1050 (Exp 04/15), 3JN1230 (Exp 04/15), 3KN1691 (Exp 05/15), 3KN1207 (Exp. 05/15), 3JN1013 (05/15), 3JN1077 (Exp 05/15), 3HN1293 (Exp 05/15), 1KN1496 (Exp 05/14), 1JN1234 (Exp 05/14), 1KN1775 (Exp. 05/14), 1LN1254 (Exp 05/14), 1LN1867 (Exp 05/14), 1MN1647 (Exp 05/14), 2AN1562 (Exp 10/14), 2AN1595 (Exp 10/14), 2BN2120 (Exp 01/15), 2DN1514 (Exp 01/15), 2DN1515 (Exp 10/14), 2DN1608 (Exp 05/14), 2DN1997 (Exp 01/15), 2EN2099 (Exp. 01/15), 2FN1524 (Exp 03/15), 2FN1923 (Exp 03/15), 2FN1939 (Exp 01/15), 2GN1806 (Exp 03/15), 2HN1412 (Exp 03/15), 2HN1496 (Exp 03/15), 2JN1383 (Exp 03/15), 2MN1156 (Exp 03/15), 3AN1835 (Exp 03/15), 3BN1683 (Exp 03/15), 3DN1482 (Exp 03/15), 3FN1132 (Exp 03/15)",,"68,534 (units/eaches)","Potential presence of Chloramphenicol contamination",11/25/2013,"11/25/2013",1/15/2014,"01/15/2014"
"Devices",66946,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Australia, Austria, Azerbaijan, Bahrain, Belgium, BRAZIL, Canada, CHILE, COSTA RICA, Cyprus, Czech Republic, Denmark, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, GUAM, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Kuwait, Lithuania, Malaysia, Malta, Mexico, NEPAL, Netherlands, New Zealand, Norway, Pakistan, PANAMA, PARAGUAY, PERU, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Turkey, United Arab Emirates, United Kingdom, URUGUAY.","Z-0927-2014","Class II","CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.","serial numbers: SEG09270517HX, SEG09270549HX, SEG09270551HX, SEG09270553HX, SEG09270554HX, SEG09270557HX, SEG09270559HX, SEG09270561HX, SEG09270562HX, SEG09270563HX, SEG09270564HX, SEG09270565HX, SEG09270566HX, SEG09270567HX, SEG09270568HX, SEG09270569HX, SEG09270583HX, SEG09270584HX, SEG09270585HX, SEG09270587HX, SEG09270588HX, SEG09270589HX, SEG09270591HX, SEG09270592HX, SEG09280596HX, SEG09280597HX, SEG09280598HX, SEG09280599HX, SEG09280600HX, SEG09280601HX, SEG09280602HX, SEG09280603HX, SEG09280604HX, SEG09280605HX, SEG09280606HX, SEG09280607HX, SEG09280608HX, SEG09280609HX, SEG09280610HX, SEG09280611HX, SEG09280612HX, SEG09280613HX, SEG09280614HX, SEG09280615HX, SEG09280616HX, SEG09280617HX, SEG09280618HX, SEG09280619HX, SEG09280620HX, SEG09280621HX, SEG09280622HX, SEG09280623HX, SEG09280624HX, SEG09280625HX, SEG09310656HX, SEG09310657HX, SEG09310658HX, SEG09310659HX, SEG09310660HX, SEG09310661HX, SEG09310662HX, SEG09310663HX, SEG09310664HX, SEG09310665HX, SEG09310666HX, SEG09310667HX, SEG09310668HX, SEG09310669HX, SEG09310670HX, SEG09310671HX, SEG09310672HX, SEG09310673HX, SEG09310674HX, SEG09310675HX, SEG09310696HX, SEG09310697HX, SEG09310698HX, SEG09310699HX, SEG09310700HX, SEG09310701HX, SEG09310702HX, SEG09310703HX, SEG09310704HX, SEG09310705HX, SEG09310706HX, SEG09310707HX, SEG09310708HX, SEG09310709HX, SEG09310710HX, SEG09310711HX, SEG09310712HX, SEG09310713HX, SEG09310714HX, SEG09310715HX, SEG09310716HX, SEG09310717HX, SEG09310718HX, SEG09310719HX, SEG09310720HX, SEG09310721HX, SEG09310722HX, SEG09310723HX, SEG09310724HX, SEG09310725HX, SEG09310726HX, SEG09310727HX, SEG09310728HX, SEG09310729HX, SEG09310730HX, SEG09310731HX, SEG09310732HX, SEG09310733HX, SEG09310734HX, SEG09310735HX, SEG09310736HX, SEG09310737HX, SEG09310738HX, SEG09310739HX, SEG09310740HX, SEG09310741HX, SEG09310742HX, SEG09310743HX, SEG09310744HX, SEG09310745HX, SEG09320797HX, SEG09320798HX, SEG09320799HX, SEG09320800HX, SEG09320801HX, SEG09320802HX, SEG09320803HX, SEG09320804HX, SEG09320805HX, SEG09320806HX, SEG09320807HX, SEG0"," SEG10293871HX, SEG10293872HX, SEG10293873HX, SEG10293874HX, SEG10293875HX, SEG10293876HX, SEG10293877HX, SEG10293878HX, SEG10293879HX, SEG10293880HX, SEG10293881HX, SEG10293882HX, SEG10293883HX, SEG10293884HX, SEG10293885HX, SEG10293886HX, SEG10293887HX, SEG10293888HX, SEG10293889HX, SEG10293890HX, SEG10293891HX, SEG10293892HX, SEG10293893HX, SEG10293894HX, SEG10293895HX, SEG10293896HX, SEG10293897HX, SEG10293898HX, SEG10293899HX, SEG10293900HX, SEG10293901HX, SEG10293902HX, SEG10293903HX, SEG10293904HX, SEG10293905HX, SEG10293906HX, SEG10293907HX, SEG10293908HX, SEG10293909HX, SEG10293910HX, SEG10293911HX, SEG10293912HX, SEG10293913HX, SEG10293914HX, SEG10293915HX, SEG10293916HX, SEG10293917HX, SEG10293918HX, SEG10293919HX, SEG10293920HX, SEG10293921HX, SEG10293922HX, SEG10293923HX, SEG10293924HX, SEG10293925HX, SEG10293926HX, SEG10293927HX, SEG10293928HX, SEG10293929HX, SEG10293930HX, SEG10293931HX, SEG10293932HX, SEG10293933HX, SEG10293934HX, SEG10293935HX, SEG10293936HX, SEG10293938HX, SEG10293939HX, SEG10293940HX, SEG10293941HX, SEG10293943HX, SEG10293944HX, SEG10293945HX, SEG10293946HX, SEG10293947HX, SEG10293948HX, SEG10293949HX, SEG10293950HX, SEG10293951HX, SEG10293952HX, SEG10293953HX, SEG10293954HX, SEG10293955HX, SEG10293956HX, SEG10293957HX, SEG10293958HX, SEG10293959HX, SEG10293960HX, SEG10304063HX, SEG10304064HX, SEG10304065HX, SEG10304066HX, SEG10304067HX, SEG10304068HX, SEG10304069HX, SEG10304070HX, SEG10304071HX, SEG10304072HX, SEG10304073HX, SEG10304074HX, SEG10304075HX, SEG10304076HX, SEG10304077HX, SEG10304078HX, SEG10304079HX, SEG10304080HX, SEG10304081HX, SEG10304082HX, SEG10304083HX, SEG10304084HX, SEG10304085HX, SEG10304086HX, SEG10304087HX, SEG10304088HX, SEG10304089HX, SEG10304090HX, SEG10304091HX, SEG10304092HX, SEG10304093HX, SEG10304094HX, SEG10304095HX, SEG10304096HX, SEG10304097HX, SEG10304098HX, SEG10304099HX, SEG10304100HX, SEG10304101HX, SEG10304102HX, SEG10304103HX, SEG10304104HX, SEG10304105HX, SEG10304106HX, SEG10304107HX, SEG10304108HX, SEG10304109HX, SEG10304110HX, SEG1","12, 945 units (6,239 US, 6,706 OUS)","There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communication loss may occur when the PDM is first attached to the host monitor, or it may lose communication spontaneously during use with no user action. ",12/20/2013,"12/20/2013",2/12/2014,"02/12/2014"
"Devices",66947,"Ongoing","Bio-Rad Laboratories, Inc.","Hercules","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.","Z-0965-2014","Class III","D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.","Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014 64000331 5/31/2014 64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014 ( 64002240 08/3112014 64002241 11/30/2014 ",".","2906 kits (318 Kits in US; 2588 kits internationally)","D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.",11/22/2013,"11/22/2013",2/19/2014,"02/19/2014"
"Devices",66949,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0551-2014","Class II","Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium. ","Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014 ",,"731","Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit. ",11/26/2013,"11/26/2013",1/1/2014,"01/01/2014"
"Biologics",66950,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","New York","B-0295-14","Class II","Red Blood Cells","1542583; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",10/18/2013,"10/18/2013",2/12/2014,"02/12/2014"
"Biologics",66951,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Minnesota","B-0297-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W051513074498; W051513074498; ",,"2","Blood products, collected on an apheresis machine undergoing validation and which did not have the required quality control testing performed, were distributed.",10/23/2013,"10/23/2013",2/12/2014,"02/12/2014"
"Food",66952,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY","F-1251-2014","Class I","Fosforel Atlantika Herring Fillet in Oil 14.1 oz. (400 g) Product of Russia Imported by: Zip International Group LLC 160 Raritan Center Parkway, Unit 6 Edison, NJ 08837 UPC: 4607095500208","best by date 18/01/2014 ",,"15 boxes","ZIP INTERNATIONAL GROUP LLC is recalling herring fillet in oil (FOSFOREL, ATLANTIKA) 400 gram in plastic packaging due to Listeria contamination which was discovered through NYSDAM sampling.",11/25/2013,"11/25/2013",1/1/2014,"01/01/2014"
"Devices",66953,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0920-2014","Class II","Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.","N/A",,"703 units","Bicarbonate Jug Adapter distributed prior to 510(k) approval",12/17/2013,"12/17/2013",2/12/2014,"02/12/2014"
"Drugs",66955,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone","D-396-2014","Class II","Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98","Lot#: 32900349B, Exp: 12/2014",,"10,512 bottles","Failed Tablet/Capsule Specifications: There is a potential for broken tablets.",11/26/2013,"11/26/2013",1/8/2014,"01/08/2014"
"Devices",66956,"Ongoing","Varian Medical Systems, Inc.","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0552-2014","Class II","Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. ","Model numbers H48, HIT, H77: Code numbers: H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H48179S H481969 H482027 H48208S H480004 H48016S H48036S H48054S H48072S H480972 H481134 H481326 H481SOS H481796 H481970 H482028 H482086 H480009 H480174 H480373 H480546 H480727 H480974 H481138 H481327 H481506 H481804 H481971 H482029 H482087 H480010 H480175 H480374 H480547 H480760 H480975 H48114S H481328 H481510 H48180S H481972 H482030 H482088 H480011 H480176 H480378 H480548 H480764 H480980 H481146 H481329 H48152S H481806 H481973 H482031 H482089 H48001S H480181 H480379 H480566 H480765 H480981 H481147 H481334 H481532 H481807 H481974 H482032 H482090 H480030 H480182 H480380 H480578 H480766 H480989 H481148 H48133S H481533 H481815 H481975 H482033 H482091 H480033 H480200 H480381 H480579 H480767 H480992 H481153 H481343 H481540 H481816 H481976 H482034 H482092 H480034 H480207 H480382 H480580 H480769 H480994 H481154 H481352 H481543 H481834 H481977 H482035 H482093 H480035 H480208 H480384 H480581 H480770 H480996 H481155 H481353 H481544 H481835 H481978 H482036 H482094 H480036 H480209 H480404 H480582 H480774 H480997 H481156 H481354 H481545 H481836 H481979 H482037 H482095 H480037 H480210 H480405 H480590 H480782 H480998 H481164 H4813SS H481581 H481837 H481980 H482038 H482096 H480038 H480219 H480408 H480591 H480785 H480999 H481165 H481358 H481582 H481838 H481981 H482039 H482097 H480039 H480222 H480409 H480593 H480786 H481000 H481166 H481359 H481583 H481843 H481982 H482040 H482098 H480043 H480223 H480410 H480610 H480787 H481005 H481168 H481360 H481587 H481846 H481983 H482041 H482099 H480044 H480224 H480422 H480626 H480794 H481006 H481171 H481376 H481601 H481847 H481984 H482042 H482100 H48004S H48022S H48042S H480632 H480795 H481007 H481172 H481414 H481610 H481850 H481985 H482043 H482101 H480051 H480226 H480427 H480633 H480803 H481008 H481176 H481415 H481611 H481851 H481986 H482044 H482102 H480052 H480227 H480428 H480634 H480804 H481009 H481177 H481416 H481612 H481852 H481987 H482045 H482103 H480053 H480228 H480429 H4"," H48F260 H48F356 H48F514 H48F651 H48F729 H48F841 H48G022 H48G247 H48G400 H48G567 H48E769 H48E954 H48F122 H48F261 H48F357 H48FS15 H48F652 H48F730 H48F842 H48G039 H48G249 H48G403 H48G568 H48E770 H48E9SS H48F125 H48F262 H48F370 H48FS16 H48F653 H48F731 H48F851 H48G040 H48G250 H48G405 H48GS69 H48E771 H48E956 H48F131 H48F263 H48F371 H48FS17 H48F654 H48F733 H48F852 H48G041 H48G251 H48G406 H48GS70 H48E790 H48E957 H48F132 H48F264 H48F372 H48FS18 H48F657 H48F740 H48F854 H48G042 H48G252 H48G407 H48GS71 H48E794 H48E958 H48F133 H48F265 H48F373 H48FS19 H48F658 H48F741 H48F856 H48G043 H48G267 H48G409 H48GS72 H48E798 H48E959 H48F134 H48F266 H48F385 H48FS20 H48F659 H48F754 H48F859 H48G044 H48G268 H48G411 H48GS79 H48E799 H48E962 H48F135 H48F268 H48F386 H48FS23 H48F660 H48F7SS H48F861 H48G077 H48G271 H48G4U H48GS80 H48E800 H48E964 H48F136 H48F269 H48F391 H48FS24 H48F661 H48F756 H48F862 H48G078 H48G274 H48G413 H48GS81 H48E816 H48E966 H48F137 H48F270 H48F393 H48FS26 H48F662 H48F757 H48F865 H48G080 H48G275 H48G415 H48GS82 H48E821 H48E973 H48F138 H48F271 H48F394 H48FS27 H48F663 H48F758 H48F867 H48G085 H48G276 H48G417 H48GS83 H48E822 H48E974 H48F139 H48F272 H48F395 H48FS34 H48F664 H48F759 H48F868 H48G105 H48G277 H48G425 H48GS84 H48E823 H48E975 H48F140 H48F273 H48F396 H48FS35 H48F665 H48F760 H48F916 H48G109 H48G278 H48G431 H48GS85 H48E825 H48E976 H48F141 H48F274 H48F400 H48FS36 H48F666 H48F761 H48F922 H48G117 H48G279 H48G432 H48GS86 H48E839 H48E977 H48F142 H48F275 H48F401 H48FS37 H48F667 H48F764 H48F923 H48G119 H48G280 H48G433 H48GS87 H48E846 H48E978 H48F143 H48F276 H48F405 H48FS39 H48F668 H48F765 H48F924 H48G120 H48G281 H48G434 H48G588 H48E849 H48E979 H48F144 H48F277 H48F409 H48FS40 H48F669 H48F767 H48F925 H48G123 H48G282 H48G435 H48G589 H48E850 H48E980 H48F145 H48F278 H48F412 H48FS41 H48F670 H48F771 H48F926 H48G127 H48G283 H48G436 H48GS90 H48E860 H48E984 H48F146 H48F279 H48F415 H48FS42 H48F671 H48F772 H48F927 H48G130 H48G284 H48G437 H48GS91 H48E861 H48E985 H48Fl49 H48F280 H48F419 H48FS43 H48F672 H48F773 H48F928 H48G140 H48G285 H48G4","6701 ","An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and ''do no clear MUs and Reference Point dose'' is selected, the Monitor units may change.",11/18/2013,"11/18/2013",1/1/2014,"01/01/2014"
"Devices",66958,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) Distribution in South Dakota and the countries of Germany, Lebanon, and China.","Z-0985-2014","Class II","UniCel DxI 600 Access Immunoassay System Analyzer. K023764. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Part Number A30260. Serial Numbers 900781.",,"1 unit","Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.",11/26/2013,"11/26/2013",2/26/2014,"02/26/2014"
"Devices",66958,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) Distribution in South Dakota and the countries of Germany, Lebanon, and China.","Z-0984-2014","Class II","Access 2 Immunoassay System Analyzer. K922823/A007. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.","Part Number 81600N. Serial Numbers 508957, 508963, 508964.",,"3 units","Beckman Coulter initiated a recall of the Access 2 Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.",11/26/2013,"11/26/2013",2/26/2014,"02/26/2014"
"Food",66960,"Ongoing","Flat Creek Farm & Dairy","Swainsboro","GA","US","Voluntary: Firm Initiated","Telephone","AL, FL, GA and TN","F-1437-2014","Class I","Heavenly Blue, (Raw milk, salt, culture, coagulant ), Flat Creek Lodge, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401. The raw milk blue cheese is packaged in clear plastic, with sizes ranging from 1/2 lb to whole wheels. ","Lot Code: 130912XHB",,"203 lbs","Product was found to be contaminated with Salmonella. ",11/22/2013,"11/22/2013",1/29/2014,"01/29/2014"
"Drugs",66961,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1043-2014","Class III","BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880","Lots: 524099M, 524100A, 521687A ",,"139,944 bottles","Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.",11/15/2013,"11/15/2013",2/5/2014,"02/05/2014"
"Drugs",66962,"Ongoing","Faria Limited LLC dba Sheffield Pharmaceuticals","New London","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1076-2014","Class II","Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320","20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13 ",,"332508","Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing ",11/22/2013,"11/22/2013",2/12/2014,"02/12/2014"
"Drugs",66962,"Ongoing","Faria Limited LLC dba Sheffield Pharmaceuticals","New London","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1077-2014","Class II","FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105 ","20022 EXP. 12/13, 20031 EXP. 12/13, 20032 EXP. 12/13, 20041 EXP. 12/13, 20042 EXP. 12/13, 20051 EXP. 12/13, 20052 EXP. 12/13, 20061 EXP. 12/13, 20071 EXP. 12/13, 20072 EXP. 12/13 ",,"147566","Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing ",11/22/2013,"11/22/2013",2/12/2014,"02/12/2014"
"Drugs",66962,"Ongoing","Faria Limited LLC dba Sheffield Pharmaceuticals","New London","CT","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1078-2014","Class II","Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072 ","20221 EXP. 04/14 ",,"26424","Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing ",11/22/2013,"11/22/2013",2/12/2014,"02/12/2014"
"Drugs",66965,"Ongoing","IQ Formulations, LLC","Sunrise","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Hawaii and Puerto Rico","D-1050-2014","Class I","Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com","ALL LOTS",,,"Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug",11/4/2013,"11/04/2013",2/5/2014,"02/05/2014"
"Food",66966,"Ongoing","Josephson's Smokehouse","Astoria","OR","US","Voluntary: Firm Initiated","Telephone","Distributed in AL, AZ, CA, CO, FL, GA, ID, IN, MA, MD, ME, MI, MN, MO, NY, OH, OR, PA, SC, TN, TX, WA, and WI.","F-1402-2014","Class II","Hot Smoked Pepper Atlantic Salmon, Item HS-C, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for net weight 0.425 lbs. is 0 240120 813603. The label is read in part: HOT SMOKED PEPPERED ATLANTIC SALMON, ATLANTIC SALMON, SALT, COARSE, BLACK PEPPER, CRUSHED RED PEPPER, MIXED HARDWOOD SMOKE, KEEP REFRIGERATED AT 38 DEGREES OR BELOW, Josephson's, Astoria, Oregon 97103. An informational flyer that the firm sends with mail order products reads in part: ''***Fresh Hot Smoked Seafood: Wrap well and store at 36 degrees Fahrenheit or below for 10 days to 2 weeks***''.","There are no manufacturing codes or expiration dates ",,"Approximately 5 lbs.","The hot smoked fisheries products in vacuum packages were undercooked and it has a potential hazard of Clostridium botulinum toxin formation.",11/27/2013,"11/27/2013",1/22/2014,"01/22/2014"
"Food",66966,"Ongoing","Josephson's Smokehouse","Astoria","OR","US","Voluntary: Firm Initiated","Telephone","Distributed in AL, AZ, CA, CO, FL, GA, ID, IN, MA, MD, ME, MI, MN, MO, NY, OH, OR, PA, SC, TN, TX, WA, and WI.","F-1400-2014","Class II","Hot Smoked Wine Maple Salmon, Item HS-B, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for net weight 0.445 lbs. is 0 240080 618023. The label is read in part: HOT SMOKED WINE-MAPLE SALMON SALMON, SALT, SUGAR, SOY, COOKING WINE, MAPLE FLAVORING, SPICES, MIXED HARDWOOD SMOKE, KEEP REFRIGERATED AT 38 DEGREES OR BELOW, Josephson's, Astoria, Oregon 97103. ","There are no manufacturing codes or expiration dates ",,"Approximately 126.7 lbs.","The hot smoked fisheries products in vacuum packages were undercooked and it has a potential hazard of Clostridium botulinum toxin formation.",11/27/2013,"11/27/2013",1/22/2014,"01/22/2014"
"Food",66966,"Ongoing","Josephson's Smokehouse","Astoria","OR","US","Voluntary: Firm Initiated","Telephone","Distributed in AL, AZ, CA, CO, FL, GA, ID, IN, MA, MD, ME, MI, MN, MO, NY, OH, OR, PA, SC, TN, TX, WA, and WI.","F-1401-2014","Class II","Hot Smoked Garlic Pepper Atlantic Salmon, Item HS-D, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for the net weight 0.445 lbs. is 0 240100 214246. The label is read in part: HOT SMOKED GARLIC PEPPER SALMON SALMON, SALT, GARLIC, PEPPER, MIXED HARDWOOD SMOKE, KEEP REFRIGERATED AT 38 DEGREES OR BELOW, Josephson's, Astoria, Oregon 97103.","There are no manufacturing codes or expiration dates ",,"Approximately 19.50 lbs.","The hot smoked fisheries products in vacuum packages were undercooked and have a potential hazard of Clostridium botulinum toxin formation.",11/27/2013,"11/27/2013",1/22/2014,"01/22/2014"
"Devices",66968,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.","Z-0608-2014","Class II","CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658","Part 00-8114-002-10, Lot 62424414 Part 00-8011-004-00, Lot 62406423 ",,"36","Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.",12/10/2013,"12/10/2013",1/8/2014,"01/08/2014"
"Devices",66968,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.","Z-0609-2014","Class II","Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661","Part 00-4349-036-11, Lot 62393502",,"25","Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.",12/10/2013,"12/10/2013",1/8/2014,"01/08/2014"
"Devices",66968,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.","Z-0610-2014","Class II","Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.","Part 00-7871-001-10 Lot 62359872",,"3","Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.",12/10/2013,"12/10/2013",1/8/2014,"01/08/2014"
"Devices",66969,"Ongoing","Orthofix, Inc.","Lewisville","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.","Z-0855-2014","Class II","Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.","Production Identification Numbers: Part Number 52-1332, All Lot Numbers.",,"443","Orthofix received 6 complaints which resulted in reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.",11/26/2013,"11/26/2013",2/5/2014,"02/05/2014"
"Devices",66971,"Ongoing","Abbott Vascular, Inc.","Temecula","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa.","Z-0558-2014","Class II","HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM","Part Number Lot Number 1012587 10097079 1012587 10168703 1012587 10168705 1012587 10171679 1012587 10262897 1012587 10281944 1012587 10303349 1012587 90021507 1012588 10087171 1012588 10087179 1012588 10108128 1012588 10108132 1012588 10137054 1012588 10137224 1012588 10155636 1012588 10155638 1012588 10156982 1012588 10171681 1012588 10181960 1012588 10186395 1012588 10187173 1012588 10201046 1012588 10201050 1012588 10202457 1012588 10213592 1012588 10213593 1012588 10220279 1012588 10220283 1012588 10220284 1012588 10226194 1012588 10226314 1012588 10226315 1012588 10226316 1012588 10226317 1012588 10226318 1012588 10244104 1012588 10303351 1012588 10303361 1012588 90020420 1012588 90020746 1012588 90021060 1012588 90021154 1012588 90021155 1012588 90021156 1012588 90021266 1012588 90021313 1012588 90021334 1012588 90021335 1012588 90021508 1012588 90021509 1012588 90021573 1012589 10087172 1012589 10087180 1012589 10087181 1012589 10087182 1012589 10087183 1012589 10108129 1012589 10108133 1012589 10111356 1012589 10111357 1012589 10118216 1012589 10122343 1012589 10137056 1012589 10156973 1012589 10157066 1012589 10167663 1012589 10171682 1012589 10171702 1012589 10181961 1012589 10187172 1012589 10187174 1012589 10187189 1012589 10194671 1012589 10200648 1012589 10202451 1012589 10202452 1012589 10219309 1012589 10219349 1012589 10220313 1012589 10220314 1012589 10220317 1012589 10222768 1012589 10226195 1012589 10226313 1012589 10237343 1012589 10239255 1012589 10239256 1012589 10239258 1012589 10239259 1012589 10265833 1012589 10281945 1012589 10281948 1012589 10288067 1012589 10294349 1012589 10294350 1012589 10298877 1012589 10300028 1012589 10303355 1012589 10303363 1012589 10303365 1012589 10305105 1012589 10305106 1012589 10309225 1012589 10309238 1012589 90020421 1012589 90020747 1012589 90020926 1012589 90021276 1012589 90021277 1012589 90021278 1012589 90021279 1012589 90021388 1012589 90021389 1012589 90021484 1012589 90021485 1012589 90021486 1012589 90021574 1012589 90021575 1012589 90021694",,"54,895 units total (5,356 units in US)","Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.",11/25/2013,"11/25/2013",1/1/2014,"01/01/2014"
"Biologics",66972,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0292-14","Class II","Red Blood Cells","2320465; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/25/2013,"10/25/2013",2/12/2014,"02/12/2014"
"Biologics",66972,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0293-14","Class II","Cryoprecipitated AHF","2320465; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/25/2013,"10/25/2013",2/12/2014,"02/12/2014"
"Biologics",66972,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0294-14","Class II","Platelets","2320465; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/25/2013,"10/25/2013",2/12/2014,"02/12/2014"
"Biologics",66974,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Massachusetts","B-0307-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W20041380902300; ",,"1","Blood product, which did not meet the platelet QC specification for pH, was distributed. ",9/10/2013,"09/10/2013",2/12/2014,"02/12/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0568-2014","Class II","Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","20006 20025 20142 20185 20216 20231 20015 20026 20151 20186 20217 20236 20016 20027 20153 20189 20225 20018 20031 20166 20198 20227 20019 20139 20184 20199 20228 ",,"27 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0563-2014","Class II","Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874",,"58 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0562-2014","Class II","Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","5652 5704 5758 5772 5792 5840 5653 5714 5759 5773 5796 5844 5654 5715 5760 5774 5798 5846 5655 5716 5761 5775 5805 5847 5656 5717 5762 5776 5809 5854 5695 5718 5763 5777 5810 5855 5696 5720 5764 5779 5814 5860 5697 5721 5765 5780 5816 5861 5698 5722 5766 5781 5823 5862 5699 5723 5767 5782 5828 5863 5700 5749 5768 5783 5830 5864 5701 5750 5769 5784 5833 5865 5702 5751 5770 5785 5838 5866 5703 5755 5771 5787 5839",,"83 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0565-2014","Class II","Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815",,"54 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0566-2014","Class II","Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","90842",,"1 device","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0564-2014","Class II","Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","9209 9277 9448 9584 9655 9211 9278 9459 9585 9656 9212 9279 9475 9586 9657 9214 9315 9478 9587 9658 9216 9316 9506 9588 9659 9217 9343 9514 9633 9660 9245 9352 9530 9634 9664 9246 9358 9531 9645 9665 9255 9376 9551 9646 9666 9256 9377 9562 9647 9672 9272 9404 9571 9653 97119273 9427 9582 9654 9728",,"60 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Devices",66976,"Ongoing","Ziehm Imaging Inc","Orlando","FL","US","Voluntary: Firm Initiated","Letter","USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.","Z-0567-2014","Class II","Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging","10016 10070 10135 10153 10235 10485 10026 10071 10092 10154 10260 10486 10028 10072 10093 10155 10265 10488 10030 10073 10094 10156 10266 10489 10031 10074 10109 10162 10396 10490 10038 10075 10111 10181 10431 10491 10042 10076 10117 10192 10434 10510 10045 10078 10118 10196 10435 10519 10046 10080 10119 10197 10436 10520 10048 10081 10121 10198 10443 10521 10049 10082 10122 10202 10457 10524 10053 10083 10123 10207 10458 10525 10054 10086 10124 10209 10459 10528 10056 10087 10125 10214 10460 10066 10088 10126 10215 10462 10067 10089 10127 10216 10472 10068 10090 10131 10223 10476 10069 10091 10134 10233 10484 ",,"103 devices","Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. ",11/21/2013,"11/21/2013",1/1/2014,"01/01/2014"
"Veterinary",66977,"Ongoing","Cargill, Inc Corporate Headquarters","Wayzata","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (IL, IN, KS, KY, MO, NM, OK, TX)","V-150-2014","Class I","40 lb poly-paper bags of poultry feed labeled in part: Nutrena; Nature Wise; Meatbird; 22% Crumbles; Minneapolis, MN 55440; www.NutrenaNatureWise.com. ","All lot codes between FL3121 - FL3325",".","40 lb. bags: 5,177 bags","Cargill Animal Nutrition is conducting a recall of Nutrena Naturewise Meatbird feeds in 40 bags due to incorrect levels of calcium.",11/22/2013,"11/22/2013",9/17/2014,"09/17/2014"
"Veterinary",66977,"Ongoing","Cargill, Inc Corporate Headquarters","Wayzata","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (IL, IN, KS, KY, MO, NM, OK, TX)","V-151-2014","Class I","40 and 50 lb poly-paper bags of poultry feed labeled in part: Nutrena; Nature Wise; Chick Starter Grower; 18% Crumbles; Minneapolis, MN 55440; www.NutrenaNatureWise.com.","All lot codes between FL3121 - FL3325, AT3121 - AT3325, MN3121 - MN3325, and OC3121 - OC3325 ",".","1) 40 lb. bags: 7,765 bags; 2) 50 lb. bags: 12,592 bags","Cargill Animal Nutrition is conducting a recall of Nutrena Nature Wise Chick Starter Grower feeds in 40 and 50 lb bags due to incorrect levels of calcium.",11/22/2013,"11/22/2013",9/17/2014,"09/17/2014"
"Devices",66979,"Completed","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.","Z-0607-2014","Class II","IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.","Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520.",,"28 devices","Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.",11/8/2013,"11/08/2013",1/8/2014,"01/08/2014"
"Devices",66980,"Ongoing","EOS Imaging","Paris France",,"FR","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-0580-2014","Class II","steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. ","Software versions: 1.3, 1.4 and 1.5",,"36 units","Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation",11/29/2013,"11/29/2013",1/1/2014,"01/01/2014"
"Devices",66981,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0604-2014","Class II","STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.","Batch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106",,"4048 units total (4014 units in US)","Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.",11/26/2013,"11/26/2013",1/8/2014,"01/08/2014"
"Devices",66982,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) including DC and PR, except DE, SD, ND, and VT; and Internationally to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.","Z-0854-2014","Class II","GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic ","Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED13027435GA 2020913-002 SED13027444GA 2020913-002 SEW11456764HA M1176021-094955 SEW11487296HA M1176021-094955 SEW11487300HA M1176021-094955 SEW11487304HA M1176021-094955 SEW11487306HA M1176021-094955 SEW11487307HA M1176021-094955 SEW11487308HA M1176021-094955 SEW11487309HA M1176021-094955 SEW11487310HA M1176021-094955 SEW11487312HA M1176021-094955 SEW11487313HA M1176021-094955 SEW11487314HA M1176021-094955 SEW11487315HA M1176021-094955 SEW11487316HA M1176021-094955 SEW11487317HA M1176021-094955 SEW11497510HA M1176021-094955 SEW11497511HA M1176021-094955 SEW11497512HA M1176021-094955 SEW11497513HA M1176021-094955 SEW11497514HA M1176021-094955 SEW11497515HA M1176021-094955 SEW11497517HA M1176021-094955 SEW11497518HA M1176021-094955 SEW11497519HA M1176021-094955 SEW11497532HA M1176021-094955 SEW11497534HA M1176021-094955 SEW11497535HA M1176021-094955 SEW11497536HA M1176021-094955 SEW11497537HA M1176021-094955 SEW11497538HA M1176021-094955 SEW11497539HA M1176021-094955 SEW11497540HA M1176021-094955 SEW11497555HA M1176021-094955 SEW11497556HA M1176021-094955 SEW11497557HA M1176021-094955 SEW11497558HA M1176021-094955 SEW11497560HA M1176021-094955 SEW11497581HA M1176021-094955 SEW11497583HA M1176021-094955 SEW11497584HA M1176021-094955 SEW11497585HA M1176021-094955 SEW12049003HA M1176021-100869 SEW12059331HA M1176021-100713 SEW12316595HA M1176021-120906 SEW12316596HA M1176021-120906 SEW12357363HA M1176021-120906 SEW12357365HA M1176021-120906 SEW12357366HA M1176021-120906 SEW12357368HA M1176021-120906 SEW12357485HA M1176021-120906 SEW12357488HA M1176021-120906 SEW12357489HA M1176021-120906 SEW12357490HA M1176021-120906 SEW13068518HA M1176021-094955 SEW13193084HA M1176021-186679 SEW13193101HA M1176021-186640 SEW13193102HA M1176021-186640 SEW13203400HA M1176021-186640 SEW13244941HA M1176021-187302 SED11168563GA 2020913-002 SED12526653GA 2020913-003 SED12526658GA 2020913-003 SED12526659GA 2020913-003 SED12526672"," M1176021-192785 SEW13245048HA M1176021-192785 SEW13245060HA M1176021-192785 SEW13245061HA M1176021-192785 SEW13245062HA M1176021-192785 SEW13245063HA M1176021-192785 SEW13245066HA M1176021-192785 SEW13245067HA M1176021-192785 SEW13245069HA M1176021-192785 SEW13245099HA M1176021-192785 SEW13245105HA M1176021-192785 SEW13245106HA M1176021-192785 SEW13245107HA M1176021-192785 SEW13245108HA M1176021-192785 SEW13245110HA M1176021-192785 SEW13245111HA M1176021-192785 SEW13245112HA M1176021-192785 SEW13245114HA M1176021-192785 SEW13245115HA M1176021-192785 SEW13245116HA M1176021-192785 SEW13245117HA M1176021-192785 SEW13245118HA M1176021-192785 SEW13255201HA M1176021-192785 SEW13255205HA M1176021-192785 SEW13255206HA M1176021-192785 SEW13255207HA M1176021-192785 SEW13265660HA M1176021-192785 SEW13275954HA M1176021-192785 SEW13275972HA M1176021-192785 SEW13275987HA M1176021-192785 SEW13276005HA M1176021-192785 SEW13276024HA M1176021-192785 SEW13276025HA M1176021-192785 SEW13276026HA M1176021-192785 SEW13276027HA M1176021-192785 SEW13276030HA M1176021-192785 SEW13276031HA M1176021-192785 SEW13276032HA M1176021-192785 SEW13276033HA M1176021-192785 SEW13276034HA M1176021-192785 SEW13276035HA M1176021-192785 SEW13276036HA M1176021-192785 SEW13276038HA M1176021-192785 SEW13276040HA M1176021-192785 SEW13276041HA M1176021-192785 SEW13276042HA M1176021-192785 SEW13276043HA M1176021-192785 SEW13276053HA M1176021-192785 SEW13276068HA M1176021-192785 SEW13286165HA M1176021-192785 SEW13286166HA M1176021-192785 SEW13286167HA M1176021-192785 SEW13286168HA M1176021-192785 SEW13286169HA M1176021-192785 SEW13286171HA M1176021-192785 SEW13286176HA M1176021-192785 SEW13286177HA M1176021-192785 SEW13286178HA M1176021-192785 SEW13286179HA M1176021-192785 SEW13286180HA M1176021-192785 SEW13286181HA M1176021-192785 SEW13286182HA M1176021-192785 SEW13286186HA M1176021-192785 SEW13286187HA M1176021-192785 SEW13286189HA M1176021-192785 SEW13286191HA M1176021-192785 SEW13286192HA M1176021-192785 SEW13286193HA M1176021-192785 SEW13286197HA M117","40,239 (17,182 units US, 23,147 units OUS).","GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.",12/27/2013,"12/27/2013",2/5/2014,"02/05/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0289-14","Class II","Platelets Pooled Leukocytes Reduced","W036809811387; W036810808738; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0291-14","Class III","Blood and Blood Products for Reprocessing","W036810111220; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0287-14","Class II","Platelets","1536622; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0285-14","Class II","Fresh Frozen Plasma","1536622; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0290-14","Class II","Cryoprecipitated AHF","W036810111220; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0286-14","Class II","Red Blood Cells Leukocytes Reduced","1536622; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Biologics",66986,"Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Michigan; Switzerland; Florida; New York","B-0288-14","Class II","Red Blood Cells","W036809291050; W036810111220; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/30/2013,"10/30/2013",2/12/2014,"02/12/2014"
"Drugs",66988,"Ongoing","GlaxoSmithKline, LLC.","Zebulon","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-387-2014","Class II","Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00","Lot#: C636293, Exp: 06/15",,"10,469 Systems","Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.",11/6/2013,"11/06/2013",1/1/2014,"01/01/2014"
"Drugs",66988,"Ongoing","GlaxoSmithKline, LLC.","Zebulon","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-388-2014","Class II","Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07. ","Lot#: C636242, Exp: 06/15",,"9,743 cartridges","Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.",11/6/2013,"11/06/2013",1/1/2014,"01/01/2014"
"Devices",66990,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.","Z-0730-2014","Class II","Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.","Cat No. 00-1113-140-01; lot 75974340",,"1,534 units","The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.",11/4/2013,"11/04/2013",1/22/2014,"01/22/2014"
"Devices",66991,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to: Belgium and Canada.","Z-0815-2014","Class II","Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter. ","Lot REXC0467",,"200","Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.",12/6/2013,"12/06/2013",1/29/2014,"01/29/2014"
"Devices",66991,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to: Belgium and Canada.","Z-0814-2014","Class II","MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter. ","Lot REXC0931 and REXC0736",,"1358","Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.",12/6/2013,"12/06/2013",1/29/2014,"01/29/2014"
"Biologics",66993,"Ongoing","Fenwal Inc","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AR, FL, IA, ID, IN, MI, MN, MO, MT, NC, ND, OH, PA, TX, UT, VA, WI, WY)","B-0370-14","Class II","The PLASMACELL-C disposable set in overpouch is a single unit open system consisting of the PLASMACELL-C separation device (containing the membrane filter), the reinfusion reservoir, two (2) transducer protectors, two (2) solution spikes, one (1) female Luer for plasma container connection and one (1) male Luer for needle connection.","Model: 4R2256; Lot Numbers and Expiration Dates: FA13J23098, expires 10/31/2015; FA13J24153 expires 10/31/2015; FA13K07107 expires 11/30/2015; and, FA13K07115 expires 11/30/2015.",,"4 Lots","PLASMACELL-C Disposable Set for Use with SPIKESMART System, with a defect in the base of the blue vent cap on the reservoir assembly that may result in a leak of the reservoir assembly, was distributed. ",11/20/2013,"11/20/2013",2/5/2014,"02/05/2014"
"Food",66994,"Ongoing","Kettle Cuisine, Inc.","Chelsea","MA","US","Voluntary: Firm Initiated","E-Mail","MD, CT, IL, NY, MA WI","F-1138-2014","Class II","Phillips Food Service Lobster Bisque, 4 lb cryobag, frozen Item #45036 ","Code Dates: 3433830, 3401830, 3405330, 3406530, 3411530,3412030, 3412930, 3418130 Sell By dates from: 12/4/14 through 6/30/2015",,"3,299 cases (4 x 4lb)","Product contains undeclared wheat",11/26/2013,"11/26/2013",1/1/2014,"01/01/2014"
"Devices",66995,"Ongoing","Neuro Kinetics, Inc.","Pittsburgh","PA","US","Voluntary: Firm Initiated","E-Mail","Distributed USA (nationwide) and the country of Canada.","Z-0966-2014","Class II","Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. ","Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1",".","148","The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process. ",11/21/2013,"11/21/2013",2/19/2014,"02/19/2014"
"Devices",66996,"Ongoing","Medrad Mr Inc","Warrendale","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: Canada.","Z-0810-2014","Class II"," Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor. ","P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.",,"922 units","The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.",11/21/2013,"11/21/2013",1/29/2014,"01/29/2014"
"Biologics",66997,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Nebraska; Iowa; New Jersey; Texas","B-0299-14","Class II","Platelets Pheresis Leukocytes Reduced","W037913565215; W037913564243; W037913564243; W037913565346; W037913565218; W037913565218; ",,"6","Blood products, tested using a pH meter that had not been calibrated, were distributed.",10/18/2013,"10/18/2013",2/12/2014,"02/12/2014"
"Biologics",66998,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota","B-0296-14","Class II","Platelets Pheresis Leukocytes Reduced","W201713801086; W201713801086; W201713801086; ",,"3 Units ","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",10/14/2013,"10/14/2013",2/12/2014,"02/12/2014"
"Biologics",66999,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-0301-14","Class III","Plasma Frozen within 24 hours (FP24)","W071213035788; ",,"1","Blood products, labeled with extended expiration dates, were distributed. ",10/31/2013,"10/31/2013",2/12/2014,"02/12/2014"
"Biologics",66999,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-0300-14","Class III","Red Blood Cells Leukocytes Reduced","W071213035788; ",,"1","Blood products, labeled with extended expiration dates, were distributed. ",10/31/2013,"10/31/2013",2/12/2014,"02/12/2014"
"Biologics",67000,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","MO","B-0265-14","Class II","Red Blood Cells Leukocytes Reduced","W045013051168",,"1 unit","Blood product, collected from a donor who may have traveled to a malarial endemic area, was distributed.",10/17/2013,"10/17/2013",1/29/2014,"01/29/2014"
"Biologics",67001,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","FAX","KS","B-0266-14","Class II","Red Blood Cells Leukocytes Reduced","W045013021918; W045013051172",,"2 units","Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed.",10/17/2013,"10/17/2013",1/29/2014,"01/29/2014"
"Devices",67002,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.","Z-0616-2014","Class II","SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. ","Model #6500 & 7500",,"6,028 units","Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.",11/21/2013,"11/21/2013",1/8/2014,"01/08/2014"
"Devices",67003,"Completed","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including the states of CA, KY, OH, RI, and TN.","Z-0579-2014","Class II","OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery. ","Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770",,"40"," Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. ",11/7/2013,"11/07/2013",1/1/2014,"01/01/2014"
"Devices",67004,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.","Z-1071-2014","Class I","GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. ","QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274 ",,"12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown","Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.",10/1/2013,"10/01/2013",3/5/2014,"03/05/2014"
"Devices",67004,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.","Z-1072-2014","Class I","GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. ","HDJQ52826, HDJR52093, HDJR50704, HDJR54140, HDJR54141, HDJR54142, HDJR54143, HDJQ52878, HDJS50670, HDJS50671,HDJS50672, HDJS50678, HDJS50679, HDJS50681, HDJS50682, HDJS50684, HDJS50686, 208600, 208601, 208610, HDJS51010, HDJR56405, HDJS52316, HDJP51364, HDJP51369, HDJP51376, HDJP51379, HDJP51380, HDJP51381, HDJR56387, HDJR56388, HDJR56389, HDJR56390, HDJR56391, HDJR56666, HDJN50977, HDJN50978, HDJP51983, HDJQ53071, HDJM51282, HDJM51283, HDJM51284, HDJM51285, HDJM51286, HDJM51287, HDJM51288, HDJM51289, HDJM51290, HDJM51291, HDJM51292, HDJM51293, HDJM51294, HDJM51295, HDJQ50845, HDJQ50846, HDJQ50361, HDJQ50362, HDJQ50363, HDJQ50364, HDJQ50365, HDJQ52097, HDJM51403, HDJM51871, HDJP52195, HDJP52198, HDJP52199, HDJP52200, HDJP52201, HDJP52202, HDJP52203, HDJP52204, HDJP52205, HDJP52206, HDJP52207, HDJN52273, HDJN52274, HDJN52275, HDJN52276, HDJP50604, HDJP50605, HDJM50831, HDJM50832, HDJM50833, HDJS51808, HDJM50053, HDJM50054, HDJM50098, HDJM50099, HDJM50101, HDJM50103, HDJM50105, HDJM50124, HDJM50388, HDJP50315, HDJP50369, HDJP50371, HDJR58044, HDJR58045, HDJP51614, HDJP51615, HDJN52372, HDJN52373, HDJS50504, HDJS50505, HDJM50027, HDJL50483, HDJM50022, HDJM50024, HDJM50411, HDJS50708, HDJS52037, HDJR57284, HDJR57285, HDJN52002, HDJN50436, HDJN50437, HDJP50552, HDJP50553, HDJQ50808, HDJP50078, HDJP50083, HDJQ52336, HDJQ52337, HDJQ52036, HDJQ52037, HDJQ52038, HDJQ52039, HDJS51666, HDJP52689, HDJR56613, HDJQ52689, HDJQ51784, HDJQ51785, HDJQ51786, HDJQ51787, HDJS50825, HDJS50826, HDJS50827, HDJS50828, HDJS50829, HDJS50830, HDJS50831, HDJS50832, HDJR56841, HDJR56842, HDJR56843, HDJR56844, HDJR56845, HDJR56846, HDJR56847, HDJR56848, HDJR56849, HDJR56850, HDJR56851, HDJR56852, HDJR56853, HDJS51131, HDJQ52031, HDJQ50663, HDJS50931, HDJS50932, HDJQ51956, HDJM50250, HDJM50251, HDJM50252, HDJM50253, HDJM50254, HDJM50255, HDJM52126, HDJM52127, HDJM52128, HDJM52129, HDJQ50066, HDJQ50067, HDJR50734, HDJR50735, HDJR50762, HDJR50763, HDJR50764, HDJR58093, HDJR58094, HDJR58095, HDJS50028, 206180, HDJR52011, HDJR52012, 206581, HDJR"," HDJR56305 HDJR56306 HDJN50300 HDJN52383 HDJN51774 HDJN51775 HDJP51521 HDJP51522 HDJQ51547 HDJQ51902 HDJQ51903 HDJQ51904 HDJQ51905 HDJQ51906 HDJQ51907 HDJQ51908 HDJQ51909 HDJQ51910 HDJQ51911 HDJQ51912 HDJS52525 HDJR57208 HDJR57226 HDJR57227 HDJR57228 HDJR57229 HDJR57231 HDJR57232 HDJR57233 HDJR57257 HDJR56855 HDJR56856 HDJR56857 HDJR56858 HDJR56859 HDJR56860 HDJR56861 HDJR56862 HDJR56864 HDJR56865 HDJR57004 HDJP50571 HDJR50778 HDJR52096 HDJP52196 HDJP52197 HDJR50584 HDJR50585 HDJR50586 HDJS52119 HDJS52120 HDJS52502 HDJS52503 HDJN50602 HDJS50440 HDJS50444 HDJQ51991 HDJS50525 HDJM51083 HDJM51894 HDJM51895 HDJM51896 HDJS52907 HDJS52908 HDJS52909 HDJS52910 HDJS52911 HDJS52912 HDJS52913 HDJR58037 HDJR58038 HDJM51636 HDJR54266 HDJR54267 HDJR57029 HDJR57030 HDJS51524 HDJS51525 HDJS51526 HDJS51527 HDJS51528 HDJS51529 HDJS51530 HDJS51531 HDJS51532 HDJS51533 HDJM52367 HDJM52369 HDJM52374 HDJM52375 HDJN50240 HDJN50241 HDJP51132 HDJP51133 HDJM52134 HDJM52150 HDJM52151 HDJM52152 HDJM52153 HDJM52154 HDJM52155 HDJM52143 HDJM52144 HDJM52145 HDJM50259 HDJM50248 HDJM50249 HDJS51957 HDJS51958 HDJP52452 HDJP52453 HDJP52454 HDJP52456 HDJP52457 HDJP52458 HDJP52459 HDJP52460 HDJP52450 HDJP52451 HDJN50207 HDJN50208 HDJP52083 HDJP52084 HDJP52085 HDJP52086 HDJP52087 HDJP52088 HDJP52089 HDJP52090 HDJP52091 HDJP52092 HDJP52093 HDJP52094 HDJP52095 HDJP52096 HDJP52097 HDJP52098 HDJP52099 HDJP52100 HDJP52101 HDJP52102 HDJP52131 HDJP52132 HDJP52133 HDJP52134 HDJP52135 HDJR56483 HDJP51566 HDJP50179 HDJN51224 HDJN51225 HDJN51226 HDJN51227 HDJN51228 HDJN51229 HDJN51230 HDJN51231 HDJQ51046 HDJQ51047 HDJQ50439 HDJQ52816 HDJP50983 HDJP50984 HDJP50986 HDJP50987 HDJP50988 HDJP50989 HDJP50992 HDJP50993 HDJP50994 HDJP50995 HDJP50996 HDJP50997 HDJP50998 HDJP50999 HDJP51000 HDJP51001 HDJP51002 HDJP51003 HDJP51004 HDJP51181 HDJP51182 HDJP51183 HDJR50265 HDJR50266 HDJR50267 HDJR50268 HDJR50269 HDJR50270 HDJR50271 HDJR50272 208113 208119 208120 208121 208122 208129 208130 208131 208133 208149 208157 208158 208161 208163 208167 208168 208173 208184 208205 2","12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown","Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.",10/1/2013,"10/01/2013",3/5/2014,"03/05/2014"
"Devices",67004,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.","Z-1070-2014","Class I","GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. ","QABR50042, QABR50036, QABR50082, QABR50110, QABR50111, QABR50031, QABR50008, QABS50107, QABS50108, QABS50139, QABR50009, QABR50043, QABS50017, QABS50072, QABS50129, QABS50076, QABR50005, QABR50060, QABR50035, QABS50084, QABS50100, QABR50038, QABR50023, QABR50095, QABR50097, QABS50151, QABS50153, QABS50154, QABR50137, QABR50144, QABR50002, QABR50001, QABR50015, QABS50119, QABS50122, QABR50112, QABR50129, QABS50098, QABS50099, QABS50101, QABR50124, QABR50141, QABR50028, QABS50148, QABR50109, QABR50030, QABR50217, QABR50159, QABR50160, QABR50161, QABR50163, QABR50165, QABR50166, QABR50167, QABR50172, QABR50173, QABR50174, QABR50175, QABR50176, QABR50177, QABR50178, QABR50179, QABR50180, QABR50181, QABR50182, QABR50183, QABR50184, QABR50185, QABR50186, QABR50187, QABR50188, QABR50189, QABR50190, QABR50191, QABR50192, QABR50193, QABR50195, QABR50209, QABR50211,QABR50212, QABR50213, QABR50214, QABR50216, QABR50219, QABR50220, QABR50222, QABR50223, QABR50224, QABR50225,QABR50232, QABR50233, QABR50234, QABR50235, QABR50236, QABR50237, QABS50120, QABS50130, QABS50132, QABR50218, QABR50221, QABR50019, QABR50032, QABR50139, QABR50142, QABR50164, QABR50194, QABR50198, QABR50199, QABR50130, QABR50046, QABR50025, QABR50058, QABR50059, QABR50033, QABR50039, QABR50061, QABR50062, QABR50063, QABR50006, QABR50048, QABS50052, QABS50053, QABS50067, QABS50028, QABS50050, QABS50051, QABR50047, QABS50083, QABR50020, QABS50025, QABS50029, QABR50016, QABR50169, QABR50170, QABR50171, QABS50071, QABS50118, QABS50147, QABR50040, QABR50044, QABR50078, QABR50084, QABR50150, QABR50231, QABR50014, QABS50077, QABS50078, QABS50079, QABS50134, QABS50140, QABS50131, QABR50208, QABR50210, QABS50018, QABS50019, QABS50150, QABS50149, QABS50160, QABR50041, QABR50022, QABR50017, QABR50010, QABR50012, QABR50136, QABR50138, QABS50024, QABS50048, QABS50049, QABR50135, QABR50143, QABR50145, QABR50146, QABR50147, QABR50162, QABR50196, QABR50197, QABR50200, QABR50201, QABR50003, QABR50051, QABR50052, QABR50057, QABR50096, QABR50098, QABR50099, QABR50081, Q",,"12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown","Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.",10/1/2013,"10/01/2013",3/5/2014,"03/05/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0638-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2211-L LN 2962",,"96 cases (288 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0641-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2220-N LN 1793",,"48 cases (384 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0637-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2210-L 1) LN 0662 2/2015 2) LN 2052 6/2015 ",,"13 cases (312 units); 24 cases (1176 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0640-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell 2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels) A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2215-L LN 2052",,"96 cases (1920 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0635-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016",,"50 cases (4800 units); 96 cases (576 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0639-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2215-N LN 1203 and 1553",," 1203 - 96 cases (4128 units) ; 1553 -96 cases (3548 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Devices",67005,"Ongoing","Ansell Sandel Medical Industries LLC","Chatsworth","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.","Z-0636-2014","Class II","Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.","510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016 ",,"15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)","Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. ",11/12/2013,"11/12/2013",1/15/2014,"01/15/2014"
"Biologics",67007,"Terminated","Csl Plasma Inc","Wichita","KS","US","Voluntary: Firm Initiated","Other","IL and Switzerland","B-0264-14","Class II","Source Plasma","41501483911; 41501455030; 41501477722",,"3 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",9/11/2013,"09/11/2013",1/29/2014,"01/29/2014"
"Biologics",67008,"Terminated","DCI Biologicals, LLC","Jonesboro","AR","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0267-14","Class II","Source Plasma","JB0359632; JB0360524",,"2 units","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.",8/28/2013,"08/28/2013",1/29/2014,"01/29/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1367-2014","Class II","Forbidden RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015 UPC# 7 08953 60101 4 ",,"18,000 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1366-2014","Class II","Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan Ready in 4 minutes; Net Wt. 10 oz; (283g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015 UPC# 7 08953 60203 5 ",,"8568 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1368-2014","Class II","Jade Pearl RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015 UPC# 7 08953 60102 1 ",,"18,150 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1364-2014","Class II","Organic Forbidden RICE RAMEN; Gluten Free/Vegan, Black Rice Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015; UPC# 7 08953 60201 1 ",,"8568 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1369-2014","Class II","Millet & Brown RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015 UPC# 7 08953 60103 8 ",,"18,000 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Food",67009,"Ongoing","Lotus Foods Inc","Richmond","CA","US","Voluntary: Firm Initiated","E-Mail","CA, NH, TX","F-1365-2014","Class II","Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) ramen per bag USDA Organic; Lotus Foods, Richmond, CA.","Lot # 07.31.2015 UPC# 7 08953 60202 8 ",,"8496 bags","Customer complaint of mold on Lotus Foods Ramen.",11/15/2013,"11/15/2013",1/8/2014,"01/08/2014"
"Drugs",67010,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-382-2014","Class III","Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9. ","Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14",,"379,463 inhalers","Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. ",12/4/2013,"12/04/2013",1/1/2014,"01/01/2014"
"Devices",67011,"Ongoing","Microgenics Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.","Z-1930-2014","Class III","MAS Omni Immune PRO Controls","Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.",".","1393","The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.",12/2/2013,"12/02/2013",7/2/2014,"07/02/2014"
"Devices",67011,"Ongoing","Microgenics Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.","Z-1929-2014","Class III","MAS Omni Immune Controls","Part Number Lot number OIM-101 OIM15091 OIM-202 OIM15092 OIM-303 OIM15093 OIM-SP OIM1509S. All lots have an expiration date of 9/30/2015.",".","3185","The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.",12/2/2013,"12/02/2013",7/2/2014,"07/02/2014"
"Devices",67012,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.","Z-0584-2014","Class II","Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.","All Essenta DR x-ray Systems",,"424 units","X-ray system C-arm casting may loosen and fall ",12/5/2013,"12/05/2013",1/8/2014,"01/08/2014"
"Devices",67013,"Ongoing","Sorin Group Italia S.r.l.","Saluggia, VC",,"IT","Voluntary: Firm Initiated","Letter","Nationwide.","Z-0805-2014","Class II","ORCHESTRA/ORCHESTRA PLUS Programmer","ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1",,"1,718","Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.",11/20/2013,"11/20/2013",1/29/2014,"01/29/2014"
"Devices",67014,"Ongoing","Mckesson Information Solutions LLC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","MO, NY, TN, WV and France.","Z-0556-2014","Class II","McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).","MR 12.0",,"6 units","When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.",10/15/2013,"10/15/2013",1/1/2014,"01/01/2014"
"Food",67015,"Ongoing","Coca Cola Bottling Company United-East, LLC","Birmingham","AL","US","Voluntary: Firm Initiated","Letter","LA and MS","F-1336-2014","Class II","Diet Coke, 2L, 67.6 FL OZ (2 QT 3.6 FL OZ), UPC 4900005011","FEB1714GBA2 with time stamps: 1830 through 1908 ",,"398 cases","One lot of Diet Coke, 2L, may contain regular Cherry Coke which contains sugar.",11/27/2013,"11/27/2013",1/8/2014,"01/08/2014"
"Devices",67016,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.","Z-1202-2014","Class II","Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray","model numbers 10848280, 10848281, 10848282, and 10848283. ",".","19","There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40). ",12/5/2013,"12/05/2013",4/2/2014,"04/02/2014"
"Devices",67017,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.","Z-0967-2014","Class II","BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.","Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032",".","25 units","Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient's body, potentially leading to infection and serious injury.",11/15/2013,"11/15/2013",2/19/2014,"02/19/2014"
"Biologics",67019,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","PA","B-0269-14","Class II","Platelets Pheresis Leukocytes Reduced","W050913056612",,"1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",10/15/2013,"10/15/2013",1/29/2014,"01/29/2014"
"Biologics",67019,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","PA","B-0268-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050913056612",,"1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.",10/15/2013,"10/15/2013",1/29/2014,"01/29/2014"
"Biologics",67020,"Terminated","Southern California Permanente Medical Group","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0271-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W072113001849",,"1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",10/24/2013,"10/24/2013",1/29/2014,"01/29/2014"
"Devices",67021,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.","Z-0929-2014","Class II","ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems","Lot # Expiry Date 19002A58 06/09/2014; 19088A58 06/09/2014; 21376A58 06/09/2014; 25657A59 09/29/2014; 26830A59 09/29/2014; 28447A59 09/29/2014.",,"1294 (296 units US)","ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. ",12/18/2013,"12/18/2013",2/12/2014,"02/12/2014"
"Devices",67021,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.","Z-0930-2014","Class II","ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems","Lot # Expiry Date 18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.",,"1294 (144 units US)","ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. ",12/18/2013,"12/18/2013",2/12/2014,"02/12/2014"
"Devices",67025,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.","Z-0622-2014","Class II","Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.","1094085, 1101479, 1101647, 1102403, 1102807, 1104174, 1110043, 1120817, 1130797, 1131331, 1131660",,"78 packages","Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.",11/13/2013,"11/13/2013",1/15/2014,"01/15/2014"
"Devices",67025,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.","Z-0621-2014","Class II","Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.","1091271, 1094671, 1104165, 1104631, 1104813, 1110404, 1120638, 1120816, 1122316, 1123940, 11311659, 1132989, 1133427",,"194 packages","Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open",11/13/2013,"11/13/2013",1/15/2014,"01/15/2014"
"Drugs",67026,"Completed","Brookfield Prescription Center Inc","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI","D-1252-2014","Class I","Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.","Lot #: 10292013@15, Beyond Use Date: 11/28/2013",,"25 Vials","Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.",11/13/2013,"11/13/2013",4/30/2014,"04/30/2014"
"Devices",67027,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and USA Nationwide.","Z-0940-2014","Class II","Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. ","ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265 ",".","3759","The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).",11/6/2013,"11/06/2013",2/19/2014,"02/19/2014"
"Biologics",67028,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","Letter","Nationwide; GERMANY, AUSTRIA, CANADA, NOVIA SCOTAIA, COLOMBIA, LEBANON, GREECE, PERU, RUSSIA, INDIA, MEXICO, JAPAN, ARGENTIAN, IRELAND, ICE.A D ITALY, NUMBAI, TURKEY, THAILAND, UNITEDKINGDOM, SINGAPORE, FRANCE, BOLIVIA, ESTONIA, ISRAEL, NEW ZEALND, SPAIN, PAKISTAN, INDONESIA, ROMANIA, CHINA, TAIWAN, VIETNAM.","B-0282-14","Class II","AllSet+'' Gold HLA-A Low Res SSP, 54310D; UniTray A Locus SSP, 7860010; UniTray A Locus SSP w/ Taq, 7860110; AllSet+'' Gold HLA-ABC Low Res SSP, 54340D; UniTray ABC SSP, 7800010; UniTray ABC SSP w/ Taq, 7800110; AllSet+'' Gold HLA-AB/DR Low Res SSP, 54350D; UniTray AB/DR SSP, 810010; UniTray AB/DR SSP w/ Taq, 7810110; AllSet+'' Gold HLA-AB/DR/DQ Low Res SSP, 54360D; UniTray AB/DR/DQ SSP, 7850010; UniTray AB/DR/DQ SSP w/ Taq 7850110.","54310D - 0221256853, 0221385981; 860010 - 0221221256, 0221256848; 7860110 - 02212568481376350, 02212568481433358, 02212568481445455; 54340D - 0381249868, 0381306788, 038 360419, 0381391657; 7800010 - 0381221266, 0381322136; 7800110 03812212661319090, 13447951346089, 03812212661353301, 135727113598341369064, 03812212661375756, 03812212661389660, 03812212661393695, 1396220, 03813221361401001, 03813221361405131, 141701414191601420378, 03813221361427117, 142788914367521438256, 03813221361452441; 54350D - 0361255129, 0361304515, 0361357615; 7810010 - 0361316325; 7810110 -03613163251409712; 54360D - 0291247232, 0291293558, 0291306794, 0291362561, 0291395129; 7850010 - 0291255127, 0291414737; 7850110 - 02912551271345427, 02912551271360761, 02912551271378014, 02912551271393696, 02912551271419162, 02912551271427119, 1439780 ",".","12 units","HLA typing assay, associated with false negative results, were distributed. ",9/19/2013,"09/19/2013",2/19/2014,"02/19/2014"
"Devices",67029,"Ongoing","Arjo Hospital Equipment AB","Eslov",,"SE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates","Z-0019-2015","Class II","ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. ","01516 , P0106045 , P0106415 , P0106416 , P0106417 , P0107780 , P0108277 , P0108715 , P0108716 , P0108717 , P0109782 , P0109783 , P0109954 , P0110233 , P0111026 , P0111276 , P0111872 , P0111873 , P0112155 , P0112156 , P0112157 , P0112158 , P0112955 , P0113151 , P0113364 , P0115133 , P0115301 , P0115302 , P0116051 , P0116614 , P0116615 , P0117468 , P0117880 , P0117881 , P0122188 , P0122460 , P0125766 , P0125767 , P0127623 , P0127849 , P0128225 , P0128420 , P0128875 , P0129052 , P0129155 , P0129451 , P0129572 , P0130354 , P0132046 , P0132726 , P0133301 , P0133777 , P0133835 , P0133836 , P0133837 , P0134515 , P0135473 , P0138875 , P0149304 , P0149305 , P0160131 , P0163554 , P0164049 , P0164216 , P0164438 , P0164532 , P0165078 , P0165079 , P0165080 , P0165081 , P0166465 , P0166466 , P0166834 , P0167425 , P0167651 , P0167682 , P0169577 , P0170398 , P0170970 , P0172128 , P0172129 , P0172423 , P0172424 , P0172425 , P0172426 , P0172623 , P0172718 , P0175806 , P0175807 , P0177061 , P0178143 , P0181261 , P0183905 , P0186868 , P0186870 , P0188652 , P018869 , P0189663 , P0189664 , P019147 , P019148 , P019149 , P019150 , P019151 , P019275 , P019276 , P019277 , P019283 , P019322 , P019323 , P019326 , P019327 , P019801 , P019802 , P019803 , P019804 , P020452 , P020453 , P021332 , P021333 , P021792 , P021794 , P022018 , P022019 , P023898 , P023901 , P024623 , P025150 , P025151 , P026436 , P026437 , P026438 , P026439 , P026440 , P026619 , P026620 , P026621 , P026804 , P027081 , P027082 , P027321 , P027322 , P027323 , P027744 , P027953 , P028299 , P030415 , P030416 , P030863 , P030864 , P031143 , P031144 , P031530 , P034344 , P034345 , P034346 , P034424 , P034425 , P034542 , P034611 , P035841 , P035976 , P035977 , P036591 , P039475 , P039476 , P039591 , P039749 , P041222 , P041223 , P041615 , P041616 , P041932 , P041972 , P0",,"1,695 beds (worldwide)","There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.",3/17/2014,"03/17/2014",10/15/2014,"10/15/2014"
"Devices",67029,"Ongoing","Arjo Hospital Equipment AB","Eslov",,"SE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates","Z-0019-2015","Class II","ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. ","2359 , P032387 , P034422 , P034423 , P034732 , P035210 , P035600 , P035705 , P036000 , P037150 , P038617 , P038752 , P038753 , P038894 , P039590 , P040635 , P040812 , P041044 , P041473 , P041617 , P042386 , P042430 , P042473 , P042474 , P042595 , P042596 , P042657 , P042727 , P042728 , P042842 , P043140 , P043232 , P043521 , P045035 , P045367 , P046255 , P046256 , P047337 , P047480 , P049467 , P049468 , P050432 , P050489 , P052233 , P056073 , P056861 , P056862 , P058743 , P060073 , P060179 , P060529 , P060857 , P060858 , P060918 , P060919 , P060920 , P062505 , P062609 , P062847 , P063301 , P063853 , P064395 , P064483 , P064500 , P064575 , P064719 , P064815 , P064816 , P065140 , P065141 , P065193 , P065314 , P065400 , P065401 , P066218 , P066570 , P066615 , P067019 , P067086 , P067087 , P067393 , P067441 , P067482 , P068002 , P068266 , P068700 , P068988 , P070081 , P070435 , P070443 , P070713 , P070770 , P071349 , P071350 , P071451 , P073778 , P073847 , P073934 , P075170 , P076716 , P076719 , P076849 , P076950 , P078419 , P079322 , P079323 , P080384 , P083938 , P084481 , P084594 , P085062 , P086507 , P086508 , P086830 , P086831 , P087584 , P087585 , P087853 , P088197 , P088210 , P088272 , P088570 , P088655 , P092355 , P093705 , P093834 , P094960 , P094961 , P096673 , P096674 , P096675 , P097132 , P097311 , P097500 , P099166 , P099167 , P099444 , P099445 , P099721 , P100052 , P100053 , PO106703 , PO106704 , PO106706 , PO29057 , PO29058 , PO29059 , PO84691 , PO84692 , PO84693 , PO84694 , PO84695 , PO84696 , PO84697 , PO84698 ; 1) Model Number C1080; Serial Numbers (US): 416930 , 766425 , 473239 , 773201 , 851902 , 416917 , 491904 , 545574 , 473246 , 416932 , 473245 , 473238 , 82730 , 783942 , 416919 , 473243 , 545569 , 473234 , 416920 , 416926 , 473236 , 83",,"1,695 beds (worldwide)","There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.",3/17/2014,"03/17/2014",10/15/2014,"10/15/2014"
"Devices",67029,"Ongoing","Arjo Hospital Equipment AB","Eslov",,"SE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates","Z-0019-2015","Class II","ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. ","1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 , 475309 , 530882 , 554079 , 554082 , 566463 , 584837 , 586554 , 592203 , 592204 , 592205 , 592206 , 597027 , 597028 , 605859 , 646152 , 664632 , 680670 , 680699 , 693924 , 695671 , 699563 , 712231 , 714227 , 714228 , 714229 , 716809 , 720277 , 725622 , 731631 , 745781 , 745782 , 747354 , 747355 , 748161 , 748162 , 748635 , 761635 , 766430 , 766430 , 766431 , 766431 , 771194 , 771195 , 771197 , 771198 , 798571 , 816742 , 821563 , 821564 , 821704 , 821705 , 821706 , 821707 , 822714 , 823713 , 823713 , 823714 , 832524 , 832525 , 832526 , 832527 , 832528 , 840918 , 840919 , 840919 , 840920 , 840920 , 840922 , 840923 , 840924 , 840925 , 840947 , 840948 , 840949 , 840950 , 847439 , 853387 , 855259 , 855260 , 855261 , 855262 , 871837 , 871840 , 871841 , 871842 , 871843 , 872720 , 873306 , 873307 , 873307 , 881203 , 881204 , 881205 , 881206 , 881207 , 889938 , 889939 , 901232 , 901233 , 901234 , 901236 , 901237 , 901244 , 904448 , 904449 , 904449. , 913969 , 916105 , 916108 , 924589 , 925887 , 929764 , 929772 , 945149 , 945151 , 945154 , 945160 , 8401918 , 648568Z1894 , 648569Z1894 , C1000 , M/M-1 , M/M-10 , M/M-2 , M/M-3 , M/M-4 , M/M-5 , M/M-6 , M/M-7 , M/M-8 , M/M-9 , P0100097 , P0100172 , P0100337 , P0100523 , P0100655 , P0100723 , P0101916 , P0101927 , P0101928 , P0101929 , P0101930 , P0101931 , P0102404 , P0102894 , P0102895 , P0102896 , P0102897 , P0102898 , P0103581 , P0103582 , P0103583 , P0106046 , P0106705 , P0106707 , P0108275 , P0108276 , P0109784 , P0110620 , P0111754 , P0114163 , P0114164 , P0115132 , P0118357 , P0118358 , P0120283 , P0120855 , P0120862 , P0121025 , P0121307 , P0121308 , P0121605 , P0121857 , P0122187 , P0122459 , P0125170 , P0126006 , P0126089 , P0126317 , P0126318 , P0126326 , ",,"1,695 beds (worldwide)","There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.",3/17/2014,"03/17/2014",10/15/2014,"10/15/2014"
"Devices",67030,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the country of Canada.","Z-0800-2014","Class II","Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.","ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01",,"1563","An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result. ",12/17/2013,"12/17/2013",1/29/2014,"01/29/2014"
"Biologics",67031,"Terminated","American Natl Red Cross Mid Atlantic Region","Norfolk","VA","US","Voluntary: Firm Initiated","Other","CA","B-0270-14","Class II","Blood and Blood Products for Reprocessing","W20291302243900",,"1 unit","Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",10/30/2013,"10/30/2013",1/29/2014,"01/29/2014"
"Biologics",67032,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0273-14","Class II","Fresh Frozen Plasma","W036811257824",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/10/2013,"11/10/2013",2/19/2014,"02/19/2014"
"Biologics",67032,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0274-14","Class II","Red Blood Cells Leukocytes Reduced","W036811257824",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/10/2013,"11/10/2013",2/19/2014,"02/19/2014"
"Biologics",67032,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0272-14","Class II","Platelets Pooled Leukocytes Reduced","W036811822421",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/10/2013,"11/10/2013",2/19/2014,"02/19/2014"
"Food",67033,"Completed","Nestle Prepared Foods Company","Haverhill","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Georgia & Pennsylvania","F-1341-2014","Class II","Joseph's Gourmet Pasta and Sauces- Asiago and Garlic Tortelloni (par cooked). Sold Frozen in 5 lb. plastic bags for food service Item Number: 22273 (G11008331) UPC Code: 00048769222738 ","Lot Codes: 13311, 13315, 13316",,"1121 Cases (6 x 5 Lb). Net Wt . 30 lbs","Potential for foreign material",12/4/2013,"12/04/2013",1/8/2014,"01/08/2014"
"Devices",67034,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.","Z-0646-2014","Class II","Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.","Lot Numbers: 2358702 ",,"54000","Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes",7/10/2013,"07/10/2013",1/15/2014,"01/15/2014"
"Devices",67034,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.","Z-0643-2014","Class II","Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.","Lot Number: 2357318",,"93700","Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes",7/10/2013,"07/10/2013",1/15/2014,"01/15/2014"
"Devices",67034,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.","Z-0642-2014","Class II","Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.","Lot Numbers: 2340530, 2344163, 2353091, 2357317, 2377316 ",,"363015","Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes",7/10/2013,"07/10/2013",1/15/2014,"01/15/2014"
"Devices",67034,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.","Z-0644-2014","Class II","Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.","Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319",,"506925","Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes",7/10/2013,"07/10/2013",1/15/2014,"01/15/2014"
"Devices",67034,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.","Z-0645-2014","Class II","Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.","Lot Numbers: 2356156, 2358706 ",,"108000","Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes",7/10/2013,"07/10/2013",1/15/2014,"01/15/2014"
"Devices",67035,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to the following countries: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MONGOLIA MOROCCO NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN","Z-0613-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician","Serial numbers ranging: From US00100100 to US00210461",,"64,972","Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and",4/10/2013,"04/10/2013",1/8/2014,"01/08/2014"
"Devices",67036,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.","Z-0605-2014","Class II","VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.","Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.",,"1,238 boxes","STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.",9/10/2013,"09/10/2013",1/8/2014,"01/08/2014"
"Food",67037,"Terminated","Safeway Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","E-Mail","Southern CA","F-1383-2014","Class III","Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg) 12 x 3 lb bags per case: Product of China: Packed in Canada Safeway, Pleasanton, CA.","Best before May 21, 2015: Packed on November 21, 2013: UPC: 0 21130 09197 3",,"22 cases (12 x 3 lb bags per case)","Product on hold pending FDA testing that found 0.015 ppm of the pesticide chlorafluazuron was inadvertently released to Safeway warehouses and a few retail stores.",12/5/2013,"12/05/2013",1/15/2014,"01/15/2014"
"Devices",67038,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV and Puerto Rico; and countries of Canada, Espana, France, Ireland, and Slovenia.","Z-1126-2014","Class II","*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.","*** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G ",,"*** 1) List Number 126970465: 21,860 units; *** 2) List Number 127200465 : 20,256 units; *** 3) List Number 046419701 : 26,900 units ","Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.",10/25/2013,"10/25/2013",3/12/2014,"03/12/2014"
"Devices",67039,"Completed","Materialise USA LLC","Plymouth","MI","US","Voluntary: Firm Initiated","Telephone","US Distribution: MO only.","Z-0628-2014","Class II","REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.","Lot 094929",,"1 ","Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. ",11/26/2013,"11/26/2013",1/15/2014,"01/15/2014"
"Devices",67040,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"US Distribution: including states of: MI, OH, and TX.","Z-0630-2014","Class II","Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE","Lot 50731155 Color code Purple ",,"5 boxes (50 units)","The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump. ",12/6/2013,"12/06/2013",1/15/2014,"01/15/2014"
"Devices",67042,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Distributed in China and Spain.","Z-0581-2014","Class II","REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.","Batch No. 12BM04836",,"38 units","One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.",11/25/2013,"11/25/2013",1/1/2014,"01/01/2014"
"Devices",67043,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0744-2014","Class II","STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.","not available",,"5584 units","Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. ",12/16/2013,"12/16/2013",1/22/2014,"01/22/2014"
"Devices",67043,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0745-2014","Class II","STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.","not available",,"233 units","Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. ",12/16/2013,"12/16/2013",1/22/2014,"01/22/2014"
"Devices",67043,"Ongoing","Advanced Sterilization Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0746-2014","Class II","STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.","not available",,"2366 units","Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. ",12/16/2013,"12/16/2013",1/22/2014,"01/22/2014"
"Devices",67044,"Ongoing","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.","Z-0713-2014","Class II","pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).","Part #: 942-042, Lot #: R0971",,"209 boxes/6 membranes","RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.",6/10/2013,"06/10/2013",1/22/2014,"01/22/2014"
"Drugs",67045,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide.","D-395-2014","Class II","0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.","Lot #32-484-EV, 32-485-EV Exp: 2/2015.",,"65109 vials","Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.",10/11/2013,"10/11/2013",1/8/2014,"01/08/2014"
"Devices",67046,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide and OUS.","Z-0570-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.","Software vwersions: F.02, R.02, 9.xx or any earlier versions Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade ",,"18,529 units","MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg",12/10/2013,"12/10/2013",1/1/2014,"01/01/2014"
"Devices",67047,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0798-2014","Class II","DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. ","Catalog Numbers: 8551046, 8791345, 1333483, 8649253, 8864605, 1155118, 1295088, 1666700, 1845122, 1671841, 8245607, 8531675, 8966780; Service Code: 8087",,"493 units Total (107 units domestically & 386 units internationally)","Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.",11/25/2013,"11/25/2013",1/29/2014,"01/29/2014"
"Devices",67047,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0797-2014","Class II","DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. ","Catalog Numbers: 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, 1030485; Service Code: 7171",,"840 units Total (181 units domestically & 659 units internationally)","Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.",11/25/2013,"11/25/2013",1/29/2014,"01/29/2014"
"Devices",67047,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0796-2014","Class II","DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. ","Service Code: 7171",,"675 units Total (145 units domestically & 530 units internationally)","Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.",11/25/2013,"11/25/2013",1/29/2014,"01/29/2014"
"Biologics",67048,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","Letter","Nationwide; CANADA, NS, COLOMBIA, MUMBAI, SINGAPORE, ARGENTINA, BOLIVIA, ISRAEL, NEW ZEALAND, PAKISTAN, INDONESIA, QATAR, JAPAN, VIETNAM, CHINA, TAIWAN, YEMEN, INDIA, LEBANON, EGYPT.","B-0283-14","Class II","Invitrogen by Life Technologies: 54350D ALLSET GOLD HLA ABDR LOW RES, 54360D ALLSET GOLD HLA ABDRDQ LOW RES, 54370D ALLSET GOLD HLA DR LOW RES SSP, 54380D ALLSET GOLD HLA DRDQ LOW RES,7810010 AB/DR SSP UNITRAY 10 TESTS, 7810110 AB/DR SSP UNITRAY W/TAQ 10 TS, 7820010 DR 4T SSP UNITRAY 40 TESTS,7840010 DR/DQ 2T SSP UNITRAY 20 TESTS,7840110 DR/DQ 2T SSP UNITRAY W/TAQ 20T. 7850010 AB/DR/DQ SSP UNITRAY 10 TESTS 7850110 AB/DR/DQ SSP UNITRAY W/TAQ 10T ","54350D: 0361255129, 0361304515, 0361357615 54360D: 0291247232, 0291293558, 0291306794 54370D: 0201205205, 0201303555 54380D: 0301216651, 0301272183, 0311312025, 0311377599 7810010: 0361316325 7810110: 0361316325, 1409712 7820010: 0201216655 7840010: 0301221267, 0311344994 7840110: 03012212671344796, 03012212671346090, 03012212671346863, 03012212671350644, 03012212671352619, 03012212671375757, 03012212671391605, 03012212671393093, 03012212671396221, 03012212671405133, 03012212671417015, 03012212671420379, 03012212671427118, 03012212671429556, 03012212671438257, 03113449941451386, 03113449941452442, 7850010: 0291255127 7850110: 02912551271345427, 02912551271360761, 02912551271378014, 02912551271393696, 02912551271419162, 02912551271427119, 02912551271439780 ",".","11 units","HLA typing assay, associated with false negative results, were distributed. ",10/30/2013,"10/30/2013",2/19/2014,"02/19/2014"
"Food",67049,"Ongoing","ANAT, LLC","Bloomfield","CT","US","Voluntary: Firm Initiated","Other","CT","F-1380-2014","Class II","IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT","54217002",,"1300 Tribulus","Potential for Chloramphenicol contamination. ",11/1/2013,"11/01/2013",1/15/2014,"01/15/2014"
"Food",67049,"Ongoing","ANAT, LLC","Bloomfield","CT","US","Voluntary: Firm Initiated","Other","CT","F-1379-2014","Class II","IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap","54179002, 54179003, 54179004",,"1666 Legume","Potential for Chloramphenicol contamination. ",11/1/2013,"11/01/2013",1/15/2014,"01/15/2014"
"Devices",67050,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.","Z-0623-2014","Class II","Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone. ","Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865 ",,"14","Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. ",12/9/2013,"12/09/2013",1/15/2014,"01/15/2014"
"Food",67051,"Ongoing","Colony Brands, Inc.","Monroe","WI","US","Voluntary: Firm Initiated","Letter","OK, TX, NY, ND, FL, PA, CA, CO, NV, AL, MI, AR, MA.","F-1386-2014","Class II","Lobster Bisque, product 45036. Net WT 4.0 lbs. Keep Frozen.","Lot number 3418130",,"19 units","Lobster Bisque contains undeclared wheat allergen.",12/5/2013,"12/05/2013",1/22/2014,"01/22/2014"
"Devices",67052,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.","Z-0593-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician","Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793 ",,"93 units","Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10",6/7/2013,"06/07/2013",1/8/2014,"01/08/2014"
"Drugs",67053,"Ongoing","Actavis Elizabeth LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1087-2014","Class II","Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)","lot 58468552 Exp. 05/15",,"13,608 bottles","Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.",11/6/2013,"11/06/2013",3/5/2014,"03/05/2014"
"Devices",67055,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","E-Mail","US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.","Z-0849-2014","Class II","Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems","Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3",,"34 units","Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.",11/7/2013,"11/07/2013",2/5/2014,"02/05/2014"
"Devices",67056,"Ongoing","Draeger Medical Systems, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.","Z-0714-2014","Class II","Draeger Infinity Acute Care System Monitoring Solution","with software versions VG2.0.3 and higher. ",,"439","After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit. ",12/10/2013,"12/10/2013",1/22/2014,"01/22/2014"
"Devices",67057,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-0818-2014","Class II","Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.","lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.",,"1586","Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges. ",12/5/2013,"12/05/2013",1/29/2014,"01/29/2014"
"Devices",67060,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including TX, IL, and GA.","Z-0774-2014","Class II","Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.","Serial Numbers 5049, 5073, 5133, 5162",,"4 units","Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.",8/20/2013,"08/20/2013",2/5/2014,"02/05/2014"
"Biologics",67061,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0320-14","Class II","Red Blood Cells Leukocytes Reduced","W038113228719",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",10/28/2013,"10/28/2013",2/19/2014,"02/19/2014"
"Biologics",67062,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","Letter","GA","B-0326-14","Class II","Platelets Pheresis Leukocytes Reduced","W201213801270",".","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",10/18/2013,"10/18/2013",2/19/2014,"02/19/2014"
"Biologics",67063,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA; Switzerland; Germany","B-0342-14","Class II","Red Blood Cells Leukocytes Reduced","W068512381698; W068512003196; W068511023243; W068511360535; W068511010284; W068510017272; W068510015032; W068510013295; W068510011204; 0902184",".","10 units","Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed.",11/2/2013,"11/02/2013",2/19/2014,"02/19/2014"
"Biologics",67063,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA; Switzerland; Germany","B-0341-14","Class II","Cryoprecipitated AHF","0902184",".","1 unit","Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed.",11/2/2013,"11/02/2013",2/19/2014,"02/19/2014"
"Biologics",67063,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA; Switzerland; Germany","B-0340-14","Class II","Plasma Frozen","W068511360535; W068511010284; W068510013295",".","3 units","Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed.",11/2/2013,"11/02/2013",2/19/2014,"02/19/2014"
"Biologics",67063,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA; Switzerland; Germany","B-0339-14","Class II","Cryoprecipitated AHF, Pooled","W068512003196; W068511023243; W068510015032",".","3 units","Blood products, collected from a donor with a history of Hepatitis after age 11, were distributed.",11/2/2013,"11/02/2013",2/19/2014,"02/19/2014"
"Devices",67064,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Canada","Z-0603-2014","Class II","Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line ","N/A",,"24,227.","Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.",6/4/2013,"06/04/2013",1/8/2014,"01/08/2014"
"Devices",67065,"Ongoing","Lab Vision Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.","Z-0775-2014","Class II","Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.","PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.",,"5","Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.",12/6/2013,"12/06/2013",1/22/2014,"01/22/2014"
"Devices",67066,"Ongoing","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.","Z-1075-2014","Class II","pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.","Model #: 942-063 Lot #'s: R338 to R493 ",,"38,890 units (7,860 units imported into the US)","RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.",7/5/2013,"07/05/2013",3/5/2014,"03/05/2014"
"Devices",67067,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","USA Distribution in the state of Illinois.","Z-1092-2014","Class II","00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem LengthTrabecular Metal'' Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.","lot 62267250",,"10 units","This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification. ",1/10/2014,"01/10/2014",3/5/2014,"03/05/2014"
"Biologics",67068,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","Letter","Nationwide; NETHERLANDS, GREECE, RUSSIA, INDIA, SOUTH AFRICA, FRANCE, GERMANY, ITALY, TURKEY, UNITED KINGDOM, DUBAI, IRELAND, SWITZERLAND, NEW ZEALAND, SWEDEN, SPAIN, INDONESIA, SAUDI ARABIA, JAPAN, URUGUAY, CHINA, TAIWAN.","B-0284-14","Class II","Invitrogen by Life Technologies: DRB1-15 SSP UniTray Kit, 450102D; DRB1-15 SSP UniTray Kit with Taq Polymerase, 450112D; AllSet+'' Gold SSP HLA DRB1-15/16 High Res Kit, 54290D. "," 450102D: 010743202, 0111049955, 0111274159, 011872999 450112D 010743202807163, 010743202824730, 010743202847129, 010743202867121, 010743202904081, 01110499551314672, 01110499551273533, 01112741591345434, 01112741591377037, 011872999934454, 011872999943913, 011872999952219, 0118729991029899 54290D: 001769069, 001796673, 0021103796, 0021216660, 0021344999, 002905389, 002979632 ",".","3 kits","HLA typing assay, associated with false negative results, were distributed. ",11/22/2013,"11/22/2013",2/19/2014,"02/19/2014"
"Devices",67069,"Ongoing","AdvanDx, Inc.","Woburn","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.","Z-0619-2014","Class III","AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures ","Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B",,"49 kits US; 17 kits OUS","Kits incompatible with certain fluorescence microscope light sources",12/11/2013,"12/11/2013",1/8/2014,"01/08/2014"
"Food",67070,"Terminated","Blooming Import Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, MA, PA, MD, NC, GA, FL, IL, TX","F-0510-2015","Class I","GOLDEN LION brand DRIED ZIZIPHUS JUJUBA MILL (DRIED DATES), NET WT. 12 oz (340 g), UPC 7 34765 04008 6 -- PRODUCT OF CHINA -- PACKED FOR AND EXCLUSIVELY DISTRIBUTED BY: BLOOMING IMPORT INC. 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- The product is packaged in a sealed flexible plastic bag. --- Nutrition Facts: Serving Size: 1.4 oz. Serving Per Container: 8.5","UPC 7 34765 04008 6 and no other coding",".","1431 cases ( 50 - 12 oz. packages per case)","The product contained undeclared sulfites (1519 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.",12/11/2013,"12/11/2013",11/26/2014,"11/26/2014"
"Biologics",67071,"Terminated","Csl Plasma, Inc.","Lansing","MI","US","Voluntary: Firm Initiated","Other","IL","B-0327-14","Class II","Source Plasma","04205157078; 04205179947; 04205172243 ",".","3 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/13/2013,"11/13/2013",2/19/2014,"02/19/2014"
"Biologics",67072,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0328-14","Class III","Red Blood Cells Deglycerolized Leukocytes Reduced","W117012114683",".","1 unit","Blood product, failed to meet the minimum specification for percent red blood cell recovery, was distributed.",10/29/2013,"10/29/2013",2/19/2014,"02/19/2014"
"Biologics",67074,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","E-Mail","VA","B-0322-14","Class II","Red Blood Cells Leukocytes Reduced","W089812403071",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/28/2013,"11/28/2013",2/19/2014,"02/19/2014"
"Biologics",67074,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","E-Mail","VA","B-0323-14","Class II","Fresh Frozen Plasma","W089812403071",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/28/2013,"11/28/2013",2/19/2014,"02/19/2014"
"Biologics",67075,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX","B-0321-14","Class II","Red Blood Cells Leukocytes Reduced","W140913280879",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",9/13/2013,"09/13/2013",2/19/2014,"02/19/2014"
"Devices",67076,"Ongoing","The Standing Company","Saginaw","MI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.","Z-0993-2014","Class II","Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.","Serial No: 1306, 1313, 1342, 1349, 1362, 1358, 1359, 1392, 1391, 1406, 1402, 1407, 1426, 1441, 1451, 1018, 1453, 1399, 1523, 1477, 1480, 1482, 1497, 1494, 1505, 1516, 1533, 1537, 1536, 1535, 1542, 1544, 1549, 1543, 1550, 1562, 1563, 1566, 1580, 1572, 1573, 1574, 1571, 1578, 1583, 1641, 1593, 1591, 1592, 1599, 1604, 1600, 1615, 1616, 1614, 1622, 1631, 1637, 1643, 1635, 1640, 1634, 1648, 1666, 1652, 1657, 1663, 1664, 1676, 1689, 1665, 1683, 1691, 1688, 1701, 1703, 1711, 1698, 1712, 1719, 1728, 1731, 1726, 1740, 2165, 2172, 2175, 2177, 2257, 2182, 2197, 2205, 2258, 2259, 2262, 2270, 2283, 2279, 2281, 2298, 2306, 2310, 2312, 2330, 2334, 2503, 2515, 2328, 2514, 2523, 2525, 2550, 2561, 2568, 2581, 2573, 1684, and 1427.",,"approximately 119","Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.",5/16/2013,"05/16/2013",2/26/2014,"02/26/2014"
"Food",67077,"Ongoing","Bee International, Inc.","Chula Vista","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in US and Canada.","F-1403-2014","Class I","Candy Sweet Spots, 2oz. (3 display packages/case; 12-2oz packages/display case). UPC 0-73563-00471-6","Mfg code: 2158613 (Date of manufacture: 158 day of 2012) Mfg code: 2335613 (Date of manufacture: 335 day of 2012) ",,"4481 cases","Bee International is recalling Sweet Spots Candy because it has undeclared egg allergen.",12/12/2013,"12/12/2013",1/22/2014,"01/22/2014"
"Devices",67078,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.","Z-0780-2014","Class II","XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.","Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher",,"13","When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. ",11/25/2013,"11/25/2013",1/29/2014,"01/29/2014"
"Veterinary",67079,"Ongoing","Fresenius Kabi USA, LLC","Lake Zurich","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA. HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; FOREIGN: Canada, New Zealand","V-038-2014","Class III","FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173","Product Code 18411; Lots and Expiration Dates: Lot 6104649, Expires 2/2014; Lot 61047869, Expries 3/2014; Lot 6105069, Expires 4/2014",,"215,340 vials","Fresenius Kabi USA, LLC is recalling three lots of Folic Acid Injection, USP 5 mg / mL, 10 mL Multiple Dose Vial due to an out-of-specification result reported for impurities at the 15 and 14 month stability test station for two lots and a third lot that remains within specification to date, however based on the root cause analysis, it is expected to exhibit the same behavior prior to expiry.",12/6/2013,"12/06/2013",1/1/2014,"01/01/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1213-2014","Class I","Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205. ","Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013 ",".","450 Vials","Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe. ",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1216-2014","Class II","Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","Lot #: 117440@1 Expiration Date: 12/27/2013 Lot #: 117901@2 Expiration Date: 01/03/2014 Lot #: 118291@32 Expiration Date: 01/05/2014 Lot #: 118392@28 Expiration Date: 01/09/2014 Lot #: 117659@66 Expiration Date: 12/26/2013 Lot #: 118348@17 Expiration Date: 01/09/2014 Lot #: 117601@38 Expiration Date: 12/26/2013 Lot #: 117847@13 Expiration Date: 12/29/2013 Lot #: 118058@47 Expiration Date: 01/02/2014 ",".","1,495 Bags","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1218-2014","Class II","Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013 ",".","60 units","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1214-2014","Class II","Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014 ",".","861 Bags","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1215-2014","Class II","Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","Lot #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013 ",".","95 Vials","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1219-2014","Class II","Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","a) Lot#118954@2 Exp. Date: 03/09/2014, Lot# 118917@2 Exp. Date: 03/06/2014; b) Lot #: 119379@24 Exp. Date: 01/19/2014, Lot#: 118815@27 Exp. Date: 03/03/2014 ",".","38 units","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. ",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Drugs",67080,"Ongoing","Zions RX Formulations Services LLC dba RX Formuations Serv.","Mesa","AZ","US","Voluntary: Firm Initiated","E-Mail","AZ","D-1217-2014","Class II","Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205","a) Lot #: 117460@5 Expiration Date: 12/12/2013, Lot #: 117911@5 Expiration Date: 12/19/2013, Lot #: 118301@9 Expiration Date: 12/25/2013 b) Lot #: 117462@6 Expiration Date: 12/12/2013, Lot #: 117916@6 Expiration Date: 12/19/2013, Lot #: 118305@10 Expiration Date: 12/25/2013 c) Lot #: 118011@23 Expiration Date: 12/18/2013, Lot #: 118092@63 Expiration Date: 12/18/2013, Lot #: 118401@31 Expiration Date: 12/25/2013, Lot #: 118013@24 Expiration Date: 12/18/2013, Lot #: 118094@64 Expiration Date: 12/18/2013, Lot #: 118403@32 Expiration Date: 12/25/2013 ",".","610 units","Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.",12/12/2013,"12/12/2013",4/16/2014,"04/16/2014"
"Food",67081,"Ongoing","Pin Hsiao & Associates","Bellevue","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed directly in WA and product was further distributed to grocery stores in Oregon and Washington","F-1346-2014","Class I","Antonina's Artisan Bakery brand, Gluten Free, Blueberry Mini Muffins, 12 pieces per package. Net wt. 12.6 oz. The UPC Code is 8 18703 01102 1.","Lot Code - 051114; Expiration Date: 5/11/14 (if kept frozen)",,"96 cases","Antonina's Artisan Bakery Gluten Free Blueberry Mini Muffins are recalled due to undeclared walnuts.",12/10/2013,"12/10/2013",1/8/2014,"01/08/2014"
"Food",67083,"Ongoing","Stuffed Foods LLC","Wilmington","MA","US","Voluntary: Firm Initiated","E-Mail","CT, DE, FL, GA, ME, MD, MA, NH, NJ, NY, NC, OH, PA, RI, VA","F-1342-2014","Class II","Stuffed Foods Asiago Risotto Bites; UPC 850821-00301","Best By Dates: November 7, 2014, November 13, 2014, November 14, 2014, November 20, 2014, November 22, 2014 ",,"602 cases","Supplier informed manufacturer that cheese used in asiago risotto bites may contain small pieces of plastic. ",12/6/2013,"12/06/2013",1/8/2014,"01/08/2014"
"Biologics",67084,"Ongoing","Greer Laboratories Inc","Lenoir","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","B-0365-14","Class III","Sterile Diluent for Allergenic Extracts, 10% Glycerin w/v, 9 mL vial packaged in 25-count vials per carton, Rx only, Greer Laboratories, Inc., Lenoir, NC 28645; Item SG2507192.","Lot #190874, Exp 11/16",,"1 Lot","Sterile Diluent for Allergenic Extracts, with lack of assurance of sterility, was distributed. ",12/11/2013,"12/11/2013",2/5/2014,"02/05/2014"
"Devices",67085,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM,M, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATE, VENEZUELA, CHILE, CANADA, BERMUDA.","Z-0806-2014","Class II","GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and m","F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ5762G DSH04532005GA G1DJ2217G E2DJ3710G M3EH8966GR L0DJ5294G SBG05463469GA SBG06264541GA M2DJ2447G J3EH5175G L2DJ1220G B0DJ1561G SD007293609GA L2DJ1263G C1DJ8662G A4EH1258G F0DJ3308G SBG06046629GA SD007262789GA AAB04254355GA SD008429849GA B2DJ1915G DSH05293139GA SD008138223GA H9DJ0155GR SD007251995GA H1DJ3351G SBG06046550GA F2DJ5089G DSH05185989GA H2DJ7244G F1DJ1599G M1DJ7820G DSH05318073GA M2DJ3629G L1DJ6712GR D2DJ2937GR K0DJ5004GR SD007335572GA AAB04231070GA H2DJ7075G K1DJ5436G K1DJ4937G F1DJ1095G B0DJ1414G E2DJ3955G E2DJ4138GR F1DJ1219G A2DJ9815G SBG06451891GA A3DJ4322G SBG05514986GA DSH05318052GA C3DJ7072G H2DJ7154G G2DJ6587GR DSH05292993GA DSH04470444GA M2DJ2896G H9DJ0359G E1DJ0785G DSH05293010GA F0DJ3187G SBG06264685GA D0DJ2288G M9DJ1149G A2DJ9164G G0DJ3490G AAB04356778GA F0DJ3109GR SD007462511GA DSH05083862GA B1DJ7749G SD007451806GA SD010387765GA B2DJ9976G E1DJ1008G C1DJ8498G DSH05043084GA SBG05525493GA DSH05032811GA SD010117163GA SD009316807GA SBG06336410GA M2DJ2785G M2DJ1981G B2DJ1162GR SD007462383GA B4EH4615G DSH05358956GA G1DJ2480G K2DJ9527G DSH05328251GA SD007303935GA SD009389115GA E3DJ8843GR L3EH8132G AAB04190508GA D3DJ8386G SD008526318GA SD008294211GA E1DJ0742G K0DJ4668G L3EH8063G F1DJ1089GR SD007397737GA E3DJ8752G C1DJ8754G DSH05307981GA E3DJ9275G L1DJ6819G F0DJ3079G B3DJ5494G B4EH4576G SD008377628GA E2DJ3754G DSH05185950GA SD008515789GA D2DJ3339GR G2DJ6198G E1DJ0656G SBG06451791GA J0DJ4421G DSH05063506GA DSH05328266GA E2DJ3688G DSH05022478GA L2DJ1506G G2DJ6199G C2DJ1967G D0DJ2360G L1DJ6959G J3EH5899G H1DJ3337G SHQ12167194SA J1DJ4547G D2DJ3227G C1DJ8552G E2DJ3637G AAB04377453GA AAB04264700GA J2DJ8391G SHQ12402047SA SD010251247GA L3EH7800GR E1DJ0720G F0DJ2863G AAB04377323GA L0DJ5701G H2DJ7092G F2DJ6031G M2DJ3100GR SD007252034GA AAB04139260GA AAB04160036GA AAB04160038GA AAB04160040GA AAB04160042GA AAB04160044GA AAB04160048GA AAB04160048GR AAB04160049GA AAB04160079GA AAB04160080GA AAB04160082GA AAB041801"," DSH04470376GA DSH04470377GA DSH04470378GA DSH04470384GA DSH04470385GA DSH04470387GA DSH04470412GA DSH04470414GA DSH04470426GA DSH04470440GA DSH04470445GA DSH04470446GA DSH04470447GA DSH04470449GA DSH04470466GA DSH04470467GA DSH04470469GA DSH04470470GA DSH04470475GA DSH04470476GA DSH04470486GA DSH04470487GA DSH04470488GA DSH04470489GA DSH04470490GA DSH04470494GA DSH04470512GA DSH04470513GA DSH04470515GA DSH04470516GA DSH04470519GA DSH04470522GA DSH04470528GA DSH04480539GA DSH04480541GA DSH04480542GA DSH04480547GR DSH04480565GA DSH04480566GA DSH04480567GA DSH04480568GA DSH04480580GA DSH04480612GA DSH04480618GA DSH04480623GA DSH04480630GA DSH04480672GA DSH04480677GA DSH04480688GA DSH04480690GA DSH04480693GR DSH04480699GA DSH04480700GA DSH04480701GA DSH04480702GA DSH04480703GA DSH04480704GA DSH04480705GA DSH04480706GA DSH04480725GA DSH04480727GA DSH04480728GA DSH04480730GA DSH04490735GA DSH04490739GA DSH04490740GA DSH04490741GA DSH04490742GA DSH04490748GA DSH04490749GA DSH04490750GA DSH04490752GR DSH04490756GA DSH04490757GA DSH04490758GA DSH04490759GA DSH04490761GA DSH04490764GA DSH04490765GA DSH04490769GA DSH04490770GA DSH04490771GA DSH04490772GA DSH04490773GA DSH04490776GA DSH04490782GA DSH04490783GA DSH04490784GA DSH04490785GA DSH04490786GA DSH04490788GA DSH04490790GA DSH04490791GA DSH04490794GA DSH04490795GA DSH04490796GA DSH04490801GA DSH04490803GA DSH04490804GA DSH04490811GA DSH04490826GA DSH04490840GA DSH04490843GA DSH04490854GA DSH04490864GA DSH04490870GA DSH04490874GA DSH04490876GA DSH04490884GA DSH04490885GA DSH04490888GA DSH04490892GA DSH04490897GA DSH0449089GA DSH04490901GA DSH04490901GR DSH04490902GA DSH04490907GA DSH04490910GA DSH04490911GA DSH04490912GA DSH04490913GA DSH04490915GA DSH04490917GA DSH04490923GA DSH04490927GA DSH04490928GA DSH04490932GA DSH04490933GA DSH04490933GR DSH04490934GA DSH04490935GA DSH04490936GA DSH04490939GA DSH04490941GA DSH04490942GA DSH04490943GA DSH04490958GA DSH04490960GA DSH04490962GA DSH04490963GA DSH04490964GA DSH04490965GA DSH04490966GA DSH04490970GA DSH04490972GA D","47,125 (38,710 US, 8,415 OUS)","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",12/5/2013,"12/05/2013",1/29/2014,"01/29/2014"
"Devices",67085,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution (all states in continental USA including DC and PR except SD, VT and WY. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM,M, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATE, VENEZUELA, CHILE, CANADA, BERMUDA.","Z-0807-2014","Class II","SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from ","SA308044521GR SA308186360GA SA310444859GA SA308186380GA SA312091241GA SA308491207GA SA308186401GA SA308186385GA SA308186374GA SA308155957GA SA308186391GA SA308186366GA SA308186410GA SA308094871GA SA308094818GA SA308186445GA SA308186381GA SA312479810GA SA308094940GA SA308094803GA SA308094872GA SA308084770GA SA310528992GA SA310506733GA SA310506696GA SA311153223GA SA311142931GA SA312080647GA SA312080894GA SA308186396GA SA308166121GA SA308186397GA SA308094807GA SA308186404GA SA311153169GA SA308186377GA SA308398894GA SA312253398GA SA308094809GA SA309263954GA SA310048616GA SA309527962GA SA310038386GA SA310048604GA SA310048613GA SA310028273GA SA310038462GA SA308317172GA SA311184814GA SA309365237GR SA311142946GA SA307332233GA SA307231341GA SA312069693GA SA309456714GA SA311163858GA SA312049242GA SA311317628GA SA307423146GA SA310259886GA SA309142960GA SA309334557GA SA307393020GA SA307453540GA SA307210827GA SA312018863GA SA307241567GA SA311163574GA SA312039090GA SA312080635GA SA309263938GA SA309304244GR SA309233517GA SA312039205GA SA312080692GA SA308347813GA SA308398654GA SA307504161GA SA312059549GA SA308491112GA SA312059550GA SA309021966GA SA310351543GA SA309193340GA SA308186334GA SA311101421GA SA310444513GA SA311518717GA SA312122048GA SA312029011GA SA309203388GA SA309344857GA SA312028978GA SA312253251GA SA312121695GA SA311508589GR SA312152342GA SA310517769GA SA310517770GA SA311297355GA SA311163926GA SA312029028GA SA308419235GA SA312069661GA SA311458372GA SA307382560GA SA311428153GA SA308511698GA SA308511500GA SA308368183GA SA309223482GA SA310361769GA SA312039183GA SA312079967GA SA308491092GA SA311458333GA SA310393014GA SA310507045GA SA310517560GA SA310331323GA SA311163587GA SA311184495GA SA307291912GA SA310393006GA SA311060085GA SA309112590GA SA310361759GA SA311194946GA SA309112586GA SA309112577GA SA309112584GA SA309112588GA SA309112583GA SA309112582GA SA309112591GA SA309112576GA SA309112569GA SA308166208GA SA308084740GA SA309112585GA SA309112578GA SA309112592GA SA309112572GA SA309112589GA SA309112587GA SA309112580GA S"," SA310475719GA SA310485843GA SA310485853GA SA312080732GA SA310393088GA SA308317266GA SA308317182GA SA309365343GA SA311195016GA SA309142875GA SA309365359GA SA307261817GA SA309365331GA SA312069707GA SA309092538GA SA311163606GA SA311163446GA SA312080671GA SA309456685GA SA307261827GA SA307231501GA SA308409099GA SA311122159GA SA309092510GA SA311195113GA SA311184355GA SA310393196GA SA309011861GA SA310518710GA SA308388438GA SA307231316GA SA309142873GA SA308317260GA SA308419297GA SA309365324GA SA310361809GA SA308074559GR SA309092536GA SA309375375GA SA311256806GA SA312522575GA SA308489952GA SA311122248GA SA311205428GA SA311205570GA SA309223497GA SA311142794GA SA311184476GA SA311121854GA SA311121894GA SA311163597GA SA311468412GA SA312091341GA SA311132326GA SA311163531GA SA311205595GA SA311194962GA SA311142753GA SA311184799GA SA311132598GA SA311174134GA SA312479842GA SA311205596GA SA311205328GA SA311122052GA SA311195172GA SA307524479GA SA311132398GA SA308378297GA SA311184753GA SA311195049GA SA311195170GA SA311122229GA SA311121850GA SA311184471GA SA311184501GA SA311163805GA SA311184816GA SA311184473GA SA311488467GA SA311174045GA SA312101394GA SA309032013GA SA311184511GA SA311122275GA SA311184719GA SA311194987GA SA311184792GA SA311184464GA SA312101367GA SA312101391GA SA311205419GA SA311163854GA SA311163821GA SA311163699GA SA311153307GA SA311174058GA SA310423834GA SA311317650GA.DEL SA312101384GA SA311142771GA SA311122031GA SA311153033GA SA311184470GA SA311142778GA SA312080786GA SA311184763GA SA312080887GA SA311184735GA SA307231407GA SA311184791GA SA311184869GA SA311132322GA SA311256736GA SA311122230GA SA312049424GA SA311184788GA SA310372100GA SA311195043GA SA311205339GA SA309223473GA SA311246532GA SA311132314GA SA311184729GA SA308105164GA SA309203399GA SA311184457GA SA311184490GA SA310496649GA SA311246508GA SA311163550GA SA311184488GA SA310393297GA SA308115240GA SA311121870GA SA311132313GA SA311163566GA SA311205620GA SA311122047GA SA311195171GA SA311132593GA SA311195007GA SA311184770GA SA311184486GA SA311205413GA SA31116379","2516 (2,321 US, 195 OUS)","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",12/5/2013,"12/05/2013",1/29/2014,"01/29/2014"
"Devices",67085,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM,M, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATE, VENEZUELA, CHILE, CANADA, BERMUDA.","Z-0808-2014","Class II","GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can b","C7HA1686G C7HA1700G C7HA1701G C7HA1696G C7HA1692G C7HA1688G C7HA1691G C7HA1689G C7HA1687G C7HA1702G B7HA1657G C7HA1683G C7HA1703G C7HA1707G C7HA1709G C7HA1711G D8HA3141G D8HA3154G D8HA3135G D8HA3136G D8HA3149G D8HA3148G D8HA3128G D8HA3134G D8HA3152G D8HA3140G D8HA3137G D8HA3144G H3S20070G H3S20072G J3S20073G J3S20075G J3S20078G J3S20084G J3S20089G J3S20090G J3S20093G J3S20085G A4S20482G A4S20471G G4S21111G G4S21108G G4S21112G G4S21090G G4S21106G F5HB0489G E5HB0418G F5HB0493G F5HB0491G F5HB0468G F5HB0497G F5HB0478G E5HB0459G C5HB0346G B5HB0261G A6HB0980G A6HB0978G D6HB1379G K7HB4546G K7HB4542G K7HB4552G K7HB4553G K7HB4547G K7HB4556G C8HB5556G C8HB5743G C8HB5744G C8HB5758G C8HB5747G C8HB5746G C8HB5750G C8HB5756G C8HB5757G C8HB5676G D8HB5922G G8HB6864G G8HB6859G B9HA4387G B9HA4403G B9HA4405G B9HA4402G F8HB6464G L4HB0063G L4HB0068G L4HB0064G M4HB0151G M4HB0143G A5HA0120G A5HA0118G A5HA0125G A5HA0122G A5HA0112G A5HA0117G A5HA0111G A5HA0119G A5HA0109G A5HA0114G A5HA0124G L4HC0003G H5HA0362G H5HA0367G D6HB1475G D6HB1467G D6HB1455G D6HB1458G D6HB1442G D6HB1469G D6HB1430G D6HB1465G D6HB1435G D6HB1476G D6HB1440G D6HB1463G D6HB1439G D6HB1438G D6HB1461G D6HB1460G M6HD8751F M6HD8723F M6HD8732F M6HD8683F M6HD8749F M6HD8725F M6HD8748F M6HD8728F M6HD8737F M6HD8730F M6HD8750F M6HD8726F M6HD8747F M6HD8724F M6HD8736F M6HD8744F M6HD8740F M6HD8731F M6HD8745F M6HD8722F M6HD8739F M6HD8741F M6HD8742F M6HD8738F M6HD8746F A7HA1527G A7HA1564G A7HA1550G A7HA1546G A7HA1562G A7HA1529G A7HA1561G A7HA1563G A7HA1560G B7HA1598G B7HA1595G B7HA1583G B7HA1579G B7HA1591G B7HB2686G B7HB2694G B7HB2676G F7HB3564G F7HB3571G F7HB3561G F7HB3567G F7HB3499G F7HB3498G F7HB3526G F7HB3511G F7HB3516G F7HB3536G F7HB3537G F7HB3538G F7HB3541G F7HB3534G F7HB3533G F7HB3539G F7HB3532G F7HB3535G F7HB3548G F7HB3540G F7HB3589G F7HB3556G G7HB3740G G7HB3773G G7HB3772G G7HB3774G G7HB3747G G7HB3769G G7HB3775G G7HB3748G G7HB3766G G7HB3746G G7HB3735G G7HB3741G G7HB3726G H7HB4010G C8HB5492G C8HB5488G C8HB5481G C8HB5480G C8HB5493G C8HB5476G C8HB5508G C8HB5485G C8HB5482G C8HB5",,"1,948 (1,834 US; 114 OUS)","GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. ",12/5/2013,"12/05/2013",1/29/2014,"01/29/2014"
"Devices",67087,"Ongoing","ArthroCare Medical Corporation","Austin","TX","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.","Z-0652-2014","Class II","Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only","Catalog #25-3011, Lot #1049402",,"76","A sharp edge on the cannulated tip of the device may damage or cut a suture. ",12/9/2013,"12/09/2013",1/15/2014,"01/15/2014"
"Drugs",67088,"Completed","Mariposa Labs, LLC","Boise","ID","US","Voluntary: Firm Initiated","E-Mail","One consignee who in turn sent it to one consignee","D-462-2014","Class II","NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201 ","0106072/2298",,"14,664 tubes","Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.",11/29/2012,"11/29/2012",1/22/2014,"01/22/2014"
"Food",67089,"Ongoing","MEGABUSINESS LLC.","Danbury","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, CT, IL","F-1427-2014","Class I","DEL CAMPO PAPA SECA DRIED POTATO NET WT 14 OZ IMPORTED BY MEGABUSINESS PRODUCT OF PERU. UPC CODE 891726000218 ","Lot/Unit Numbers STD 08-13 Expires June 2014",,"39.5 cases","Undeclared sulfites.",12/13/2013,"12/13/2013",1/22/2014,"01/22/2014"
"Devices",67090,"Ongoing","BioHorizons Implant Systems Inc","Birmingham","AL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.","Z-1058-2014","Class II","External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental ","Lot Number 1302762, Exp 31 MAY 2018",,"119 units ","The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. ",12/10/2013,"12/10/2013",2/26/2014,"02/26/2014"
"Veterinary",67091,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY,LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV); FOREIGN: Austria, Belgium, Canada, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom","V-039-2014","Class II","OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain","*** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014. *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05-2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.",,"*** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.","Abbott Animal Health is voluntarily recalling the ten lots of OroCAM (meloxicam) Transmucosal Oral Spray for Dogs due to the possibility that some animals could receive an incorrect dose during administration. A limited number of units from lots FEBU-2 and FEBU-3 were found to contain incorrect pumps.",12/11/2013,"12/11/2013",2/5/2014,"02/05/2014"
"Drugs",67092,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.","D-1163-2014","Class I","0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.","Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14",,"716,544 containers","Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.",11/21/2013,"11/21/2013",3/26/2014,"03/26/2014"
"Drugs",67092,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.","D-1162-2014","Class I","5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.","Lot #: P285288, Exp 11/13",,"105,216 containers","Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.",11/21/2013,"11/21/2013",3/26/2014,"03/26/2014"
"Devices",67093,"Ongoing","RTI Surgical, Inc.","Marquette","MI","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.","Z-0627-2014","Class II","C-Plus'' 10mm x 12mm Webless implants Pioneer Surgical's C-Plus '' 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.","part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.",,"1906","As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a slightly greater chance for subsidence or expulsion.",10/7/2013,"10/07/2013",1/15/2014,"01/15/2014"
"Devices",67094,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA ( Nationwide ) and the countries of : UK, Saudi Arabia, South Africa, Brunei, China, France, Poland, Turkey, Greece, Sweden, United Arab Emirates, Russia, Spain, Pakistan, Finland, Israel, Italy, Slovenia, Japan, Poland, Malaysia, Germany and Panama.","Z-0602-2014","Class II","Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems. ","MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004 MEK1201104 MEK1201204 MEK1201304 MEK1201404 MEK1201504 MEK1201604 MEK1201704 MEK1201804 MEK1201904 MEK1202004 MEL1200104 MEL1200204 MEL1200304 MEL1200404 MEL1200504 MEL1200604 MEL1200704 MEL1200804 MEL1200904 MEL1201004 MEL1201104 MEL1201204 MEL1201304 MEL1201404 MEL1201504 MEL1201604 MEL1201704 MEL1201804 MEL1201904 MEL1202004 MEL1202104 MEL1202204 MEL1202304 MEL1202404 MEL1202504 MEL1202604 MEL1202704 MEL1202804 MEL1202904 MEL1203004 MEL1203104 MEL1203204 MEL1203304 MEL1203404 MEL1203504 MEL1203604 MEL1203704 MEL1203804 MEL1203904 MEL1204004 MEL1204104 MEL1204204 MEL1204304 MEL1204404 MEL1204504 MEL1204604 MEL1204704 MEL1204804 MEL1204904 MEL1205004 MEM1200104 MEM1200204 MEM1200304 MEM1200404 MEM1200504 MEM1200604 MEM1200704 MEM1200804 MEM1200904 MEM1201004 MEM1201104 MEM1201204 MEM1201304 MEM1201404 MEM1201504 MEM1201604 MEM1201704 MEM1201804 MEM1201904 MEM1202004 MEM1202104 MEM1202204 MEM1202304 MEM1202404 MEM1202504 MEM1202604 MEM1202704 MEM1202804 MEM1202904 MEM1203004 MEM1203104 MEM1203204 MEM1203304 MEM1203404 MEM1203504 MEM1203604 MEM1203704 MEM1203804 MEM1203904 MEM1204004 MEA1300104 MEA1300204 MEA1300304 MEA1300404 MEA1300504 MEA1300604 MEA1300704 MEA1300804 MEA1300904 MEA1301004 MEA1301104 MEA1301204 MEA1301304 MEA1301404 MEA1301504 MEA1301604 MEA1301704 MEA1301804 MEC1300104 MEC1300204 MEC1300304 MEC1300404 MEC1300504 MEC1300604 MEC1300704 MEC1300804 MEC1300904 MEC1301004 MEC1301104 MEC1301204 MEC1301404 MEC1301504 MEC1301604 MEC1301704 MEC1301804 MEC1301904 MEC1302004 MED1300104 MED1300204 MED1300304 MED1300404 MED1300504 MED1300604 MED1300704 MED1300804 MED1300904 MED1301004 MED1301104 MED1301204 MED1301304 MED1301404 MED1301504 MED1301604 MED1301704 MED1301804 MED1301904 MED1302004 MEE1300104 MEE1300204 MEE1300304 MEE1",,"275 CAM01 Monitors","Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly. ",11/26/2013,"11/26/2013",1/8/2014,"01/08/2014"
"Drugs",67095,"Ongoing","B. Braun Medical Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US and Puerto Rico.","D-407-2014","Class II","0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.","Lot No. J3D548, expiry: Oct, 2015",,"19,572 bags","Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).",11/27/2013,"11/27/2013",1/22/2014,"01/22/2014"
"Biologics",67096,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","California","B-0309-14","Class II","Source Plasma","TT0293525; TT0293738; TT0294774; TT0295033; TT0299609; TT0299911; TT0301422; TT0302615; TT0302930; ",,"9","Blood products, collected from a donor whose physical examination was incomplete, were distributed. ",11/29/2013,"11/29/2013",2/26/2014,"02/26/2014"
"Biologics",67097,"Terminated","Dci Biologicals Llc","San Angelo","TX","US","Voluntary: Firm Initiated","FAX","Israel","B-0329-14","Class II","Source Plasma","SA0015984; SA0016100; SA0016594; SA0016704; SA0016904; SA0017498; SA0017779; SA0018020; SA0023090; SA0023184; SA0023436; SA0023525; SA0023793; SA0023967; SA0024162; SA0024359; SA0024732; SA0024955; SA0025171; SA0025426; SA0025652; SA0027251; SA0027604; SA0027737; SA0027966; SA0028102; SA0028315; SA0028472; SA0028877; SA0028966; SA0029196; SA0029323; SA0029557; SA0029711; SA0029948; SA0030102; SA0014673; SA0015398; SA0015482; ",,"39","Blood products, collected from a donor who engaged in high risk behavior, were distributed.",11/5/2013,"11/05/2013",2/26/2014,"02/26/2014"
"Devices",67098,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.","Z-0772-2014","Class II","BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV fluid administration. ","Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392",,"268,500 products","BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility. ",11/26/2013,"11/26/2013",1/22/2014,"01/22/2014"
"Devices",67099,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV","Z-0734-2014","Class II","Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.","Lot number: 1223566 EXP: 8/31/2013",,"45/5/50 - discs/cartridges/packs","Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.",11/21/2013,"11/21/2013",1/22/2014,"01/22/2014"
"Devices",67100,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and Internationally to: Canada and Japan.","Z-0848-2014","Class II","Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.","Part number 6481779",,"237 units","Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.",12/5/2013,"12/05/2013",2/5/2014,"02/05/2014"
"Drugs",67102,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-394-2014","Class III","Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).","Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14; L082K12B, exp. 4/14; L059A13A, exp. 7/14; L114E13A, exp. 10/14; L026G13A, exp. 12/14; and L081J13A, exp. 3/15.",,"438,055 bottles ","Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. ",12/16/2013,"12/16/2013",1/8/2014,"01/08/2014"
"Food",67105,"Ongoing","Cuisine Med. Catering","Port Townsend","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Washington only","F-1339-2014","Class II","Down Unders Cookie Mobile Meal sold under brand Down Unders, approximately 6.75 oz. (189 gram).","No codes",,"164 pieces","Down Unders Cookie Mobile Meal is recalled because the coconut is declared in the ingredient statement but the label also lists NO NUTS.",12/11/2013,"12/11/2013",1/8/2014,"01/08/2014"
"Drugs",67107,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-1160-2014","Class I","Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.","Lot# P285122, Exp 5/2014",,"7,388 bags","Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.",11/18/2013,"11/18/2013",3/26/2014,"03/26/2014"
"Drugs",67107,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-1158-2014","Class I","Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.","Lot#: P287045, Exp 6/2014",,"14,574 bags","Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.",11/18/2013,"11/18/2013",3/26/2014,"03/26/2014"
"Drugs",67107,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","D-1159-2014","Class I","Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.","Lot#: P275883, Exp 10/2013",,"7,068 bags","Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.",11/18/2013,"11/18/2013",3/26/2014,"03/26/2014"
"Devices",67108,"Ongoing","Covidien","Boulder","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherlands, Turkey, Croatia, Andorra, Albania, Algeria, Bahrain, Bosnia and Herzegovina, Egypt, Georgia, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Morocco, Russia, Saudi Arabia, Serbia, South Africa, Syria, Sudan, Tunisia, UAE, Uganda, Puerto Rico, Mexico, Columbia, Chile, Brazil, Argentina, Uruguay, Panama, Costa Rica, Peru, China, Korea, Japan, Taiwan, Hong Kong, Malaysia, Singapore, Sri Lanka, Australia, New Zealand.","Z-0611-2014","Class I","Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.","Software Part number 4-070212-85, revision AB-AG",,"16,756 US, 39,372 OUS","Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error. ",12/16/2013,"12/16/2013",1/15/2014,"01/15/2014"
"Biologics",67109,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-0302-14","Class II","Platelets Pooled Leukocytes Reduced","W036811805704; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/12/2013,"11/12/2013",2/26/2014,"02/26/2014"
"Biologics",67109,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida","B-0303-14","Class III","Blood and Blood Products for Reprocessing","W036811074718; ",,"1","Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.",11/12/2013,"11/12/2013",2/26/2014,"02/26/2014"
"Biologics",67110,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","California","B-0310-14","Class III","Red Blood Cells Leukocytes Reduced","W036213722644; ",,"1","Blood product, with insufficient red cell preservative solution added, was distributed.",9/24/2013,"09/24/2013",2/26/2014,"02/26/2014"
"Food",67112,"Ongoing","HP Hood LLC","Lynnfield","MA","US","Voluntary: Firm Initiated","Letter","Pennsylvania & New York","F-1377-2014","Class II","Hood brand Fat Free Chocolate Milk, 8 oz. UPC: 0 44100 11244 7","Sell by Date: DEC 31 2014 xx:xx 42-207 L1",,"6,734 units","Product labeled with an extended sell by date",12/18/2013,"12/18/2013",1/15/2014,"01/15/2014"
"Veterinary",67113,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY,LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV); FOREIGN: Austria, Belgium, Canada, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom","V-053-2014","Class II","OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain","*** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014. *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05 -2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.",".","*** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.","Some particles were observed in a limited number of OroCAM units. The particles if present could clog the pump mechanism and could also potentially result in under-administration.",12/11/2013,"12/11/2013",2/19/2014,"02/19/2014"
"Drugs",67114,"Ongoing","Medisca Inc.","Irving","TX","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1263-2014","Class I","Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3 ","Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3. NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. ",,"296 units","Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.",10/21/2013,"10/21/2013",5/7/2014,"05/07/2014"
"Devices",67115,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN, MS, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, TN, TX, UT,VT, VA, WA, WI, and WY. Internationally to: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt,England, Estonia, Finland,France, Germany,Greece, Guatemala, Hungary,India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates and United Kingdom.","Z-0747-2014","Class II","GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.","Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA307070455GA SA307080472GA SA307080477GA SA307080478GA SA307080504GA SA307080520GA SA307080526GA SA307110559GA SA307110560GA SA307110572GA SA307110575GA SA307110579GA SA307120587GA SA307120588GA SA307150681GA SA307180694GA SA307180696GA SA307180697GA SA307190717GA SA307190718GA SA307190720GA SA307190722GA SA307190724GA SA307190727GA SA307190728GA SA307190729GA SA307190730GA SA307190732GA SA307190733GA SA307190734GA SA307190738GA SA307190741GA SA307190742GA SA307190743GA SA307190744GA SA307190745GA SA307190749GA SA307190764GA SA307190766GA SA307190769GA SA307190770GA SA307190771GA SA307020383GA SA307030411GA SA307030413GA SA307050429GA SA307070443GA SA307080459GA SA307080467GA SA307080521GA SA307080522GA SA307080524GA SA307150651GA SA307180699GA SA307190736GA SA307190755GA SA307190773GA SA307190774GA SA307200784GA SA307220983GA SA307221081GA SA307221089GA SA307020393GA SA307020396GA SA307020397GA SA307020399GA SA307030417GA SA307030419GA SA307030423GA SA307070438GA SA307080473GA SA307080493GA SA307080498GA SA307080499GA SA307080509GA SA307080510GA SA307080533GA SA307150671GA SA307180698GA SA3071807"," SA307483690GA SA307483692GA SA307483697GA SA307483698GA SA307483699GA SA307483700GA SA307483701GA SA307483702GA SA307483704GA SA307483705GA SA307483706GA SA307483707GA SA307483711GA SA307483714GA SA307483721GA SA307483728GA SA307483729GA SA307483733GA SA307483734GA SA307483736GA SA307483737GA SA307483738GA SA307483740GA SA307483741GA SA307483742GA SA307483745GA SA307483746GA SA307483747GA SA307483749GA SA307483750GA SA307483751GA SA307483753GA SA307483754GA SA307483756GA SA307483757GA SA307483758GA SA307483759GA SA307483760GA SA307483762GA SA307483765GA SA307483766GA SA307483767GA SA307483771GA SA307483775GA SA307483777GA SA307483782GA SA307483783GA SA307483789GA SA307483794GA SA307483795GA SA307483796GA SA307483797GA SA307483798GA SA307483800GA SA307483801GA SA307483803GA SA307483804GA SA307483805GA SA307483806GA SA307483809GA SA307483810GA SA307483812GA SA307483814GA SA307483816GA SA307483817GA SA307483818GA SA307483819GA SA307483821GA SA307483823GA SA307483825GA SA307483826GA SA307483832GA SA307483834GA SA307483841GA SA307483843GA SA307504090GA SA307504092GA SA307504093GA SA307504094GA SA307504136GA SA307504138GA SA307504143GA SA307504144GA SA307504145GA SA307504151GA SA307504152GA SA307504153GA SA307504186GA SA307504217GA SA307504219GA SA307382620GA SA307443226GA SA307443233GA SA307443234GA SA307443237GA SA307443255GA SA307443256GA SA307443258GA SA307443259GA SA307443261GA SA307443263GA SA307443264GA SA307443265GA SA307443266GA SA307443268GA SA307443271GA SA307443272GA SA307443366GA SA307443368GA SA307443369GA SA307443372GA SA307443373GA SA307443376GA SA307443377GA SA307443379GA SA307443380GA SA307443382GA SA307443384GA SA307453398GA SA307453415GA SA307453419GA SA307453426GA SA307453436GA SA307453524GA SA307453580GA SA307453581GA SA307453612GA SA307483663GA SA307483664GA SA307483674GA SA307483675GA SA307483693GA SA307483695GA SA307483709GA SA307483710GA SA307483716GA SA307483717GA SA307483719GA SA307483723GA SA307483724GA SA307483725GA SA307483727GA SA307483731GA SA307483735GA SA307483755GA SA307483763GA ","43,033 (25,681 USA; 17,352 OUS)","GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.",11/27/2013,"11/27/2013",1/22/2014,"01/22/2014"
"Food",67116,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, WI, WV, WY)","F-1254-2014","Class II","White Corn Meal sold under the Aunt Jemima brand and packaged in a paper bag with a net weight of 80 oz. (5 lb.) 2.26 kg.","Quaker; White Corn Meal; net weight 80 oz. (5 lb.) 2.26 kg.; UPC: 30000 037102; Best Before Date: April 6, 2014; Cases of 8 bags labeled with UPC: 30000 03718",,"1,908 cases (15,264 bags)","Some Aunt Jemima and Quaker brand Self-Rising Corn Meal Mix, Buttermilk Self-Rising Corn Meal Mix, Corn Meal, and Quick Grits have levels of aflatoxin above the legal limit.",10/29/2013,"10/29/2013",1/1/2014,"01/01/2014"
"Food",67116,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, WI, WV, WY)","F-1255-2014","Class II","Buttermilk Self-Rising White Cornmeal Mix sold under the Aunt Jemima brand and packaged in a paper bag with a net weight of 32 oz. (2 lb.) 907 g.","Aunt Jemima; Self-Rising White Corn Meal Mix net weight 32 oz. (2 lb.) 907 g.; UPC: 30000 54505; Best Before Date: April 8, 2014; Cases of 12 bags labeled with UPC: 30000 05450",,"4,553 cases (54,636 bags)","Some Aunt Jemima and Quaker brand Self-Rising Corn Meal Mix, Buttermilk Self-Rising Corn Meal Mix, Corn Meal, and Quick Grits have levels of aflatoxin above the legal limit.",10/29/2013,"10/29/2013",1/1/2014,"01/01/2014"
"Food",67116,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, WI, WV, WY)","F-1252-2014","Class II","Self-Rising White Cornmeal Mix sold under the Aunt Jemima brand and packaged in a paper bag with a net weight respectively of 32 oz. (2 lb.) 907 g. or 5 lb. (2.26 kg.).","1) Aunt Jemima; Self-Rising White Corn Meal Mix net weight 32 oz. (2 lb.) 907 g.; UPC: 30000 55700; Best Before Date: February 15, 2014 and March 11, 2014; Cases of 12 bags labeled with UPC: 30000 05570; 2) Aunt Jemima Self-Rising White Corn Meal Mix net weight 5 lb. (2.26 kg.); UPC: 30000 55809; Best Before Dates: February 15, 2014 and February 16, 2014; Cases of 8 bags labeled with UPC: 30000 05588",,"15,334 cases (157,356 bags)","Some Aunt Jemima and Quaker brand Self-Rising Corn Meal Mix, Buttermilk Self-Rising Corn Meal Mix, and Quick Grits have levels of aflatoxin above the legal limit.",10/29/2013,"10/29/2013",1/1/2014,"01/01/2014"
"Food",67116,"Ongoing","Quaker Foods and Snacks North America","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, WI, WV, WY)","F-1253-2014","Class II","White quick grits and grits packaged in a paper bag sold under the Aunt Jemima or Quaker brand and packaged in a paper bag with a net weight respectively of 36.8 oz. (2 lb. 4 oz.) 1.04 kg., 5 lb. (80 oz.) 2.26 kg., or a club pack of three 5 lb. bags bundled together.","1) Aunt Jemima; Quick Grits net weight 36.8 oz. (2 lb. 4 oz.) 1.04 kg.; UPC: 30000 042601; Best Before Date: April 18, 2014; Cases of 8 bags labeled with UPC: 30000 04260. 2) Quaker; Grits net weight 36.8 oz. (2 lb. 4 oz.) 1.04 kg.; UPC: 30000 043680; Best Before Date: May 13, 2014; Cases of 8 bags labeled with UPC: 30000 04360. 3) Quaker; Quick Grits net weight 5 lb. (80 oz.) 2.26 kg.; UPC: 30000 43707; Best Before Dates: April 6, 2014 and May 17, 2014; Cases of 8 bags labeled with UPC: 30000 04378. 4) Quaker; Club Pack of 3 Quick Grits bags each with a net weight 5 lb. (80 oz.) 2.26 kg. and bundled together; UPC: 30000 43537; Best Before Dates: April 6, 2014, April 7, 2014, and May 17, 2014; Cases of 1 club pack labeled with UPC: 30000 44053.",,"13,671 cases (108,956 units)","Some Aunt Jemima and Quaker brand Self-Rising Corn Meal Mix, Buttermilk Self-Rising Corn Meal Mix, Corn Meal, and Quick Grits have levels of aflatoxin above the legal limit.",10/29/2013,"10/29/2013",1/1/2014,"01/01/2014"
"Devices",67117,"Ongoing","ACUTE Innovations, LLC","Hillsboro","OR","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of: Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.","Z-0852-2014","Class II","The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws. The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. Part Numbers: RBL1301- 50 mm Rib Plate; RBL1302- 75 mm Rib Plate; RBL1303- 115 mm Rib Plate; RBL1304- 155 mm Rib Plate; RBL1305- 215 mm Rib Plate; ","LOT numbers: RBL1301 for 50 mm Rib Plate: L1209002; L1302002; L1308001; RBL1302 for 75 mm Rib Plate: L1209003; L1302003; RBL1303 for 115 mm Rib Plate: L1209004; L1302004; RBL1304 for 155 mm Rib Plate: L1209005; RBL1305 for 215 mm Rib Plate: L1209006; ",,"176 units","The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. ",10/30/2013,"10/30/2013",2/5/2014,"02/05/2014"
"Drugs",67118,"Ongoing","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","CA, GA, NC, and MO","D-390-2014","Class II","Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3.","NDC 54868-0816-8, LOT: 6REE, EXP. 8/14; NDC 54868-0816-4, LOT: 6RED, EXP. 8/14; NDC 54868-0816-3, LOT: 6REB, EXP. 8/14; ",,"3,000 tablets","Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing. ",11/22/2013,"11/22/2013",1/1/2014,"01/01/2014"
"Biologics",67119,"Terminated","American Red Cross Blood Services","Birmingham","AL","US","Voluntary: Firm Initiated","Other","California","B-0311-14","Class III","Blood and Blood Products for Reprocessing","W204113003575; ",,"1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",11/15/2013,"11/15/2013",2/26/2014,"02/26/2014"
"Biologics",67120,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0312-14","Class II","Platelets Pheresis Leukocytes Reduced","W117013545858; ",,"1","Blood product, which was not prepared according to specifications, was distributed. ",10/24/2013,"10/24/2013",2/26/2014,"02/26/2014"
"Biologics",67121,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-0319-14","Class II","Plasma Frozen within 24 hours (FP24)","W0410130933715; W041013033805T; ",,"2","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",10/25/2013,"10/25/2013",2/26/2014,"02/26/2014"
"Devices",67122,"Ongoing","Navilyst Medical, Inc.","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.","Z-0826-2014","Class II","Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. ","Batch/Lot Numbers: 4688881, 4688883, 4688884, 4688885, 4688887, 4668695, 4654060, 4654060, 4659108, 4668699, 4654061, 4659109, 4668700, 4654062, 4659110, 4668701, 4654063, 4658398, 4662581, 4664985, 4675021, 4681156, 4654064, 4654065, 4658399, 4658400, 4662583 and 4675023",,"920 Total kits ","Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.",11/25/2013,"11/25/2013",2/5/2014,"02/05/2014"
"Devices",67123,"Ongoing","Ranir Corporation","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","Distributed in MN and IL.","Z-0782-2014","Class II","UP & UP kids' power toothbrush","UPC 071031015523, all lots",,"601,616 total","Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.",12/18/2013,"12/18/2013",1/29/2014,"01/29/2014"
"Devices",67123,"Ongoing","Ranir Corporation","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","Distributed in MN and IL.","Z-0781-2014","Class II","TopCare Clifford THE BIG RED DOG power toothbrush for kids!","UPC 071031069496, all lots",,"601,616 total","Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.",12/18/2013,"12/18/2013",1/29/2014,"01/29/2014"
"Devices",67124,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,","Z-0708-2014","Class II","Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.","All Lots for MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. ",,"6,824 imits (4,7324 in USA / 2,100 Foreign)","During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/burr fracture. ",10/26/2012,"10/26/2012",1/15/2014,"01/15/2014"
"Devices",67125,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including Washington D.C., Guam, and Puerto Rico; and Internationally to: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Lebanon, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Niger, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.","Z-0804-2014","Class II","Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. ","182, 00000000159728, 719723, 00000000045GP5, 00000000047GP1, 00000000120GP6, 00000000167GP7, 00000000168GP5, 00000000169GP3, 00000000170GP1, 00000000171GP9, 00000000175GP0, 00000000177GP6, 00000000180GP0, 00000000182GP6, 00000000184GP2, 00000000185GP9, 00000000186GP7, 00000000190GP9, 00000000223GQ8, 00000000252GP7, 00000000254GP3, 00000000256GP8, 00000000259GP2, 00000000277GQ4, 00000000331GP9, 00000000334GP3, 00000000353GP3, 00000000379GP8, 00000000380GP6, 00000000381GP4, 00000000382GP2, 00000000438GP2, 00000000439GP0, 00000000440GP8, 00000000444GP0, 00000000490GP3, 00000000491GP1, 00000000506GP6, 00000000556GP1, 00000000558GP7, 00000000590GP0, 00000000591GP8, 00000000592GP6, 00000000593GP4, 00000000594GP2, 00000000669GQ2,, 00000000694GP0, 00000000695GP7, 00000000701GP3, 00000000708GP8, 00000000778GP1, 00000000817GP7, 00000000818GP5, 00000000848GP2, 00000000884GP7, 00000000885GP4, 00000000917GP5, 00000000920GP9, 00000000921GP7, 00000000922GP5, 00000000923GP3, 00000000924GP1, 00000000946GP4, 00000000963GP9, 00000000964GP7, 00000000965GP4, 00000000AD6037, 00000000AD7002, 00000000AI6036, 00000001032GP2, 00000001033GP0, 00000001034GP8, 00000001035GP5, 00000001046GP2, 00000001067GP8, 00000001088GP4, 00000001091GP8, 00000001098GP3, 00000001106GP4, 00000001107GP2, 00000001109GP8, 00000001111GP4, 00000001232GP8, 00000001233GP6, 00000001267GQ4, 00000001341GP7, 00000001367GP2, 00000001374GP8, 00000001380M35, 00000001425GP8, 00000001433GP2, 00000001434GP0, 00000001435GP7, 00000001438GP1, 00000001441GP5, 00000001442GP3, 00000001453GP0, 00000001483GP7, 00000001540GP4, 00000001541GP2, 00000001543GP8, 00000001612GP1, 00000001614GP7, 00000001615GP4, 00000001663GP4, 00000001665GP9, 00000001737GP6, 00000001803M36, 00000001835GP8, 00000001848GP1, 00000001867GP1, 00000001868GP9, 00000001881M32, 00000001894GP5, 00000001895GP2, 00000001896GP0, 00000001897GP8, 00000001898GP6, 00000001942GP2, 00000001943GP0, 00000001944GP8, 00000001946GP3, 00000001971M31, 00000001991GP9, 00000001998GP4, 00000001999GP2, 00000002000GP8, 00000002115GP4,"," FMITR000751, FMITR000752, FMITR000753, FMITR000754, FMITR000755, FMITR000756, FMITR000757, FMITR000758, FMITR000759, FMITR000760, FMITR000761, FMITR000762, FMITR000763, FMITR000764, FMITR000765, FMITR000766, FMITR000767, FMITR000768, FMITR000769, FMITR000770, FMITR000771, FMITR000772, FMITR000773, FMITR000774, FMITR000775, FMITR000776, FMITR000777, FMITR000778, FMITR000779, FMITR000780, FMITR000781, FMITR000782, FMITR000783, FMITR000784, FMITR000785, FMITR000786, FMITR000787, FMITR000788, FMITR000789, FMITR000790, FMITR000791, FMITR000792, FMITR000793, FMITR000794, FMITR000795, FMITR000796, FMITR000797, FMITR000798, FMITR000799, FMITR000800, FMITR000801, FMITR000802, FMITR000803, FMITR000804, FMITR000805, FMITR000806, FMITR000807, FMITR000808, FMITR000809, FMITR000810, FMITR000811, FMITR000812, FMITR000813, FMITR000814, FMITR000815, FMITR000816, FMITR000817, FMITR000818, FMITR000819, FMITR000820, FMITR000821, FMITR000822, FMITR000823, FMITR000824, FMITR000825, FMITR000826, FMITR000827, FMITR000828, FMITR000829, FMITR000830, FMITR000831, FMITR000832, FMITR000833, FMITR000834, FMITR000835, FMITR000836, FMITR000837, FMITR000838, FMITR000839, FMITR000840, FMITR000841, FMITR000842, FMITR000843, FMITR000844, FMITR000845, FMITR000846, FMITR000847, FMITR000848, FMITR000849, FMITR000850, FMITR000851, FMITR000852, FMITR000853, FMITR000855, FMITR000856, FMITR000857, FMITR000858, FMITR000859, FMITR000860, FMITR000861, FMITR000862, FMITR000863, FMITR000864, FMITR000865, FMITR000866, FMITR000867, FMITR000868, FMITR000869, FMITR000870, FMITR000871, FMITR000872, FMITR000873, FMITR000874, FMITR000875, FMITR000876, FMITR000877, FMITR000878, FMITR000879, FMITR000880, FMITR000881, FMITR000882, FMITR000883, FMITR000884, FMITR000885, FMITR000886, FMITR000887, FMITR000888, FMITR000889, FMITR000890, FMITR000891, FMITR000892, FMITR000893, FMITR000894, FMITR000895, FMITR000896, FMITR000897, FMITR000898, FMITR000899, FMITR000900, FMITR000901, FMITR000902, FMITR000903, FMITR000904, FMITR000905, FMITR000906, FMITR000907, FMITR000908, FMI","5651","GE has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension. During several Preventive Maintenance activities it was discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.",11/8/2013,"11/08/2013",1/29/2014,"01/29/2014"
"Devices",67126,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.","Z-0787-2014","Class II","PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE'', ONCOR'' and PRIMUS'' family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.","550 TxT table - part number 07346534.",,"305 active devices.","Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT'' Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit caused overheating of an electronic circuit board inside the table base. ",12/5/2013,"12/05/2013",1/29/2014,"01/29/2014"
"Food",67127,"Ongoing","Concertos In Chocolate LLC","Boulder","CO","US","Voluntary: Firm Initiated","Press Release","COLORADO, NEW MEXICO, KANSAS, UTAH AND IDAHO; No foreign, military, government, or VA consignees.","F-1404-2014","Class I","SOLID MILK CHOCOLATE SANTA candy","ENJOY BY DATES FROM SEPTEMBER 1, 2014 THROUGH NOVEMBER 1, 2014",,"420","Concertos in Chocolate LLC is recalling Solid Milk Chocolate Santa, 5oz, because the product was incorrectly labeled and has an undeclared milk allergen.",12/18/2013,"12/18/2013",1/22/2014,"01/22/2014"
"Devices",67128,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada.","Z-0614-2014","Class II","Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.","Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237",,"59","Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.",12/6/2013,"12/06/2013",1/8/2014,"01/08/2014"
"Devices",67129,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0771-2014","Class II","Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.","Catalog Number: 809610, Lot Number: 01A1100610.",,"17,450 ea","Sterility cannot be guaranteed.",12/19/2013,"12/19/2013",1/22/2014,"01/22/2014"
"Devices",67129,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0770-2014","Class II","Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.","Catalog Number: 809600, Lot Numbers: 01M1000201, 01A1100320, 01C1000012, 01C1000385, 01E1000392.",,"17,450 ea.","Sterility cannot be guaranteed.",12/19/2013,"12/19/2013",1/22/2014,"01/22/2014"
"Devices",67130,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN, TX, VA, VT, WA, WI & WV; and Internationally to: Austria, Belgium, Canada, Denmark, Germany, Great Britain, Italy, Netherlands, Norway, Pakistan, Russia, Singapore & South Korea.","Z-0785-2014","Class II","ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH","ADAC ARGUS: Model #882060; Serial #: 1023, 1178, 106785, 136560, 1100005, 9051005, 9304030, 9309011, 9501007, 9509005, 9510027, 9510028, 9603042, 9603043, 9604044, 9604047, 9605011, 9607060, 9609065, 9610072, 9704081, 9709090, 9710097, 9711103, 9712105, 9712106, 9801107, 9801109, 9802112, 9803001, 9803116, 9804126, 9804129, 9806136, 9807138, 9807422,9810527, 9901156, 9901160, 9901162, 9908167, 9909172, 9910176, 00709B, 0101003A, 01310B, 01525B, 01920B, 01921B, 01922B, 03041B, 03094B, 03338B, 03368B, 2145-30074A, 7718B, A0103015, A0103213, A0105217, A02100230, A02100231, A02110248, A02110249, A02110250, A02110251, A02120254, A02120256, A03010262, A03010264, A03010265, A03010266, A03010270, A03020274, A03020275, A03030282, A03070283, A03120294, B0003196, B0007200, B0309014, ID3935B, M@10639, M@10645, M@10774, M@10777, M@10877, M@11239, M@11568, M@11640, M@11684, M@11685, M@11729, M@11769, M@11813, M@11947, M@12378-1, M@12462, M@12765, M@13725, M@24470, M@4750028851, M@4750028853, M@5348B, M@5807B, M@5874B, M@5894B, M@5932B, M@5941B, M@5963B, M@6041B, M@6062B, M@6229B, M@6354B, M@6477B, M@6485B, M@6546B, M@6555B, M@6692B, M@6754B, M@6809B, M@6815B, M@6948B, M@7007B, M@7023B, M@7093B, M@7194B, M@7198B, M@7207B, M@7214B, M@7280B, M@7285B, M@7286B, M@7408B, M@7540B, M@7596B, M@7675B, M@7704B, M@8156B, M@8324B, M@8344B, M@8429B, M@8523B, M@8578B, M@8588B, M@8637B, M@8639RB, M@8648B, M@8808B, M@8813B, M@8898B, M@8977B, M@9050B, M@9261B, M@9276B, M@9355RB, M@9475B, M@9544B, M@9647B, M@9656B, M@9733B & M@9796B. ADAC ARGUS: Model #88295; Serial #: 9211014, 9301005, 9304019, 9304024, 9304028, 9401028, 9401031, 9401037, 9505014, 9910033, 93-10678- 1292, 9910028P, M@10225AMT, M@3732B, M@3903B, M@3954B, M@3956B, M@3960B, M@4249B, M@4415B, M@4646B, M@4868B, M@5172B, M@5321B, M@7341B & M@AMT1154. ADAC CIRRUS: Model #88294; 34, 718558, 9206009, 9207003, 9207004, 9207005, 9207007, 9211006, 9300113, 9304013, 9309012, 9404022, 9407028, 9509042, 9604098, 9910030, 93-10735-0393, 9621RQ, M@10110AMT, M@10324AMT, M@10402AMT, M@35",,"255 units","The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.",12/4/2013,"12/04/2013",1/29/2014,"01/29/2014"
"Devices",67131,"Completed","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Telephone","US Distribution: Maryland only.","Z-0632-2014","Class II","Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.","Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)",," 1 B-Blue-S and 1 B-Green","Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).",6/11/2012,"06/11/2012",1/15/2014,"01/15/2014"
"Devices",67131,"Completed","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Telephone","US Distribution: Maryland only.","Z-0631-2014","Class II","Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.","Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)",,"4 ( BLACKMAX-N) and 1 (Foot Control)","Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).",6/11/2012,"06/11/2012",1/15/2014,"01/15/2014"
"Devices",67132,"Ongoing","On Site Gas Systems Inc.","Newington","CT","US","Voluntary: Firm Initiated","Letter","US Distribution: PA only.","Z-0647-2014","Class II","On Site Gas Systems POGS 33C Portable Oxygen Generation System","Serial Numbers: 4220FA 4221FA 4222FA 4223FA 4224FA 4225FA 4226FA 4227FA 4228FA 4229FA 4230FA 4231FA 4232FA 4233FA 4234FA 4235FA 4236FA 4237FA 4238FA 4239FA 4240FA 4241FA 4242FA 4243FA 4244FA 4245FA 4246FA 4247FA 4248FA 4249FA 4250FA 4251FA 4252FA 4253FA 4254FA 4255FA 4256FA 4257FA 4258FA 4259FA 4260FA 4261FA 4262FA 4263FA 4264FA 4265FA 4266FA 4267FA 4268FA 4269FA 4270FA 4271FA 4272FA 4273FA 4274FA 4275FA 4276FA 4277FA 4278FA 4279FA 4280FA 4281FA 4282FA 4283FA 4284FA 4285FA 4286FA 4287FA 4288FA 4289FA 4290FA 4291FA 4292FA 4293FA 4294FA 4295FA 4296FA 4297FA 4298FA 4299FA 4300FA 4301FA 4302FA 4303FA 4304FA 4305FA 4306FA 4307FA 4308FA 4309FA 4310FA 4311FA 4312FA 4313FA 4314FA 4315FA 4316FA 4317FA 4318FA 4319FA 4320FA 4322FA 4323FA 4324FA 4325FA 4326FA 4327FA 4328FA 4329FA 4330FA 4331FA 4332FA 4333FA 4334FA 4335FA 4336FA 4337FA 4338FA 4339FA 4340FA 4341FA 4342FA 4343FA 4344FA 4345FA 4346FA 4347FA 4348FA 4349FA 4350FA 4351FA 4352FA 4353FA 4354FA 4355FA 4356FA 4357FA 4358FA 4359FA 4360FA 4361FA 4362FA 4363FA 4364FA 4365FA 4366FA 4367FA 4368FA 4369FA 4370FA 4371FA 4372FA 4373FA 4374FA 4375FA 4376FA 4377FA 4378FA 4379FA 4380FA 4381FA 4382FA 4383FA 4384FA 4385FA 4386FA 4387FA 4388FA. 4389FA 4390FA 4391FA 4392FA 4393FA 4394FA 4395FA 4396FA 4397FA 4398FA 4399FA 4400FA 4401FA 4402FA 4403FA 4404FA 4405FA 4406FA 4407FA 4408FA 4409FA 4410FA 4411FA 4412FA 4413FA 4414FA 4415FA 4416FA 4417FA 4418FA ",,"198 units","Heat exchanger hose becomes weak and may fail.",12/19/2013,"12/19/2013",1/15/2014,"01/15/2014"
"Devices",67133,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-0924-2014","Class III","ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.","Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014. ",,"531","HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.",12/18/2013,"12/18/2013",2/12/2014,"02/12/2014"
"Devices",67134,"Completed","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Visit","US Distribution: Michigan only.","Z-0634-2014","Class II","Tracer IV wheelchairs, Heavy duty manual wheel chair, 24'' seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.","Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.",,"227 Wheelchairs","The wheels on Tracer IV wheelchairs (Tracer IV 24'' seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.",4/16/2012,"04/16/2012",1/15/2014,"01/15/2014"
"Drugs",67135,"Ongoing","Abrams Royal Pharamacy","Dallas","TX","US","Voluntary: Firm Initiated","Letter","Nationwide and to Canada","D-1564-2014","Class II","All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX","All unexpired lots of sterile drug products ",".",,"Lack of Assurance of Sterility",12/19/2013,"12/19/2013",9/3/2014,"09/03/2014"
"Drugs",67135,"Ongoing","Abrams Royal Pharamacy","Dallas","TX","US","Voluntary: Firm Initiated","Letter","Nationwide and to Canada","D-1563-2014","Class I","MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX","Lot number 11142013@74 ",".","74","Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis",12/19/2013,"12/19/2013",9/3/2014,"09/03/2014"
"Devices",67136,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Washington D.C., and Guam and the countries of ALBANIA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA , COLOMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAQ, IRELAND, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, NIGERIA, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-0725-2014","Class II","GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.","Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, 00000102937WK7, 00000130778WK3, 00000UA45526-8, 00001027058WK5, 00001027061WK9, 00001027146WK8, 00001027149WK2, 00001027150WK0, 00001027151WK8, 00001027153WK4, 00001027154WK2, 00001027167WK4, 00001027168WK2, 00001027169WK0, 00001027175WK7, 00001027193WK0, 00001027194WK8, 00001027195WK5, 00001027199WK7, 00001027200WK3, 00001027203WK7, 00001027204WK5, 00001027207WK8, 00001027214WK4, 00001027256WK5, 00001027259WK9, 00001027260WK7, 00001027262WK3, 00001027264WK9, 00001027265WK6, 00001027267WK2, 00001027268WK0, 00001027269WK8, 00001027276WK3, 00001027277WK1, 00001027278WK9, 00001027280WK5, 00001027293WK8, 00001027294WK6, 00001027295WK3, 00001027297WK9, 00001027298WK7, 00001027299WK5, 00001027300WK1, 00001027301WK9, 00001027302WK7, 00001027303WK5, 00001027314WK2, 00001027318WK3, 00001027322WK5, 00001027323WK3, 00001027324WK1, 00001027325WK8, 00001027326WK6, 00001027344WK9, 00001027346WK4, 00001027347WK2, 00001027349WK8, 00001027350WK6, 00001027351WK4, 00001027352WK2, 00001027353WK0, 00001027354WK8, 00001027356WK3, 00001027359WK7, 00001027362WK1, 00001027363WK9, 00001027364WK7, 00001027369WK6, 00001027371WK2, 00001027372WK0, 00001027373WK8, 00001027374WK6, 00001027376WK1, 00001027377WK9, 00001027380WK3, 00001027382WK9, 00001027383WK7, 00001027384WK5, 00001027386WK0, 00001027387WK8, 00001027388WK6, 00001027389WK4, 00001027390WK2, 00001027406WK6, 00001027407WK4, 00001027416WK5, 00001027417WK3, 00001027418WK1, 00001027421WK5, 00001027422WK3, 00001027423WK1, 00001027438WK9, 00001027445WK4, 00001027450WK4, 00001027451WK2, 00001027452WK0, 00001027464WK5, 00001027465WK2, 00001027466WK0, 00001027487WK6, 00001027488WK4, 00001027489WK2, 00001027490WK0, 00001027506WK3, 00001027507WK1, 00001027508WK9, 00001027539WK4, 00001027540WK2, 00001027541W",,"1027 ","There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient.",11/7/2013,"11/07/2013",1/22/2014,"01/22/2014"
"Drugs",67137,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-745-2014","Class III","Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84 ","Lot Number/Expiration Date G81845, Exp 10/03/14 0B0CJ, Exp 02/06/15 G44710, Exp 07/10/15 G65241, Exp 07/11/15 G80003, Exp 10/17/15 G82722, Exp 11/27/15 G93028, G95309, Exp: 01/23/16 G97641, Exp 01/30/16 ",,"101,681 Vials","Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.",1/2/2014,"01/02/2014",1/22/2014,"01/22/2014"
"Devices",67138,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0907-2014","Class II","Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.","models 8098027, 7740769, 10430603, 10590000, with multiple serial numbers: 64789, 64492, 66767, 66649, 64067, 66182, 65364, 64673, 64419, 66518, 66243, 64368, 64081, 60398, 66929, 66327, 66146, 66188, 66355, 66467, 64860, 64342, 73579, 73813, 64179, 66498, 64172, 66433, 66572, 66768, 64790, 66193, 64270, 66503, 65013, 65014, 64821, 64337, 64734, 65036, 66455, 66451, 66928, 65403, 65597, 64770, 66964, 66924, 64082, 66151, 66911, 65576, 67017, 64481, 64694, 66844, 73366, 64430, 65302, 64624, 66458, 60124, 66667, 64913, 64834, 73642, 66618, 66396, 66473, 73499, 64194, 64455, 60121, 64260, 66183, 64536, 83056, 64478, 65044, 60331,64424, 73738,64103,64232,64299,66851,66404,64929,64591,83014, 64114, 66381, 60404, 67000, 66422, 64181, 66490, 66738, 65225, 64308, 66253, 64822, 64484, 66757, 66679, 66616, 83059, 66813, 64603, 73679, 66695, 66878, 65948, 65572, 66248, 64304, 83044, 73160, 64019, 66375, 66689, 60173, 73030, 73655, 64504, 73818, 66112, 64882, 65341, 64243, 64297, 64378, 66824, 64370, 64340, 66445, 73547, 66462, 66882, 73761, 66316, 64927, 66694, 66700, 64071, 66634, 64827. ",,"147","During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.",11/15/2013,"11/15/2013",2/12/2014,"02/12/2014"
"Devices",67139,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Puerto Rico and Internationally.","Z-0710-2014","Class II","Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.","Lot Number:16231178 ",,"39 units","Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size",12/18/2013,"12/18/2013",1/22/2014,"01/22/2014"
"Devices",67139,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Puerto Rico and Internationally.","Z-0711-2014","Class II","Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110 ","Lot Number: 16231174",,"38 units","Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size",12/18/2013,"12/18/2013",1/22/2014,"01/22/2014"
"Devices",67139,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Puerto Rico and Internationally.","Z-0712-2014","Class II","Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140 ","Lot Number: 16230354",,"34 units","Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size",12/18/2013,"12/18/2013",1/22/2014,"01/22/2014"
"Drugs",67140,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1278-2014","Class I","Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.","Lot 32135DD; Exp 08/15",,"68,350 vials","Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.",12/23/2013,"12/23/2013",5/7/2014,"05/07/2014"
"Devices",67142,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.","Z-0716-2014","Class II","Locking Cortical Screw 3.5mmX38mm REF 8161-35-038","Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D",,"52","3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.",12/19/2013,"12/19/2013",1/22/2014,"01/22/2014"
"Biologics",67143,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX and Austria","B-0324-14","Class II","Red Blood Cells Leukocytes Reduced","W035213118675A",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/16/2013,"12/16/2013",3/5/2014,"03/05/2014"
"Biologics",67143,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX and Austria","B-0325-14","Class III","Blood and Blood Products for Reprocessing","W035213118675A",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/16/2013,"12/16/2013",3/5/2014,"03/05/2014"
"Biologics",67144,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","TN","B-0362-14","Class II","Platelets Pheresis Leukocytes Reduced","W071213048078",,"1 unit","Blood product, with insufficient plasma volume to support the platelet yield, was distributed. ",11/15/2013,"11/15/2013",3/5/2014,"03/05/2014"
"Biologics",67145,"Terminated","Winter Haven Hospital Community Blood Center, Inc.","Winter Haven","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0361-14","Class II","Blood and Blood Products for Reprocessing","W222111101736",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",7/19/2013,"07/19/2013",3/5/2014,"03/05/2014"
"Devices",67146,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.","Z-0729-2014","Class II","Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium","All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)",,"28,562 products for the entire recall","Some carbide cutting burr fractured during use.",12/17/2013,"12/17/2013",1/22/2014,"01/22/2014"
"Devices",67146,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.","Z-0728-2014","Class II","Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium","All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)",,"28,562 total of all products in this recall","Some carbide cutting burr fractured during use.",12/17/2013,"12/17/2013",1/22/2014,"01/22/2014"
"Devices",67146,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.","Z-0727-2014","Class II","Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium","All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)",,"28,562 total of all products in this recall","Some carbide cutting burr fractured during use.",12/17/2013,"12/17/2013",1/22/2014,"01/22/2014"
"Devices",67146,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.","Z-0726-2014","Class II","Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium","All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18) ",,"28,562 total of all products in this recall","Some carbide cutting burr fractured during use.",12/17/2013,"12/17/2013",1/22/2014,"01/22/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0893-2014","Class II","Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M264060",,"12 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0880-2014","Class II","25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M261810",,"108 Units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0872-2014","Class II","Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M269420",,"12 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0877-2014","Class II","25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M269200",,"36 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0873-2014","Class II","23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M272660",,"38 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0879-2014","Class II","25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M266040 and M269190",,"36 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0887-2014","Class II","27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M262090",,"96 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0874-2014","Class II","Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M258430 and M265950",,"44 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0885-2014","Class II","25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M260010 and M275520",,"96 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0891-2014","Class II","Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M264400, M265330, and M270010",,"36 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0884-2014","Class II","23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M257130 and M265370",,"102 Units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0882-2014","Class II","23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M259970 and M267870",,"72 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0889-2014","Class II","23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M264050, M269440, and M277900",,"108 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0883-2014","Class II","Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M270130",,"72 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0899-2014","Class II","25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M271960",,"28 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0896-2014","Class II","23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M270550",,"26 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0881-2014","Class II","27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M254140",,"24 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0898-2014","Class II","23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M265310 and M262070",,"43 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0890-2014","Class II","25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M262080 and M270970",,"96 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0888-2014","Class II","''The Corona'' Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M266740",,"12 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0897-2014","Class II","25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M276380",,"6 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0894-2014","Class II","23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M261310, M262650, M263630, M265960, and M268970",,"568 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0875-2014","Class II","Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M261320",,"108 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0878-2014","Class II","29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M25990, M263810, M265710, and M271040",,"233 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0876-2014","Class II","23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M260620, M265860, M267100, and M269230",,"240 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0886-2014","Class II","Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M271440",,"48 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0895-2014","Class II","Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot numbers: M260800, M262050, M263140, M264420, and M267440",,"507 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67147,"Ongoing","Synergetics Inc","O Fallon","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.","Z-0892-2014","Class II","Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.","Lot number: M274760",,"48 units","Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Food",67148,"Ongoing","Baugher Ranch Organics, Inc","Orland","CA","US","Voluntary: Firm Initiated","E-Mail","En-route to one location in Sarasota, FL.","F-1378-2014","Class II","Organic Almonds: Baugher Ranch Organics; Certified Organic by California Organic Farmers May Contain occasional Shell fragments. Keep Refrigerated; 25 lbs. Baugher Farms, Orland, CA","Lot number BR08-13A23-1333803; Expiration date June 2015",,"80 cases (25 lbs per case","Potential for metal fragments in product after a single wire from metal detector was confirmed to be cut into fragments and not all pieces are accounted for. ",12/18/2013,"12/18/2013",1/15/2014,"01/15/2014"
"Devices",67149,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.","Z-0819-2014","Class II","Composix L/P with Echo PS 10'' X 13'' Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. ","Lot# HUXH0294",,"19","Product labeling does not match product configuration. ",1/3/2014,"01/03/2014",1/29/2014,"01/29/2014"
"Devices",67149,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.","Z-0820-2014","Class II","Composix L/P with Echo PS 6'' X 8'' Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. ","Lot# HUXG0491, HUXH0295",,"46","Product labeling does not match product configuration. ",1/3/2014,"01/03/2014",1/29/2014,"01/29/2014"
"Devices",67150,"Ongoing","Optimedica Corporation","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and countries of: Dominican Republic, Germany, Switzerland, Australia, Spain, Japan, United Kingdom, Canada, France, The Netherlands, Austria, and Singapore.","Z-0649-2014","Class II","Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.","All units shipped prior to Octotber 18, 2013. US Serial numbers: 44055311, 44055611, 44055811, 44056012, 44056312, 44056612, 44056712, 44056812, 44057312, 44057812, 44058012, 44058212, 44058312, 44059212, 44059312, 44059612, 44059712, 44059812, 44059912, 44060012, 44060112, 44060312, 44060412. International Serial numbers: 44000811, 44055211, 44055411, 44055711, 44055911, 44056112, 44056212, 44056412, 44056512, 44056912, 44057012, 44057112, 44057212, 44057412, 44057512, 44057612, 44057712, 44057912, 44058112, 44058512, 44058612, 44058912, 44059012. 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062513 44062913 44063013 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062613 44062813 44063313 44063513 44063613 44063713 44063913. ",,"78 (39 in US, 39 internationally)","Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.",12/20/2013,"12/20/2013",1/15/2014,"01/15/2014"
"Food",67151,"Ongoing","Good Neighbors Specialty Foods, LLC","Derry","NH","US","Voluntary: Firm Initiated","Visit","NH, CT, MA, ME, NY, NJ","F-1675-2014","Class II","Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068","B339",,"1998","Customer found blade inside the salad. ",12/19/2013,"12/19/2013",3/26/2014,"03/26/2014"
"Devices",67152,"Ongoing","Nipro Diagnostics, Inc.","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.","Z-0910-2014","Class II","MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. ","Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.",,"105","Manufactured with an incorrect factory set unit of measure.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Devices",67152,"Ongoing","Nipro Diagnostics, Inc.","Ft Lauderdale","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.","Z-0909-2014","Class II","MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. ","Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.",,"501","Manufactured with an incorrect factory set unit of measure.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Devices",67153,"Ongoing","Siemens Medical Solutions USA, Inc","Martinez","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Inationwide) including the states of: California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan; and Internationally to: Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, Portugal, Greece, Bulgaria, Vietnam, Hungary, Italy, Palestinian Ter, Hungary, Jordan, Egypt Poland, Greece, Curacao, St Eus, Malaysia, Egypt, Malaysia, South Africa Turkey, Thailand, Qatar and Iraq.","Z-0786-2014","Class II","SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.","SIMVIEW NT Part number: 5496992 SIMVIEW NT with IDI Part number: 5497016 US Serial numbers: 6019 6029 6032 6035 6068 6080 6001 International serial numbers: 6060 6027 6067 1236 3654 4190 6006 6007 6014 6015 6020 6022 6023 6024 6030 6042 6048 6049 6053 6054 6062 6065 6069 6070 6084 6085 6088 6092 6095 6098 6099 6103 6104 6041DEL 6099-1 1256 6017 6028 6034 6036 6041 6044 6047 6050 6052 6055 6056 6058 6066 6072 6073 6079 6082 6083 6089 6090 6093 6105. ",,"65 active devices","In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.",12/11/2013,"12/11/2013",1/29/2014,"01/29/2014"
"Devices",67154,"Ongoing","Perrigo Diabetes Care","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA & TX","Z-0990-2014","Class II","Orbit soft Infusion sets, 9 mm soft cannula, P10 (42'') tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump. ","400064, 400069, 400070, & 400072 UPC: 7613117009502",,"7924 units","Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a distribution customer. ",12/20/2013,"12/20/2013",2/26/2014,"02/26/2014"
"Drugs",67155,"Ongoing","Betachem, Inc.","Upper Saddle River","NJ","US","Voluntary: Firm Initiated","E-Mail","MO","D-406-2014","Class II","Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4 ","Lot #: DMFH-366/11, DMFH-367/11, DMFH-368/11, DMFH-369/11, DMFH-370/11, DMFH-371/11, DMFH-372/11, DMFH-373/11, DMFH-374/11, DMFH-375/11, DMFH-376/11, DMFH-393/11, DMFH-394/11, DMFH-395/11, DMFH-396/11, DMFH-397/11, DMFH-399/11, DMFH-400/11, DMFH-401/11, DMFH-402/11, DMFH-403/11, DMFH-404/11, DMFH-405/11, DMFH-406/11 ",,"27,000 kilos (1080 drums)","CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.",10/7/2013,"10/07/2013",1/22/2014,"01/22/2014"
"Devices",67157,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.","Z-1175-2014","Class II","GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Ox","Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380503HA SEW13380504HA SEW13380505HA SEW13380506HA SEW13380507HA SEW13380508HA SEW13380509HA SEW13380512HA SEW13380520HA SEW13380524HA SEW13380525HA SEW13380526HA SEW13380534HA SEW13380535HA SEW13380536HA SKA13130068GA SKA13130071GA SKA13130075GA SKA13130077GA SKA13130078GA SKA13130082GA SKA13130085GA SKA13140118GA SKA13370167GA SKA13370211GA SKA13370214GA SKA13370215GA SKA13370216GA SKA13370217GA SKA13370218GA SKA13370219GA SKA13370220GA SKA13370221GA SKA13370222GA SKA13370223GA SKA13370224GA SKA13370225GA SKA13370226GA SKA13370227GA SKA13370228GA SKA13370229GA SKA13370230GA SKA13370231GA SKA13370232GA SKA13370233GA SKA13370234GA SKA13370235GA SKA13370236GA SKA13370237GA SKA13370238GA SKA13370239GA SKA13370240GA SKA13370241GA SKA13370242GA SKA13370263GA SKA13370265GA SKA13370267GA SKA13370268GA SKA13370269GA SKA13370270GA SKA13370271GA SKA13370272GA SEW13380133HA SEW13380155HA SEW13380256HA SEW13380258HA SEW13380259HA SEW13380260HA SEW13380264HA SEW13380265HA SEW13380266HA SEW13380267HA SEW13380268HA SEW13380269HA SEW13380271HA SEW13380305HA SEW13380319HA SEW13380371HA SEW13380375HA SEW13380377HA SEW13380400HA SEW13380413HA SEW13380415HA SEW13380422HA SEW13380423HA SEW13380424HA SEW13380425HA SEW13380426HA SEW13380427HA SEW13380429HA SEW13380432HA SEW13380433HA SEW13380434HA SEW13380435HA SEW13380436HA SEW13380437HA SEW13380438HA SEW13380439HA SEW13380440HA SEW13380441HA SEW13380442HA SEW13380443HA SEW13380444HA SEW13380445HA SEW13380446HA SEW13380447HA SEW13380453HA SEW13380459HA SEW13380461HA SEW13380463HA SEW13380464HA SEW13380465HA SEW13380497HA SEW13380498HA SEW13380499HA SKA13130089GA SKA13130101GA SED13017065GA SED13017067GA SED13027233GA SED13027251GA SED13027253GA SED13027259GA SED13027261GA SED13027263GA SED13027265GA SED13027266GA SED13027267GA SED13027268GA SED13027269GA SED13027270GA SED13027271GA SED13027272GA SED13027273GA SED13027274GA SED13027275GA SED13027276GA SED13027277GA SED130272",".","676 units OUS","GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues.",2/28/2014,"02/28/2014",3/19/2014,"03/19/2014"
"Biologics",67158,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","CN","B-0360-14","Class II","Platelets Leukocytes Reduced","W051713811110",,"1 unit","Blood product, collected from a donor who received an ear piercing within 12 months of donation, was distributed.",11/4/2013,"11/04/2013",3/5/2014,"03/05/2014"
"Devices",67159,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.","Z-1077-2014","Class II","PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility. ","Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)",,"2","PFC SIGMA Cruciate Retaining (CR) Cemented Femoral devices were found to have anomalous microstructure. Due to the manufacturing method employed, there may be the potential for increased levels of porosity, as well as blocky grain boundary carbides in the microstructure when compared to parts manufactured under the current accepted and validated protocols. Porosity and the presence of blocky carbides, within the cobaltchrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.",12/9/2013,"12/09/2013",3/5/2014,"03/05/2014"
"Food",67160,"Ongoing","Biery Cheese Co","Louisville","OH","US","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: IL, KY, MA, MD, NJ, OH & WI.","F-1426-2014","Class III","Shredded Swiss Cheese, INGREDIENTS: Milk, Cheese Culture, Enzymes......Aged 60 days. CONTAINS: MILK NET WT. 80 OZ. (5 LB.) 2.2kg MFG By Biery cheese Co., Louisville, OH 44641","Item #1550, Lot code: Sell By 2/19/2014",,"830 cs/4/5 lb plastic bags","The firm was notified by a customer of foreign yellow plastic material in the product.",12/5/2013,"12/05/2013",1/22/2014,"01/22/2014"
"Devices",67161,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,SC, TN, TX, UT, VT, VA, WA, WI, and WY. Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON,LITHUANIA, MALAYSIA, MAURITIUS, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR , SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-0648-2014","Class II","SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) ","Mfg Lot or Serial # SA307140598GA SA307140599GA SA307140600GA SA307140601GA SA307140605GA SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140612GA SA307140614GA SA307140615GA SA307140618GA SA307140619GA SA307140622GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140632GA SA307140636GA SA307140637GA SA307140639GA SA307140640GA SA307140641GA SA307140642GA SA307140644GA SA307150645GA SA307150646GA SA307150655GA SA307150656GA SA307020391GA SA307030405GA SA307030424GA SA307070446GA SA307070447GA SA307070448GA SA307080462GA SA307080463GA SA307080484GA SA307080508GA SA307080523GA SA307110548GA SA307110556GA SA307110571GA SA307190716GA SA307190737GA SA307190739GA SA307190750GA SA307190768GA SA307020379GA SA307020384GA SA307020386GA SA307030407GA SA307030409GA SA307030412GA SA307030414GA SA307060432GA SA307070436GA SA307070440GA SA307070441GA SA307070442GA SA307070450GA SA307070453GA SA307070454GA SA307070455GA SA307080472GA SA307080477GA SA307080478GA SA307080504GA SA307080520GA SA307080526GA SA307110559GA SA307110560GA SA307110572GA SA307110575GA SA307110579GA SA307120587GA SA307120588GA SA307150681GA SA307180694GA SA307180696GA SA307180697GA SA307190717GA SA307190718GA SA307190720GA SA307190722GA SA307190724GA SA307190727GA SA307190728GA SA307190729GA SA307190730GA SA307190732GA SA307190733GA SA307190734GA SA307190738GA SA307190741GA SA307190742GA SA307190743GA SA307190744GA SA307190745GA SA307190749GA SA307190764GA SA307190766GA SA307190769GA SA307190770GA SA307190771GA SA307020383GA SA307030411GA SA307030413GA SA307050429GA SA307070443GA SA307080459GA SA307080467GA SA307080521GA SA307080522GA SA307080524GA SA307150651GA SA307180699GA SA307190736GA SA307190755GA SA307190773GA SA307190774GA SA307200784GA SA307220983GA SA307221081GA SA307221089GA SA307020393GA SA307020396GA SA307020397GA SA307020399GA SA307030417GA SA307030419GA SA307030423GA SA307070438GA SA307080473GA SA307080493GA SA307080498GA SA307080499GA SA307080509GA SA307080510GA SA307080533GA SA307150671GA SA307180698GA SA3071807"," SA307483754GA SA307483756GA SA307483757GA SA307483758GA SA307483759GA SA307483760GA SA307483762GA SA307483765GA SA307483766GA SA307483767GA SA307483771GA SA307483775GA SA307483777GA SA307483782GA SA307483783GA SA307483789GA SA307483794GA SA307483795GA SA307483796GA SA307483797GA SA307483798GA SA307483800GA SA307483801GA SA307483803GA SA307483804GA SA307483805GA SA307483806GA SA307483809GA SA307483810GA SA307483812GA SA307483814GA SA307483816GA SA307483817GA SA307483818GA SA307483819GA SA307483821GA SA307483823GA SA307483825GA SA307483826GA SA307483832GA SA307483834GA SA307483841GA SA307483843GA SA307504090GA SA307504092GA SA307504093GA SA307504094GA SA307504136GA SA307504138GA SA307504143GA SA307504144GA SA307504145GA SA307504151GA SA307504152GA SA307504153GA SA307504186GA SA307504217GA SA307504219GA SA307382620GA SA307443226GA SA307443233GA SA307443234GA SA307443237GA SA307443255GA SA307443256GA SA307443258GA SA307443259GA SA307443261GA SA307443263GA SA307443264GA SA307443265GA SA307443266GA SA307443268GA SA307443271GA SA307443272GA SA307443366GA SA307443368GA SA307443369GA SA307443372GA SA307443373GA SA307443376GA SA307443377GA SA307443379GA SA307443380GA SA307443382GA SA307443384GA SA307453398GA SA307453415GA SA307453419GA SA307453426GA SA307453436GA SA307453524GA SA307453580GA SA307453581GA SA307453612GA SA307483663GA SA307483664GA SA307483674GA SA307483675GA SA307483693GA SA307483695GA SA307483709GA SA307483710GA SA307483716GA SA307483717GA SA307483719GA SA307483723GA SA307483724GA SA307483725GA SA307483727GA SA307483731GA SA307483735GA SA307483755GA SA307483763GA SA307483764GA SA307483769GA SA307483770GA SA307483772GA SA307483773GA SA307483776GA SA307483778GA SA307483780GA SA307483784GA SA307483788GA SA307483790GA SA307483792GA SA307483808GA SA307483813GA SA307483822GA SA307483824GA SA307483827GA SA307483828GA SA307483829GA SA307483835GA SA307483838GA SA307483840GA SA307493845GA SA307493846GA SA307493847GA SA307493848GA SA307493849GA SA307493850GA SA307493851GA SA307493854GA SA307493863GA SA307493933GA ","17,444 (11,418 units US, 6,026 units OUS).","GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.",12/16/2013,"12/16/2013",1/15/2014,"01/15/2014"
"Drugs",67162,"Ongoing","Deseo Rebajar","Fajardo","PR","US","Voluntary: Firm Initiated","Press Release","Puerto Rico only","D-1351-2014","Class I","Burn 7 Capsules, supplied in 30 capsules bottle ","MFD: 07.18.2013, EXP: 07.17.2015",,"120 bottles","Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement",12/23/2013,"12/23/2013",6/4/2014,"06/04/2014"
"Devices",67164,"Ongoing","Vital Signs Colorado Inc.","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Rosersberg, Lebanon, South Korea, Finland, United Arab Emirate, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.","Z-0812-2014","Class II","Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.","PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028,",,"1,827,920 units US , 504,760 units OUS","Vital Signs Devices (VSD), a GE Healthcare Company, has become aware through a customer complaint of a safety issue associated with a certain Breathing Circuit. A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.",12/26/2013,"12/26/2013",1/29/2014,"01/29/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0706-2014","Class II","6'' (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item # A1003, Lot # 2773812.",,"250","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0673-2014","Class II","8'' Smallbore Pentafuse Ext Set w/5 NanoClave'', 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773046",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0690-2014","Class II","6'' (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave'', 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767366",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0683-2014","Class II","7'' (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave'', Clamp, Luer Lock, Part No. A1000, Item No. K7089-001 ","Lot No. 2784699",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0703-2014","Class II","5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item # B3304-T, Lot # 2791244.",,"750","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0662-2014","Class II","184 cm (72'') Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item No. 011-A1095. Lot No. 2776972, 2785650, 2796669.",,"250 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0687-2014","Class II","78'' Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave'' T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767012",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0697-2014","Class II","8'' (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767376",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0689-2014","Class II","6'' (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767365",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0677-2014","Class II","14'' (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2776502",,"100 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0674-2014","Class II","10'' Smallbore Pentafuse Ext Set w/5 NanoClave'', 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773047",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0678-2014","Class II","103'' (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave'', Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773813",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0680-2014","Class II","6'' (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave'' TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767356",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0688-2014","Class II","7'' (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave'', Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767364",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0686-2014","Class II","106'' (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave'' TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2778180",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0672-2014","Class II","8'' (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773045",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0676-2014","Class II","13'' Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2777116",,"25 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0663-2014","Class II","31 cm (12'') Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item No. 011-A1097. Lot No. 2781155, 2796667.",,"250 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0699-2014","Class II","120'' 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2774004 2776121 2778498 2783073 2790601",,"2000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0670-2014","Class II","78'' Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773123 2777666 2781424",,"1300 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0660-2014","Class II","6'' (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2776452",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0668-2014","Class II","7'' (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2770580 2774284 2777867 2781557 2782915",,"10,400 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0694-2014","Class II","7'' (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767372",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0681-2014","Class II","6'' (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave'' TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767357",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0682-2014","Class II","7'' (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767359",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0691-2014","Class II","7'' (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767368",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0692-2014","Class II","10'' (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2784698",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0664-2014","Class II","NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2781529",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0695-2014","Class II","11'' Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave'', 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767374",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0671-2014","Class II","11'' Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave'', 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2788311",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0700-2014","Class II","5'' (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 34-892-HE",,"100 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0679-2014","Class II","8'' Ext Set w/NanoClave'' Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2764741",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0702-2014","Class II","5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","B3303-T, Lot # 2791243.",,"50","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0661-2014","Class II","183 cm (72'') Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave , NanoClave T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item No. 011-A1094. Lot No. 2776971, 2785649, 2796670.",,"250 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0684-2014","Class II","7'' (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave'' T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767361",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0693-2014","Class II","10'' (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave'', Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767371",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0665-2014","Class II","17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2788003",,"50 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0705-2014","Class II","6.5'' (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item # A1099, Lot # 2791393.",,"4150","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0701-2014","Class II","5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item # B33101-T, Lot # 2791358.",,"800","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0675-2014","Class II","87'' (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2764552",,"150 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0707-2014","Class II","17 cm (7'') Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item #011-A1096, Lot # 2796668.",,"100","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0685-2014","Class II","10'' (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave'' T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767362 2782698",,"4000 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0704-2014","Class II","28'' (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item # B33071-T, Lot # 2791245.",,"50","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0659-2014","Class II","6'' (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2781528",,"100 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0669-2014","Class II","8'' (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2770581 2774286 2777870 2781558 2790342",,"2800 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0696-2014","Class II","13'' Pentafuse Smallbore Ext Set w/NanoClave'', 1.2 Micron Filter, 3 MicroClave Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2767375",,"500 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0658-2014","Class II","NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2766916 2781527 2776455 2767054 2768331 2770578 2781554 2785375 2767355 2783362 2787992 34-463-HE",,"69100 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0666-2014","Class II","6'' (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2773810 2777115 2781555",,"700 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0667-2014","Class II","7'' (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Lot No. 2740579 2767063 2771738",,"7150 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67166,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.","Z-0698-2014","Class II","30'' (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.","Item No. SC124. Lot No. 2774006, 2778500, 2783068, 2794495.",,"2250 units","ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.",12/24/2013,"12/24/2013",1/15/2014,"01/15/2014"
"Devices",67167,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped to the following countries: Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Cuba, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Ukraine, United Kingdom, Venezuela & Vietnam.","Z-0932-2014","Class II","Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) ","Model #882412; Serial #'s:14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711. Model #882438; Serial #'s:17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019, 17021, 17022, 17023, 17024, 17025, 17026 & 17028. Model #882470; Serial #'s: 7003, 7004, 7005, 7006, 7008, 7009, 7010, 7011, 7014, 7015, 7017, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7031, 7034, 7035, 7036, 7039, 7043, 7045, 7049, 7050, 7052, 7053, 7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7074, 7075, 7077, 7080, 7081, 7084, 7085, 7086, 7087, 7089, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7108, 7112, 7114, 7115, 7118, 7120, 7121, 7122, 7123, 7124, 7125, 7128, 7129, 7131, 7135, 7137, 7138, 7139, 7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7166, 7168, 7173, 7174, 7176, 7177, 7181, 7183, 7184, 7185, 7186, 7187, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7200, 7207, 7208, 7210, 7211, 7215, 7216, 7223, 7224, 7226, 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7501, 7503, 7507, 7508, 7511, 7514, 7517, 7518, 7520, 7521, 7523, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7536, 7538, 7540, 7545, 7546, 7554, 7559, 7564, 7566, 7568, 7570, 7573, 7581, 7583, 7584, 7586, 7590, 7591, 7104M, 7106M, 7170M &7582M. Model #882471; Serial #'s: 7007, 7012, 7013, 7016, 7027, 7028, 7029, 7030, 7032, 7037, 7042, 7044, 7048, 7055, 7057, 7059, 7061, 7063, 7065, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152, 7153, 7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178, 7179, 7180, 7182, 7188, 7189, 7190, 7192, 7201, 7202, 7203, 7204, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7236, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7",,"386 units","The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.",12/4/2013,"12/04/2013",2/12/2014,"02/12/2014"
"Devices",67168,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.","Z-0801-2014","Class II","Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. ","Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835. Model #728244; 7621, 7636, 7809 & 7844.",,"32 units","Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.",12/4/2013,"12/04/2013",1/29/2014,"01/29/2014"
"Biologics",67169,"Terminated","Blood Systems, Inc. DBA United Blood Services","Lafayette","LA","US","Voluntary: Firm Initiated","FAX","LA","B-0364-14","Class III","Red Blood Cells Leukocytes Reduced","W042013052033C",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/5/2013,"12/05/2013",3/26/2014,"03/26/2014"
"Biologics",67170,"Terminated","American National Red Cross (the)","Charlotte","NC","US","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0338-14","Class II","Platelets Pheresis Leukocytes Reduced","12KR889661; 12KR889662; ",,"2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",9/18/2013,"09/18/2013",3/5/2014,"03/05/2014"
"Devices",67171,"Ongoing","Symmetry Medical/SSI","Antioch","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Columbia, Korea, and Chile.","Z-0833-2014","Class II","Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) brands, QUAD-LOCK (TM) Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., 3034 Owen Drive, Antioch, TN 37013 Symmetry and CODMAN(R) bran","all lots ",,"2,991 units ","The Quad-Lock(TM) Sterilization Container System may not maintain an effective sterile barrier.",12/5/2013,"12/05/2013",2/5/2014,"02/05/2014"
"Devices",67172,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","US Distribution one importer/wholesale distributor in MO.","Z-0921-2014","Class II","B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.","Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.",,"30, 240 units","Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.",12/13/2013,"12/13/2013",2/12/2014,"02/12/2014"
"Devices",67174,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.","Z-0989-2014","Class II","Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. ","4 lots: 4505268906, 4505336973, 4505408485, 4505238953",,"79","The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.",12/23/2013,"12/23/2013",2/26/2014,"02/26/2014"
"Devices",67175,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1080-2014","Class II","Siemens Artis zee Ceiling Systems. Angiographic x-ray system.","Artis zee Ceiling systems serial numbers from 146352 to 147617",,"284","During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.",12/16/2013,"12/16/2013",3/5/2014,"03/05/2014"
"Devices",67176,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.","Z-0829-2014","Class II","AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.","Lot #'s: D293037349, D323038110 and D363039140",,"599 cutting burs","Cutter was longer than was stated on the label.",3/31/2011,"03/31/2011",2/5/2014,"02/05/2014"
"Devices",67176,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.","Z-0830-2014","Class II","Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.","Lot #'s: D323038131 and D343038845",,"29 cutting burs","Cutter was longer than was stated on the label.",3/31/2011,"03/31/2011",2/5/2014,"02/05/2014"
"Devices",67177,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.","Z-0715-2014","Class II","Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures","ALL LOTS for product code 18-0001",,"492 (321 US)","Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.",3/29/2012,"03/29/2012",1/22/2014,"01/22/2014"
"Devices",67178,"Ongoing","Zeiss, Carl Inc","Thornwood","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.","Z-0799-2014","Class II","Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.","part number 473704-0000-000",,"335 units Total (14 domestically & 321 internationally)","Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate. ",12/20/2013,"12/20/2013",1/29/2014,"01/29/2014"
"Devices",67179,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.","Z-0779-2014","Class II","Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.","ALL LOTS",,"183","Product did not reach expected sterility assurance level",5/6/2013,"05/06/2013",1/22/2014,"01/22/2014"
"Drugs",67180,"Ongoing","Cubist Pharmaceuticals, Inc.","Lexington","MA","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico.","D-0229-2015","Class I","CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01 ","Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.",".","371,879 Vials","Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.",8/8/2014,"08/08/2014",11/5/2014,"11/05/2014"
"Biologics",67181,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Florida; New York","B-0355-14","Class II","Red Blood Cells","2385378; W036810163635; 2297584; 2301005; 2777223; ",,"5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/12/2013,"11/12/2013",3/5/2014,"03/05/2014"
"Biologics",67181,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Florida; New York","B-0354-14","Class II","Fresh Frozen Plasma","2297584; 2385378; W036810163635; 2301005; ",,"4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/12/2013,"11/12/2013",3/5/2014,"03/05/2014"
"Biologics",67181,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Florida; New York","B-0356-14","Class II","Platelets Pooled Leukocytes Reduced","2297584; W036810816301; 2301005; 2777223; ",,"4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/12/2013,"11/12/2013",3/5/2014,"03/05/2014"
"Biologics",67181,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Pennsylvania; Florida; New York","B-0353-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","2036521; 2036521; ",,"2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",11/12/2013,"11/12/2013",3/5/2014,"03/05/2014"
"Devices",67182,"Completed","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to CA only.","Z-0809-2014","Class II","Pulmonary Hemi-Artery SG Used in heart surgery","Serial No. 10119759, Model SGPH00",,"One","Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.",11/22/2013,"11/22/2013",1/29/2014,"01/29/2014"
"Devices",67183,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.","Z-1170-2014","Class II","Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.","NCATD0C (PSDT1)",".","250","During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.",7/22/2013,"07/22/2013",3/19/2014,"03/19/2014"
"Devices",67183,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.","Z-1171-2014","Class II","Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.","NPSDK0 aka PSKDO (PSKDT1)(",".","181","During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.",7/22/2013,"07/22/2013",3/19/2014,"03/19/2014"
"Devices",67183,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.","Z-1169-2014","Class II","Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.","NCATDO aka CATD0 (PSDT1)",".","541","During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.",7/22/2013,"07/22/2013",3/19/2014,"03/19/2014"
"Devices",67183,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.","Z-1168-2014","Class II","Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.","SGTIKIT (SGTTRAY)",".","170","During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.",7/22/2013,"07/22/2013",3/19/2014,"03/19/2014"
"Devices",67183,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.","Z-1167-2014","Class II","Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.","SGKIT (SGTRAY)",".","21","During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.",7/22/2013,"07/22/2013",3/19/2014,"03/19/2014"
"Devices",67184,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.","Z-1083-2014","Class II","Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.","Model 1.1",,"455","During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.",11/25/2013,"11/25/2013",3/12/2014,"03/12/2014"
"Devices",67184,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.","Z-1085-2014","Class II","Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.","Model 3.1",,"134","During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.",11/25/2013,"11/25/2013",3/12/2014,"03/12/2014"
"Devices",67184,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.","Z-1084-2014","Class II","Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.","Model 3.0",,"300","During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.",11/25/2013,"11/25/2013",3/12/2014,"03/12/2014"
"Food",67185,"Ongoing","Giant Eagle","Pittsburgh","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Exclusively to Giant Eagle retail supermarkets in PA, OH, and MD.","F-1438-2014","Class I","Candy Place Chocolate Santas, in 11 oz clear plastic bags, individually wrapped assortment of double chocolate, caramel, and peanut butter flavored chocolates, distributed by Giant Eagle, Pittsburgh, PA. Ingredients: Sugar, partially hydrogenated vegetable oil (Palm kernel, coconut, and/or palm), cocoa (processed with alkali) whey, lactose, skim milk, soy lecithin (emulsifier), vanillin (artificial flavor). ","UPC 3003407341, Sell date: 6/24/14 Lot #: 309 (a four digit time code that changes) 27 ",,"1372 units purchased by customers","Giant Eagle Candy Place Chocolate Santas do not declare the peanut allergen ingredient on the primary package label. Also, the caramel variety ingredient statement was not included in the finished product label.",12/27/2013,"12/27/2013",1/29/2014,"01/29/2014"
"Food",67186,"Terminated","West Coast Produce, LLC","Oakland","CA","US","Voluntary: Firm Initiated","Telephone","CA only - all but 2 sales were cash and carry.","F-1446-2014","Class III","Hnos. Perez brand cactus leaves (pads): distributed by: West Coast Produce 300 Franklin St. Oakland, CA 94607","Product number 58164",,"10 cases","State of California, Department of Pesticide Regulation samples Cactus Pads and found the following pesticides that are not permitted in the US: Permethrin - 0.094 ppm; Chlorpyriphos - 0.136 ppm; Monocrotophos - 0.030 ppm. ",12/13/2013,"12/13/2013",2/5/2014,"02/05/2014"
"Food",67187,"Terminated","Shasta Produce","South San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA only","F-1447-2014","Class II","Mexpogroup Cactus Grown in Mexico; 44 lbs, 20 KG; Calle El Rosario #20581 Col Buenos Aires Norte C.P. 22700 Tijuana, Mexico.","Lot 305083",,"42 cases 44 lbs each","CA Dept of Pesticide Regulation, Enforcement Branch, sampled Mexpogroup Cactus and found the following chemical which do not have a tolerance level in the US: Monocrotophos - 2.37 ppm; Carbendazim as Thiophanate Methyl - 0.154 ppm; Chlorothalonil - 3.61 ppm.",12/19/2013,"12/19/2013",2/5/2014,"02/05/2014"
"Devices",67188,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.","Z-0844-2014","Class II","KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A.","Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675 ",,"164 units Total (42 domestically & 122 internationally)","Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. ",12/26/2013,"12/26/2013",2/5/2014,"02/05/2014"
"Biologics",67189,"Terminated","Talecris Plasma Resources Inc Dba International Bioresources","Glendale","AZ","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0298-14","Class II","Source Plasma","3680276999; ",,"1","Blood product, collected from a donor who was incarcerated for more than 72 hours within 12 months of donating, was distributed.",12/4/2013,"12/04/2013",3/5/2014,"03/05/2014"
"Biologics",67190,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","Iowa; New Jersey","B-0345-14","Class II","Platelets Pheresis Leukocytes Reduced","W037913564193; W037913555356; W037913555356; W037912890103; W037912890103; ",,"5","Blood products, which may not have met the criteria for leukoreduced products because the WBC count was performed incorrectly, were distributed.",12/26/2013,"12/26/2013",3/5/2014,"03/05/2014"
"Biologics",67190,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","Iowa; New Jersey","B-0346-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W037913564890; W037911893490; ",,"2","Blood products, which may not have met the criteria for leukoreduced products because the WBC count was performed incorrectly, were distributed.",12/26/2013,"12/26/2013",3/5/2014,"03/05/2014"
"Devices",67191,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada","Z-0902-2014","Class II","Neptune 2 Rover Ultra Waste Management System. ","Manufacturer Part Number 0702-001-000 (120V) All serial numbers",,,"The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.",12/30/2013,"12/30/2013",2/12/2014,"02/12/2014"
"Devices",67191,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada","Z-0903-2014","Class II","Neptune 2 Rover Ultra Waste Management System","Manufacturer Part Number 0702-002-000 (230V) All serial numbers",,,"The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.",12/30/2013,"12/30/2013",2/12/2014,"02/12/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1527-2104","Class II","Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.","Lots2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1508-2014","Class II","Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.","Lots 2413, 2643, 2663, 2673, 2883",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1515-2014","Class II","Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2143, 2243, 2253, 2263, 2413, 2423, 2633",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1522-2014","Class II","Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2203, 2223, 2363, 2503, 2583, 2683, 2173, 2203, 2213, 2223,2273, 2433, 2463, 2483, 2493, 2503, 2513, 2623, 2653, 2673,2763",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1525-2014","Class II","Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2213, 2283",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1531-2014","Class II","Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.","Lots 2373, 2383, 2393, 2433, 2503, 2543, 2773, 2783, 2793, 2843,2853",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1519-2014","Class II","Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2173, 2203, 2363, 2393, 2463, 2483, 2493, 2503, 2593, 2603, 2623, 2643, 2653, 2663, 2883",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1491-2014","Class II","Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2393, 2433, 2443, 2453, 2503, 2523, 2533, 2713, 2723, 2733",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1507-2014","Class II","Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.","Lots 2263, 2353, 2403, 2833, 2863, 2873",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1504-2014","Class II","Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2743, 2753, 2763, 2863",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1529-2014","Class II","Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.","Lots 2193, 2323, 2693, 2803",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1497-2014","Class II","Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2283, 2333, 2343, 2413, 2813",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1503-2014","Class II","Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lots 2113, 2523, 2533, 2543, 2773, 2783, 2843",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1514-2014","Class II","Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2613, 2633",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1516-2014","Class II","Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2143, 2163, 2213, 2243, 2253, 2263, 2333, 2343, 2403, 2413, 2703",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1510-2014","Class II","GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lot 2813",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1526-2014","Class II","Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags.","Lots 2333, 2483, 2493, 2613",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1523-2014","Class II","GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2773, 2783, 2843",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1520-2014","Class II","Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2603, 2623",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1498-2014","Class II","Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lots 2333, 2763, 2813",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1532-2014","Class II","Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.","Lot 2203",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1512-2014","Class II","GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lot 2763",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1500-2014","Class II","Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lot 2233",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1521-2014","Class II","Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2173, 2183, 2203, 2223, 2273, 2283, 2303, 2593, 2603, 2623",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1513-2014","Class II","Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2343, 2353, 2413, 2423, 2483, 2633, 2663, 2673, 2703, 2713, 2723, 2743, 2753, 2763, 2803, 2813, 2823, 2833, 2853, 2863, 2893",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1509-2014","Class II","Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.","Lots 2653, 2663",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1530-2014","Class II","Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.","Lots 2573, 2583, 2593, 2693",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1505-2014","Class II","Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.","Lots 2143, 2173, 2613, 2633, 2683, 2693, 2703",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1499-2014","Class II","Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lots 2163, 2243, 2253, 2423, 2473, 2583, 2593, 2743, 2753, 2813",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1506-2014","Class II","Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.","Lots 2143, 2173, 2323, 2603, 2623, 2683, 2693",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1490-2014","Class II","BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lot 2463",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1528-2014","Class II","Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.","Lots 2193, 2323, 2693, 2803",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1511-2014","Class II","GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lot 2673",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1501-2014","Class II","Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lots 2183, 2193, 2413, 2483, 2493, 2593, 2803, 2813",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1518-2014","Class II","GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2683, 2873",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1524-2014","Class II","Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2133, 2293, 2373, 2453, 2533, 2543, 2573, 2733, 2773, 2783,2793, 2803, 2843, 2853, 2260, 2383, 2402",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1533-2014","Class II","Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2323, 2613",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1502-2014","Class II","Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.","Lots 2383, 2393, 2433, 2443, 2453, 2523, 2543, 2733, 2773, 2783",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1517-2014","Class II","Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.","Lots 2413, 2833",".","Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/19/2014,"02/19/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1525-2014","Class II","Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots2213, 2283",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1529-2014","Class II","Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs."," Lots 2193, 2323, 2693, 2803",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1518-2014","Class II","GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2683, 2873",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1498-2014","Class II","Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lots 2333, 2763, 2813",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1517-2014","Class II","Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2413, 2833",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1505-2014","Class II","Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs."," Lots 2143, 2173, 2613, 2633, 2683, 2693, 2703",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1531-2014","Class II","Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed."," Lots 2373, 2383, 2393, 2433, 2503, 2543, 2773, 2783, 2793, 2843,2853",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1516-2014","Class II","Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2143, 2163, 2213, 2243, 2253, 2263, 2333, 2343, 2403, 2413, 2703",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1520-2014","Class II","Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2603, 2623",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1507-2014","Class II","Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs."," Lots 2263, 2353, 2403, 2833, 2863, 2873",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1524-2014","Class II","Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2133, 2293, 2373, 2453, 2533, 2543, 2573, 2733, 2773, 2783,2793, 2803, 2843, 2853, 2260, 2383, 2402",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1530-2014","Class II","Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs."," Lots 2573, 2583, 2593, 2693",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1497-2014","Class II","Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2283, 2333, 2343, 2413, 2813",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1533-2014","Class II","Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2323, 2613",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1522-2014","Class II","Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2203, 2223, 2363, 2503, 2583, 2683, 2173, 2203, 2213, 2223,2273, 2433, 2463, 2483, 2493, 2503, 2513, 2623, 2653, 2673,2763",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1523-2014","Class II","GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots2773, 2783, 2843",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1532-2014","Class II","Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs."," Lot 2203",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1491-2014","Class II","Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2393, 2433, 2443, 2453, 2503, 2523, 2533, 2713, 2723, 2733",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1502-2014","Class II","Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lots 2383, 2393, 2433, 2443, 2453, 2523, 2543, 2733, 2773, 2783",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1500-2014","Class II","Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lot 2233",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1526-2014","Class II","Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags."," Lots2333, 2483, 2493, 2613",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1512-2014","Class II","GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lot 2763",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1506-2014","Class II","Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs."," Lots 2143, 2173, 2323, 2603, 2623, 2683, 2693",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1509-2014","Class II","Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs."," Lots 2653, 2663",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1514-2014","Class II","Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2613, 2633",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1513-2014","Class II","Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2343, 2353, 2413, 2423, 2483, 2633, 2663, 2673, 2703, 2713, 2723, 2743, 2753, 2763, 2803, 2813, 2823, 2833, 2853, 2863, 2893",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1528-2014","Class II","Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs."," Lots 2193, 2323, 2693, 2803",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1490-2014","Class II","BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lot 2463",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1519-2014","Class II","Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2173, 2203, 2363, 2393, 2463, 2483, 2493, 2503, 2593, 2603, 2623, 2643, 2653, 2663, 2883",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1511-2014","Class II","GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lot 2673",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1521-2014","Class II","Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2173, 2183, 2203, 2223, 2273, 2283, 2303, 2593, 2603, 2623",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1501-2014","Class II","Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lots 2183, 2193, 2413, 2483, 2493, 2593, 2803, 2813",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1504-2014","Class II","Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2743, 2753, 2763, 2863",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1499-2014","Class II","Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lots 2163, 2243, 2253, 2423, 2473, 2583, 2593, 2743, 2753, 2813",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1510-2014","Class II","GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lot 2813",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1508-2014","Class II","Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs."," Lots 2413, 2643, 2663, 2673, 2883",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1527-2104","Class II","Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags."," Lots2273, 2283, 2343, 2603, 2633, 2703, 2743, 2883",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1503-2014","Class II","Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs."," Lots 2113, 2523, 2533, 2543, 2773, 2783, 2843",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Food",67192,"Ongoing","El Encanto, Incorporated","Albuquerque","NM","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign. Includes military/govt/VA consignees.","F-1515-2014","Class II","Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs."," Lots 2143, 2243, 2253, 2263, 2413, 2423, 2633",,"Unknown","Products were recalled due to possible Listeria monocytogenes contamination.",12/27/2013,"12/27/2013",2/26/2014,"02/26/2014"
"Devices",67193,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the state of LA, NJ, and NY.","Z-1069-2014","Class II","VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. ","Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K",,"26 units","Sterility of medical devices intended for use in surgical procedures may be compromised.",12/12/2013,"12/12/2013",3/5/2014,"03/05/2014"
"Devices",67194,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.","Z-1233-2014","Class III","ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.","Model # ROX05, Batch # S0171051",,"704","Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.",10/3/2013,"10/03/2013",3/26/2014,"03/26/2014"
"Food",67195,"Ongoing","Campbell Soup Supply Co., LLC","Camden","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, NM, OK, AR, MO, NB, and KS","F-1748-2014","Class II","Prego Italian Sauce Traditional, NET WT. 24 OZ (1 LB. 80 Z.)(680 g) in glass jars.","UPC 51000 2549 4, Expiration date JUN 16, 2015, Lid Codes JUN 16 2015 12153 CT BJ ZV 0330 through JUN 16 2015 12153 CT BJ ZV 0449",".","308 cases","Product may have become spoiled due to an elevated pH caused by dilute cleaning solution in the product.",12/31/2013,"12/31/2013",4/16/2014,"04/16/2014"
"Biologics",67196,"Terminated","Las Cruces Biologicals LLC","Las Cruces","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0347-14","Class II","Source Plasma","LC0785600; LC0785942; ",,"2","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/4/2013,"11/04/2013",3/5/2014,"03/05/2014"
"Food",67197,"Ongoing","Zip International Group LLC.","Edison","NJ","US","Voluntary: Firm Initiated","FAX","NY","F-1417-2014","Class I","Fosforel Atlantika Herring Fillet in Oil (200 g) Product of Russia Imported by: Zip International Group LLC 160 Raritan Center Parkway, Unit 6 Edison, NJ 08837 UPC: 4607106577526","Production date: 9/18/13 Best By Date : 18/01/2014",,"80 cases x 16 containers x 200 grams","NYSDAM analysis has revealed the presence of Listeria monocytogenes in two samples of Fosforel Herring in oil (200g size containers) .",12/16/2013,"12/16/2013",1/22/2014,"01/22/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1542-2014","Class I","The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922714 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1543-2014","Class I","The Cultured Kitchen Smoked Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 736211079134 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1546-2014","Class I","The Cultured Kitchen Pesto or Basil Pesto Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504851120 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1547-2014","Class I","The Cultured Kitchen White Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504924015 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1544-2014","Class I","The Cultured Kitchen Pepper Jack Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922615 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Food",67198,"Ongoing","The Cultured Kitchen","West Sacramento","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA. Reno, NV.","F-1545-2014","Class I","The Cultured Kitchen Habanero Cilantro Lime Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922813 Produced by: The Cultured Kitchen LLC Sacramento, CA.","All expiry dates up to and including 4/19/2014.",,,"Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination.",12/31/2013,"12/31/2013",3/5/2014,"03/05/2014"
"Devices",67199,"Ongoing","Sorin Group Deutschland GmbH","Munchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.","Z-0857-2014","Class II","CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. ","Item Number: 60-02-60",,"75","Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.",12/4/2013,"12/04/2013",2/5/2014,"02/05/2014"
"Devices",67199,"Ongoing","Sorin Group Deutschland GmbH","Munchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and PR; and Internationally to:BE, ES, FI, GB, NL, SE, AR, AT, AU, CA, CH, CN, CR, EG, HK, ID, JO, JP, KR, KW, LB, LY, MM, PL, RO, RS, RU, SG. TH, TN, TR, TW, UA, VN, and ZA.","Z-0856-2014","Class II","S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.","S5 Item Number: 10-80-00, 10-85-00, 28-9S-80, 28-95-8S. C5 Item Number: S8-00-00",,"323","Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.",12/4/2013,"12/04/2013",2/5/2014,"02/05/2014"
"Drugs",67200,"Ongoing","Watson Laboratories Inc","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-397-2014","Class II","Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.","Lot # 244152A, exp 01/15. ",,"4,439 bottles","Presence of Foreign Substance; metal particulates were visually observed in tablets.",12/23/2013,"12/23/2013",1/15/2014,"01/15/2014"
"Biologics",67201,"Terminated","Bergen Comm Reg Blood Center","Montvale","NJ","US","Voluntary: Firm Initiated","FAX","New Jersey","B-0348-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W065613007822; ",,"1","Blood product, collected from a donor who had previously been deferred, was distributed.",11/26/2013,"11/26/2013",3/5/2014,"03/05/2014"
"Biologics",67202,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas, Missouri","B-0434-14","Class III","Fresh Frozen Plasma","W045013091254",,"1 unit","Blood products, collected from a donor with Porphyria Cutanea Tarda, were distributed.",11/22/2013,"11/22/2013",3/5/2014,"03/05/2014"
"Biologics",67202,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Kansas, Missouri","B-0435-14","Class III","Red Blood Cells Leukocytes Reduced","W045013093415, W045013091254",,"2 units","Blood products, collected from a donor with Porphyria Cutanea Tarda, were distributed.",11/22/2013,"11/22/2013",3/5/2014,"03/05/2014"
"Devices",67203,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of CA, NC, TX, IN, NJ, and MI.","Z-0866-2014","Class II","SET SCREW RETAINING DRIVER, REF 3010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132. Screwdriver - orthopedic manual surgical instrument.","TI13J01811",,"7 units ","The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw. ",1/3/2014,"01/03/2014",2/5/2014,"02/05/2014"
"Food",67204,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Letter","IL, OK ID, CA, WI, TX","F-1451-2014","Class II","Uncle Ben's (R), Infused(R) Rice Mexican Flavor rice, NET WT 5 LB (2.27 kg), distributed by MARS Foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059","332DMGRV01",,"1680 cases of 2 units per case","The firm received reports of flushing reactions after consumption of product led to concern of possible production issue. ",12/27/2013,"12/27/2013",2/5/2014,"02/05/2014"
"Food",67205,"Ongoing","Condies Foods, Inc","Kearns","UT","US","Voluntary: Firm Initiated","Letter","5 Distributors within UT","F-1444-2014","Class II","Condies Food fine shred lettuce, and 1/4 shred lettuce; 5 lbs bags, 4 bags per case","Fine shred lettuce 1-7; 1/4 shred lettuce 1-6 ",,"Fine shred lettuce (1-7): 90 cases; 1/4 shred lettuce (1-6): 28 cases","A piece of hard brittle plastic was found inside a bag of 41890 Lettuce Shred Fine. The bag of lettuce had the following code date: Use Thru 1/7. Upon receipt of a picture of the plastic, it was determined that the plastic had originated from an instrument used by Condies Foods for quality control purposes. It is believed that there is a possibility that additional pieces may be within other bags of product. As a precaution, Condies Foods has decided to recall any product which potentially may have been affected.",1/2/2014,"01/02/2014",2/5/2014,"02/05/2014"
"Devices",67206,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.","Z-0901-2014","Class II","Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.","lot B507171",,"11","Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs.",12/18/2013,"12/18/2013",2/5/2014,"02/05/2014"
"Devices",67207,"Ongoing","Zimmer Dental Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.","Z-0847-2014","Class II","Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227. ","Catalog Number TSVWB11, Lot 62470008.",,"307","Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.",1/6/2014,"01/06/2014",2/5/2014,"02/05/2014"
"Food",67208,"Ongoing","Ann's House of Nuts, Inc","Robersonville","NC","US","Voluntary: Firm Initiated","Telephone","AL, AR, AZ, CA, CO, FL, GA, IL, KY, MN, MO, MS, NC, NH, NY, PA, TX, VA, and WA.","F-1464-2014","Class II","Walmart Great Value Tex Mex Trail Mix, Net Wt 28 oz (793g), Distributed by Wal Mart Stores, Inc., Bentonville, AR, packed in rigid clear plastic jars. ","Best By date range: 04/18/2014 through 12/12/2014, UPC: 0 78742 03371 6",,"55,717 cases (6/28 oz clear plastic jars per case)","Product contains undeclared allergen; milk. ",12/20/2013,"12/20/2013",2/5/2014,"02/05/2014"
"Devices",67209,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, Norway, Oman, P.R. China, Philippines, Poland, Qatar, Rep of Yemen, Republic Korea, Romania, Russian Fed. San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. United Kingdom and Venezuela.","Z-0824-2014","Class II","ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.","Model number 10433816; Serial numbers lower than 401100. Serial numbers: 400935 400686 400597 400833 400140 400753 400752 400771 401016 400166 400635 400582 400983 400532 400580 400592 400804 400733 400737 400652 401036 400643 400746 400349 400784 400919 400685 400777 400186 400499 400896 400809 400259 400282 400758 400762 400831 400723 400402 400633 401027 400111 400319 400515 400942 400793 400699 400849 400816 400216 400212 400713 400764 400730 400734 401021 400215 400735 400920 401052 400815 400766 401018 400729 400731 400213 400903 400254 400670 400560 401048 401056 400280 400722 400945 400405 400407 400546 400975 400904 400982 400980 400151 400961 400941 400325 400562 401073 400242 400415 400952 400732 400444 400149 400543 400661 400547 400726 400939 400510 401050 400243 400779 401072 400106 400147 400173 400302 400347 400348 400453 400553 400557 400558 400995 400996 400936 400341 400289 400987 401009 400575 400922 400702 400125 400199 400200 400611 400755 400808 400926 400950 400744 400150 400806 400427 400426 400428 400429 400495 400756 400624 400568 400911 400418 400566 400977 400551 400801 400157 400696 400727 400834 400207 400933 401079 400115 400416 400422 400599 400600 400500 400180 400307 400711 400608 400601 401068 400927 400424 401033 400127 400642 400637 400880 400205 400569 400690 400745 401004 401074 400802 400778 400614 400524 400523 400240 400591 401037 400901 400247 400263 400511 400514 400276 400703 400281 400469 401046 400627 401032 400819 401060 401058 400113 400241 400825 400653 400328 400910 400844 400869 401059 400598 401057 400677 400332 400824 400607 400842 401076 400419 400323 400329 400651 401053 401097 400785 400644 400602 400237 400432 400684 400413 400938 400625 400335 400976 400330 400525 400714 400333 401094 400838 400971 400609 400434 400845 400522 400068 400085 400906 400916 401091 400863 400706 400871 400286 400780 401051 400256 400937 400327 400482 400846 401045 400594 400724 400973 400497 400490 400219 401039 400966 401017 400300 400588 400798 401026 400279 400512 40057",,"843 active units","The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system.",12/22/2013,"12/22/2013",2/5/2014,"02/05/2014"
"Devices",67210,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution.","Z-1517-2014","Class II","IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.","Lots 326 through 333",,"5953 units","Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.",12/20/2013,"12/20/2013",5/7/2014,"05/07/2014"
"Devices",67210,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution.","Z-1518-2014","Class II","IMMULITE2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.","Lots 260 through 275",,"18,489 units","Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.",12/20/2013,"12/20/2013",5/7/2014,"05/07/2014"
"Devices",67211,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.","Z-1531-2014","Class II","IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum. ","Lot Numbers 409 and above",,"892","Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue. ",12/20/2013,"12/20/2013",5/7/2014,"05/07/2014"
"Devices",67211,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.","Z-1532-2014","Class II","IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.","Lot Numbers 314 and above",,"7741","Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue. ",12/20/2013,"12/20/2013",5/7/2014,"05/07/2014"
"Biologics",67212,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0351-14","Class II","Red Blood Cells Leukocytes Reduced","W270113516227",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",12/6/2013,"12/06/2013",3/5/2014,"03/05/2014"
"Devices",67213,"Ongoing","Focus Diagnostics Inc","Cypress","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, Kamnick, and Slovenia.","Z-0846-2014","Class II","Simplexa'' Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. ","Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.",,"1,052 kits","Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate. ",1/10/2014,"01/10/2014",2/5/2014,"02/05/2014"
"Drugs",67214,"Ongoing","Specialty Medicine Compounding Pharmacy, P.C.","South Lyon","MI","US","Voluntary: Firm Initiated","Press Release","Hospitals, clinics, physicians, and patients in the Michigan area only.","D-1156-2014","Class I","Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178","All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07222013@19, 07222013@22, 07222013@23, 07222013@24, Exp 10/20/13; 07232013@1, 07232013@2, 07232013@3, 07232013@5, Exp 10/21/13; 07252013@1, 07252013@3, 07252013@4, 07252013@5, Exp 10/23/13; 07302013@24, 07302013@28, 07302013@30, 07302013@31, 07302013@32, Exp 10/28/13; 08052013@4, 08052013@6, 08052013@7, 08052013@8, 08052013@9, 08052013@10, Exp 11/03/13; 08092013@1, 08092013@8, 08092013@3, 08092013@4, 08092013@5, 08092013@6, Exp 11/07/13; 08122013@1, 08122013@3, 08122013@4, 08122013@5, 08122013@6, 08122013@7, Exp 11/10/13; 08162013@1, 08162013@3, 08162013@4, Exp 11/14/13; 08192013@2, 08192013@4, Exp 11/17/13 ",".","1000 vials","Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.",10/19/2013,"10/19/2013",3/19/2014,"03/19/2014"
"Devices",67215,"Ongoing","Exactech, Inc.","Gainesville","FL","US",,,"USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.","Z-0906-2014","Class II","***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. ","Catalog Numbers: 186-01-08, 186-01-11, 186-01-13, 186-02-08, 186-02-11, 186-02-13, 186-03-11, 186-03-08, 186-03-11, 186-03-13, 186-04-08, 186-04-11, 186-04-13, 186-05-08, 186-05-11, 186-05-13.",,"235","Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.",9/11/2013,"09/11/2013",2/12/2014,"02/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1614-2014","Class I","Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Almond dipped in Dark Chocolate Biscotti-individually wrapped- is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1615-2014","Class I","Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. ","NONE",,"unknown","Blueberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1613-2014","Class I","Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Cranberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1620-2014","Class I","Hazelnut Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Hazelnut Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1618-2014","Class I","Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1616-2014","Class I","Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Traditional Toasted Almond-individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1621-2014","Class I","Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Mandarin Orange Tozzetti Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1611-2014","Class I","Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand.","NONE",,"unknown","Sampler Bag of Biscotti is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1612-2014","Class I","Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz.","NONE",,"unknown","Lemon Biscotti dipped in White Chocolate Bag is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1619-2014","Class I","Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.","NONE",,"unknown","Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Food",67216,"Ongoing","Yukon Concessions Alaska LLC","Wasilla","AK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Alaska only and products were sold on www.toniasbiscotti.com","F-1617-2014","Class I","Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. Alaskan Birch Brittle Drizzled in dark chocolate-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. ","NONE",,"unknown","Alaska Birch with Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Devices",67217,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.","Z-1081-2014","Class II","RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. ","R4.2, R5.0, R5.1, R6.0, R6.1",,"489","During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.",11/25/2013,"11/25/2013",3/12/2014,"03/12/2014"
"Biologics",67218,"Terminated","The Blood Center","New Orleans","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-0366-14","Class III","Red Blood Cells Leukocytes Reduced","W067113060580",,"1 unit","Blood product, which did not meet the manufacturer's instructions for preparing a leukoreduced product, was distributed.",11/14/2013,"11/14/2013",3/5/2014,"03/05/2014"
"Biologics",67219,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida, New York","B-0367-14","Class II","Fresh Frozen Plasma","W036810172390",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Biologics",67219,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida, New York","B-0368-14","Class II","Platelets Pheresis Leukocytes Reduced","W036810172390",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Biologics",67220,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0349-14","Class II","Fresh Frozen Plasma","W120613068130; ",,"1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/25/2013,"11/25/2013",3/5/2014,"03/05/2014"
"Biologics",67221,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana, Arkansas","B-0352-14","Class II","Red Blood Cells Leukocytes Reduced","W036512122900, W036512066221",,"2 units","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",7/26/2013,"07/26/2013",3/5/2014,"03/05/2014"
"Biologics",67222,"Terminated","Blood Bank of Alaska, Inc.","Anchorage","AK","US","Voluntary: Firm Initiated","FAX","AK","B-0386-14","Class II","Red Blood Cells Leukocytes Reduced","W066513703061; W066513703071; W066513703101; W066513703115; W066513703121",,"5 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",12/30/2013,"12/30/2013",3/5/2014,"03/05/2014"
"Devices",67223,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.","Z-1082-2014","Class II","Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. ","Identifier - 6.0, 6.1.0, 7.0.1",,"1309","During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.",11/25/2013,"11/25/2013",3/12/2014,"03/12/2014"
"Devices",67224,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Argentina, Austria, Australia, Bosnia, Bulgaria, Belgium, Bahrain, Brazil, Belarus, Botswana, Bangladesh, Canada, China, Columbia, Costa Rica, Croatia, Cuba, Cyprus, Chile, Czech Republic, Ecuador, Egypt, Estonia, France, Finland, Gabon, Germany, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Italy, Ireland, Israel, Iraq, Jordan, Japan, Kosovo, Kuwait, Lithuania, Libya, Latvia, Morocco, Malaysia, Malta, Mexico, Myanmar, Netherland, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sudan, Syria, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, Venezuela, and Vietnam.","Z-0928-2014","Class II","XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.","MUJ",,"1424","When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.",11/25/2013,"11/25/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0914-2014","Class II","Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.","Serial Numbers: QABS50026 QABR50066 QABR50068 QABR50133 QABS50023 QABR50102 QABR50103 QABR50064 QABR50065 QABR50067 QABS50070 QABS50069 QABR50275 QABS50027 QABR50274 ",,"15 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0917-2014","Class II","Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants. ","Serial Numbers: 100341 100342 100348 200118 200143 200513 200522 200590 200598 200617 201111 201375 201384 201409 201424 201567 201621 201622 201625 201627 201814 202013 202021 202141 202143 202147 202280 202300 202365 202395 202439 202538 203117 203186 203419 203448 203452 203453 203755 203961 204048 204153 204154 204166 204170 204323 204333 204732 204848 204858 204882 204888 204896 204898 204904 204906 204908 205060 205062 205074 205076 205077 205078 205079 205095 205096 205098 205101 205105 205106 205110 205114 205115 205118 205121 205124 205129 205131 205132 205133 205134 205135 205136 205137 205139 205140 205141 205142 205143 205144 205145 205146 205147 205148 205150 205151 205152 205164 205169 205233 205238 205239 205285 205324 205326 205328 205331 205341 205355 205380 205461 205475 205481 205531 205547 205557 205561 205628 205629 205630 205632 205635 205699 205832 205836 205848 205849 205850 205856 205861 205863 205866 205875 205922 205925 205939 205942 205944 205949 205952 205961 205990 206006 206026 206033 206035 206036 206059 206068 206101 206105 206116 206118 206123 206124 206126 206128 206129 206130 206135 206144 206153 206158 206160 206165 206180 206183 206203 206206 206208 206210 206236 206239 206248 206250 206255 206259 206278 206279 206282 206293 206304 206312 206313 206314 206315 206317 206318 206319 206320 206322 206323 206324 206327 206328 206329 206330 206331 206332 206334 206335 206337 206341 206343 206357 206379 206380 206381 206382 206383 206385 206386 206387 206388 206389 206390 206391 206392 206393 206395 206396 206399 206400 206403 206408 206412 206420 206422 206425 206428 206430 206457 206463 206476 206512 206519 206523 206579 206581 206624 206634 206636 206639 206640 206641 206642 206645 206648 206650 206651 206652 206653 206656 206658 206659 206660 206661 206662 206665 206666 206669 206670 206679 206682 206685 206687 206693 206827 206944 206955 206961 206966 207025 207031 207034 207277 207278 207279 207280 207281 207287 207289 207385 207386 207395 207403 207405 207409 207412 207417",,"561 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0912-2014","Class II","Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.","Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJR56358 HDJP50531 HDJP50532 HDJR56107 HDJR56370 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJM51930 HDJM52089 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJS51291 HDJS51292 HDJR54229 HDJQ51474 HDJQ51475 HDJQ51476 HDJM52059 HDJM50272 HDJP50634 HDJQ51827 HDJR50477 HDJR57730 HDJM50483 HDJQ52812 HDJS52096 HDJR57172 HDJM50694 HDJN51776 HDJN51777 HDJN51778 HDJQ51257 HDJR56005 HDJR56006 HDJR56007 HDJR56008 HDJQ52597 HDJQ52598 HDJQ52599 HDJQ52600 HDJQ52601 HDJN50850 HDJM50704 HDJM50705 HDJM50706 HDJM50707 HDJM50708 HDJM50709 HDJQ53073 HDJR57718 HDJP50352 HDJM50012 HDJP51078 HDJP51079 HDJP51080 HDJQ51561 HDJQ51562 HDJQ51563 HDJR56749 HDJR56750 HDJR56751 HDJR56752 HDJR56753 HDJS50790 HDJS50791 HDJS50792 HDJR57719 HDJR57720 HDJR57721 HDJQ50915 HDJQ50916 HDJQ50917 HDJQ50918 HDJQ50919 HDJS51692 HDJS51693 HDJM51900 HDJM52091 HDJM52092 HDJM52093 HDJS50046 HDJS50047 HDJS50048 HDJR50230 HDJR50231 HDJS50297 HDJP51783 HDJP51784 HDJP51792 HDJP51793 HDJP51796 HDJQ52082 HDJS50733 HDJS50734 HDJS50735 HDJP52863 HDJR50596 HDJR50597 HDJR50598 HDJN50595 HDJM50200 HDJM50201 HDJP52156 HDJP52071 HDJP52072 HDJQ52813 HDJQ52814 HDJQ52815 HDJQ52895 HDJS51414 HDJS51415 HDJS51417 HDJM51320 HDJM51321 HDJM51883 HDJN50762 HDJN50763 HDJN51327 HDJS50042 HDJS50043 HDJR50133 HDJR50134 HDJR50135 HDJR50136 HDJR50138 HDJR50139 HDJR50140 HDJR50141 HDJR50142 HDJR50144 HDJR50145 HDJR50146 HDJR50147 HDJR50148 HDJR50149 HDJR50150 HDJR50151 HDJR50152 HDJR50153",,"1970 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0916-2014","Class II","Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.","Serial Numbers: QABR50001 QABR50002 QABR50003 QABR50004 QABR50005 QABR50006 QABR50007 QABR50008 QABR50009 QABR50010 QABR50011 QABR50012 QABR50013 QABR50014 QABR50015 QABR50016 QABR50017 QABR50018 QABR50019 QABR50020 QABR50021 QABR50022 QABR50023 QABR50024 QABR50025 QABR50026 QABR50027 QABR50028 QABR50029 QABR50030 QABR50031 QABR50032 QABR50033 QABR50034 QABR50035 QABR50036 QABR50037 QABR50038 QABR50039 QABR50040 QABR50041 QABR50042 QABR50043 QABR50044 QABR50045 QABR50046 QABR50047 QABR50048 QABR50049 QABR50050 QABR50051 QABR50052 QABR50053 QABR50054 QABR50055 QABR50056 QABR50057 QABR50058 QABR50059 QABR50060 QABR50061 QABR50062 QABR50063 QABR50077 QABR50078 QABR50079 QABR50080 QABR50081 QABR50082 QABR50083 QABR50084 QABR50085 QABR50093 QABR50094 QABR50095 QABR50096 QABR50097 QABR50098 QABR50099 QABR50109 QABR50110 QABR50111 QABR50112 QABR50113 QABR50114 QABR50115 QABR50120 QABR50121 QABR50124 QABR50125 QABR50127 QABR50128 QABR50129 QABR50130 QABR50131 QABR50134 QABR50135 QABR50136 QABR50137 QABR50138 QABR50139 QABR50140 QABR50141 QABR50142 QABR50143 QABR50144 QABR50145 QABR50146 QABR50147 QABR50148 QABR50149 QABR50150 QABR50151 QABR50152 QABR50153 QABR50154 QABR50155 QABR50156 QABR50157 QABR50158 QABR50159 QABR50160 QABR50161 QABR50162 QABR50163 QABR50164 QABR50165 QABR50166 QABR50167 QABR50168 QABR50169 QABR50170 QABR50171 QABR50172 QABR50173 QABR50174 QABR50175 QABR50176 QABR50177 QABR50178 QABR50179 QABR50180 QABR50181 QABR50182 QABR50183 QABR50184 QABR50185 QABR50186 QABR50187 QABR50188 QABR50189 QABR50190 QABR50191 QABR50192 QABR50193 QABR50194 QABR50195 QABR50196 QABR50197 QABR50198 QABR50199 QABR50200 QABR50201 QABR50202 QABR50203 QABR50204 QABR50205 QABR50207 QABR50208 QABR50209 QABR50210 QABR50211 QABR50212 QABR50213 QABR50214 QABR50215 QABR50216 QABR50217 QABR50218 QABR50219 QABR50220 QABR50221 QABR50222 QABR50223 QABR50224 QABR50225 QABR50226 QABR50227 QABR50228 QABR50229 QABR50231 QABR50232 QABR50233 QABR50234 QABR50235 QABR50236 QABR50237 QABR50238 QABR50239 QABR50240 QABR50241 QABR50242 QABR50243",,"375 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0915-2014","Class II","Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s","Serial Numbers: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767 401769 401772 401775 401776 401825 401773 401777 401771 401774 401778 401766 401763 401764 401765 401768 401770 400802 400657 400434 400768 401203 401208 402081 402245 402180 401965 400493 400504 400506 401998 402345 402352 400311 401481 410773 ",,"48 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67225,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-0913-2014","Class II","Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. ","Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380 HDJP51381 HDJR56387 HDJR56388 HDJR56389 HDJR56390 HDJR56391 HDJR56666 HDJN50977 HDJN50978 HDJQ53071 HDJM51282 HDJM51283 HDJM51284 HDJM51285 HDJM51286 HDJM51287 HDJM51288 HDJM51289 HDJM51290 HDJM51291 HDJM51292 HDJM51293 HDJM51294 HDJM51295 HDJQ50845 HDJQ50846 HDJQ50361 HDJQ50362 HDJQ50363 HDJQ50364 HDJQ50365 HDJQ52097 HDJM51403 HDJM51871 HDJP52195 HDJP52198 HDJP52199 HDJP52200 HDJP52201 HDJP52202 HDJP52203 HDJP52204 HDJP52205 HDJP52206 HDJP52207 HDJM50831 HDJM50832 HDJM50833 HDJS51808 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJP50315 HDJP50369 HDJP50371 HDJR58044 HDJR58045 HDJP51614 HDJP51615 HDJN52372 HDJN52373 HDJS50504 HDJS50505 HDJM50027 HDJL50483 HDJM50022 HDJM50024 HDJM50411 HDJS50708 HDJS52037 HDJR57284 HDJR57285 HDJN52002 HDJN50436 HDJN50437 HDJP50552 HDJP50553 HDJQ50808 HDJP50078 HDJP50083 HDJQ52336 HDJQ52337 HDJQ52036 HDJQ52037 HDJQ52038 HDJQ52039 HDJS51666 HDJP52689 HDJQ51784 HDJQ51785 HDJQ51786 HDJQ51787 HDJS50825 HDJS50826 HDJS50827 HDJS50828 HDJS50829 HDJS50830 HDJS50831 HDJS50832 HDJR56841 HDJR56842 HDJR56843 HDJR56844 HDJR56845 HDJR56846 HDJR56847 HDJR56848 HDJR56849 HDJR56850 HDJR56851 HDJR56852 HDJR56853 HDJS51131 HDJQ52031 HDJQ50663 HDJS50931 HDJS50932 HDJQ51956 HDJM50250 HDJM50251 HDJM50252 HDJM50253 HDJM50254 HDJM50255 HDJM52126 HDJM52127 HDJM52128 HDJM52129 HDJQ50066 HDJQ50067 HDJR50762 HDJR50763 HDJR50764 HDJR58093 HDJR58094 HDJR58095 HDJR52011 HDJR52012 HDJR54180 HDJR50307 HDJR50308 HDJR50309 HDJR50310 HDJS51721 HDJM51686 HDJM51687 HDJN51900 HDJN51901 HDJP51716 HDJS50570 HDJS50571 HDJS50572 HDJS50573 HDJM50391 HDJM50392 HDJP50523 HDJP50524 HDJP50525 HDJP50526 HDJP50527 HDJP50528 HDJL50044 HDJP50572 HDJP52345 HDJP52349 HDJP52350 HDJQ52153 HDJQ52154 HDJQ52155 HDJQ52156 HDJQ52157 HDJM50520 HDJM50521 HDJM50522 HDJN50060"," HDJS52409 HDJS52410 HDJS52411 HDJS52488 HDJM51589 HDJM51590 HDJP52671 HDJM50722 HDJM50723 HDJM51236 HDJM51304 HDJQ53090 HDJQ53092 HDJQ53093 HDJQ53096 HDJQ53097 HDJQ53098 HDJQ53099 HDJQ53176 HDJS52649 HDJQ53094 HDJQ53100 HDJQ53101 HDJQ53175 HDJP52387 HDJR50410 HDJR50414 HDJP52351 HDJQ50372 HDJQ50463 HDJQ50464 HDJQ50465 HDJQ50466 HDJQ50467 HDJQ50468 HDJR50615 HDJR50645 HDJR50646 HDJR50647 HDJR50648 HDJR50649 HDJM50126 HDJM50127 HDJM50128 HDJM50129 HDJM50130 HDJM50131 HDJM50133 HDJM50134 HDJM50135 HDJM50136 HDJM50137 HDJM50132 HDJM52045 HDJM52046 HDJR56683 HDJR56684 HDJN51339 HDJN51338 HDJN52012 HDJN52013 HDJN52014 HDJM50873 HDJM50874 HDJP50047 HDJP50048 HDJQ52782 HDJQ52841 HDJS50951 HDJS51217 HDJS51218 HDJS51219 HDJS51220 HDJS51221 HDJS51222 HDJS52057 HDJS51513 HDJQ50589 HDJQ52984 HDJQ52985 HDJR56179 HDJR56180 HDJR56188 HDJR56219 HDJR57921 HDJL50254 HDJL50255 HDJM50073 HDJM50074 HDJM50075 HDJM50076 HDJM50077 HDJM50078 HDJM50079 HDJM50080 HDJM50081 HDJM50082 HDJR50737 HDJR58040 HDJR50404 HDJR50463 HDJL50461 HDJR58173 HDJR56790 HDJM51864 HDJM51866 HDJN51929 HDJN51930 HDJN51931 HDJN51932 HDJN51928 HDJS52438 HDJS52439 HDJS52440 HDJP50080 HDJP50081 HDJP50082 HDJP50155 HDJP50469 HDJP50470 HDJN50412 HDJN50413 HDJN50414 HDJN50415 HDJP51084 HDJP51085 HDJM52036 HDJN51993 HDJN51994 HDJN51995 HDJN51999 HDJN52004 HDJN51989 HDJP52695 HDJQ51261 HDJR57954 HDJR57956 HDJR57957 HDJR57987 HDJR57988 HDJR50577 HDJM50943 HDJM50944 HDJM50945 HDJM50946 HDJM50947 HDJM50948 HDJM50949 HDJM50950 HDJQ50204 HDJQ50205 HDJR57519 HDJS51680 HDJS51681 HDJS51682 HDJS51683 HDJS51684 HDJS51685 HDJS52562 HDJS52563 HDJS52573 HDJS52555 HDJS52556 HDJS52557 HDJS52558 HDJS52559 HDJS52560 HDJS52561 HDJS52564 HDJS52565 HDJS52566 HDJS52567 HDJS52568 HDJS52569 HDJS52570 HDJS52571 HDJS52572 HDJS52574 HDJS52575 HDJS52576 HDJS52127 HDJS52128 HDJS52129 HDJS52132 HDJN50600 HDJR56175 HDJP51865 HDJM51920 HDJM51921 HDJM51923 HDJS52381 HDJS52382 HDJS52383 HDJS52384 HDJP50182 HDJP51813 HDJQ51388 HDJQ51453 HDJQ51454 HDJR57634 HDJM51013 HDJQ52166 HDJN52134 HDJN52135 HDJM","9232 units","Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Devices",67226,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed. Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0825-2014","Class II"," ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system. ","Model 10433816; Serial numbers: 401283 401284 401377 401291 401275 401208 401316 401337 401376 401390 401159 401188 401191 401223 401400 401143 401325 401371 401368 401232 401140 401393 401239 401128 401196 401133 401334 401273 401225 401210 401144 401229 401209 401288 401142 401120 401121 401123 401189 401260 401338 401344 401329 401253 401295 401217 401192 401119 401312 401389 401126 401224 401227 401276 401293 401214 401317 401199 401240 401219 401238 401242 401218 401362 401349 401395 401382 401173 401122 401215 401179 401270 401313 401203 401340 401264 401357 401167 401222 401310 401206 401352 401164 401263 401201 401354 401299 401162 401298 401205 401339 401171 401296 401262 401353 401318 401289 401186 401254 401183 401195 401374 401398 401145 401157 401331 401399 401381 401356 401146 401153 401200 401220 401129 401178 401151 401152 401259 401147 401211 401228 401230 401233 401301 401231 401148 401321 401277 401332 401113 401150 401272 401274 401292 401302 401303 401304 401131 401367 401394 401154 401161 401306 401118 401185 401127 401180 401197 401379 401271 401286 401307 401216 401279 401280 401322 401323 401327 401115 401134 401111 401267 401268 401269 401287 401117 401282 401155 401181 401182 401226 401156 401257 401351 401397 401348 401290 401387 401244 401258 401314 401247 401194 401187 401365 401149 401300 401326 401333 401335 401336 401116 401236 401347 401204 401141 401311 401366 401370 401137 401245 401175 401285 401237 401369 401392 401234 401256 401383 401250 401360 401346 401241 401345 401246 401315 401193 401320 401294 401177 401114 401135 401136 401138 401255 401110 401176 401169 401174 401363 401278 401386 401328 401385 401132 401243 401124 401373 401378 401391 401361 401343 401375 401108 401109 401384 401235 401252 401198 401213 401158 4013",,"271 units","The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.",12/22/2013,"12/22/2013",2/5/2014,"02/05/2014"
"Devices",67227,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.","Z-0972-2014","Class II","TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. ","SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018. ",,"8 units","Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.",12/11/2013,"12/11/2013",3/12/2014,"03/12/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1337-2014","Class I","MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.","1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.",".","49 blister packs","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1335-2014","Class I","BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO. ","12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.",".","500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1338-2014","Class I","Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638","12-ct.bottle, Lot GP808, Exp. 10/16, 1-ct. blister Lot BN030613, EXP 020615",".","59/1-ct blister pack, 97/12-ct bottles","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1340-2014","Class I","XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. ","Lot 130520PL Exp. 05/31/2017",".","89 blister packs","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1336-2014","Class I","SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.","NO LOT NUMBER, Exp 12/31/14",".","2 blister packs","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1334-2014","Class I","XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.","Lot # 130710GL, Exp. 07/31/2018",".","175 blister packs","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Drugs",67228,"Ongoing","Schindele Enterprises dba Midwest Wholesale","Nixa","MO","US","Voluntary: Firm Initiated","Press Release","Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI","D-1339-2014","Class I","ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.","Lot 0512058, Exp. 05/16",".","57 boxes","Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. ",1/9/2014,"01/09/2014",5/28/2014,"05/28/2014"
"Food",67229,"Ongoing","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MN","F-1443-2014","Class II","Simply balanced, herb mixed freeze dried vegetables all natural, Ingredients: Super sweet corn, edamame, peas, carrots, (carrots, sugar, dextrose, tapioca starch), Italian seasoning (Garlic, tomato (tomato, salt), crushed red pepper, basil, oregano), coconut oil, sea salt. May contain peanut, tree nuts, milk, soy, and wheat., Net WT 2.5 oz (71 g), UPC 0 85239 08318 5, distributed by Target Corporation, Minneapolis, MN 55403.","Lot #: 205X317, 213X317, 253X317. Best By: 24JUL14; 01AUG14; 10SEPT14",,"2,288 cases (12/case)","Amport Foods is recalling a limited amount of Target Simply Balanced Herb Mixed Freeze Dried Vegetable due to a potential for undeclared soy. ",1/7/2014,"01/07/2014",2/5/2014,"02/05/2014"
"Devices",67230,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.","Z-1061-2014","Class II","Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.","Model 4.2.1",,"312","Potential collision risk when using XVI and external beam shaping devices.",11/25/2013,"11/25/2013",2/26/2014,"02/26/2014"
"Devices",67231,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CT, FL, GA, ID, IL, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY and DC., and the countries of Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela","Z-1059-2014","Class II","Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.","Model 4.5, 4.5.1, 4.6, 5.0",,"1028","XVI can incorrectly calculate the target position of the treatment table.",11/25/2013,"11/25/2013",2/26/2014,"02/26/2014"
"Food",67232,"Ongoing","Triarco Industries, Inc.","Paterson","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CA","F-1468-2014","Class II","Triarco Industries, LLC an Innophos company Multicolor Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale","40421 40597 40598 40766",,"2787 KG","Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Food",67232,"Ongoing","Triarco Industries, Inc.","Paterson","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CA","F-1469-2014","Class II","Triarco Industries, LLC an Innophos company Red Lightening Drink Granulation Notice- For manufacturing Use Only Not for Resale","40779",,"487.90 kg","Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Food",67232,"Ongoing","Triarco Industries, Inc.","Paterson","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CA","F-1471-2014","Class II","Triarco Industries, LLC an Innophos company Activessence (R) Notice- For Manufacturing Use Only Not for Resale","40829",,"25 kg","Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Food",67232,"Ongoing","Triarco Industries, Inc.","Paterson","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CA","F-1470-2014","Class II","Triarco Industries, LLC an Innophos company Green Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale","40546",,"920 kg","Triarco Industries Inc. is recalling product that may have been contaminated with Chloramphenicol.",10/2/2013,"10/02/2013",2/12/2014,"02/12/2014"
"Food",67233,"Ongoing","Abbott Nutrition","Columbus","OH","US","Voluntary: Firm Initiated","Letter","All product in these lots were shipped to Canada.","F-1540-2014","Class II","Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, ''ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES''","Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1; Lot L27385Z200 List # 54598-934(13) USE BY 2014OC1 & Lot L30698Z200 List # 54598 -934(13) USE BY 2015JA1",,"Lot # L31056Z200-249cs/3 ctns/50/0.9 oz packets; Lot L27385Z200-328 cs/3 ctns/50/0.9 oz packets & Lot L30698Z200-349 cs/3 ctns/50/0.9 oz packets.","Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak",10/11/2013,"10/11/2013",2/26/2014,"02/26/2014"
"Devices",67234,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","IL MA, MN, ND, OR, & PA","Z-0964-2014","Class II","Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile","Catalog no. 2124-1400 All lots",".","211 units","Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.",11/20/2013,"11/20/2013",2/19/2014,"02/19/2014"
"Devices",67235,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1076-2014","Class II","Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.","lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.",,"3496","Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67236,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0987-2014","Class II","SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.","Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date. ",,"2,357,944","Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.",1/8/2014,"01/08/2014",2/26/2014,"02/26/2014"
"Devices",67237,"Ongoing","ITC-Nexus Dx","Edison","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.","Z-0937-2014","Class II","Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.","E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08",,"25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)","ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.",12/19/2013,"12/19/2013",2/12/2014,"02/12/2014"
"Food",67239,"Ongoing","Flat Creek Farm & Dairy","Swainsboro","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA and FL.","F-1467-2014","Class I","Heavenly Blue cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 8 lbs). Labeled in part: ''367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE HEAVENLY BLUE Raw milk, salt,***130916XHB''. ","Lot #: 130916XHB",,"89.66 lbs","Routine testing by the GA Department of Agriculture revealed that the firm's Heavenly Blue and Aztec Cheddar products were positive for Salmonella. ",12/23/2013,"12/23/2013",2/12/2014,"02/12/2014"
"Food",67239,"Ongoing","Flat Creek Farm & Dairy","Swainsboro","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA and FL.","F-1466-2014","Class I","Aztec Cheddar Cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 13 lbs). Labeled in part: ''367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE AZTEC CHEDDAR Raw milk, salt,***130823XCAZ''","Lot #: 130823XCAZ",,"78.01 lbs","Routine testing by the GA Department of Agriculture revealed that the firm's Heavenly Blue and Aztec Cheddar products were positive for Salmonella. ",12/23/2013,"12/23/2013",2/12/2014,"02/12/2014"
"Biologics",67240,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","Washington","B-0350-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W068513012979; W068513012979; W068513012979; ",,"3","Blood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed.",11/28/2013,"11/28/2013",3/5/2014,"03/05/2014"
"Devices",67241,"Ongoing","Siemens Hearing Instruments, Inc","Piscataway","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-0988-2014","Class II","Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. ","Part numbers 1) 7773182 2) 7244028 3) 8757374 4) 8747086 5) 10056937 6) 10056938",,"738 units","Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.",7/1/2005,"07/01/2005",2/26/2014,"02/26/2014"
"Devices",67242,"Ongoing","Medtronic Cardiovascular Surgery-the Heart Valve Division","Santa Ana","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide)","Z-0908-2014","Class II","Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.","Model 7305. Lot/Serial Numbers: The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD. Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants.",,"8276 units","Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant. ",1/9/2014,"01/09/2014",2/12/2014,"02/12/2014"
"Devices",67243,"Ongoing","Spacelabs Healthcare, Llc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.","Z-0871-2014","Class II","ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.","Serial Numbers IN the US: 6281- 002002, 6281- 002003, 6281- 002004, 6281- 002005, 6281- 002006, 6281- 002007, 6281- 002008, 6281- 002009, 6281- 002010, 6281- 002011, 6281- 002012, 6281- 002013, 6281-000295, 6281-000401, 6281-000402, 6281-000403, 6281-000404, 6281-000405, 6281-000406, 6281-000407, 6281-000408, 6281-000503, 6281-000504, 6281-000505, 6281-000506, 6281-000507, 6281-000508, 6281-000512, 6281-000513, 6281-000514, 6281-000515, 6281-000516, 6281-000517, 6281-000518, 6281-000519, 6281-000520, 6281-000521, 6281-000522, 6281-000523, 6281-000524, 6281-000526, 6281-000527, 6281-000528, 6281-000529, 6281-000530, 6281-000531, 6281-000532, 6281-000533, 6281-000534, 6281-000535, 6281-000536, 6281-000537, 6281-000538, 6281-000539, 6281-000540, 6281-000541, 6281-000542, 6281-000543, 6281-000544, 6281-000545, 6281-000546, 6281-000547, 6281-000549, 6281-000550, 6281-000551, 6281-000552, 6281-000553, 6281-000554, 6281-000555, 6281-000556, 6281-000557, 6281-000558, 6281-000559, 6281-000560, 6281-000561, 6281-000562, 6281-000563, 6281-000564, 6281-000565, 6281-000566, 6281-000567, 6281-000570, 6281-000574, 6281-000575, 6281-000576, 6281-000577, 6281-000578, 6281-000579, 6281-000580, 6281-000581, 6281-000582, 6281-000583, 6281-000584, 6281-000585, 6281-000586, 6281-000587, 6281-000588, 6281-000589, 6281-000590, 6281-000591, 6281-000592, 6281-000593, 6281-000594, 6281-000595, 6281-000596, 6281-000597, 6281-000598, 6281-000599, 6281-000600, 6281-000601, 6281-000602, 6281-000603, 6281-000604, 6281-000605, 6281-000606, 6281-000607, 6281-000608, 6281-000609, 6281-000610, 6281-000611, 6281-000612, 6281-000613, 6281-000614, 6281-000615, 6281-000616, 6281-000617, 6281-000618, 6281-000619, 6281-000620, 6281-000621, 6281-000622, 6281-000623, 6281-000624, 6281-000625, 6281-000626, 6281-000627, 6281-000628, 6281-000629, 6281-000630, 6281-000631, 6281-000632, 6281-000633, 6281-000634, 6281-000635, 6281-000636, 6281-000637, 6281-000638, 6281-000639, 6281-000640, 6281-000641, 6281-000642, 6281-000643, 6281-000644, 6281-000645, 6281-",,"1057 units (988 in the US and 69 outside of the US).","The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions.",12/19/2013,"12/19/2013",2/5/2014,"02/05/2014"
"Biologics",67244,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0343-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050913066210; ",,"1","Quality Control and Distribution/Distribution of product that did not meet specifications.",11/13/2013,"11/13/2013",3/5/2014,"03/05/2014"
"Biologics",67244,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0344-14","Class II","Platelets Pheresis Leukocytes Reduced","W050913066210; ",,"1","Quality Control and Distribution/Distribution of product that did not meet specifications.",11/13/2013,"11/13/2013",3/5/2014,"03/05/2014"
"Devices",67245,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.","Z-0869-2014","Class II","BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing. ","Catalog number 441385 and 441386",,"198 units","Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67245,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.","Z-0870-2014","Class II","BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing. ","Catalog number 442296",,"2 units","Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67246,"Ongoing","RTI Surgical, Inc.","Alachua","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to Florida.","Z-0939-2014","Class II","***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.","Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.",".","14 units","RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts. ",12/6/2013,"12/06/2013",2/19/2014,"02/19/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1493-2014","Class II","Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005","all lot codes",,,"Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1494-2014","Class II","Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007. ","all lot codes 30 ml and 50 ml",,,"Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1495-2014","Class II","Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.","all lot codes 30 ml and 50 ml",,,"Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1491-2014","Class II","Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.","all lot codes",,,"Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1489-2014","Class II","Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.","all lot codes",,"unknown","Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1488-2014","Class II","Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.","all lot codes, .25 oz and 2 oz sizes",,"unknown","Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1487-2014","Class II","Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 ","all lot codes",,"unknown","Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1490-2014","Class II","Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002. ","all lot codes",,"unknown","Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Drugs",67247,"Ongoing","Dermamedics, L.L.C.","Oklahoma City","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1492-2014","Class II","Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019","all lot codes",,,"Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. ",1/10/2014,"01/10/2014",8/6/2014,"08/06/2014"
"Devices",67248,"Ongoing","ArjoHuntleigh Inc.","San Antonio","TX","US","Voluntary: Firm Initiated",,"US Nationwide and Middle East","Z-0926-2014","Class II","The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.","Model #209500",,"231 units","The lock pin can become stuck in the ''in'' position during the manual rotation, resulting in the inability to prone a patient",9/11/2013,"09/11/2013",2/12/2014,"02/12/2014"
"Devices",67249,"Terminated","Ossur Americas, Inc.","Foothill Ranch","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.","Z-0936-2014","Class II","The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use. "," Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413",,"17 units","OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.",2/12/2012,"02/12/2012",2/12/2014,"02/12/2014"
"Devices",67250,"Completed","Ossur Americas, Inc.","Foothill Ranch","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution.","Z-1097-2014","Class II","The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.","Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322 ",,"144 units","OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. ",10/15/2012,"10/15/2012",3/5/2014,"03/05/2014"
"Biologics",67253,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0390-14","Class II","Platelets Pheresis Leukocytes Reduced","W227013054019; W227013054019; W227013054019; ",,"3","Blood products, with no assurance that platelet counts met the specified minimum requirement, were distributed. ",12/6/2013,"12/06/2013",3/5/2014,"03/05/2014"
"Biologics",67254,"Terminated","American National Red Cross, The","Tucson","AZ","US","Voluntary: Firm Initiated","Telephone","California","B-0389-14","Class III","Red Blood Cells Leukocytes Reduced","W20071302139300; ",,"1","Blood product, which failed to meet the criteria for total weight during a validation study of the collection scales, was distributed.",11/7/2013,"11/07/2013",3/5/2014,"03/05/2014"
"Devices",67255,"Ongoing","Churchill Medical Systems, Inc.","Dover","NH","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH","Z-0813-2014","Class II","AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.","Lot Number: 1306034, 1307011",,"3850","Defective component may cause extension sets to leak. ",1/7/2014,"01/07/2014",1/29/2014,"01/29/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1657-2014","Class I","Maple Nut with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1664-2014","Class I","Divinity with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk & pecans ",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1669-2014","Class II","Candied pecans: creamy white","product has no lot codes or expiration date",".","unknown","Presence of undeclared soy allergen",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1663-2014","Class I","Pumpkin Pie with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1668-2014","Class II","Candied pecans: dark chocolate","product has no lot codes or expiration date",".","unknown","Presence of undeclared soy allergen",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1654-2014","Class I","Plain Chocolate Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, and milk",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1661-2014","Class I","Chocolate Mint Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, and milk",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1662-2014","Class I","Pumpkin Pie Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, and milk",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1665-2014","Class I","Sucrose Free Chocolate Pecan; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, pecans & milk ",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1660-2014","Class I","Sucrose Free Chocolate Plain Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, and milk",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1659-2014","Class I","Tiger Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk, and peanuts ",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1653-2014","Class I","Chocolate Pecan Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1667-2014","Class II","Candied pecans: milk chocolate","product has no lot codes or expiration date",".","unknown","Presence of undeclared soy allergen",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1670-2014","Class II","Candied pecans: honey toasted","product has no lot codes or expiration date",".","Unknown","Presence of undeclared allergens soy",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1656-2014","Class I","Pecan Shed Special Turtle Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1655-2014","Class I","Butter Pecan Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1658-2014","Class I","Dark Chocolate with Pecans Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy, milk, and pecans",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Food",67256,"Ongoing","Pecan Shed","Wichita Falls","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product is sold at onsite retail store and through the internet (5%) to customers in ID, TX, OR, MN, Washington DC, MT, PA, IA, AZ, GA","F-1666-2014","Class I","Birthday Cake Fudge; Label reads in part ''***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***''","product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years",".","Unknown","Presence of undeclared allergens soy & milk",1/10/2014,"01/10/2014",3/19/2014,"03/19/2014"
"Devices",67257,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SPAIN, SRI LANKA, TURKEY and UNITED KINGDOM.","Z-1163-2014","Class II"," The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. ","Mfg Lot or Serial # System ID 00000550134BU1 2035763100A 00000581573BU3 203932VA4100 00000523132BU9 205783BCL5 00000560743BU7 206598UWBP 00000446090BU3 207351YCL1 00000504213BU0 212305CATH1 00000437215BU7 214324INNOVA2 00000562417BU6 2198864100 00000093723VE5 229228INNOV21C 00000583484BU1 240566CATH2 00000478109BU2 251435ICV3 00000477896BU5 3016094100 00000441137BU7 3018774100 00000466659BU0 303788CL1 00000466984BU2 304424INNOVA 00000445301BU5 309691P3100 00000424103BU0 310423INNOVA1 00000579612BU3 313745IN1 00451726BU4BU8 316268INNOVAA 00000466810BU9 318449INNOVA2 00000482326BU6 3184734100 00000499386BU1 330375LAB2 00000445906BU1 334286BSP 00000551081BU3 336832MCCL6 00000464558BU6 352333CATH2 00000463833BU4 361980INNOVA2 00000427056BU7 401274IN41 00000585912BU9 404712SP11 00000585915BU2 405271P4100 00000593051BU6 405610MWC3100EP 00000449428BU2 405840OIC3100 00000541272BU1 407518EP 00000431502BU4 407518SP3 00000452126BU6 407SPECIALS 00000490443BU9 408559INV1 00000421698BU2 4103374100 00000461599BU3 410337INNOVA6 00000571721BU0 410368INNOVA1 00000442436BU2 4105434100 00000533867BU8 410554INNOVA1 00000548841BU6 410554INNOVA4 00000560325BU3 410614CV1 00000443912BU1 412623LAB3 00000454264BU3 419251LAB1 00000576989BU8 423493CL1 00000450075BU7 480821IN2 00000468193BU8 501257VALAB1 00000434782BU9 502587LAB4 FMI12204DUMM03 508383IN4100 00000581740BU8 509473RM1 00000459476BU8 5135844100 00000415698BU0 5136864100 00000479625BU6 516562INNOVA5A 00000460641BU4 516562INNOVA6 00000460969BU9 516562INNOVA7 00000441966BU9 516663INNOVA2 00000467462BU8 518525LAB1 00000467645BU8 540953INNOVA 00000513959BU7 570476INNOVA21 00000466830BU7 573256MHC 00000479758BU5 573815BCR2 00000433021BU3 573882UMC1 00000446439BU2 6012884100SP1 00000558894BU2 601376SP4100 00000437985BU5 6082634100 00000410733BU0 608324DAL 00000543076BU4 608775NOVA1 00000561529BU9 609267IN2100 00000546435BU9 609757IN3100 00000491706BU8 610250INNOVA3 00000442603BU7 614293LIBERTY2 00000563635BU2 614722INNOVA1 00000458814BU1 615338CV2 00000493727BU2 615446CV1 00000458501",".","257(159 US, 98 OUS)","GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.",12/11/2013,"12/11/2013",3/19/2014,"03/19/2014"
"Food",67258,"Ongoing","Green Mountain Coffee Roasters","Waterbury","VT","US","Voluntary: Firm Initiated","E-Mail","GA, TN","F-1592-2014","Class II","Newmans Own Organics Newmans Special Blend 80 Count K-Cup Packs; UPC 09955515593; Product Code: 15593 281792","Lot Number: LA 15593 PL086 3300",,"8,928 retail boxes","Some individual Coffee K-Cup packs (caffeinated) received Decaffeinated lids/labels during packaging. ",1/10/2014,"01/10/2014",3/5/2014,"03/05/2014"
"Drugs",67259,"Ongoing","Watson Laboratories, Inc.-(Actavis) - Florida","Davie","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1082-2014","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.","Lot# 605957A, Exp 09/14",".","5987 bottles","Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.",12/20/2013,"12/20/2013",2/19/2014,"02/19/2014"
"Drugs",67260,"Ongoing","Slim Beauty USA","Kearney","NE","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1222-2014","Class I","Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing). ","Lot # 20130328, Exp 3/27/15",".","3 bottles","Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.",12/10/2013,"12/10/2013",4/16/2014,"04/16/2014"
"Drugs",67260,"Ongoing","Slim Beauty USA","Kearney","NE","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1221-2014","Class I","Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles. ","No lot code information or exp date on packaging.",".","2 bottles","Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.",12/10/2013,"12/10/2013",4/16/2014,"04/16/2014"
"Drugs",67260,"Ongoing","Slim Beauty USA","Kearney","NE","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1220-2014","Class I","Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.","Lot #: 18 04 12, Exp 17 04 14",".","4 bottles","Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.",12/10/2013,"12/10/2013",4/16/2014,"04/16/2014"
"Devices",67261,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution.","Z-1057-2014","Class II","Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows. ","Part No. 03.010.523, Lot Nos. 8279162 & 8429004",,"143","The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate. ",1/7/2014,"01/07/2014",2/26/2014,"02/26/2014"
"Drugs",67262,"Ongoing","Bracco Diagnostics Inc","Monroe Township","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico","D-1083-2014","Class III","VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.","Lot #: 67603, Expiry: 2/2014",".","54,648 bottles","Failed Stability Testing: This product is below specification for preservative content.",12/16/2013,"12/16/2013",2/19/2014,"02/19/2014"
"Devices",67263,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.","Z-1274-2014","Class II","Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.","Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040. ",".","343","The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template. ",1/7/2014,"01/07/2014",4/2/2014,"04/02/2014"
"Devices",67264,"Ongoing","Tandem Diabetes Care Inc","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide)","Z-0827-2014","Class I","Product trade name t:slim'' Insulin Delivery System Generic name Insulin Infusion Pump 510(k) Number K111210 cleared on Nov. 9, 2011 Description of the product - The Tandem t:slim'' Insulin Delivery System (t:slim System or t:slim) is an Insulin Infusion Pump, product code LZG, per 21 CFR 880.5725. The t:slim System consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort'' Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pumps internal battery, cartridge Instructions for Use, and Users Guide. ","Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120. ",".","12, 807 boxes (10packs)","Tandem Diabetes Care, Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandems internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.",1/10/2014,"01/10/2014",2/19/2014,"02/19/2014"
"Drugs",67265,"Ongoing","HUMAN SCIENCE FOUNDATION","Gardena","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1327-2014","Class I","PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA","Lot# 220113; Exp. 01/16 Lot# 800213; Exp. 03/16 Lot# U133000; Exp. 04/16 Lot# U143200; Exp. 08/16 Lot# YJK015311; Exp. 10/16",".","24,268 bottles","Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin ",1/13/2014,"01/13/2014",5/28/2014,"05/28/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0961-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14016, Lot numbers: 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036 and 01J1300339.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0951-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055 and 01F1300297.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0953-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0957-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14012, Lot numbers: 01A1200213 and 01A1200341.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0962-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14017, Lot numbers: 01B1200215.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0956-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13018, Lot numbers: 01A1000435, 01D1000122, 01G1000099, 01J1000398, 01A1100276, 01A1100516, 01B1100012, 01F1100336, 01C1100113, 01A1200212, 01G1200208, 01G1100440 and 01D1100342",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0954-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284, 01B1100011, 01B1100070, 01C1100114, 01C1100529, 01E1100227, 01C1100606, 01B1100505, 01B1100248, 01H1100103, 01A1200116, 01B1200547, 01B1200422, 01E1100492, 01C1200085, 01C1200385, 01D1100348, 01D1200270, 01D1200087, 01G1100117, 01E1200562, 01G1200079, 01C1300339, 01C1300437, 01D1300076, 01E1300297, 01D1300194 and 01E1300061.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0952-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13014, Lot numbers: 01A1000326, 01B1000081, 01A1000502, 01B1000256, 01A1000549, 01G1000048, 01J1000341, 01M1000185, 01C1100227, 01C1100150, 01B1100464, 01B1100237, 01E1100346, 01F1100505, 01D1100077, 01F1100031, 01H1100158, 01D1100330, 01C1100371, 01C1100400, 01C1100626, 01C1200266, 01D1200419, 01C1200466, 01E1200204, 01D1100299, 01F1200172, 01H1200411, 01K1200231, 01G1200206, 01J1200072, 01G1200285, 01G1200452, 01E1200546, 01L1200131, 01K1200336 and 01E1300296.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0959-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14014, Lot numbers: 01B1200106, 01D1200157 and 01B1200424.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0950-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0960-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14015, Lot numbers: 01B1200107, 01J1200211, 01C1200387, 01H1200157, 01E1300478 and 01K1300343.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0955-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0958-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14013, Lot numbers: 01A1200341 and 01B1200423.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67266,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.","Z-0963-2014","Class I","ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.","Product Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336.",,"190,871 each (148, 275 US)","The tracheal tube can kink during patient use.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67267,"Ongoing","Medtronic Sofamor Danek USA Inc","Memphis","TN","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.","Z-0977-2014","Class II","Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void","A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147",".","30 units","Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.",1/6/2014,"01/06/2014",2/19/2014,"02/19/2014"
"Food",67268,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores in Illinois, Indiana, Kentucky, Michigan, and Ohio Food Banks in","F-1646-2014","Class II","Markets of Meijer Pretzel Dinner Roll, 8 count, 14.0 oz ( 0.87 lb) UPC 0-4125099036-9 Ingredients: Enriched Flour ( Wheat Flour, Malted Barley Flour, niacin, iran, thiamine mononitrate....) water, sugar, canola oil, salt, why (milk) , yeast, wheat starch soy lecithin, wheat gluten Allergens: Contains wheat, soy Meijer Distribution, Inc. Grand Rapids, MI 49544 "," all products with a sell date through 1/15/2014 ",".","Approx 8837 for all products","Milk not listed as Allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. ",1/11/2014,"01/11/2014",3/19/2014,"03/19/2014"
"Food",67268,"Ongoing","Meijer Distribution, Inc","Grand Rapids","MI","US","Voluntary: Firm Initiated","E-Mail","Meijer stores in Illinois, Indiana, Kentucky, Michigan, and Ohio Food Banks in","F-1645-2014","Class I","Markets of Meijer Pretzel Hamburger Bun, 4 count, NT.WT. 12.0 oz (0.75 lb), 16 oz ( 1 lb) UPC 412500558-2; Ingredients: Enriched Wheat Flour( Wheat Flour, malted barley flour, niacin.....)water, sugar, canola oil, salt, .. , dough conditioner, whey powder, yeast, dough conditioner... soy oil, wheat gluten Allergens: Contains wheat, soy Pretzel Demi Roll 6'' , 4 count,12.0 oz (0.75 lb), 16 oz (1 lb) UPC 0-4125000560-2 Ingredients: Wheat Flour...water, sugar, canola oil, salt, dough conditioner, cultured , whey powder, yeast, dough conditioner...soy oil, wheat gluten Allergens: Contains wheat, soy Meijer Distribution, Inc. Grand Rapids, MI 49544 "," all products with a sell date through 1/15/2014 ",".","Approx 8837 for all products","Source of whey powder ingredient is not identified as milk and the allergen statement does not include milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. ",1/11/2014,"01/11/2014",3/19/2014,"03/19/2014"
"Biologics",67269,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0381-14","Class III","Red Blood Cells Leukocytes Reduced","W117013546525; ",,"1","Blood products, collected from a donor whose arm inspection was not documented, were distributed.",12/3/2013,"12/03/2013",3/5/2014,"03/05/2014"
"Biologics",67269,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0382-14","Class III","Plasma Frozen","W117013546525; ",,"1","Blood products, collected from a donor whose arm inspection was not documented, were distributed.",12/3/2013,"12/03/2013",3/5/2014,"03/05/2014"
"Biologics",67270,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0358-14","Class II","Red Blood Cells","W036808121748; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/26/2013,"12/26/2013",3/19/2014,"03/19/2014"
"Biologics",67270,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0357-14","Class II","Fresh Frozen Plasma","W036808121748; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/26/2013,"12/26/2013",3/19/2014,"03/19/2014"
"Biologics",67271,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0380-14","Class II","Platelets Pheresis Leukocytes Reduced","W20221380115300; W20221380115300; ",,"2","Blood products, with unacceptably high platelet yields, were distributed. ",11/21/2013,"11/21/2013",3/5/2014,"03/05/2014"
"Biologics",67272,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0379-14","Class II","Platelets Pheresis Leukocytes Reduced","W20221380114400; W20221380114400; ",".","2","Blood products, with platelet yields below the specified minimum requirement, were distributed.",11/20/2013,"11/20/2013",3/19/2014,"03/19/2014"
"Biologics",67273,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","Virginia","B-0399-14","Class II","Red Blood Cells Leukocytes Reduced","W087613553381",,"1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",12/7/2013,"12/07/2013",3/12/2014,"03/12/2014"
"Biologics",67273,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","Virginia","B-0398-14","Class II","Cryoprecipitated AHF, Pooled","W087613902271",,"1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",12/7/2013,"12/07/2013",3/12/2014,"03/12/2014"
"Food",67274,"Ongoing","Paskesz Candy Co.,Inc. ","Brooklyn","NY","US","Voluntary: Firm Initiated","Press Release","nationwide to various retail stores and internet companies","F-1474-2014","Class I","PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g) packaged in a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178. MADE IN HOLLAND FOR: PASKESZ CANDY CO., Inc. Brooklyn, NY 11232. ","all lots",".","2,334 Total cases (not including 1,472 cases and 6 boxes in stock, quarantined)","Paskesz Candy Co., Inc. has recalled PREMIUM BELGIAN CHOCOLATE coins due to Undeclared Milk.",1/14/2014,"01/14/2014",2/19/2014,"02/19/2014"
"Devices",67275,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada","Z-0919-2014","Class II","IMPAX RIS QDOC 5.8","Software IMPAX RIS 58 and higher",,"14","Patient name displayed (printed) on the Patient Report was the wrong patient name.",1/8/2014,"01/08/2014",2/12/2014,"02/12/2014"
"Veterinary",67276,"Terminated","Cargill, Inc Corporate Headquarters","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","One consignee in each of three states: IA, NE, and SD.","V-203-2015","Class I","Bulk PEG GROW'EM BASE MIX (SC), 99226 SC 1311. Firm name on the label is Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.","Lot number: 773347165",".","18 tons","Hog feed grower base mix was contaminated with salt.",1/8/2014,"01/08/2014",11/19/2014,"11/19/2014"
"Veterinary",67276,"Terminated","Cargill, Inc Corporate Headquarters","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","One consignee in each of three states: IA, NE, and SD.","V-204-2015","Class I","Bulk JEM GRAIN 102 CTC/DENAGARD, MEDICATED, Active Drug Ingredients: Tiamulin 35 g/ton, Chlortetracycline 400 g/ton, Custom Mix Not For Resale or Redistribution, Product Code 187201_CD. Manufactured by Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.","Lot number: 774007081",".","12.13 tons","Hog feed grower base mix was contaminated with salt.",1/8/2014,"01/08/2014",11/19/2014,"11/19/2014"
"Veterinary",67276,"Terminated","Cargill, Inc Corporate Headquarters","Wayzata","MN","US","Voluntary: Firm Initiated","Telephone","One consignee in each of three states: IA, NE, and SD.","V-205-2015","Class I","TRITECH NURSERY II 600 AN (SC), 471023-N SC 1311, packaged in 50-lb. bags. Manufactured for Tritech, Inc. Huron, SD 57350. Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.","Lot number: 773352214",".","157 - 50 lbs bags (3.925 tons)","Hog feed grower base mix was contaminated with salt.",1/8/2014,"01/08/2014",11/19/2014,"11/19/2014"
"Food",67277,"Ongoing","L. M. Noodle Company, LLC","Wiggins","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Colorado, Wyoming, Nebraska","F-1452-2014","Class I","Marlyce's Homemade Butterballs","no specific code provided; recall applies to all product in commerce",,"50","Undeclared allergens. The product label does not declare allergens of Wheat Flour, Soy Flour, Whey, and Milk.",1/3/2014,"01/03/2014",2/5/2014,"02/05/2014"
"Devices",67278,"Ongoing","Accuray Incorporated","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Columbia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam","Z-0828-2014","Class II","Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. ","Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051 C0052 C0053 C0055 C0056 C0057 C0058 C0059 C0061 C0062 C0063 C0064 C0067 C0068 C0070 C0071 C0072 C0074 C0078 C0079 C0080 C0088 C0090 C0091 C0092 C0094 C0095 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0108 C0109 C0111 C0112 C0114 C0118 C0119 C0122 C0123 C0126 C0127 C0128 C0131 C0132 C0133 C0134 C0135 C0136 C0137 C0139 C0141 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0160 C0162 C0163 C0165 C0174 C0177 C0178 C0179 C0181 C0182 C0183 C0184 C0186 C0192 C0194 C0196 C0197 C0198 C0199 C0200 C0201 C0203 C0205 C0206 C0207 C0208 C0209 C0210 C0213 C0214 C0219 C0220 C0222 C0223 C0224 C0225 C0226 C0233 C0243 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0257 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0332 C0335 C0336 C0338 C0343 C0124 Out of US: C0202 C0231 C0238 C0351 C0170 C0171 C0235 C0267 C0282 TBD C0032 C0054 C0060 C0093 C0105 C0110 C0113 C0115 C0117 C0125 C0130 C0154 C0161 C0175 C0176 C0180 C0185 C0187 C0188 C0189 C0191 C0195 C0204 C0211 C0215 C0216 C0217 C0218 C0221 C0227 C0228 C0230 C0232 C0234 C0236 C0237 C0240 C0242 C0245 C0249 C0251 C0255 C0264 C0265 C0266 C0268 C0269 C0270 C0272 C0275 C0276 C0277 C0279 C0286 C0287 C0288 C0292 C0294 C0295 C0299 C0305 C0306 C0309 C0314 C0315 C0319 C0321 C0322 C0324 C0325 C0326 C0330 C0334 C0337 C0339 C0342 C0344 C0348 C0349 C0006 C0007 C0008 C0012 C0013 C0014 C0019 C0020 C0033 C0190 C0193 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0038 C0041 C0065 C0073 C0075 C0076 C0077 C0084 C0085 C0086 C0087 C0089 C0107 C0120 C0121 C0138 C0140 C0145 C0147 C0148 C0157 ",,"302 devices; 149 in US, 153 out of US.","Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.",1/13/2014,"01/13/2014",2/5/2014,"02/05/2014"
"Food",67280,"Terminated","Marquez Produce Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA","F-1448-2014","Class II","Fresh Cactus (''Nopal''), 40lbs/bx","Lot Code: 1209-12",,"352 units","Marquez Produce is recalling Fresh Cactus because of unapproved pesticides.",12/13/2013,"12/13/2013",2/5/2014,"02/05/2014"
"Food",67281,"Terminated","Marquez Produce Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","CA","F-1449-2014","Class II","Cactus Leaves/pads (''Nopales''), 40 lbs","Lot Number: 1228-12",,"168 units","Marquez Produce is recalling cactus leaves due to unapproved pesticides.",1/15/2014,"01/15/2014",2/5/2014,"02/05/2014"
"Devices",67282,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.","Z-1226-2014","Class II","VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated ","Lot 9052-0045-6358, expiry date 01 Aug 2015",,"64 units worldwide","An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658. ",1/9/2014,"01/09/2014",3/26/2014,"03/26/2014"
"Devices",67283,"Ongoing","Bausch & Lomb Surgical, Inc.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.","Z-1062-2014","Class II","Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.","Model Numbers(s): AO60 and MI60L",,"336 IOLs (283 IOLs in the US, 53 IOLs outside the US)","Lens was manufactured with incorrect raw material.",10/16/2013,"10/16/2013",2/26/2014,"02/26/2014"
"Veterinary",67284,"Terminated","Western Sugar Company","Lovell","WY","US","Voluntary: Firm Initiated","Telephone","19 customers within WY, 1 customer in MT","V-041-2014","Class III","Cattle Feed- Tailings and Pulp from beet production","bulk product manufactured from 01/04/14 01/11/14",,"Distributed in WY and MT","Product was prepared under insanitary conditions.",1/14/2014,"01/14/2014",2/12/2014,"02/12/2014"
"Biologics",67285,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0396-14","Class II","Red Blood Cells Leukocytes Reduced","W038113264435",,"1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",11/26/2013,"11/26/2013",3/12/2014,"03/12/2014"
"Biologics",67285,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0397-14","Class II","Plasma Frozen within 24 hours (FP24)","W038113264435",,"1 unit","Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.",11/26/2013,"11/26/2013",3/12/2014,"03/12/2014"
"Biologics",67286,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0395-14","Class II","Red Blood Cells Leukocytes Reduced","W037712017691",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",9/11/2013,"09/11/2013",3/12/2014,"03/12/2014"
"Biologics",67287,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0394-14","Class II","Red Blood Cells Leukocytes Reduced","W036813171414",,"1 unit","Blood product, which was incorrectly labeled as leukoreduced, was distributed.",8/29/2013,"08/29/2013",3/12/2014,"03/12/2014"
"Biologics",67288,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0393-14","Class II","Red Blood Cells Leukocytes Reduced","W036813132985",,"1 unit","Blood product, which was incorrectly labeled as leukoreduced, was distributed.",8/16/2013,"08/16/2013",3/12/2014,"03/12/2014"
"Biologics",67289,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Kentucky","B-0405-14","Class II","Red Blood Cells Leukocytes Reduced","W037713042561",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",8/26/2013,"08/26/2013",3/12/2014,"03/12/2014"
"Biologics",67290,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","Oregon","B-0404-14","Class II","Red Blood Cells Leukocytes Reduced","W137513107352",,"1 unit","Blood product, collected from a donor who was taking the medication Avodart, was distributed.",8/20/2013,"08/20/2013",3/12/2014,"03/12/2014"
"Food",67294,"Completed","DPI Specialty Foods Northwest Inc.","Tualatin","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WA and OR","F-1535-2014","Class I","Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. DPI item # 55844.","20131209 and 20131231",,"2220 cases","DPI Specialty Foods NW is recalling Kinnikinnick Brand gluten free original homestyle waffles because they have the potential to contain the allergen milk, which is not declared on the label. Package contains a logo which indicates the product is dairy free.",1/13/2014,"01/13/2014",2/26/2014,"02/26/2014"
"Food",67295,"Ongoing","STEMVIDA INTERNATIONAL INC","Ontario","CA","US","Voluntary: Firm Initiated","Press Release","'' Arizona '' California '' Colorado '' Florida '' New Jersey '' New York '' Nevada '' Oklahoma '' Texas '' Utah","F-1536-2014","Class I","STEMALIVE, 90 Capsules. The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label. Product labeling reads in part:''STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supplement***90 Capsules***Formulated exclusively for STEMVIDA International Corporation 4295 Jurupa St Ste 116, Ontario CA 91741***This exclusively formulated product is only available through ETEMVIDA International independent distributors***www.stemvidainternational.com***''. The StemAlive product is shipped as a single unit or in boxes of 4 units or 16 units. ","The lot numbers and expiration dates are 8419 (Exp.05/2015 and 06/2015), 8486 (Exp.07/2015), 8535 (Exp. 08/2015), 8598 (Exp. 10/2015), 8652 (Exp. 12/2015), 8863 (Exp. 01/2016 and 02/2016), 8872 (Exp. 03/2016), 8873 (Exp. 04/2016 and 05/2016), 9040 (Exp. 08/2016 and 09/2016), 9258 (Exp. 10/2016) and 9314 (Exp. 11/2016). ",,"458,692","Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk. ",1/17/2014,"01/17/2014",2/26/2014,"02/26/2014"
"Food",67296,"Terminated","Washington Vegetable Co","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","Northern CA only","F-1450-2014","Class III","Cactus Pads (Nopal) Mexpogroup: Product of Mexico","44 lb crate - lot 14-5126",,"17 cases (44 pounds each)","Unapproved pesticides were found by the CA Department of Pesticide Regulation during sampling,",1/8/2014,"01/08/2014",2/5/2014,"02/05/2014"
"Food",67297,"Ongoing","Unified Western Grocers Inc","Tukwila","WA","US","Voluntary: Firm Initiated","FAX","OR, WA, and AK","F-1488-2014","Class I","Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. ","2014AL15, 2014JN24, 2014MA07, and 2014JL29. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The new notification states Up to and including Best Before 2014AU10, 20140810, and 140810..",".","44 cases","Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67297,"Ongoing","Unified Western Grocers Inc","Tukwila","WA","US","Voluntary: Firm Initiated","FAX","OR, WA, and AK","F-1486-2014","Class I"," Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz. UPC 62013360015 3 2","20140111, 2014AL20, and 2014JL23. The last two lot codes were part of the first expanded recall. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December, 2013. The 1/23/14 announcment states Up to and including Best Before 2014AU09, 20140809, and 140809.",".","351 cases","Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67297,"Ongoing","Unified Western Grocers Inc","Tukwila","WA","US","Voluntary: Firm Initiated","FAX","OR, WA, and AK","F-1489-2014","Class I","Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten free, dairy free, nut free. 210 g/7.4oz Qty/pkg - 6 UPC 62013300199 8 ","2014AL15, 2014JN25, and 2014JL14. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The expanded recall notice dated 1/23/14 states up to and including 2014AU11, 20140811 and 140811.",".","35 cases","Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67297,"Ongoing","Unified Western Grocers Inc","Tukwila","WA","US","Voluntary: Firm Initiated","FAX","OR, WA, and AK","F-1487-2014","Class I","Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 g/ 16 oz UPC 62013300512 2","20140502, and 20140417. Kinnikinnick expanded the recall again on 1/23/14 to include all products produced prior to late December 2013. The 1/23/14 notice states up to and including Best Before 2015JA06, 20150106, and 150106.",".","120 cases","Unified Grocers is recalling Kinnikinnick brand bakery products due to undeclared milk. The labels also have a logo on them which indicate the product is dairy free.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Devices",67298,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and Mexico","Z-0900-2014","Class II","Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire. ","Product number: H749364560, Catalog number: 36456; Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014. ",,"1068 single units","Reports of physicians experiencing inability to pass a 0.035'' guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.",1/6/2014,"01/06/2014",2/5/2014,"02/05/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1601-2014","Class I","A. Rise n Roll Specialties, Homemade, Nutty Crunch, ..., boiled to perfection, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 3 B Simply Amish, Crunch N Nutter, Mixed Nut,... No Preservatives, ...NT. WT 4 oz. Ingredients: cashews, pecans, almonds, butter (milk) sugar. Contains Nuts, Milk, and Soy, Merrell Food Group, Inc., Dalton, WI 53926 UPC#861522000042. ","Rise N Roll, Nutty Crunch Best by date June 13th, 2014 or earlier Simply Amish, Crunch N Nutter, Best by date of June 1, 2014 or earlier; ",,"Unknown","Undeclared peanuts",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1598-2014","Class I","Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code 6 26570 61743 3. Cinnamon Caramel Donuts, donut holes Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), dextrose, cornstarch, cinnamon, palm and soy oil, salt and flavor. Contains wheat, soy and milk","no codes, manuactured 1/13/2014 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1600-2014","Class I","Rise n Roll Bakery & Deli, Raspberry Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Raspberry Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: Black raspberries, granulated sugar, permaflo, lemon juice and natural flavor. Contains wheat, soy and milk"," No codes, manufactured 1/13/2014 or before ",,"Unknown","Undeclared egg ingredient and undeclared Yellow # 6 and Yellow #5",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1602-2014","Class II","Amish Wedding, Nutty Crunch, ... boiled to perfection, Distributed by Troyer Cheese, Inc. ... Millersburg, OH 44654, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 "," Best by date June 13th, 2014 or earlier ",,"Unknown","Undeclared peanuts",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1593-2014","Class I","Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) COATING: Dextrose, cornstarch, partially hydrogenated vegetable oil, titanium dioxide, rice flour, hydrogenated cottonseed oil, artificial flavor, silicon dioxide. Contains wheat, soy and milk","no code, produced 1/13/14 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1594-2014","Class I","Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Chocolate Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, butter (milk), chocolate drops (sugar, cocoa butter, chocolate liquor), cocoa powder, flavor salt. Contains wheat, soy and milk","no code, produced 1/13/2014 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1596-2014","Class I","Rise n Roll Bakery & Deli, Apple Fritter, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Apple Fritter Enriched wheat flour, apples, soybean oil, dextrose, cinnamon, salt, leavening, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, conrnstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk","no code, manufactured 1/13/14 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1597-2014","Class I","Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and found in 6 count (436 g)UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Caramel Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), salt Contains wheat, soy and milk","no codes, producte 1/13/2014 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1599-2014","Class I","Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Glazed Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, cornstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk","no codes, produced 1/13/14 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67299,"Ongoing","Rise'n Roll Bakery, LLC","Middlebury","IN","US","Voluntary: Firm Initiated","Telephone","Rise N Roll and Amish Wedding Nutty Crunch and Crunch N Nutter Distributors in PA, OH, WI, NJ, and retail PA, IL, KS, MI, OH, WI, IN, MN, MO, VA; Product also sold on the website www.risenrollbakery.com Bakery products sold in retail stores in Indiana.","F-1595-2014","Class I","Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Bavarian Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: High fructose corn syrup, sugar, food starch modified, palm oil, salt, titanium dioxide, agar sorbic acid, sodium benzoate, potassium sorbate, artificial flavor, modified cellulose, propylene glyocol, glycerin, corn starch, dextrose, polysorbate 80 & 60, sorbitan monostearate, sodium citrate, xanthangum, annatto, caramel color, yellow 5, yellow 6. Contains wheat, soy and milk","no code, manufactured 1/13/14 or before",,"Unknown","Undeclared egg ingredient",1/15/2014,"01/15/2014",3/12/2014,"03/12/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1730-2014","Class I","Nutty Cow Chips, Nutty Calf Chips, and Nutty Bull Chips cookies","none",".","unknown","Butter Creek Farms, Inc is recalling Nutty Cow Chip Cookies due to undeclared Walnut, Egg, Wheat, Soy, and Milk (butter was listed). The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1737-2014","Class I","Oatmeal Raisin Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Oatmeal Raisin Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1735-2014","Class I","M&M Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling M&M Cookies due to undeclared Wheat, Egg, Milk, and Soy. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1729-2014","Class I","Mock Baby Ruth Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Mock Baby Ruth Cookies due to undeclared peanut, egg, wheat, soy, wheat, and milk. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1732-2014","Class I","Cow Chip, Calf Chip and Bull Chip are Chocolate Chip Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Chocolate Chip Cookies (Cow Chip, Calf Chip and Bull Chip) due to undeclared Wheat, Soy, Egg, Milk (butter is listed). The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1736-2014","Class I","Snickerdoodle Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Snickerdoodle Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1733-2014","Class I","Double Chocolate Amaretto Cookies","none",".","unkonwn","Butter Creek Farms, Inc. is recalling Double Chocolate Amaretto Cookies due to undeclared Wheat, Soy, Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1738-2014","Class I","Sprinkle Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Sprinkle Cookies due to undeclared Wheat, Egg and Soy. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1728-2014","Class I","Peanut Butter Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling peanut butter cookies due to undeclared peanut, wheat, soy, egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1731-2014","Class I","White Chocolate Macadamia Cookie","none",".","unknown","Butter Creek Farms, Inc is recalling White Chocolate Macadamia Cookie due to undeclared Macadamia nut, Egg, Wheat, Soy, and Milk. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67300,"Ongoing","Butter Creek Farms, Inc.","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to internet customers from the website cowchipcookies.com and at two retail stores owned by recalling firm in WA.","F-1734-2014","Class I","Lemon Sugar Cookies","none",".","unknown","Butter Creek Farms, Inc. is recalling Lemon Sugar Cookies due to undeclared Wheat and Egg. The firm sold single product or combined this product with other products in gift boxes from the website http://cowchipcookies.com/index.htm.",12/31/2013,"12/31/2013",4/9/2014,"04/09/2014"
"Food",67301,"Ongoing","Sauer Company The C F","Mauldin","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MD, SC & TN.","F-1445-2014","Class I","Monarch Breakfast Syrup, in 1.5 oz. portion control cups, Distributed by US Foods, Inc., Rosemont, IL 60018.","Lot #14006M, UPC #758108012714",,"759 cases (100 count/1.5 oz cups)","Undeclared allergen; peanuts",1/9/2014,"01/09/2014",2/5/2014,"02/05/2014"
"Devices",67302,"Ongoing","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.","Z-0934-2014","Class II","3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc'' Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.","Lot 009SV",,"12 units","OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.",1/8/2014,"01/08/2014",2/12/2014,"02/12/2014"
"Drugs",67303,"Ongoing","Dr. Reddy's Laboratories, Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1146-2014","Class II","a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 ","Lot #: a) 79305114A, b) 79305114B, c) 79305114C, d) 79305114D, e) 79305114E, f) 79305114F, Exp 05/2015",,"58,656 Bottles","Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.",1/3/2014,"01/03/2014",3/12/2014,"03/12/2014"
"Biologics",67304,"Terminated","LifeSouth Community Blood Centers Inc","Madison","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0403-14","Class II","Platelets Pheresis Leukocytes Reduced","W1151132824302",,"1 unit","Blood products, for which the testing for pH was invalid, were distributed.",12/5/2013,"12/05/2013",3/12/2014,"03/12/2014"
"Biologics",67304,"Terminated","LifeSouth Community Blood Centers Inc","Madison","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0402-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W1151132824302",,"1 unit","Blood products, for which the testing for pH was invalid, were distributed.",12/5/2013,"12/05/2013",3/12/2014,"03/12/2014"
"Devices",67305,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.","Z-0979-2014","Class II","GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH","Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229, 9231.",".","47 Units","The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.",12/5/2013,"12/05/2013",2/19/2014,"02/19/2014"
"Devices",67306,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.","Z-0832-2014","Class II","Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.","Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121",,"7 units","Patient images exhibited ring artifacts. ",12/9/2013,"12/09/2013",2/5/2014,"02/05/2014"
"Devices",67307,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.","Z-1074-2014","Class II","Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.","BrightView SPECT, Product code: 882480; Serial #'s: 400054, 4000002, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065, 4000066, 4000067, 4000068, 4000070, 4000071, 4000072, 4000073, 4000074, 4000075, 4000076, 4000077, 4000078, 4000079, 4000080, 4000081, 4000083, 4000086, 4000087, 4000088, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120, 4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000135, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000195, 4000196, 4000197, 4000198, 4000199, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000252, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 40002",,"1,143 units","Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As the gantry system was moving to a relative 90 scan position of the detectors, a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. While a user was manually positioning a patient for their exam and translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Devices",67308,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada.","Z-1166-2014","Class II","VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.","Model LCC019, Lot #: 024552A",".","94 boxes/20 units","STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.",12/19/2013,"12/19/2013",3/19/2014,"03/19/2014"
"Biologics",67309,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","California","B-0401-14","Class II","Source Plasma","TT0294494, TT0295547, TT0296098",,"3 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",12/18/2013,"12/18/2013",3/12/2014,"03/12/2014"
"Biologics",67310,"Terminated","Blood Center of Northcentral Wisconsin, Inc.","Wausau","WI","US","Voluntary: Firm Initiated","E-Mail","Wisconsin","B-0400-14","Class II","Platelets Pheresis Leukocytes Reduced","W229813800598",,"1 unit","Blood product, with a low platelet yield, was distributed.",1/10/2014,"01/10/2014",3/12/2014,"03/12/2014"
"Biologics",67311,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","MS, LA","B-0387-14","Class II","Platelets Pheresis Leukocytes Reduced","W067113708039- part 1; W067113708039- part 2",,"2 units","Blood products, in which donor testing was not performed or incomplete, were distributed. ",11/15/2013,"11/15/2013",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1100-2014","Class II","Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13LU02004 13LU02005 13LU02008 13LU03006 13LU03007 13LU03008 13LU04005 13LU04006 13LU04007 13LU04008 13LU04009 13LU04010 13LU03009 13LU03010 13LU03011 13LU03012 13LU04011 13LU04012 13LU03014 13LU02018 13LU03015 13LU03016 13LU03017 13LU03018 13NU03001 13NU02001 13NU03002 13NU03004 13NU03005 13NU02005 13NU02006 13NU02007 13NU03006 13NU03007 13NU03008 13NU03009 13NU05006 13NU05007 13NU05009 13NU03011 13NU03012 13NU04011 13NU05016 13NU05017 13NU05018 13NU03018 13NU04017 13PU02003 13NU03019 13PU03001 13PU03002 13PU03003 13PU05002 13PU05003 13PU02004 13PU02005 13PU02006 13PU02007 13PU03004 13PU03006 13PU03007 13PU03008 13PU05004 13PU02010 13PU02011 13PU02012 13PU03010 13PU04011 13PU04012 13PU04013 13PU05009 13PU05010 13PU05011 13PU02013 13PU02014 13PU02015 13PU02016 13PU02017 13PU03013 13PU03014 13PU03015 13PU03016 13PU03017 13PU04014 13PU05016 13PU05017 13SU05001 13SU02003 13SU03004 13SU02004 13NU04012 13NU05010 13NU05011 13NU02012 13NU02013 13NU02014 13NU03016 13NU03017 13NU04015 13NU04016 13NU05014 13NU05015 13PU04015 13PU04016 13PU04017 13PU04018 13PU05012 13PU05013 13PU05014 13PU05015 13PU02018 13PU02019 13SU02001 13PU04019 ",,"3,744,122","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1099-2014","Class II","Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13NU01014 13SU01001 13SU01002 ",,"6720 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1104-2014","Class II","Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment. ","Lot Number: 13NU04009 ",,"5,244 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1105-2014","Class II","Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13LU02011 13LU02013 13NU02016 13NU02017 ",,"100,008 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1102-2014","Class II","Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002 ",,"317,796 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1106-2014","Class II","Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.","Lot Number: 13PU03011 ",,"34,752 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1101-2014","Class II","Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13NU03003 13NU03010 13PU04010 13SU03001 ",,"52,752 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1098-2014","Class II","Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.","Lot Numbers: 13LU01001 13KU05018 13LU05001 13KU06026 13LU06001 13LU06002 13LU05002 13LU06003 13LU01007 13LU01008 13LU01009 13LU05003 13LU05004 13LU05005 13LU05006 13LU05007 13LU05008 13LU06004 13LU06005 13LU06006 13LU06008 13LU06009 13LU06010 13LU06011 13LU06012 13LU06013 13LU06014 13LU06015 13LU06016 13LU01010 13LU01011 13LU06017 13LU06018 13LU01012 13LU01013 13LU05014 13LU06019 13LU06020 13LU06021 13LU01015 13LU05015 13LU06022 13NU05002 13NU06002 13NU01004 13NU05003 13NU06003 13NU06004 13NU06007 13NU01005 13NU01006 13NU01007 13NU01008 13NU06008 13NU06009 13NU06010 13NU06011 13NU06012 13NU06013 13NU06014 13NU01009 13NU01010 13NU06015 13NU06016 13NU06017 13NU06018 13NU06020 13NU06021 13NU06022 13NU06023 13NU06024 13NU06025 13NU06026 13NU06027 13NU01015 13NU01016 13NU01017 13NU01018 13PU01001 13PU01002 13PU01003 13NU06029 13PU06001 13PU06002 13PU06018 13PU01013 13PU01014 13PU01015 13PU01017 13PU06019 13PU06020 13PU06021 13PU06022 13PU06023 13PU06024 13PU06025 13PU06026 13PU06027 13PU06028 13SU06004 13SU06005 13LU06023 13LU06024 13LU06025 13LU06027 13LU06028 13NU06001 13LU05016 13LU01016 13LU01017 13NU01001 13LU05017 13NU01002 13PU06003 13PU01004 13PU01007 13PU06006 13PU06007 13PU01008 13PU01010 13PU01011 13PU01012 13PU06015 13PU06016 13PU06017 ",,"3,460,672 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67313,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) and the country of: Mexico.","Z-1103-2014","Class II","Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.","Lot Number: 13NU04008 ",,"19,596 units","Dialysate Port Leak During Priming of the Dialyzers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67315,"Ongoing","Zest Anchors LLC","Escondido","CA","US","Voluntary: Firm Initiated","Letter","Distributed in Ohio and Switzerland.","Z-0935-2014","Class II","LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878","Part Numbers: 8875-SPI, 8875-SPI-TMS, 8876-SPI, 8876-SPI-TMS, 08877-SPI, 08877-SPI-TMS, 08878-SPI, 08878-SPI-TMS, 08879-SPI, 08880-SPI; Lot Numbers: 11052, 15306, 20665, 21351, 12025,12259, 22440, I0K7X, I0K7Y, 11963,15307,17676,18934, 25294, 25567, I0JQ7, 12258,12941,15000, 19735, 20666, I0K7Z, I0KY7, 12703, 14568, 19832, 22170, I0LCG, 11093, 13364, 14151, 15624, 20043, 25026, 13530, I0LE4, 10055, 14152, 15001, 25027, 10892, 10893. Since the LOCATOR Implant Attachment System (including the restorative components) is not sold by the Zest Anchors as a sterilized product, it does not have a designated shelf-life.",,"3,130","Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommended torque, the abutment torque value should be 20 N-cm.",1/16/2014,"01/16/2014",2/12/2014,"02/12/2014"
"Food",67316,"Ongoing","Cal-Fresh Produce","Bell","CA","US","Voluntary: Firm Initiated","E-Mail","CA","F-1534-2014","Class I","Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box UPC: 62013300198 1 ","lot: 2014AL29",,"117 units","Cal Fresh Produce is recalling Kinnikinnick Foods Original Homestyle Waffles due to undeclared milk.",1/17/2014,"01/17/2014",2/26/2014,"02/26/2014"
"Devices",67319,"Ongoing","Philips Healthcare","San Diego","CA","US","Voluntary: Firm Initiated","Other","Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherland, Spain, Sweden, and Switzerland.","Z-0845-2014","Class II","InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908","Model Numbers: 861470 (120V), 861472 (240V). ",,"50","Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.",1/13/2014,"01/13/2014",2/5/2014,"02/05/2014"
"Food",67321,"Ongoing","Farm To Market Bread Co Inc","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","The product is distributed in KS and MO only to local grocery stores.","F-1475-2014","Class II","Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C. Farm to Market Bread Co., Kansas City, MO.","No lot number or use by date.",".","640 loaves","The product label does not list wheat flour as an ingredient. Undeclared allergen.",1/18/2014,"01/18/2014",2/19/2014,"02/19/2014"
"Food",67323,"Ongoing","NatureBox, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Letter","US distribution only.","F1462-2014","Class II","NatureBox Salsa Spiced Nut Mix; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Almonds, Corn chips with flax (yellow corn masa, flax seed, soybean oil, salt), Cashews, seasoning ( tomato powder, salt, sugar, onion powder, garlic powder, spices, cilantro, lime juice powder, corn syrup, lime juice, lime oil, paprika, soybean oil), corn syrup, sugar. No UPC on product. Distributed by NatureBox, San Carlos, CA 94070 ","Expiry dates of 3/16/14, 4/21/14 and 6/19/14. (includes consumer facing lot codes 2BC13323, 2BC13330, 1BC13294. Supplier lot codes 13259, 13323 and 13360. 4BC13339, 3BC13552, 1BC14006, 5BC14010, 1BC14013) ",,"8,672 bags.","It was discovered that the specification used by the supplier was incorrect and therefore the ingredient statement was incorrect and did not include unbleached wheat flour and bulgur wheat. The packaging does note that the products are packaged in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy.",1/16/2014,"01/16/2014",2/5/2014,"02/05/2014"
"Food",67323,"Ongoing","NatureBox, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Letter","US distribution only.","F-1463-2014","Class II","NatureBox Picante Ranch Mix Spicy Snack Mix with Corn Nuts and Masa Chips; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Corn Nuts (corn, canola oil, soybean oil, salt), Sugar, Flax Chips (Yellow corn masa, flax seeds, soybean oil, salt) Snack Seasoning(sour cream, salt, whey, corn syrup, tomato, maltodextrin, garlic powder, onion powder, cheddar cheese ([pasteurized milk, cheese cultures, salt, enzymes], whey, buttermilk solids, salt, disodium phosphate), milk, vinegar, soybean oil, citric acid, spice, parsley), corn Syrup, chili Powder, Red Pepper. No UPC on product. Distributed by NatureBox, San Carlos, CA 94070 ","all lot codes with expiration date of 4/1/14 (includes consumer facing lot codes 3BC13324, 4BC13339, 5BC13340, 5BC13354, 5BC14003, 4BC13009). Supplier lot code 13274.",,"5,371 bags","It was discovered that the specification used by the supplier was incorrect and therefore the ingredient statement was incorrect and did not include unbleached wheat flour and bulgur wheat. The packaging does note that the products are packaged in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy.",1/16/2014,"01/16/2014",2/5/2014,"02/05/2014"
"Cosmetics",67324,"Ongoing","Valeant Pharmaceuticals North America LLC DBA Orapharma Inc.","Bridgewater","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA","F-1874-2014","Class III","Obagi Medical C-Cleansing Gel, deeply Cleans to Remove Makeup and Excess Oil, 33.8 fl. oz. (1 L), Not for Retail Sale, Distributed by OMP, Inc., Long Breach, CA 90806","Lot No. 1304400-13B1017, UPC Code 362032070544",,"Less than 200","Product was mislabeled as Obagi Medical Toner",9/25/2013,"09/25/2013",4/30/2014,"04/30/2014"
"Devices",67325,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.","Z-0853-2014","Class II","GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems."," Serial # System ID 00000616724BU1 956389IGS630 00000618156BU4 MCMIGS630 FMI12200DUMMY2 702731ANGIO2 00000619372BU6 732828IGS30 00000618158BU0 210705CATH1 00000622076BU9 661327IGS630 00000621314BU4 904202WCL2 00000628656BU1 281MHWCL1 00000622220BU2 303839CL4 00000625357BU9 281420LAB3BP 00000626085BU5 817BGIGS630 00000628654BU6 215576IGS4 FMI12200DUMMY3 CS1340VA01 00000614683BU1 M4152252 00000618160BU6 YV1900 00000617143BU3 YV1901 00000618157BU2 YV1902 00000620495BU2 YV1903 00000624842BU1 YV1904 00000627935BU0 YV1905 00000630300BU2 YV1906 00000617142BU5 YV1950 FMI12200DUMMY4 YV1907 00000622672BU4 850060746 00000626239BU8 850060749 FMI12200DUMMY1 SA2308VA01 00000622221BU0 ZA2239VA01 00000614682BU3 34006VAS02 ",,"28 (12 US, 16 OUS).","GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring a restart of the system in order to recover its operations. No injury has been reported due to this issue.",11/15/2013,"11/15/2013",2/5/2014,"02/05/2014"
"Devices",67326,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and Canada","Z-0931-2014","Class II","Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.","Trifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.",,"9,550 units","CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.",1/16/2014,"01/16/2014",2/12/2014,"02/12/2014"
"Food",67327,"Ongoing","New Japan International, Inc.","Commerce","CA","US","Voluntary: Firm Initiated","Letter","CA, FL, WA, VA, TX, UT, NY, MS, KS, MA","F-1478-2014","Class II","Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068 ","n/a",,"86 units","Product contains unapproved colors, 16185-Amaranth (E123)-Delisted FD&C Red #2, 45170-Rhodamine B-Basic Violet 10, 42000-Malachite Green-Basic Green 4, 4100-Auramine O-Basic Yellow 2, and undeclared colors FD&C Yellow #5 and FD&C Blue #1.",1/20/2014,"01/20/2014",2/26/2014,"02/26/2014"
"Devices",67328,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ IRELAND ISRAEL ITALY JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LITHUANIA MACAU MALAYSIA MALTA MAURITIUS MOROCCO MYANMAR (Burma) NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PALESTINE PERU PHILIPPINES POLAND PORTUGAL,QATAR ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SERBIA SEYCHELLES SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VIET NAM.","Z-1107-2014","Class II","Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.","Serial Numbers: Serial Number Range USO1100106-USO1100372 USN1100376-USN1100960 USD1100961-USD1101095 US11201095-US11201186 US21201187-US21201239 US31201240-US31201537 US41201538-US41201585 US51201586-US51201721 US61201722-US61201924 US71201925-US71202048 US81202049-US81202168 US91202169-US91202514 US01202515-US01202990 USN1202991-USN1203537 USD1203538-USD1203968 US11303969-US11303972 US21303980-US21304488 US31304489-US31305042 US41305043-US41305295 US51305296-US51305450 US61305451-US61306138 US71306139-US71306542 US81306543-US81306998 US91306999-US91307261 US01307306-US01307458 ",,"7157 units","HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling",1/24/2014,"01/24/2014",3/5/2014,"03/05/2014"
"Drugs",67329,"Ongoing","Fougera Pharmaceuticals Inc.","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1152-2014","Class III","Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.","Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15",".","493,192 tubes","Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.",1/29/2014,"01/29/2014",3/19/2014,"03/19/2014"
"Drugs",67330,"Ongoing","Fresenius Kabi USA, LLC","Grand Island","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1148-2014","Class II","Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11. ","Lot Number: 6004137, Expiration date: 06/2014",,"161,650 vials","Subpotent; 18 month time point",1/22/2014,"01/22/2014",3/12/2014,"03/12/2014"
"Biologics",67331,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US States: CA, IL, MI, WI, PA, VA, CT, MA, NY, AL. International: Canada, Bulgaria, Saudi Arabia, United Kingdom & Ireland, France, Germany, Greece, Italy, Lithuania, Czech Republic, Romania, Serbia, Austria, Netherlands, Spain, Peru.","B-0488-14","Class II","Lambda Cell Tray'' Cell Panels, Article Number: LCT-TRAY-PI, Rev 14. BK840013.","Catalog Identification: LCT1W30 (Lots 26, 27); LCT1W60 (Lots 26, 27); and LCT1W72 (Lots 3, 4). Article Number: LCT-TRAY-PI, Rev 14. ",,"992 kits; 6 lots","One Lambda, Inc., part of Thermo Fisher Scientific, is conducting a correction of Lambda Cell Tray'', because the product insert for Lambda Cell Tray products (document identification LCT-TRAY-PI-EN-00, Rev 14), contains a documentation error. In the product insert, line 2 in the Directions For Use section is mistakenly repeated. The documentation error in the protocol may cause an end user to incorrectly perform a second incubation and wash off the product. This duplication may result in additional cell loss during the washing procedure.",1/17/2014,"01/17/2014",3/12/2014,"03/12/2014"
"Devices",67332,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1146-2014","Class II","ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.","Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601. Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.",,"2,023 units","HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers or other analyte values are affected.",1/20/2014,"01/20/2014",3/12/2014,"03/12/2014"
"Biologics",67333,"Terminated","Central Jersey Blood Center, Inc.","Eatontown","NJ","US","Voluntary: Firm Initiated","Telephone","NJ","B-0427-14","Class III","Red Blood Cells Leukocytes Reduced","W053513021187",,"1 unit","Blood product, which did not meet acceptable product specifications, was distributed.",12/9/2013,"12/09/2013",3/26/2014,"03/26/2014"
"Biologics",67334,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0385-14","Class II","Fresh Frozen Plasma","W036810049239",,"1 unit","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Biologics",67334,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0384-14","Class II","Platelets Pooled Leukocytes Reduced","W036810800088",,"1 unit","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Biologics",67334,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0383-14","Class II","Red Blood Cells","W036810049239",,"1 unit","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/5/2014,"03/05/2014"
"Biologics",67335,"Terminated","Dendreon Corp","Seattle","WA","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0359-14","Class II","Sipuleucel-T","3000131; 3000221; 3000237; 3000501; 3002534; 3003761; 3003951; 3006171; 3006671; 3008071; 3008691; 3009072; 3012481; 3013795; 3022092; 3024811; 3025542; 3027702; 3030102; 3031713; 3032091; 3032163; 3033241; 3033651; 3033815; 3034311; 3035051; 3037373; 3038251; 3038252; 3039141; 3040121; 3041333; 3044111; 3044952; 3047292; 3051971; 3056722; 3061182; 3070302; 3082421; 3085442; 3076793; 3065582; 3065781; 3073441; 3090651; 3091811; 3017963; 3033041; 3035712; 3037893; 3043781; 3050081; 3050872; 3050874; 3051781; 3051783; 3052763; 3052942; 3053201; 3055312; 3076201; 3083621; 3089793; 3090652; 3000481; 3093211; 3099501; 3105001; 3004201; 3012822; ",,"72 lots","PROVENGE, which did not meet the release spec for CD54 upregulation, or which had the potential to not meet the potency release specification for CD54 upregulation, was distributed. ",12/18/2013,"12/18/2013",2/12/2014,"02/12/2014"
"Biologics",67336,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL","B-0421-14","Class II","Platelets Pooled Leukocytes Reduced","W036813807738",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/10/2013,"12/10/2013",3/26/2014,"03/26/2014"
"Biologics",67336,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL","B-0422-14","Class II","Fresh Frozen Plasma","W036813120047",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed",12/10/2013,"12/10/2013",3/26/2014,"03/26/2014"
"Biologics",67336,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL","B-0423-14","Class II","Red Blood Cells Leukocytes Reduced","W036813120047",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed",12/10/2013,"12/10/2013",3/26/2014,"03/26/2014"
"Biologics",67336,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL","B-0419-14","Class II","Red Blood Cells","W036811129421",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/10/2013,"12/10/2013",3/26/2014,"03/26/2014"
"Biologics",67336,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL","B-0420-14","Class III","Blood and Blood Products for Reprocessing","W036811129421",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",12/10/2013,"12/10/2013",3/26/2014,"03/26/2014"
"Biologics",67337,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","CA; Switzerland","B-0424-14","Class II","Cryoprecipitated AHF, Pooled","W333613056988",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/13/2013,"11/13/2013",3/26/2014,"03/26/2014"
"Biologics",67337,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","CA; Switzerland","B-0425-14","Class II","Blood and Blood Products for Reprocessing","W333613055388; W333612069481",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",11/13/2013,"11/13/2013",3/26/2014,"03/26/2014"
"Biologics",67338,"Terminated","Biomat USA, Inc","Colorado Springs","CO","US","Voluntary: Firm Initiated","E-Mail","Spain","B-0430-14","Class II","Source Plasma","0700212145",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",11/22/2013,"11/22/2013",3/26/2014,"03/26/2014"
"Biologics",67339,"Completed","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Letter","California","B-0449-14","Class II","Red Blood Cells Leukocytes Reduced","W044213874332; W044213851195; W044213838507",".","3 units","Blood products, collected from a donor who visited a malarial endemic region, were distributed. ",1/20/2014,"01/20/2014",3/19/2014,"03/19/2014"
"Biologics",67340,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-0417-14","Class II","Red Blood Cells Leukocytes Reduced","W036813160797",,"1 unit","Blood product, mislabeled as to antigen phenotype, was distributed. ",12/13/2013,"12/13/2013",3/26/2014,"03/26/2014"
"Food",67341,"Ongoing","Delhaize America (Hannaford Bros)","South Portland","ME","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","ME, NH, MA, VT, NY","F-1754-2014","Class I","St. Mary's River Smokehouses Oven Smoked Atlantic Salmon Stix, Chili Mango Flavor","UPC Code 6 26425 10092 9. Production code 347 31##, marked on a sticker on the end of the styrofoam tray. ",".","estimated to be 51 cases","Potential for Listeria monocytogenes contamination. ",1/14/2014,"01/14/2014",4/16/2014,"04/16/2014"
"Devices",67342,"Ongoing","Instrumentarium Dental, PaloDEx Group Oy","Tuusula",,"FI","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom.","Z-1091-2014","Class II","The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.","Device Model Number / Sales Code: 50600-IMG; Serial Numbers (US and Foreign): F21221 - F21641, and F21643; Serial Numbers (US Devices): F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 - F21486, F21490 - F21519, F21525 - F21542, F21545 - F21550, F21565 - F21588, F21623 - F21628, F21636 - F21641, and F21643",,"101 units (US Distribution)","Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS X-ray machines that had not been properly welded at our supplier. As a result of the incomplete welding operation, the wall mount unit on the FOCUS X-ray unit may not properly support the unit as expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, there is also a possibility that the wall mount unit will fail to support the weight of the unit, resulting in the FOCUS X-ray unit falling unexpectedly from its mounted position.",1/14/2014,"01/14/2014",3/5/2014,"03/05/2014"
"Devices",67343,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to: AUSTRALIA, AUSTRIA BELGIUM BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, COLOMBIA, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, FINLAND, GEORGIA, GERMANY, HONG KONG, IRAN, ISRAEL INDIA,M ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEW ZEALAND, NORWAY, RUSSIA, REPUBLIC OF KOREA, POLAND, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TUNISIA, THAILAND, TURKEY, UNITED KINGDOM.","Z-0981-2014","Class II","GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.","FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00000012544PT3 856247PETUPS 00000012561PT7 505216D710 00000012574PT0 858805PCT 00000012615PT1 630432D710 00000012674PT8 801581D710 00000012723PT3 602839D710 00000012732PT4 402327D610 00000012752PT2 719365PETCT 00000012771PT2 414805D710 00000012834PT8 904710PET 00000012843PT9 918505PETCT1 00000012849PT6 205975PET1 00000012865PT2 205975PET2 00000012896PT7 985542D610 00000012915PT5 256386HKPETCT 00000012924PT7 318675D710 00000012937PT9 504842D600 00000012961PT9 303673PETCT 00000012975PT9 605328D710 00000013017PT9 608WIMRD710 00000013057PT5 847872D610 00000013066PT6 4056793 00000013067PT4 212288DST710 00000013072PT4 002902086 00000013081PT5 253968D710 00000013101PT1 270688PETCT 00000012473PT5 910452029 00000012749PT8 910456003 00000012837PT1 83095572097 00000012888PT4 83092720723 00000013026PT0 83092879582 00000012626PT8 AH0132PE01 00000012774PT6 306655D710 00000012533PT6 CT428868CN4 00000012900PT7 EGL067 00000012538PT5 HC1992PE01 00000012582PT3 DK1043PT02 00000012819PT9 DK1054PT17 00000012963PT5 EG1017PT01 00000012993PT2 EG1525PT01 00000012822PT3 A4166968 00000012970PT0 M9886853 00000013082PT3 M4145026 00000013099PT7 EGL110 00000012717PT5 8.30458E+13 00000012722PT5 8.3045E+13 00000012738PT1 8.3045E+13 00000012871PT0 4065738 00000012881PT9 4108707 00000012909PT8 83045062157413 00000012921PT3 8.30452E+13 00000013020PT3 8.30452E+13 00000013127PT6 4119154 00000012600PT3 A5124541 00000012638PT3 A5367810 00000012644PT1 A5366305 00000012655PT7 B5801736 00000012756PT3 A51142135 00000012877PT7 A51051131 00000012887PT6 A51273167 00000012930PT4 A5330720 , A5330718 , A5330719 00000012940PT3 B5315353 00000013023PT7 B5811440 00000012553PT4 GQF002 00000012568PT2 SQF701 00000012585PT6 GQF001 00000012649PT0 SQF001 00000012735PT7 GQF003 00000012766PT2 GQF004 00000012807PT4 SQF710 00000012811PT6 GQ0001 00000012951PT0 SQF003 00000013048PT4 EGL098 00000013078PT1 EGL106 00000013112PT8 EGL116 00000013118PT5 EGL117 00000012599PT7 850450166 00000012665PT6 8",,"376 (101 US, 275 OUS)","GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.",11/20/2013,"11/20/2013",2/26/2014,"02/26/2014"
"Drugs",67344,"Ongoing","Merck & Co Inc","Whitehouse Station","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1311-2014","Class III","Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 ","a) Liptruzet 10/40mg 30 count, 346304, 346342, 350256, 353107, 353108, 353109, Exp. 06/14; 353110, Exp.12/14 b) Liptruzet 10/40mg 90 count 346382, Exp. 06/14; 353186, Exp.12/14.",".","36,493 cartons","Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.",1/13/2014,"01/13/2014",5/14/2014,"05/14/2014"
"Drugs",67344,"Ongoing","Merck & Co Inc","Whitehouse Station","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1309-2014","Class III","Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889","a) Liptruzet 10/10mg, 30 count, 346380,353183, Exp. 07/14 b) Liptruzet 10/10mg, 90 count 346381, 350264, Exp 07/14; 357235, Exp. 12/14. ",".","11,175 cartons","Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.",1/13/2014,"01/13/2014",5/14/2014,"05/14/2014"
"Drugs",67344,"Ongoing","Merck & Co Inc","Whitehouse Station","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1310-2014","Class III","Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 ","a) Liptruzet 10/20mg 30 count, 346353, 346354, Exp. 06/14; 351809, Exp. 07/14, 360530, Exp. 12/14. b) Liptruzet 10/20mg, 90 count, 346387, Exp. 06/14; 353185, Exp.12/14. ",".","20,259 cartons","Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.",1/13/2014,"01/13/2014",5/14/2014,"05/14/2014"
"Drugs",67344,"Ongoing","Merck & Co Inc","Whitehouse Station","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1312-2014","Class III","Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 ","a) Liptruzet 10/80mg 30 count, 346379, 350257, Exp.07/14; 353591, Exp. 06/15. b) Liptruzet 10/80mg 90 count, 346383, 371072, Exp. 06/15. ",".","11,462 cartons","Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.",1/13/2014,"01/13/2014",5/14/2014,"05/14/2014"
"Food",67345,"Terminated","Tijuana'S Produce Co.","LOS ANGELES","CA","US","Voluntary: Firm Initiated","Letter","NV, CO, WA, OR","F-1557-2014","Class III","Cactus Leaves (Nopales), 44 lbs.","n/a",,"210 units","Tijuana's Produce is recalling cactus leaves (nopales) due to unapproved levels of pesticide contamination.",1/21/2014,"01/21/2014",3/5/2014,"03/05/2014"
"Devices",67346,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.","Z-0925-2014","Class II","SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle. ","Lot Numbers: 13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362",,"3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)","CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during infusion.",1/22/2014,"01/22/2014",2/12/2014,"02/12/2014"
"Food",67347,"Ongoing","UNFI","Chesterfield","NH","US","Voluntary: Firm Initiated","Other","Nationwide","F-1550-2014","Class I","Kinnikinnick Kinni-Kwik Bread & Bun Mix-Weight 350g/16oz Cardboard Box UPC 62013310550 4 ","All lots up to and including Best Before 2014DE19, 20141219, 141219",,"7","Undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67347,"Ongoing","UNFI","Chesterfield","NH","US","Voluntary: Firm Initiated","Other","Nationwide","F-1548-2014","Class I","Kinnikinnick Original Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300198 1 ","All lots up to and including Best Before 2014AU10, 20140810, 140810",,"2,051","Undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67347,"Ongoing","UNFI","Chesterfield","NH","US","Voluntary: Firm Initiated","Other","Nationwide","F-1551-2014","Class I","Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2 ","All lots up to and including Best Before 2015JA06, 20150106, 150106",,"1,547","Undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67347,"Ongoing","UNFI","Chesterfield","NH","US","Voluntary: Firm Initiated","Other","Nationwide","F-1552-2014","Class I","Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3","All lots up to and including Best Before 2014AU09, 20140809, 140809",,"6,881","Undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67347,"Ongoing","UNFI","Chesterfield","NH","US","Voluntary: Firm Initiated","Other","Nationwide","F-1549-2014","Class I","Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300199 8 ","All lots up to and including Best Before 2014AU11, 20140811, 140811",,"641","Undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Devices",67349,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and the country of Canada.","Z-1127-2014","Class II","Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. ","Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD",,"Domestic: 347 units (total for both)","Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Devices",67349,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and the country of Canada.","Z-1128-2014","Class II","Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. ","Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD",,"Domestic: 347 units (total for both)","Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Devices",67350,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.","Z-0938-2014","Class II","Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu'' System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.","Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date. ",".","40","Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.",1/22/2014,"01/22/2014",2/19/2014,"02/19/2014"
"Biologics",67351,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Other","CA","B-0418-14","Class III","Blood and Blood Products for Reprocessing","002K50984",,"1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",12/9/2013,"12/09/2013",3/26/2014,"03/26/2014"
"Food",67352,"Ongoing","Natures Best Inc","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-1495-2014","Class I","Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item #616961.","Lot codes: 2013DE25 20131225 131225 2014JA27 20140127 140127 2014AL15* 2014JN25* 2014AU10* 2014AL29* 2014JL13* 2014AU11* 2014MA28* 2014JL14*",".","31 units","Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67352,"Ongoing","Natures Best Inc","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-1492-2014","Class I","Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886","Lot codes: 2013NO25 20131125 131125 2013NO26 20131126 131126 2013DE03 20131203 131203 2013DE11 20131211 131211 2013DE22 20131222 131222 2013DE23 20131223 131223 2013DE24 20131224 131224 2013DE30 20131230 131230 2014JA04 20140104 140104 2014JA11 20140111 140111 2014JA15 20140115 140115 2014JA19 20140119 140119 2014JA28 20140128 140128 2014JA29 20140129 140129 2014FE02 20140202 140202 2014FE09 20140209 140209 2014FE11 20140211 140211 2014FE19 20140219 140219 2014FE22 20140222 140222 2014MR11 20140311 140311 2014MR30* 2014AL27* 20140427* 2014AL15* 2014AL16* 2014AL20* 2014MA19* 2014JN11* 2014JL23* 2014MA21* 2014JN22* 2014NO28* 2014MA27* 2014JN23* 2014JL29* 2014JN02* 2014JL01* 2014AU04* 2014JN03* 2014JL05* 2014AU05* 2014JN04* 2014JL15* 2017JN07* 2014JL21*",".","538 units","Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67352,"Ongoing","Natures Best Inc","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-1496-2014","Class I","Bread & Bun Mix, 16.4oz, Qty/pkg: 6, UPC 620133105504, NB Item 645564","Lot codes: 2014AL04 20140404 140404 2014MA09 20140509 140509 140905* 2014NO20* 2014OC25* 2014DE19*",".","17 units","Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67352,"Ongoing","Natures Best Inc","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-1494-2014","Class I","Original Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001981, NB Item #616953","Lot codes: 2013DE09 20131209 131209 2013DE31 20131231 131231 2014JA26 20140126 140126 2014MR10 20140310 140310 2014MR15 20140315 140315 2014MR16 20140316 140316 2014AL15* 2014MA07* 2014JN24* 2014AL29* 2014JN10* 2014JL13* 2014JL29*",".","48 units","Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Food",67352,"Ongoing","Natures Best Inc","Chino","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-1493-2014","Class I","Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556","Lot codes: 2014AL16 20140416 140416 2014AL17 20140417 140417 2014AL23 20140423 140423 2014AL24 20140424 140424 2014AL26 20140426 140426 2014AL29 20140429 140429 2014MA02 20140502 140502 2014MA06 20140506 140506 2014MA15 20140515 140515 2014MA16 20140516 140516 2014MA22 20140522 140522 2014MA30 20140530 140530 2014MA31 20140531 140531 2014JN03 20140603 140603 2014JN05 20140605 140605 2014JN10 20140610 140610 2014JN11 20140611 140611 2014JN13 20140613 140613 2014JN21 20140621 140621 2014JN28 20140628 140628 2014JL04 20140704 140704 140927* 2014SE27* 20140927* 2014OC15* 20141016* 2014OC16* 2014OC18* 141021* 2014OC21* 2014NO01* 2014NO07* 2014DE11* 2014NO05* 2014NO25*",".","78 units","Natures Best is recalling Kinnikinnick pancake and waffle products due to undeclared milk.",1/13/2014,"01/13/2014",2/19/2014,"02/19/2014"
"Drugs",67354,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1540-2014","Class I","DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02","Lot # 27-352-DK; Exp 03/15",,"123,900 vials","Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. ",1/10/2014,"01/10/2014",8/27/2014,"08/27/2014"
"Food",67355,"Ongoing","Bozzutos' Inc.","Cheshire","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ct, MA, ME, NH, NJ, NY, RI","F-1555-2014","Class I","Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3","All lots up to and including Best Before 2014AU09, 20140809, 140809",,"385 cases","Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67355,"Ongoing","Bozzutos' Inc.","Cheshire","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ct, MA, ME, NH, NJ, NY, RI","F-1554-2014","Class I","Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2","All lots up to and including Best Befor 2015JA06, 20150106, 150106",,"50 cases","Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk. ",1/13/2014,"01/13/2014",3/5/2014,"03/05/2014"
"Food",67356,"Terminated","RCI Produce","Oakland","CA","US","Voluntary: Firm Initiated","Telephone","CA only","F-1558-2014","Class II","Cactus Leaves/Pads (Nopales) MexpoGroup Brand MexpoGroup Fresh Produce Colonia Buenos Aires Norte, Tijuana, Baja California, Mexico.","no code numbers",,"50 cases (44 lbs each)","CA Dept of Pesticides tested Cactus pads and found pesticides Monocrotophos at 0.581 ppm, Carbendazim as Thiophanate Methyl at 0.510 ppm and Captan (THPI) at 0.313 ppm. There is no tolerance for these pesticides in the US.",1/17/2014,"01/17/2014",3/5/2014,"03/05/2014"
"Food",67357,"Ongoing","Araya, Inc","Katy","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-1481-2014","Class II","Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com","UPC Codes 729440332044, 729440332006, 729440332051, 729440332037, 729440332075, 729440332082",".","2264 units wholesale (total for all products), plus internet sales","Product may contain undeclared allergens",1/23/2014,"01/23/2014",2/19/2014,"02/19/2014"
"Food",67357,"Ongoing","Araya, Inc","Katy","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-1484-2014","Class II","Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com","UPC Codes 729440332167, 729440332488, 729440332235",".","2264 units wholesale (total for all products), plus internet sales","Product may contain undeclared allergens",1/23/2014,"01/23/2014",2/19/2014,"02/19/2014"
"Food",67357,"Ongoing","Araya, Inc","Katy","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-1485-2014","Class II","Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com","UPC Code 729440332402",".","2264 units wholesale (total for all products), plus internet sales","Product may contain undeclared allergens",1/23/2014,"01/23/2014",2/19/2014,"02/19/2014"
"Food",67357,"Ongoing","Araya, Inc","Katy","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-1483-2014","Class II","Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pear Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com","UPC Codes 729440332082, 729440332105, 729440332136",".","2264 units wholesale (total for all products), plus internet sales","Product may contain undeclared allergens",1/23/2014,"01/23/2014",2/19/2014,"02/19/2014"
"Food",67357,"Ongoing","Araya, Inc","Katy","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-1482-2014","Class II","Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread, peppermint, red velvet, vanilla Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com","UPC Codes 760921366004, 760921366011, 760921366066, 760921366003, 760921366097, 760921366073, 760921366028",".","2264 units wholesale (total for all products), plus internet sales","Product may contain undeclared allergens",1/23/2014,"01/23/2014",2/19/2014,"02/19/2014"
"Devices",67358,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM, VENEZUELA, and YEMEN.","Z-0911-2014","Class II","GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.","System ID Model, Catalogue or Code # 828213AIRF2 2385123-2 309454FJRM1 2385123-2 217935WF1 2385123-2 434924UVAP1 2385123-2 717627RF2 2385123-2 608287PRE500 2385123-2 304473RF1 2385123-2 717627RF1 2385123-2 801807RM3 2385123-2 904858RM1 2385123-2 325658RF1 2385123-2 828322F6 2385123-2 623327RF1 2385123-2 864573MBR3 2385123-2 913696CRF1 2385123-2 817255NHRM1 2385123-2 217442VXF3A 2385123-2 509332PRF 2385123-2 405752P500 2385123-2 520498RF1 2385123-2 718518RF2 2385123-2 601426PRF1 2385123-2 256MIRF1 2385123-2 231876P500D1 2385123-2 765448DF1 2385123-2 404325EFL1 2385123-2 231935DF2 2385123-2 407321PRF5 2385123-2 903416PD1 2385123-2 970544RM2 2385123-2 314344DR10 2385123-2 423562RF1 2385123-2 608372P500 2385123-2 231876P500D2 2385123-2 765747PRE1 2385123-2 256974P1 2385123-2 972665BPPRE1 2385123-2 423562RF2 2385123-2 937352RM3 2385123-2 972665BPPRE2 2385123-2 314996MBRM2 2385123-2 JAC3D14 2385123-2 410871RF 2385123-2 434924UVAP2 2385123-2 256249CVRF 2385123-2 304526PRE1 2385123-2 843784RF 2385123-2 623327RF2 2385123-2 319235500D 2385123-2 606678RF2 2385123-2 507283P500 2385123-2 802674500D 2385123-2 JAC3E63 2385123-2 972665DDARF 2385123-2 314344DR11 2385123-2 804287RF1 2385123-2 757466RM7 2385123-2 757889RM8 2385123-2 320255F3 2385123-2 865458RF2 2385123-2 337948RF1 2385123-2 601288PRF6 2385123-2 225924RF2 2385123-2 586573P500 2385123-2 940764ROOMD 2385123-2 909793P5R6 2385123-2 602867RM1 2385123-2 740454PRE2 2385123-2 909793P5R4 2385123-2 717657PRE1 2385123-2 706733V8 2385123-2 704735P500D 2385123-2 336719NH135 2385123-2 713359RF3 2385123-2 719546P500 2385123-2 251580RF2 2385123-2 804594RM3 2385123-2 251580RF1 2385123-2 614293PRE4 2385123-2 541396RF1 2385123-2 443481RF4 2385123-2 617726PR64A 2385123-2 215538PRE1 2385123-2 775423RF 2385123-2 765348PR 2385123-2 503215P500D 2385123-2 316689RF500 2385123-2 520TMCRF1 2385123-2 573875CRM2 2385123-2 757886RM2 2385123-2 415600PRC1 2385123-2 414805P500 2385123-2 205387WRF6 2385123-2 352331SPINE 2385123-2 260373RF4 2385123-2 205939SVRF1 2385123-2 734712P500 2385123-2 26236",,"816 (722 US, 94 OUS).","GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no injury has been reported due to this.",12/12/2013,"12/12/2013",2/12/2014,"02/12/2014"
"Biologics",67359,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0429-14","Class II","Cryoprecipitated AHF","2522469",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/2/2014,"01/02/2014",3/26/2014,"03/26/2014"
"Biologics",67359,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0428-14","Class II","Red Blood Cells","2522469",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/2/2014,"01/02/2014",3/26/2014,"03/26/2014"
"Biologics",67360,"Terminated","Southern California Permanente Medical Group","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0426-14","Class II","Red Blood Cells Leukocytes Reduced","W702113004590",,"1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",12/12/2013,"12/12/2013",3/26/2014,"03/26/2014"
"Food",67361,"Ongoing","Winn-Dixie Logistics, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","Florida","F-1727-2014","Class I","Winn-Dixie Chocolate Flavored Drink Mix NET WT 30 OZ (1 LB 14 OZ) 851 G Distributed by: Winn-Dixie Stores, Jacksonville, FL 32254 ","Expiration Date JUL1415B",".","29 cases - 348 retail units (30 oz - 12 plastic canisters per case)","Product may contain incorrect formula mixture, which could result in an undeclared milk allergen.",1/20/2014,"01/20/2014",4/9/2014,"04/09/2014"
"Devices",67362,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0918-2014","Class II","Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.","lot 59617777 and 59658495.",,"422","Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.",1/20/2014,"01/20/2014",2/12/2014,"02/12/2014"
"Devices",67363,"Ongoing","Medtronic Navigation, Inc.","Littleton","MA","US","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution","Z-0973-2014","Class II","Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems. ","Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769",,"449 in US","Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)",7/25/2013,"07/25/2013",3/12/2014,"03/12/2014"
"Food",67364,"Ongoing","Bonduelle USA Inc","Oakfield","NY","US","Voluntary: Firm Initiated","E-Mail","AR, IA","F-1691-2014","Class III","Bonduelle USA Inc (Oakfield) BEANS GREEN CUT GRADED, Net weight: 1,480 lbs (bulk form in Totes), Keep frozen. ","Item # 1103805, Lot # A0002813",".","26 totes (Total Net Wt. 38, 480 lbs)","Bonduelle North America has recalled bulk totes of Cut and Whole Green Beans due to the presense of filth. ",1/24/2014,"01/24/2014",4/2/2014,"04/02/2014"
"Food",67364,"Ongoing","Bonduelle USA Inc","Oakfield","NY","US","Voluntary: Firm Initiated","E-Mail","AR, IA","F-1692-2014","Class III","Bonduelle USA Inc (Oakfield) BEANS GREEN WHOLE GRADED, Net weight: 1,100 lbs (bulk form in Totes), Keep frozen. ","Item # 1103905, Lot #'s: A0002962, A0003047",".","87 totes (Total Net Wt. 95,700 lbs) (10 totes remained quarantined in stock)","Bonduelle North America has recalled bulk totes of Cut and Whole Green Beans due to the presense of filth",1/24/2014,"01/24/2014",4/2/2014,"04/02/2014"
"Food",67365,"Ongoing","Charlemagnes Tree Farm Ltd","Craryville","NY","US","Voluntary: Firm Initiated","Letter","NY, ME, MA","F-1651-2014","Class II","HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Hot & Spicy, Net Wt. 14 oz., UPC 7 51122 00092 1, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com","all lots",".","2100 bottles","Charlemagne's Tree Farm, Ltd. dba HUDSON VALLEY HOMESTEAD recalled BUSHWHACKER'S Savory Sauce ''Mild'' and ''Hot & Spicy'' types due to Undeclared Anchovies (fish).",1/31/2014,"01/31/2014",3/19/2014,"03/19/2014"
"Food",67365,"Ongoing","Charlemagnes Tree Farm Ltd","Craryville","NY","US","Voluntary: Firm Initiated","Letter","NY, ME, MA","F-1650-2014","Class II","HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com","all lots",".","2100 bottles","Charlemagne's Tree Farm, Ltd. dba HUDSON VALLEY HOMESTEAD recalled BUSHWHACKER'S Savory Sauce ''Mild'' and ''Hot & Spicy'' types due to Undeclared Anchovies (fish).",1/31/2014,"01/31/2014",3/19/2014,"03/19/2014"
"Biologics",67367,"Terminated","American Red Cross Blood Services","Wichita","KS","US","Voluntary: Firm Initiated","Letter","CA","B-0431-14","Class III","Blood and Blood Products for Reprocessing","02K50984",,"1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",12/9/2013,"12/09/2013",3/26/2014,"03/26/2014"
"Food",67369,"Ongoing","Chicken Soup For The Soul Food","Stamford","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DE, FL, GA, KY, MD, NC,OH, PA, SC, TN, VA, WV, OK and District of Colombia","F-1683-2014","Class II","Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Foods, LLC, Stamford, CT 06902-7532 UPC: 8 19239 01021 2. ","All lot codes",".","2070 cases (12/case)","Product contains undeclared wheat",1/23/2014,"01/23/2014",4/2/2014,"04/02/2014"
"Devices",67370,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOLDOVIA,MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA MONETENO, SINGAPORE, SLOVAKIA, SLOVENIA SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD TOBAGO, TUNISIA, TURKEY, TURKMENISPAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN, and ZIMBABWE.","Z-0982-2014","Class II","GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. ","Parent SN SBG06451608GA SBG06451606GA SBG06451607GA SBG06451638GA SBG06451605GA A4EH1211G A4EH1212G A4EH1251G A4EH1284G A4EH1286G A4EH1287G A4EH1288G A4EH1196G A4EH1197G A4EH1199G A4EH1203G A4EH1204G A4EH1281G A4EH1192G A4EH1193G A4EH1214G A4EH1227G A4EH1228G A4EH1216GR A4EH1219G A4EH1220GR A4EH1291G A4EH1191G A4EH1229G A4EH1230G A4EH1231G A4EH1240G A4EH1245GR A4EH1275G A4EH1264G A4EH1195G A4EH1246G A4EH1247G A4EH1267G A4EH1268GR A4EH1269G A4EH1271G A4EH1200G A4EH1249G A4EH1250G A4EH1254G A4EH1256G A4EH1257G A4EH1258G A4EH1201G A4EH1202G A4EH1222G A4EH1223G A4EH1205G A4EH1206G A4EH1224G A4EH1225G A4EH1226G A4EH3954GR A4EH1356G A4EH1359G A4EH1342G A4EH1343G A4EH1344G A4EH1345G A4EH1346G A4EH3471G A4EH3472G A4EH3475G A4EH3477G A4EH3478G A4EH3479G A4EH3483G A4EH3487G A4EH1334G A4EH1335G A4EH1336G A4EH1351G A4EH1353G A4EH1355G A4EH3461G A4EH3467G A4EH3468G A4EH1347G A4EH1339G A4EH1174G A4EH1175G A4EH1176G A4EH1180G A4EH1166G A4EH1189G A4EH1168G SBG06451639GA SBG06451640GA SBG06451643GA SBG06451645GA SBG06451646GA SBG06451647GA A4EH1172G A4EH1173G A4EH1295G A4EH1296G A4EH1297G A4EH1298G A4EH1299G A4EH1302G A4EH1310G A4EH1326G A4EH1327G A4EH1328G A4EH1304G A4EH1305G A4EH1306G A4EH1308G A4EH1318G SBG06451694GA SBG06451697GA SBG06451695GA SBG06451698GA SBG06451699GA SBG06451700GA SBG06451702GA E3DJ8567G B3DJ5517G B3DJ5145G B3DJ5502G K1DJ5583G D3DJ7826G SBG06451648GA SBG06451650GA SBG06451652GA SBG06451653GA SBG06451654GA SBG06451655GA SBG06451656GA SBG06451657GA SBG06451658GA SBG06451659GA SBG06451662GA SBG06451693GA SD011123114SA SD007387598GA SE511138483GA SD007397748GA DSH05221531GA K3EH7609G SE511138480GA SD008097705GA SD008097711GA AAB04469930GA SD007180035GA SD007241786GA SD007252045GA SD007252072GA SD010117127GA SD011225071SA H3EH4161G A4EH3811GR A4EH3813G A4EH3819G A4EH3820G A4EH3827G A4EH3828G A4EH3829G A4EH3830G A4EH3832G A4EH3833G A4EH3834GR A4EH3838G A4EH3839G A4EH3842G A4EH3846G A4EH3847G A4EH3849G A4EH3857G A4EH3860G A4EH3861G A4EH3862G A4EH3863G A4EH3864G A4EH3866G A4EH3869G A4EH3871G A4EH3872G A4EH3873"," SBG06295444GA SBG06295446GA SBG06295455GA SBG06295456GA SBG06295458GA SBG06295460GA SBG06295461GA SBG06295462GA SBG06295463GA SBG06295464GA SBG06295465GA SBG06295466GA SBG06295493GA SBG06295513GA SBG06295516GA SBG06295527GA SBG06295528GA SBG06295529GR SBG06295549GA SBG06295550GA SBG06295565GA SBG06295566GA SBG06295570GA SBG06305584GA SBG06305585GR SBG06316061GA SBG06316063GA SBG06316070GA SBG06316079GA SBG06316080GA SBG06316081GA SBG06316083GA SBG06316084GA SBG06316085GA SBG06316086GA SBG06316087GA SBG06316088GA SBG06316089GA SBG06316090GA SBG06316091GA SBG06316092GA SBG06316094GA SBG06316095GA SBG06316096GA SBG06316097GA SBG06316098GA SBG06316100GA SBG06316101GA SBG06316104GA SBG06316105GA SBG06316106GA SBG06316107GA SBG06316108GA SBG06316109GA SBG06316110GA SBG06316112GA SBG06316114GA SBG06316115GA SBG06316116GA SBG06316117GA SBG06305649GA SBG06305651GA SBG06305654GA SBG06305656GA SBG06305658GA SBG06305659GA SBG06305664GA SBG06305666GA SBG06305671GA SBG06305673GA SBG06305675GA SBG06305679GA SBG06305680GA SBG06305683GA SBG06305684GA SBG06305685GA SBG06305686GA SBG06305688GA SBG06305690GA SBG06305691GA SBG06305692GA SBG06305693GA SBG06305694GA SBG06305695GA SBG06305697GA SBG06305698GA SBG06305699GA SBG06305700GA SBG06305702GA SBG06305703GA SBG06305704GR SBG06305705GA SBG06305706GA SBG06305707GR SBG06305708GA SBG06305709GA SBG06305711GA SBG06305712GA SBG06305713GA SBG06305714GA SBG06305715GR SBG06305717GA SBG06305718GR SBG06305719GR SBG06305721GA SBG06305722GA SBG06305723GA SBG06305726GA SBG06305727GA SBG06305729GA SBG06305730GA SBG06305731GA SBG06305732GA SBG06305733GA SBG06305734GA SBG06305735GA SBG06305736GA SBG06305737GA SBG06305746GA SBG06305747GA SBG06305750GA SBG06305754GA SBG06305755GA SBG06305756GA SBG06305757GA SBG06305762GA SBG06305763GR SBG06305764GA SBG06305765GA SBG06305766GA SBG06305768GA SBG06305769GR SBG06305771GA SBG06305772GR SBG06305773GA SBG06305774GA SBG06305775GA SBG06305776GR SBG06305778GA SBG06305779GR SBG06305780GA SBG06305781GA SBG06305783GR SBG06305786GA SBG06305789GR SBG06305793GA ","178,711 (92,123 US, 86,588 OUS)","GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE'' CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network. 4. Dash date reverts to 1993. DASH PORT 2: Dash Port 2 stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE'' CIC Pro Central Station*. *Despite communication loss, the Dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage. ",11/27/2013,"11/27/2013",2/26/2014,"02/26/2014"
"Food",67371,"Ongoing","Gotera, Inc","Houston","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, IA, TN, AR, OK, LA, FL, KS, GA","F-1465-2014","Class II","Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email contact@mamalycha.com www.mamalycha.com Product of Honduras","No lot code",,"217 cases","Product contains undeclared wheat",1/23/2014,"01/23/2014",2/12/2014,"02/12/2014"
"Food",67373,"Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Distribution was nationwide. There was no foreign/military/government distribution.","F-1591-2014","Class II","Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefiber Fiber Supplement, On-The-Go Stick Packs, Sugar Free, Clear & Taste-Free, packaged in 8.16-oz. boxes containing 68/0.12-oz. stick packs, UPC 300670176686. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; (2) Benefiber Fiber Supplement, Taste Free, Sugar Free, packaged in 0.36-oz. foil packages containing 3/0.12-oz. stick packs, UPC 300670186036. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; (3) Benefiber Fiber Supplement, Taste Free, Sugar Free, packaged in 0.36-oz. foil packages containing 3/0.12-oz. stick packs, 8/0.36-oz. foil packages clipped together on a strip, UPC 300679110766. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; ","68-ct. boxes - 25574002, 25515001, 25515002, and 25574001, all with exp. dates of 02/2014; 3-ct. packages - 26096201, exp. 07/2014; 26096203, exp. 07/2014; 26096202, exp. 07/2014; and 26248201; exp. 05/2014; 8-package clip pack - 26128701, exp. 07/2014, and 26128702, exp. 07/2014.",,"57,808/68-ct. pkgs., 142,088/3-ct. pkgs., and 11,678/8/3-ct. pkg. clip strips","The products are being recalled due to the receipt of a relatively high number of consumer complaints.",12/18/2013,"12/18/2013",3/5/2014,"03/05/2014"
"Devices",67374,"Ongoing","Mckesson Information Solutions LLC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.","Z-0976-2014","Class II","Horizon Medical Imaging, Picture Archive Communication System (PACS).","HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9. ",".","618 units","Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.",12/23/2013,"12/23/2013",2/19/2014,"02/19/2014"
"Devices",67375,"Ongoing","Hologic, Inc","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of: Canada, France, Germany, and Sweden","Z-1094-2014","Class II","NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. ","Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J13D0 34009J13D0 34011J13D0 33868H13D0 33869H13D0 33870H13D0 33871H13D0 33872H13D0 33873H13D0 33874H13D0 33875H13D0 33876H13D0 33877H13D0 33878H13D0 33879H13D0 33880H13D0 33881H13D0 33882H13D0 33883H13D0 33884H13D0 33885H13D0 33886H13D0 33888H13D0 33889H13D0 33890H13D0 33891H13D0 33892H13D0 33893H13D0 33894H13D0 33895H13D0 33896H13D0 33897H13D0 33898H13D0 33900H13D0 33901H13D0 33902H13D0 33903H13D0 33904H13D0 33948I13D0 33951I13D0 33952I13D0 33953I13D0 33954I13D0 33955I13D0 33956I13D0 33957I13D0 33958I13D0 33959I13D0 33960I13D0 33961I13D0 33962I13D0 33963I13D0 33964I13D0 33965I13D0 33966I13D0 33967I13D0 33968I13D0 33969I13D0 33978J13D0 33979J13D0 33980J13D0 33981J13D0 33982J13D0 33983J13D0 33984J13D0 33990J13D0 33991J13D0 33995J13D0 33997J13D0 33998J13D0 34000J13D0 34001J13D0 34003J13D0 34017K13D0 34021K13D0 34023K13D0 34026K13D0 34027K13D0 34028K13D0 34029K13D0 34031K13D0 34032K13D0 34033K13D0 34035K13D0 34039K13D0 ",,"93 units","NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, ",1/24/2014,"01/24/2014",3/5/2014,"03/05/2014"
"Food",67376,"Ongoing","Kellogg Company","Battle Creek","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors in California, Indiana, Iowa, Michigan, Missouri, Pennsylvania, and Tennessee with further distribution to retail stores nationwide.","F-1476-2014","Class I","Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code 0 38000 84496 6 Ingredients: INGREDIENTS: DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFLOWER OIL), CORN FLOUR, WHEAT STARCH, MALTODEXTRIN, SALT, RICE FLOUR AND DEXTROSE. CONTAINS WHEAT INGREDIENTS Product was placed in 226 display shippers with a variety of Pringles products. PRINGLES US 4-FLV 84ct ALT SHPR UPC 38000 84832 PRINGLES US 3FLV MXD 728/164G PALLET UPC 38000 84620"," individual cans codeL 3269KT70 0830 - L 3269KT70 0930 BEST BY 12/26/2014 Manufacturing Code on Shippers PRINGLES US 4-FLV 84ct ALT SHPR KT 12064C and KT12074A PRINGLES US 3FLV MXD 728/164G PALLET KT 12264",".","~ 75 affected cans w/in the ~ 4,760 produced w/in time frame","Undeclared milk, an allergen ",1/27/2014,"01/27/2014",2/19/2014,"02/19/2014"
"Devices",67377,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and to the country of: Canada.","Z-1115-2014","Class II","CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.","Model(s) 5251, 5261, 525S, 526S: Serial Numbers: 525108626 thru 525108774, 526100851 thru 526100919, 525S100070 thru 525S100081, 526S100037.",,"369 units (all models)","This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.",9/6/2013,"09/06/2013",3/5/2014,"03/05/2014"
"Devices",67377,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and to the country of: Canada.","Z-1117-2014","Class II","XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.","Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050.",,"369 units (all models)","This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.",9/6/2013,"09/06/2013",3/5/2014,"03/05/2014"
"Devices",67377,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and to the country of: Canada.","Z-1114-2014","Class II","PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.","Model 5570. Serial numbers: 557A1100178 thru 557A100206.",,"369 units (all models)","This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.",9/6/2013,"09/06/2013",3/5/2014,"03/05/2014"
"Devices",67377,"Ongoing","Winco Mfg., LLC","Ocala","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and to the country of: Canada.","Z-1116-2014","Class II","DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.","Model(s) 5271, 5281. Serial numbers: 527A101756 thru 527A101816, 528A100187 thru 528A100199.",,"369 units (all models)","This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.",9/6/2013,"09/06/2013",3/5/2014,"03/05/2014"
"Devices",67378,"Terminated","Highland Metals, Inc.","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.","Z-0923-2014","Class II","SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.","Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper ",,"37 packages","Labeling issue: Product labeled as ''Upper'' may contain ''Lower'' archwires with a red midline mark. Product labeled ad ''Lower'' may contain ''Upper'' archwires with a black midline mark.",12/13/2013,"12/13/2013",2/12/2014,"02/12/2014"
"Devices",67378,"Terminated","Highland Metals, Inc.","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.","Z-0922-2014","Class II","SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.","Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper ",,"9 packages of each lot number.","Labeling issue: Product labeled as ''Upper'' may contain ''Lower'' archwires with a red midline mark. Product labeled ad ''Lower'' may contain ''Upper'' archwires with a black midline mark.",12/13/2013,"12/13/2013",2/12/2014,"02/12/2014"
"Food",67379,"Ongoing","Braum's Ice Cream and Dairy","Tuttle","OK","US","Voluntary: Firm Initiated","E-Mail","OK, KS, MO, TX, AR","F-1479-2014","Class I","Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free","Up to and including Best Before 2014AU09, 20140809, 140809",".","930 cases","contains undeclared milk",1/17/2014,"01/17/2014",2/19/2014,"02/19/2014"
"Devices",67380,"Ongoing","Dako North America Inc.","Carpinteria","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA Nationeide and in the country of Chile.","Z-1093-2014","Class II","Product Name: HER2 CISH pharmDx'' Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.","Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 C. Expiration Date: 2014 June 30. ",,"49","Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.",1/21/2014,"01/21/2014",3/5/2014,"03/05/2014"
"Biologics",67381,"Terminated","American Red Cross Greater Alleghenies Region","Johnstown","PA","US","Voluntary: Firm Initiated","Telephone","Arizona; Idaho; Utah","B-0412-14","Class II","Platelets Pheresis Leukocytes Reduced","W2020138071301; W2020138071302; W202013807158; ",".","3","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",12/17/2013,"12/17/2013",4/2/2014,"04/02/2014"
"Biologics",67381,"Terminated","American Red Cross Greater Alleghenies Region","Johnstown","PA","US","Voluntary: Firm Initiated","Telephone","Arizona; Idaho; Utah","B-0411-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W202013807120; ",".","1","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",12/17/2013,"12/17/2013",4/2/2014,"04/02/2014"
"Biologics",67382,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0415-14","Class II","Source Plasma","3740398610; 3740396742; ",".","2 units","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/23/2013,"11/23/2013",4/2/2014,"04/02/2014"
"Food",67383,"Ongoing","Windsor Frozen Foods","Houston","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, WA","F-1480-2014","Class II","Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack","Lot #'s 1024020A and 1023020B (Products also contain a BEST BEFORE NOV 15 14 code, and UPC code 2113010895)",".","2502 cases","product has the potential to be contaminated with Listeria monocytogenes",1/24/2014,"01/24/2014",2/19/2014,"02/19/2014"
"Devices",67384,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Distributed in PA.","Z-0975-2014","Class II","Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. ","510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB",".","one unit","Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.",12/6/2013,"12/06/2013",2/19/2014,"02/19/2014"
"Devices",67385,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.","Z-1123-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients. ","1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310 1000691310 1231001309 1231601309 1000101310 1000401310 1000701310 1231011309 1231311309 1231611309 1000111310 1000411310 1000711310 1231021309 1231321309 1231621309 1000121310 1000421310 1000721310 1231031309 1231331309 1231631309 1000131310 1000431310 1000731310 1231641309 1000141310 1000441310 1000741310 1231051309 1231351309 1231651309 1000151310 1000451310 1000751310 1231061309 1231361309 1231661309 1000161310 1000461310 1000761310 1231071309 1231371309 1000171310 1000471310 1000771310 1231081309 1231381309 1231681309 1000181310 1000481310 1000781310 1231091309 1231391309 1000191310 1000491310 1000791310 1231101309 1231401309 1231701309 1000201310 1000501310 1000801310 1231111309 1231411309 1231711309 1000211310 1000811310 1231121309 1231421309 1231721309 1000221310 1000521310 1000821310 1231131309 1231431309 1000231310 1000531310 1000831310 1231141309 1231441309 1231741309 1000241310 1000541310 1231151309 1231451309 1231751309 1000251310 1000551310 1231161309 1231461309 1231761309 1000261310 1000561310 1231171309 1231471309 1231771309 1000271310 1000571310 1231181309 1231481309 1231781309 1000281310 1000581310 1231191309 1231491309 1231791309 1000291310 1000591310 1231501309 1231801309",,"169 units","Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.",1/28/2014,"01/28/2014",3/12/2014,"03/12/2014"
"Drugs",67386,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1085-2014","Class II","Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland.","Lot #: 13J081, Exp 05/15",".","99 cartons","Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.",12/9/2013,"12/09/2013",2/19/2014,"02/19/2014"
"Devices",67387,"Ongoing","Invivo Corporation","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom.","Z-0983-2014","Class II","Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. ","Model 865471 Lot or serial Numbers: US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, US23200293, US23200294, US23200295, US23200296, US23200297, US23200298, US23200299, US23200300, US23200301, US23200302, US23200303, US23200304, US23200305, US23200306, US23200307, US23200308, US23200309, US23200310, US23200311, US23200312, US23200313, US23200314, US23200315, US23200316, US23200317, US23200318, US23200319, US23200320, US23200321, US23200322, US23200323, US23200324, US232",,"299","Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. ",12/4/2013,"12/04/2013",2/26/2014,"02/26/2014"
"Devices",67388,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1086-2014","Class II","Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.","D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242",,"21 units","Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.",12/18/2013,"12/18/2013",3/5/2014,"03/05/2014"
"Food",67389,"Ongoing","Gano Excel USA Inc","Irwindale","CA","US","Voluntary: Firm Initiated","Press Release","nationwide in US via internet","F-1477-2014","Class I","Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)","Lot: 290712 (290712 MFG July 2012)",".","27,139 units","Gano Excel USA is recalling the C'Real Spirulina because it contains undeclared wheat and soy.",1/29/2014,"01/29/2014",2/19/2014,"02/19/2014"
"Devices",67390,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.","Z-0986-2014","Class II","Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.","part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333. ",,"1,132,096","Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. ",1/27/2014,"01/27/2014",2/26/2014,"02/26/2014"
"Devices",67391,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1174-2014","Class II","Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements. ","All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, and 489.424.",".","18747","Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. ",1/27/2014,"01/27/2014",3/19/2014,"03/19/2014"
"Devices",67392,"Ongoing","Greatbatch Medical","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.","Z-1119-2014","Class I","Greatbatch Medical, Offset Cup Impactor. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA).","all lots",,"4870 worldwide (2482 US)","Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.",1/31/2014,"01/31/2014",3/12/2014,"03/12/2014"
"Drugs",67393,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","Rockford","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide","D-1155-2014","Class III","Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20","Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015",".","3,252 cartons","Failed Impurity/degradation Specification",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Biologics",67394,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Tennessee","B-0416-14","Class II","Fresh Frozen Plasma","W227712350078; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",1/6/2014,"01/06/2014",4/2/2014,"04/02/2014"
"Biologics",67395,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Austria; Texas","B-0409-14","Class II","Red Blood Cells Leukocytes Reduced","W035212147740Z; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",1/22/2014,"01/22/2014",4/2/2014,"04/02/2014"
"Biologics",67395,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Austria; Texas","B-0410-14","Class III","Blood and Blood Products for Reprocessing","W035212147740Z; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",1/22/2014,"01/22/2014",4/2/2014,"04/02/2014"
"Devices",67396,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in MI, TX,and CA.","Z-0992-2014","Class II","Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible."," part No. 03.503.043, lot #7908431",,"12","One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.",1/27/2014,"01/27/2014",2/26/2014,"02/26/2014"
"Food",67397,"Completed","New Horizon Cuisine","Ankeny","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to IA, IL, and MI. There was no foreign/military/government distribution.","F-1697-2014","Class III","New Horizon Cuisine Chicken Demi-Glace Xpress, packaged in 16-oz. plastic cups (6/case) and New Horizon Cuisine Chicken Demi-Glace packaged in 16-lb. (2-gal.) buckets. The firm name on the label is New Horizon Cuisine, Ankeny, IA.","Lot numbers 1062, 1065, and 1068",".","59/16-lb. buckets and 20/6/16-oz. plastic cup cases","Product was manufactured using chicken that was reported to be spoiled by another government agency.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67398,"Terminated","Antigen Laboratories Inc","Liberty","MO","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0414-14","Class III","Bermuda Grass","B29032613; ",".","1 vial","One lot of Standardized Bermuda Grass Pollen Allergenic Extract, with a decreased potency, was distributed. ",1/15/2014,"01/15/2014",2/19/2014,"02/19/2014"
"Drugs",67399,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1084-2014","Class II","Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01","Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14",".","138,970 bottles","Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.",1/14/2014,"01/14/2014",2/19/2014,"02/19/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-0996-2014","Class II","Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. ","Model 78622, Lot numbers: 2011031714, 2011040345, 2011050373, 2011060471, 2011060641, 2011060642, 2011070099, 2011072408, 2011081502, 2011102965, 2011111215, 2011120575, 2012011143, 2012011425, 2012020052, 2012040536, 2012051387, 2012090216, 2012101333 ,2013010957, 2013011791, 2013020303, 2013030729, 2013040209, 2013040282, 2013040710, 2013041272, 2013051447, 2013060736, 2013071836, 2013072009, 201105C105, 201203C854. Model 78722, Lot numbers: 2011031588, 2011031885, 2011051006, 2011051226, 2011061585, 2011071672, 2011082216, 2011091825 , 2011101670, 2011102093, 2011110717, 2011120059, 2012060478, 2012061056, 2012061057, 2012061725, 2012070570, 2012090657, 2013011121, 2013021260, 2013030685, 2013040494, 2013040595, 2013070162, 2013070483, 2013081289, 2013081603, 201108C227. ",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-1000-2014","Class II","Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures. ","Model 3Y90R3, Lot numbers: 12227513, 12277464, 206420618, 206618641, 206842458, 206932996, 207184816. Model C300901B, Lot number 206499164.",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-0999-2014","Class II","Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8'' (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5'' (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.","Lot numbers: 12259014, 206292900, 12011874, 12286525, 12086013, 06867511, 206784461. ",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-0998-2014","Class II","Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. The proximal end features a pressure monitoring line with a 3-way stopcock. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.","Model 78818, Lot Numbers: 2011021826, 2011070534, 2011090245, 2011110207, 2011111844. Model 78820, Lot Numbers: 2011062305, 2011072337. Model 78822, Lot Number: 2011011178 Model 78920, Lot Numbers: 2011050717, 2011082464, 2011120308, 2012070891, 2012071268, 2013081135, 2013121551, 201106C038. Model 78922, Lot Numbers: 2011011187, 2011020121, 2011020785, 2011021532, 2011070801, 2011081266, 2011090483, 2012012160, 2012021436, 2012021695, 2012071735, 2013010416, 2013030273, 2013050807, 2013051036, 2013070174, 2013091410, 2013101028, 201311C767. Model 78924, Lot Numbers: 2011041201, 2011041542, 2011080058, 2011080606, 2011081545, 2011081637, 2011110914, 2012031176, 2012051794, 2012100256, 2012111224, 2013030583, 2013050865, 2013060210. ",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-0997-2014","Class II","Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to a molded, clear, flexible PVC tapered body or wirebound PVC body. The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation. The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap. The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.","Model 78624, Lot numbers: 2011010432, 2011010514, 2011010515, 2011011141, 2011011543, 2011021907, 2011040344, 2011040946, 2011060613, 2011060865, 2011070535, 2011071749, 2011081635, 2011110330, 2011120304, 2011120305, 2011121133, 2012060424, 2012060431, 2012070886, 2012080324, 2012081353, 2012081928, 2012090013, 2012120521, 2012121021, 2012121414, 2013031142, 2013050555, 2013050805, 2013051225, 2013051640, 2013060249, 2013090499, 2013090570, 2013091332, 2013091924, 201106C140, 201203C844, 201310C579. Model 78724, Lot numbers: 2011032145, 2011050718, 2011060852, 2011092067, 2011102225, 2012032345, 2012071614, 2012081704, 2012081973, 2013031364, 2013051818, 2013060581, 2013070831, 2013080858, 2013100654, 2013110548, 2014010275, 201108C228, 201203C842. ",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67400,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.","Z-0995-2014","Class II","Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8'' (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5'' (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.","Model 78618, Lot numbers: 2011041199, 2011062306, 2011100971, 2011102092, 2011120307, 2012051764, 2012061644, 2012080274, 2012110107, 2012120373, 2013010071, 2013050197, 2013081170, 2013102358, 201203C853. Model 78620, Lot numbers: 2011030255, 2011040939, 2011041341, 2011101160 2011111043, 2012011041, 2012020540, 2012070617, 2012110017, 2012111257, 2013031297, 2013050408, 2013060024, 2013060816, 2013070896, 2013090420, 2013091570, 2013101359. Model 78718, Lot numbers: 2011020219, 2011051461, 2011051501, 2011060279, 2011081265, 2011091551, 2011100022, 2011111305, 2012011048, 2012032171, 2012040645, 2012070832, 2012071313, 2013031493, 2013041737, 2013051367, 2013060409, 2013091960, 2013102157, 2013110588, 201110C116, 201203C855. Model 78720, Lot numbers: 2011010067, 2011021825, 2011062606, 2011062607, 2011070536, 2011071117, 2011080605, 2011081029, 2011081501, 2011082463, 2011090046, 2011090047, 2011100092, 2012011142, 2012011424, 2012051863, 2012060210, 2012061344, 2012061868, 2012120133, 2012120781, 2012120941, 2012121072, 2013030331, 2013030943, 2013080633, 2013081206, 2013110894, 2013120553. ",,"19483 total (7669 US, 11814 OUS)","Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. ",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Devices",67401,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.","Z-1078-2014","Class II","GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.","Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2 410392RAD 00000076028HL0 318495WDR1 00000076285HL6 0002952447 00000076286HL4 918579PROTEUS 00000076287HL2 518926FLRM3 00000076288HL0 ORMCP500DIG 00000076290HL6 713791P500FP4 00000076379HL7 518243WDR1 00000076380HL5 504873FP1 00000076381HL3 435722GDXR 00000076487HL8 989224FLSHPD1 00000076489HL4 229924P500 00000076490HL2 405752RF2 00000076643HL6 COR481360 00000076644HL4 713UTPROTEUS 00000076646HL9 518243WDR1 00000076647HL7 706754EF1 00000076648HL5 COR481360 00000076649HL3 518243WDR1 00000076650HL1 918273CNNP1 00000076651HL9 918434P500 00000076652HL7 714827P500 00000076986HL9 325574WDRRM2 00000076990HL1 878WDR 00000076991HL9 919RALCPFLASH2 00000076995HL0 912384FP5 00000076996HL8 540829RF1DR 00000076997HL6 305LEON27FLGD 00000076998HL4 205877BPRF1 00000077642HL7 989224FLSHPD1 00000077644HL3 240566EDWDR1 00000077647HL6 925370PAD 00000077648HL4 603524500D 00000077649HL2 618443SFP 00000077652HL6 540CULRF2 00000077653HL4 501202WDR14 00000078002HL3 760873FP2 00000078196HL3 318259RM2 00000078201HL1 757736WDR1 00000078669HL9 419538RAD 00000078670HL7 601928PXR 00000078671HL5 512LRMCRF 00000079045HL1 417347P500 00000079046HL9 608364PRFPCL 00000079047HL7 218828WDR1 00000079048HL5 269637FP 00000079049HL3 281274P5DGR 00000079457HL8 501202BNLER 00000079460HL2 507434DR1 00000079461HL0 570455GDXR 00000079662HL3 312CMP500D2 00000079663HL1 330841AND 00000080016HL9 724285WDR 00000080196HL9 325574WDRRM1 00000080556HL4 315425A320WDR1 00000080560HL6 301874UBWDR1",,"359 (333 US, 26 OUS).","GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient. If the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file.",1/20/2014,"01/20/2014",3/5/2014,"03/05/2014"
"Food",67402,"Ongoing","YoungYou International Inc","Tarzana","CA","US","Voluntary: Firm Initiated","Press Release","US and Canada.","F-1541-2014","Class II","Mega Slim Herbal Appetite Management, 30 Capsules Bottle. Product labeling reads in part:''MEGASLIM Herbal Appetite Management***30 Capsules***YoungYou Weight Loss Center***MegaSim Propriety Blend 590 mg, Garcinia Cambogia Extract, Green Tea, Aloe Ferox, L-Carnitine, Caralluma fimbriata Extract***Distributed by YoungYou International Inc. Earth Creation, USA (877) 496-8649 www.youngyoucorp.com***''. ","No Lot Codes. Product sold/distributed September 15, 2013 through January 23, 2014. UPC code 7 36211 61409. Expiration date June 2014.",,"27 bottles","YoungYou International is voluntarily recalling Mega Slim Herbal Appetite Management, 30 capsules, sold from September 15, 2013 through January 23, 2014, because it was found to contain DMAA.",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Food",67403,"Ongoing","Savory Foods, Inc.","Grand Rapids","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Michigan, Vermont, California, Georgia","F-1652-2014","Class II","MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable Oil, Egg or Vegetable Albumen , Salt, Natural and Artificial Flavors and Certified Food Colors. Fruits Contain Sulfur Dioxide, Savory Foods, Inc. Grand Rapids, MI 49507 SIGNATURE ASSORTMENT 5PC, 3 oz UPC 733549030336 SIGNATURE ASSORTMENT 12PC-7OZ PINK BOX UPC 733549030343 CANDY-8OZ HEART BOXED ASSORTED CHOCOLATES 14.0 0Z BOX M CHOCOLATES SIGNATURE ASSORTMENT 13.0 OZ BOX M CHOCOLATES GRAND TRUFFLE ASSORTMENT 14 oz asstd UPC 733549030350 19 oz asstd UPC 733549030367 25 oz asstd UPC 733549030442 CANDY-CANDY-CANDY-GRAND TRUFFLE ASSTD 4 PC CANDY-GRAND TRUFFLE ASSTD 9 PC CANDY-ASSORTED SNAPPERS 5PC-5OZ PINK BOX Pictured Label placard on all boxes, all varieties: Mary Ann's Chocolates Signature Assortment: Lemon Creme Milk; Cherry Cordial Milk Raspberry Cream Milk, Tiramisu Truffle Dark, Caramel Milk/Dark Raspberry Truffle Dark, Almond Cluster Milk/Dark Chocolate; Coconut Cluster Milk, Chocolate Insanity Truffle Dark, Peanut Cluster Milk, Coconut Creme Milk, Maple Cream Milk, Pecan Cluster Milk, Irish Creme Truffle Dark","No manufacturing codes",".","~3424 all varieties","The ingredient panel for assorted chocolates did not identify peanuts and specific tree nuts (almond, walnut, pecan, pistachio, cashew, macadamia and coconut). The source of lecithin was not identified as soy and lakes yellow 5, lakes yellow 6, red 3, red 40 and blue lake 1 were not identified as ingredients.",1/27/2014,"01/27/2014",3/19/2014,"03/19/2014"
"Devices",67404,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.","Z-1066-2014","Class II","Reflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.","Batch No. 13EM03053",,"10 units","Inner spherical radius of the shell is undersized.",1/23/2014,"01/23/2014",3/5/2014,"03/05/2014"
"Devices",67405,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY, TX, ID, AR, CA and AL","Z-1073-2014","Class II","NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.","Lot Number: F113662",,"969 cases (2 bags per case)","Mislabeled product. ",1/24/2014,"01/24/2014",3/5/2014,"03/05/2014"
"Devices",67406,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldide Distribution - USA (nationwide) amd Internationally to: ARAB EMIRATES, AUSTRIA, AUSTRALIA, BANGLADESH, BELGIUM, BULGARIA, BRAZIL, CHINA, COLUMBIA, COSTA RICA, CZECH REPUBLIC, DOMINIACAN REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, INDA, ITALY, JAPAN, KUWAIT, LYBIA, LATVIA, MACEDONIA, MEXICO, MAYLAYSIA, NETHERLANDS, PAKISTAN, PHILLIPINES, POLAND, PORTUGAL, QUWAIT, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, TUNISIA AND VIETNAM.","Z-0994-2014","Class II","Integra Cusa Excel Rx Only CEM'' Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently. ","All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM'' Nosecone, Catalogue No. C6623: 1083655, 1084219, 1084398, 1084399, 1084400, 1084682, 1084683, 1090937, 1091712, 1091714, 1091715, 1093125, 1093126, 1093128, 1093129, 1093471, 1093847, 1094575, 1094740, 1095587, 1095873, 1100237, 1100238, 1101217, 1101547, 1101548, 1102069, 1102070, 1102544, 1102545, 1102546, 1103102, 1103392, 1103444, 1103445, 1103446, 1104264, 1104265, 1105065, 1105066, 1105067, 1110208, 1110311, 1110348, 1110349, 1110473, 1110474, 1110892, 1111760, 1112182, 1112808, 1112809, 1113175, 1113176, 1113177, 1113178, 1113662, 1114112, 1114654, 1114655, 1114656, 1115224, 1115225, 1115499, 1115500, 1115501, 1115853, 1115854, 1120771, 1120772, 1120773, 1120774, 1121141, 1121142, 1121383, 1121627, 1121628, 1122257, 1122259, 1122260, 1123050, 1123312, 1123915, 1124642, 1124643, 1124980, 1125393, 1125394, 1125933, 1130036, 1130037, 1130038, 1130039, 1130218, 1130219, 1130663, 1130664, 1131340, 1131344, 1131986, 1132207, 1132326, 1132327, 1132328, 1132880 CEM'' Nosecone, Catalogue No. C6636: 1084216, 1084293, 1084377, 1084680, 1084681, 1090123, 1090124, 1090125, 1090126, 1090660, 1090661, 1090826, 1091395, 1091434, 1091700, 1092388, 1092389, 1092390, 1092391, 1092392, 1093012, 1093013, 1093130, 1093131, 1093472, 1093473, 1093474, 1093824, 1093825, 1093826, 1093827, 1094741, 1095104, 1095105, 1095106, 1095414, 1095415, 1095418, 1095419, 1100239, 1100240, 1100241, 1101220, 1101221, 1102647, 1102648, 1102649, 1102650, 1102651, 1103103, 1103394, 1103395, 1103437, 1103848, 1103851, 1103916, 1103917, 1103919, 1103920, 1103921, 1103922, 1104258, 1104259, 1104260, 1104261, 1104262, 1105068, 1105069, 1105070, 1110333, 1110975, 1110976, 1110977, 1111491, 1111492, 1111493, 1112186, 1112187, 1112211, 1112212, 1112769, 1112770, 1112771, 1113180, 1113181, 1113182, 1113183, 1113184, 1113664, 1113665, 1113666, 1114358, 1114359, 1114657, 1114658, 1114659, 1114660, 1115036, 1115037, 1115038, 111",,"17253 boxes","The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.",12/5/2013,"12/05/2013",2/26/2014,"02/26/2014"
"Food",67407,"Ongoing","Unified Grocers Inc.","City Of Commerce","CA","US","Voluntary: Firm Initiated","Letter","CA, AZ, and NV","F-1556-2014","Class I","Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359","Best By Date: SEP 23 14",,"482 cases","Unified Grocers is recalling special value ginger snap cookies because it was mislabeled and it contains undeclared egg.",1/30/2014,"01/30/2014",3/5/2014,"03/05/2014"
"Veterinary",67408,"Completed","Zoetis Inc","Florham Park","NJ","US","Voluntary: Firm Initiated","Telephone","US: IA","V-062-2014","Class III","Cattlyst 50G is a Type A Medicated Article packaged in 50 lb (22.68 kg) multiwall paper bag with protective barrier ply.","Lot Number: HC220009; Expiries: October 2015",".","17 bags","Lot HC220009 was mislabeled with the manufacturing date and the expiration dates inverted.",12/18/2013,"12/18/2013",5/14/2014,"05/14/2014"
"Biologics",67409,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","IA","B-0446-14","Class II","Platelets Pooled Leukocytes Reduced","W044114003315",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",1/20/2014,"01/20/2014",3/26/2014,"03/26/2014"
"Biologics",67410,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-0445-14","Class II","Red Blood Cells","W038113338931",,"1 unit","Blood products, routine testing/testing performed, interpreted, or documented incorrectly, was distributed.",1/14/2014,"01/14/2014",3/26/2014,"03/26/2014"
"Biologics",67411,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0363-14","Class III","Cryoprecipitated AHF, Pooled","W038113986219; W038113986203; W038113986180; W038113986151; W038113986204",,"5 units","Blood products, not manufactured in accordance to current Good Manufacturing Practices, were distributed.",1/8/2014,"01/08/2014",3/26/2014,"03/26/2014"
"Drugs",67412,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1095-2014","Class II","Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.","Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.",,"35746 capsules","CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Drugs",67412,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1092-2014","Class II","Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.","Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16. ",,"10405 tablets","CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Drugs",67412,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1093-2014","Class II","Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 ","Lot # 34017426A, Exp. 10/16. ",,"2494 capsules","CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Drugs",67412,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1094-2014","Class II","Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02. ","Lot # 34017575A, Exp. 10/16. ",,"9796 tablets","CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. ",1/24/2014,"01/24/2014",3/12/2014,"03/12/2014"
"Devices",67415,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.","Z-1112-2014","Class II","Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.","Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015",,"44/10/500-ml. vial boxes","The product may contain high levels of microbial contamination ",1/24/2014,"01/24/2014",3/5/2014,"03/05/2014"
"Devices",67416,"Ongoing","Golden Technologies, Inc.","Old Forge","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-1235-2014","Class II","Buzzaround XL scooters' Product Usage: mobility","GB 116 and GB146 series, with multiple serial numbers",,"5044","Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw. ",1/21/2014,"01/21/2014",3/26/2014,"03/26/2014"
"Veterinary",67417,"Ongoing","Sogeval Laboratories Inc","Oldsmar","FL","US","Voluntary: Firm Initiated","E-Mail","USA: FL, KY, MI, MN, OH, TX, WA.","V-057-2014","Class III","***Joint Support for Dogs***SYNOVIAL-FLEX SOFT CHEWS***TRP*Advanced Soft Chew Technology***Combining Glucosamine HCl, MSM, Creatine Monohydrate, Perna Canaliculus, Omega-3 Fatty Acids and Antioxidants in a Palatable Liver Flavored Chew***SOGEVAL***Shared solutions***Net Content: Contains 120 soft chews***","Model # FNGL9002120, Lot # 52070-1 exp 12/2015.",".","77","Consumer complaint of the smell of their Synovial Flex Soft Chews associated with Joint Max Double Strength soft chews that were inadvertently mislabeled as Synovial Flex Soft Chews. ",1/29/2014,"01/29/2014",3/19/2014,"03/19/2014"
"Devices",67418,"Ongoing","Leica Biosystems Imaging, Inc.","Vista","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH.","Z-1152-2014","Class II","plastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. Note: The IHC ER and PR Image Analysis applications are an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of estrogen and progesterone receptor proteins. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores. IHC PR Breast Tissue Manual Read of Digital Slides: The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The ScanScope system is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. ","23elHCKIT2500, 23elHCKIT5000, 23elHCKIT500.",".","78","In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. As a result, we are including with this notice updated manuals for the image analysis algorthithms listed above so that the intended use in the hardware and software manuals is consistent.",2/7/2014,"02/07/2014",3/19/2014,"03/19/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1179-2014","Class III"," SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04","13F015C exp. 12/14.",".","4,142 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1174-2014","Class III","Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04 ","12J030C exp. 03/14, 12L041C exp. 05/14",".","14,226 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1175-2014","Class III"," Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04","13D010A exp. 10/14.",".","8,734 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1178-2014","Class III","ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20","13F015B exp. 12/14, 13G023B exp. 01/15",".","13,379 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1177-2014","Class III"," ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04","13E014A exp. 11/14, 13F02C exp 12/14.",".","7,292 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1180-2014","Class III"," SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04","13F016A exp. 12/14.",".","7,676 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1173-2014","Class III","DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20","12H028B exp. 01/14",".","4,080 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1176-2014","Class III"," ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04 ","13E013A exp. 11/14.",".","8,734 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Drugs",67420,"Ongoing","Hill Dermaceuticals, Inc.","Sanford","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1181-2014","Class III","SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20","13F017B exp. 12/14, 13F020B exp 12/14",".","13,591 bottles","Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Devices",67421,"Ongoing","MEDICAMAT S.A.","Malakoff",,"FR","Voluntary: Firm Initiated","Letter","US Distribution including TX.","Z-1129-2014","Class II","Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.","Serial numbers of units distributed from October 16, 2012 to December 18, 2013: 189,190,191,192,193,207,208,209,210,211,212,213,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,235,236,237,238,244,245,246,247,248,249,264,265,266,267,268,269,270,271,272,273,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299.",,"71 units","Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.",2/18/2013,"02/18/2013",3/12/2014,"03/12/2014"
"Food",67422,"Ongoing","Mid Pac Foods, Inc.","Honolulu","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI,, CA. NV","F-1539-2014","Class II","Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by Mid Pac Foods, Inc. Honolulu, HI.","Lots 10204 and 10247",,"400 cases (12 units per case)","Inspection at firm found that sauce for Char Siu declares Hoisin sauce as an ingredient, but does not declare the sub ingredient of wheat.",1/30/2014,"01/30/2014",2/26/2014,"02/26/2014"
"Food",67423,"Terminated","K-Fat Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York and New Jersey","F-0460-2015","Class I","KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC. 13 MEADOW STREET, BROOKLYN, NY 11206, USA TEL: 718-381-0306 FAX: 718-381-0089 --- The product is packed in a clear, hard plastic container.","UPC 8 935001 201304 and no other coding",,"75 cases (24 x 8.8 oz containers)","The product was found to contain undeclared sulfites (268.8 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.",2/3/2014,"02/03/2014",11/12/2014,"11/12/2014"
"Devices",67424,"Ongoing","Invivo Corporation","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.","Z-1096-2014","Class II","Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters. ","US23200113, US23200120, US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, US232",,"271","Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use.",10/3/2013,"10/03/2013",3/5/2014,"03/05/2014"
"Food",67425,"Terminated","Humei Trading Inc.","Jamaica","NY","US","Voluntary: Firm Initiated","Press Release","Flushing, NY","F-2085-2014","Class I","Humei Foods DRIED LILY, Net Wt. 340 g 12 oz +- 5 g -- PRODUCT OF CHINA --- Firms on label: Shanghai Dingmei International Trade Co., LTD, Add: Room 516B, No. 1218, Walma Road, Shanghai, China 200011 Tel: 86 21 33761911 Fax: 86 21 33761933 -- Shanghai Huipu Food Co., LTD, Add: No. 4545, Daye Highway, Fengxian, Shanghai, China 201404 Tel: 86 21 57488229 Fax: 86 21 57489557 -- Distributed By: Humei Trading INC (New York), Add: 1811 Neck Road, Brooklyn, NY 11229 Tel: 1 646 708 6758 --- Nutrition Facts: Serving Size 50 g, Serving About 3","No coding",,"30 x 12 oz. packages","The product contained undeclared sulfites (409.1 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.",2/3/2014,"02/03/2014",7/16/2014,"07/16/2014"
"Drugs",67426,"Ongoing","Caraco Pharmaceutical Laboratories Ltd.","Cranbury","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1081-2014","Class II","Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI.... ","Lot #: JKM7075A, Expiry:10/15",".","7005 bottles","Failed Tablet Specifications: Broken Tablets Present.",1/29/2014,"01/29/2014",2/19/2014,"02/19/2014"
"Devices",67427,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma) NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN","Z-1110-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC","MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028",,"58466 units","HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Biologics",67428,"Terminated","Arup Laboratories, Inc.","Sandy","UT","US","Voluntary: Firm Initiated","Visit","UT","B-0447-14","Class II","Platelets Pheresis Leukocytes Reduced","W158013703093; W158013703093; W158013703093; W158013703098; W158013703105; W158013703105; W158013703109; W158013703109; W158013703115; W158013703115; W158013703119; W158013703119; W158013703124; W158013703131; W158013703139; W158013703139; W158013703144; W158013703144; W158013703148; W158013703153; W158013703155; W158013703155; W158013703159; W158013703164; W158013703168; W158013703168; W158013703168; W158013703170; W158013703175; W158013703179; W158013703179; W158013703188; W158013703189; W158013703189; W158013703194; W158013703195 ",,"36 units","Blood products, which did not meet the acceptable product specifications, were distributed.",12/30/2013,"12/30/2013",3/26/2014,"03/26/2014"
"Devices",67429,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Canada, AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and YEMEN.","Z-1090-2014","Class II","HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.","Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020 ",,"39,128","A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.",2/18/2014,"02/18/2014",3/5/2014,"03/05/2014"
"Devices",67430,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, NS, NO, NE, NH, NH, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and WY., and the countries of : AUSTRALIA, CANADA, AUSTRIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, CHINA, COSTA RICA, CYPRUS, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, JAPAN, MALAYSIA, MEXICO, NAMBIA, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM, SERBIA AND YUGOSLAVIA.","Z-1147-2014","Class II","GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both th","Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR F1RF6114GR F1RF6118GR F1RF6123GR F1RF6130GR F1RF6227GR F1RF6236G F1RF6236GR F1RF6243GR F1RF6282GR F2G40578G F2G40579G F2G40580G F2G40581G F2G40584G F2G40585G F2G40586G F2G40588G F2G40592G F2G40593G F2G40594G F2G40595G F2G40596G F2G40598G F2G40599G F2G40605G F2G40606G F2G40607G F2G40609G F2G40610G F2G40611G F2G40615G F2G40631G F2G40705G F2G40820G F2G40835G F2RF3572G F2RF3640G F2RF3651G F3G45957G F3G45980G F3G46200G F43S0355G F43S0356G G0RF0516GR G0RF0592GR G0RF0596GR G1RF6518G G1RF6544G G1RF6546G G3G46241G G3G46616G G3G46649G G3G46664G G3G46674G G3G46679G H0RF0607GR H0RF0772G H0RF0845GR H2G41289G H2G41307G H2G41571GR H2G41786G H2G41787G H2RF4002GR J0RF0465G J0RF1103G J1RF7280G J1RF7281G J1RF7282G J1RF7283G J1RF7284G J1RF7285G J1RF7286G J1RF7289G J1RF7290G J1RF7298G J1RF7387G J2G42049G J2G42100GR J33T0400G J43S0499G J43S0503G J43S0504G J43S0506G J43T5719G J43T5720G J43T5727G J43T5731G J43T5799G J43T5801G J43T5810G J43T5812G J43T5813G J43T5814G J43T5815G J43T5827G J43T5831G J43T5832G J43T5877G J43T6078G K1RF7644G K1RF7673G K1RF7674G K1"," SE409513813GA SE409513815GA SE409513815GR SE409513817GA SE409513818GA SE409513821GA SE409513822GA SE409513824GA SE409513825GA SE409513826GA SE409513832GA SE409513833GA SE409513834GA SE409513836GA SE409513839GA SE409513839GR SE409513843GA SE409513846GA SE409513848GA SE409513849GA SE409513850GA SE409513851GA SE409513852GA SE409513853GA SE409513854GA SE409513855GA SE409513856GA SE409513857GA SE409513858GA SE409513859GA SE409513860GA SE409513861GA SE409513862GA SE409513863GA SE409513864GA SE409513865GA SE409513866GA SE409513867GA SE409513869GA SE409513870GA SE409513873GA SE409523874GA SE409523875GA SE409523876GA SE409523884GA SE409523885GA SE409523886GA SE409523887GA SE409523888GA SE409523890GA SE409523894GA SE409523896GA SE409523899GA SE409523900GA SE409523901GA SE409523903GA SE409523905GA SE409523907GA SE409523911GA SE409523912GA SE409523914GA SE409523915GA SE409523916GA SE409523917GA SE409523918GA SE409523919GA SE409523920GA SE409523922GA SE409523923GA SE409523934GA SE409523935GA SE409523938GA SE409523939GA SE409523942GA SE409524026GA SE409524030GA SE409524031GA SE409524038GA SE409524039GA SE409534040GA SE409534042GA SE409534043GA SE409534044GA SE409534046GA SE409534047GA SE409534050GA SE409534051GA SE409534053GA SE409534054GA SE410024117GA SE410024140GA SE410024141GA SE410024161GA SE410024162GA SE410024164GA SE410024176GA SE410024177GA SE410024178GA SE410024179GA SE410024180GA SE410024181GA SE410024183GA SE410024184GA SE410024186GA SE410024188GA SE410024191GA SE410024194GR SE410024197GA SE410024198GA SE410024203GA SE410024206GA SE410024212GA SE410024220GA SE410024225GA SE410024227GA SE410024229GA SE410024231GA SE410024234GA SE410024235GA SE410024243GR SE410024245GA SE410024272GA SE410034327GA SE410034330GA SE410034332GA SE410034333GA SE410034337GA SE410034338GA SE410034354GA SE410034391GA SE410034406GA SE410034413GA SE410034420GA SE410034421GA SE410034426GA SE410034430GA SE410034443GA SE410044469GA SE410044473GA SE410044474GA SE410044475GA SE410054491GA SE410054523GA SE410054526GA SE410054528GA SE410054529GA ","10,211 (7,549 units US, 2,662 units OUS)","GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AVOA alarms will not automatically appear on the left side of the Solar display. In addition, the user interface menus on the discharged patient monitor will not function correctly. This may result in delayed treatment due to missed alarms that may be serious.",2/13/2014,"02/13/2014",3/12/2014,"03/12/2014"
"Food",67431,"Ongoing","Deb-El Food Products, LLC.","Elizabeth","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, MA, NJ & NY; Canada, Mexico, Denmark, Costa Rica","F-1608-2014","Class I","Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206","Lot 1573, 1873, 1843 , 2073 (which was repackaged into 3253 and 3263), & 3273",,"165,684.70 lbs.","Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk.",1/20/2014,"01/20/2014",3/12/2014,"03/12/2014"
"Drugs",67432,"Ongoing","RX South LLC DBA RX3 Pharmacy","Chester","VA","US","Voluntary: Firm Initiated","Letter","Product was distributed in Virginia and Maryland.","D-1164-2014","Class II","Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** ","Lot number: 12052013:03 Expiration date: 06/03/2014 ",,"250 syringes","Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping",1/28/2014,"01/28/2014",3/26/2014,"03/26/2014"
"Drugs",67433,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1089-2014","Class II","Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02","Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016 ",,"2528 bottles","Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER",1/28/2014,"01/28/2014",3/5/2014,"03/05/2014"
"Drugs",67434,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1097-2014","Class III","Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.","Lot #: 151631, Exp 10/15 and 152767, Exp 11/15",,"43,921 bottles","Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.",2/4/2014,"02/04/2014",3/12/2014,"03/12/2014"
"Devices",67435,"Ongoing","AlterG, Incorporated","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.","Z-1131-2014","Class II","Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.","Product M320, Accessory Shorts with lot numbers XIN1212 and XIN0413.",,"2221 devices","Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.",1/28/2014,"01/28/2014",3/12/2014,"03/12/2014"
"Devices",67436,"Ongoing","Focus Diagnostics Inc","Cypress","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.","Z-1144-2014","Class II","Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.","Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.",,"2,175 kits","Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. ",2/4/2014,"02/04/2014",3/12/2014,"03/12/2014"
"Devices",67437,"Ongoing","Boston Scientific Corporation","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.","Z-0971-2014","Class II","Boston Scientific, Coyote'' MONORAIL'' PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151. ","16310947 ",".","35 for both products","Boston Scientific is initiating this Recall Removal of one lot of the Coyote'' OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote'' MONORAIL'' PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.",2/4/2014,"02/04/2014",2/19/2014,"02/19/2014"
"Devices",67437,"Ongoing","Boston Scientific Corporation","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.","Z-0969-2014","Class II","Boston Scientific, 2.5mm Coyote'' OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. ","16397693",".","35 for both products.","Boston Scientific is initiating this Recall Removal of one lot of the Coyote'' OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote'' MONORAIL'' PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.",2/4/2014,"02/04/2014",2/19/2014,"02/19/2014"
"Devices",67438,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC, KUWAIT, LATIVA, LEBANON, LIBYAN ARAB, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERAL, SAUDIA ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE, THAILAND, TRINIDAND AND TABAGO, TUNISIA, TURKEY, TURKMENISTANIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIETNAM.","Z-1120-2014","Class II","HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician","Serial numbers: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P ",,"43,792 batteries","Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source",2/18/2014,"02/18/2014",3/5/2014,"03/05/2014"
"Devices",67439,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","Z-1193-2014","Class III","VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.","0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110",".","1554 units domestically","Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs. ",1/15/2014,"01/15/2014",3/19/2014,"03/19/2014"
"Devices",67440,"Terminated","Carl Zeiss Meditec AG","Jena",,"DE","Voluntary: Firm Initiated","Letter","US Distribution: NV only.","Z-1153-2014","Class II","Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.","P/N 1462-333, Size M, Lot # M130010",".","1 package containing 10 individual treatment packs","Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.",2/3/2014,"02/03/2014",3/19/2014,"03/19/2014"
"Devices",67441,"Ongoing","Roche Molecular Systems, Inc.","Branchburg","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1111-2014","Class II","cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas PCR Female Swab Kit, cobas PCR Urine kit, and cobas PCR media 100 T kit. -The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas CT/NG Test. - The cobas PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas CT/NG Test. ","K110923 cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884) IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches ",,"84 kit batches","Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from different lots of the cobas PCR Urine kits, cobas PCR Female Swab kits, and cobas PCR media kits.",1/6/2014,"01/06/2014",3/5/2014,"03/05/2014"
"Devices",67442,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.","Z-1134-2014","Class II","DeRoyal(R) ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries, 200 DeBusk Lane, Powell, TN 37849","lot numbers 33347799, 33444071, and 33423747",,"2504 units ","Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. ",1/16/2014,"01/16/2014",3/12/2014,"03/12/2014"
"Devices",67444,"Ongoing","Mako Surgical Corporation","Plantation","FL","US","Voluntary: Firm Initiated","Letter","Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.","Z-1132-2014","Class II","Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. ","Part Number #180704-1, Lot #12151013-1.",,"41 units","The product may be mislabeled and could result in the incorrect implant being used.",1/9/2014,"01/09/2014",3/12/2014,"03/12/2014"
"Devices",67445,"Ongoing","Cardiovascular Systems, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.","Z-1095-2014","Class III","CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.","Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.",,"318","Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. CSI is taking this action to remove the subject units from distribution in order to correct the error in the device build. These saline lines are in use with peripheral Orbital Atherectomy Device (OAD); therefore, there is no patient risk associated with this recall.",1/27/2014,"01/27/2014",3/5/2014,"03/05/2014"
"Devices",67446,"Ongoing","Implantech Associates Inc","Ventura","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.","Z-1063-2014","Class II","Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.","Catalog Number SLV634, Lot Number 852766.",,"300","Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.",1/29/2014,"01/29/2014",2/26/2014,"02/26/2014"
"Devices",67447,"Ongoing","Veridex, LLC","Raritan","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-1195-2014","Class II","CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS AUTOPREP System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.","First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024 ",".","19 units","Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.",1/8/2014,"01/08/2014",3/19/2014,"03/19/2014"
"Food",67448,"Ongoing","Nutra Balance Products","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","TX, IN, MN, NJ, NY, VA, CA","F-1700","Class II","Thickened Water Nectar Thick 32 oz. (944ml) Phase 1 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate, Citric Acid.","3310133 Best By Date: 11/06/2015 Best By Date: 07/30/2015 Best By Date: 05/02/2015 ",".","5518","NUTRA Balance Thickened Water Nectar Thick was found by the FDA to contain mold. In addition, Thickened Water Pudding thick was sampled by Nutra Balance Products and it subsequently tested positive for Enterobacter sp. and Xanthomonas sp.",12/19/2013,"12/19/2013",4/2/2014,"04/02/2014"
"Food",67448,"Ongoing","Nutra Balance Products","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","TX, IN, MN, NJ, NY, VA, CA","F-1699-2014","Class II","Thickened Water Pudding Thick 32 oz. (944ml) Phase 3 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate.","3310133 Best By Date: 11/06/2015 ",".","432","NUTRA Balance Pre-Thickened Water was found to contain mold.",12/19/2013,"12/19/2013",4/2/2014,"04/02/2014"
"Biologics",67449,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","Letter","Hawaii","B-0448-14","Class II","Red Blood Cells Leukocytes Reduced","W088413545499; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",1/20/2014,"01/20/2014",4/2/2014,"04/02/2014"
"Biologics",67450,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; Switzerland","B-0450-14","Class II","Red Blood Cells","W036808185457; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67450,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida; Switzerland","B-0451-14","Class III","Blood and Blood Products for Reprocessing","W036808185457; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67451,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0433-14","Class II","Red Blood Cells Leukocytes Reduced","W333613106336",".","1 unit","Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count for leukoreduced products, was distributed.",12/24/2013,"12/24/2013",3/19/2014,"03/19/2014"
"Biologics",67452,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Switzerland, Mississippi","B-0436-14","Class II","Red Blood Cells Leukocytes Reduced","W069113134332",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/13/2013,"12/13/2013",3/19/2014,"03/19/2014"
"Biologics",67452,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Switzerland, Mississippi","B-0437-14","Class III","Recovered Plasma","W069113134332",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",12/13/2013,"12/13/2013",3/19/2014,"03/19/2014"
"Devices",67453,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.","Z-1702-2014","Class II","LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.","List Number: 02507; Serial Numbers: All.",,"List Number 02507: 132,889 pumps","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",6/11/2014,"06/11/2014"
"Devices",67453,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.","Z-1703-2014","Class II","Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.","List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All.",,"List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859: 147,399 pumps","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",6/11/2014,"06/11/2014"
"Devices",67453,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.","Z-1704-2014","Class II","Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.","List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.",,"List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846: 22,671 pumps","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",6/11/2014,"06/11/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1135-2014","Class II","PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.","Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1140-2014","Class II","PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot # 2410919",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1141-2014","Class II","PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot #'s 2367883, 2383868, 2397882, 2410914",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1136-2014","Class II","PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.","Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871 ",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1142-2014","Class II","PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot # 2410918",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1138-2014","Class II","PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot #'s 2373869, 2375897, 2382870, 2397889, 2410932",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1139-2014","Class II","PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot #'s 2383867, 2397883",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Devices",67454,"Ongoing","KCI USA, INC.","San Antonio","TX","US",,"Visit","USA Nationwide Distribution","Z-1137-2014","Class II","PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. ","Kit Lot #'s 2373868, 2397890, 2407867, 2410931, 2417878, 2417880",,"20,850 units total","Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing",1/30/2014,"01/30/2014",3/12/2014,"03/12/2014"
"Food",67455,"Ongoing","Creation Gardens","Louisville","KY","US","Voluntary: Firm Initiated","Telephone","Product was distributed to the following states: IN, KY and TN","F-1561-2014","Class II","Creation Special Snack Mix 25 lb plastic bags in a cardboard box. Box labeled ''DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405'' with a white stick on label which reads, ''25# CREATION SPECIAL MIX","All product and lot codes.",,"30 cs/25 lb plastic bags","During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.",1/31/2014,"01/31/2014",3/5/2014,"03/05/2014"
"Food",67455,"Ongoing","Creation Gardens","Louisville","KY","US","Voluntary: Firm Initiated","Telephone","Product was distributed to the following states: IN, KY and TN","F-1560-2014","Class II","Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405 with a white stick on label which reads, ''25# BAR STAR MIX","All product and lot codes",,"271/1 lb plastic bags + 41 cs/25 lb plastic bags","During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.",1/31/2014,"01/31/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1584-2014","Class II","''***Brazo gitano (rolled cake)***strawberry filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1580-2014","Class II","''***Brazo gitano (rolled cake)***bavarian cream cake filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1572-2014","Class II","''***Brazo gitano (rolled cake)***pineapple paste filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1583-2014","Class II","''***Brazo gitano (rolled cake)***mango-cheese filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1575-2014","Class II","''***Brazo gitano (rolled cake)***guava paste filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1578-2014","Class II","''***Brazo gitano (rolled cake)***cheese filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1573-2014","Class II","''***Brazo gitano (rolled cake)***pumpkin paste filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1574-2014","Class II","''***Brazo gitano (rolled cake)***pistachio filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1577-2014","Class II","''***Brazo gitano (rolled cake)***mango filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1586-2014","Class II","''***Brazo gitano (rolled cake)***coconut-pineapple filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1588-2014","Class II","''***Brazo gitano (rolled cake)***pineapple-cheese filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1576-2014","Class II","''***Brazo gitano (rolled cake)***coconut filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1585-2014","Class II","''***Brazo gitano (rolled cake)***chocolate filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1581-2014","Class II","''***Brazo gitano (rolled cake)***lemon filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1587-2014","Class II","''***Brazo gitano (rolled cake)***papaya-cheese filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1579-2014","Class II","''***Brazo gitano (rolled cake)***chocolate cake filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67456,"Ongoing","E. Franco & Co. Inc","Mayaguez","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only","F-1582-2014","Class II","''***Brazo gitano (rolled cake)***guava-cheese filling***''","no code",,"Approx. 2300/14-oz rolls for all varieties","Undeclared allergens: wheat",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Drugs",67457,"Ongoing","Actavis","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.","D-1088-2014","Class III","Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77."," Lot #: 514656; Expiry: 03/14",,"38,227 Clamshells","Subpotent Drug: Drug potency was compromised during shipment.",2/7/2014,"02/07/2014",3/5/2014,"03/05/2014"
"Devices",67458,"Ongoing","Medical Information Technology, Inc.","Canton","MA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.","Z-1124-2014","Class II","MEDITECH Microbiology - Calculator/data processing module, for clinical use.","Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.",,"737","Potential for patient results being removed from LAB/EMR. ",1/17/2014,"01/17/2014",3/12/2014,"03/12/2014"
"Devices",67459,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.","Z-1194-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician","MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587",".","6583 units","When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon. ",2/18/2014,"02/18/2014",3/19/2014,"03/19/2014"
"Food",67460,"Ongoing","BIG RED TOMATO PACKERS, LLC","Fort Pierce","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, MI, MN, NC, PA and TN","F-1604-2014","Class I","Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each.","1106",,"790 Boxes","Positive Salmonella finding",2/7/2014,"02/07/2014",3/12/2014,"03/12/2014"
"Food",67461,"Ongoing","Natural Grocers by Vitamin Cottage","Denver","CO","US","Voluntary: Firm Initiated","Press Release","Nationwide, no military/govt/VA or foreign consignees.","F-1589-2014","Class I","Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0","Julian packed-on date 13-351",,"994 bags","Natural Grocers by Vitamin Cottage is recalling one lot of six ounce packages of Natural Grocers brand Dark Chocolate Almonds with the Julian packed-on date 13-351 because some bags in this lot may contain dark chocolate covered peanuts which are not declared on the label. ",2/7/2014,"02/07/2014",3/5/2014,"03/05/2014"
"Drugs",67462,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1187-2014","Class III","Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.","Lot #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015",".","5,172 bottles","Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.",1/27/2014,"01/27/2014",4/9/2014,"04/09/2014"
"Drugs",67462,"Ongoing","Lupin Pharmaceuticals Inc.","Baltimore","MD","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1186-2014","Class III","Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.","Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015 ",".","4,038 bottles","Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.",1/27/2014,"01/27/2014",4/9/2014,"04/09/2014"
"Devices",67463,"Ongoing","Biomerieux Inc","Hazelwood","MO","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.","Z-1177-2014","Class II","bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.","Serial number range: AS 180-00001 to AS 180-00476",".","471 instruments","The firm has determined the product may fail to dispense the sample to the agar plate resulting in a ''failure to dispense'' in conjunction with urine specimens. This could lead to a ''false'' negative growth result.",2/10/2014,"02/10/2014",3/19/2014,"03/19/2014"
"Devices",67464,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.","Z-1199-2014","Class II","GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. ","all serial numbers are listed in Product 1",".","3062 units (1182 US, 1880 OUS)","Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.",2/7/2014,"02/07/2014",3/19/2014,"03/19/2014"
"Devices",67464,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.","Z-1198-2014","Class II","GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. ","Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 10224, 10225, 10228, 10229, 10230, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10246, 10249, 10250, 10251, 10253, 10254, 10256, 10260, 10262, 10263, 10264, 10265, 10267, 10268, 10269, 10270, 10272, 10276, 10279, 10280, 10281, 10282, 10283, 10284, 10287, 10288, 10292, 10294, 10295, 10297, 10298, 10300, 10302, 10303, 10305, 10307, 10308, 10309, 10311, 10312, 10313, 10314, 10316, 10319, 10320, 10323, 10325, 10326, 10328, 10332, 10333, 10334, 10335, 10336, 10336, 10337, 10338, 10339, 10340, 10342, 10343, 10345, 10346, 10347, 10348, 10352, 10353, 10354, 10355, 10357, 10359, 10360, 10362, 10363, 10364, 10366, 10367, 10368, 10370, 10371, 10373, 10374, 10375, 10376, 10377, 10378, 10379, 10381, 10382, 10383, 10384, 10385, 10386, 10387, 10388, 10389, 10390, 10392, 10393, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10401, 10402, 10403, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10416, 10417, 10420, 10422, 10424, 10425, 10426, 10428, 10431, 10434, 10435, 10436, 10437, 10438, 10439, ",".","3062 units (1182 US, 1880 OUS)","Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.",2/7/2014,"02/07/2014",3/19/2014,"03/19/2014"
"Devices",67464,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.","Z-1200-2014","Class II","Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.","all serial numbers are listed in Product 1.",".","3062 units (1182 US, 1880 OUS)","Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.",2/7/2014,"02/07/2014",3/19/2014,"03/19/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1567-2014","Class II","Uncle Ben's (R), Infused(R) Rice Saffron Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547","All codes",,"43,004 units, 2 units per case","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1590-2014","Class II","Uncle Ben's (R), Infused(R) Rice Cheese Flavor, net weight 5 LB (2.27 kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-1547 ","All codes. NOTE: The firm placed this product on their recall list as a precaution as although the shelf life is one year, it could still be on the market.",,"none since prior to the recall","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1564-2014","Class II","Uncle Ben's (R), Infused(R) Rice Roasted Chicken Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059","All codes",,"33,634 units","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1565-2014","Class II","Uncle Ben's (R), Infused(R) Rice Garlic & Butter Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059","All codes",,"19,304 units, 2 units per case","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1563-2014","Class II","Uncle Ben's (R), Infused(R) Rice Mexican Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA","All codes",,"140,225 units","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1568-2014","Class II","Uncle Ben's (R), Infused(R) Rice Spanish Flavor, net weight 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059 ","All codes",,"1448 units, 2 units per case","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67465,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","F-1566-2014","Class II","Uncle Ben's (R), Infused(R) Rice Pilaf, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547 ","All codes",,"32,778 units, 2 units per case","Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. ",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Devices",67466,"Ongoing","HeartWare Inc","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.","Z-1471-2014","Class I","Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.","Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW 11215 and HW20001 to HW 20296.",,"4,586","The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.",12/6/2013,"12/06/2013",4/30/2014,"04/30/2014"
"Food",67467,"Ongoing","Popcorn Factory, The","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (CA, CT, FL, GA, IL, KS, MI, NJ, NM, NV, NY, OH, PA, TX, VT ,WI)","F-1553-2014","Class II","Candy coated popcorn shaped into a heart weighing 1.5 ounces per piece and individually wrapped in clear plastic packaging. There are 24 popcorn balls per case.","Product Lot Number: 14022. Case Lot Number: 14034. Expiration Date: April 7, 2014.",,"27 cases (648 popcorn balls)","The Nutrition Facts and allergen label was not applied individual popcorn balls in a Valentine's Day promotion package. The popcorn balls contain milk and soy allergens.",2/4/2014,"02/04/2014",3/5/2014,"03/05/2014"
"Devices",67468,"Ongoing","Djo Surgical","Austin","TX","US",,"Visit","Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.","Z-1130-2014","Class II","FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.","Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa",,"10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089","Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (10 units)were not distributed. The units labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 on the outside and containing Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the inside (10 units) were distributed. ",2/7/2014,"02/07/2014",3/12/2014,"03/12/2014"
"Food",67469,"Ongoing","All American Seasonings","Denver","CO","US","Voluntary: Firm Initiated","Telephone","1 distributor in CA. No foreign, military/govt/VA consignees.","F-1676-2014","Class I","Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags.","Lots 34577 and 40257",,"550 pounds","All American Seasonings is recalling T3695 White cheddar jalapeno seasoning powder, lots 34577 and 40257 after being notified by Elite spice that there was a potential recall for salmonella in the Jalapeno powder they received.",2/10/2014,"02/10/2014",3/26/2014,"03/26/2014"
"Devices",67470,"Ongoing","Clarity Medical Systems Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.","Z-1154-2014","Class II","RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.","no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025 RC6026 RC6027 RC6028 RC6029 RC6030 RC6031 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6042 RC6043 RC6044 RC6045 RC6046 RC6047 RC6048 RC6049 RC6050 RC6051 RC6052 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6061 RC6062 RC6063 RC6064 RC6065 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6091 RC6092 RC6093 RC6094 RC6095 RC6096 RC6097 RC6098 RC6099 RC6100 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6300 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6308 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6345 RC6346 RC6347 RC6348 RC6349 RC6350 RC6351 RC6352 RC6353 RC6354 RC6355 RC6356 RC6357 RC6358 RC6359 RC6360 RC6361 RC6362 RC6363 RC6364 RC6365 RC6366 RC6367 RC6368 RC6369 RC6370 RC6371 RC6372 RC6373 RC6374 RC6375 RC6376 RC6377 RC6378 RC6379 RC6380 RC6381 RC6382 RC6383 RC6384 RC6385 RC6386 RC6387 RC6388 RC6389 RC6390 RC6391 RC6392 RC6393 RC6394 RC6395 RC6396 RC6397 RC6398 RC6399 RC6400 RC6401 RC6402 RC6403 RC6404 RC6405 RC6406 RC6407 RC6408 RC6410 RC6411 RC6412 RC6413 RC6414 RC6415 RC6416 RC6417 RC6418 RC6419 RC6420 RC6421 RC6422 RC6423 RC6424 RC6425 RC6426 RC6427 RC6428 RC6429 RC6430 RC6431 RC6432 RC6433 RC6434 RC6435 RC6436 RC6437 RC6438 RC6439 RC6440 RC6441 RC6442 RC6443 RC6444 RC6445 RC6446 RC6447 RC6448 RC6449 RC6450 RC6451 RC6452 RC6453 RC6454 RC6455 RC6456 RC6457 RC6458 RC6459 RC6460 RC6461 RC6462 RC6463 RC6464 RC6466 RC6467 RC6469 RC6470 RC6471 RC6472 RC6473 R",".","166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.","Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.",1/24/2014,"01/24/2014",3/19/2014,"03/19/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1379-2014","Class I","Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1373-2014","Class I","Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","2 boxes","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1375-2014","Class I","Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1377-2014","Class I","Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","5 bottles","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1371-2014","Class I","REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL","ALL LOTS",".","100 boxes","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1376-2014","Class I","SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","2 boxes","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1378-2014","Class I","Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1374-2014","Class I","Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1372-2014","Class I","JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Drugs",67471,"Ongoing","MyNicNaxs, Inc.","Deltona","FL","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1380-2014","Class I","Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL","ALL LOTS",".","unknown","Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine",1/24/2014,"01/24/2014",6/18/2014,"06/18/2014"
"Devices",67472,"Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.","Z-1211-2014","Class I","FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. Intended to monitor blood glucose from samples taken from the body. IVD use only,","Part number CAT11001-0; all serial numbers",,"not provided. Device has not been shipped in the last 5 years.","Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.",2/19/2014,"02/19/2014",3/26/2014,"03/26/2014"
"Devices",67472,"Ongoing","Abbott Diabetes Care, Inc.","Alameda","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.","Z-1212-2014","Class I","FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,","Catalog Number 17002 NDC 99073-0170-02. All serial numbers",,"25,203 units","Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.",2/19/2014,"02/19/2014",3/26/2014,"03/26/2014"
"Devices",67473,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM VIET NAM","Z-1155-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491","Serial numbers within the range: US00100204 to US00570921",".","3541 units","MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing",2/18/2014,"02/18/2014",3/19/2014,"03/19/2014"
"Devices",67475,"Ongoing","Heraeus Kulzer, LLC.","South Bend","IN","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV","Z-1133-2014","Class II","BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.","Part #1010-451 Lot #13121434 ",,"812 units (gallons)","As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states ''Benco Tartar and Stain'', the immediate gallon container in which the solution is contained incorrectly states ''Benco Temporary Cement Remover''.",2/10/2014,"02/10/2014",3/12/2014,"03/12/2014"
"Food",67476,"Ongoing","International Foodsource, LLC","Dover","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1634-2014","Class III","Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801 Packaged in 8 oz bag 12 per case.","UPC 7-90429-22603-6 Retail Lots - 62289, 62752, 63046, 63374, 63541, 63614, 63800 UPC 7-90429-22603-6 12x6x6 (5# boxes) - 63059 ",".","20,569 lbs.","NYSDAM Laboratory Analysis Reports has determined that Valued Naturals Natural Coconut contains 28.1 ppm sulfites.",12/17/2013,"12/17/2013",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1160-2014","Class II","Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large",".","498,980 individuals units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1158-2014","Class II","Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large",".","1,710,773 invididuals units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1161-2014","Class II","Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #s 2013020740 and lower",".","7,353 individuals units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1162-2014","Class II","Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #'s 2013010287 and lower ",".","28,250 individual units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1159-2014","Class II","Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #: 2013011830 and lower",".","15,754 indivdual units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Devices",67477,"Ongoing","Smith & Nephew Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.","Z-1157-2014","Class II","Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)","ALL LOT #s 2013010311 and lower",".","162,629 invididual units","Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.",1/9/2014,"01/09/2014",3/19/2014,"03/19/2014"
"Food",67478,"Ongoing","Pepper Source Limited","Van Buren","AR","US",,"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR","F-1605-2014","Class I","Dark Meat Fajita School Lunch #3","88835 Dark Meat Fajita School Lunch, lot #'s 020401, 020402, 020403, 020404, 020405, 020406, 020407, 020408, 020409, 020410, 020411, 020412 (611 bags, manufactured on 1/20/14), and lot #'s 022401, 022402, 022403 (152 bags, manufactured on 1/22/14)",,"750 - 50 lb. bags","An ingredient used to manufacture the product tested positive for Salmonella",2/5/2014,"02/05/2014",3/12/2014,"03/12/2014"
"Food",67479,"Ongoing","Ed Fields & Sons, Inc","Andover","MN","US","Voluntary: Firm Initiated","E-Mail","IA, KS, MN, MO, and WI","F-1603-2014","Class III","Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes","No lot codes used",,"5000 lbs.","Parsnips were found to be above tolerance, maximum residue level, for the pesticide linuron.",2/8/2014,"02/08/2014",3/12/2014,"03/12/2014"
"Food",67480,"Ongoing","Comarco Products, Inc.","Camden","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","F-1538-2014","Class II","IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013 24/30 lb bags - 720 lb totes Keep Frozen Bin# Comarco Products 501 Jackson Street, Camden, NJ 08104","Lot 4013 -R46500001",,"2,610 lbs.","Gorgonzola stuffed jalapeno peppers tested positive for Listeria monocytogenes.",1/24/2014,"01/24/2014",2/26/2014,"02/26/2014"
"Devices",67481,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including states of: AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and to the countries of: Australia, Norway, and Spain.","Z-1108-2014","Class II","M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.","US00100253, US00547494, US00565643, US00567331, US00100950, US00558361, US00565651, US00567332, US00204282, US00560173, US00565652, US00567333, US00210992, US00560174,US00565653, US00567334, US00210993, US00560175, US00565655, US00567335, US00210994, US00560176, US00565656, US00567336, US00210995, US00560177, US00565657, US00567337, US00210996, US00560178, US00565658, US00567338, US00210997, US00561068, US00565660, US00567339, US00210998, US00561724, US00565661, US00567340, US00210999, US00563602, US00565662, US00567341, US00211000, US00563603, US00565663, US00567720, US00211001, US00563606, US00565664, US00567721, US00212264, US00563607, US00565665, US00567722, US00212265, US00565069, US00565666, US00567723, US00212266, US00565414, US00566434, US00567724, US00212267, US00565415, US00566564, US00568419, US00212268, US00565416, US00567302, US00568656, US00322574, US00565417, US00567303, US00568703, US00322575, US00565418, US00567304, US00568704 US00322876, US00565419, US00567305, US00568705, US00322877, US00565420, US00567306, US00568706, US00323134, US00565421, US00567307, US00568748, US00323135, US00565422, US00567308, US00568749, US00323137, US00565423, US00567309, US00568750, US00323138, US00565424, US00567310, US00568751, US00541205, US00565425, US00567311, US00568752, US00541250, US00565427, US00567312, US00568753, US00541254, US00565428, US00567313, US00568754, US00541364, US00565429, US00567314, US00568755, US00541370, US00565430, US00567315, US00568756, US00541397, US00565446, US00567316, US00568757, US00541402, US00565447, US00567317, US00568758, US00541403, US00565448, US00567318, US00568759, US00541405, US00565449, US00567319, US00568760, US00543683, US00565450, US00567320, US00568761, US00543684, US00565451, US00567321, US00568762, US00543860, US00565452, US00567322, US00568763, US00544078, US00565453, US00567323, US00568764, US00544082, US00565454, US00567324, US00568765, US00544089, US00565455, US00567325, US00568766, US00544095, US00565456, US00567326, US00568767, US00547383, U",,"220 devices","Wireless Link may be unable to transmit data when configured for a specific data flow. ",2/18/2014,"02/18/2014",3/5/2014,"03/05/2014"
"Food",67482,"Ongoing","F & S Produce Co., Inc.","Rosenhayn","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-1627-2014","Class II","Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333","Best by Dates of 1/5/14; 1/7/14; 1/8/14",".","429 units","Roasting cinnamon butternut squash is mislabeled.",12/31/2013,"12/31/2013",3/19/2014,"03/19/2014"
"Devices",67483,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, KAZAKHSTAN, KOREA, REPUBLIC OF, MALAYSIA, MEXICO, MONACO, NEPAL, NETHERLANDS, PORTUGAL, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIET NAM,","Z-1109-2014","Class II","Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED","Serial numbers within the range: US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.",,"5234 units","Philips HeartStart XL may experience a power board failure causing failure to defibrillate ",2/14/2014,"02/14/2014",3/5/2014,"03/05/2014"
"Food",67484,"Ongoing","Tortillas Mexico Mexico, Incorporated","Denver","CO","US","Voluntary: Firm Initiated","Letter","Regional; to various grocery stores in Colorado, Wyoming, Nebraska and Kansas. For foreign, military/govt/VA consignees.","F-1679-2014","Class II","CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 LB,USPC Code 1569603331, 100 COUNT WHITE CORN 100 OZ USPC Code 1569603336, 36 COUNT MINI 24 OZ USPC Code 1569603332, 36 COUNT TAQUITO 23 OZ UPC Code 1569603345, 100 COUNT TAQUITO 4 LB UPC Code 1569603346. Packaged in clear poly plastic bags.","Expiration Dates from December 20 to February 27, 2014",,"249,158","Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning.",2/10/2014,"02/10/2014",3/26/2014,"03/26/2014"
"Food",67484,"Ongoing","Tortillas Mexico Mexico, Incorporated","Denver","CO","US","Voluntary: Firm Initiated","Letter","Regional; to various grocery stores in Colorado, Wyoming, Nebraska and Kansas. For foreign, military/govt/VA consignees.","F-1680-2014","Class II","WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.","Expiration Dates from December 20 to February 27, 2014",,"13,954","Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning.",2/10/2014,"02/10/2014",3/26/2014,"03/26/2014"
"Food",67484,"Ongoing","Tortillas Mexico Mexico, Incorporated","Denver","CO","US","Voluntary: Firm Initiated","Letter","Regional; to various grocery stores in Colorado, Wyoming, Nebraska and Kansas. For foreign, military/govt/VA consignees.","F-1678-2014","Class II","FLOUR TORTILLAS: FAJITA 6'' 15 0Z UPC Code 1569602222, HOMESTYLE 8'' 24 OZ UPC Code 1569602221, BURRITO 10'' 28OZ UPC Code 1569602223, GRANDE 12'' 36 OZ UPC Code 1569602224, JUAREZ 8'' 24 OZ UPC Code 1569603337, 8'' RESTAURANT 23 OZ UPC Code 1569602230, 10'' RESTAURANT 28 OZ UPC Code 1569602226. Packaged in clear poly plastic bags.","Expiration Dates from December 20 to February 27, 2014",,"842,036","Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 due to metal detector malfunction during production and therefore potential for metal in product.",2/10/2014,"02/10/2014",3/26/2014,"03/26/2014"
"Drugs",67485,"Ongoing","Ranbaxy Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1086-2014","Class II","Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90","2407255, 2407256 Exp. 05/14 ",,"64,626 bottles","Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.",1/16/2014,"01/16/2014",3/5/2014,"03/05/2014"
"Devices",67486,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Letter","USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.","Z-1217-2014","Class II","Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.","size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001. size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002. size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003. size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004. size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005. size 4.0mm x 20mm, Catalog #05-000-20-4020, Lot Number 35917006. size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011.",,"242","The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.",1/6/2014,"01/06/2014",3/26/2014,"03/26/2014"
"Devices",67487,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN.","Z-1118-2014","Class II","Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.","Serial numbers within the range: US00100100 through US00550668",,"49929 units"," ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal ",2/18/2014,"02/18/2014",3/5/2014,"03/05/2014"
"Food",67488,"Ongoing","Evolution Fresh Inc","Rancho Cucamonga","CA","US","Voluntary: Firm Initiated","Letter","California, Texas, and Nevada","F-1742-2014","Class III","Evolution fresh Organic sweet Greens and Ginger, 15.2 fluid-ounce bottle, 6 bottles/case, UPC code is 762357378927.","Enjoy by date of March 2, 2014.",".","1727 units","Evolution Fresh is recalling Organic Sweet Green and Ginger Juice out of an abundance of caution.",2/7/2014,"02/07/2014",4/16/2014,"04/16/2014"
"Biologics",67489,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-0452-14","Class II","Blood and Blood Products for Reprocessing","3881200; ",".","1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",3/29/2013,"03/29/2013",4/2/2014,"04/02/2014"
"Devices",67490,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including TX, ME, IA, PA, OR, and NH.","Z-1121-2014","Class III","Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.","Lot Number: 50755851",,"191 devices","Incorrect master label.",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1638-2014","Class II","Energy Clarity (bulk), 6 boxes x 15 kg, 1 box x 10.55 kg.","Lot 1843",".","100,000 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1639-2014","Class II","Multi Vitamin (bulk), 6 boxes x 12 kg, 1 box x 5.5kg.","Lot 1671",".","100,000 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1641-2014","Class II","Pain Power, 100 vegetarian capsules, 55 boxes x 72 bottles, 1 box x 7 bottles.","Lot 1533",".","244,800 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1643-2014","Class II","Colon Rebuild II, 210 capsules, 6 boxes x 72 bottles, 1 box x 70 bottles.","Lot 1579",".","105,420 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1635-2014","Class II","Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles. ","Colon Rebuild I, Lot 1471 ",".","63,180 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1636-2014","Class II","Fat Sugar (bulk), 3 boxes x 12 kg, 1 box x 8.76 kg.","Lot 1845",".","100,000 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1637-2014","Class II","Adrenal Support (bulk), 4 boxes x 12 kg, 1 box x 11.48 kg.","Lot 2037",".","99,133 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1642-2014","Class II","Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.","Lot 1585",".","69,800 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Food",67491,"Ongoing","Global Vitality, Inc. dba Enzyme Process International","Chandler","AZ","US","Voluntary: Firm Initiated","E-Mail","PA, AZ, HI,","F-1640-2014","Class II","Total Digestion, Lot 1635, 4 boxes x 9.92 kg. Lot 1841, 4 boxes x 12 kg, 1 box x 11.24 kg. Lot 2017, 3 boxes x 10 kg, 1 box x 9.32 kg.","Lot 1635, 1841, and 2017",".","348,300 units","Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.",10/22/2013,"10/22/2013",3/19/2014,"03/19/2014"
"Devices",67492,"Ongoing","Biocardia, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of FL, MA, WY. OH, MI and KS.","Z-0991-2014","Class II","MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.","Catalog number MAP690; Lot numbers 01162 and 01186.",,"11 units","Tyvek packaging may be worn, causing loss of package integrity.",2/7/2014,"02/07/2014",2/26/2014,"02/26/2014"
"Cosmetics",67493,"Ongoing","Trigg Laboratories, Inc","Santa Clarita","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to EU, Australia, and Russia","F-1607-2014","Class II","Wet Nuru Massage Gel, Nuru Concentrate, Net Wt. 8.8 oz and 38 oz.","Lot No. 25563, 25659, and 25672. ",,"2,867 units","Due to microbial contamination",2/12/2014,"02/12/2014",3/12/2014,"03/12/2014"
"Cosmetics",67493,"Ongoing","Trigg Laboratories, Inc","Santa Clarita","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to EU, Australia, and Russia","F-1606-2014","Class II","Wet Nuru Massage Gel, Nuru Original, Net Wt. 8.8 oz and 38 oz.","Lot No. 25562 and 25674. ",,"3,688 units","Due to microbial contamination",2/12/2014,"02/12/2014",3/12/2014,"03/12/2014"
"Devices",67495,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide Distribution","Z-1156-2014","Class II","Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.","p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX",".","732 units in the US","Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindrays V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack. ",1/8/2014,"01/08/2014",3/19/2014,"03/19/2014"
"Food",67497,"Ongoing","Roth Farms Inc","Belle Glade","FL","US","Voluntary: Firm Initiated","Letter","Shipped to distribution centers in Florida","F-1624-2014","Class I","18 lb box of Curly Parsley packaged in 3 wire wooden crates","Lot AG01GN",,"504 boxes","Sample of Parsley was found positive with Salmonella.",2/12/2014,"02/12/2014",3/12/2014,"03/12/2014"
"Devices",67498,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.","Z-1125-2014","Class II","Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft. ","part no. 02.231.240, lot no. 823111",,"45","Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). ",2/5/2014,"02/05/2014",3/12/2014,"03/12/2014"
"Devices",67499,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1456-2014","Class II","Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.","Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974, 6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225, 6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870, 6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395, 7138319. ",".","20081","The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label. ",1/30/2014,"01/30/2014",4/23/2014,"04/23/2014"
"Veterinary",67500,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, DE, FL, IA, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-136-2014","Class II","The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.","List Number: 12570; Serial Numbers: 13735001 , 13735002 , 13735003 , 13735004 , 13735005 , 13735006 , 13735007 , 13735008 , 13735009 , 13735010 , 13735011 , 13735012 , 13735013 , 13735014 , 13735015 , 13735016 , 13735017 , 13735018 , 13735019 , 13735020 , 13735021 , 13735022 , 13735023 , 13735024 , 13735025 , 13735026 , 13735027 , 13735028 , 13735029 , 13735030 , 13735031 , 13735032 , 13735033 , 13735034 , 13735035 , 13735036 , 13735037 , 13735038 , 13735039 , 13735040 , 13735041 , 13735042 , 13735043 , 13735044 , 13735045 , 13735046 , 13735047 , 13735048 , 13735049 , 13735050 , 13735051 , 13735052 , 13735053 , 13735054 , 13735055 , 13735056 , 13735057 , 13735058 , 13735059 , 13735060 , 13735061 , 13735062 , 13735063 , 13735064 , 13735065 , 13735066 , 13735067 , 13735068 , 13735069 , 13735070 , 13735071 , 13735072 , 13735073 , 13735074 , 13735075 , 13735076 , 13735077 , 13735078 , 13735079 , 13735080 , 13735081 , 13735082 , 13735083 , 13735084 , 13735085 , 13735086 , 13735087 , 13735088 , 13735089 , 13735090 , 13735091 , 13735092 , 13735093 , 13735094 , 13735095 , 13735096 , 13735097 , 13735098 , 13735099 , 13735100 , 13735101 , 13735102 , 13735103 , 13735104 , 13735105 , 13735106 , 13735107 , 13735108 , 13735109 , 13735110 , 13735111 , 13735112 , 13735113 , 13735114 , 13735115 , 13735116 , 13735117 , 13735118 , 13735119 , 13735120 , 13735121 , 13735122 , 13735123 , 13735124 , 13735125 , 13735126 , 13735127 , 13735128 , 13735129 , 13735130 , 13735131 , 13735132 , 13735133 , 13735134 , 13735135 , 13735136 , 13735137 , 13735138 , 13735139 , 13735140 , 13735141 , 13735142 , 13735143 , 13735144 , 13735145 , 13735146 , 13735147 , 13735148 , 13735149 , 13735150 , 13735151 , 13735152 , 13735153 , 13735154 , 13735155 , 13735156 , 13735157 , 13735158 , 13735159 , 13735160 , 13735161 , 13735162 , 13735163 , 13735164 , 13735165 , 13735166 , 13735167 , 13735168 , 13735169 , 13735170 , 13735171 , 13735172 , 13735173 , 13735174 , 13735175 , 13735176 , 13735177 , 13735178 , 13735179 , 13735180 , 13735181 , 13735182 , 1373518",".","1,168 pumps","There is the potential for the door roller assembly on the Plum XL family of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door toller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",7/23/2014,"07/23/2014"
"Food",67501,"Ongoing","Lyons Magnus","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, OR, ID, CO, TX","F-1626-2014","Class II","Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 Manufactured for Sysco by Lyons Magnus, Fresno, CA","Item 1847; Cherry Pie code 9204 SUPC 6346167",".","55 cases (6 X #10 cans per case)","Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product.",2/6/2014,"02/06/2014",3/19/2014,"03/19/2014"
"Food",67501,"Ongoing","Lyons Magnus","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","CA, WA, OR, ID, CO, TX","F-1625-2014","Class II","Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA","Item 1846; Cherry Pie code 8004 SUPC 6346134",".","500 cases (6 x #10 cans per casae)","Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product.",2/6/2014,"02/06/2014",3/19/2014,"03/19/2014"
"Devices",67502,"Ongoing","Draeger Medical Systems, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1298-2014","Class I","Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.","all lots",".","1544","The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. ",2/7/2014,"02/07/2014",4/9/2014,"04/09/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1255-2014","Class II","Natural-Knee II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM ","Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1261-2014","Class II","Apollo'' Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER ","Item Number 682000016 682001011 682001016 682001022 682001030 682002011 682002013 682002016 682002022 682002030 682003016 682003022 682003025 682004013 682004016 682005011 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1253-2014","Class II","Natural-Knee/Apollo'' Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE ","Item Number 620001100 620001101 620001102 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1256-2014","Class II","Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R ","Item Number 672009100 672009101 672009103 672009200 672009203 672011101 672011103 672011200 672011201 672011203 672013100 672013101 672013103 672013200 672013203 672016101 672016103 672016200 672016203 672019100 672019101 672019200 672019201 672022101 672022103 672022200 672022201 672025100 672025200 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1250-2014","Class II","MOST Options'' System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM ","Item Number 502001016 502004006 502004009 502004016 502010006 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1252-2014","Class II","Natural-Knee II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm ","Item Number 613001007 613001009 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1260-2014","Class II","Apollo'' Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL ","Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1259-2014","Class II","Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO ","Item Number 681100019 681100022 681101009 681101011 681101019 681102013 681102019 681103009 681103013 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1249-2014","Class II","Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 ","Item Number 00591101128 00591101137 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1254-2014","Class II","Natural-Knee Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5 ","Item Number 620005819 620005909 620006916 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1251-2014","Class II","Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U ","Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1262-2014","Class II","Natural-Knee II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5 ","Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1258-2014","Class II","Apollo'' Knee System: APOLLO PATELLA SZ0 28MM R ","Item Number 680001000 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1257-2014","Class II","Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ ","Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67503,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.","Z-1248-2014","Class II","Gender Solutions'' Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT ","Item Numbers 00541800000 00541800001 00541800002 ",,"3638 units","A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.",2/25/2014,"02/25/2014",3/26/2014,"03/26/2014"
"Devices",67504,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.","Z-1307-2014","Class II","RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. ","MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9 ",".","151 units Total (88 units domestically & 63 units internationally)","Potential for dose errors due to software program errors.",2/6/2014,"02/06/2014",4/9/2014,"04/09/2014"
"Devices",67505,"Ongoing","Biosense Webster, Inc.","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.","Z-1045-2014","Class II","CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.","Serial No. 13201, 11125, 11519, 11320, 11115. ",,"8 units total (5 units in US)","Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.",2/12/2014,"02/12/2014",2/26/2014,"02/26/2014"
"Food",67506,"Ongoing","Ohio Valley Herbal Products, Inc.","East Liverpool","OH","US","Voluntary: Firm Initiated","Letter","Product was distributed in CT, IN, MD, OH, PA and WV.","F-0079-2015","Class III","Wild'erb Herbal Tea 1.2 oz. and 4 oz. paper bags, tea contained less than 5% sassafras leaves.","All lots",,"1.2 oz. - 306; 4 oz. - 100","The firm was notified by the Ohio Department of Agriculture that Sassafras Leaves may be an illegal ingredient for their product.",11/20/2013,"11/20/2013",10/29/2014,"10/29/2014"
"Food",67506,"Ongoing","Ohio Valley Herbal Products, Inc.","East Liverpool","OH","US","Voluntary: Firm Initiated","Letter","Product was distributed in CT, IN, MD, OH, PA and WV.","F-0078-2015","Class III","Wild'erb Seasoning 2 oz and 4 oz plastic jars; seasoning contained less than 1% sassafras leaves. ","All lots",,"401 - 2 oz pkgs & 148 - 4 oz pkgs","The firm was notified by the Ohio Department of Agriculture that Sassafras Leaves may be an illegal ingredient for their product.",11/20/2013,"11/20/2013",10/29/2014,"10/29/2014"
"Food",67507,"Ongoing","C. H. Guenther & Sons, Inc.","San Antonio","TX","US",,"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to distributors located in Texas, Louisiana, and Oklahoma.","F-1649-2014","Class II","MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)","Lot number 3357",".","1296 cases","brown gravy mix product mislabeled as pancake mix, resulting in undeclared soy (as hydrolyzed vegetable protein)",2/13/2014,"02/13/2014",3/19/2014,"03/19/2014"
"Devices",67508,"Ongoing","Accumetrics Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1172-2014","Class II","VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. ","Lot/Serial No. WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.",".","576 units total (524 units in US)","Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.",2/13/2014,"02/13/2014",3/19/2014,"03/19/2014"
"Devices",67509,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1490-2014","Class II","VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY ","Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.",,"US: 284 units, Ex-US: 4772 units","Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.",1/29/2014,"01/29/2014",4/30/2014,"04/30/2014"
"Food",67510,"Terminated","CSM Bakery Products NA","Bonner Springs","KS","US","Voluntary: Firm Initiated","Telephone","Distribution was made to MA and WI.","F-1571-2014","Class II","Multifoods Bakery Products, Artificial Pistachio Flavored Muffin with Other Nuts, 4.5oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 27 lbs case is unit for sale. UPC 024800486383. Manufactured by CSM Bakery Products NA, Inc., Tucker, GA.","Item # 48638, Lot# 1401000970, Exp date 7/2/2014",,"60 cases","Products may contain undeclared coconut.",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Food",67510,"Terminated","CSM Bakery Products NA","Bonner Springs","KS","US","Voluntary: Firm Initiated","Telephone","Distribution was made to MA and WI.","F-1570-2014","Class II","Multifoods Bakery Products, Cranberry Orange Muffins, 5.4oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 25.3lbs case is unit for sale. UPC 10035074485443. Manufactured by: CSM Bakery NA, Inc, Tucker, GA.","Item# 48544, Lot# 1400300688, Expiration Date: 07/02/2014.",,"120 cases","Products may contain metal dust.",2/6/2014,"02/06/2014",3/5/2014,"03/05/2014"
"Devices",67511,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,","Z-1308-2014","Class II","RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software","Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses",".","19 units (16 units domestically & 3 units internationally)","RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.",2/6/2014,"02/06/2014",4/9/2014,"04/09/2014"
"Drugs",67512,"Ongoing","Ben Venue Laboratories Inc","Bedford","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","D-1326-2014","Class I","Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02"," 2005479, Exp 03/14",".","5,131 vials","Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution ",2/14/2014,"02/14/2014",5/28/2014,"05/28/2014"
"Devices",67513,"Ongoing","Abbott Point Of Care Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada.","Z-1306-2014","Class II","i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.","List number 03P78-25 :Lot number N13183",".","48, 450 US, 1400 OUS (49,850 catridges)","Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.",1/1/2014,"01/01/2014",4/2/2014,"04/02/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1633-2014","Class I","Jalapeno Burger Seasoning, Elite Spice # 32680B2, 50 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lots 1-230813 and 1-230814",".","100 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1631-2014","Class I","Ole Hot Chorizo Seasoning, Elite Spice # 32581A9, 32 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lot 1-230758",".","32 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1629-2014","Class I","Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lot 1-230880",".","500 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1632-2014","Class I","Mexican Style Mild Chorizo, Elite Spice # 32582A9, 24 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lot 1-230647",".","24 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1628-2014","Class I","Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lot 1-227954 ",".","800 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Food",67514,"Ongoing","Elite Spice Inc.","Jessup","MD","US","Voluntary: Firm Initiated","Letter","Product was distributed to AL, AR, CO, IN, GA, LA, NY, TX, VA and WI.","F-1630-2014","Class I","Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***","Lot 1-230879",".","500 lbs","Bulk spice for futher manufacturing may be contaminated with Salmonella.",2/12/2014,"02/12/2014",3/19/2014,"03/19/2014"
"Devices",67515,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey","Z-1165-2014","Class II","MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours. ","Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15929-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16115-06 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16346-06 70105.0967 BO-T 1260 Adult Cardioplegia Pack 15760-07 70105.0975 BO-TOP 26300 Custom Pack 15796-13 70105.1736 BEQ-TOP 4903 Open Heart Pack 15921-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16073-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16153-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16321-07 70105.1861 BO-TOP 14601 Open Heart Tubing Pack 15880-02 70105.2463 BO-T 25102 Custom Pack 15755-07 70105.2463 BO-T 25102 Custom Pack 15889-07 70105.2463 BO-T 25102 Custom Pack 16046-07 70105.2463 BO-T 25102 Custom Pack 16155-07 70105.2463 BO-T 25102 Custom Pack 16267-07 70105.2650 BO-TOP 23102 Scott &White OR CPB Pack 15818-10 70105.2659 BO-TOP 4903 Adult Open Heart Pack 15780-03 70105.2659 BO-TOP 4903 Adult Open Heart Pack 16047-03 70105.3832 BO-TOP 32400 Adult CPB Pack 15814-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16063-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16449-06 70105.5015 BO-TOP 36500 Cardiac Surgery 15658-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15772-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15883-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16078-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16250-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16410-17 70105.6041 BEQ-T 4906 Pediatric CPB Pack w/o VKMO 15819-02 70105.6238 BO-TOP 38800 Open Heart Pack 15635-05 70105.6238 BO-TOP 38800 Open Heart Pack 16013-05 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16039-09 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16238-10 70105.6869 BO-TOP 4113 Pediatric 1/4x3/8 15574-03 70106.2237 T 24260 St Louis Childrens Cardioplegia 15659-05 70106.2237 T 24260 St Louis Childrens Cardioplegia 15967-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 15892-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 16122-07 70106.2707 BEQ-TOP 40000 Open H",".","1,424 units","The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.",1/31/2014,"01/31/2014",3/19/2014,"03/19/2014"
"Devices",67516,"Ongoing","Mar Cor Purification","Minneapolis","MN","US","Voluntary: Firm Initiated","Telephone","nationwide. No distribution outside the US.","Z-1201-2014","Class II","Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. ","serial numbers: 1289064, 1289069, 1289159, 1289259, 1289387, 1289650, 1289747, 1289826, 1289949, 1290088, 1290151, 1290333, 1290367, 1290480, 1290489, 1290845, 1290988, 1291042, 1291120, 1291233, 1291373, 1291378, 1291634, 1291777, 1291828, 1291933, 1292031, 1292114, 1292185, 1292185, 1292192, 1292391, 1292546, 1292597, 1292670, 1292674, 1292899, 1292960, 1293010, 1293039, 1293185, 1293190, 1293311, 1293379, 1293414, 1293687, 1293724, 1293771, 1293777, 1293953, 1293957, 1294093, 1294103, 1294171, 1294307, 1294362, 1294433, 1294516, 1294589, 1294727, 1294864, 1294999, 1295113, 1295137, 1295160, 1295186, 1295274, 1295391, 1295514, 1295622, 1295813, 1295871, 1296237, 1296241, 1296246, 1296484, 1296491, 1296582, 1296621, 1296650, 1296695, 1296806, 1297041, 1297046, 1297118, 1297231, 1297234, 1297372, 1297375, 1297394, 1297453, 1297484, 1297610, 1297655, 1297939, 1297943, 1298037, 1298210, 1298266, 1298270, 1298377, 1298407, 1298450, 1298457, 1298575, 1298619, 1298624, 1298704, 1298734, 1298797, 1298820, 1298879, 1298913, 1298952, 1298953, 1299037, 1299120, 1299144, 1299170, 1299241, 1299262, 1299285, 1299331, 1299393, 1299473, 1299512, 1299599, 1299655, 1299656, 1299732. ",".","130","There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.",6/27/2012,"06/27/2012",3/19/2014,"03/19/2014"
"Devices",67517,"Ongoing","Mar Cor Purification","Minneapolis","MN","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Distribution including Puerto Rico.","Z-1213-2014","Class II","Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..","Serial Numbers: 1294627, 1298383, 1298386, 1299352, 1299353, 1299354, 1299355, 1299356, 1299486, 1299487, 1299488, 1299489, 1299503, 1299572, 1299712, 1299713, 1299716, 1299718, 1299719, 1299720, 1299740, 1299742, 1299777, 1299779, 1299780, 1299831, 1299835, 1299850, 1299867, 1299868, 1299895, 1299897, 1299992, 1299993, 1299994, 1299996, 1299997, 1300138, 1300224, 1300248, 1300363, 1300364, 1300367, 1300368, 1300558, 1300560, 1300561, 1300562, 1300564, 1300565, 1300621, 1300649, 1300650, 1300700, 1300701, 1301081, 1301116, 1301360, 1301361, 1301386, 1301888, 1301990, 1301992, 1301997, 1302030, 1302032, 1302149, 1302214, 1302226, 1302342, 1302345, 1302346, 1302385, 1302430, 1302447, 1302448, 1302452, 1302456, 1302464, 1302517, 1302555, 1302558, 1302642, 1302696, 1302706, 1302708, 1302748, 1302767, 1302768, 1302810, 1302813, 1302922, 1302923, 1302924, 1302925, 1302926, 1302927, 1302987, 1303005, 1303108, 1303315, 1303316, 1303346, 1303348, 1303351, 1303352, 1303505, 1303516, 1303532, 1303533, 1303534, 1303557, 1303558, 1303625, 1303626, 1303689, 1303690, 1303693, 1303702, 1303711, 1303768, 1303781, 1303799, 1303806, 1303821, 1303872, 1303877, 1303908, 1303920, 1303975, 1303976, 1304070, 1304076, 1304077, 1304081, 1304163, 1304166, 1304167, 1304170, 1304173, 1304174, 1304194, 1304196, 1304203, 1304273, 1304293, 1304294, 1304297, 1304333, 1304340, 1304343, 1304344, 1304346, 1304349, 1304376, 1304381, 1304501, 1304502, 1304503, 1304507, 1304508, 1304551, 1304585, 1304587, 1304724, 1304725, 1304775, 1304778, 1304779, 1304829, 1304870, 1304902, 1304903, 1304929, 1305006, 1305007, 1305038, 1305040, 1305041, 1305087, 1305088, 1305089, 1305131, 1305133, 1305210, 1305238, 1305239, 1305355, 1305363, 1305608, 1305609, 1305650, 1305651, 1305655, 1305698, 1305700, 1305701, 1305717, 1305732, 1305735, 1305750, 1305751, 1305752, 1305795, 1305928, 1305931, 1305932, 1305975, 1305995, 1306007, 1306042, 1306046, 1306078, 1306125, 1306154, 1306178, 1306209, 1306215, 1306226, 1306259, 1306322, 1306341, 1306428, 1306429, 1306430, 130",,"232 units","High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. ",6/26/2013,"06/26/2013",3/26/2014,"03/26/2014"
"Drugs",67518,"Ongoing","Actavis Elizabeth LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1091-2014","Class II","Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.","Lot #: 57617531, Exp 03/14",,"5,148 bottles","Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.",2/4/2014,"02/04/2014",3/12/2014,"03/12/2014"
"Drugs",67519,"Ongoing","Actavis Elizabeth LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1153-2014","Class II","Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50","Lot # 1826E131, Exp 04/2015",".","9447 Bottles","Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.",2/10/2014,"02/10/2014",3/19/2014,"03/19/2014"
"Devices",67520,"Ongoing","China Daheng Group Inc.","Beijing",,"CN","Voluntary: Firm Initiated","Visit","US Distribution .","Z-1145-2014","Class II","Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.","Denlase and Penlase Dental Laser Systems. ",,"238","Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers ",7/15/2013,"07/15/2013",3/26/2014,"03/26/2014"
"Devices",67521,"Ongoing","Lin-Zhi International Inc","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.","Z-1178-2014","Class II","Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.","Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.",".","130 items","Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.",2/6/2014,"02/06/2014",3/19/2014,"03/19/2014"
"Devices",67521,"Ongoing","Lin-Zhi International Inc","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.","Z-1179-2014","Class II","Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.","Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.",".","216 items","Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.",2/6/2014,"02/06/2014",3/19/2014,"03/19/2014"
"Veterinary",67522,"Ongoing","American Health Service Sales","Mettawa","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AR, AZ, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MT, NC, NJ, NM, NV, OH, OK, OR, PA, SC, TX, WA, WI, WV) + Puerto Rico","V-059-2014","Class II","1/2cc Insulin Syringe U-40 with 29G x 1/2'' Needles are individually packages in a container consisting of a transparent plastic bottom and a white top with green printing. 100 individual wrapped syringes per carton. The cartons are white with green printing.","Catalog Number: MV1/2CCINS-40; Lot Number: 20120610",".","137 cartons (13,700 syringes)","The barrels on 1/2cc Insulin Syringe U-40 with 29G x 1/2'' Needles are not marked correctly. The marking on the barrel indicate that 1/2cc of U40 insulin contains 40 units of insulin instead of 20 units of insulin.",2/19/2014,"02/19/2014",4/16/2014,"04/16/2014"
"Food",67525,"Ongoing","Diamond Foods Inc","San Francisco","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed directly in the following states: AZ, CA, FL, NV, PA, TX, WA, and WI.","F-1609-2014","Class I","Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5.","Best By Date: 01MAY14. Case Manufacturing Code: 09309210 05:00 through 09309210 10:30 05:00 and 10:30 represent 5:00 am-10:30 am - production time stamp.",,"144 cases/15 bags/4 oz.","Kettle Foods, Inc. is recalling Bakes Sea Salt Potato Chips, Kettle Brand, due to potential undeclared milk.",2/13/2014,"02/13/2014",3/12/2014,"03/12/2014"
"Drugs",67526,"Ongoing","Legacy Pharmaceutical Packaging","Earth City","MO","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1279-2014","Class II","Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.","Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15",,"667,068 bottles","Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.",2/14/2014,"02/14/2014",5/7/2014,"05/07/2014"
"Devices",67527,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Algeria , Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bahamas , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Brunei , Bulgaria , Cameroon , Canada , Cayman Islands , Chile , China , Columbia , Costa Rica , Croatia , Cyprus , Czech Republic , Denmark , Dominican Republic , Ecuador , Egypt , El Salvador , Ethiopia , Finland , France , Gaza & Jerichno , Georgia , Germany , Greece , Guatemala , Honduras , Hong Kong , Hungary , India , Indonesia , Iran , Iraq , Ireland , Israel , ITALY , Jamaica , Japan , Jordan , Kenya , Korea (South Korea) , Kuwait , Kyrgystan , Latvia , Lebanon , Libya , Lithuania , Luxembourg , Macedonia , Malaysia , Maldives , Mali , Mauritania , Mexico , Montenegro , Morocco , Netherlands , New Zealand , Norway , Oman , Pakistan , Palestine , Panama , Panam , Paraguay , Peru , Phillipines , Poland , Portugal , Qatar , Romania , Russia , San Marino , Saudi , Senegal , Serbia , Singapore , Slovakia , Slovenia , South Africa , SPAIN , Sri Lanka , Sweden , Switzerland , Taiwan , Thailand , Trinidad & Tobago , Tunisia , Turkey , United Arab Emirates , United Kingdom , Ukraine , Uruguay , Venezuela , Vietnam , Yemen","Z-1671-2014","Class II","ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. ","List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014; Lot 01913C000, Expires 14 MAR 2014; Lot 01913K000, Expires 12 NOV 2014; Lot 02413E000, Expires 09 MAY 2014; Lot 01312K000, Expires 12 NOV 2013; Lot 00813A000, Expires 08 JAN 2014; Lot 01412H000, Expires 16 AUG 2013; Lot 00912F000, Expires 30 MAY 2013.",,"7,780 calibrator kits","Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT Intact PTH Controls do not detect the shift. All current reagent, calibrator, and control inventory is impacted.",2/12/2014,"02/12/2014",6/4/2014,"06/04/2014"
"Devices",67527,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Algeria , Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bahamas , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Brunei , Bulgaria , Cameroon , Canada , Cayman Islands , Chile , China , Columbia , Costa Rica , Croatia , Cyprus , Czech Republic , Denmark , Dominican Republic , Ecuador , Egypt , El Salvador , Ethiopia , Finland , France , Gaza & Jerichno , Georgia , Germany , Greece , Guatemala , Honduras , Hong Kong , Hungary , India , Indonesia , Iran , Iraq , Ireland , Israel , ITALY , Jamaica , Japan , Jordan , Kenya , Korea (South Korea) , Kuwait , Kyrgystan , Latvia , Lebanon , Libya , Lithuania , Luxembourg , Macedonia , Malaysia , Maldives , Mali , Mauritania , Mexico , Montenegro , Morocco , Netherlands , New Zealand , Norway , Oman , Pakistan , Palestine , Panama , Panam , Paraguay , Peru , Phillipines , Poland , Portugal , Qatar , Romania , Russia , San Marino , Saudi , Senegal , Serbia , Singapore , Slovakia , Slovenia , South Africa , SPAIN , Sri Lanka , Sweden , Switzerland , Taiwan , Thailand , Trinidad & Tobago , Tunisia , Turkey , United Arab Emirates , United Kingdom , Ukraine , Uruguay , Venezuela , Vietnam , Yemen","Z-1672-2014","Class II","ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. ","List Number: 8K25-10. Lot Numbers and Expiration Dates: Lot 00713I000, Expires 05 SEP 2014; Lot 01813C000, Expires 14 MAR 2014; Lot 01813K000, Expires 12 NOV 2014; Lot 02613E000, Expires 09 MAY 2014; Lot 01412K000, Expires 12 NOV 2013; Lot 00713A000, Expires 08 JAN 2014; Lot 01012F000, Expires 30 MAY 2013.",,"List Number 8K25-10: 9,463 control kits","Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT Intact PTH Controls do not detect the shift. All current reagent, calibrator, and control inventory is impacted.",2/12/2014,"02/12/2014",6/4/2014,"06/04/2014"
"Devices",67527,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen","Z-1670-2014","Class II","ARCHITECT Intact PTH Reagent Kit (8K25) consists of: 1 Bottle (6.6 mL) Anti-PTH (goat, polyclonal) coated microparticles in TRIS buffer with a preservative of sodium azide; 1 Bottle (5.9 mL) Anti-PTH (goat, polyclonal) acridinium-labeled conjugate in MES buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide; and, 1 Bottle (10.0 mL) Intact PTH Assay Diluent containing phosphate buffer with protein (bovine, goat) stabilizer with a preservative of sodium azide. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. ","1) List Number 8K25-20; Lot Numbers and Expiration Dates: Lot 00913F000, Expires 23 NOV 2014; Lot 01313C000, Expires 21 AUG 2014; Lot 01512K000, Expires 25 APR 2014; Lot 01712H000, Expires 23 FEB 2014; Lot 01813I000, Expires 13 MAR 2015; Lot 02213K000, Expires 08 MAY 2015; Lot 01312G000, Expires 13 JAN 2014; Lot 00512H000, Expires 13 JAN 2014. 2) List Number: 8K25-25; Lot Numbers and Expiration Dates: Lot 00112K000, Expires 25 APR 2014; Lot 01113C000, Expires 21 AUG 2014; Lot 01313G000, Expires 05 JAN 2015; Lot 01612H000, Expires 23 FEB 2014; Lot 01913I000, Expires 02 FEB 2015; Lot 02213D000, Expires 05 OCT 2014; Lot 00113K000, Expires 11 APR 2015; Lot 01212G000, Expires13 JAN 2014; Lot 00412H000, Expires 13 JAN 2014. 3) List Number: 8K25-27; Lot Numbers and Expiration Dates: Lot 00212K000, Expires 25 APR 2014; Lot 01213C000, Expires 21 AUG 2014; Lot 01413G000, Expires 05 JAN 2015; Lot 01812H000, Expires 23 FEB 2014; Lot 02013I000, Expires 02 FEB 2015; Lot 02313D000, Expires 05 OCT 2014; Lot 00213K000, Expires 11 APR 2015; Lot 01412G000, Expires 13 JAN 2014; Lot 00612H000, Expires 13 JAN 2014. ",,"1) List Number 08K25-20: 6,433 assay kits; 2) List Number 08K25-25: 20,124 assay kits; 3) List Number 08K25-27: 10,968 assay kits ","Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT Intact PTH Controls do not detect the shift. All current reagent, calibrator, and control inventory is impacted.",2/12/2014,"02/12/2014",6/4/2014,"06/04/2014"
"Devices",67528,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1173-2014","Class II","Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers. ","Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A",".","15","HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.",2/14/2014,"02/14/2014",3/19/2014,"03/19/2014"
"Devices",67529,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.","Z-1214-2014","Class II","Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.","Catalog Number 94400, Lots W56013B and W56035B",,"305 kits (239 kits of W56013B, 66 kits of W56035B)","Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.",2/5/2014,"02/05/2014",3/26/2014,"03/26/2014"
"Food",67530,"Ongoing","Ice Cream Specialities","Carlinville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: IL, IN, NY","F-1610-2014","Class I","Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton.","Best By: 06/14/2015. UPC: 0-71580-08103-1.",,"2,448 cartons","This voluntary recall has been initiated because Dairy Rich Chocolate Ice Cream may contain peanut butter, which contains a peanut allergen.",2/14/2014,"02/14/2014",3/12/2014,"03/12/2014"
"Drugs",67532,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide, Italy and Republic of South Korea","D-1356-2014","Class II","GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1","Lot # A358502; Exp 01/15 ",,"4,155 bottles","Defective Container: Tamper evident ring failures discovered on some bottles. ",1/29/2014,"01/29/2014",6/11/2014,"06/11/2014"
"Food",67533,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Letter","PA","F-1569-2014","Class II","True Botanica brand Enzymes Plus, 45 CAPSULES, Product No. TB043-45, a Dietary Supplement --- Manufactured for True Botanica LLC, 1005 Richards Rd, Suite D, Hartland, WI 53029 ","Lot No. 130951",,"990 bottles","The dietary supplement lot contains Chloramphenicol at a level of 9.7 ppb. ",2/14/2014,"02/14/2014",3/5/2014,"03/05/2014"
"Food",67534,"Ongoing","Falafel King Ent, Inc.","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Colorado and NM. No foreign, military/govt,VA consignees.","F-1623-2014","Class I","Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps","Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014",,"4000 total, for all varieties","Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. ",2/14/2014,"02/14/2014",3/12/2014,"03/12/2014"
"Food",67534,"Ongoing","Falafel King Ent, Inc.","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Colorado and NM. No foreign, military/govt,VA consignees.","F-1622-2014","Class I","Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL**","Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014",,"4000 total, for all varieties","Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. ",2/14/2014,"02/14/2014",3/12/2014,"03/12/2014"
"Devices",67535,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.","Z-1481-2014","Class II","RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.","Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9. ",,"251 units (148 units domestically & 103 units internationally)","RaySearch Laboratories has recalled ''RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0'' software due to dose miscalculations for bolus/external/fixation support structures on CT-image.",2/14/2014,"02/14/2014",4/30/2014,"04/30/2014"
"Biologics",67540,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","California","B-0502-14","Class II","Source Plasma","TT0308385, TT0298307, TT0298890, TT0299106, TT0299722, TT0300033, TT0300655, TT0300997, TT0301648, TT0301996, TT0302655, TT0302965, TT0303520, TT0303853, TT0304415, TT0304711, TT0305341, TT0305807, TT0306289, TT0306773, TT0307060, TT0307523, TT0307909, TT0308792, TT0309310, TT0309776, TT0310290, TT0310736, TT0311210, TT0311619, TT0312146, TT0312600, TT0313131, TT0318444, TT0339890, TT0313612, TT0314151, TT0314608, TT0315068, TT0315474, TT0315951, TT0297947, TT0316332, TT0316791, TT0317203, TT0317478, TT0317919, TT0318850, TT0319314, TT0319732, TT0320218, TT0320623, TT0321102, TT0321399, TT0321754, TT0322179, TT0322446, TT0322982, TT0323292, TT0323745, TT0324157, TT0326275, TT0326576, TT0327088, TT0327371, TT0327855, TT0328682, TT0328840, TT0329393, TT0329627, TT0330105, TT0330372, TT0330863, TT0333432, TT0333741, TT0334634, TT0334826, TT0335554, TT0335767, TT0336481, TT0337008, TT0337314, TT0337823, TT0338725, TT0339060, TT0339554",".","86 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",12/19/2013,"12/19/2013",4/9/2014,"04/09/2014"
"Biologics",67541,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","CA","B-0471-14","Class II","Source Plasma","TT0306091; TT0307155; TT0307638; TT0305128; TT0305458",,"5 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",12/18/2013,"12/18/2013",3/26/2014,"03/26/2014"
"Biologics",67542,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","CA","B-0472-14","Class II","Source Plasma","TT0332120; TT0332466; TT0332926; TT0298638; TT0299019; TT0299579; TT0300059; TT0302035; TT0302785; TT0303087; TT0303804; TT0310875; TT0311187; TT0319719; TT0320023; TT0320584; TT0321162; TT0321623; TT0322549; TT0322679; TT0323400; TT0323655; TT0324230; TT0324464; TT0325344; TT0325718; TT0326545; TT0326954; TT0327595; TT0327837; TT0328375; TT0328664; TT0329243; TT0329742; TT0330045; TT0330481; TT0330841; TT0331263; TT0331645",,"39 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",2/19/2013,"02/19/2013",3/26/2014,"03/26/2014"
"Biologics",67543,"Terminated","DCI Biologicals, LLC","Bryan","TX","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0474-14","Class III","Source Plasma","BY0386092; BY0386376; BY0387157; BY0387287; BY0387767; BY0387954; BY0388378",,"7 units","Blood products, collected from a donor who was previously deferred, were distributed.",11/29/2013,"11/29/2013",3/26/2014,"03/26/2014"
"Biologics",67544,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","CA","B-0473-14","Class II","Source Plasma","TT0297450; TT0297848; TT0298354; TT0298821",,"4 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",12/19/2013,"12/19/2013",3/26/2014,"03/26/2014"
"Devices",67545,"Ongoing","WalkMed Infusion, LLC","Englewood","CO","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of IL, MA, KS, and, NJ.","Z-1122-2014","Class II","Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments. ","PFA14001,PFA14002,PFA14003,PFA14004,PFA14005,PFA14006,PFA14007,PFA14008,PFA14009,PFA14010,PFA14011,PFA14012,PFA14013,PFA14014,PFA14015,PFA14016,PFA14017,PFA14018,PFA14019,PFA14020,PFA14021,PFA14022,PFA14023,PFA14024,PFA14025,PFA14026,PFA14027,PFA14028,PFA14029,PFA14030,PFA14031,PFA14032,PFA14033,PFA14034,PFA14035,PFA14036,PFA14037,PFA14038,PFA14039,PFA14040,PFA14041,PFA14042,PFA14043,PFA14044,PFA14045,PFA14046,PFA14047,PFA14048,PFA14049,PFA14050,PFA14051,PFA14052,PFA14053,PFA14054,PFA14055,PFA14056,PFA14057,PFA14058,PFA14059,PFA14060,PFK13106,PFK13107,PFK13108,PFK13109,PFK13110,PFK13111,PFK13112,PFK13113,PFK13114,PFK13115,PFK13116,PFK13117,PFK13118,PFK13119,PFK13120,PFK13121,PFK13122,PFK13123,PFK13124,PFK13125,PFK13126,PFK13127,PFK13128,PFK13129,PFK13130,PFK13131,PFK13132,PFK13133,PFK13134,PFK13135,PFK13136,PFK13137,PFK13138,PFK13139,PFK13140,PFK13141,PFK13142,PFK13143,PFK13144,PFK13145,PFL13001,PFL13002,PFL13003,PFL13004,PFL13005,PFL13006,PFL13007,PFL13008,PFL13009,PFL13010,PFL13011,PFL13012,PFL13013,PFL13014,PFL13015,PFL13016,PFL13017,PFL13018,PFL13019,PFL13020,PFL13021,PFL13022,PFL13023,PFL13024,PFL13025,PFL13026,PFL13027,PFL13028,PFL13029,PFL13030,PFL13031,PFL13032,PFL13033,PFL13034,PFL13035,PFL13036,PFL13037,PFL13038,PFL13039,PFL13040,PFL13041,PFL13042,PFL13043,PFL13044,PFL13045,PFL13046,PFL13047,PFL13048,PFL13049,PFL13050,",,"797","WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.",2/17/2014,"02/17/2014",3/12/2014,"03/12/2014"
"Food",67546,"Ongoing","Raymond-Hadley Corp.","Spencer","NY","US","Voluntary: Firm Initiated","E-Mail","New Hampshire","F-1644-2014","Class II","STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909","Enjoy By Dates: 17 APR 2014 1, 16 AUG 2014 1, 03 SEPT 2014 1, 21 OCT 2014 1, 27 NOV 2014 1, 20 JAN 2015 1, 7 FEB 2015 1",".","7476 units","Labeling error. The cupcake mix is made with coconut milk powder which contains the sub-ingredients coconut milk and sodium caseinate (milk). These are listed in the ingredient statement. The ''Contains'' allergen statement lists Soy, Tree Nuts (coconut), and Wheat, but Milk is not listed. ",2/13/2014,"02/13/2014",3/19/2014,"03/19/2014"
"Devices",67547,"Completed","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Denmark only.","Z-2566-2014","Class II","Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.","Part #CP751506 Lot #478490",,"1","Product mix occurred prior to final package and labeling process.",9/20/2013,"09/20/2013",9/10/2014,"09/10/2014"
"Devices",67549,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide including PR and the country of Guam.","Z-1315-2014","Class II","Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin ","all serial numbers",".",," Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.",2/28/2014,"02/28/2014",4/9/2014,"04/09/2014"
"Devices",67550,"Ongoing","Phillips Respironics, Inc.","Murrysville","PA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.","Z-1143-2014","Class I","Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. ","Model (s), Catelogue, or Code Numbers were identified as: 1040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International, 1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447; TV114011448; TV114011449 TV11401144A; TV11401144B; TV11401144C; TV11401144D; TV11401144E; TV114011450; TV114011451; TV11401145B; TV11401145C; TV11401145D; TV11401145F; TV114011460; TV114011461; TV114011462; TV114011464; TV114012326; TV114012364;TV1140120A9; TV114012323; TV11401212C; TV11401230F; TV11401235A; TV11401235C; TV114012370TV114012371 TV114012372; TV114012376; TV114012415; TV114012465; TV21401150C; TV214011510; TV11401153D; TV11401213E; TV21401150F;TV114012165; TV11401133A;TV114012318; TV114012433; TV11401223A; TV11401223E; TV114012170; TV114011722; TV1140120B2;TV114012416; TV114012235; TV114012148; TV114011550; TV1140120BB; TV114012469; TV114012459; TV114012732;TV21401150A; TV11401130C; TV11401236D; TV114011455 ; TV114011465; TV114012239;TV11401223B; TV11401224D;TV114011336 TV11401133B;TV21401150E;TV214011511;TV214011513;TV214011515; TV214011516;TV214011519;TV21401151B;TV21401151F;TV21401210B TV214012117;TV214012119;TV21401211A;TV21401211D;TV214012122; TV114011712;TV114011458; TV114012133;TV114012361; TV114012429 TV11401245B TV114011724 TV114011727 TV114011740 TV214011512 TV21401210C TV214012111 TV214012120 TV214012121 TV21401240D TV114012333 TV11401233E TV114012349 TV11401234C TV114012422 TV11401243B TV11401245F TV11401231C TV114012355 TV114012137 TV11401233C TV1140120DB TV114012453 TV114011635 TV114011752 TV11401134F TV114011741 TV114011757 TV114012095 TV1140120CD TV1140120E3 TV11401215B TV114012130 TV114012134 TV114012343 TV114012347 TV114012462 TV114012473 TV114011554 TV114011711 TV114011719 TV114011723 TV114011725 TV114012259 TV014011405 TV014011503 TV014011504 TV21401210D TV21401210F TV214012114 TV214012116 TV11401207D TV11401207F TV114012085 TV114",,"572","Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.",2/11/2014,"02/11/2014",3/12/2014,"03/12/2014"
"Biologics",67551,"Terminated","Csl Plasma, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Other","Indiana","B-0468-14","Class II","Source Plasma","41205422321; 41205387140; 41205353899; ",".","3","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",1/9/2014,"01/09/2014",4/2/2014,"04/02/2014"
"Biologics",67552,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0470-14","Class III","Blood and Blood Products for Reprocessing","W069113101516; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/20/2014,"01/20/2014",4/2/2014,"04/02/2014"
"Biologics",67552,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0469-14","Class II","Red Blood Cells Leukocytes Reduced","W069113101516; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/20/2014,"01/20/2014",4/2/2014,"04/02/2014"
"Biologics",67553,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0476-14","Class II","Cryoprecipitated AHF","1619813; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67553,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0477-14","Class II","Platelets","1619813; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67553,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0475-14","Class II","Red Blood Cells","1444044; 1619813; ",".","2","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/31/2014,"01/31/2014",4/2/2014,"04/02/2014"
"Biologics",67554,"Terminated","Biomat USA Inc","Reno","NV","US","Voluntary: Firm Initiated","FAX","Spain; California","B-0392-14","Class III","Source Plasma","0300487938; 0300488345; 0300489002; 0300489570; 0300490435; 0300490684; 0300491382; 0300491737; 0300492711; 0300493807; 0300494158; 0300495122; 0300495417; 0300496174; 0300496553; 0300497384; 0300498402; 0300498745; 0300499952; 0300500251; 0300501085; 0300501524; 0300502548; ",".","23","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",1/17/2014,"01/17/2014",4/2/2014,"04/02/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2355-2014","Class II","Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 101613-108, Exp Date 1/16/2014; Lot# 110413-106, V 2/4/2014; Lot# 011314-108, Exp Date 4/13/2014",".","1,000 lbs. (20-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2360-2014","Class II","Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 121713-102",".","1,000 lbs. (20-50 lbs.)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2362-2014","Class II","Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 100813-108, Exp Date 4/8/2014; Lot# 112113-102, Exp Date 5/21/2014 ",".","1,000 lbs. (20-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2368-2014","Class II","Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 082813-103/104/105/106, Exp Date 11/28/2013; Lot# 090413-104/105, Exp Date 12/4/2013; Lot# 092413-103, Exp Date 12/24/2013; Lot# 102113-101/102, Exp Date 1/21/2014; Lot# 102413-101-104, Exp Date 1/24/2014; Lot# 102513-102-104, Exp Date 1/25/2014; Lot# 102513-105, Exp Date 1/25/2014; Lot# 112113-103, Exp Date 2/21/2014; Lot# 121013-104, Exp Date 3/10/2014; Lot# 121213-103/104, Exp Date 3/12/2014; Lot# 121213-105, Exp Date 3/12/2014 Lot# 121713-103/104, Exp Date 3/17/2014",".","83,050 lbs. (1661-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2354-2014","Class II","Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dip","Lot# 121213-101 ",".","495 lbs. (11-45 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2358-2014","Class II","Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 082013-101, 2/20/2014; Lot# 080813-102, 2/8/2014; Lot# 090413-102, 3/4/2014; Lot# 092413-101, 3/24/2014; Lot# 092513-106, 3/25/2014; Lot# 093013-104, 3/30/2014; Lot# 100813-107, 4/8/2014; Lot# 103013-101, 4/30/2014; Lot# 120413-103, 6/4/2014; Lot# 011314-101, 7/13/2014",".","3,850 lbs. (67-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2352-2014","Class II","French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture of French onion dip","Lot # 111413-107, Exp Date 2/14/2014;.Lot # 112513-105, Exp Date 2/25/2014; Lot # 120213-101, Exp Date 3/2/2014; Lot # 121 113-106, Exp Date 3/11/2014",".","650 lbs (13-50lbs bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2351-2014","Class II","Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of cheese dip ","Lot # 09041 3-1 03, Exp Date 12/4/2013; Lot # 091913-101, Exp Date 12/19/2013; Lot # 09301 3-1 07, Exp Date 12/30/2013; Lot # 1 0281 3-1 02, Exp Date 1/28/2014; Lot # 112013-106, Exp Date 2/20/2014; Lot # 121213-102, Exp Date 3/12/2014; Lot # 012814-101, Exp Date 4/28/2014",".","7,650 (153-50 lbs bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2365-2014","Class II","Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 073113-101/102",".","6,000 lbs. (120-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2369-2014","Class II","Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 080813-102, Exp Date 2/8/2014; Lot# 090413-102, Exp Date 3/4/2014; Lot# 092413-101, Exp Date 3/24/2014; Lot# 093013-104, Exp Date 3/30/2014; Lot# 120413-103, Exp Date 6/4/2014",".","4,350 lbs. (87-50 lbs.)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2363-2014","Class II","Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 091913-102 ",".","500 Lbs. (10-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2364-2014","Class II","Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 073113-103/104, Exp Date 1/31/2014; Lot# 091913-105/106, Exp Date 3/19/2014; Lot# 102813-104/105, Exp Date 4/28/2014; Lot# 121013-103, Exp Date 6/10/2014 ",".","19,000 lbs (380-50 lbs bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2353-2014","Class II","Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot # 100313-103. Exp Date 1/3/2014, Lot # 112013-105, Exp Date 2/20/2014 ",".","600 Lbs. (12-50 lbs bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2366-2014","Class II","Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the manufacture of dip","Lot# 092513-108, Exp Date 12/25/2013; Lot# 010814-103, Exp Date 4/8/2014 ",".","500 lbs. (10-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2350-2014","Class II","Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip ","Lot # 090313-103, Exp date 3/3/2014; Exp date Lot #091 91 3-1 04, Exp date 3/19/2014; Lot # 093013-105, Exp date 3/30/2014; Lot # 102813-101, Exp date 4/28/2014; Lot # 112113-107, Exp date 5/21/2014; Lot# 121013-102, Exp date 6/10/2014; Lot # 012814-102, Exp date 7/28/2014",".","10,300 Lbs (203-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2367-2014","Class II","Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the manufacture of dip","Lot# 080113-101/102, Exp Date 2/1/2014; Lot# 092413-104/105, Exp Date 3/24/2014; Lot# 102513-103, Exp Date 4/25/2014; Lot# 120513-102/103/104/105, Exp Date 6/5/2014; Lot# 010814-104/105, Exp Date 7/8/2014 ",".","28,500 lbs. (570-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2361-2014","Class II","All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 100813-109, Exp Date 1/8/2014; Lot# 121013-101, Exp Date 3/10/2014 ",".","2,900 lbs. (58-50 lbs.)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2357-2014","Class II"," All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 101613-104",".","350 Lbs. (7-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2359-2014","Class II","Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 072913-104, Exp Date 10/29/2013; Lot# 082213-101, Exp Date 11/22/2013; Lot# 082113-101, Exp Date 11/21/2013; Lot# 091713-103, Exp Date 12/17/2013; Lot# 101613-107, Exp Date 1/16/2014; Lot# 121913-101, Exp Date 3/19/2014 ",".","5,200 lbs. (104-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Food",67555,"Ongoing","Custom Ingredients LLC ","New Braunfels","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY","F-2356-2014","Class II","Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of cheese dip","Lot# 082913-102, Exp Date 11/29/2013; Lot# 091713-101, Exp Date 12/17/2014",".","200 lbs. (4-50 lbs. bags)","Undeclared wheat",2/17/2014,"02/17/2014",9/3/2014,"09/03/2014"
"Devices",67556,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.","Z-1272-2014","Class II","AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. ","Model nos. 7412807, 7727717, 7728392 with serial numbers: 35020, 34999,35098 35113 35042 35061 35064 35073 35014 35069 35053 35055 35056 35054 35008 35057 35044 35018 35097 35108 35046 35048 35050 35045 35004 35019 46004 46005 40000 40009 40011 40006 40007 40010 44016 44005 44011 ",".","37","Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system. ",2/7/2014,"02/07/2014",4/2/2014,"04/02/2014"
"Drugs",67557,"Ongoing","Gilead Sciences, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico.","D-1090-2014","Class III","Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland ","Lot #'s: 002390, 002400, Exp 02/17.",,"39,223 bottles","Presence of Particulate Matter: Red Silicone Rubber Particulates are Present in Drug.",2/19/2014,"02/19/2014",3/5/2014,"03/05/2014"
"Devices",67558,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","MN, WI, PA, MI, AL, OH, NC, AR, and NJ.","Z-1309-2014","Class II","Artis Zee Angiographic x-ray systems.","Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959. ",".","9","An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.",2/7/2014,"02/07/2014",4/9/2014,"04/09/2014"
"Devices",67559,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.","Z-1216-2014","Class II","syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673","Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.",,"50","Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis. ",1/27/2014,"01/27/2014",3/26/2014,"03/26/2014"
"Devices",67560,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.","Z-1457-2014","Class II","The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.","part no. 399.24, lot number T974302",".","20","The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.",2/11/2014,"02/11/2014",4/23/2014,"04/23/2014"
"Devices",67562,"Ongoing","Medefil Incorporated","Glendale Heights","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.","Z-1149-2014","Class III","Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.","Product Number: MIH-3333; NDC Number: 64253-333-33; Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.",,"1,608 Master Cartons","The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe). ",2/19/2014,"02/19/2014",3/12/2014,"03/12/2014"
"Drugs",67563,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1280-2014","Class II","Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. ","Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15 ",,"257904 bottles","Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. ",2/12/2014,"02/12/2014",5/7/2014,"05/07/2014"
"Drugs",67563,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1281-2014","Class II","Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.","Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15",,"72,356 bottles","Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. ",2/12/2014,"02/12/2014",5/7/2014,"05/07/2014"
"Drugs",67564,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1190-2014","Class III","QVAR (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.","lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations ",".","257,832 cylinders","Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Food",67565,"Ongoing","Newman'S Own Inc.","Westport","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1562-2014","Class II","Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9","Production code Use By dates: 3/28/15, 4/28/15, 5/28/15, 6/28/15, 7/28/15, 8/28/15 ",,"36,951 cases (12/case)","Undeclared wheat",2/18/2014,"02/18/2014",3/5/2014,"03/05/2014"
"Devices",67566,"Ongoing","Biosense Webster, Inc.","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1176-2014","Class II","PENTARAY NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128204, D128205. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.","Lot Numbers: 15791519L 15803349L 15825343L 15845012L 15852437L 15859153L 15869785L 15793496L 15803350L 15825344L 15845013L 15852438L 15859154L 15869786L 15793497L 15803351L 15825345L 15845014L 15854132L 15859155L 15869787L 15793499L 15803352L 15825346L 15845015L 15854136L 15859156L 15869788L 15793500L 15803353L 15825347L 15845016L 15854141L 15859157L 15869789L 15793502L 15803354L 15825348L 15845017L 15854145L 15859158L 15869790L 15795833L 15803355L 15825863L 15845018L 15854147L 15859159L 15869791L 15795836L 15805357L 15825864L 15847688L 15854150L 15859160L 15872341L 15795838L 15805358L 15830258L 15847689L 15854157L 15859161L 15872342L 15795839L 15805359L 15830259L 15847690L 15854158L 15859318L 15872343L 15795843L 15805360L 15830260L 15847691L 15854161L 15859853L 15872344L 15795844L 15805361L 15830261L 15847692L 15854162L 15860904L 15872346L 15795846L 15805362L 15830262L 15847693L 15854936L 15862710L 15872347L 15795847L 15805363L 15830263L 15847694L 15854938L 15862711L 15872348L 15798652L 15805364L 15830264L 15847695L 15856101L 15862712L 15872349L 15798653L 15805365L 15830265L 15847696L 15856102L 15862714L 15872350L 15798655L 15805366L 15830266L 15847697L 15856103L 15862715L 15872351L 15798657L 15808932L 15830267L 15850674L 15856104L 15864760L 15880079L 15798659L 15808933L 15835408L 15850675L 15856105L 15864762L 15880082L 15798660L 15808934L 15835409L 15850676L 15856106L 15864763L 15881092L 15798661L 15808935L 15835410L 15850677L 15856107L 15864765L 15881093L 15798663L 15808936L 15835411L 15850690L 15856108L 15864766L 15881436L 15798664L 15808937L 15835412L 15850692L 15856109L 15864767L 15881437L 15801121L 15808938L 15835413L 15850693L 15856110L 15864768L 15881818L 15801122L 15808939L 15835414L 15850695L 15857409L 15864769L 15881819L 15801123L 15808940L 15835415L 15850696L 15857410L 15864770L 15882156L 15801124L 15808941L 15835416L 15850708L 15857411L 15864771L 15885446L 15801125L 15811171L 15835417L 15852429L 15857412L 15868804L 15885447L 15801126L 15811173L 15837216L 15852430L 15857413L 15868805L 15885819L 15",".","4,034 units total (2,914 units in US)","Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft.",2/20/2014,"02/20/2014",3/19/2014,"03/19/2014"
"Devices",67567,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: VA, WA, KY, IL, and IA.","Z-1300-2014","Class II","PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070","Lot Numbers: REXA1302, REXA1350, REXB1160",".","777","Bard Access Systems, Inc. has notified customers of a labeling discrepancy involving PowerPort Slim Implantable Port 1716000, 1716070 in which the label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.",2/27/2014,"02/27/2014",4/2/2014,"04/02/2014"
"Devices",67568,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.","Z-1505-2014","Class II","MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. ","model nos. 10746665, 10746666, 10847610, 10746700",,"12","It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose, and could potentially crash down during an examination.",2/13/2014,"02/13/2014",4/30/2014,"04/30/2014"
"Devices",67569,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.","Z-1469-2014","Class II","Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 ","Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 00000",".","133 units","The ''fluoro match registration'' function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated C-arm, the software algorithm may not find an adequate match between the intraoperatively acquired 2D fluoroscopic images and the preoperative CT or other compatible 3D data sets. If such an incorrect match would occur, the display of instruments by the navigation system would be shifted compared to the actual patient anatomy.",11/18/2013,"11/18/2013",4/23/2014,"04/23/2014"
"Biologics",67570,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","Rhode Island","B-0483-14","Class III","Red Blood Cells Leukocytes Reduced","W051714101583",".","1 unit","Blood product, for which the additive solution was not added during manufacturing, was distributed.",1/14/2014,"01/14/2014",3/19/2014,"03/19/2014"
"Biologics",67571,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0479-14","Class II","Plasma Frozen within 24 hours (FP24)","W036813256009",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Biologics",67571,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0481-14","Class II","Red Blood Cells","W036813023947, 2300334",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Biologics",67571,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0482-14","Class II","Platelets Pooled Leukocytes Reduced","W036813817523, 2909442",".","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Biologics",67571,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0480-14","Class II","Red Blood Cells Leukocytes Reduced","W036813256009",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Biologics",67571,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0478-14","Class III","Blood and Blood Products for Reprocessing","W036813023947",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/19/2014,"03/19/2014"
"Devices",67572,"Ongoing","Atricure Inc","West Chester","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.","Z-1209-2014","Class II","Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.","Lot Number MFR-0424-1",,"46 units","The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.",1/23/2014,"01/23/2014",3/26/2014,"03/26/2014"
"Food",67573,"Ongoing","Jardine Foods Inc","Buda","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, Canada","F-2065-2014","Class II","HT Traders Medium Queso (Item#HT510) ; Label: Medium Queso; Premium Salsa; Net Wt. 16 oz. Distributed by Harris Teeter, Matthews, NC","Lot Codes Q-301-13, P-301-13, L-315-13, K-315-13, L-315-13",,"9072 jars (or 856 cases each holding 12 jars)","Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/20/2014,"02/20/2014",7/9/2014,"07/09/2014"
"Food",67573,"Ongoing","Jardine Foods Inc","Buda","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, Canada","F-2064-2014","Class II","Mi Queso, Su Queso (Item#50440) ; Label: Jardine's 7J Ranch Mi Queso, Su Queso; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.","Lot Codes T-261-13, I-339-13, H-031-14, M-021-14",,"6,233 jars","Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/20/2014,"02/20/2014",7/9/2014,"07/09/2014"
"Food",67573,"Ongoing","Jardine Foods Inc","Buda","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, Canada","F-2063-2014","Class II","DL Jardines Queso Loco (Item#R5230) ; Label: Special Edition D. L. Jardine's Texas Ranch Recipes Queso Loco Cheese Salsa & Dip; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.","Lot Codes R-261-13, S-261-13, Q-261-13, H-331-13, N-274-13, F-031-14, G-031-14, N-017-14",,"14,200 jars","Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/20/2014,"02/20/2014",7/9/2014,"07/09/2014"
"Food",67573,"Ongoing","Jardine Foods Inc","Buda","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, Canada","F-2066-2014","Class II","Three Compadres Gift Box containing a varying combination of three Jardine products in 16 oz. glass jars. Some Gift Boxes included one jar of either Jardine's 7J Ranch Mi Queso, Su Queso (See Product #3) or one jar of Queso Loco Cheese Salsa & Dip (See Product #2)","Gift Box Lot Codes: Y-284-13, Z-276-13, Z-305-13, Y-305-13, W-325-13, V-329-13, W-343-13, Z-345-13, Z-007-14, Y-014-14, Y-030-14, Y-030-14, Q-035-14",,"1805 gift boxes","Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/20/2014,"02/20/2014",7/9/2014,"07/09/2014"
"Food",67573,"Ongoing","Jardine Foods Inc","Buda","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, Canada","F-2062-2014","Class II","Jardines 7J Queso Amarillo (Item#50100) ; label: Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.","Lot Codes R-248-13, R-301-13, O-274-13, J-339-13, J-008-14, H-031-14",,"9,649 jars","Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/20/2014,"02/20/2014",7/9/2014,"07/09/2014"
"Devices",67574,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.","Z-1322-2014","Class II","Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.","152718, 152003, 152007, 151963, 152081, 151693, 152131, 152318, 105792, 105570, 152778, 151052, 152363, 152472, 152195, 153022, 152689, 152640, 152642, 152663, 152680, 152782, 152796, 152829, 152862, 152962, 153030, 153125, 153244, 153270, 153211, 153296, 152834, 152596, 151354, 151353, 152664, 151200, 151823, 151822, 151610, 152026, 152027, 152692, 151276, 152856, 151106, 152877, 152986, 152810, 105935, 153105, 153069, 151023, 152914, 151975, 151240, 151239, 153135, 105810, 153145, 153129, 151182, 151650, 152886, 151850, 152831, 153132, 151343, 153063, 105985, 152832, 152845, 152837, 152863, 152859, 152776, 152857, 152866, 152876, 152820, 152870, 152884, 152865, 152872, 152909, 152910, 152911, 152918, 152934, 152961, 152966, 153009, 153041, 153026, 153078, 153079, 153083, 153070, 153066, 153027, 153154, 153157, 153159, 153165, 153131, 153352, 152675, 152737, 152299, 152403, 152676, 151670, 152252, 151153, 151482, 151296, 152068, 152286, 152097, 151554, 151768, 151853, 151854, 151786, 151495, 151787, 153099, 152935, 151865, 151466, 105920, 152521, 151536, 151263, 105988, 151028, 151058, 152719, 151174, 151597, 152645, 152650, 152647, 105755, 152743, 151857, 151921, 105896, 151986, 152855, 152092, 151006, 151277, 105314, 105919, 152746, 152770, 105901, 151635, 152575, 152627, 151701, 151922, 151852, 152422, 152309, 152498, 152628, 152706, 152616, 105850, 152014, 151688, 151638, 152721, 153234, 152816, 105554, 105987, 151452, 151166, 152913, 151740, 152042, 152904, 152254, 152753, 152554, 152591, 152644, 152607, 152648, 152687, 152714, 152899, 152739, 152672, 152900, 152952, 152977, 153080, 153169, 153183, 152908, 153349, 153325, 152702, 152869, 152724, 151529, 152840, 152841, 151442, 151445, 151612, 151613, 151756, 105677, 151755, 151189, 151034, 151652, 152757, 105893, 105892, 152945, 151060, 105711, 105997. 151324, 151316, 151318, 151385, 152873, 151660, 152734, 152646, 152682, 151087, 151088, 105833, 152613, 152958, 105946, 151117, 151308, 151108, 151280, 151912, 152106, 152157, 152294, 152637, 152624, 15266",".","498","The problem is that the ''static tolerances'' from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.",3/28/2013,"03/28/2013",4/9/2014,"04/09/2014"
"Food",67575,"Ongoing","Dayton Nut Specialties Inc","Dayton","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in KY","F-1671-2014","Class II","Creation Special Snack Mix; 25 lb. cardboard carton","Lot #s: 13037, 13114, 13309 and 13333.",,"42 cases","Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.",1/31/2014,"01/31/2014",3/26/2014,"03/26/2014"
"Food",67575,"Ongoing","Dayton Nut Specialties Inc","Dayton","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in KY","F-1672-2014","Class II","Bar Star Snack Mix; 25 lb. cardboard carton","Lot #s: 13013037, 13078, 13114, 13163, 13227, 13288 and 13333.",,"59 cases","Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.",1/31/2014,"01/31/2014",3/26/2014,"03/26/2014"
"Food",67577,"Ongoing","Whole Foods Market Mid-Atlantic Kitchen","Landover","MD","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to MD, NJ, OH, VA, KY, PA, and Washington, D.C.","F-1743-2014","Class I","Tom Yom Soup, 24 oz. plastic cups, packed 6 cups\cardboard case, and labeled in part ***Manufactured by Whole Foods Market, Landover, MD 20785***UPC 00000601467***","Use by 4/8/14",".","504 cups","Ready to eat soup lists whey in the ingredient statement, but the product does not declare milk as the source for the allergen.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Devices",67578,"Ongoing","Gyrus Medical, Inc","Osseo","MN","US","Voluntary: Firm Initiated","Letter","US Distribution.","Z-1196-2014","Class II","Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).","Lots: MK761655, MK764022, MK767655, MK526401",".","856 units","Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.",2/19/2014,"02/19/2014",3/19/2014,"03/19/2014"
"Food",67579,"Ongoing","L. M. Noodle Company, LLC","Wiggins","CO","US","Voluntary: Firm Initiated","Letter","Product was distributed to retail stores in NE, CO, WY. No foreign, military/govt/VA consignees.","F-1559-2014","Class II","Marlyce's Homemade Style Noodles, Net Wt. 8 oz, Packaged in plastic bags, 10 per case, UPC 094219217069. Manufactured by L.M.Noodle Company, LLC, 416 Main Street, Wiggins, CO 80654.","UPC 094219217069, ",,"18,200","L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles due to an undeclared allergen. The product label does not declare ''wheat'' flour.",12/20/2013,"12/20/2013",3/5/2014,"03/05/2014"
"Drugs",67580,"Ongoing","Agila Specialties Private Ltd.","Bangalore, Karnataka",,"IN","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1225-2014","Class II","etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.","Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14 ",".","7919 cartons ","Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials. ",2/14/2014,"02/14/2014",4/16/2014,"04/16/2014"
"Veterinary",67581,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide (AL, AR, AZ, CA, CO, CT, , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV) + District of Columbia","V-145-2014","Class II","The Acclaim Encore is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.","List Number: 12569. Serial Numbers: 13733228 , 13734668 , 13733008 , 13733509 , 13733048 , 13734803 , 13733014 , 13733062 , 13734655 , 13734993 , 13734378 , 13734376 , 13734512 , 13734831 , 13734978 , 13734584 , 13734762 , 13733065 , 13734554 , 13734594 , 13734610 , 13734612 , 13734771 , 13734973 , 13733032 , 13734396 , 13734900 , 13734996 , 13733547 , 13734357 , 13734726 , 13734666 , 13733194 , 13733550 , 13734436 , 13734551 , 13734574 , 13734597 , 13734811 , 13733230 , 13734171 , 13734793 , 13733000 , 13733504 , 13734767 , 13734799 , 13734817 , 13734904 , 13734905 , 13734988 , 13734673 , 13734766 , 13734906 , 13734913 , 13734977 , 13733064 , 13734178 , 13734552 , 13734606 , 13734969 , 13734801 , 13734813 , 13734822 , 13733110 , 13733197 , 13733200 , 13733394 , 13733793 , 13734325 , 13734546 , 13734730 , 13734756 , 13734773 , 13734776 , 13734614 , 13734825 , 13733175 , 13733809 , 13734559 , 13734739 , 13734827 , 13734912 , 13734956 , 13733732 , 13733687 , 13733786 , 13733132 , 13733275 , 13734948 , 13734984 , 13734832 , 13733045 , 13733415 , 13734187 , 13733017 , 13733179 , 13733385 , 13733739 , 13734747 , 13734960 , 13734962 , 13733131 , 13734556 , 13734732 , 13734882 , 13734902 , 13734300 , 13733050 , 13733181 , 13733734 , 13734346 , 13734365 , 13734553 , 13734783 , 13733266 , 13734350 , 13734608 , 13734750 , 13734774 , 13734802 , 13734909 , 13734361 , 13734809 , 13734957 , 13733392 , 13734352 , 13734375 , 13734498 , 13734727 , 13734761 , 13734815 , 13734976 , 13734547 , 13734562 , 13734899 , 13733102 , 13733214 , 13733463 , 13734429 , 13734495 , 13734549 , 13734565 , 13734571 , 13734829 , 13734914 , 13734991 , 13734299 , 13734684 , 13733029 , 13733066 , 13733193 , 13733374 , 13733461 , 13733686 , 13734170 , 13734560 , 13734723 , 13734781 , 13734788 , 13734794 , 13734898 , 13734926 , 13733030 , 13733172 , 13733548 , 13733599 , 13733614 , 13733804 , 13734619 , 13734711 , 13734738 , 13734760 , 13734907 , 13734911 , 13734954 , 13733173 , 13733196 , 13733237 , 13733272 , 13734100 , 13734101 , 13734336 , 1373451",,"2,503 pumps","Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.",10/31/2013,"10/31/2013",7/30/2014,"07/30/2014"
"Devices",67582,"Ongoing","Infantino LLC","San Diego","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide.","Z-1313-2014","Class II","Infantino Squeeze & Teethe Monkey, ''Go Gaga Squeeze & Teether Coco the Monkey''. Non-Fluid Filled Teething Ring.","Model # 206-647. All lot numbers are included in the scope of the recall ",".","144,000 units","Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, ''Go Gaga Squeeze & Teethe Coco the Monkey'', Model Number 206-647, because the tail of the monkey may pose a choking hazard to young children.",1/6/2014,"01/06/2014",4/9/2014,"04/09/2014"
"Devices",67584,"Ongoing","Medical Information Technology, Inc.","Canton","MA","US","Voluntary: Firm Initiated","Other","Distributed USA (nationwide) and Canada.","Z-1234-2014","Class II","MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).","Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.",,"438","Potential for erroneous result reporting. ",2/21/2014,"02/21/2014",3/26/2014,"03/26/2014"
"Biologics",67585,"Terminated","Talecris Plasma Resources, Inc","Research Triangle Park","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0491-14","Class III","Source Plasma","3520277021; 3520276367; 3520275784; 3520275235; 3520274652; 3520273706; 3520272384; 3520272017; 3520271116; 3520270771; 3520268608; 3520268234; 3520267426; 3520266968",,"14 units","Blood products, collected from a donor who was previously deferred, were distributed.",12/31/2013,"12/31/2013",3/26/2014,"03/26/2014"
"Devices",67586,"Ongoing","Siemens Medical Solutions Diagnostics","Flanders","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Foreign Distribution.","Z-1316-2014","Class II","IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000","IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839",".","1006 units","There is a potential for incorrect results to be reported from processing of a sample tube.",2/3/2014,"02/03/2014",4/9/2014,"04/09/2014"
"Food",67587,"Ongoing","Fannie May Confection Brands Inc","North Canton","OH","US","Voluntary: Firm Initiated","Letter","Product was distributed in AZ, FL, IA, IL, IN, MI, MN AND WI.","F-1682-2014","Class I","4 oz. Heart - Shaped Box of Assorted Chocolates","13344, 13345, 13361, 14010, 14014, 12365, and 13002.",,"500 cases (24 units per case)","Undeclared Allergen - peanut",2/19/2014,"02/19/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1237-2014","Class II","Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.","540204R001",,"3840 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1238-2014","Class II","SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. ","540204R001",,"5,540 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1240-2014","Class II","'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. ","540204R001",,"54,590 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1241-2014","Class II","SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. ","540204R001",,"4,760 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1239-2014","Class II","JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.","540204R001",,"31,250 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67588,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and in the state of TX","Z-1236-2014","Class II","Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.","540204R001",,"600 catheters","The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. ",2/7/2014,"02/07/2014",3/26/2014,"03/26/2014"
"Devices",67590,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1246-2014","Class II","Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.","Lot 1174497, exp. 2015/04",,"40/5/50-disc cartridge packages","Some of the discs may not be impregnated with the antibiotic.",2/18/2014,"02/18/2014",3/26/2014,"03/26/2014"
"Devices",67591,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-1483-2014","Class I","Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.","List Number: 12237; Serial Numbers: 12670196, 12670182, 12670203, 12670281, 12671061, 12671058, 12671175, 12718477, 12672450, 12672413, 12716099, 12716071, 12671563, 12672061, 12672079, 12672156, 12718948, 12717835, 12716259, 12716268, 12671580, 12671554, 12716244, 12716293, 12671647 , 12672014 , 12672021 , 12672064 , 12672074 , 12672137 , 12672138 , 12672143 , 12672173 , 12672179 , 12672185 , 12672186 , 12672161 , 12672217 , 12716140 , 12716324 , 12716396 , 12716489 , 12716316 , 12671666 , 12672065 , 12672175 , 12716251 , 12716550 , 12716398 , 12716963 , 12716451 , 12716345 , 12716519 , 12716693 , 12716477 , 12716610 , 12716638 , 12716344 , 12716538 , 12716515 , 12716315 , 12716720 , 12716623 , 12716787 , 12716822 , 12717186 , 12716738 , 12717343 , 12716798 , 12716812 , 12716532 , 12717123 , 12716849 , 12717281 , 12717049 , 12717160 , 12717359 , 12717028 , 12717298 , 12673508 , 12673609 , 12673114 , 12673524 , 12673629 , 12673529 , 12673563 , 12673597 , 12673610 , 12673700 , 12673741 , 12673584 , 12673647 , 12673679 , 12673711 , 12672796 , 12672848 , 12672740 , 12672801 , 12673033 , 12673099 , 12671687 , 12673054 , 12673127 , 12673035 , 12673144 , 12672775 , 12673082 , 12673131 , 12673638 , 12672747 , 12672784 , 12672789 , 12673069 , 12673083 , 12673159 , 12673180 , 12673350 , 12673443 , 12718788 , 12716217 , 12672791 , 12672794 , 12672766 , 12672925 , 12672990 , 12673212 , 12673165 , 12672749 , 12672777 , 12672882 , 12672886 , 12671505 , 12673916 , 12717412 , 12673887 , 12673899 , 12673919 , 12673922 , 12673915 , 12673926 , 12673947 , 12674013 , 12674024 , 12672845 , 12673050 , 12674010 , 12673971 , 12716417 , 12717963 , 12718476 , 12672244 , 12716470 , 12671680 , 12717834 , 12718964 , 12718713 , 12673944 , 12717693 , 12671566 , 12672008 , 12674347 , 12674349 , 12674392 , 12674416 , 12671926 , 12674363 , 12674380 , 12674428 , 12674475 , 12674534 , 12674362 , 12674407 , 12674430 , 12674443 , 12716672 , 12671859 , 12717799 , 12717966 , 12674144 , 12674098 , 12674119 , 12674086 , 12674090 , 12674110 , 12674117 "," 12674611 , 12674628 , 12674636 , 12674662 , 12674676 , 12674691 , 12674702 , 12674716 , 12674743 , 12675292 , 12675414 , 12675415 , 12675471 , 12675493 , 12674751 , 12674771 , 12674901 , 12675221 , 12675351 , 12675352 , 12675381 , 12675412 , 12675418 , 12675421 , 12675458 , 12675459 , 12675791 , 12675916 , 12675921 , 12676048 , 12676070 , 12676075 , 12676133 , 12676154 , 12676159 , 12676165 , 12676190 , 12676191 , 12676671 , 12676732 , 12676741 , 12676754 , 12676769 , 12678384 , 12672205 , 12678943 , 12678993 , 12679185 , 12680019 , 12717355 , 12717713 , 12671804 , 12671567 , 12670105 , 12672289 , 12678291 , 12679842 , 12674264 , 12716347 , 12670190 , 12675271 , 12678649 , 12670041 , 12671136 , 12717443 , 12676275 , 12678849 , 12716274 , 12719188 , 12675290 , 12677011 , 12672449 , 12672087 , 12679012 , 12717258 , 12718083 , 12717347 , 12671552 , 12674802 , 12675816 , 12679659 , 12677390 , 12716946 , 12673970 , 12677308 , 12676943 , 12679425 , 12675731 , 12717522 , 12678343 , 12672930 , 12719445 , 12678897 , 12678791 , 12719238 , 12717262 , 12671523 , 12676210 , 12717375 , 12716490 , 12718537 , 12717554 , 12716636 , 12717168 , 12717402 , 12718140 , 12716923 , 12670124 , 12718484 , 12671606 , 12719451 , 12670297 , 12672983 , 12673465 , 12674529 , 12675699 , 12671707 , 12677387 , 12671585 , 12718506 , 12717889 , 12670467 , 12718089 , 12717939 , 12719069 , 12673140 , 12719342 , 12719368 , 12677464 , 12716087 , 12719317 , 12671841 , 12675237 , 12677399 , 12671364 , 12719073 , 12672928 , 12716661 , 12716369 , 12716749 , 12717818 , 12719663 , 12716854 , 12718807 , 12718260 , 12718043 , 12717445 , 12675256 , 12675845 , 12716372 , 12718585 , 12717423 , 12717079 , 12718462 , 12671177 , 12717513 , 12672081 , 12673386 , 12675817 , 12673591 , 12676591 , 12677710 , 12717573 , 12719047 , 12673439 , 12718628 , 12672102 , 12670388 , 12718403 , 12717344 , 12671219 , 12677419 , 12719297 , 12719671 , 12718247 , 12673621 , 12672083 , 12716580 , 12678869 , 12716360 , 12716146 , 12719301 , 12671974 , 12675831 , 12679161 , 12678813 ","13,218 infusion pumps total","Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.",10/31/2013,"10/31/2013",5/7/2014,"05/07/2014"
"Devices",67591,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-1482-2014","Class I","Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.","List Number: 12032; Serial Numbers: 12322921, 12323859, 12322780, 12322801, 12322810, 12322812, 12322878, 12322880, 12322887, 12322896, 12322903, 12322904, 12322911, 12322917, 12322936, 12322939, 12323867, 12322916, 12323056, 12321139, 12324767, 12324854, 12324802, 12322873, 12324375, 1231453, 1231610.",,"13,218 infusion pumps total","Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.",10/31/2013,"10/31/2013",5/7/2014,"05/07/2014"
"Devices",67592,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to states of: CO, IN, MA, NJ, NC, OH, PA, TX, and VA; and countries of: Algeria,France, Germany, Poland, Russia, and Taiwan.","Z-1245-2014","Class II","GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.","Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR F1RF6114GR F1RF6118GR F1RF6123GR F1RF6130GR F1RF6227GR F1RF6236G F1RF6236GR F1RF6243GR F1RF6282GR F2G40578G F2G40579G F2G40580G F2G40581G F2G40584G F2G40585G F2G40586G F2G40588G F2G40592G F2G40593G F2G40594G F2G40595G F2G40596G F2G40598G F2G40599G F2G40605G F2G40606G F2G40607G F2G40609G F2G40610G F2G40611G F2G40615G F2G40631G F2G40705G F2G40820G F2G40835G F2RF3572G F2RF3640G F2RF3651G F3G45957G F3G45980G F3G46200G F43S0355G F43S0356G G0RF0516GR G0RF0592GR G0RF0596GR G1RF6518G G1RF6544G G1RF6546G G3G46241G G3G46616G G3G46649G G3G46664G G3G46674G G3G46679G H0RF0607GR H0RF0772G H0RF0845GR H2G41289G H2G41307G H2G41571GR H2G41786G H2G41787G H2RF4002GR J0RF0465G J0RF1103G J1RF7280G J1RF7281G J1RF7282G J1RF7283G J1RF7284G J1RF7285G J1RF7286G J1RF7289G J1RF7290G J1RF7298G J1RF7387G J2G42049G J2G42100GR J33T0400G J43S0499G J43S0503G J43S0504G J43S0506G J43T5719G J43T5720G J43T5727G J43T5731G J43T5799G J43T5801G J43T5810G J43T5812G J43T5813G J43T5814G J43T5815G J43T5827G J43T5831G J43T5832G J43T5877G J43T6078G K1RF7644G K1RF7673G K1RF7674G K1"," SE409513813GA SE409513815GA SE409513815GR SE409513817GA SE409513818GA SE409513821GA SE409513822GA SE409513824GA SE409513825GA SE409513826GA SE409513832GA SE409513833GA SE409513834GA SE409513836GA SE409513839GA SE409513839GR SE409513843GA SE409513846GA SE409513848GA SE409513849GA SE409513850GA SE409513851GA SE409513852GA SE409513853GA SE409513854GA SE409513855GA SE409513856GA SE409513857GA SE409513858GA SE409513859GA SE409513860GA SE409513861GA SE409513862GA SE409513863GA SE409513864GA SE409513865GA SE409513866GA SE409513867GA SE409513869GA SE409513870GA SE409513873GA SE409523874GA SE409523875GA SE409523876GA SE409523884GA SE409523885GA SE409523886GA SE409523887GA SE409523888GA SE409523890GA SE409523894GA SE409523896GA SE409523899GA SE409523900GA SE409523901GA SE409523903GA SE409523905GA SE409523907GA SE409523911GA SE409523912GA SE409523914GA SE409523915GA SE409523916GA SE409523917GA SE409523918GA SE409523919GA SE409523920GA SE409523922GA SE409523923GA SE409523934GA SE409523935GA SE409523938GA SE409523939GA SE409523942GA SE409524026GA SE409524030GA SE409524031GA SE409524038GA SE409524039GA SE409534040GA SE409534042GA SE409534043GA SE409534044GA SE409534046GA SE409534047GA SE409534050GA SE409534051GA SE409534053GA SE409534054GA SE410024117GA SE410024140GA SE410024141GA SE410024161GA SE410024162GA SE410024164GA SE410024176GA SE410024177GA SE410024178GA SE410024179GA SE410024180GA SE410024181GA SE410024183GA SE410024184GA SE410024186GA SE410024188GA SE410024191GA SE410024194GR SE410024197GA SE410024198GA SE410024203GA SE410024206GA SE410024212GA SE410024220GA SE410024225GA SE410024227GA SE410024229GA SE410024231GA SE410024234GA SE410024235GA SE410024243GR SE410024245GA SE410024272GA SE410034327GA SE410034330GA SE410034332GA SE410034333GA SE410034337GA SE410034338GA SE410034354GA SE410034391GA SE410034406GA SE410034413GA SE410034420GA SE410034421GA SE410034426GA SE410034430GA SE410034443GA SE410044469GA SE410044473GA SE410044474GA SE410044475GA SE410054491GA SE410054523GA SE410054526GA SE410054528GA SE410054529GA ","33 (21 US, 12 OUS)","GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO), the image clarity between the cranial -brain interface, may not be clinically acceptable. The artifact degrades image quality at the boundary between the cranium and brain surface, but does not affect the bone image quality. No injuries have been reported to date.",2/14/2014,"02/14/2014",3/26/2014,"03/26/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1714-2014","Class I","Santa Rosa De Lima Queso Fresco Round Fresh Cheese, packaged in 80 oz (5 lbs) cellophane wrapping, Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436,UPC code 095548003569. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures). Santa Rosa de Lima Queso Fresco Round Fresh Cheese, 16 oz. Wrapped in cellophane, Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436,UPC code 095548003569. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures). ","all lots and expiration dates,UPC code 095548003569 ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1708-2014","Class I"," Mexicana Brand Queso Cotija Molido packaged in 1, 6 oz rigid plastic containers (Clamshell), Distributed/Distribuido por: Roos Foods Inc., DE 19955, UPC code 095548001435. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid). ","all lots and expiration dates, UPC code 095548001435",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1707-2014","Class I"," Santa Rosa de Lima Queso Duro Blando (Hard Cheese), packaged in 14 oz and 8 oz clear, rigid plastic containers (Clamshell), Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955, Plant No. 10-5436, UPC codes 095548003194 and 095548003118. (Ingredients: Pasteurized milk, nonfat dry milk, potassium sorbate, salt, cultures, calcium chloride, natamycin (mold inhibitor) and titanium dioxide (whitener)). ","all lots and expiration dates, UPC codes 095548003194 and 095548003118",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1712-2014","Class I","Mexicana Brand Queso Fresco Fresh Cheese, 16 oz. Wrapped in cellophane, ) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003330 (Ingredients: Cultured and pasteurized milk, salt). ","all lots and expiration dates, UPC code 095548003330 ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1721-2014","Class II","Amigo Brand Crema Centroamericana Cultured Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 09554800079. (Ingredients: Cream, milk, salt, nonfat dry milk, skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). ","all lots and expiration dates, UPC code 09554800079",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1715-2014","Class I","Mexicana Cuajadita Casera (Fresh Cheese), 16 oz. wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003651. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). Santa Rosa de Lima Cuajadita Casera (Fresh Cheese), 16 oz. wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003699. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). Amigo Brand Cuajadita Casera (Fresh Cheese), 16 oz., wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003224. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). ","all lots and expiration dates, UPC code 095548003651, UPC code 095548003699, UPC code 095548003224",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1713-2014","Class I","Queso Fresco Amigo Brand Round Fresh Cheese, 16 oz. wrapped in cellophane, Manufactured by: Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003316. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid). ","all lots and expiration dates, UPC code 095548003316",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1706-2014","Class I"," Requeson Mexicana Part-Skim Ricotta, 15 oz., packaged in a plastic cup, Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . Requeson Mexicana Part-Skim Ricotta, 16 oz. packaged in a rigid plastic container (Clamshell), Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . ","all lots and expiration dates,UPC code 095548003415 ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1719-2014","Class II","Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream, 80 oz. (5lbs), packaged in a Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003934. Santa Rosa de Lima Crema Salvadorena Culture Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003507. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream, Grade A, 30 oz., packaged in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003873. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream , Grade A, 16 oz., packaged in a plastic pouch, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000483. Santa Rosa de Lima Crema Salvadorena (Cultured Sour Cream), Grade A, 14 oz., packaged in a plastic bag, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003842. Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream , Grade A, 30 oz., packaged in a plastic bag, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003873. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). ","all lots and expiration dates, UPC code 095548003934,UPC code 095548003507, UPC code 095548003873, UPC code 095548000483, UPC code 095548003842, UPC code 095548003873. ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1723-2014","Class II","La Chapina Crema Guatemalteca Guatemalan Style Cream, 16 oz. packaged in a plastic bag, Distribuido por: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548000414. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). ","all lots and expiration dates, UPC code 095548000414",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1718-2014","Class I","Santa Rosa de Lima Cuajada en Terron (Fresh Cheese Curd), 16 oz packaged in a plastic bag, Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548003033. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). Santa Rosa de Lima Cuajada en Terron, packaged in a 10 lb vacuum packaged plastic bag, Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548000551. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). Santa Rosa de Lima Cuajada en Terron Fresh Cheese Curd, 16 oz., packed in a rigid plastic container (Clamshell) Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548003026. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). ","all lots and expiration dates, UPC code 095548003033, UPC code 095548000551, UPC code 095548003026",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1709-2014","Class I"," Santa Rosa de Lima Queso Rallado Aserrin (Grated Cheese) Queso Duro Viejo packaged in a 16 oz Plastic Pouch, Manufactured by Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, Distributed by: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548003460. (Ingredients: Pasteurized milk, whey, skim milk, cultured milk solids, carrageenan, salt, potassium sorbate, (preservative)). ","all lots and expiration dates,UPC code 095548003460 ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1720-2014","Class II","Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream, packaged in a 80 oz Plastic Tub, Grade A, packaged in a 80 oz (5lbs) Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000247. La Original Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , packaged in a 16 oz White Plastic Jar with a yellow plastic lid, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000285. Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , Grade A, 30 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000230. Crema Pura Mexicana Brand (Crema Mexicana) Cultured Sour Cream , Grade A, 16 oz., packed in a plastic pouch, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548000407. (Ingredients: Cream, milk, salt, nonfat dry milk, cultured skim milk powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). ","all lots and expiration dates, UPC code 095548000247, UPC code 095548000285, UPC code 095548000230, UPC code 095548000407. ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1711-2014","Class I","Queso Fresco Anita, 16 oz., packaged in a rigid plastic container (Clamshell), Kenton, DE 19955 Plant No. 10-5436. ","all lots and expiration dates",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1716-2014","Class I","Mexicana Brand Cuajada Fresca (Fresh Cheese) 16 oz., packaged in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003606. (Ingredients: Cultures, pasteurized milk, salt). Amigo Brand Cuajada Fresca (Fresh Cheese), 16 oz. Packaged in a rigid plastic container (Clamshell), Mfd. By: Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003064. (Ingredients: Cultured and pasteurized milk, salt). ","all lots and expiration dates, UPC code 095548003606, UPC code 095548003064",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1722-2014","Class II","Santa Rosa de Lima Mantequilla de Bolsa Tradicion Centroamericana, 15 oz., packaged in a plastic bag, Manufactured by Roos Foods, Inc., UPC code 095548002159. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim powder, gelatin, stabilizers (carrageean gum, disodium phosphate), color (annato extract), dairy cultures). ","all lots and expiration dates,UPC code 095548002159 ",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1717-2014","Class I","Santa Rosa de Lima Cuajada Fresca (Fresh Cheese) , 16 oz packed in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003538. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). ","all lots and expiration dates, UPC code 095548003538",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67593,"Ongoing","Roos Foods Inc","Kenton","DE","US","Voluntary: Firm Initiated","Visit","Products were distributed through retail stores in Delaware, Maryland, New Jersey, New York, Virginia and Washington, DC.","F-1710-2014","Class I"," Santa Rosa de Lima Queso de Huerta (Fresh Cheese), 12 oz. packaged in a rigid plastic container (Clamshell), Manufacturado y Distribuido por (manufactured and distributed for) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003859. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, cultures, natamycin).","all lots and expiration dates, UPC code 095548003859",".","122,587.5-lbs for all products","Samples of Santa Rosa De Lima Cuajada en Terron (fresh curd cheese) were found positive for Listeria Monocytogenes. Based on these findings, the firm recalled all brands, lots, date codes, and container sizes of the cheese products that were manufactured and/or repackaged in their facility. Out of an abundance of caution, the firm expanded the recall to include all brands, lots, date codes, and container sizes of the grade A sour cream products that were manufactured in their facility.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Biologics",67596,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","NY, FL","B-0489-14","Class II","Red Blood Cells","2262099; 2365718; 2233002",,"3 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/26/2014,"03/26/2014"
"Biologics",67596,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","NY, FL","B-0490-14","Class II","Fresh Frozen Plasma","2233002",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",1/28/2014,"01/28/2014",3/26/2014,"03/26/2014"
"Devices",67597,"Ongoing","Energizer Personal Care","Shelton","CT","US","Voluntary: Firm Initiated","Press Release","USA Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, ON, OR, PA, SC, TN, TX, VA, VT, WA, WI Canada - one consignee, Energizer (recalling firm's) company store","Z-1336-2014","Class II","Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.","Suspect date codes for Breast Pumps: P12324-91667C to P13205-30673C. Suspect adaptor date codes: 1241 to 1324.",".","35,803","Some of the power adapters outer casing may become loose and separate, resulting in a potential for electric shock.",3/18/2014,"03/18/2014",4/16/2014,"04/16/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1221-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' connector, 15'' (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 4936",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1223-2014","Class II","Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2'' flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 16472",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1220-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2'' connector, 15'' (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 4935",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1219-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2'' connector, 14.5'' (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 4934X",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1224-2014","Class II","Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 16473",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1222-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' connector, 15'' (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 4936X",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67598,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.","Z-1218-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2'' connector, 14.5'' (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Catalog Number 4934",,,"During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Devices",67599,"Ongoing","AMS Diagnostics, LLC","Weston","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.","Z-1268-2014","Class II","AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.","Model Numbers: 40147, 80147. Lot codes: 131253, 131254, 131255.",".","13 kits","Marketing the devices outside 510(k) requirements",2/11/2014,"02/11/2014",4/2/2014,"04/02/2014"
"Devices",67599,"Ongoing","AMS Diagnostics, LLC","Weston","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.","Z-1269-2014","Class II","AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.","Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.",".","116 kits","Marketing the devices outside 510(k) requirements",2/11/2014,"02/11/2014",4/2/2014,"04/02/2014"
"Devices",67599,"Ongoing","AMS Diagnostics, LLC","Weston","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.","Z-1267-2014","Class II","AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.","Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.",".","167 kits","Marketing the devices outside 510(k) requirements",2/11/2014,"02/11/2014",4/2/2014,"04/02/2014"
"Food",67600,"Ongoing","Wolfgang B. Gourmet Foods, Inc.","Catskill","NY","US","Voluntary: Firm Initiated","E-Mail","NY, NJ, and CT","F-1684-2014","Class II","FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT 12 oz (340 g), UPC 7 58940 70609 3 -- Distributed By: Fairway Group Central Services LLC New York, New York 10027 --- The product is packaged in a glass bottle, 12 bottles per case.","Lot 340 GRSC with a ''use by'' date of 03/08/2014, and Lot 357 GRSC with a ''use by'' date 03/25/2014 (located on side of glass bottle)",".","348 units","The Grilling Sauce contains undeclared fish (anchovies), a a sub-ingredient in the Worcestershire Sauce ingredient used in making the product. ",2/20/2014,"02/20/2014",4/2/2014,"04/02/2014"
"Drugs",67601,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1147-2014","Class II","Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02","Lot 25-097-DK; Exp 01/01/2015",,"115,500 Vials","Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.",2/10/2014,"02/10/2014",3/12/2014,"03/12/2014"
"Food",67602,"Ongoing","World Pure Foods Wholesalers, Inc.","Dearborn","MI","US","Voluntary: Firm Initiated","FAX","retail stores in Michigan","F-1694-2014","Class I","Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981 ","BB 20131209, 20131231, BB 2014 0126, 2014 AL15, 2014 JN24, 2014 JL29",".","39 cases ","Undeclared milk ",1/13/2014,"01/13/2014",4/2/2014,"04/02/2014"
"Food",67602,"Ongoing","World Pure Foods Wholesalers, Inc.","Dearborn","MI","US","Voluntary: Firm Initiated","FAX","retail stores in Michigan","F-1696-2014","Class I"," Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3","BB 20140209, 20140119, 20140211, 2014MR30, 2014 JN02, 2014JL23, 20131230",".","87 cases","Undeclared milk ",1/13/2014,"01/13/2014",4/2/2014,"04/02/2014"
"Food",67602,"Ongoing","World Pure Foods Wholesalers, Inc.","Dearborn","MI","US","Voluntary: Firm Initiated","FAX","retail stores in Michigan","F-1695-2014","Class I","Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981 ","BB 20140127, 2014 MA28, 2014JN25",".","26 cases of 12","Undeclared milk ",1/13/2014,"01/13/2014",4/2/2014,"04/02/2014"
"Devices",67603,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and internationally","Z-1553-2014","Class II","ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.","All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.",".","5,900 units total (1,679 domestically & 4,221 internationally)","Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling. ",2/18/2014,"02/18/2014",5/14/2014,"05/14/2014"
"Biologics",67604,"Completed","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Minnesota; Texas; Pennsylvania; Florida","B-0492-14","Class II","Tendon","2643580002008; 2643590002008; 2643600002008; 2643610002008; 2643620002008; 2643630002008; 2643640002008; 2643650002008; 2643660002008; 2643670002008; ",,"10 allografts","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",10/7/2013,"10/07/2013",3/12/2014,"03/12/2014"
"Drugs",67605,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1096-2014","Class II","0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09","Lot 34-609-FW; Exp 10/15",,"603,768 bags","Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.",2/11/2014,"02/11/2014",3/12/2014,"03/12/2014"
"Drugs",67606,"Ongoing","Viiv Healthcare Company","Durham","NC","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico","D-1185-2014","Class III","Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13","Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15",".","1,056 bottles","Cross Contamination with Other Products: Product contains Promecta (eltrombopag).",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Devices",67607,"Ongoing","Lin-Zhi International Inc","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","US Distribution in state of: CA.","Z-1270-2014","Class III","Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer","Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.",".","120 units, 60 of each lot number","Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).",2/18/2014,"02/18/2014",4/2/2014,"04/02/2014"
"Drugs",67608,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1276-2014","Class I","Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 ","Lot number: C903799, Exp 05/15",,"27,169 containers","Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.",2/11/2014,"02/11/2014",5/7/2014,"05/07/2014"
"Devices",67609,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Columbia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South), Lebanon, Liechtenstein, Lithuania, Mexico, Netherlands, Poland, Portugal, Paraguay, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, Uruguay, Vietnam and South Africa.","Z-1458-2014","Class II","BIOMET 3i Endosseous Dental Implant.","Model Number(s): Affected devices catalog names are: BNES310, BNET3210, BNPS6511, BNPS6513, BNPS6585, BNPT6510, BNPT6511, BNPT6513, BNPT6585, BNSS310, BNSS311, BNSS313, BNSS610, BNSS613, BNSS615, BNSS685, BNST3210, BNST3211, BNST3213, BNST3215, BNST3285, BNST611, BNST613, BNST685, BOPS6510, BOPS6511, BOPS6515, BOPS6585, BOPT6510, BOPT6511, BOPT6513, BOPT6585, BOSS310, BOSS311, BOSS313, BOSS315, BOSS611, BOSS613, BOSS685, BOST3210, BOST3211, BOST3213, BOST3215, BOST3285, BOST610, BOST611, BOST613, BOST685, FNT3210, FNT3211, IFNT3210, IFNT3211, IFNT3213, IFNT3215, IFNT3285, IFNT610, IFNT611, IFNT613, IFNT685, IFOSS5611, IFOS5685, IFOS610, IFOS611, IFOS615, IFOSM310, IFOSM311, IFOSM313, IFOSM385, IIOS5610, IIOS5611, INT3210, INT3211, INT3213, INT3215, INT3285, INT610, INT611, INT613, INT685, IOSM311, IOSM313, IOSM315, IOSM385, IOSS610, IOSS613, NIIITP6510, NIIITP6511, NIIITP6513, NIIITP6515, NIIITP6585, NINT3210, NINT3211, NINT3213, NINT3215, NINT610, NINT611, NINT613, NINT685, NIOSM311, NIOSM313, NIOSS610, NT3210, NT3211, OSM310, XIFNT3210, XIFNT3211, XIFNT3213, XIFNT3215, XIFNT3285, XIFN610, XIFNT611, XIFNT613, XIFNT685, XIFOSM310, XIFOSM311, XIFOSM313, XIFOSS610, XIFOSS611, XIIOS6510, XIIOS6511, XIIOS6513, XIITP6510, XIITP6511, XIITP6513. Manufactured dates from November 5, 2012 through August 21, 2013.",".","34,744","Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.",8/29/2013,"08/29/2013",4/23/2014,"04/23/2014"
"Food",67611,"Completed","Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce","Macon","GA","US","Voluntary: Firm Initiated","Telephone","GA","F-1704-2014","Class I","Mrs. Griffin's Original Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206","Lot codes: 14016 and 14038.",".","4000 units total for all varieties","Product contains undeclared allergen: milk (as a preservative).",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Food",67611,"Completed","Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce","Macon","GA","US","Voluntary: Firm Initiated","Telephone","GA","F-1703-2014","Class I","Mrs. Griffin's Hot Barbecue Sauce, Net 1 Gallon (13.785L), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206","Lot codes: 14016 and 14038.",".","4000 units total for all varieties","Product contains undeclared allergen: milk (as a preservative).",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Food",67611,"Completed","Bar-Jim Inc., dba Mrs. Griffins Barbecue Sauce","Macon","GA","US","Voluntary: Firm Initiated","Telephone","GA","F-1705-2014","Class I","Mrs. Griffin's Hickory Smoke Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206","Lot codes: 14016 and 14038.",".","4000 units total for all varieties","Product contains undeclared allergen: milk (as a preservative).",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Devices",67612,"Ongoing","Philips Medical Systems North America Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-1232-2014","Class II","Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home). ","SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, A13G-00081, A13G-00082, A13G-00083, A13G-00084, A13G-00085, A13G-00086, A13G-00087, A13G-00088, A13G-00089, A13G-00090, A13G-00091, A13G-00092, A13G-00093, A13G-00095, A13G-00096, A13G-00097, A13G-00098, A13G-00099, A13G-00100, A13G-00101, A13G-00102, A13G-00103, A13G-00104, A13G-00105, A13G-00106, A13G-00107, A13G-00108, A13G-00109, A13G-00110, A13G-00111, A13G-00112, A13G-00114, A13G-00115, A13G-00116, A13G-00117, A13G-00118, A13G-00119, A13G-00120, A13G-00122, A13G-00123, A13G-00124, A13G-00125, A13G-00126, A13G-00127, A13G-00128, A13G-00129, A13G-00130, A13G-00131, A13G-00132, A13G-00133, A13G-00134, A13G-00135, A13G-00136, A13G-00137, A13G-00138, A13G-00139, A13G-00140, A13G-00141, A13G-00142, A13G-00143, A13G-00144, A13G-00145, A13G-00146, A13G-00147, A13G-00148, A13G-00149, A13G-00150, A13G-00151, A13G-00152, A13G-00153, A13G-00154, A13G-00155, A13G-00156, A13G-00157, A13G-00158, A13G-00159, A13G-00160, A13G-00161, A13G-00162, A13G-00163, A13G-00164, A13G-00165, A13G-00166, A13G-00167, A13G-00168, A13G-00169, A13G-00170, A13G-"," A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-06564, A13G-06566, A13G-06567, A13G-06568, A13G-06569, A13G-06570, A13G-06571, A13G-06572, A13G-06573, A13G-06574, A13G-06575, A13G-06576. SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA: A13G-00066, A13G-00094, A13G-00113, A13G-00191, A13G-00203, A13G-00205, A13G-00206, A13G-00207, A13G-00208, A13G-00209, A13G-00210, A13G-00211, A13G-00212, A13G-00213, A13G-00214, A13G-00216, A13G-00217, A13G-00218, A13G-00219, A13G-00220, A13G-00221, A13G-00224, A13G-00225, A13G-00226, A13G-00227, A13G-00228, A13G-00229, A13G-00230, A13G-00231, A13G-00232, A13G-00233, A13G-00234, A13G-00235, A13G-00236, A13G-00237, A13G-00238, A13G-00239, A13G-00240, A13G-00241, A13G-00242, A13G-00243, A13G-00246, A13G-00247, A13G-00248, A13G-00249, A13G-00250, A13G-00251, A13G-00252, A13G-00253, A13G-00254, A13G-00255, A13G-00256, A13G-00257, A13G-00266, A13G-00267, A13G-00268, A13G-00269, A13G-00270, A13G-00271, A13G-00272, A13G-00273, A13G-00274, A13G-00275, A13G-00276, A13G-00278, A13G-00279, A13G-00280, A13G-00281, A13G-00282, A13G-00283, A13G-00284, A13G-00285, A13G-00286, A13G-00287, A13G-00290, A13G-00291, A13G-00292, A13G-00293, A13G-00295, A13G-00296, A13G-00297, A13G-00298, A13G-00300, A13G-00301, A13G-00302, A13G-00303, A13G-00304, A13G-00305, A13G-00306, A13G-00307, A13G-00308, A13G-00309, A13G-00311, A13G-00312, A13G-00313, A13G-00314, A13G-00315, A13G-00316, A13G-00317, A13G-00318, A13G-00319, A13G-00320, A13G-00321, A13G-00322,","5075 units total (2724 units in the US and 2351 units outside the US)","Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.",2/6/2014,"02/06/2014",3/26/2014,"03/26/2014"
"Biologics",67613,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","E-Mail","U.S.A., Saudi Arabia, and Hong Kong.","B-0499-14","Class III","Terasaki HLA Tissue Typing Trays (HLA Class II Tissue Typing Trays only). Terasaki HLA Tissue Typing Trays are for use in determining HLA cell surface antigens with a complement dependent microlymphocytotoxic technique. BK840023","Catalog ID - DR72; Lot Number - 030; Batch 087 ",".","1 Product","HLA typing assay, associated with false positive results, was distributed. ",2/17/2014,"02/17/2014",3/19/2014,"03/19/2014"
"Biologics",67614,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Kentucky, Michigan, Tennessee","B-0543-14","Class II","Red Blood Cells Leukocytes Reduced","W201613030441, W201613030442, W201613030443, W201613030445, W201613030450, W201613036325, W201613037354, W201613037364, W201613038749, W201613039963, W201613048178, W201613050691, W201613051040, W201613051075, W201613054010, W201613054460, W201613054474, W201613056396, W201613056417, W201613057188, W201613057199, W201613058622, W201613058682, W201613061118, W201613061587, W201613065155",".","26 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/17/2014,"01/17/2014",4/23/2014,"04/23/2014"
"Biologics",67614,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Kentucky, Michigan, Tennessee","B-0542-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W201613063294 (2 units)",".","2 units","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/17/2014,"01/17/2014",4/23/2014,"04/23/2014"
"Biologics",67614,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","Ohio, Kentucky, Michigan, Tennessee","B-0544-14","Class II","Platelets Pooled Leukocytes Reduced","W201613900233",".","1 unit","Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.",1/17/2014,"01/17/2014",4/23/2014,"04/23/2014"
"Devices",67615,"Completed","Velocity Medical Solutions, LLC","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including the states of AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, WI, and the countries of Belarus, Italy and Switzerland.","Z-1275-2014","Class II","DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. ","VelocityAIS 3.0.0",".","54 installs ","An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.",7/25/2013,"07/25/2013",4/2/2014,"04/02/2014"
"Food",67616,"Ongoing","Axel Chemicals","Brentwood","TN","US","Voluntary: Firm Initiated","E-Mail","NY, NJ, and NC","F-1685-2014","Class I","L-Citrulline, bulk product, 25 kg","Lot number 121109",".","1000 kg","The recall was initiated due to an adverse event report from a consignee and the discovery of a compound other than L-Citrulline in at least one drum. ",2/24/2014,"02/24/2014",4/2/2014,"04/02/2014"
"Drugs",67617,"Ongoing","Pfizer Us Pharmaceutical Group","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1166-2014","Class III","Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43","G85041",,"70,704 bottles","Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.",2/26/2014,"02/26/2014",3/26/2014,"03/26/2014"
"Devices",67618,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.","Z-1243-2014","Class II","Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.","Lot 239430, 239450 ",,"10","Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.",2/26/2014,"02/26/2014",3/26/2014,"03/26/2014"
"Devices",67618,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.","Z-1242-2014","Class II","Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.","Lot 669420 ",,"1","Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.",2/26/2014,"02/26/2014",3/26/2014,"03/26/2014"
"Devices",67618,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.","Z-1244-2014","Class II","Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.","Lot 239470, 457450 ",,"6","Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.",2/26/2014,"02/26/2014",3/26/2014,"03/26/2014"
"Food",67619,"Ongoing","HP Hood LLC","Lynnfield","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","ME, PA, VA, NC, SC, FL","F-1690-2014","Class II","my essentials brand sour cream, NET WT. 24 OZ. (680g), UPC 7 25439 10546 0 --- Firm on label: DISTRIBUTED BY DZA BRANDS, LLC 2110 Executive Drive, Salisbury, NC 28147 --- The sour cream is packed in a plastic container.","APR 05 14 (ink jetted onto the lip of the lid on each container)",".","2789 cases (12 x 24 oz. containers per case)","HP Hood LLC received one complaint of a foreign object in sour cream product with APR 05 14 code. The object was subsequently identified to be part of a metal bolt from a filling machine. ",2/26/2014,"02/26/2014",4/2/2014,"04/02/2014"
"Devices",67620,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR, CA, CO,DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MI, MN, MO, NC, NV, NY, OH, OK, TN, TX, UT, WA, WI, WY. OUS: ARGENTINA. AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGRY, INDIA, IRA, ISRAEL, ITALY, JAPAN, KAZAKTSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PANAMA, POLAND, QATAR, ROMANIA, RUSSIAN, FDRATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, TAIWAN, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.","Z-1640-2014","Class II","GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only. ","Mfg Lot or Serial # SJC13245126HA SJC13519186HA SJC13519394HA SJC14041559HA SJC13213573HA SJC13213578HA SJC13213797HA SJC13223964HA SJC13265581HA SJC13265706HA SJC13275798HA SJC13213782HA SJC13223961HA SJC13223967HA SJC13223968HA SJC13234211HA SJC13234212HA SJC13234219HA SJC13234220HA SJC13286412HA SJC13338471HA SJC13338472HA SJC13338473HA SJC13348496HA SJC13348502HA SJC13348506HA SJC13348507HA SJC13348511HA SJC13348512HA SJC13348829HA SJC13369137HA SJC13369138HA SJC13369142HA SJC13369143HA SJC13369145HA SJC13369146HA SJC13369147HA SJC13369148HA SJC13369149HA SJC13369150HA SJC13369151HA SJC13369152HA SJC13369153HA SJC13369154HA SJC13369155HA SJC13369158HA SJC13369159HA SJC13369160HA SJC13369162HA SJC13369163HA SJC13369164HA SJC13369165HA SJC13369166HA SJC13369167HA SJC13369168HA SJC13369176HA SJC13369177HA SJC13369178HA SJC13369181HA SJC13369182HA SJC13369184HA SJC13401366HA SJC13401368HA SJC13422129HA SJC13454007HA SJC13454009HA SJC13454010HA SJC13464878HA SJC13465034HA SJC13465035HA SJC13465036HA SJC13465141HA SJC13465142HA SJC13465144HA SJC13465145HA SJC13476319HA SJC13476321HA SJC13476322HA SJC13476323HA SJC13476327HA SJC13476350HA SJC13476351HA SJC13476353HA SJC13476354HA SJC13476355HA SJC13476356HA SJC13476357HA SJC13476358HA SJC13476359HA SJC13476360HA SJC13476361HA SJC13476364HA SJC13476365HA SJC13476366HA SJC13476371HA SJC13476372HA SJC13487132HA SJC13487139HA SJC13487141HA SJC13487142HA SJC13487145HA SJC13487146HA SJC13487147HA SJC13487148HA SJC13529493HA SJC13529495HA SJC13529496HA SJC13529497HA SJC13529500HA SJC13529501HA SJC14030674HA SJC14030675HA SJC14030676HA SJC14030748HA SJC14030749HA SJC14030750HA SJC14030751HA SJC14030777HA SJC14030813HA SJC14030815HA SJC14030817HA SJC14030818HA SJC14030824HA SJC13193216HA SJC13265704HA SJC13265712HA SJC13265755HA SJC13348508HA SJC13348510HA SJC13348515HA SJC13369170HA SJC13369179HA SJC13369183HA SJC13369290HA SJC13369291HA SJC13369294HA SJC13369307HA SJC13379607HA SJC13379609HA SJC13379610HA SJC13379686HA SJC13379690HA SJC13379692HA SJC13379693HA SJC133796",".","1,727 (494 units US, 1,233 units OUS)","When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual amount of movements. This issue may lead to an inadequate dose of muscle relaxants. This issue may occur when the E-NMT-01 module is plugged into the CARESCAPE or the Datex-Ohmeda S/5 Anesthesia monitor.",4/9/2014,"04/09/2014",5/28/2014,"05/28/2014"
"Devices",67622,"Ongoing","Philips Medical Systems North America Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of Australia, Austria, Canada, France, Germany, India, Italy, Ireland, Japan, Malaysia, Netherlands, Norway, Switzerland, Taiwan and United Kingdom.","Z-1225-2014","Class II","Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.","Serial numbers of units distributed in the USA: C13A-00592, C13C-00131, C13C-00150, C13C-00270, C13C-00679, C13C-00681, C13C-00769, C13D-00048, C13D-00197, C13E-00088, C13E-00168, C13E-00234, C13E-00242, C13E-00245, C13E-00326, C13E-00340, C13E-00368, C13E-00372, C13E-00380, C13E-00382, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13",,"251 units total (128 in USA and 123 untils outside USA)","Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.",2/6/2014,"02/06/2014",3/26/2014,"03/26/2014"
"Devices",67623,"Ongoing","Philips Medical Systems (Cleveland), Inc.","Fitchburg","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including US: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Internationally to AUSTRALIA, AUSTRIA. BELGIUM, CANDA, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, RUSSIA, SOUTH ARICA, SOUTH KOREA. SPAIN,. SWITZERLAND, TAIWAN, THAILAND, TURKEY, EMIRATES, UNITED KINGDOM. .","Z-1312-2014","Class II","Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.","System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 DC030938457 DC070948475 DC070948476 DC100956827 DC120961879 DC011064963 DC090775316 DC021070642 DC061086404 DC091095147 DC060767368 DC010887574 DC110782289 DC120787279 DC061132521 DC061132519 DC081138659 DC081138643 DC081139521 DC081139520 1755367 DC080815579 DC070813153 1685358 1134FMM0UW DC090777023 15 DC030936391 15 1708792 1708999 0841BD200F 3/1133FMM0C2 DC110781164 DC060764615 DC060764372 0908QAC00B 0926QAD063 0925QAD076 1666738 0925QAD09E 1029QAD07C 1678826 1684436 0926QAC016 1029QAD06F 0926QAC01C 1714167 1049FMMOGP 1113FMMORB 1113FMMORL 1688542 1688675 1691300 1691303 1694794 1696697 1699759 1699760 1700756 1699761 1699762 1701404 1701389 1715642 1704521 1708407 1709924 1710887 36 1734189 1721212 1723472 1723474 1722542 1730747 1722550 1723491 1730850 1730848 1730746 1737467 1730852 1732235 1732294 1734761 1735978 1736604 1737853 1734675 1738571 1737480 1741347 1746235 1740700 1747900 1745450 1751925 1753082 1753079 1753777 1759510 1759731 1757173 1762113 1665097 1659082 1657556 1659148 1655919 1657364 1657112 1657781 1657783 1657782 1659128 1659129 1685591 1685365 1685354 1685589 1700520 1685685 1685608 1685590 1685604 1702674 1718378 DC051081744 1685357 1700519 1700649 1707577 1706939 1707985 1724442 1724444 58 1746975 1734748 1 5 12 2 3 1753818 1754275 1759838 10 DC090775322 DC090776030 DC120787277 DC020893856 DC070811143 DC070812912 DC050802592 DC050802591 DC050802954 DC030895175 DC050802595 DC121008240 DC070899024 DC030895174 DC030895490 DC020893296 DC090818684 DC090819874 DC030936392 DC090816435 DC120830822 DC120830821 21DC041125223 DC030937243 DC040939540 DC040941365 DC050943690 DC100820417 1661883 1657952 1658310 1657202 DC050802593 70 DC100955993 1663161 1662399 1662400 80 DC031121325 1663005 1675295 1675300 1675298 1675304 1672877 1675302 1676359 1702701 1685603 1685516 1685512 DC040941365 1685511 1702616 1702222 1702214 DC060945180 1702617 1702404 1707900 1703883 1712072 42 DC01088895",".","1016","Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.",2/11/2014,"02/11/2014",4/9/2014,"04/09/2014"
"Devices",67624,"Ongoing","Bio-Rad Laboratories, Inc.","Hercules","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezuela, Colombia, Brazil, Jamaica, Austria, Switzerland, France, Germany, Greece, Portugal, Spain, Italy, UK, Belgium, Sweden Norway, Finland ,Israel/Palestine, Tunisia, Algeria, Egypt, ,Morocco, Jordan, Yemen, Iraq, Kuwait, Qatar, Oman, Lybia, Lebanon ,UAE, Saudi Arabia, Pakistan, Afghanistan, Turkey, South Africa, Chad, Kenya, Benin, Burkina Faso, Cameroon, Gabon, Senegal, Ghana, Mali, Ivory Coast, Nigeria, Djibouti, Czech Republic, Slovakia, Slovenia, Serbia, Hungary, Romania, Poland, Russia, Ukraine, Kazakhstan, Bulgaria, Belarus, Georgia, Mauritius, Maldives, Vietnam, Philippines, Korea, Thailand, Hong Kong , Indonesia, Taiwan, Malaysia, Singapore, New Zealand, and Australia.","Z-1299-2014","Class II","D-10'' Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis. ","Model number: 220-0220 ",".","483 instruments in US. OUS to be determined.","On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.",2/27/2014,"02/27/2014",4/2/2014,"04/02/2014"
"Devices",67625,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Telephone","USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and Internationally to Albania, Algeria, Argentina, Australia, Austria, Bahamas, Barbados, Bermuda, British Guiana, Boliva, Brazil, British West Indies, Burundi, Canada, Chile, China, Columbia, Costa Rica, Cuba, Curacao, Cyprus, Czechoslovakia, Dominica, Equator, Estonia, Egypt, Finland, France, Gambia, Germany, Great Britain, Georgia, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lativa, Lithunia, Madagascar, Malaysia, Malta, Mexico, Mongolia, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, San Salvador, Saudia Arabia, Serbia, Singapore, Sir Lanka, South Korea, Spain, Sudan Slovenia, Suriname, Tajikistan, Thailand, Turkey, Turkmenistan, Taiwan, Ukraine, Uruguay, Venezuela, Viet Nam, Zambia.","Z-1197-2014","Class II","XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.","Versions 4.1 and higher",".","1776","Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.",2/17/2014,"02/17/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1208-2014","Class II","REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4 ",".","132"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1207-2014","Class II","REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4 ",".","130"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1203-2014","Class II","REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447, 456738, 456740, 466369, 466370, 466371, 058401LA, 137401LA, D2WBG4, D37FW4, D37GP4, DV6LY4, DY5EC4, DY5ED4, E1VHM4, E3SDW4, E6CE94, E82E14, EA8EH4, EF5BS4, EJ6G34, EW6HT4, FJ3D14, FJ3D24, and FJ3DY4 ",".","129"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1205-2014","Class II","REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806",".","134"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1206-2014","Class II","REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837, 409583, 412683, 414752, 430490, 430491, 430492, 448537, 456744, 456745, 456747, 456748, 464644, 464646, 464647, 266411RA, 467411RB, D1TAN4, E1VHX4, E4EGB4, E73H74, E82E74, E82E84, E82E94, EN7JC4, EW6H24, FK8GP4, and FL1VH4.",".","137"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67627,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.","Z-1204-2014","Class II","REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.","102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4",".","128"," DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. ",2/24/2014,"02/24/2014",3/19/2014,"03/19/2014"
"Devices",67628,"Terminated","Technidata S.A.","Montbonnot St Martin",,"FR","Voluntary: Firm Initiated","E-Mail","Distributed in the state of PA.","Z-1310-2014","Class III","TDWorkstation version 11.01.A or higher. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).","version 11.01.A or higher",".","85 units total (1 unit in US)","If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.",2/17/2014,"02/17/2014",4/9/2014,"04/09/2014"
"Food",67629,"Ongoing","Fast-Pak Trading Inc.","Secaucus","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-1745-2014","Class III","Evropa Zele Bonboni Jelly Candy Net Wt. 500 g Imported in USA by: Fast-Pak Trading Inc., 375 County Ave., Secaucus, NJ 07094 UPC 5310002480041","Lot # L3505131",".","50 cases (12 units per case)","NYSDAM laboratory analysis report has revealed that Zele Bonboni Jelly Candy contains unallowed green colorant chlorophillyn.",2/4/2014,"02/04/2014",4/9/2014,"04/09/2014"
"Devices",67630,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV and WI,and the countries of United Arab Emirates, Austria, Australia, Azerbaijan, Belgium, Belgrade, Bahrain, Canada, Switzerland, Cameroon, China, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guyana, Croatia, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Serbia, Malaysia, Martinique, Nigeria, Netherlands, Norway, Oman, Panama, French Polynesia, Philippines, Poland, Portugal, Qatar, Reunion, Russia, San Salvador, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, San Marino, Thailand, Trinidad, Tunisia, Turkey, Venezuela, Yemen and Zambia","Z-1231-2014","Class II","Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung. ","Product Code - 116200260, Batch 09LE51, 10GE31, 11LE42, 12DE17, 12IE37, 13CT26, 13DT32; Product Code - 116200280 - Batch 09HE34, 09JE41, 10BE07, 11HE33, 11JE41, 13ET12; Product Code - 116200350 - Batch 0918M, 0915M, 09JE43, 09JE42, 0917M, 11AE03, 11DE15, 11GE27, 09HE34, 11JE43, 11JE42, 12AE02, 12BE07, 12DE17, 12EE19, 12GE27, 12HE33, 13AE01, 13CT26, 13DT33, 13ET12; Product Code 116200370 - Batch 0915M, 0917M, 0914M, 09JE41, 09JE43, 11DE15, 11EE20, 11GE27, 11JE42, 11HE32, 11JE43, 11IE39, 12AE01, 12AE03, 12GE31, 12BE06, 12DE18, 12IE39, 12JE44, 13AT44, 13BT44, 13AE01, 12LE49, 13DT33; Product Code 116200390 - Batch 0914M, 0922M, 0917M, 09JE44, 09FE23, 09HE35, 09JE42, 10GE29, 10AE02, 09JE43, 09KE46, 09LE51, 10AE01, 10CE11, 10DE18, 10EE19, 10JE41, 10EE20, 11DE15, 11KE42, 11GE30, 11HH33, 11IE37, 11IE38, 11IE39, 13AT36, 13BT25, 13BT29; Product Code 116200410 - Batch 0922M, 0915M, 0918M, 09IE36, 09JE43, 10AE05, 10BE06, 10DE16, 10GE28, 10JE41, 11DE15, 11GE27, 11HE34, 11JE43, 13BT44, 13DT32; Product Code 116201350 - Batch 0921M, 09JE40, 09FE23, 13GT05; Product Code 116201370 - Batch 0922M, 0915M, 13AE01, 13ET18, 13HT12, 09FE24; Product Code 116201390 - Batch 09JE44, 10CE10; Product Code 116201410 - Batch 10KE47",,"63,568 ea.","The product may fail to achieve seal of right lung due to the cuff inflating to one side",2/28/2014,"02/28/2014",3/26/2014,"03/26/2014"
"Drugs",67631,"Ongoing","Ohm Laboratories, Inc.","North Brunswick","NJ","US","Voluntary: Firm Initiated","Letter","CA OH, PA, RI,& TX","D-1256-2014","Class II","Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistam","Lot # 2554936, 2554938; Exp 09/15",,"29,790 blister packs","Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.",2/7/2014,"02/07/2014",4/30/2014,"04/30/2014"
"Food",67632,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","F-1762-2014","Class II","vitacost brand Men's Passion Booster, 30 Capsules, PREMIUM FORMULA DIETARY SUPPLEMENT, ITEM # NSI 3004713, UPC 8 35003 00471 3, and 120 CAPSULES, ITEM # NSI 3009473, UPC 8 35003 00947 3 --- Manufactured for Vitacost Lexington, NC 27295","30 capsules: Lot Nos. 1768600, 1783100, 2091200, 1979500; -- 120 capsules: Lot Nos. 1768600, 1646900, 1783100, 2050500, 2091200, 1979500",".","30 capsules: 2169 bottles; 120 capsules: 2052 bottles","The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. ",2/24/2014,"02/24/2014",4/16/2014,"04/16/2014"
"Food",67632,"Ongoing","Nature's Value Inc. ","Coram","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","F-1761-2014","Class II","vitacost brand L-Citrulline Amino Acid 750 mg, 90 CAPSULES, DIETARY SUPPLEMENT, ITEM # NSI 3003310, UPC 8 35003 00331 0 --- Manufactured for Vitacost Lexington, NC 27295","Lot Nos. 1607500, 1612700, 1794500, 1810500,1937500, 2044500",".","9076 bottles","The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. ",2/24/2014,"02/24/2014",4/16/2014,"04/16/2014"
"Drugs",67633,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1227-2014","Class III","Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05","Lot #: F0126",".","10,930 Bottles","Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients. ",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67633,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1228-2014","Class III","Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05 ","Lot #: F0131",".","10,781 bottles ","Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients. ",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Food",67634,"Ongoing","JIN SUN MI INTERNATIONAL INC","LOS ANGELES","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-1689-2014","Class I","Frozen Ice Cake (Watermelon), 17.98 oz, 6 retail units/carton, UPC 8 801062 443055","Lot codes: 13.05.01F2 and 13.07.17F2 13.05.01F2 - This code date was printed on the retail units contained within Entry #EJA-5046135-1 (November) 13.07.17F2 - This code date was printed on the retail units contained within Entry #EJA-5045319-2 (October) ",".","194 units","Jin Sun Mi International is recalling watermelon ice bar product because it contains undeclared peanuts. ",2/26/2014,"02/26/2014",4/2/2014,"04/02/2014"
"Food",67635,"Ongoing","Unilever United States, Inc.","Englewood Cliffs","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","F-1725-2014","Class I","Popsicle Orange Cherry Grape 20 pops Net 33 fl oz Unilever Englewood Cliffs, NJ 07632 USA UPC 077567121301","best before dates of JUN0315GBV, JUN0415GBV, JUN0515GBV and JUN0615GBV",".","17,922 cases approximately","Unilever United States, Inc. is voluntarily recalling a limited number of 20-count boxes of Popsicle brand Orange, Cherry and Grape flavored ice pops because they may have been inadvertently exposed to milk, which is not listed as an ingredient on the label.",2/28/2014,"02/28/2014",4/9/2014,"04/09/2014"
"Drugs",67636,"Ongoing","Pfizer Us Pharmaceutical Group","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1328-2014","Class I","Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.","Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15",".","49,847 bottles","Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.",3/6/2014,"03/06/2014",5/28/2014,"05/28/2014"
"Drugs",67637,"Ongoing","Greenstone Llc","Peapack","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1361-2014","Class I","Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.","V130014, Exp 08/15",".","16,018 bottles","Presence of Foreign Tablets/Capsules: A Pharmacist reported a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule in a lot of Effexor XR 150 mg capsules that was packaged in the same packaging campaign as this Venlafaxine HCl lot.",3/6/2014,"03/06/2014",6/18/2014,"06/18/2014"
"Devices",67638,"Ongoing","Spacelabs Healthcare, Llc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.","Z-1273-2014","Class II","Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. ","Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Serial numbers distributed in the US: ''040-1565-10'' and ''063-1829-11''. Serial number distributed outside the US: ''063-1829-11''. ",".","36 units total: 17 units were distributed in the US and 19 units distributed outside the US. ","Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access. ",2/14/2014,"02/14/2014",4/2/2014,"04/02/2014"
"Devices",67639,"Ongoing","Thoratec Corporation","Pleasanton","CA","US","Voluntary: Firm Initiated","Press Release","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.","Z-1230-2014","Class I","Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. ","Catalog number 105109 (found on side of unit) all serial numbers",".","7436 in total","Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Devices",67639,"Ongoing","Thoratec Corporation","Pleasanton","CA","US","Voluntary: Firm Initiated","Press Release","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.","Z-229-2014","Class I","HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. ","Catalog number 107801 all serial numbers",".","36","Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Devices",67639,"Ongoing","Thoratec Corporation","Pleasanton","CA","US","Voluntary: Firm Initiated","Press Release","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.","Z-1228-2014","Class I","HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.","Catalog number 106762 (NAm) 106017 - EU all serial numbers",".","4120","Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Devices",67639,"Ongoing","Thoratec Corporation","Pleasanton","CA","US","Voluntary: Firm Initiated","Press Release","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.","Z-1227-2014","Class I","HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.","Catalog number 106015 (NAm) 106016 - EU all serial numbers",".","1737 catalog number 106015; 609 catalog number 106016","Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Devices",67640,"Ongoing","Coltene Whaledent Inc","Cuyahoga Falls","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Memphis, TN.","Z-2151-2014","Class II","Latex Dental Dams labeled as Non-Latex Dental Dams","Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10 ",".","32 boxes, 15 individual dams per box","Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. ",12/11/2013,"12/11/2013",8/13/2014,"08/13/2014"
"Devices",67641,"Ongoing","Megadyne Medical Products, Inc.","Draper","UT","US","Voluntary: Firm Initiated","Letter","USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.","Z-1151-2014","Class II","Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.","Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018 ",".","494","Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.",2/27/2014,"02/27/2014",3/19/2014,"03/19/2014"
"Food",67642,"Ongoing","Renfro Foods, Inc.","Fort Worth","TX","US","Voluntary: Firm Initiated","Telephone","ME, TX","F-2340-2014","Class II","XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252","Lot Code FA2046252",,"3552 jars (296 cases of 12/16 oz jars)","Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/28/2014,"02/28/2014",8/27/2014,"08/27/2014"
"Food",67642,"Ongoing","Renfro Foods, Inc.","Fort Worth","TX","US","Voluntary: Firm Initiated","Telephone","ME, TX","F-2342-2014","Class II","Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY STONEWALL KITCHEN; STONEWALL LANE, YORK MAINE 03909 USA 800-207-JAMS; STONEWALLKITCHEN.COM","Lot Code FJ2236225, Exp date 10/22/2015; Lot Code FK253C225, Exp Date 11/25/2015",,"13,452 jars (1,121 cases of 12/16 oz jars)","Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/28/2014,"02/28/2014",8/27/2014,"08/27/2014"
"Food",67642,"Ongoing","Renfro Foods, Inc.","Fort Worth","TX","US","Voluntary: Firm Initiated","Telephone","ME, TX","F-2341-2014","Class II","XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252","Lot Code FA2045253",,"6528 jars (544 cases of 12/16 oz jars)","Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/28/2014,"02/28/2014",8/27/2014,"08/27/2014"
"Devices",67643,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.","Z-1648-2014","Class II","VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.","Catalog Number: 139 3396, Lot Number: 1590",".","583 units Total (357 units domestically & 226 units internationally)","Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.",2/20/2014,"02/20/2014",5/28/2014,"05/28/2014"
"Food",67644,"Ongoing","Fischer & Wieser Specialty Foods","Fredericksburg","TX","US","Voluntary: Firm Initiated","Telephone","OH, OR","F-1411-2014","Class II","Harry & David; WILD 'N SPICY; DOS QUESOS DIP; NET WT 1 lb.; (453g);Mild; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD OR, HARRYANDDAVID.COM; 800-547-3033","Lot codes 10204",".","2712 units (units are glass jars; cases contain 12 jars each for a total of 226 cases shipped.)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Food",67644,"Ongoing","Fischer & Wieser Specialty Foods","Fredericksburg","TX","US","Voluntary: Firm Initiated","Telephone","OH, OR","F-1412-2014","Class II","Harry & David; WILD 'N SPICY; JALAPENO TOMATO CHEESE DIP; NET WT 1 lb.; (453g);Medium; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD, OR, HARRYANDDAVID.COM; 800-547-3033","Lot code 10364",".","636 units (units are glass jars; cases contain 12 jars each for a total of 53 cases shipped.)"," Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Devices",67646,"Ongoing","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.","Z-1303-2014","Class II","FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.","US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.",".","50 total, all sizes: 18 in US, 32 Internationally.","Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. ",3/3/2014,"03/03/2014",4/2/2014,"04/02/2014"
"Devices",67646,"Ongoing","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.","Z-1305-2014","Class II","FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. ","US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.",".","50 total, all sizes: 18 in US, 32 Internationally.","Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. ",3/3/2014,"03/03/2014",4/2/2014,"04/02/2014"
"Devices",67646,"Ongoing","Medtronic Vascular, Inc.","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.","Z-1304-2014","Class II","FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., 25030 Roncadelle, Italy; Manufacturer: Medtronic Inc. Minneapolis, MN 55432. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm. ","US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.",".","50 total, all sizes: 18 in US, 32 Internationally.","Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. ",3/3/2014,"03/03/2014",4/2/2014,"04/02/2014"
"Devices",67647,"Ongoing","Allesee Orthodontic Appliances","Sturtevant","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and the country of : Canada.","Z-1314-2014","Class II","AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.","All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013",".","411","The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.",2/24/2014,"02/24/2014",4/9/2014,"04/09/2014"
"Devices",67648,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the countries of Algeria, Andorra, Armenia, Argentina, Austria, Australia, Azerbaijan, Belarus, Bermuda, Bahamas, Boliva, Brazil, Canada, Chile, China, Costa Rica, Cyprus, Czechoslovakia, Germany Guatemala, Denmark, Estonia, Egypt, Finland, France, Great Britain, Georgia, Guadeloupe, Greece, Guyana, Curacao, Hungary, Israel, India, Italy, Jordan, Japan, Kuwait, Kazakhstan, Luxembourg, Latvia, Libya, Madagascar, Macedonia, Martinique, Malta, Mauritius, Mexico, Nicaragua, Nigeria, Netherlands, Norway, Oman, Peru, French Polynesia, Poland, Portugal, San Marino, Singapore, Spain, Suriname, San Salvador, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan, Wallis & Futuna Islands, Zambia.","Z-1506-2014","Class II","Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.","Lots 10251, 10201, 10301, 10401, 10481, 10381, 11041, 11321, 12151, 12231, 1226, 11201, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381",,"117,801 ea.","Sterility of the product cannot be guaranteed.",3/4/2014,"03/04/2014",4/30/2014,"04/30/2014"
"Food",67649,"Ongoing","Laboratories Cop Inc","Gatineau","PQ","CA","Voluntary: Firm Initiated","E-Mail","Nationwide: AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY","F-1741-2014","Class II","Ideal Protein Double Chocolate Brownie. Individually wrapped, sold in boxes of 7. ","Lot Numbers: 30213, 30913, 31113, 31613, 31813, 32313, 33213, 02814, 03614",".","54,060","Possible contamination with thin metal fragments. ",2/20/2014,"02/20/2014",4/9/2014,"04/09/2014"
"Food",67650,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","PA, NJ, MD, VA, WVA, DE, Washington, DC","F-2447-2014","Class I","Lehigh Valley Dairy Farms Orange Juice FROM CONCENTRATE; DISTRIBUTED BY LEHIGH VALLEY DAIRY FARMS, A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers ","UPC 0-70472-44014-7 Sell by 3/23/14",,"7,498 gallons","undeclared dairy in orange juice ",2/26/2014,"02/26/2014",9/24/2014,"09/24/2014"
"Food",67650,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","PA, NJ, MD, VA, WVA, DE, Washington, DC","F-2448-2014","Class I","Swiss PREMIUM 100% Pure Orange Juice FROM CONCENTRATE; DIST BY: SWISS PREMIUM DAIRY; A DEAN FOODS COMPANY; DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers","UPC 0-76545-00132-1 Sell by 3/23/14",,"3,700 gallons ","undeclared dairy in orange juice ",2/26/2014,"02/26/2014",9/24/2014,"09/24/2014"
"Food",67650,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","PA, NJ, MD, VA, WVA, DE, Washington, DC","F-2445-2014","Class I","Price Chopper Orange Juice; 100% Pure ORANGE JUICE FROM CONCENTRATE; DISTRIBUTED BY THE PRICE CHOPPER, INC., SCHENECTADY, NY 12306; in one gallon plastic containers ","UPC 0-41735-17135-1 Sell by 3/23/14",,"140 gallons","undeclared dairy in orange juice ",2/26/2014,"02/26/2014",9/24/2014,"09/24/2014"
"Food",67650,"Ongoing","Dean Foods, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","PA, NJ, MD, VA, WVA, DE, Washington, DC","F-2446-2014","Class I","Lehigh Valley Dairy Farms Orange Juice from concentrate HALF PINT (236 mL); DISTRIBUTED BY TUSCAN/LEHIGH DAIRIES, INC., A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in paper cartons","UPC 0-70472-43022-3 Sell by 3/23/14",,"435 gallons","undeclared dairy in orange juice ",2/26/2014,"02/26/2014",9/24/2014,"09/24/2014"
"Biologics",67651,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","E-Mail","Austria","B-0517-14","Class II","Blood and Blood Products for Reprocessing","W088413540238",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",2/14/2014,"02/14/2014",4/9/2014,"04/09/2014"
"Biologics",67652,"Terminated","Houchin Community Blood bank","Bakersfield","CA","US","Voluntary: Firm Initiated","FAX","California","B-0516-14","Class II","Red Blood Cells Leukocytes Reduced","W224313304965",".","1 unit","Blood product, collected from a donor who lived with an individual who had Hepatitis B, was distributed.",1/16/2014,"01/16/2014",4/9/2014,"04/09/2014"
"Biologics",67653,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0514-14","Class II","Red Blood Cells Leukocytes Reduced","W037712087577",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",1/15/2014,"01/15/2014",4/9/2014,"04/09/2014"
"Biologics",67653,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0515-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W037712010967",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",1/15/2014,"01/15/2014",4/9/2014,"04/09/2014"
"Biologics",67654,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","E-Mail","Argentina","B-0498-14","Class II","Cornea","111215OD; 111215OS",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.",2/11/2014,"02/11/2014",3/19/2014,"03/19/2014"
"Food",67655,"Terminated","Hong Lee Trading Inc","Brooklyn","NY","US","Voluntary: Firm Initiated","Press Release","New York State","F-2424-2014","Class I","Mut Dua Non YOUNG COCONUT CANDY, Net Weight: 10.6oz (300g), UPC 8 935054 702377 -- Product of Vietnam -- Packed for: HONG LEE TRADING INC. 225 JOHNSON AVE BROOKLYN, NEW YORK 11206 (718) 386-2100 --- NUTRITION FACTS: Serving Size 30oz. (85g), Servings per container 6","UPC code 8935054702377 and no other coding",".","40 cases (300 grams/10.6 oz. x 24 lbs.)","The product was found to contain undeclared sulfites (258.6 ppm) plus undeclared colors Yellow #5, Blue #1 and Red #3 based on sampling and analysis by New York State Department of Agriculture & Markets. ",3/4/2014,"03/04/2014",9/17/2014,"09/17/2014"
"Devices",67657,"Ongoing","Mevion Medical Systems, Inc.","Littleton","MA","US","Voluntary: Firm Initiated","Visit","USA Nationwide Distribution in the state of MO","Z-1271-2014","Class II","MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy ","S250-0001",".","1 unit","Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields",3/5/2014,"03/05/2014",4/2/2014,"04/02/2014"
"Devices",67658,"Ongoing","Boston Scientific Corporation","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","TX and Russia","Z-1164-2014","Class II","Boston Scientific, RunWay'' Guide Catheter, UPN H749389696640, Catalog Number 38969-664.","2013040058",".","7","Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay'' Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date, Boston Scientific has received one complaint for this issue. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.",3/3/2014,"03/03/2014",3/19/2014,"03/19/2014"
"Food",67660,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and small quantities exported to Hong Kong, Singapore and Malaysia.","F-1687-2014","Class II","Stage 2 World Baby Thailand; Roasted Pumpkin & Coconut Rice, 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA ","Best Before 10SEP14",".","11,595 total cases, both varieties. 12 x 3.5 oz pouches per case.","Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two production dates may cause plastic fragments to break loose and cause a potential choking hazard.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Food",67660,"Ongoing"," Plum Inc ","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and small quantities exported to Hong Kong, Singapore and Malaysia.","F-1688-2014","Class II","Stage 2 World Baby ; Zucchini & Spinach with Pasta Marinara; 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA ","Best Before 09SEP14",".","11,595 cases total, both varieties (12 x 3.5 oz pouches per cast)","Intermittent damage to the plastic spouts during manufacturing of two varieties of Plum products on two product dates may cause plastic fragments to break loose and cause a potential choking hazard.",3/4/2014,"03/04/2014",4/2/2014,"04/02/2014"
"Drugs",67661,"Ongoing","Traxx International Corp","Pine Brook","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1165-2014","Class II","Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001","211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322",,"30,800 Kg","Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. ",1/14/2014,"01/14/2014",3/26/2014,"03/26/2014"
"Food",67662,"Ongoing","H.C. Schau & Son","Woodridge","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: IN, IL, WI","F-1724-2014","Class I","8 oz. Tuscan Style Combo on Tomato Basil Spread sandwiches individually wrapped in clear plastic wrap sold under the Fresh To Go brand.","''Best By'' codes: Friday 0228, Saturday 0301, Sunday 0302, Monday 0303, Tuesday 0304",".","3,422 sandwiches","''Fresh To Go Tuscan Style Combo on Tomato Basil Bread'' sandwiches contain undeclared pine nuts (tree nuts).",3/3/2014,"03/03/2014",4/9/2014,"04/09/2014"
"Food",67663,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, DE, FL, GA, IA, IL, IN, KS, ME, MI, MN, MO, NC, NH, NY, OH, PA, SD, TN, WI","F-1686-2014","Class II","UNCLE BEN's(R) READY RICE(R) Original Enriched Long Grain White Rice, 8.8 oz. (250g), UPC 054800 031764","Best Before Date 12/14 MADE IN CANADA 351GBBFP [1L, 2L, 3L, 1R, 2R, 3R]",".","3329 cases of 12 units","Voluntary recall was initiated after identifying a number of packages with punctures on the back of the package that led to spoilage (off odors and appearance). ",2/28/2014,"02/28/2014",4/2/2014,"04/02/2014"
"Drugs",67664,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.","D-1182-2014","Class II","Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06 ","Lot #: 48D001, Exp. 5/2015; 48D002, Exp. 9/2015",".","127,585 Bottles","Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. ",3/4/2014,"03/04/2014",4/9/2014,"04/09/2014"
"Drugs",67664,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.","D-1184-2014","Class II","Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56","Lot #: 50D003, Exp. 2/2015; 50D004, 50D005, Exp. 3/2015; 50D006, Exp. 5/2015; 50D010, Exp. 6/2015; 50D028, Exp. 9/2015; 50D029, 50D031, Exp. 10/2015; 50D032, 50D033, Exp. 11/2015 ",".","324,648 Bottles","Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. ",3/4/2014,"03/04/2014",4/9/2014,"04/09/2014"
"Drugs",67664,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.","D-1183-2014","Class II","Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56 ","Lot #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015 ",".","598,033 Bottles","Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. ",3/4/2014,"03/04/2014",4/9/2014,"04/09/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1379-2014","Class II","MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74024, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1377-2014","Class II","EDDP Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74022, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1381-2014","Class II","Methadone Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74026, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1403-2014","Class II","Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74057, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1400-2014","Class II","Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74052, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1367-2014","Class II","Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74007, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1352-2014","Class II","Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71053, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1394-2014","Class II","Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74041 All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1371-2014","Class II","Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74016, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1396-2014","Class II","Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74043, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1361-2014","Class II","PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054"," Catalog number: 72003, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1408-2014","Class II","K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74066, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1413-2014","Class II","Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75005, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1388-2014","Class II","PCP Test (Strip); LumiQuick, Santa Clara, CA 95054"," Catalog number: 74033, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1345-2014","Class II","Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71032, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1404-2014","Class II","Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74058, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1389-2014","Class II","PCP Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74034, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1399-2014","Class II","Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74051, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1338-2014","Class II","Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054"," Catalog number: 71016, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1401-2014","Class II","Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74055, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1348-2014","Class II","H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71046, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1373-2014","Class II","Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74018, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1405-2014","Class II","Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74059, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1378-2014","Class II","MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74023, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1398-2014","Class II","Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74049, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1355-2014","Class II","Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054"," Catalog number: 71057, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1339-2014","Class II","Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054"," Catalog number: 71017, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1342-2014","Class II","H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054"," Catalog number: 71024, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1380-2014","Class II","Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74025, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1391-2014","Class II","THC Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74036 All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1347-2014","Class II","Legionella Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71034, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1414-2014","Class II","Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75006, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1393-2014","Class II","Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74040 All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1344-2014","Class II","Rotavirus Test Card LumiQuick, Santa Clara, CA 95054"," Catalog number: 71029, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1390-2014","Class II","THC Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74035 All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1375-2014","Class II","Cocaine Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74020, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1402-2014","Class II","Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74056, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1416-2014","Class II","CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75008, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1397-2014","Class II","Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74044, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1365-2014","Class II","Tramadol Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74002, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1370-2014","Class II","Barbiturate Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74015, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1374-2014","Class II","Cocaine Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74019, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1363-2014","Class II","Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 72006, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1350-2014","Class II","Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71049, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1353-2014","Class II","Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71054, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1384-2014","Class II","Morphine Strip (300); LumiQuick, Santa Clara, CA 95054"," Catalog number: 74029, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1362-2014","Class II","PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054"," Catalog number: 72004, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1337-2014","Class II","Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054"," Catalog number: 71015, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1383-2014","Class II","Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 74028, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1369-2014","Class II","Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74014, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1409-2014","Class II","Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75001, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1410-2014","Class II","Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75002, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1356-2014","Class II","Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71062, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1360-2014","Class II","Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 72001, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1351-2014","Class II","Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054"," Catalog number: 71050, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1357-2014","Class II","Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71063, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1406-2014","Class II","Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74060, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1412-2014","Class II","Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75004, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1386-2014","Class II","Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054"," Catalog number: 74031, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1382-2014","Class II","Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054"," Catalog number: 74027, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1411-2014","Class II","Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75003, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1359-2014","Class II","Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71087, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1372-2014","Class II","Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74017, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1415-2014","Class II","CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054"," Catalog number: 75007, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1366-2014","Class II","Tramadol Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74003, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1358-2014","Class II","Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71066, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1364-2014","Class II","Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74001, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1407-2014","Class II","K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74065, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1346-2014","Class II","Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71033, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1349-2014","Class II","Strep A Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71048, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1354-2014","Class II","Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054"," Catalog number: 71055, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1385-2014","Class II","Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054"," Catalog number: 74030, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1376-2014","Class II","EDDP Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74021, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1340-2014","Class II","Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71019, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1341-2014","Class II","H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054"," Catalog number: 71020, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1343-2014","Class II","Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054"," Catalog number: 71028, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1368-2014","Class II","Amphetamine Strip; LumiQuick. Santa Clara, CA 95054"," Catalog number: 74013, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1395-2014","Class II","Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74042, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1387-2014","Class II","Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054"," Catalog number: 74032, All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Devices",67665,"Ongoing","LumiQuick Diagnostics Inc.","Santa Clara","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, NJ, TX, and NY.","Z-1392-2014","Class II","Ketamine Strip; LumiQuick,. Santa Clara, CA 95054"," Catalog number: 74039 All lots",".","ALL","Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.",3/4/2014,"03/04/2014",4/16/2014,"04/16/2014"
"Food",67666,"Ongoing","Gretchen's Shoebox Express","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in Western WA and Western OR.","F-1677-2014","Class I","Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a white sticky label. UPC 6211198649.","''Enjoy by 03 05'', which represents March 5th, 2014.",,"1726 cups/ 6.1 oz","Gretchen's Shoebox Express is recalling Greek Yogurt Raspberry & Lemon Parfait cups sold under the Starbucks brand due to undeclared egg. ",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Food",67667,"Ongoing","House Of Flavors, Inc.","Ludington","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, IL, MI, OH","F-1726-2014","Class I","Belmont Premium Ice Cream, Chocolate Chip Cookie Dough, All Natural, 1.5 Quarts (1.42 L), Nutrition Facts....., Ingredients: Skim milk, Cream, Sugar, Cookie dough pieces (unenriched wheat flour, sugar, butter (cream, salt), brown sugar, water, corn oil, fructose, corn syrup solids, salt, vanilla extract, sodium bicarbonate, coconut oil) corn syrup, chocolate flakes (sugar, coconut oil, cocoa processed with alkali, butter oil, soy lecithin, natural flavor, whey flavor base ( brown sugar, water, natural flavor, molasses, salt) egg, carob bean gum, guar gum, carrageenan, annatto (color), Contains: milk, wheat , egg, soy Distributed by ALDI Inc. Batavia, IL 60510, UPC code 4149816310","date code 13340 and 13341, Best by Date: Dec. 7, 2014",".","26,534 units","may contain undeclared nut allergen. ",3/4/2014,"03/04/2014",4/9/2014,"04/09/2014"
"Biologics",67668,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0568-14","Class II","Platelets Pheresis Leukocytes Reduced","W050912000317",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",1/22/2014,"01/22/2014",4/30/2014,"04/30/2014"
"Biologics",67669,"Terminated","Mid-America Transplant Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0313-14","Class II","Cornea","01272013060OS; 01272013060OD",".","2 corneas ","Human corneas, recovered from a donor who was not properly evaluated for hemodilution, were distributed. ",11/26/2013,"11/26/2013",3/19/2014,"03/19/2014"
"Food",67670,"Ongoing","Consolidated Mills, Inc","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-2371-2014","Class II","DOS PADRES BRAND; CHIPOTLE QUESO; NET WT. 15.6 oz. (442g); Distributed by; CYCLONE ENTERPRISES; Houston, Texas 77060 UPC: 64258 20120"," Lot # 29513 C DPSQ",".","127 cases of 12/15.6 oz jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67670,"Ongoing","Consolidated Mills, Inc","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-2372-2014","Class II","TRULY TEXAS; CHIPOTLE CON QUESO; Queso With Chipotles; NET WT.; 16 OZ. (453g) and NET WT. 8 OZ. (226g); Distributed by: Double T Gourmet Foods, Inc.; PO Box 1582 Montgomery, TX 77356; Phone 936-582-6798; ww.trulytexasfoods.com UPC: 90191 00105 (16 oz.) and UPC: 90191 00129 (8 oz.)","16 OZ: Lot # 30913 B TTCQ Exp Date 11/5/2014; Lot # 00814 B TTCQ Exp Date 1/8/2015 8 OZ: Lot # 29413G TTCQ, Exp Date 10/21/2014; 02114A TTCQ, Exp Date 1/21/2015; 30913 A TTCQ E, Exp Date 11/5/2014",".","99 cases of 12/16 oz jars and 279 cases of 12/8 oz jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67670,"Ongoing","Consolidated Mills, Inc","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","TX","F-2370-2014","Class II","DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060 UPC: 64258 20110","Lot # 03614 A DPSQ",".","53 cases of 12/15.6 oz jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67671,"Ongoing","Crown Food Distributors Inc","North Bergen","NJ","US","Voluntary: Firm Initiated","Telephone","NY and NJ","F-1701-2014","Class I","Golden Natural Fruit Island Net Wt. 25.00 oz Product of Crown Food North Bergen, NJ 07047 Packed by: Crown Food/North Bergen 07047 USA UPC 098346021032","Sell by Date 11/19/14",".","120- 25 oz. containers","NYSDAM analysis has revealed the presence of undeclared sulfites and undeclared FD&C Yellow #6 in Golden Natural Brand ''Fruit Island''.",1/27/2014,"01/27/2014",4/2/2014,"04/02/2014"
"Devices",67672,"Ongoing","Trivascular, Inc","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.","Z-1297-2014","Class II","Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.","All codes",".","45","Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.",2/27/2014,"02/27/2014",4/2/2014,"04/02/2014"
"Food",67673,"Ongoing","Walong Marketing, Inc.","Buena Park","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide.","F-1746-2014","Class III","Asian Taste (Brand) Green Tea Pumpkin Seeds, 8 oz., UPC 673367418186. ","UPC 673367418186. ",".","3499 cartons","Walong Marketing, Inc. initiated the recall of Asian Taste Green Tea Pumpkin Seeds because it contains the ingredient sodium copper chlorophyllin, not permitted for use in food or foold products sold in the U.S.",2/20/2014,"02/20/2014",4/9/2014,"04/09/2014"
"Devices",67675,"Ongoing","Pega Medical Inc.","Laval",,"CA","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.","Z-1448-2014","Class II","Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.","Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS]. ",".","Total of 5 units (2 units in the US and 3 units in Germany)","The Male Components in this lot are made of material with lower strength than manufacturing specifications.",2/7/2014,"02/07/2014",4/16/2014,"04/16/2014"
"Food",67676,"Ongoing","Creative Foodworks, Inc","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, GA","F-2375-2014","Class II","Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 454g; DISTRIBUTED BY H-E-B CENTRAL MARKET, AUSTIN, TX 78735","Lot # 218afd3A, Exp Date 8/6/2015; 218afd3B,, Exp Date 8/6/2015; 219afd3A, Exp Date 8/7/2015; 219afd3B, Exp Date 8/7/2015; 219afd3C,Exp Date 8/7/2015; 221afd3A Exp Date 8/9/2015; 225afd3A,Exp Date 8/13/2015; 235afd3A, Exp Date 8/23/2015; 235afd3B, Exp Date 8/23/2015; 235afd3C, Exp Date 8/23/2015; 235afd3D, Exp Date 8/23/2015; 262afd3B, Exp Date 9/19/2015; 262afb3C, Exp Date 9/19/2015; 262afd3D, Exp Date 9/19/2015; 269afd3A, Exp Date 9/26/2015; 269afd3B, Exp Date 9/26/2015",".","33,132 jars (2,761 cases of 12/16 oz jars)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67676,"Ongoing","Creative Foodworks, Inc","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, GA","F-2376-2014","Class II","Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 453g; DISTRIBUTED BY Native Texan Food Co. Box 50583, Austin 78763 www.NATIVETEXAN1836.com","Lot # 225afd3A, Exp Date 8/13/2015; 225afd3B, Exp Date 8/13/2015; 262afd3A, Exp Date 9/19/2015; 262afd3B,Exp Date 9/19/2015; 290afd3A,Exp Date 10/17/2015; 006afd4A, Exp Date 1/6/2016",".","9270 jars 1,545 cases of 6/16 oz jars)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67676,"Ongoing","Creative Foodworks, Inc","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, GA","F-2373-2014","Class II","SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX 78763","Lot # 310afv3A Exp date 11/15/2015; Lot # 022afv4A Exp Date 1/22/2015",".","3726 jars (621 cases of 6/16 oz jars)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67676,"Ongoing","Creative Foodworks, Inc","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, GA","F-2374-2014","Class II","NATIVE TEXAN QUESO; NACHO; Medium; NATIVE TEXAN FOOD Co.; NET WT 16oz 453g 1LB.; NATIVE TEXAN FOOD CO. box 50583, Austin TX 78763 www.NativeTexan1836.com","Lot # 290afs3A",".","1740 jars (290 cases of 6/16 oz jars)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Food",67676,"Ongoing","Creative Foodworks, Inc","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, GA","F-2377-2014","Class II","CRAZY JERRY''S DA BIG CHEESE; NET WT. 16 OZ. ( 1 LB.) 454g; Prepared for Crazy Jerry's Inc. P.O. Box 891 Roswell, GA 30077","Lot # 289mf3A",".","504 jars (42 cases of 12/16 oz jars)","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.",2/25/2014,"02/25/2014",9/3/2014,"09/03/2014"
"Devices",67677,"Ongoing","Draeger Medical Systems, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of WI and NY.","Z-1440-2014","Class I","Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833","Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005",".","3","The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.",3/5/2014,"03/05/2014",4/16/2014,"04/16/2014"
"Devices",67678,"Ongoing","Ion Beam Applications S.A.","Louvain La Neuve",,"BE","Voluntary: Firm Initiated","Letter","US Distribution including the states of OK, IL, NJ, and WA.","Z-1492-2014","Class II","Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy","Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.",,"4","Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). ",12/4/2013,"12/04/2013",4/30/2014,"04/30/2014"
"Food",67681,"Ongoing","Net Food Import and Export llc.","Clifton","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ","F-1744-2014","Class I","Net Food Turkey Dried Apricots Net Weight 16.1 oz (454 g) Thunderbolt Export & Imports 743 Fairview Avenue. Suit :2 Arcadia, CA 91007 USA UPC 8697445250019","none.",".","61 boxes (24 containers in each case)","NYSDAM Analysis has revealed the presence of undeclared sulfites in Dried Apricots.",2/24/2014,"02/24/2014",4/9/2014,"04/09/2014"
"Food",67683,"Ongoing","Durrset Amigos, Ltd.","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, WI, NC","F-2429-2014","Class II","H-E-B Chipotle Con Queso; HOT; with Real Chipotle Peppers; NET WT; 16 OZ (1 LB) 454g; Made with Pride and Care for H-E-B, SAN ANTONIO, TEXAS 78204. Distributed in cases of 12/16 oz. jars."," Lot #s SA13254, SA13268; SA13304, SA13331, SA14015, SA14029 ",".","3340 cases of 12/16 oz jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/26/2014,"02/26/2014",9/17/2014,"09/17/2014"
"Food",67683,"Ongoing","Durrset Amigos, Ltd.","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, WI, NC","F-2432-2014","Class II","HY-TOP FRENCH ONION DIP; NET WT 9 OZ. (255g); DISTRIBUTED BY FEDERATED GROUP, INC.; ARLINGTON HEIGHTS IL. 60005-1096. Shipped in cases of 12/9 oz containers."," Lot # SA13320",".","67 cases of 12/ 9 oz containers","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/26/2014,"02/26/2014",9/17/2014,"09/17/2014"
"Food",67683,"Ongoing","Durrset Amigos, Ltd.","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, WI, NC","F-2430-2014","Class II","HILL COUNTRY FARE; Salsa Con QUESO Sauce; Medium - PICANTE; NET WT 16 OZ (1LB) CONT. NET. 454g; DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78294. distributed in cases of 12/16 oz. jars"," Lot #s SA13254, SA13268, SA13304, SA13282, SA14015, SA14029, SA13331",".","3802 cases of 12/16 oz jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/26/2014,"02/26/2014",9/17/2014,"09/17/2014"
"Food",67683,"Ongoing","Durrset Amigos, Ltd.","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, WI, NC","F-2431-2014","Class II","Roundy's Salsa Con Queso; NET WT; 16 OZ (1 LB) 454g; DISTRIBUTED BY Roundy's Milwakee, WI 53202. Distributed in cases of 12/16 W jars."," Lot # SA13282",".","374 cases of 12/16 W jars","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/26/2014,"02/26/2014",9/17/2014,"09/17/2014"
"Food",67683,"Ongoing","Durrset Amigos, Ltd.","San Antonio","TX","US","Voluntary: Firm Initiated","E-Mail","TX, WI, NC","F-2433-2014","Class II","Laura Lynn French Onion; DIP; NET WT 9 OZ (255g); DISTRIBUTED BY INGLES MARKETS, INC.; ASHEVILLE, NC 28816. Shipped in cases of 12. "," Lot # SA13320, Lot # SA14041",".","295 cases of 12/9 oz. containers","Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.",2/26/2014,"02/26/2014",9/17/2014,"09/17/2014"
"Devices",67684,"Ongoing","HeartWare Inc","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.","Z-1607-2014","Class II","HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.","Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers",,"32,349","Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.",4/16/2014,"04/16/2014",5/21/2014,"05/21/2014"
"Devices",67685,"Ongoing","Philips Medical Systems North America Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.","Z-1263-2014","Class II","Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis. ","All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014). ",,"489 total =227 units in US and 262 units Internationally (no Canadian consignees)","A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. ",2/28/2014,"02/28/2014",3/26/2014,"03/26/2014"
"Devices",67685,"Ongoing","Philips Medical Systems North America Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.","Z-1264-2014","Class II","Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis. ","All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014). ",,"1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada)","A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. ",2/28/2014,"02/28/2014",3/26/2014,"03/26/2014"
"Devices",67686,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.","Z-1210-2014","Class II","DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others","lot numbers 1143442 and 1161762",,"8,962 pairs","Moldy smell in product",2/21/2014,"02/21/2014",3/26/2014,"03/26/2014"
"Drugs",67687,"Ongoing","New England Home Therapies, Inc","Southborough","MA","US","Voluntary: Firm Initiated","Telephone","US: New England","D-0003-2015","Class II","All sterile drugs compounded between 2/21/14 and 2/24/14. ","Expiration dates between 3/5/14 and 3/10/14.",".","87 Products","Lack of Assurance of Sterility: All compounded products.",2/26/2014,"02/26/2014",10/7/2014,"10/07/2014"
"Drugs",67688,"Ongoing","Pinnacle Biologics Inc","Bannockburn","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide and Taiwan","D-1157-2014","Class III","Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75","Lot Number: 0M396; Expiry: Nov 2014",".","261 vials","Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.",2/10/2014,"02/10/2014",3/19/2014,"03/19/2014"
"Drugs",67689,"Ongoing","Sagent Pharmaceuticals Inc","Schaumburg","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1615-2014","Class II","Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82","NDC 25021-830-82; Lot Numbers and Expiration Dates: Lot 30076, Expires 01/2015; Lot 30077, Expires 01/2015.",".","10,622 bags","Lack of Assurance of Sterility; leaking of premix bags ",3/4/2014,"03/04/2014",10/7/2014,"10/07/2014"
"Drugs",67690,"Ongoing","Shire Human Genetic Therapies, Inc.","Lexington","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide including Puerto Rico; Mexico, Columbia","D-1251-2014","Class I","VPRIV (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.","US: Lot #: FEW13-001, FEW13-002, FED13-006; Expiry: 10/15. Mexico: Lot #: FED 013-010; Expiry: 10/15. Columbia: Lot #: FED 013-011; Expiry: 10/15.",,"8359 vials","Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.",3/14/2014,"03/14/2014",4/30/2014,"04/30/2014"
"Devices",67691,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","USA Nationwide Distribution including Canada","Z-1437-2014","Class II","GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel. ","Label Lot Laser Lot D38FX4 PG0809 D5AA34 PG1009 D5AA44 PG1109 E1WC14 PG0710 E1WC24 PG0710 E1WC34 PG0810 E1WC44 PG0810 E1WCY4 PG0710 E24A44 PG0810 E24A54 PG0810 E28CB4 PG0810 E29G14 PG1210 E2FCW4 PG0810 E2FCX4 PG0810 E2FCY4 PG0810 E2VB24 PG0910 E2VB34 PG0810 E2VB44 PG0810 E2VB54 PG0910 E2VB64 PG0910 E2VB74 PG1010 E41E44 PG1010 E41E54 PG1010 E4DA54 PG0910 E4FDM4 PG0910 E4FDN4 PG1110 E4FDP4 PG0910 E4FKJ4 PG1010 E4FKK4 PG1110 E4FKL4 PG1010 E4XFD4 PG0910 E4XFE4 PG0910 E4XGL4 PG1010 E4XGM4 PG1010 E4XGN4 PG1010 E4XGR4 PG1010 E4XGS4 PG1010 E4XGT4 PG1010 E54BL4 PG1110 E54BP4 PG1110 E56JF4 PG1210 E56JG4 PG1210 E57F14 PG1210 E57F24 PG1210 E57F34 PG1210 E57F44 PG1110 E57FV4 PG1110 E57FW4 PG1110 E57FY4 PG1210 E5CCG4 PG1010 E5CCH4 PG1010 E5CCJ4 PG1010 E5CCK4 PG1010 E5NJV4 PG1110 E5PBJ4 PG1210 E5PEA4 PG1110 E6CHE4 PG1110 E6DDE4 PG1210 E6DDF4 PG1210 E75AK4 PG1210 E75AL4 PG1210 E87GG4 PG1210 E87GH4 PG0111 E87GJ4 PG0111 E87GK4 PG1210 E87GL4 PG0111 E87GM4 PG0111 E87GN4 PG0111 E87HW4 PG0111 EG8FF4 PG0410 EG8FG4 PG0410 EL6PY4 PG0510 EP4F84 PG0510 EP4GF4 PG0510 ET3BY4 PG0610 ET3JD4 PG0510 ET3JE4 PG0610 ET3JF4 PG0510 EW1D64 PG0710 EW1D74 PG0610 EW1D84 PG0610 EW1D94 PG0610 EW1EA4 PG0710 EW1EB4 PG0610 FA3D54 PG0111 FA3D64 PG0111 FA3D74 PG0211 FA5LE4 PG1210 FB1FP4 PG0211 FB1GY4 PG0211 FC2RC4 PG0211 FE8AP4 PG0211 FF8HC4 PG0211 FL5D44 PG0411 FL5D54 PG0411 FL5D74 PG0411 FL5D84 PG0411 FL6BG4 PG0311 FP3C14 PG0411 PG000035 PG0611 PG000036 PG0511 PG000037 PG0511 PG000038 PG0511 PG000039 PG0411 PG000040 PG0411 PG000042 PG0411 PG000043 PG0411 PG000116 PG0511 PG000117 PG0611 PG000316 PG0611 PG000317 PG0511 PG000360 PG0611 PG000361 PG0611 PG000400 PG0511 PG000401 PG0611 PG000427 PG0611 PG000428 PG0611 PG000468 PG0711 PG000469 PG0711 PG000470 PG0711 PG000471 PG0611 PG000472 PG0611 PG000473 PG0611 PG000628 PG0711 PG001042 PG0411 PG217084 PG217084 PG217085 PG217085 PG217574 PG217574 PG217575 PG217575 PG217576 PG217576 PG217577 PG217577 PG217578 PG217578 PG218621 PG218621 PG218622 PG218622 PG218623 PG218623 PG218624 PG218624 PG218625 PG218625 PG21862",".","21,675","Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient. ",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Biologics",67692,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-0520-14","Class III","Platelets","W035214030217P; ",".","1","Blood Product, collected from a donor whose health history screening was not adequately performed, was distributed.",2/4/2014,"02/04/2014",4/9/2014,"04/09/2014"
"Biologics",67693,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","New York; Switzerland","B-0500-14","Class III","Blood and Blood Products for Reprocessing","W036808110290; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. ",2/3/2014,"02/03/2014",3/19/2014,"03/19/2014"
"Biologics",67693,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","New York; Switzerland","B-0501-14","Class II","Red Blood Cells Leukocytes Reduced","W036808110290; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. ",2/3/2014,"02/03/2014",3/19/2014,"03/19/2014"
"Biologics",67694,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0503-14","Class II","Red Blood Cells Leukocytes Reduced","W035213230655I; ",".","1 unit ","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/14/2014,"02/14/2014",4/23/2014,"04/23/2014"
"Biologics",67694,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0505-14","Class III","Blood and Blood Products for Reprocessing","W035213230655I; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/14/2014,"02/14/2014",4/23/2014,"04/23/2014"
"Biologics",67694,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0504-14","Class II","Platelets","W035213230655I; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",2/14/2014,"02/14/2014",4/23/2014,"04/23/2014"
"Biologics",67695,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0524-14","Class II","Platelets Pheresis Leukocytes Reduced","W115113365044B",".","1 unit","Blood product, with a low pH, was distributed.",2/11/2014,"02/11/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0555-14","Class II","Platelets","1775267; 2046554; ",".","2 units","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0556-14","Class II","Plasma Frozen Cryoprecipitated Reduced","2046554; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0557-14","Class II","Red Blood Cells","1775267; 2046554; 2321193; 2411016; ",".","4 units","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0554-14","Class II","Cryoprecipitated AHF","1775267; 2046554; ",".","2 units","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0558-14","Class II","Fresh Frozen Plasma","2321193; 2411016; ",".","2 units","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67696,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0553-14","Class II","Red Blood Cells Irradiated","1451519; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not fully evaluated, were distributed. ",2/6/2014,"02/06/2014",4/23/2014,"04/23/2014"
"Biologics",67697,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","FAX","Wisconsin","B-0506-14","Class II","Cryoprecipitated AHF, Pooled","W036313927961; W036313927960; W036313927962; W036313927963; W036313927965; W036313927967; ",".","6","Blood products, not prepared in accordance with specifications, were distributed.",1/23/2014,"01/23/2014",4/23/2014,"04/23/2014"
"Biologics",67698,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Maryland","B-0525-14","Class III","Red Blood Cells Leukocytes Reduced","W201713076276",".","1 unit","Blood product which was not quarantined after the donor reported having had a shingles vaccination prior to donation was distributed.",11/21/2013,"11/21/2013",4/23/2014,"04/23/2014"
"Biologics",67699,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0527-14","Class II","Red Blood Cells Leukocytes Reduced","W227014007259, W227014007255",".","2 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",2/8/2014,"02/08/2014",4/23/2014,"04/23/2014"
"Biologics",67699,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0528-14","Class II","Fresh Frozen Plasma","W227014007263, W227014007829, W227014007824",".","3 units","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",2/8/2014,"02/08/2014",4/23/2014,"04/23/2014"
"Biologics",67699,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0526-14","Class II","Platelets Pooled Leukocytes Reduced","W356514000875",".","1 unit","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",2/8/2014,"02/08/2014",4/23/2014,"04/23/2014"
"Food",67701,"Ongoing","AMS Health Sciences","Oklahoma City","OK","US","Voluntary: Firm Initiated","Other","OK, CO,","F-0018-2015","Class II","saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105","Lot #s 81721,81722,101022,61327,61328,61329,31424,31422,31423,40926,40925,33125,31421,31324,30922,30923,30924,31322,31323,31321,12428,30925, 12426,21325,12521,112214,112216,52231,52232,20634,31832,31833,40833,31831,31838,33033,330353,33031,33034,33032,31834,31837,31835,31836, 20634,20635,21837,21834,21835,21836,31537,11131,20633,121024,121025,121026,121027,21831,36000250,110524,110525,101024,33126,61325, 981723,101023,110523",,"1,021,350 - 2 pack samples; 8,595,450 - 60 ct bottle","Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013. ",2/26/2014,"02/26/2014",10/15/2014,"10/15/2014"
"Devices",67702,"Ongoing","Clarity Medical Systems Inc","Pleasanton","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy.","Z-1265-2014","Class II","Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.","Lot of Halogan Lamp Component is #020612C. RetCam 3, Part number 21-100500. RetCam 3 affected serial numbers: RC3066 RC3079 RC6013 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6043 RC6044 RC6045 RC6047 RC6049 RC6050 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6063 RC6064 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6092 RC6093 RC6094 RC6095 RC6096 RC6098 RC6099 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6364 ",,"234 lamps","One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.",3/7/2014,"03/07/2014",3/26/2014,"03/26/2014"
"Biologics",67703,"Terminated","San Diego Eye Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0519-14","Class III","Cornea","126688OSC; ",,"1 cornea","Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",3/7/2014,"03/07/2014",3/26/2014,"03/26/2014"
"Biologics",67704,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0523-14","Class II","Platelets Leukocytes Reduced","W037712092426",".","1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.",2/18/2014,"02/18/2014",4/23/2014,"04/23/2014"
"Biologics",67704,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0522-14","Class II","Red Blood Cells Leukocytes Reduced","W037712092426",".","1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.",2/18/2014,"02/18/2014",4/23/2014,"04/23/2014"
"Biologics",67705,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0550-14","Class II","Red Blood Cells Leukocytes Reduced","W227712350683",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",1/27/2014,"01/27/2014",4/30/2014,"04/30/2014"
"Biologics",67705,"Terminated","Mid-South Regional Blood Center","Memphis","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0551-14","Class II","Blood and Blood Products for Reprocessing","W227712350683",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",1/27/2014,"01/27/2014",4/30/2014,"04/30/2014"
"Biologics",67707,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Switzerland","B-0552-14","Class II","Blood and Blood Products for Reprocessing","W036513108377",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/14/2013,"11/14/2013",4/30/2014,"04/30/2014"
"Biologics",67708,"Terminated","Alba Bioscience Limited","Edinburgh",,"GB","Voluntary: Firm Initiated","E-Mail","Multiple U.S. States","B-0518-14","Class III","Reagent Red Blood Cells","V139824; V139825",,"2 lots; 182 panels","Misbranded Reagent Red Blood Cells were distributed. ",10/30/2013,"10/30/2013",3/26/2014,"03/26/2014"
"Drugs",67709,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1291-2014","Class II","Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.","Lot #: 1012381, 1012383, Exp 08/22/16",,"2915 kits","Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Drugs",67709,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1287-2014","Class II","Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.","Lot #: 1014204, Exp 10/11/15; 1014485, Exp 12/11/16; and 1015007, Exp 12/06/16",,"7362 kits","Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Drugs",67709,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1290-2014","Class II","Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7.","Lot #: 1013906, Exp 09/21/16",,"1,530 kits","Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Drugs",67709,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1288-2014","Class II","Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.","Lot # 1013976, Exp 09/25/15",,"36 kits","Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Drugs",67709,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1289-2014","Class II","LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5.","Lot #:1013566, Exp 12/08/16",,"12 kits","Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1276-2014","Class II","Weck Vista'', Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405910, Lot Number: 01G1200242, 01G1200341, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01L1200182, 01A1300139, 01B1300050, 01D1300318, 01E1300217, and 01E1300432.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1283-2014","Class II","5/10/12 mm Weck Vista'' Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405910RC, Lot Numbers: 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, and 01D1300319.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1290-2014","Class II","5/10/12 Weck Vista'' Universal Balloon Open Access Port Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 412944L, Lot Numbers: 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, and 01E1300436.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1282-2014","Class II","12mm Weck Vista'' Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405910R, Lot Numbers: 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1289-2014","Class II","5/10/12 Weck Vista'' Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1277-2014","Class II","10mm Weck Vista'' Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405912, Lot Number: 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01L1200369, 01A1300106, 01E1300218, 01E1300311, 01F1300135, and 01F1300079.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1280-2014","Class II","Weck Vista'' Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 40591213, Lot Numbers: 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1279-2014","Class II","5/10 mm Weck, Vista'' Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 410944, Lot Numbers: 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1284-2014","Class II","5/10/12 mm Weck Vista'' Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405912C, Lot Numbers: 01J1200384, 01K1200725, 01L1200352, and 01B1300009.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1287-2014","Class II","5/10 Weck Vista'' Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 410944L, Lot Numbers: 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1278-2014","Class II","5/10 mm Weck, Vista'' Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405933, Lot Numbers: 01L1200353, and 01F1300080.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1281-2014","Class II","Weck Vista'' Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405910C, Lot Numbers: 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1285-2014","Class II","5/10/12MM X 100MM Weck Vista'' UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405912R, Lot Numbers: 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1286-2014","Class II","5/10 Weck Vista'' Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 405912RC, Lot Numbers: 01G1200244, 01M1200020, 01M1200068, 01A1300546, and 01A1300559.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67710,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.","Z-1288-2014","Class II","5/10 Weck Vista'' Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. ","Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.",".","55,521 ea. in total","Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1555-2014","Class II","Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.","Product Code 1154654 - Lot 02K0801212",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1559-2014","Class II","Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.","Product Code H5300 - Lot 1450153E13",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1557-2014","Class II","Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.","Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348. ",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1558-2014","Class II","Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.","Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137 ",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1560-2014","Class II","Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.","Product Code X-4981M4 - Lot 02J0800451",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1556-2014","Class II","Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.","Product Code 0100019-507 -Lot 02F1301128, Product Code 6-511 - Lot 02M0800561, Product Code 6-559 - Lot 02A0800005, Product Code 69-403 - Lot 02H0802530, Product Code 7-5008M4 - Lot 02C0900466, Product Code 7-518 - Lot 02E1302561, Product Code 7-565 - Lot 02B1100185, Product Code 7-655A - Lot 02C0901963, Product Code 7-655A - Lot 02M0800836, Product Code 7-740 - Lot 02L1000536, Product Code 833-114 - Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509, Product Code E13-6351 - Lot 02F0902446, Product Code E13-6354 - Lot 02F0902439, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67711,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.","Z-1561-2014","Class II","Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.","Product Code X-6371M5 - Lot 02E0801603",".","32,271 ea.","Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.",3/11/2014,"03/11/2014",5/14/2014,"05/14/2014"
"Devices",67712,"Ongoing","Biocardia, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and country of: Israel.","Z-1302-2014","Class II","Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.","Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186 ",".","~2541 units - both catalog numbers.","Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.",3/3/2014,"03/03/2014",4/2/2014,"04/02/2014"
"Devices",67712,"Ongoing","Biocardia, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and country of: Israel.","Z-1301-2014","Class II","Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.","Catalog number MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190 ",".","~2541 - both models","Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.",3/3/2014,"03/03/2014",4/2/2014,"04/02/2014"
"Devices",67713,"Ongoing","Claymount Assembli","Dinxperlo",,"NL","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of CA, CO, FL, IL, NC, NJ, OH and PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom.","Z-1835-2014","Class II","The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. ","*** US Devices Only *** 1) Part ID: 17007; Serial Numbers: WO171240/E-1, WO171240/E-2. 2) Part ID: 17009; Serial Numbers: WO165307/E-1 , WO165308/E-1 , WO170263/E-1 , WO172341/E-1 , WO172341/E-1 , WO172760/E-1 , WO172760/E-2 , WO174533/E-2 , WO174980/E-2 , WO175009/E-1 , WO175010/E-2 , WO175011/E-1 , WO175011/E-2 , WO175013/E-1 , WO175013/E-2 , WO177682/E-1 , WO187248/E-1 , WO191933/E-2. 3) Part ID: 17675; Serial Numbers: WO160580/E-1 , WO166945/E-1 , WO166945/E-2 , WO166946/E-1 , WO166946/E-2 , WO166949/E-1 , WO166949/E-2 , WO166950/E-1 , WO166951/E-1 , WO166952/E-1 , WO166952/E-2 , WO166954/E-1 , WO166954/E-2 , WO166955/E-1 , WO166955/E-2 , WO166957/E-1 , WO166957/E-2 , WO169388/E-1 , WO169388/E-2 , WO172050/E-1 , WO172050/E-2 , WO172051/E-1 , WO172051/E-2 , WO172345/E-1 , WO174072/E-2 , WO175014/E-1 , WO175014/E-2 , WO175015/E-1 , WO175993/E-2 , WO179503/E-1 , WO182220/E-1. 4) Part ID: 17676; Serial Numbers: WO160452/E-1 , WO160453/E-1 , WO165325/E-1 , WO166958/E-1 , WO166958/E-2 , WO166961/E-1 , WO166962/E-1 , WO166962/E-2 , WO166963/E-1 , WO166963/E-2 , WO166964/E-1 , WO166968/E-1 , WO166968/E-1 , WO166968/E-2 , WO166969/E-1 , WO166970/E-1 , WO166970/E-2 , WO167440/E-1 , WO167440/E-2 , WO169398/E 2 , WO169398/E-1 , WO169400/E-1 , WO169400/E-2 , WO169402/E-1 , WO171077/E-1 , WO171077/E-2 , WO171390/E-1 , WO171390/E-2 , WO171391/E-1 , WO171391/E-2 , WO172052/E-1 , WO172052/E-2 , WO172054/E-1 , WO172054/E-2 , WO174099/E-2 , WO175166/E-1 , WO175166/E-2 , WO175169/E-1 , WO175169/E-2. 5) Part ID: 17985; Serial Numbers: WO166912/E-1 , WO166912/E-2 , WO166913/E-1 , WO166913/E-2 , WO169337/E-1 , WO169337/E-2 , WO169338/E-1 , WO172968/E-1 , WO172968/E-2 , WO172969/E-1 , WO172969/E-2 , WO175175/E-1 . 6) Part ID: 18423; Serial Numbers: WO193031/E-1 , WO193031/E-2 , WO193032/E-1 , WO193032/E-2 , WO196488/U-1 , WO196488/U-2 , WO196488/U-3 , WO198927/E-1 , WO198927/E-2 , WO200261/U-",,"125 units shipped to United States","Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.",3/15/2014,"03/15/2014",7/9/2014,"07/09/2014"
"Devices",67714,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.","Z-1444-2014","Class II","Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions","2513261 2531612 2540540 2545044 2588656",".","870 units","Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged",3/17/2014,"03/17/2014",4/16/2014,"04/16/2014"
"Devices",67714,"Ongoing","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.","Z-1443-2014","Class II","Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions","2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096",".","393,210","Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.",3/17/2014,"03/17/2014",4/16/2014,"04/16/2014"
"Devices",67715,"Ongoing","Claymount Assembli","Dinxperlo",,"NL","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1836-2014","Class II","The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.","*** US Devices Only *** 1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Part ID: 17361; Serial Numbers: WO186723/E-1. 3) Part ID: 17362; Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2. 4) Part ID: 18476; Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2. 5) Part ID: 18477; Serial Numbers: WO198547/E-1. 6) Part ID: 18479; Serial Numbers: WO198552/E-1.",,"12 devices","Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.",3/15/2014,"03/15/2014",7/9/2014,"07/09/2014"
"Devices",67716,"Ongoing","3M Company - Health Care Business","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including the states of AL, AZ, CA,CO, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, NE, NJ, NY, NC, ND, OH, OK,OA, SC, TX, WA, WV and WI. and the countries of COLOMBIA, VENEZUELA, UAE, THAILAND, GERMANY, CHINA, KOREA, CANADA, JAPAN, RUSSIA, INDIA, POLAND, PERU, AUSTRIA, ISRAEL, INDONESIA, SPAIN, CHILE, MALAYSIA, SWITZERLAND, EL SALVADOR, ECUADOR, LEBANON, MEXICO, ARGENTINA, BULGARIA, TAIWAN, TURKEY,ROMANIA, GUATEMALA and NEW ZEALAND.","Z-1318-2014","Class II","3M'' Steri-Vac'' Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M'' Steri-Vac'' Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.","Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027 4XL 523122, 522205, 522502, 522287, 522655.",".","73 US, 346 OUS","Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M'' Steri-Vac'' Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 2007 and September 23, 2008. ",3/17/2014,"03/17/2014",4/9/2014,"04/09/2014"
"Drugs",67718,"Ongoing","Noven Pharmaceuticals, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1171-2014","Class II","Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.","Lot #69618, Exp. 09/14",,"187,860 patches","Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. ",2/13/2014,"02/13/2014",3/26/2014,"03/26/2014"
"Drugs",67718,"Ongoing","Noven Pharmaceuticals, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1172-2014","Class II","Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.","Lot #70132, Exp. 09/14",,"117,600 patches","Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. ",2/13/2014,"02/13/2014",3/26/2014,"03/26/2014"
"Devices",67719,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.","Z-1513-2014","Class II","ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED","ExacTrac version v.6.0.3.",,"41 systems (13 systems in US; 28 systems to foreign countries)","When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.",2/24/2014,"02/24/2014",5/7/2014,"05/07/2014"
"Devices",67720,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - All states in USA. OUS: List not provided at this time.","Z-1570-2014","Class II","Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.","This Medical Device Correction notification affects all SynchroMed II pumps. ",".","195,198 pumps (146,435 US, 48,763 OUS)","This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. This communication is based on information available to date and was developed in collaboration with clinical experts. Medtronic continues to investigate this issue and we are committed to providing updates as more information becomes available.",2/26/2014,"02/26/2014",5/14/2014,"05/14/2014"
"Food",67721,"Ongoing","High Mowing Organic Seed","Wolcott","VT","US","Voluntary: Firm Initiated","E-Mail","CA,CO, CT, GA, HA, KY, MA, ME, MI, MN, NC, NH, NV, NY, OH, OK, OR, PA, PA, SC, SD, TN, UT, VT, WA","F-1674-2014","Class II","High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445","Lot code: MUM19-10",,"655 units","Contains undeclared wheat",2/28/2014,"02/28/2014",3/26/2014,"03/26/2014"
"Devices",67722,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.","Z-1479-2014","Class II","LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.","Product List Number: 112410403; Lot Numbers: 280055H, 341005H",,"3,893 sets","Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.",2/25/2014,"02/25/2014",4/30/2014,"04/30/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1210-2014","Class II","Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.","Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108. ",".","3440 bottles","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1194-2014","Class II","Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.","Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017. ",".","4955 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1212-2014","Class II","Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.","Batch # 08060; EXP: May 2015; Batch # 07119, EXP: August 2014; Batch # 03043, EXP: May 2018. ",".","428 bottles ","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1209-2014","Class II","Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.","Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018. ",".","5940 Packages","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1208-2014","Class II","Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.","Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018. ",".","4770 Cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1204-2014","Class II","Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.","Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017. ",".","2147 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1205-2014","Class II","Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.","Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017. ",".","4050 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1206-2014","Class II","Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2. ","10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. ",".","126 10 x 1 ml Cartons; 76 50 x 1ml Cartons ","Penicillin Cross Contamination.",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1195-2014","Class II","Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1. ","Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017.",".","21,445 Bottles","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1193-2014","Class II","Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. ","Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017.",".","7408 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1198-2014","Class II","Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.","(10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014.",".","32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1199-2014","Class II","Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.","Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017. ",".","6120 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1203-2014","Class II","Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.","10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015. ",".","211 10 x 1 ml vials; 152 50 x 1 vials","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1202-2014","Class II","Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1.","Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016. ",".","10,725 bottles","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1207-2014","Class II","Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1. ","Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018. ",".","8405 bottles","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1192-2014","Class II","Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.","Batch # 1080, EXP: July 2015; Batch # 1102, EXP: Septempber 2017. ",".","4860 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1191-2014","Class II","Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.","Batch # 03051, EXP: April 2014; Batch # 13072, EXP: June 2015; Batch #21033, EXP: April 2016.",".","1368 tubes","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1196-2014","Class II","Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.","(10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018. ",".","730 10 x 1mL Cartons; 367 50 x 1 mL Cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1200-2014","Class II","Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.","Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016. ",".","3725 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1211-2014","Class II","Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.","10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. ",".","111 10 x 1 mls; 39 50 x 1 mls ","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1197-2014","Class II","Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .","(10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015. ",".","55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Drugs",67723,"Ongoing","Terra-Medica Inc.","Ferndale","WA","US","Voluntary: Firm Initiated","E-Mail","Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.","D-1201-2014","Class II","Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1.","Batch # 25030; EXP: April 2015; Batch # 27101, EXP: Sept 2016. ",".","3066 cartons","Penicillin Cross Contamination",3/3/2014,"03/03/2014",4/16/2014,"04/16/2014"
"Devices",67724,"Ongoing","Clinical Diagnostic Solutions","Plantation","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.","Z-1436-2014","Class II","Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control Product Usage: Is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.","Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014",".","3,540 ","Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.",2/24/2013,"02/24/2013",4/16/2014,"04/16/2014"
"Food",67725,"Ongoing","Smiley National Inc","Farr West","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-1757-2014","Class II","All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package.","UPC code 5410600307",".","2880","Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Food",67725,"Ongoing","Smiley National Inc","Farr West","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-1756-2014","Class II","Enhanced Maeng Da Leaf Powder, Maeng Da Kratom, capsule, UPC code 5410600330, 10 Pack, 2 Servings Per Pack, 10 grams.","UPC code 5410600330",".","864","Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Food",67725,"Ongoing","Smiley National Inc","Farr West","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-1755-2014","Class II","Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement.","UPC Code 5410600332",".","2592","Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Food",67725,"Ongoing","Smiley National Inc","Farr West","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-1758-2014","Class II","Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle.","UPC code 5410600335",".","900","Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Drugs",67726,"Ongoing","Pain Free By Nature","Harper","KS","US","Voluntary: Firm Initiated","Press Release","Nationwide including Puerto Rico","D-1322-2014","Class I","REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.","All lots",,"7,123 bottles","Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.",3/13/2014,"03/13/2014",5/21/2014,"05/21/2014"
"Devices",67727,"Ongoing","Instratek, Incorporated","Houston","TX","US","Voluntary: Firm Initiated","E-Mail","Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado","Z-2679-2014","Class II","Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System","Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103",,"82-69 countersink","Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.",4/25/2013,"04/25/2013",10/1/2014,"10/01/2014"
"Food",67728,"Ongoing","Oregon Freeze Dry Inc","Albany","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and Puerto Rico.","F-1739-2014","Class I","Kirkland Signature brand Real Sliced Fruit, Item # 527069. The UPC on the master cardboard case is 0 96619 52706 9. Each cardboard case consists of 20 plastic pouches (7.41 oz): 10 pouches of Fuji Apple Slices, 5 pouches of Strawberry Banana Slices, and 5 pouches of Fuji Apple Slices with Cinnamon. The UPC on Fuji Apple Slices pouch is 0 96619 27072 9; The UPC Strawberry Banana Slices pouch is 0 96619 27070 5; The UPC Fuji Apple Slices with Cinnamon pouch is 0 96619 27071 2; Product is distributed by: Costco Wholesale Corp., P.O.Box 34535, Seattle, WA 98124-1535, 1-800-774-2678, www.costco.com ","Best Before: FEB142015 to MAR112015. It interprets as February 14, 2015 to March 11, 2015; ",".","59,780 cases (20 pouches per case)","Oregon Freeze Dry, Inc. is recalling Kirkland Signature brand Real Sliced Fruit due to contamination of Salmonella.",3/8/2014,"03/08/2014",4/9/2014,"04/09/2014"
"Veterinary",67729,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA, WA)","V-130-2014","Class II","LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette","Product List Number: 112410403; Lot Numbers: 280055H, 341005H",,"3,893 sets","Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a Hemoset containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.",2/25/2014,"02/25/2014",7/9/2014,"07/09/2014"
"Biologics",67730,"Terminated","Plasma Biological Services Inc","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","California","B-0521-14","Class II","Source Plasma","12MTNC4364; 12MTNC3952; ",".","2","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",11/6/2013,"11/06/2013",4/23/2014,"04/23/2014"
"Biologics",67731,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Telephone","Louisiana","B-0569-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W036513147804",,"1 unit","Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed.",2/6/2014,"02/06/2014",4/30/2014,"04/30/2014"
"Biologics",67732,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0570-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W2885103008452, W288314000067, W287914000029",,"3 units","Blood products, which were incorrectly stored in a single storage bag, were distributed.",3/3/2014,"03/03/2014",4/30/2014,"04/30/2014"
"Biologics",67732,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0571-14","Class II","Platelets Pheresis Leukocytes Reduced","W287313002231, W288314000014",,"2 units","Blood products, which were incorrectly stored in a single storage bag, were distributed.",3/3/2014,"03/03/2014",4/30/2014,"04/30/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1292-2014","Class II","Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.","Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594. ",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1293-2014","Class II","Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. ","Product Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code: D-5007K, Lot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294; Product Code: D-5007M4A, Lot number: 02M0902844; Product Code: D-5007M4K, Lot numbers: 02C1002252, & 02F1100124; Product Code: D-7016M4K, Lot number: 02G1301749; Product Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: Product Code: D-7070M4K, Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739; Product Code: D-7076M1K, Lot number: 02H1103237; Product Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: Product Code: D-7375K, Lot number: 02A1201015; Product Code: D-793M4K, Lot number: 02L1002488; Product Code: ED-6072, Lot numbers: 02C1002218, 02E1002342 & 02J0902517; Product Code: ED-6276, Lot number: 02F0902457; Product Code: ED-6896, Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755; Product Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and Product Code: EP4049N, Lot number: 02A1003137. ",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1291-2014","Class II","Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. ","Product Code: 1154654, Lot number: 02K0801212",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1294-2014","Class II","Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.","Product Code: BON100, Lot numbers: 02H1302839, 02J1101705, 02D1101137, and 02F1103013.",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1295-2014","Class II","Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ","Product Code: X-4981M4, Lot number: 02J0800451",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67733,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland","Z-1296-2014","Class II","Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.","Product Code: X-6371M5, Lot numbers: 02E0801603",".","Total 32,271 ea.","The products are being recalled because they did not meet minimum needle attachment strength requirements. ",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67734,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-1317-2014","Class II","Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.","v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901",".","48 units","Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Sze # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Sze #3.",2/3/2014,"02/03/2014",4/9/2014,"04/09/2014"
"Drugs",67735,"Ongoing","Paddock Laboratories, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1168-2014","Class II","Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01"," 2013313915 Exp 08/15, 2013374398 Exp 09/15, 2013323969 Exp 08/15, 2013364336 Exp 09/15, 2013323971 Exp 08/15, 2013364334 Exp 09/15, 2013313913 Exp 08/15",,"156,012 bottles","Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. ",3/11/2014,"03/11/2014",3/26/2014,"03/26/2014"
"Devices",67736,"Ongoing","Ethicon, Inc.","Somerville","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.","Z-1329-2014","Class II","Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.","Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159",".","223 units","The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.",2/19/2014,"02/19/2014",4/9/2014,"04/09/2014"
"Food",67737,"Ongoing","Northern Valley Baking Co.","Dumont","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.","F-1747-2014","Class II","The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA","LOT #: 338B009C, 338B010C, 007C015C, 007C016C, 013C014C, 007C016C, 007C020C, 007C021C ",".","600 containers","Northern Valley Baking Company did not declare milk or soy on the allergen statement of G'nache P'nache.",2/13/2014,"02/13/2014",4/16/2014,"04/16/2014"
"Drugs",67739,"Ongoing","Blu Pharmaceuticals Inc","Franklin","KY","US","Voluntary: Firm Initiated","Letter","NJ, UT, IL and CT","D-1301-2014","Class II","Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05","Lot # 13E0008F3P8V; Exp. 03/15",".","14,000 tablets","Defective container: Product distributed without inner seal on bottles.",3/13/2014,"03/13/2014",5/14/2014,"05/14/2014"
"Drugs",67739,"Ongoing","Blu Pharmaceuticals Inc","Franklin","KY","US","Voluntary: Firm Initiated","Letter","NJ, UT, IL and CT","D-1302-2014","Class II","Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05","Lot # 13E0014F1P8V; Exp. 04/15",".","101,500 tablets","Defective container: Product distributed without inner seal on bottles.",3/13/2014,"03/13/2014",5/14/2014,"05/14/2014"
"Devices",67740,"Ongoing","Wal Mart Stores, Inc","Bentonville","AR","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of AR, AL, CA, FL, KS, LA, MN, NJ, NV,OH, TX, and SC.","Z-1810-2014","Class II","Safety glasses made with ''Rage'' frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear","Serial Numbers: 00174-1030010, 01839-1257619, 01249-1 013988, 00036-1175608, 01052-1100006, 00359-1150914, 03283-1 055954, 00773-1 043248, 05385-1 051400, 00644-1151291, 02402-1 028575, 01903-1041038, 02294-1 024246, 03729-1 020577, 02937-1071566 ",,"15 safety glasses","Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.",2/26/2014,"02/26/2014",6/25/2014,"06/25/2014"
"Devices",67741,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Saudi Arabia, Serbia, Seychelles, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad,Tobago, Turkey, U.A.E. and United Kingdom.","Z-1331-2014","Class II","Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.","Model number 10433816 - ACUSON P3000 Ultrasound System; Model numbers 10852384 - P300 PA 320E transducer. Serial numbers: 105 106 114 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 148 149 150 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 178 186 187 188 189 193 194 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 257 258 259 260 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 330 331 334 336 337 339 340 341 342 343 344 345 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 371 373 374 375 377 378 379 380 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 501 506 507 508 509 510 511 512 513 515 516 518 519 520 521 522 526 527 529 530 535 536 537 538 539 540 541 542 544 545 546 547 548 549 550 551 552 5",".","675","ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit. ",3/7/2014,"03/07/2014",4/9/2014,"04/09/2014"
"Food",67742,"Ongoing","Simply Natural Foods LLC","Commack","NY","US","Voluntary: Firm Initiated","Press","CA, FL, GA, IN, MA, NC, NV, NJ, NY, PA, VA, WA and Canada","F-1827-2014","Class I","Simply Lite brand 50% CaCao Low Carb Sugar Free Dark Chocolate (NET WT 3 oz (85g), packaged in a brown plastic foil wrapper. Produced by Simply Natural Foods, LLC. 74 Mall Drive Commack, New York 11725. ","lot codes: Best By: 01 18 2015A or Best By: 01 19 2015A",".","1202 Cartons (40 bars/carton)","Simply Natural Foods, LLC manufactured and distributed Simply Lite brand Dark Chocolate with high levels of Undeclared Milk. ",3/17/2014,"03/17/2014",4/23/2014,"04/23/2014"
"Biologics",67743,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","E-Mail","NY","B-0537-14","Class II","Red Blood Cells Leukocytes Reduced","W280313301085",,"1 unit","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",2/13/2014,"02/13/2014",4/30/2014,"04/30/2014"
"Biologics",67744,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","TX; Austria","B-0536-14","Class III","Blood and Blood Products for Reprocessing","W035213060977E",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/4/2014,"03/04/2014",4/30/2014,"04/30/2014"
"Biologics",67744,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","TX; Austria","B-0535-14","Class II","Platelets","W035213060977E",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/4/2014,"03/04/2014",4/30/2014,"04/30/2014"
"Biologics",67744,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","TX; Austria","B-0534-14","Class II","Red Blood Cells Leukocytes Reduced","W035213060977E",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/4/2014,"03/04/2014",4/30/2014,"04/30/2014"
"Biologics",67745,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","CO","B-0538-14","Class II","Red Blood Cells Leukocytes Reduced","W036213874696",,"1 unit","Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.",1/30/2014,"01/30/2014",4/30/2014,"04/30/2014"
"Devices",67746,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.","Z-1493-2014","Class II","Stryker PenAdapt''; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.","Part Number 0702-045-027",,"35,310 unexpired units","During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the package of the product.",3/26/2014,"03/26/2014",4/30/2014,"04/30/2014"
"Drugs",67747,"Ongoing","McKesson Packaging Services","Concord","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1167-2014","Class III","Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10","Lot #: 91357",,"1,557 Boxes","Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.",3/3/2014,"03/03/2014",3/26/2014,"03/26/2014"
"Food",67748,"Ongoing","Dole Fresh Vegetables Inc","Monterey","CA","US","Voluntary: Firm Initiated","Press Release","CT, FL, IL, IN, KY, MA, MD. MI, NC, NJ, NY, OH, PA, SC, VA and Canada","F-1702-2014","Class I","Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045); Little Salad Bar Italian Salad, (UPC 4149811014); Marketside Italian Style Salad, (Wal Mart) (UPC 8113102780) 10 oz. bags (283 g) Dole Fresh Vegetables Monterey, CA 93942","A058201A, A058201B, Best By March 12, 2014.",".","3,807 cases (6 x 10 oz bag per case)","Canadian Food Inspection Agency tested a random sample of bagged Italian Blend which tested positive for Listeria Monocytogenes.",3/13/2014,"03/13/2014",4/2/2014,"04/02/2014"
"Devices",67749,"Ongoing","ZOLL Medical Corporation","Chelmsford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.","Z-1311-2014","Class II","Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.","System Software Version 02.10.02.00 or Higher",".","3,169 units","Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used",3/5/2014,"03/05/2014",4/9/2014,"04/09/2014"
"Drugs",67750,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1226-2014","Class III","Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.","Lot: 221303A, 1OCT2014",".","237,850 ampoules","Labeling; Missing label; ampoules are missing the immediate container label",3/25/2014,"03/25/2014",4/16/2014,"04/16/2014"
"Devices",67752,"Ongoing","Remington Medical Inc.","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution including Canada","Z-1441-2014","Class II","FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device. ","Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.",".","41,499 cables","Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).",3/5/2014,"03/05/2014",4/16/2014,"04/16/2014"
"Food",67753,"Ongoing","RAW DEAL","ALLAMUCHY","NJ","US","Voluntary: Firm Initiated","Letter","CT, UT, Canada","F-1933-2014","Class I","Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net","Batch @992-20131107-00-02",,"60 kg","Raw Deal is recalling dietary blends which may contain salmonella.",3/17/2014,"03/17/2014",5/21/2014,"05/21/2014"
"Food",67753,"Ongoing","RAW DEAL","ALLAMUCHY","NJ","US","Voluntary: Firm Initiated","Letter","CT, UT, Canada","F-1934-2014","Class I","Cilantro Powder Item #13151 22.5 KGS PO #P41049 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net","Batch #CP-20131024-00178",,"45 kg","Raw Deal is recalling dietary blends which may contain salmonella.",3/17/2014,"03/17/2014",5/21/2014,"05/21/2014"
"Food",67753,"Ongoing","RAW DEAL","ALLAMUCHY","NJ","US","Voluntary: Firm Initiated","Letter","CT, UT, Canada","F-1935-2014","Class I","Parsley Powder Organic 25 KGS PO# GV93-6 & PO#RV19-4 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net","Batch #PPO-20131113-15-178 and Batch #PPO-20131003-00-01",,"1025 kg","Raw Deal is recalling dietary blends which may contain salmonella.",3/17/2014,"03/17/2014",5/21/2014,"05/21/2014"
"Veterinary",67754,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-148-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315003 , 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315020 , 14315022 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315019 , 14315037 , 14315023 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315047 , 14315046 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315062 , 14315064 , 14315061 , 14315063 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315073 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 14315204 , 1431520",,"467 pumps","There is the potential for the distal (occlusion) pressure sensor pin to break on Plum A+ infusers. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pressure pin can only be detected via a visual inspection of the distal pressure pin.",3/12/2014,"03/12/2014",7/30/2014,"07/30/2014"
"Devices",67755,"Ongoing","Alcon LenSx, Inc.","Aliso Viejo","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1445-2014","Class II","Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.","(US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166. ",".","75","Alcon LenSx received reports of unexpected downward motion of the gantry.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Food",67756,"Ongoing","Fannie May Confection Brands Inc","North Canton","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AZ, IA, IL, IN, MI, MN & WI.","F-1760-2014","Class I","Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorted Chocolates Nutrition Facts:***Ingredients: SUGAR, MILK CHOC LATES***CONTAINS: EGGS, MILK, SOY, TREE NUTS. WHEAT, GLUTEN***Distributed By: Fannie May Confections Brands, Inc., Chicago, IL 60160 www.fanniemay.com'' UPC 0 52745 72804 6","Lot #14058 & Lot # 14059",".","89.08 cs/12/14 oz boxes","The product is being recalled due to an undeclared allergen of peanuts in the ingredient statement. ",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1419-2014","Class II","10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage","Product Number 310017",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1428-2014","Class II","10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340003",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1431-2014","Class II","10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340007",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1432-2014","Class II","15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340018",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1435-2014","Class II","7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340004",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1423-2014","Class II","7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage","Product Number 322205",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1430-2014","Class II","7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340006",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1426-2014","Class II","19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage","Product Number 332265",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1425-2014","Class II","15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage","Product Number 332264",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1422-2014","Class II","Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems","Product Number 310101",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1418-2014","Class II","10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage","Product Number 310007",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1420-2014","Class II","15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage","Product Number 310018",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1429-2014","Class II","10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340005",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1433-2014","Class II","19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340019",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1424-2014","Class II","10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage","Product Number 332263",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1427-2014","Class II","10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340001",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1417-2014","Class II","7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage","Product Number 310006",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1434-2014","Class II","7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage","Product Number 340002",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67757,"Ongoing","Aspen Surgical Products, Inc.","Caledonia","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.","Z-1421-2014","Class II","Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems","Product Number 310100",".",,"The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.",3/20/2014,"03/20/2014",4/16/2014,"04/16/2014"
"Devices",67758,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1332-2014","Class II","5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.","Part number 428061-03: Lot numbers: VE105001 VE120201 VE121301 VE121803 VE122502 VE123106 VE105002 VE120301 VE121304 VE121907 VE122605 VE111201 VE120503 VE121403 VE122002 VE122606 VE114501 VE120703 VE121508 VE122101 VE122902 VE114601 VE121002 VE121605 VE122203 VE123006 VE115201 VE121112 VE121701 VE122401 VE123104.",".","5217 total cannulae","Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.",3/13/2014,"03/13/2014",4/16/2014,"04/16/2014"
"Devices",67758,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1334-2014","Class II","5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.","Part number 428071-03: Lot numbers: VE113001 VE121004 VE121205 VE122004 VE122604 VE123014 VE113401 VE121007 VE121407 VE122005 VE122901 VE123107 VE114001 VE121103 VE121410 VE122104 VE122904 VE123202 VE114401 VE121105 VE121604 VE122204 VE122908 VE120602 VE121109 VE121608 VE122302 VE122911 VE120701 VE121110 VE121804 VE122403 VE123007.",".","5217 total cannulae","Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.",3/13/2014,"03/13/2014",4/16/2014,"04/16/2014"
"Devices",67758,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1335-2014","Class II","5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.","Part number 428072-03: Lot numbers: VE113001 VE121005 VE121204 VE121904 VE122404 VE123008 VE113402 VE121008 VE121406 VE121906 VE122607 VE123013 VE114002 VE121104 VE121507 VE122102 VE122706 VE114402 VE121106 VE121511 VE122103 VE122905 VE120603 VE121111 VE121609 VE122301 VE122909 VE120702 VE121203 VE121708 VE122402 VE122912.",".","5217 total cannulae","Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.",3/13/2014,"03/13/2014",4/16/2014,"04/16/2014"
"Devices",67758,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.","Z-1333-2014","Class II","5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.","Part number 428062-03: Lot numbers: VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402 VE121502 VE121905 VE122705 VE123103 VE114502 VE120504 VE121506 VE122201 VE122707 VE123105 VE114602 VE120902 VE121512 VE122202 VE122903 VE115202 VE121003 VE121606 VE122303 VE123005 VE120202 VE121113 VE121702 VE122501 VE123012.",".","5217 total cannulae","Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.",3/13/2014,"03/13/2014",4/16/2014,"04/16/2014"
"Food",67759,"Ongoing","Creole Delicacies Kitchens Inc","Metairie","LA","US","Voluntary: Firm Initiated","Telephone","LA and FL","F-1693-2014","Class II","Cookin' Cajun (TM) Acadiana Style Etouffee Seasoning Blend, UPC 898851004","all product distributed 03/10/2012 - 03/10/2014",".","1046 units","Product is labeled as containing flour, but contains wheat flour which is not declared on the label.",3/10/2014,"03/10/2014",4/2/2014,"04/02/2014"
"Food",67760,"Ongoing","Bay State Milling Company","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CT, IA, IL, IN, GA, KS, MI, MN, MO, NJ, OH, TX, WI,","F-1759-2014","Class II","Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran.","Lot #'s W021014, W021114, W021214, W021314, W021414, W021714, W021814, VV021914, VV0220 14, W022114, W022414, W022514, VV022614, W022714, W030114, W030314, W030614.",".","295,160 lbs","Bay State Milling Company is recalling select lot codes of bran produced in its Winona, MN mill between February 10, 2014 and March 7, 2014. The decision to voluntarily recall the product is based upon findings of metal fragments in the product.",3/8/2014,"03/08/2014",4/16/2014,"04/16/2014"
"Veterinary",67761,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-138-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315003 , 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315020 , 14315022 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315019 , 14315037 , 14315023 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315047 , 14315046 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315062 , 14315064 , 14315061 , 14315063 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315073 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 14315204 , 1431520",".","467 pumps","Certain Plum A+ fluid shield diaphragms may be out of specification and may cause N250 ''Door Open while pumping'' or N100 ''Unrecognizable Cassette'' alarms. Both the N250 and N100 alarm conditions trigger an audible and visual warning to the user, which may occur during setup, infusion or Performance Verification Testing (PVT). If an N250 or N100 alarm is triggered, a delay or interruption in therapy may result.",3/12/2013,"03/12/2013",7/23/2014,"07/23/2014"
"Devices",67762,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution including San Juan PR","Z-1449-2014","Class II","Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.","not applicable",".","76 units","The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures that manually filled cassettes are at the proper level.",3/13/2014,"03/13/2014",4/16/2014,"04/16/2014"
"Devices",67763,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.","Z-1464-2014","Class II","Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.","System code: 728323; Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105,320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 336013 & 336015.",".","116 units","A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.",3/6/2014,"03/06/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1763-2014","Class II","Strawberry Fruit Bar, 3 oz., Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242-10001 5",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1787-2014","Class II","Mango c/chile Chamoy Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 40007. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1786-2014","Class II","Coffee Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 40005. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1798-2014","Class II","Mango Milk Bars, 3 oz; also packed in ice cream containers and Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20007 4, (3 oz bar); 6 34242-14006 6 (Ice Cream container); 6 34242-21002 (Canada 4 oz. HLT. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1813-2014","Class II","Pistachio Almond Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 60009 6; 6 34242-21004 (Canada 4 oz HLT)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1802-2014","Class II","Peach Yogurt Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20011 1, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1765-2014","Class II","Pineapple Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup, 4 oz. HLT packaged for Canadian distribution and 4 pack 9 oz. cups. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242-10003 9 (3 oz. bar); 6 34242-22003 4 (9 oz. cup); 6 34242-21003 5 (Canada 4 oz HLT); 6 34242-23003 4 (4 pack cups 9 oz.)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1803-2014","Class II","Esquimal Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20011 1, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1788-2014","Class II","Dozen Mix Bag Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 30010 1. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1811-2014","Class II","Choco-Coco Milk Bar, 4 oz; Also packages as Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 60005 8; 6 34242-21007 (Canada 4 oz. HLT. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1812-2014","Class II","Nuez Pecan Milk Bar, 4 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 60006 5; ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1815-2014","Class II","Manhattan Tropical for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242-21008.",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1764-2014","Class II","Lemon Fruit Bar, 3 oz.,. Also packaged in six pack box. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242-10002 2 (3 oz. bar) and 6 34242-16001 9 (six pack box).",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1766-2014","Class II","Tamarindo Fruit Bar, 3 oz.,. Also packaged in 9 oz. cup and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10004 6 (3 oz. bar); 6 34242-22004 1 (9 oz. cup); 6 34242-40006 (Bolis 4 oz.)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1785-2014","Class II","Coco Bolis - 4 oz.; Also packaged in 4 oz. milk bars and ice cream container. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 40005 4; 6 34242-60001 0 (4 oz. milk bars); 6 34242-14001 1 (ice cream container) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1789-2014","Class II","Coconut Frutero; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 23001. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-18010-201","Class II","Vainilla con Membrillo Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 60004 1. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1799-2014","Class II","Rice Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20008 1, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1774-2014","Class II","Mandarina Fruit Bar,4 oz.,; also packaged in 9 oz. cups and 4 pack of 9 oz cups Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61002 6 (4 oz. bar) ; 6 34242-22001 0 (9 oz cups); 6 34242-23001 0 (4 pack 9 oz. cups).",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1784-2014","Class II","Rompope Bolis - 4 oz.; Also packages in six pack boxes. (9 oz cups) Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 40003 0 (Bolis, 4 oz; 6 34242-15005 8 (six pack boxes 9 oz. cups) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1768-2014","Class II","Watermelon Fruit Bar, 3 oz.,. Also packaged in 9 oz. cups. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10006 0 (3 oz. bar) and 6 34242-22007 2 (9 oz. cups).",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1806-2014","Class II","Mamey Milk Bars, 3 oz; Also packaged in 9 oz. cups six pack. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20054 9, (3 oz bar); 6 34242-15004 1 (six pack boxes of 9 oz cups). ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1800-2014","Class II","Eggnog Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20009 8, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1814-2014","Class II","Granola for Canada 4 oz. HLT.. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242-21006.",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1807-2014","Class II","Pecan Ice Cream container . Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 14002 8 ). ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1783-2014","Class II","Limon Bolis - 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 40002 3. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1782-2014","Class II","Cappuccino 9 oz cups Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 22009 6. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1795-2014","Class II","Banana Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20004 3, (3 oz bar); ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1776-2014","Class II","Fresa Fruit Bar,4 oz.,; Also packaged as Bolis 4 oz. and 4 oz. milk bar. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61004 0 (4 oz. bar) ; 6 34242-4004 7 (Bolis 4 oz.); 6 34242-60002 7 (4 oz. milk bar)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1777-2014","Class II","Lemon Lime (french) Fruit Bar,4 oz.,; Also packaged for Canada 4 oz. HLT. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61005 7 (4 oz. bar) ; 6 34242 61005 7 (Canada 4 oz. HLT)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1808-2014","Class II","Cookies n Cream Ice Cream container . Also packaged as 4 oz. milk bar (cookies n Cream french), Canada 4 oz. HLT and six pack of 9 oz cups. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 14003 5; 6 34242-60007 2 (4 oz. mik bar); 6 34242-60007 2 (Canada 4 oz. HLT); 6 34242-15003 4 (six pack boxes). ). ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1797-2014","Class II","Walnut Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20006 7, (3 oz bar); ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1772-2014","Class II","Pica de Gallo Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10012 1 (3 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1781-2014","Class II","Elote 9 oz cups Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 22008 9. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1773-2014","Class II","Chicle Fruit Bar,4 oz.,. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61001 9 (4 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1801-2014","Class II","Cookie Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20010 4, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1767-2014","Class II","Bubblegum Fruit Bar, 3 oz.,. Also packaged in six pack boxes and Bolis 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10005 3 (3 oz. bar); 6 34242-16002 6 (six pack boxes); 6 34242-40001 6 (Bolis 4 oz.)",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1804-2014","Class II","Coffee Milk Bars, 3 oz; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20013 5, (3 oz bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1792-2014","Class II","Strawberry Milk Bars, 3 oz. Also packaged as six pack boxes; Canada 4 oz. HLT and ice cream containers. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20001 2, (3 oz bar); 6 34242-15001 0 (Six pack boxes); 6 34242-21005 (Canada 4 oz. HLT); 6 34242-14006 9 (ice cream container) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1809-2014","Class II","Orange n Cream Milk Bar, 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 600003 4. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1769-2014","Class II","Jamaica Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10008 4 (3 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1770-2014","Class II","Guava Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10009 1 (3 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1794-2014","Class II","Chocolate Milk Bars, 3 oz; Also packaged as 4 oz, bars and in ice cream containers; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20003 6, (3 oz bar); 6 34242-60008 9 (4 oz. bar); 6 434242-14007 3. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1771-2014","Class II","Nance Fruit Bar, 3 oz.,. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 10011 4 (3 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1793-2014","Class II","Coconut Milk Bars, 3 oz. Also packaged as six pack boxes of 9 oz cups.. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20002 9, (3 oz bar); 6 34242-15002 7 (Six pack boxes). ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1779-2014","Class II","Lemonade 9 oz cups Also packaged in 4 pack 9 oz cups; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 22002 7 (9 oz. cup) ; 6 34242-23002 7 (4 pack 9 oz. cups). ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1805-2014","Class II","Pina Colada Milk Bars, 3 oz;, 4 oz. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20014 2, (3 oz bar); 6 34242-60010 2 (4 oz. bar) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1775-2014","Class II","Pink Lemonade Fruit Bar,4 oz., Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61003 3 (4 oz. bar) ; ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1791-2014","Class II","Vanilla Sundae Cup. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 50002 1. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1780-2014","Class II","Changunga/Nance 9 oz cups Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 22006 5. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1790-2014","Class II","Vanilla Ice Cream Sandwich Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 70001 7. ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F-1796-2014","Class II","Vanilla Milk Bars, 3 oz; Also packaged as Vanilla Ice Cream container. Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 20005 0, (3 oz bar); 6 34242-14001 2 (ice cream container) ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67764,"Ongoing","Helados La Tapatia, Inc","Fresno","CA","US","Voluntary: Firm Initiated","Press Release","CA, NV, AZ, WA, Canada and Guam","F1778-2014","Class II","Sandia Fruit Bar,4 oz.,; Helados La Tapatia Fresno, CA 93706","All units with UPC 6 34242- 61006 (4 oz. bar) ; ",".","Not Reported","FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Food",67765,"Ongoing","Losurdo Foods Inc","Hackensack","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-1886-2014","Class II","Losurdo IMPORTED GRATED PECORINO ROMANO, NET WT. 80 OZ. (5 LB.) 2.27 Kg, UPC 0 75009 00232 4. Product packaged within black plastic bag, with 5 bags per carton (20 LB) total per carton. Distributor LOSURDO FOODS, INC. 20 Owens Roads Hackensack, NJ 07601. ","Lot number: 021914",,"12 cases","Losurdo Foods has recalled one lot of Grated Cheese Pecorino Romano due to Listeria monocytogenes contamination.",3/18/2014,"03/18/2014",5/7/2014,"05/07/2014"
"Biologics",67766,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","VA","B-0541-14","Class II","Red Blood Cells Leukocytes Reduced","W087613610841",,"1 unit","Blood products, collected from a donor who was taking the medication Propecia, were distributed.",2/21/2014,"02/21/2014",4/30/2014,"04/30/2014"
"Biologics",67766,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","VA","B-0540-14","Class II","Plasma Frozen within 24 hours (FP24)","W087613610841",,"1 unit","Blood products, collected from a donor who was taking the medication Propecia, were distributed.",2/21/2014,"02/21/2014",4/30/2014,"04/30/2014"
"Biologics",67767,"Terminated","Blood Center Hammond Laboratory (the)","Hammond","LA","US","Voluntary: Firm Initiated","Telephone","LA","B-0539-14","Class III","Red Blood Cells Leukocytes Reduced","W067113096468",,"1 unit","Blood product, labeled with the incorrect anticoagulant, was distributed.",2/7/2014,"02/07/2014",4/30/2014,"04/30/2014"
"Biologics",67768,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","TN","B-0533-14","Class III","Red Blood Cells Leukocytes Reduced","W201914018033",,"1 unit","Blood Product, prepared from an overweight unit, was distributed. ",2/6/2014,"02/06/2014",4/30/2014,"04/30/2014"
"Biologics",67769,"Terminated","Yale Blood Plasma LLC","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0586-14","Class III","Source Plasma","AY0882006",,"1 unit","Source Plasma, collected from an ineligible donor, was distributed. ",1/26/2014,"01/26/2014",4/30/2014,"04/30/2014"
"Biologics",67770,"Terminated","DCI Biologicals Temple Terrace, LLC","Temple Terrace","FL","US","Voluntary: Firm Initiated","FAX","CA","B-0532-14","Class II","Source Plasma","TT0296070",,"1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",12/18/2013,"12/18/2013",4/30/2014,"04/30/2014"
"Biologics",67771,"Terminated","Blood Systems, Inc. DBA United Blood Services","Lafayette","LA","US","Voluntary: Firm Initiated","Telephone","Mississippi","B-0545-14","Class II","Plasma Frozen","W041613052132U; ",,"1 unit","Blood product, manufactured from an overweight whole blood unit, was distributed.",1/31/2014,"01/31/2014",4/30/2014,"04/30/2014"
"Biologics",67772,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","California","B-0546-14","Class II","Red Blood Cells Leukocytes Reduced","W115913223046; ",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",2/26/2014,"02/26/2014",4/30/2014,"04/30/2014"
"Biologics",67773,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0547-14","Class II","Platelets Pheresis Leukocytes Reduced","W201713805168 ",," 1 unit","Blood product, in which quality control/distribution of product did not meet specifications.",12/17/2013,"12/17/2013",4/30/2014,"04/30/2014"
"Devices",67774,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI","Z-1459-2014","Class II","SmartSite Extension Set, Model No. 20029E, intravascular administration set","Lot No. 13085791",".","7,700 units","CareFusion is recalling the SmartSite Extension Set because there are reports of disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.",3/19/2014,"03/19/2014",4/23/2014,"04/23/2014"
"Devices",67775,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia","Z-1247-2014","Class II","2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.","P/N 5290-628-000, Lot #13280CG2",,"90 units","Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm 7cm.",3/18/2014,"03/18/2014",3/26/2014,"03/26/2014"
"Drugs",67776,"Ongoing","Glenmark Generics Inc., USA","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1229-2014","Class II","Rantidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.","Lot 12AN118A, Exp 10/14",".","2904 bottles","Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a ''foreign material'', identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg. ",3/18/2014,"03/18/2014",4/16/2014,"04/16/2014"
"Devices",67777,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.","Z-1474-2014","Class II","Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.","DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014",,"2/50-test boxes","A reagent contained within the product may return false negative results.",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Devices",67777,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.","Z-1473-2014","Class II","Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.","DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014",,"72/50-test boxes","A reagent contained within the product may return false negative results.",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Veterinary",67778,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-137-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315003 , 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315020 , 14315022 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315019 , 14315037 , 14315023 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315047 , 14315046 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315062 , 14315064 , 14315061 , 14315063 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315073 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 14315204 , 1431520",".","467 pumps","There is a potential for the Plum A+ fluid shield to inadequately prevent fluid from entering into the Plum A+ device (fluid ingress) and potentially causing damage to the pumping mechanism, and/or sensors. Fluid ingress could result in the device being unable to recognize installed cassettes, cause Valve Cassette Test Failures, or result in one or more of the following error codes being displayed: E/N180, E/N181, E/N186, E/N187, E/N250, E/N251, and E346 and cause the devices set up to be interrupted or infusion to stop.",3/12/2013,"03/12/2013",7/23/2014,"07/23/2014"
"Cosmetics",67779,"Ongoing","Kiss My Face","Gardner","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA nationwide, Singapore, Ireland, Canada, Czech Republic, Saipan, Panama, Norway, and Nigeria.","F-1981-2014","Class II","KISS MY Face Lemon & Ginger Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL) - UPC 0 28367 83473 1, 2) Net Wt. 17.5 Fl Oz (516 mL) - UPC 028367 834779. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.","Lot numbers: 1) K110112, K031913, K031813, K071513, K011314; 2) K122112, K011713, K031913, K071613, K081613, K012114",,"7,978 bottles","Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination.",3/18/2014,"03/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",67779,"Ongoing","Kiss My Face","Gardner","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA nationwide, Singapore, Ireland, Canada, Czech Republic, Saipan, Panama, Norway, and Nigeria.","F-1980-2014","Class II","KISS MY Face Grapefruit & Bergamot Foaming Soap: 1) Net Wt. 8.75 Fl Oz (258 mL), UPC 0 28367 83309 3; 2) Net Wt. 17.5 Fl Oz (516 mL), UPC 0 28367 83479 3. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.","Lot numbers: 1) K102512, K020513, K032113, K050913, K100213, K011414; 2) K122012, K011613, K032213, K041613, K051013, K091613, K100113",,"23,875 bottles","Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination.",3/18/2014,"03/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",67779,"Ongoing","Kiss My Face","Gardner","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA nationwide, Singapore, Ireland, Canada, Czech Republic, Saipan, Panama, Norway, and Nigeria.","F-1982-2014","Class II","KISS MY Face Lavender & Chamomile Foaming Soap: 1) Net Wt. 8.75 Fl Oz, UPC 0 28367 83308 6; 2) Net Wt. 17.5 Fl Oz (516 mL), 028367 834786. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.","Lot numbers: 1) K110212, K032013, K050613, K081513, K092513; 2) K031913, K050613, K092613",,"11,721 bottles","Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination.",3/18/2014,"03/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",67779,"Ongoing","Kiss My Face","Gardner","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA nationwide, Singapore, Ireland, Canada, Czech Republic, Saipan, Panama, Norway, and Nigeria.","F-1983-2014","Class II","KISS MY Face obsessively natural KIDS Self-Foaming Hand Wash, orange U smart, Net Wt. 8 Fl Oz (236 mL), UPC 0 28367 83591 2. Distributed by Kiss My Face LLC, Gardiner, NY 12525, Made in USA.","Lot numbers: K121112, K032513, K050813, K011514, K021014",,"9,255 bottles","Kiss My Face, LLC has recalled various foaming hand soap products due to Pseudomonas aeruginosa/fluorescens contamination.",3/18/2014,"03/18/2014",6/11/2014,"06/11/2014"
"Devices",67780,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including MO and OH.","Z-1460-2014","Class II","AXIOM Vertix MD Trauma systems radiographic X-ray","AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058. ",".","2","There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury. ",3/5/2014,"03/05/2014",4/23/2014,"04/23/2014"
"Devices",67781,"Ongoing","Del Mar Reynolds Medical, Ltd.","Hertford",,"GB","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of North Carolina and South Carolina","Z-1442-2014","Class I","SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.","SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031. ",".","16 units distributed in the US","The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.",3/10/2014,"03/10/2014",4/23/2014,"04/23/2014"
"Biologics",67783,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: CO, MO, NY, PA. OUS: CANADA, UNITED KINGDOM, TAIWAN, PORTUGAL, LEBANON.","B-0560-14","Class II","Invitrogen by Life Technologies, AllSet+ Gold SSP HLA ABC Low Res Kit, REF 54340D. ","Lot 038 1249868",,"1 Lot","HLA typing assay, associated with false typing assignments, was distributed. ",3/11/2014,"03/11/2014",5/7/2014,"05/07/2014"
"Drugs",67784,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1284-2014","Class II","Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.","Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14. ",,"91,777 bottles","Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.",3/20/2014,"03/20/2014",5/7/2014,"05/07/2014"
"Drugs",67784,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1283-2014","Class II","Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. ","Lot #: a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14. ",,"160,105 bottles","Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.",3/20/2014,"03/20/2014",5/7/2014,"05/07/2014"
"Veterinary",67785,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-146-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315003 , 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315019 , 14315020 , 14315022 , 14315023 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315037 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315046 , 14315047 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315061 , 14315062 , 14315063 , 14315064 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315073 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315172 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 1431520",,"467 pumps","Hospira has received reports related to distal pressure sensor calibration drift on Plum A+ Infusers. If the distal pressure sensor calibration has drifted, it will need to be recalibrated. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, you may experience nuisance (false) distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user.",3/12/2013,"03/12/2013",7/30/2014,"07/30/2014"
"Devices",67786,"Ongoing","Fisher Scientific Co","Pittsburgh","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1521-2014","Class II","Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces","all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015",,"7430","A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. ",2/5/2014,"02/05/2014",5/7/2014,"05/07/2014"
"Devices",67787,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan. .","Z-1647-2014","Class II","Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.","CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06. ",".","4175","A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%",3/19/2014,"03/19/2014",5/28/2014,"05/28/2014"
"Devices",67788,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","US Distribution to states of: IN, MD, and TN.","Z-1470-2014","Class II","VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Lot 3920-0080-8403, expiry date 15-JUNE-2014",".","20 units","The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403. ",3/5/2014,"03/05/2014",4/23/2014,"04/23/2014"
"Food",67789,"Terminated","Mrs Rigg's Sandwiches","Ventura","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California.","F-1823-2014","Class II","Italian Torpedo Sandwich, 10oz. Product labeling reads in part:''ITALIAN TORPEDO SANDWICH***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***''","Lot Number/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014",".","650 ","Mrs. Rigg's Sandwiches is recalling certain lots (Lot Number Jan 31, 2014, Feb 7, 2014, Feb 14, 2014) of Poor Boy Sandwiches and Italian Torpedo Sandwiches because they were produced using meat recalled by Rancho Feeding Company for meat distributed without the benefit of a federal inspection.",2/21/2014,"02/21/2014",4/23/2014,"04/23/2014"
"Food",67789,"Terminated","Mrs Rigg's Sandwiches","Ventura","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California.","F-1822-2014","Class II","Poor Boy Sandwich, 7oz. Product labeling reads in part:''POOR BOY SANDWICH***Perishable Keep Refrigerated***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***''","Lot Numbers/Production Dates: Jan 31, 2014, Feb 7, 2014, Feb 14, 2014.",".","425","Mrs. Rigg's Sandwiches is recalling certain lots (Lot Number Jan 31, 2014, Feb 7, 2014, Feb 14, 2014) of Poor Boy Sandwiches and Italian Torpedo Sandwiches because they were produced using meat recalled by Rancho Feeding Company for meat distributed without the benefit of a federal inspection.",2/21/2014,"02/21/2014",4/23/2014,"04/23/2014"
"Biologics",67791,"Terminated","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","Other","Switzerland","B-0596-14","Class II","Blood and Blood Products for Reprocessing","W0410111987753",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",11/18/2013,"11/18/2013",5/7/2014,"05/07/2014"
"Food",67792,"Ongoing","Flying Food Group LLC","Upper Marlboro","MD","US","Voluntary: Firm Initiated","Telephone","Product was distributed in MD, DE, and VA","F-1698-2014","Class II","Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204.","Sell Thru 03/15/14 11:59 pm",".","450 sandwiches","Ready to eat breakfast sandwich was assembled with raw suasage meat.",3/11/2014,"03/11/2014",4/2/2014,"04/02/2014"
"Devices",67793,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1468-2014","Class II","CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only, 82-8801 In Line Valve with Catheter and Accessories, 82-8802 In Line Valve with Unitized Catheter and Accessories, 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories, 82-8804 In Line Valve only with SIPHONGUARD Device, 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories, 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories, 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories, 82-8850 Certas Therapeutic Management System","All serial numbers","."," 9,445 units","Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.",12/13/2013,"12/13/2013",4/23/2014,"04/23/2014"
"Food",67794,"Ongoing","Perfect Pasta","Addison","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: PA","F-1740-2014","Class I","Macaroni and cheese packaged in plastic bags, 12 oz. to a bag, and sold under the Sweet Street Desserts brand. Cases of product contain 36 bags for a total case weight of 27 lbs.","Product Code: B254A1",".","184 cases","Mac & Cheese Shells (Product Code B254A1) sold under the Sweet Street Desserts brand in 12 oz. plastic bags is being recalled due to the presence of Listeria monocytogenes.",3/17/2014,"03/17/2014",4/9/2014,"04/09/2014"
"Devices",67795,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.","Z-1496-2014","Class II","TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.","00-6202-060-22; lot 62490588",,"17 units","Three complaints were received in which it was noted intra-operatively that the shell was missing the locking ring.",4/1/2014,"04/01/2014",4/30/2014,"04/30/2014"
"Drugs",67796,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1230-2014","Class III","Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany. ","a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014 ",".","1,276,710 Blister Cards","Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. ",3/27/2014,"03/27/2014",4/16/2014,"04/16/2014"
"Devices",67797,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.","Z-1455-2014","Class II","Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.","Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553",".","306,525 sets (20435 boxes of 15 sets)","Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.",12/9/2013,"12/09/2013",4/23/2014,"04/23/2014"
"Veterinary",67799,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-144-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315003 , 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315019 , 14315020 , 14315022 , 14315023 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315037 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315046 , 14315047 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315061 , 14315062 , 14315063 , 14315064 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315073 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315172 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 1431520",,"467 pumps","The is a possible interruption of therapy which may occur when in E321 error code occurs while using a Plum A+ infuser. The E321 error code occurs when the Plum A+ infuser is operating on AC power and the software detects that the batter could not be fully recharged within eight hours. If the E321 error code occurs during infusion, the infuser will stop delivery, which may result in a delay/interruption of therapy.",3/12/2013,"03/12/2013",7/30/2014,"07/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1245-2014","Class III","Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.","(20 ct) Lot #13444 (exp 05/14), 13486 (exp 06/14), 13547 (exp 06/14), 13619 (exp 06/14), 13675 (exp 07/14), 13833 (exp 11/14), 13921 (exp 11/14), 14008 (exp 1/15), 14150 (exp 4/15), 14195 (exp 4/15), 14260 (exp 7/15), 14286 (exp 7/15), 14379 (exp 9/15), 14428 (exp 9/15), 14463 (exp9/15) & 14507 (exp 10/15); (27 ct) Lot: 14190 (exp 5/15), 14383 (exp 9/15); (81 ct) Lot # 13374 (exp 4/14), 13392 (exp 4/14), 13445 (exp 5/14), 13487 (exp 6/14), 13559 (exp 6/14), 13575 (exp 7/14), 13594 (exp 7/14), 13678 (exp 8/14), 13737 (exp 9/14), 13797 (exp 10/14), 13817 (exp 11/14), 13891 (exp 11/14), 13996 (exp 1/15), 14104 (exp 3/15), 14127 (exp 4/15), 14131 (exp 4/15), 14137 (exp 4/15), 14142 (exp 4/15), 14149 (exp 4/15), 14186 (exp 5/15), 14198 (exp 5/15), 14259 (exp 7/15), 14354 (exp 9/15), 14355 (exp 9/15), 14438 (exp 10/15), 14455 (exp 10/15) & 14477 (ex[ 10/15); (135 ct) Lot #12J08N (exp 8/14), 12K06N (exp 8/14), 12K30N (exp 8/14), 12L18N (exp 8/14), 13B04N (exp 11/14), 13C11N (exp 8/15), 13F18N (exp 5/15), 13H05N (exp 5/15), 13I12N (exp 5/15), 13I28N (exp 5/15), 13K12N (exp 9/15), 13K19N (exp 9/15), 13K20N (exp 9/15).",,"834,072 81 ct Vials, 414,500 20 ct Vials, 9456 135 ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1246-2014","Class III","Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.","(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)",,"189,900 20 ct Vials, 145,068 81 ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1243-2014","Class III","Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03. ","81 Ct Vial Lot # 13728 (exp 8/14), 13771 (exp 10/14), 13993 (exp 1/15) & 13994 (exp 1/15); 189 Ct Vial Lot # 12H23N (exp 5/14), 12K02N (exp 6/14), 12K06N (exp 10/14), 12K30N (exp 10/14), 12L04N (exp 10/14), 12L04N1 (exp 10/14), 13A08N (exp 10/14), 13B08N (exp 1/15), 13D02N (2/15), 13E01N (exp 3/15), 13E21N (exp 4/15), 13G18N (exp 5/15), 13H06N (exp 5/15), 13H07N (exp 7/15), 13H30N (exp 7/15), 13H30NN (exp 7/15), 13I25N (exp 7/15), 13I26N (exp 8/15) & 13K27N (exp 8/15).",,"146,424 81 Ct. Vials, 105,091 189 Ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1244-2014","Class III","Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.","Lot #12K16W (exp 5/14), 12K27N (exp 6/14), 12K27W (exp 6/14), 12K29N (exp 6/14), 13K20W (exp 6/15), 13K20W1 (exp 6/15) & 13K25N (exp 6/15).",,"12,162 Pallets","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1238-2014","Class III","Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.","Labeled A) 72 Ct Vial: Lot #13468 (exp 4/14), 13618 (exp 6/14) & 14105 (exp 2/15); 81 Ct- Vial, Lot #13815 (exp 10/14), 13864 (exp 11/14) & 13941 (exp 12/14); 108 Ct- Vial, Lot # 13574 (exp 7/14). Labeled B) 72 Ct Vial, Lot #13573 (exp 6/14) & 14257 (exp 7/15). Labeled C) 72 Ct Vial: Lot # 13875 (exp 5/14), 13642 (exp 7/14), 13770 (exp 8/14) & 13875 (exp 11/14).",,"109,848 72 Ct Vials, 61,332 81 Ct Vials, 16,218 108 Ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1241-2014","Class III","Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.","Labeled A) 72 Count Vial, Lot # 13404 (exp 4/14),13499 (exp 5/14), 13549 (exp 6/14), 14004 (exp 1/15), 14079 (exp 2/15), 14178 (exp 5/15), 14297 (exp 7/15) & 14425 (exp 9/15); 108 Ct Vial: Lot # 13449 (exp 5/14), 13657 (exp 8/14), 13723 (exp 8/14), 13781 (exp 11/14), 13867 (exp 11/14), 13897 (exp 12/14), 13960 (exp 1/15), 13981 (exp 12/14), 14016 (exp 2/15), 14254 (exp 7/15), 14305 (exp 7/15), 14341 (exp 7/15), 14370 (exp 8/15) & 14465 (exp 11/15). Labeled B) 72 Count Vial, Lot #13417 (exp 5/14), 13570 (exp 6/14), 13974 (exp 1/15), 14089 (exp 2/15), 14225 (exp 5/15), 14269 (exp 7/15), 14311 (exp 7/15) & 14396 (exp 8/15).Labeled C) 108 Ct Vial: Lot #:13656 (exp 8/14), 13753 (exp 9/14).",,"488,628 72 Ct Vial, 255,594 108 Ct Vial","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1247-2014","Class III","Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.","Lot #13L05N, Expiry: 8/15",,"150 cases","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1239-2014","Class III","Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.","Labeled A) 72 Ct Vial, Lot # 13481 (exp 5/14), 13674 (exp 5/14), 14056 (exp 2/15), 14092 (exp 3/15), 14258 (exp 7/15), 14450 (exp 10/15); 81 Ct Vial, Lot # 13855 (exp 1/15), 13927 (exp 10/14) & 14093 (exp 3/15); 108 Ct Vial, Lot # 13643 (exp 8/14) & 13992 (exp 12/14). Labeled B) 72 Ct Vial, Lot # 14041 (exp 2/15), 14117 (exp 2/15) & 14268 (exp 4/15); Labeled C) 72 Ct Vial Lot #13671 (exp 8/14) & 13890 (exp 11/14).",,"304,332 72 Ct Vials, 85,080 81 Ct Vials 22,992 108 Ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1240-2014","Class III","Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.","Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).",,"603,696 72 Ct Vials, 191,040 108 Ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Drugs",67800,"Ongoing","GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline","Aiken","SC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1242-2014","Class III","Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.","81 Ct Vial, Lot # 13727 (exp 8/14), 13816 (exp 10/14), & 13965 (exp 12/14); 189 Ct Vial, Lot # 12H17N (exp 4/14), 12H20N (exp 6/14), 12J16N (exp 6/14), 12K03N (exp 9/14), 12L05N (exp 10/14), 12L07N (exp 9/14), 12L17N (exp 10/14), 13A04N (exp 11/14), 13A23N (exp 11/14), 13C04N (exp 1/15), 13C08N (exp 1/15), 13D17N (exp 11/14), 13D18N (exp 1/15), 13D18N1 (exp 3/15), 13E24N (exp 4/15), 13E28N (exp 4/15), 13G16N (exp 4/15), 13G17N (exp 5/14), 13H02N (exp 5/15), 13H22N (exp 5/15), 13I18N (exp 8/15), 13I20N (exp 5/15), 13J24N (exp 8/15), 13J24N1 (exp 9/15), 13K08N (exp 8/15), 13K11N (exp 9/15), 13L11N (exp 10/15) & 13L11N1 (exp 10/15).",,"147,684 81 Ct Vials, 130564 189 Ct Vials","Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",2/20/2014,"02/20/2014",4/30/2014,"04/30/2014"
"Veterinary",67801,"Terminated","Mercer Milling Co. Inc.","Liverpool","NY","US","Voluntary: Firm Initiated","Telephone","NY and VT","V-162-2014","Class I","MERRSM - MERRELL MEDICATED STOCK MIX -- For Further Manufacture of Feed -- MEDICATED -- ACTIVE DRUG INGREDIENT: Monensin (as Monensin Sodium) 6000 g/ton. Ingredients: Processed Grain By-Products and Calcium Carbonate --- Manufactured For: Eagle Supply Company, LLC, PO Box 4844, Syracuse, NY 13221 --- Rumensin 90 - NADA # 95-735, Production Date 12/18/13","Lot Number 39155 (The full lot code of the tag will read 1335239155) ",,"2 Totes - 3065 lbs.","Firm received an adverse reaction report from a farm. Private lab analysis of stock mix revealed sodium monensin at 470% of label claim (super-potent). ",3/21/2014,"03/21/2014",10/1/2014,"10/01/2014"
"Veterinary",67801,"Terminated","Mercer Milling Co. Inc.","Liverpool","NY","US","Voluntary: Firm Initiated","Telephone","NY and VT","V-163-2014","Class III","FCI RUMENSIN 10 G Premix (FCIRUM10), MEDICATED --- ACTIVE DRUG INGREDIENT: Monensin, USP . . . . . 20,000 g/ton; Guaranteed Analysis: Calcium, (Min) . . . 31 % , (Max) . . . 35% LIST OF INGREDIENTS: Calcium Carbonate and Mineral Oil --- Rumensin 90 - NADA # 95-735 --- Manufactured for: Feed Commodities Int., Inc., Middlebury, VT. 05753 -- Net Wt. 50 lbs (22.68 kg) FCIRUM10","Lot Number 39156 (The full lot code of the tag will read 1335239156) ",,"49 x 50 lb. bags","Private lab analysis of stock mix revealed monensin at 34% of label claim (sub-potent). ",3/21/2014,"03/21/2014",10/1/2014,"10/01/2014"
"Devices",67802,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France, Germany, Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.","Z-1512-2014","Class I","GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX","*** US DOCKING STATIONS *** List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09. *** FOREIGN DOCKING STATIONS *** List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09",,"26,765 docking stations total (6866 in US)","There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.",2/18/2014,"02/18/2014",5/7/2014,"05/07/2014"
"Devices",67803,"Ongoing","Pega Medical Inc.","Laval",,"CA","Voluntary: Firm Initiated","E-Mail","Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.","Z-1472-2014","Class II","Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.","Catalogue Number: FD-040(L)-SS Lot #: 111208-03 and 110808-13 111019-01 and 110808-13 110302-01 and 110808-13",,"48","The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.",3/5/2014,"03/05/2014",4/30/2014,"04/30/2014"
"Devices",67804,"Ongoing","ErgoSafe Product LLC dba Prism Medical Services ","Toronto, ON",,"CA","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE,NH,NY, ND,OH, OK, OR, PA , SD, TX, WI.","Z-1450-2014","Class II","400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.","Serial # 0810LS1522 0810LS1523 0910LS1524 0910LS1525 0910LS1526 0910LS1527 0910LS1528 0804LS0854 0910LS1529 0910LS1530 1010LS1532 0910LS1531 1010LS1533 1010LS1534 1010LS1535 1010LS1536 1010LS1537 1010LS1538 1010LS1539 1010LS1540 1010LS1541 1010LS1542 1010LS1543 1010LS1544 1010LS1545 1010LS1546 1010LS1547 1010LS1548 1110LS1549 1201LS1551 1210LS1550 1210LS1552 1210LS1553 1210LS1554 1210LS1555 1210LS1556 1210LS1557 0111LS1558 0111LS1561 0111LS1560 0111LS1562 0111LS1563 0111LS1564 0111LS1565 0111LS1566 0111LS1567 0111LS1559 0111LS51559 0111LS1568 0211LS1569 0211LS1570 0211LS1571 0211LS1572 0311LS1573 0311LS1575 0311LS1576 0311LS1578 0311LS1577 0311LS1579 0311LS1580 0311LS1583 0311LS1581 0311LS1582 0311LS1586 0311LS1574 0311LS1585 0311LS1587 0411LS1588 0411LS1589 0411LS1590 0411LS1591 0411LS1592 0411LS1593 0411LS1594 0511LS1597 0511LS1598 0511LS1599 0511LS1596 0511LS1600 0511LS1601 0511LS1602 0411LS1595 0511LS1603 0611LS1605 0611LS1604 0611LS1606 0611LS1607 0611LS1608 0611LS1609 0611LS1610 0611LS1611 0711LS1612 0711LS1613 0711LS1614 0711LS1615 0711LS1616 0711LS1617 0711LS1618 0711LS1619 0711LS1620 0311LS1584 0711LS1621 0711LS1622 0711LS1623 0811LS1624 0711LS1625 0811LS1625 0811LS1626 0811LS1627 0811LS1628 0811LS1629 0811LS1631 0811LS1630 0911LS1632 0911LS1633 0911LS1639 0911LS1636 0911LS1641 0911LS1642 0911LS1643 0911LS1644 0911LS1634 0911LS1637 0911LS1638 0911LS1640 0911LS1645 1011LS1647 1011LS1646 1011LS1648 1011LS1649 1011LS1650 1011LS1651 1011LS1652 1011LS1653 1011LS1655 1011LS1654 1011LS1656 1011LS1658 1011LS1657 1011LS1659 1011LS1660 1211LS1661 1211LS1662 1211LS1663 1211LS1664 1211LS1665 1211LS1666 1211LS1667 1211LS1668 1211LS1669 1211LS1670 1211LS1671 1211LS1672 1211LS1673 1211LS1674 1211LS1678 0112LS1683 0112LS1681 0112LS1682 0112LS1684 1211LS1675 1211LS1676 1211LS1677 0112LS1680 0112LS1685 0911LS1635 1211LS1679 0112LS1686 0112LS1687 0112LS1688 0112LS1689 0112LS1690 0112LS1691 0212LS1693 0212LS1694 0212LS1692 0212LS1697 0212LS1698 0212LS1699 0212LS1700 0212LS1701 0212LS1702 0312LS1703 0312LS1704 0312LS1705 ",".","514","MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare's high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break. ",5/10/2013,"05/10/2013",4/16/2014,"04/16/2014"
"Food",67805,"Completed","J. R. Simplot Co. Corporate HQ","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed to one consignee's warehouse located in Fairfield, OH","F-1968-2014","Class III","PDP reads in part ''***GOOD FOOD MADE SIMPLE***breakfast in a bowl *** SOUTHWESTERN VEGGIES***'' UPC 0 80618 41801 5","0214 Best By: January 21, 2015",".","2664 cases (8 - 7oz packages per case)","Raw material supplier accidently added sodium benzoate to the salsa used in manufacturing the finished product. Sodium benzoate was not declared on the ingredient statement of both the raw material and finished product.",2/7/2014,"02/07/2014",5/28/2014,"05/28/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1857-2014","Class I","Garlic Cheddar Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (11108) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1868-2014","Class I","Peanut Butter sold under the following sizes, brands: HONEY CRUNCHY (55204) Peanut Butter in 16 oz tubs with snap on lid.","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1846-2014","Class I","Pimento Cheese Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 12 ounce (20100) cup with snap on lid; 2. Block & Barrel in 4 lb. pail with snap on lid (2382588). 3. HYTOP label in 12 ounce (952549) and 20 ounce (952556) cups with snap on lid.","Sell by Date before 9/20/2014 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1831-2014","Class I","Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), and 16 ounce round or square plastic containers (tub with snap on lid) (17001UL), 5 lb. pail with snap on lid (11341 & 11441), 10 lb. pail with snap on lid (12341). 2. Amish Classic in 8 oz. cups with snap on lid (AC14001) 3. Biery in 5 lb. pail with snap on lid (5004). 4. Block & Barrel in 5 lb. pail with snap on lid (2388254). 5. Bucky Badger in 8 oz. (31411), 12 oz. (51411), and 14 oz. (41411) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27056). 7. Cobblestone Market in 5 lb. pail (42403) and 30 lb. pails (42803) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442) ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1869-2014","Class I","Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CRUNCHY (55104), 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CRUNCHY (55304) ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1833-2014","Class I","Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (10201) cup with snap on lid, and 10 lb. (12341OS), white tub with snap on lid; 2. Win Schuler in 10 lb. pail with snap on lid (01498) ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1851-2014","Class I","Sharp Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40506) and balls (40106) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1867-2014","Class I","HYTOP Jalapeno Pimento cheese spread in 12 ounce (952754) cups with snap on lid ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1834-2014","Class I","Swiss Almond Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14005), 13.5 ounce (17005) cups with snap on lid; 5 lb. (52244) and 10 lb. (53244) pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14005). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2388270). 4. Bucky Badger in 8 oz. (31711) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27058). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42703). 7. Dierks Waukesha in 5 lb. pail with snap on lid (52242). ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1847-2014","Class I","Bacon Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51611) cups with snap on lids.","Sell by Date before 9/20/2014 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1836-2014","Class I","Bacon Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14002) and 14 ounce (17002) cups with snap on lid; 5 lb. Cheeseball Base - Bacon (14441) and 10 lb. (61760) pail with snap on lid; 2. Bucky Badger in 8 oz. (31611) and 14 oz. (41611) cups with snap on lid. ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1838-2014","Class I","Onion Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (14003) cups with snap on lid; ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1849-2014","Class I","Jalapeno Nacho Dip sold under the following sizes and brands: Parkers Farm or Parkers label in 12 ounce (20200) cups with snap on lids.","Sell by Date before 9/20/2014 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1859-2014","Class I","Pimento Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80208) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1865-2014","Class II","Black Bean & roasted Chili Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 32 ounce (80598) jug with screw on lid; ","Sell by Date before 7/20/2014",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1861-2014","Class II","Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid, 32 ounce (10794) and 1 gallon (11600) jug with screw on lid; 2. San Pablo in 16 ounce container with snap on lid (12826). ","Sell by Date before 7/20/2014",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1862-2014","Class II","Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid, 32 ounce (10894) jug with screw on lid; ","Sell by Date before 7/20/2014",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1860-2014","Class I","Beer Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (80408) in film overwrap and Say Cheez Beer cheese - Creamy (17051) in 14 oz. cups with snap on lid. ","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1858-2014","Class I","Smokey Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40206) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1866-2014","Class I","Peanut Butter sold under the following sizes, brands: Honey CREAMY (55200) Peanut Butter in 16 oz tubs with snap on lid.","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1845-2014","Class I","Spicy Beer Cheese Spread sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (01508) pails with snap on lid, Say Cheez Beer cheese - spicy (17050) in 14 oz. cups with snap on lid","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1832-2014","Class I","Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), 5 lb. (11951), 10 lb. (12951), white tub with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC14010). 3. Biery in 5 lb. pail with snap on lid (5010). 4. Block & Barrel in 5.5 lb. pail with snap on lid (2388247). 5. Bucky Badger in 8 oz. (31511), 12 oz. (51511), and 14 oz. (41311) cups with snap on lid. 6. Central Markets in 8 oz cups with snap on lid (27057). 7. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 8. Dierks Waukesha in 5 lb. pail with snap on lid (11952). 9. Happy Farms in 8 ounce cup with snap on lid (43316). ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1841-2014","Class I","Smoked Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13004) cups with snap on lid; ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1854-2014","Class I","Ranch Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce balls (40406) in film overwrap. ","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1855-2014","Class I","Jalapeno Cheese Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce logs (12208) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1856-2014","Class I","Jalapeno Bacon Cheese Ball sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce ball (40906) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1853-2014","Class I","Port Wine Cheese Ball and Logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 10 ounce logs (40306) and balls (40606) in film overwrap.","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1839-2014","Class I","Cheddar Ranch Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (12221) pail with snap on lid.","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1848-2014","Class I","Garlic Cheese Spread sold under the following sizes and brands: Bucky Badger label in 12 ounce (51811) cups with snap on lids.","Sell by Date before 9/20/2014 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1864-2014","Class II","Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid, 32 ounce (41596) jug with screw on lid; ","Sell by Date before 7/20/2014",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1835-2014","Class I","Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13006), 14 ounce (17006), 16 ounce (17006UL) cups with snap on lid; 5 lb. (41550) and 10 lb. (42550 pail with snap on lid; 2. Amish Classic in 8 ounce cup with snap on lid (AC13006). 3. Block & Barrel in 5.5 lb. pail with snap on lid (2593424). 4. Bucky Badger in 12 oz. (51311) cups with snap on lid. 5. Central Markets in 8 oz cups with snap on lid (27055). 6. Cobblestone Market in 5 lb. pail pails with snap on lid (42603). 7. Dierks Waukesha in 5 lb. pail with snap on lid (41552). ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1830-2014","Class I","Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CREAMY (55100) 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CREAMY (55300) 3. 5 lb. pail (2 pails in box) Parkers Farm Creamy (55105) 4. 34 oz. tubs with snap on lid (8 tubs in box) Costco Peanut Butter (55300) ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1850-2014","Class I","Restaurant Bar Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (21811) pails with snap on lids. ","Sell by Date before 9/20/2014 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1837-2014","Class I","Swiss & Cheddar Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 8 ounce (13012) cups with snap on lid; and 10 lb. (81774) pail with snap on lid; ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1863-2014","Class II","Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid, 1 gallon (11900) jug with screw on lid; 2. San Pablo in 1 gallon jug with screw on lid (12827). ","Sell by Date before 7/20/2014",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1842-2014","Class I","Garlic Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (13008) cups with snap on lid; 10 lb. (11269) pail with snap on lid; 2. Bucky Badger in 8 oz. (31811) and 14 oz. (41811) cups with snap on lid. ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1844-2014","Class I","Sharp Cheddar & Port Wine Cold Pack Cheese sold under the following sizes and brands: Aldi label in 14 oz. (112699 / #7742) cup with snap on lid.","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1852-2014","Class I","Cheddar Cheese Ball and Logs sold under the following sizes and brands: 1. Aldi label in 10 ounce balls (1087 / #7713) in film overwrap; 2. Win Schuler Original label in 10 ounce balls (55560) and logs (55570) in film overwrap; 3. CP in 8 ounce cheese logs (CH111000) in film overwrap. ","Sell by Date before 3/20/2015",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1840-2014","Class I","Green Onion Cheeseball Base Cold Pack Cheese sold under the following sizes and brands: Parkers Farm or Parkers label in 5 lb. (13331) pail with snap on lid;","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67806,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-Mail","Nationwide. No distribution outside the US.","F-1843-2014","Class I","Jalapeno Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail (91347) with snap on lid; 5 lb. Cheeseball Base - Jalapeno (15551) pail with snap on lid; 2. Bucky Badger in 8 oz. (31911) and 14 oz. (41911) cups with snap on lid. ","Sell by Date before 3/20/2015 ",".","369,840 total cases for all varieties","Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Devices",67808,"Ongoing","Draeger Medical, Inc.","Telford","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.","Z-1452-2014","Class II","Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.","Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542. ",".","433","Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. Although this is the standard abbreviation for natural rubber (latex), CFR 21 Part 801 Sec. 801.437 requires additional language. It is unclear whether the labelling of the product played any part in the reported incident.",3/25/2014,"03/25/2014",4/16/2014,"04/16/2014"
"Drugs",67809,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","NY and KY","D-1354-2014","Class II","ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY","508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units ",,"47890","Non-sterility: due to a failed sterility test",3/21/2014,"03/21/2014",6/4/2014,"06/04/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1365-2014","Class I","Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # 201303 EXP: 14/03/07",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1367-2014","Class I","Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # BTRM3452 EXP: 2015/07/03",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1370-2014","Class I","Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1368-2014","Class I","Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # BTRX7654 EXP: 2015/07/08",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1369-2014","Class I","Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # VINA2013 EXP: 2015/06/12",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67810,"Ongoing","Pure Edge Nutrition","Toms River","NJ","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1366-2014","Class I","Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ","lot # BTX13 EXP: 2015/08/15",".","unknown","Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein",10/10/2013,"10/10/2013",6/18/2014,"06/18/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1295-2014","Class II","INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 ","TE38139, Exp. 08/16, TE39022, Exp. 09/16, ",,"5812 bottles","This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/7/2014,"05/07/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1294-2014","Class II","INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 ","TE32134, Exp. 02/15",,"7,694 bottles","This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/7/2014,"05/07/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D1292-2014","Class II","METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 ","TE36053A,TE36063A, Exp. 06/16",,"22820 bottles","This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/7/2014,"05/07/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1293-2014","Class II","GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 ","TE36018, Exp. 06/15",,"2532 bottles","This recall was initiated because laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/7/2014,"05/07/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1295-2014","Class II","INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 ","TE38139, Exp. 08/16, TE39022, Exp. 09/16, ",,"5812 bottles","CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/21/2014,"05/21/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D1292-2014","Class II","METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 ","TE36053A,TE36063A, Exp. 06/16",,"22820 bottles","CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements",3/24/2014,"03/24/2014",5/21/2014,"05/21/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1293-2014","Class II","GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 ","TE36018, Exp. 06/15 ",,"2532 bottles","CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements",3/24/2014,"03/24/2014",5/21/2014,"05/21/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1294-2014","Class II","INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 ","TE32134, Exp. 02/15",,"7,694 bottles","CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements",3/24/2014,"03/24/2014",5/21/2014,"05/21/2014"
"Drugs",67811,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1295-2014","Class II","INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 ","TE38139, Exp. 08/16, TE39022, Exp. 09/16, ",".","5812 bottles","CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.",3/24/2014,"03/24/2014",5/28/2014,"05/28/2014"
"Drugs",67812,"Terminated","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","MO, TN, MS, WI","D-1258-2014","Class III","Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.","Lot #: 1905, Expiry: 4/30/14",,"1 vial","Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Drugs",67812,"Terminated","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","MO, TN, MS, WI","D-1259-2014","Class III","Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.","Lot #: 565:27, Expiry: 5/31/14",,"2 vials","Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Drugs",67812,"Terminated","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","MO, TN, MS, WI","D-1260-2014","Class II","Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.","Lot #: 641:07, Expiry: 8/11/14 ",,"3 vials","Presence of Particulate Matter",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Drugs",67812,"Terminated","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","MO, TN, MS, WI","D-1257-2014","Class II","Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203."," Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14 ",,"7 vials","Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Devices",67813,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia","Z-2053-2014","Class II","SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.","Serial numbers 111018DF001 through 120409DF045 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.",".","953 total STRYKER SHAPE Arms of all types","During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. ",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Devices",67813,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia","Z-2056-2014","Class II","BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.","Serial numbers 080909DB001 through 131021DB015 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.",".","953 SHAPE Arms of all types","During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. ",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Devices",67813,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia","Z-2054-2014","Class II","SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.","Serial numbers 111108DD001 through 131115DD020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.",".","953 TOTAL SHAPE Arms of all types","During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. ",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Devices",67813,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia","Z-2052-2014","Class II","SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. ","Serial numbers 111018DE001 through 140210DE020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.",".","953 STRYKER SHAPE ARMS of all types","During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. ",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Devices",67813,"Ongoing","Stryker Communications","Flower Mound","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia","Z-2055-2014","Class II","BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.","Serial numbers 080924DC001 through 120227DC025 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.",".","953 SHAPE Arms of all types","During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. ",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Devices",67814,"Ongoing","Hyperion Medical","Dallas","TX","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.","Z-2264-2014","Class II","All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.","All brochures and online literature printed before November 20, 2013.",,"3,346 brochures. Quantity not applicable to web site.","Brochures and web site information for the Hyper blue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. Specifically, the web site and brochures misbranded the product with claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, as well as a claim that the product could be used with a 15 mm hand piece.",11/20/2013,"11/20/2013",8/27/2014,"08/27/2014"
"Devices",67815,"Ongoing","Maquet Datascope Corp - Cardiac Assist Division","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide), worldwide to approximately 104 countries.","Z-1523-2014","Class I","Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump Product Usage: The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. ","IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx ",".","11,881 units (US 5183 and OUS 6698)","Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.",3/21/2014,"03/21/2014",5/28/2014,"05/28/2014"
"Food",67816,"Ongoing","Vermont Common Foods, LLC","North Clarendon","VT","US","Voluntary: Firm Initiated","Other","New England","F-1819-2014","Class I","Orton Bros. Brand Zesty Lemon Cookie Buttons; 6 oz. yellow box, UPC code 20104 19100. The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14. ","The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14. ",".","1188 boxes","Undeclared peanuts. ",3/24/2014,"03/24/2014",4/16/2014,"04/16/2014"
"Devices",67818,"Ongoing","Branan Medical Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and country of Canada.","Z-1508-2014","Class II","ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.","Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079",,"9,800 units","Branan Medical is recalling the ToxCup Drug Screen Cup because they may be labeled with incorrect result interpretation graphics on the ToxCup lid label.",3/26/2014,"03/26/2014",4/30/2014,"04/30/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1323-2014","Class II","Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1324-2014","Class II","10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots - Catalog No. 405910C - 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435, Catalog No. 405912C - 01J1200384, 01K1200725, 01L1200352, 01D1300319",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1325-2014","Class II","5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots - Catalog No. 40591OR - 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373; Catalog No. 405912R - 01H1200064, 01K1200379, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A130042001A1300545, 01F1300136",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1328-2014","Class II","5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 412944; 5/10/12 Weck Vista Universal Balloon Open Access Port - Long Length (100 mm), Catalog No. 412944L. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944 01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436 ",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1326-2014","Class II","5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots - Catalog No. 405910RC - 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, 01D1300319; Catalog No. 405912RC - 01G1200244, 01M1200020, 01M1200068, 01A1300546, 01A1300559",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67819,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.","Z-1327-2014","Class II","5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.","Lots - Catalog No. 405933 - 01L1200353, 01F1300080",".","55,521 total","Complaints of leakage of insufflation gas through the device.",3/11/2014,"03/11/2014",4/9/2014,"04/09/2014"
"Devices",67820,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-1476-2014","Class II","FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.","Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014",,"33,853","bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent",3/6/2014,"03/06/2014",4/30/2014,"04/30/2014"
"Devices",67820,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-1477-2014","Class II","API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. ","Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014",,"33,853","bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent",3/6/2014,"03/06/2014",4/30/2014,"04/30/2014"
"Devices",67820,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-1478-2014","Class II","API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms. ","Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014",,"33,853","bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent",3/6/2014,"03/06/2014",4/30/2014,"04/30/2014"
"Devices",67820,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-1475-2014","Class II","ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.","Codes - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 1002760700, Exp. Date 11/4/2014, 1002821420, Exp. Date 11/26/2014, 1002857840, Exp. Date 12/12/2014, 1002860530, Exp. Date 12/12/2014 ",,"33,853","bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent",3/6/2014,"03/06/2014",4/30/2014,"04/30/2014"
"Devices",67821,"Ongoing","Breg Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.","Z-1446-2014","Class II","Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. ","Lot No. 705764",".","20 units ","Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Devices",67821,"Ongoing","Breg Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Telephone","USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.","Z-1447-2014","Class II","K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support. ","Lot No. 705593",".","2 units","Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.",3/14/2014,"03/14/2014",4/16/2014,"04/16/2014"
"Biologics",67822,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0575-14","Class II","Red Blood Cells Leukocytes Reduced","W270113513474",,"1 unit","Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.",2/18/2014,"02/18/2014",4/30/2014,"04/30/2014"
"Biologics",67823,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0574-14","Class II","Platelets Pooled Leukocytes Reduced","W270113587483",,"1 unit","Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.",2/18/2014,"02/18/2014",4/30/2014,"04/30/2014"
"Biologics",67823,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0573-14","Class II","Red Blood Cells Leukocytes Reduced","W270113513482, W270113588339",,"2 units","Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.",2/18/2014,"02/18/2014",4/30/2014,"04/30/2014"
"Biologics",67824,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Letter","Illinois","B-0572-14","Class III","Red Blood Cells Leukocytes Reduced","W204014019129",,"1 unit","Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed.",1/31/2014,"01/31/2014",4/30/2014,"04/30/2014"
"Biologics",67825,"Terminated","Mid-America Transplant Services","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","Mexico; Iraq","B-0601-14","Class II","Cornea","12292013017OD; 12292013017OS",,"2 corneas","Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. ",3/7/2014,"03/07/2014",5/7/2014,"05/07/2014"
"Biologics",67826,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0548-14","Class II","Platelets Pooled Leukocytes Reduced","W037914556888; ",,"1","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.",2/10/2014,"02/10/2014",6/11/2014,"06/11/2014"
"Biologics",67827,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Illinois","B-0561-14","Class II","Red Blood Cells Leukocytes Reduced","W038314013506; ",".","1","Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.",2/18/2014,"02/18/2014",5/14/2014,"05/14/2014"
"Biologics",67828,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","North Carolina; Arizona; New Jersey; California; Oklahoma","B-0565-14","Class III","Blood and Blood Products for Reprocessing","W200613136253; W200613136263; W200613157689; W200613157692; W200613175963; W200613175967; W200613175976; W200613175977; W200613175980; W200613175981;",".","10","Blood products, possibly contaminated by air during collection, were distributed.",1/31/2014,"01/31/2014",5/14/2014,"05/14/2014"
"Biologics",67828,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","North Carolina; Arizona; New Jersey; California; Oklahoma","B-0563-14","Class II","Plasma Frozen within 24 hours (FP24)","W200613136251; W200613136252; W200613136255; W200613136257; W200613136260; W200613136261; W200613136266; W200613157676; ",".","8","Blood products, possibly contaminated by air during collection, were distributed.",1/31/2014,"01/31/2014",5/14/2014,"05/14/2014"
"Biologics",67828,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","North Carolina; Arizona; New Jersey; California; Oklahoma","B-0564-14","Class II","Red Blood Cells Leukocytes Reduced","W200613136251; W200613136252; W200613136255; W200613136257; W200613136261; W200613136263; W200613136266; W200613157676; W200613157689; W200613157692; W200613175963; W200613175967; W200613175976; W200613175977; W200613175980; ",".","15","Blood products, possibly contaminated by air during collection, were distributed.",1/31/2014,"01/31/2014",5/14/2014,"05/14/2014"
"Biologics",67828,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","FAX","North Carolina; Arizona; New Jersey; California; Oklahoma","B-0562-14","Class II","Red Blood Cells Irradiated","W200613136260; ",".","1","Blood products, possibly contaminated by air during collection, were distributed.",1/31/2014,"01/31/2014",5/14/2014,"05/14/2014"
"Biologics",67829,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","New Jersey","B-0566-14","Class II","Platelets Pheresis","W20221380044100; ",".","1","Blood product, inappropriately stored in one platelet bag instead of two, was distributed. ",11/22/2013,"11/22/2013",5/14/2014,"05/14/2014"
"Biologics",67830,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0577-14","Class III","Platelets Pheresis Leukocytes Reduced","W043814300166; W043814300161; W043814300161; W043814300161; W043814300165; W043814300165; W043814300165; W043814320100; W043814320100; W043814320105; W043814320105; W043814320105; W043814320104; W043814320104",,"14 units","Blood products, in which quality control testing was performed, interpreted, or documented incorrectly, were distributed.",2/4/2014,"02/04/2014",4/30/2014,"04/30/2014"
"Devices",67831,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca","Z-1494-2014","Class II","Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.","lot #23F14A0375",,"789","Arrow is recalling the Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet due to a labeling inconsistency. Arrow has received complaints for lot 23F14A0375 that kits are packaged with the incorrect catheter, specifically the kits contain a 40cm catheter and should contain a 50cm catheter.",3/24/2014,"03/24/2014",4/30/2014,"04/30/2014"
"Food",67832,"Ongoing","BBM Chocolate Distributors, Ltd.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MD, MN, MO, NC, NJ, NY, OH, ON, OR, PA, TN, TX, WA, WI, and Canada.","F-0048-2015","Class I","Alprose Swiss Chocolate Dark Chocolate within a gold colored pillow gift box. NET WT 3.5 oz (100g). Packed as a carton with 6 boxes x 20 units. UPC 689423027308. Product of Switzerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 12205.","all lots, Item number 5106",,"188 cartons definitively identified ","BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen.",3/27/2014,"03/27/2014",10/29/2014,"10/29/2014"
"Food",67832,"Ongoing","BBM Chocolate Distributors, Ltd.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MD, MN, MO, NC, NJ, NY, OH, ON, OR, PA, TN, TX, WA, WI, and Canada.","F-0049-2015","Class I","CHOCOLAT Alprose NAPOLITAINS SWITZERLAND, NET WT. 1 Kg (35 oz). Product packed as the following: 1) bulk in clear plastic bags, 230 pieces with gold, black and white labeling, each carton contains 6 x 1 Kg bags, 2) 100g packages (3.5oz/~24 pieces. UPC 712963000354. Produced in Switzerland for: GROSS & COMPANY INTERNATIONAL, LONDON UK. US Importer: BBM CHOCOLATE DISTRIBUTORS, BROOKLYN, NY 11205.","all lots, Item numbers 6359",,"379 cartons definitively identified ","BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen.",3/27/2014,"03/27/2014",10/29/2014,"10/29/2014"
"Food",67832,"Ongoing","BBM Chocolate Distributors, Ltd.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MD, MN, MO, NC, NJ, NY, OH, ON, OR, PA, TN, TX, WA, WI, and Canada.","F-0047-2015","Class I","SWISS CHOCOLATE CHOCOLAT ALPROSE 52% CACAO PREMIUM DARK CHOCOLATE, within stand-up maroon colored gift box. NET WT 3.5 oz (100g). Packed as a carton containing 6 boxes x 20 units. UPC 689423025038. Product of Swtizerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 11205.","all lots, Item number 5120",,"194 cartons definitively identified ","BBM Chocolate Distributors, Ltd. has recalled three (3) Alprose Dark Chocolate products due to the presence of undeclared milk allergen.",3/27/2014,"03/27/2014",10/29/2014,"10/29/2014"
"Devices",67833,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","US Distribution only to MI.","Z-1633-2014","Class II","Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.","MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733",".","4285","The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-ray with the assumption that the component was echogenic, the needle would appear less prominently than expected but would still be visible.",7/17/2013,"07/17/2013",5/28/2014,"05/28/2014"
"Devices",67834,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.","Z-1507-2014","Class II","Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.","lot RF2110924",,"170","Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM",7/17/2013,"07/17/2013",4/30/2014,"04/30/2014"
"Devices",67835,"Ongoing","Solta Medical, Inc.","Hayward","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution","Z-1463-2014","Class II","FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.","Model MC-SYS-SR1500-D, Revisions A and B.",".","1077 units","Solta Medical became aware that obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.",3/20/2014,"03/20/2014",4/23/2014,"04/23/2014"
"Food",67836,"Ongoing","NW Nutritional Foods LLC","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in US to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,MMS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, VT, WA, AND WI. Product was distributed outside the US to British Columbia, Ontario and Quebec, Canada.","F-2188-2014","Class II","Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured For: Zing Bars Seattle, WA 98125. Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, 100% natural CASHEW CRANBERRY ORANGE, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OX (600g). Nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8-55531-00203-6; Display Carton UPC code: 8-55531-00210-4; Master Case UPC code: 1-08-55531-00210-1.","Best Before: 19 SEPT 2014 ",".","1812 bars","Undeclared milk found in bars labeled ''dairy free'' or ''vegan.''",3/27/2014,"03/27/2014",7/23/2014,"07/23/2014"
"Food",67836,"Ongoing","NW Nutritional Foods LLC","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in US to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,MMS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, VT, WA, AND WI. Product was distributed outside the US to British Columbia, Ontario and Quebec, Canada.","F-2187-2014","Class II","There are three different labels for this product. Label #1 individual bar 100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 display Carton 100% Natural Zing Nutrition Bar, Gluten Free & Vegan, DARK CHOCOLATE SUNFLOWER MINT, 12/1.76 OZ(50g) Bars, NET WT. 1 LB 5.12 OZ. (600g). Label #2 individual bar 100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #3 individual bar 100% Natural Zing Nutrition Bar, NUT FREE DARK CHOCOLATE MINT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8 55531 00206 7; Display Box UPC code: 8 55531 00213 5; Master Case UPC code: 1 08 55531 00213 2.","Best Before: 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2104; 23 AUG 2014; 23 SEPT 2014; 29 OCT 2014 and 3 DEC 2014. ",".","50,904 bars","Undeclared milk found in bars labeled ''dairy free'' or ''vegan.''",3/27/2014,"03/27/2014",7/23/2014,"07/23/2014"
"Food",67836,"Ongoing","NW Nutritional Foods LLC","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in US to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,MMS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, VT, WA, AND WI. Product was distributed outside the US to British Columbia, Ontario and Quebec, Canada.","F-2186-2014","Class II","There are two different labels for this product same UPC codes. Version #1 individual bars: 100% natural Zing Complete Nutrition, CHOCOLATE COCONUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g). Version # 1 display carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, Zing Nutrition Bar, 100% natural CHOCOLATE COCONUT, 12/176 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Gluten, Soy & Dairy Free. Version # 2 individual bars: 100% Natural Zing Nutrition Bar, DARK CHOCOLATE COCONUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ, Manufactured For: Zing Bars Seattle, WA 98125. Version # 2 display carton: 100% Natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE COCONUT, NET WT. 1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g), Manufactured For: Zing Bars Seattle, WA 98125. Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. UPC code for Bar: 8-55531-00205-0; UPC code for Display Box: 8-55531-00212-8; UPC code for Master Case: 1-08-55531-00212-5.","Best Before: 14 FEB 2014; 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2104; 23 AUG 2014; 23 SEPT 2014; 29 OCT 2014 and 3 DEC 2014. ",".","475,308 bars","Undeclared milk found in bars labeled ''dairy free'' or ''vegan.''",3/27/2014,"03/27/2014",7/23/2014,"07/23/2014"
"Food",67836,"Ongoing","NW Nutritional Foods LLC","Seattle","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed in US to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,MMS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, VT, WA, AND WI. Product was distributed outside the US to British Columbia, Ontario and Quebec, Canada.","F-2185-2014","Class II","There are 2 different labels for this same product with the same UPC. Label #1 Individual Bars: 100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, DARK CHOCOLATE HAZELNUT, 100% natural, 12/1.76 OZ (50g) Bars, NET WT 1 LB 5.12 OZ (600g) Label #2 Individual Bars: 100% natural Zing Nutrition Bar, DARK CHOCOLATE HAZELNUT, Gluten Free, Vegan & Non GMO, NET WT. 1.76 OZ. (50g). Label #2 Display Carton: ''100% natural Zing Nutrition Bar, Gluten Free, Vegan & Non GMO, DARK CHOCOLATE HAZELNUT, 12/1.76 oz (50g) Bars, NET WT 1 LB 5.12 OZ (600g) Chocolate covered nutrition bar packaged in 2 layer metallized BOPP film, 1.76 oz each. 12 individually wrapped bars per display box. Bar UPC code: 8-55531-00216-6; Display Carton UPC code: 8-55531-00217-3; Master Case UPC code: 1-08-55531-00217-0.","Best Before: 14 FEB 2014; 21 FEB 2014; 30 MARCH 2014; 13 JUNE 2014; 31 JULY 2014; 23 AUG 2014; 23 SEPT 2014; and 29 OCT 2014. ",".","242,676 bars","Undeclared milk found in bars labeled ''dairy free'' or ''vegan.''",3/27/2014,"03/27/2014",7/23/2014,"07/23/2014"
"Devices",67837,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.","Z-1461-2014","Class II","Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems. ","Brilliance CT 16: Model Number: 728246; Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213. Brilliance CT 64: Model Number: 728231; Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology: Model Number: 728243; Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology: Model Number: 728244; Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT: Model Number: 728306; Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT: Model Number: 728326; Serial Number: 300165 and 333013. Ingenuity Core: Model Number: 728321; Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017. Ingenuity Core128: Model Number: 728323; Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex: Model Number: 728317; Serial Number: 345005",".","135","Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table top's subframe. ",3/27/2014,"03/27/2014",4/23/2014,"04/23/2014"
"Drugs",67838,"Ongoing","Alkermes, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1556-2014","Class II","VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.","Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01. ",".","4,364 vials","Customer complaints for failure to deliver the dose.",3/4/2014,"03/04/2014",9/3/2014,"09/03/2014"
"Devices",67839,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir.","Z-1564-2014","Class II","Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems","Kit Lots ending in and exp date: 219 Exp. Date 25 March, 2014; 222 Exp Date 12 May, 2014; 224 Exp Date 04 August, 2014; 225 Exp Date 04 August, 2014; 226 Exp Date 12 September, 2014; 227 Exp. Date 06 October, 2014 ",".","49123 units","Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223",3/25/2014,"03/25/2014",5/14/2014,"05/14/2014"
"Food",67840,"Ongoing","Clif Bar And Company","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA , IL, IN, KS, MA, MD, ME, MI, MT, NC NH, NJ , NJ, NM , NV, NY, OH, OR, PA , RI, SC, TN, TX, UT, VT, WA, WI, WY.","F-1825-2014","Class II","Luna Chocolate Chunk; Whole Nutrition Bar for Women; 15 count box. Clif Bar & Company, Emeryville, CA","Individual Bar UPC: 7-22252-10068-9; 15 Count Box UPC: 7-22252-20068-6: Best By Dates of 11NOV14 and 14OCT14.",".","19,119 packaging units ; 15 individual bars per box","Chocolate Chunk Luna Bars made with macadamia nut butter but macadamia nuts are not included in the ingredient listing or allergen statement.",3/27/2014,"03/27/2014",4/23/2014,"04/23/2014"
"Food",67841,"Ongoing","Borden Dairy Co Of Cincinnati Llc","Cincinnati","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was shipped to the following states: IN, KY, OH & WV.","F-1974-2014","Class III","Vitamin D Milk GRADE A PASTEURIZED HOMOGENIZED; 4-oz paper, 300-gal totes, Gallons, 1/2 gallons, pints, quarts, paper 1/2 pints, 5-gal dispense bags. INGREDIENTS: MILK AND VITAMIN D3. Product is sold under the following brand names and UPC codes: American Fare: Gal: 0 72000 15233 1, Gal: 0 72000 15238 6; Community Market: Gal: 0 70554 27197 9; Dairymens: Gal: 0 72804 00190 3, Gal: 0 72804 00158 3 & Pint: 0 72804 00159 0; Friendly Farms: Gal: 0 41498 19215 0; Glenview Farms: Gal: 7 58108 22723 1, 1/2Pt: 7 58108 22724 8; IGA: Gal: 0 41270 02491 4 & Gal: 0 41270 05844 5; Modern Foods: Gal: 0 80761 03000 3; Our Family: Gal: 0 70253 65100 7; UDF: Gal: 0 76310 05005 9, Gal: 0 76310 05002 8, Qt: 0 76310 05300 5 & Pt: 0 76310 05250 3.","IMS # 39-112; exp dates: 2/16/14, 2/17/14, 2/18/14, 2/19/14, 2/20/14. ",,"30/300 gal totes, 13,457cs/4/1 gal ctn, 51.44cs/9/ gal ctn, 45cs/12/1 qt ctn, 221.75cs/20/1 pt ctn, 31.18cs/50/ pt ctn, & 8/5gal bags.","The firm was informed that the product has more than double the labeled amount of Vitamin D. The target minimum level is 400 IU per Qt. The product contains 1006 IU per Qt.",2/6/2014,"02/06/2014",6/4/2014,"06/04/2014"
"Food",67842,"Ongoing","Command Nutritionals, LLC","Fairfield","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-1818-2014","Class II","Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs. Manufactured in the USA Infinite Labs, LLC PO Box 533736 Orlando, FL 32853 1-877-455-2271 ","a) Crimson Punch - Lot #13086 - exp date 04/01/2015 b) Orange - Lot #13085 - exp date 04/01/2015 c) Raspberry Lemonade - Lot #13087 - exp date 01/01/2015 ",".","1990 units","Command Nutritionals LLC is recalling Hard Blast-Pink Lemonade and Juggernaut- Various flavors due to contaminated L-Citrulline which was received from Axel Chemicals, Brentwood, TN.",3/11/2014,"03/11/2014",4/16/2014,"04/16/2014"
"Food",67842,"Ongoing","Command Nutritionals, LLC","Fairfield","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-1817-2014","Class II","Hard Blast Pink Lemonade Net Wt. 19 oz. Developed and exclusively distributed by: TBI Labs LLC, Miami, FL 33137 www.tbilabs.com 888-253-0958 Made in USA UPC 628586182561","Lot 13075 Exp. Date 4/29/2015",".","989 units","Command Nutritionals LLC is recalling Hard Blast-Pink Lemonade and Juggernaut- Various flavors due to contaminated L-Citrulline which was received from Axel Chemicals, Brentwood, TN.",3/11/2014,"03/11/2014",4/16/2014,"04/16/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0065-2015","Class I","OSCAR'S SMOKE HOUSE CHEDDAR SPREAD & BLUE CHEESE, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,510 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0069-2015","Class I","OSCAR'S SMOKE HOUSE TANGY HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,981 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0064-2015","Class I","OSCAR'S SMOKE HOUSE JALAPENO PEPPER CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,724 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0067-2015","Class I","OSCAR'S SMOKE HOUSE GARLIC CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"2,107 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0070-2015","Class I","OSCAR'S SMOKE HOUSE PLAIN CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,131 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0073-2015","Class I","OSCAR'S SMOKE HOUSE BACON & HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"6,241 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0066-2015","Class I","OSCAR'S SMOKE HOUSE CHAMPAGNE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,205 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0072-2015","Class I","OSCAR'S SMOKE HOUSE HICKORY SMOKED CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,069 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0074-2015","Class I","OSCAR'S SMOKE HOUSE BACON CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"6,134 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0071-2015","Class I","OSCAR'S SMOKE HOUSE ''MORE THAN'' CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,612 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Food",67843,"Ongoing","Oscar's Hickory House, Inc.","Warrensburg","NY","US","Voluntary: Firm Initiated","Press Release","Nationwide through internet mail order sales and to NY retail stores","F-0068-2015","Class I","OSCAR'S SMOKE HOUSE PORT WINE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.","lot numbers: 719-959",,"1,241 units","Products were recalled due to potential Listeria monocytogenes contamination.",3/26/2014,"03/26/2014",10/29/2014,"10/29/2014"
"Devices",67844,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.","Z-1320-2014","Class II","Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.","Lot Number H574228",".","15","The products are labeled as sterile but were not sterilized.",3/13/2014,"03/13/2014",4/9/2014,"04/09/2014"
"Devices",67844,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.","Z-1319-2014","Class II","Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.","Lot Number H591335",".","80","The products are labeled as sterile but were not sterilized.",3/13/2014,"03/13/2014",4/9/2014,"04/09/2014"
"Food",67845,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","United States including: AL, AZ, CA, FL, GA, IL, KS, KS, NM, NY, OH, OK, SD, TX, UT, WA, and WI.","F-1872-2014","Class II","1031 GA Artifical Cherry Concentrate (Flavoring for shaved ice) - Plastic Gallon","14030610001",".","11 gallons","Flavor concentration is too high",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67845,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","United States including: AL, AZ, CA, FL, GA, IL, KS, KS, NM, NY, OH, OK, SD, TX, UT, WA, and WI.","F-1871-2014","Class II","327 Ace Cherry Berry Flossugar (Flavoring for cotton candy)- Paperboard Carton","140306A1001",".","86 cases","Flavor concentration is too high",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67845,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","United States including: AL, AZ, CA, FL, GA, IL, KS, KS, NM, NY, OH, OK, SD, TX, UT, WA, and WI.","F-1873-2014","Class II","1358 Artificial Cherry Kola (Flavoring for shaved ice)- Plastic Gallon","14030710001",".","29 gallons","Flavor concentration is too high",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67845,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","United States including: AL, AZ, CA, FL, GA, IL, KS, KS, NM, NY, OH, OK, SD, TX, UT, WA, and WI.","F-1870-2014","Class II","2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton","14022402002, 14022502003, 14022502004 and 14022602005.",".","6.25 cases","Flavor concentration is too high",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Drugs",67846,"Ongoing","First Aid Only Inc","Vancouver","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1323-2014","Class II","Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA ","Aspirin was packed into Ibuprofen boxes (Item Number FAE-7014) coded: B11340515, B11840515, B12040615, B12540615, B12640615, B12740615, C10340615 and B11040516. ",,"802","First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).",3/25/2014,"03/25/2014",5/21/2014,"05/21/2014"
"Food",67847,"Ongoing","Emparedados Boricua","Bayamon","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-1958-2014","Class II","''Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich), net Wt. 7.6 oz (220 g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''","No codes are used",".","780 units","Undeclared soy coming from the Cheese Swiss.",3/28/2014,"03/28/2014",5/28/2014,"05/28/2014"
"Food",67847,"Ongoing","Emparedados Boricua","Bayamon","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-1957-2014","Class I","''Emparedados Boricua, Pollo & Queso (Chicken & Cheese), Net Wt. 6.5 oz, Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''","No codes are used",".","136 units","Undeclared eggs in Chicken (fully cooked)/Cheese sandwich.",3/28/2014,"03/28/2014",5/28/2014,"05/28/2014"
"Food",67847,"Ongoing","Emparedados Boricua","Bayamon","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-1959-2014","Class II","''Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich), Net Wt. 7.6 oz (220g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''","No codes are used",".","780 units","Undeclared soy coming from the Cheese Swiss.",3/28/2014,"03/28/2014",5/28/2014,"05/28/2014"
"Food",67847,"Ongoing","Emparedados Boricua","Bayamon","PR","US","Voluntary: Firm Initiated","Visit","Puerto Rico only","F-1960-2014","Class II","''Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich), Net Wt. 8 oz. (230g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956''","No codes are used",".","910 units","Undeclared soy coming from the Cheese Swiss.",3/28/2014,"03/28/2014",5/28/2014,"05/28/2014"
"Food",67848,"Ongoing","keen-wah LLC","Chicago ","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","F-1752-2014","Class II","i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz","All codes which read EXPDDMMYY (all dates)",".","approximately 4979 cs -4 oz 12 units/cs; approximately 511 cs -1 oz 24 units/cs","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Food",67848,"Ongoing","keen-wah LLC","Chicago ","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","F-1751-2014","Class II","i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz ","All codes which read EXPDDMMYY (all dates)",".","approximately 3143 cs - 4 oz 12 units/case; approximately 322 cs - 1 oz 24 units/cs","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Food",67848,"Ongoing","keen-wah LLC","Chicago ","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","F-1750-2014","Class II","i heart keenwah Almond All Natural Quinoa Clusters. UPC 736211802347 for the 4 oz UPC 713757598200 for the 1 oz","All codes which read EXPDDMMYY (all dates)",".","approximately 4899 cs - 4 oz 12 units/case; approximately 475 cs - 1 oz 24 units/cs","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Food",67848,"Ongoing","keen-wah LLC","Chicago ","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","F-1753-2014","Class II","i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters. UPC 736211884442 - 4 oz 12 units/cs","All codes which read EXPDDMMYY (all dates)",".","approximately 1405 cs - 4 oz packages/12 per case","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Food",67848,"Ongoing","keen-wah LLC","Chicago ","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","F-1749-2014","Class II","i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz","All codes which read EXPDDMMYY (all dates)",".","Approximately 8032 cs 4 oz 12 units/cs; 1 oz 24 units/cs","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.",3/28/2014,"03/28/2014",4/16/2014,"04/16/2014"
"Food",67850,"Ongoing","Kellogg Company","Battle Creek","MI","US","Voluntary: Firm Initiated","E-Mail","Canada only; no product distributed in the USA","F-1824-2014","Class II","Kellogg's Eggo Buttermilk au babeurre waffles 280g 8ct, UPC 0 64100 23817 6 Ingredients/ Ingredients: Water, Wheat Flour, soybean and palm oil shortening, whole egg, baking powder, sugar, salt milk ingredients, hydrogenated soybean oil, soy lecithin Contains wheat, egg, milk and soy ingredients .... Imported by / Importe par Kellogg Canada Inc. Mississauga, Ontario L4W5S1 Case Label: Kellogg's Eggo Frozen Waffles 64100,12/280 g 23817 Buttermilk Waffles UPC 0 64100 23817 3 ","2015 FE 13 EJCE",".","12,000 cartons (1,000 cases)","There may be small pieces of plastic found in a limited number of Eggo Buttermilk waffles distributed in Canada. ",3/21/2014,"03/21/2014",4/23/2014,"04/23/2014"
"Food",67851,"Ongoing","Vita Food Products, Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: IL, MI, MN, WI","F-1826-2014","Class I","Herring Fillets in Wine Sauce sold under the ELF brand in 12 oz. plastic jars.","UPC Code on Cases: 10073302221111. UPC Code on Jars: 73302 12111. Item Number: 005725. Best Before Date: 21 May 14. Lot Number: 03553.",".","2,280 Jars","Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling 2,280 individual plastic jars of 12 ounce Elf Herring Fillets in Wine Sauce that actually contains herring fillets in sour cream and therefore contains undeclared milk. ",3/26/2014,"03/26/2014",4/23/2014,"04/23/2014"
"Biologics",67853,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0580-14","Class III","Red Blood Cells Leukocytes Reduced","W035814018093",,"1 unit","Blood product, collected from a donor without documentation of a body temperature, was distributed.",2/11/2014,"02/11/2014",4/30/2014,"04/30/2014"
"Biologics",67854,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","NC","B-0579-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W051513043766- part 1; W051513043766-part 2 ",,"2 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",1/27/2014,"01/27/2014",4/30/2014,"04/30/2014"
"Biologics",67855,"Terminated","Northern California Community Blood Bank","Eureka","CA","US","Voluntary: Firm Initiated","FAX","CA","B-0578-14","Class II","Platelets Pheresis Leukocytes Reduced","W149514940848; W149514221179 ",,"2 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.",2/13/2014,"02/13/2014",4/30/2014,"04/30/2014"
"Biologics",67856,"Terminated","Northern California Community Blood Bank","Eureka","CA","US","Voluntary: Firm Initiated","FAX","CA","B-0576-14","Class II","Platelets Pheresis Leukocytes Reduced","W149514221269-part 1; W149514221269-part 2; W149514221269-part 3 ",,"3 units","Blood products, which did not meet the acceptable product specifications for release, were distributed",2/24/2014,"02/24/2014",4/30/2014,"04/30/2014"
"Devices",67857,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.","Z-1439-2014","Class II","Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 automatic external defibrillator.","Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269 ",".","19 units","A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy",3/31/2014,"03/31/2014",4/16/2014,"04/16/2014"
"Devices",67858,"Ongoing","Medline Industries Inc","Mundelein","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.","Z-1649-2014","Class II","Esmark Elastic Bandage (Sterile), 4'' x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.","Product Number: DYNJ05116A . Lot Number: 13LA1009.",".","2,860 bandages","This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.",3/20/2014,"03/20/2014",5/28/2014,"05/28/2014"
"Devices",67859,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico","Z-1503-2014","Class II","Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85","Units distributed from November 2006 through March 2014.",,"985 devices","The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. ",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1601-2014","Class I"," Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: xzone, Orlando, FL 32789"," Lot# 13071012",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1599-2014","Class I","XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012","Lot# 130520PL",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1598-2014","Class I","XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012","Lot# 130310GL",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1596-2014","Class I","AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. "," 2006-000926",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1602-2014","Class I","XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789","lot# 131110GL",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1603-2014","Class I","MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663","Lot# 10081359",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling MOJO RISEN, because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1597-2014","Class I","Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA., ","2006-3627878",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Drugs",67860,"Ongoing","Nova Products, Inc.","Aston","PA","US","Voluntary: Firm Initiated","Press Release","Nationwide to retailers and distributors","D-1600-2014","Class I","Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012","Lot# 13051012",,"Unknown","Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. ",3/28/2014,"03/28/2014",9/24/2014,"09/24/2014"
"Devices",67861,"Ongoing","Ormco/Sybronendo","Glendora","CA","US","Voluntary: Firm Initiated","Letter","US and Canada.","Z-1321-2014","Class II","Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.","Part Number 449-6212, Lot Number 121359169. ",".","150 units","Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets. ",3/25/2014,"03/25/2014",4/9/2014,"04/09/2014"
"Devices",67862,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of: ARGENTINA AUSTRALIA AUSTRIA BELGIUM CANADA CHINA CZECH REPUBLIC DENMARK FRANCE GERMANY ITALY LATVIA NETHERLANDS NEW ZEALAND NORWAY PHILIPPINES PORTUGAL SOUTH KOREA SPAIN SWITZERLAND THAILAND TURKEY and UNITED KINGDOM.","Z-1438-2014","Class II","Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.","USO1100106 to USO1100372 USN1100376 to USN1100960 USD1100961 to USD1101095 US11201096 to US11201186 US21201187 to US21201239 US31201240 to US31201537 US41201538 to US41201585 US51201586 to US51201721 US61201722 to US61201924 US71201925 to US71202048 US81202049 to US81202168 US91202169 to US91202514 USO1202515 to USO1202990 USN1202991 to USN1203537 USD1203538 to USD1203968 US11303969 to US11303972 US21303980 to US21304488 US31304489 to US31305042 US41305043 to US41305295 US51305296 to US51305450 US61305451 to US61306138 US71306139 to US71306542 US81306543 to US81306998 US91306999 to US91307261 USO1307306 to USO1307458 USN1307616 to USN1308423 USD1308424 to USD1309471 US11409472 to US11410212 US21410213 to US21410563 ",".","9872 units","Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. ",4/2/2014,"04/02/2014",4/16/2014,"04/16/2014"
"Food",67864,"Ongoing","Lao Thai Nam Corporation","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","TX","F-2057-2014","Class II","Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4","All product distributed prior to 03/31/14.",,"120 packs","The product has the potential to be contaminated with Clostridium botulinum.",3/31/2014,"03/31/2014",7/9/2014,"07/09/2014"
"Food",67865,"Ongoing","Betty Lou's, Inc.","McMinnville","OR","US","Voluntary: Firm Initiated","Telephone","Nationwide including internet sales","F-2189-2014","Class II","Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The displays are shrink wrapped.","Produced: 6/1/2013 Code Date: BB 1JUN14 Produced: 6/15/2013 Code Date: BB 15JUN14 Produced: 8/13/2013 Code Date: BB 13AUG14 F1 2253 Produced: 10/24/2014 Code Date: BB 24OCT14 F2 2973 Produced: 12/31/2013 Code Date: BB31DEC14 F4 3653 Produced: 2/20/2014 Code Date: BB20FEB15 F2 0514 Best By date/F1 thru F4 represents the machine the product was wrapped on and the last four digits represent the Julian date. The three numbers are the day of the year and the last digit is the last digit of the year. ",".","70,397 - 42g bars (product distributed in 12 ct displays)","Undeclared milk which was a contaminant of the dark chocolate ingredient.",4/1/2014,"04/01/2014",7/23/2014,"07/23/2014"
"Biologics",67866,"Ongoing","One Lambda Inc","Canoga Park","CA","US","Voluntary: Firm Initiated","Letter","US nationwide, Canada, France, Greece, Israel, Italy, Poland, Spain, Brazil, China, Japan, Malaysia, Singapore, and Thailand.","B-0559-14","Class II","Micro SSP'' Allele Specific HLA Class I DNA Typing Tray-C*02, Catalog Identification: SSPR1-C02. BK960062","Catalog Identification: SSPR1-C02. Micro SSP'' Allele Specific HLA Class I DNA Typing Tray C*02 Catalog Identification: SSPR1-C02 Article Number: SSP_DNAT_PI Rev 18 Lot number: 002, batches 001-006 (Batch 002 not distributed).",,"1 Lot","HLA typing assay, associated with false typing assignments, was distributed. ",3/25/2014,"03/25/2014",5/7/2014,"05/07/2014"
"Devices",67867,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.","Z-1462-2014","Class II","The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion. ","Model Numbers - OEC 9900 Elite ",".","453 units","GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward. ",3/31/2014,"03/31/2014",4/23/2014,"04/23/2014"
"Devices",67868,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.","Z-1495-2014","Class II","Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others ","Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1 ",,"373 units","Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations ",4/2/2014,"04/02/2014",4/30/2014,"04/30/2014"
"Drugs",67870,"Ongoing","Pfizer Inc.",,,,"Voluntary: Firm Initiated","Letter","US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc","D-1253-2014","Class II","Tikosyn (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60","H48496, H48497; Exp 05/15",,"23,064 bottles","Presence of Foriegn Tablets/Capsules: A single Tikosyn (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn (dofetilide) 500 mcg (0.5 mg).",4/8/2014,"04/08/2014",4/30/2014,"04/30/2014"
"Devices",67871,"Ongoing","Med-Mizer, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide)","Z-1541-2014","Class II","RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 '' bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.","Model 762: 300000-300191 Model 763: 200000 Model 763A: 400000-40103 ",".","191","All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. ",4/18/2014,"04/18/2014",5/14/2014,"05/14/2014"
"Devices",67871,"Ongoing","Med-Mizer, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide)","Z-1543-2014","Class II","RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 '' bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.","Model 801 : 50000-50018; Model 802n : 600000-600789 Model 803: 500000-500342; 803A 700000-701724 ",".","2980","All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. ",4/18/2014,"04/18/2014",5/14/2014,"05/14/2014"
"Devices",67871,"Ongoing","Med-Mizer, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide)","Z-1542-2014","Class II","RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.","Serial Number 2000",".","1","All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring. ",4/18/2014,"04/18/2014",5/14/2014,"05/14/2014"
"Food",67873,"Ongoing","Schwan's Global Supply Chain, Inc. (This correction has already been made)","Marshall","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Texas, Illinois, New Jersey, Maryland, Virginia. Consignee list to be provided later.","F-1888-2014","Class I","Holiday Foods Gourmet Cold Canapes Assortment, 4800361, UPC 70220748003616, 100 OCS. Keep Frozen, For Institutional Use Only, Defrost in Refrigerator for Approximately 3 hours Before Serving, Consume Immediately. Prepared by Holiday Foods Inc, Hollywood, Florida 33020.","4800361",,"971 cases","Schwans Food Company is recalling Cheddar Cheese Puffs and Gourmet Cold Canapes Assortment manufactured by Holiday Foods, Inc that were prepared with ingredients which are being recalled by Parker Farm Inc. because of the potential of Listeria monocytogenes contamination.",3/25/2014,"03/25/2014",5/7/2014,"05/07/2014"
"Food",67873,"Ongoing","Schwan's Global Supply Chain, Inc. (This correction has already been made)","Marshall","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Texas, Illinois, New Jersey, Maryland, Virginia. Consignee list to be provided later.","F-1887-2014","Class II","Holiday Foods, Cheddar Cheese Puffs, 4800308, UPC 70220748003081, 100 PCS, Not Fully Cooked - Cook Before Eating, Keep Frozen, For Institutional Use Only, Prepared by Holiday Food Inc, Hollywood, Florida 33020.","4800308",,"110 cases","Schwans Food Company is recalling Cheddar Cheese Puffs and Gourmet Cold Canapes Assortment manufactured by Holiday Foods, Inc that were prepared with ingredients which are being recalled by Parker Farm Inc. because of the potential of Listeria monocytogenes contamination.",3/25/2014,"03/25/2014",5/7/2014,"05/07/2014"
"Food",67874,"Completed","Whole Foods Market South Seafood Distribution","Roswell","GA","US","Voluntary: Firm Initiated","Telephone","GA","F-2056-2014","Class II","Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)","PLU: 29216300000, 29641800000 and 29712400000 ",,"314.6 pounds total region","Firm received complaints of illness after consumption of Amberjack fish.",3/15/2014,"03/15/2014",7/9/2014,"07/09/2014"
"Food",67875,"Ongoing","Creative Snacks Co., LLC","Greensboro","NC","US","Voluntary: Firm Initiated","E-Mail","MA and NJ.","F-1878-2014","Class I","Creative Snacks Co. Dried Apricots (10.5 oz Rigid Plastic Cup, and 7 oz Clear Plastic Bag), Distributed by: Creative Snacks, Co., Greensboro, NC 27409","Lot # - 2368112613 / Best Before: 07/24/2014; Lot # - 2406121313 / Best Before: 08/10/2014; Lot # - 2452010814 / Best Before: 09/5/2014; Lot # - 2481012114 / Best Before: 09/18/2014; Lot # - 7245123013 / Best Before: 07/28/2014.",,"276 cs (3312 units) 10.5 oz Dried Apricot (Cups) & 44 cs (264 units) 7 oz Dried Apricot (Bags)","Product contains undeclared allergen, Sulfites",3/26/2014,"03/26/2014",4/30/2014,"04/30/2014"
"Devices",67876,"Ongoing","Central Purchasing LLC DBA Harbor Freight Tools ","Calabasas","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1451-2014","Class II","Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.","SKU/Item Number 66838, Sold June 2009 to March 2014.",".","43,621","Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.",3/27/2014,"03/27/2014",4/16/2014,"04/16/2014"
"Food",67877,"Ongoing","Chiquita Brands International, Inc.","Charlotte","NC","US","Voluntary: Firm Initiated","Press Release","CT, DE, MA, MD, ME, NC, NH, NY, NJ, OH, PA, RI, VA, VT WV and DC.","F-1932-2014","Class I","Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plastic bags, UPC: 71279-21100.","Product Code: H071A11A, Best buy date: 26-Mar",,"60 cases","Product was found to be contaminated with Listeria monocytogenes",3/28/2014,"03/28/2014",5/21/2014,"05/21/2014"
"Food",67878,"Ongoing","Lam Sheng Kee (Usa) Enterprise C","Bayonne","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","State of NY","F-1816-2014","Class II","Diced Dry Bean Curd. Manufactured by: E Won Trading Company, LTD. Distributed by: Win Luck Trading Co. LLC, 100 Pulaski Street, Bayonne, NJ 07002. UPC 4716670715248. 10.58 oz (300g) plastic bag."," UPC 4716670715248",".","20 Cartons (each carton contains 12 bags)","The recall was initiated after it was discovered that the product contains unallowed dye:16255-Ponceau 4r(E124) Acid Red 18 and undeclared FD&C Yellow # 6.",2/28/2014,"02/28/2014",4/16/2014,"04/16/2014"
"Food",67880,"Ongoing","Deb-El Food Products, LLC.","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","Mexico, Canada and Denmark","F-1947-2014","Class I","Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206","2053, 2353, 3173, 3193, 3243, 2343, 3313, 3463, 0863",,"86,550 kg; lot 0863-50 lbs","Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk.",3/27/2014,"03/27/2014",5/21/2014,"05/21/2014"
"Drugs",67881,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1189-2014","Class II","HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01","Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14",".","8,570 blister packs","Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.",1/31/2014,"01/31/2014",4/9/2014,"04/09/2014"
"Drugs",67881,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1188-2014","Class II","HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01","Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14",".","14,665 blister packs","Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.",1/31/2014,"01/31/2014",4/9/2014,"04/09/2014"
"Drugs",67882,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1499-2014","Class II","triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78 "," 35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15. ",,"89,215 blister pack","Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. ",4/2/2014,"04/02/2014",8/6/2014,"08/06/2014"
"Devices",67883,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-1520-2014","Class II","VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626","Lot 01-3266 (exp. 23-SEPTEMBER-2014)",,"1042 distributed (220 went to warehouse in France)","Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Devices",67883,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-1519-2014","Class II","VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY","Lot F3168 (exp. 30 Sep 2014)",,"1656 distributed (1200 went to warehouse in France)","Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Devices",67884,"Ongoing","Baxter Corporation Englewood","Englewood","CO","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan.","Z-1566-2014","Class I","ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.","Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169",,"2034","1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software versions of ABACUS may display an inaccurate estimation for calcium/phosphate precipitation in certain circumstances where multiple ingredients provide calcium.",4/2/2014,"04/02/2014",5/21/2014,"05/21/2014"
"Devices",67885,"Ongoing","Acumed LLC","Hillsboro","OR","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.","Z-1515-2014","Class II","The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures.","2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281. 2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261. 8, 7 hole SS compression plate: Lot # 300381. 10, 9 hole SS compression plate: Lot # 299641. ",,"141 units in the US; 294 units outside the US.","Acumed is voluntarily recalling specific lot numbers of Osteo-Clage Stainless Steel Bone Plates and Tension Band Pins due to the manufacturing of these devices with a grade of stainless steel that is not within specifications.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Devices",67885,"Ongoing","Acumed LLC","Hillsboro","OR","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.","Z-1516-2014","Class II","The Acumed Tension Band Pin is a fixation pin which is .0625'' in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. ","50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949. 50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056. 70.0 mm Tension Band Kit: Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493. 90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.",,"2544 unit in the US and 3584 units outside the US","Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Biologics",67886,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0600-14","Class II","Plasma Cryoprecipitated Reduced","W036808152202 ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/26/2014,"03/26/2014",5/14/2014,"05/14/2014"
"Biologics",67886,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0598-14","Class II","Red Blood Cells","W0368098152202 ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/26/2014,"03/26/2014",5/14/2014,"05/14/2014"
"Biologics",67886,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0599-14","Class II","Platelets Pooled Leukocytes Reduced","W036808193925 ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",3/26/2014,"03/26/2014",5/14/2014,"05/14/2014"
"Biologics",67887,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","Arkansas","B-0626-14","Class II","Red Blood Cells Leukocytes Reduced","W036513123097 ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. ",3/28/2014,"03/28/2014",6/11/2014,"06/11/2014"
"Biologics",67888,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-0627-14","Class II","Red Blood Cells Leukocytes Reduced","W037914120526 ",,"1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",3/3/2014,"03/03/2014",6/11/2014,"06/11/2014"
"Biologics",67889,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0628-14","Class III","Red Blood Cells Leukocytes Reduced","W038113344953, W038113272643",".","2 units","Blood products, collected from a donor with Erythrocytosis, were distributed.",2/21/2014,"02/21/2014",5/28/2014,"05/28/2014"
"Biologics",67890,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0633-14","Class II","Red Blood Cells Leukocytes Reduced","W201214038268",".","1 unit","Blood product, collected from a donor with an incomplete donor suitability determination, was distributed.",2/18/2014,"02/18/2014",5/28/2014,"05/28/2014"
"Food",67891,"Ongoing","John B. Sanfilippo & Son Inc.","Elgin","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: IA, IL, WI","F-1828-2014","Class II","''Honey Roasted Peanuts Golden Roast'' sold under the Fisher brand and packaged in 14 oz. plastic jars.","Best By Date: 5/20/15 N; UPC: 70690 23990; Case Item Code: P27750",".","945 Cases (11,340 Jars)","Cases containing 12 x 14 oz. plastic jars of Fisher ''Honey Roasted Peanuts Dry Roasted'' with a ''Best By'' date of ''5/20/15 N'' may contain plastic jars that are mislabeled as Fisher ''Peanuts Dry Roasted Golden Roast''. Dry roasted honey roasted peanuts contain wheat, which is an allergen, and this allergen is not declared on the dry roasted peanut label.",3/20/2014,"03/20/2014",4/23/2014,"04/23/2014"
"Drugs",67892,"Ongoing","United Therapeutics Corp.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Fl, TX.","D-1423-2014","Class II","Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709 ","Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887 TD-100 S/N's 23103982 23103985 23103988 23103990 23103992 23103984 23103986 23103989 23103991 23103993 23103959 23103961 23103963 23103994 23103958 23103960 23103962 23103972 Kit S/N 1888 1889 1890 1891 1892 1893 1899 1900 1901 TD-100 S/N's 23103970 23103997 23103996 23104022 23104019 23103975 23103998 23103999 23104024 23104020 23104014 23103981 23103980 23103974 23104013 23103978 23103973 23103964 Kit S/N 1902 1903 1904 1905 1906 1907 1908 1909 1910 TD-100 S/N's 23103966 23103968 23103956 23103952 23103950 23103967 23103977 23103957 23103955 23103951 23103948 23103945 23103941 23103943 23103942 23103940 23103944 Kit S/N 1911 1912 1913 1914 1916 1917 1918 1919 1921 TD-100 S/N's 23103947 23103949 23103939 23103946 23104001 23103965 23103969 23104002 23104005 23104003 23104011 23104007 23104008 TD-100 devices shipped to Accredo (continued): Kit S/N 1922 1923 1933 1934",,"188 Units","Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.",3/28/2014,"03/28/2014",7/16/2014,"07/16/2014"
"Devices",67893,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.","Z-1454-2014","Class I","Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.","ARD Model/ Lot FA8881040 / 9769118 FA8881030 / 9816048 FA8881040 / 9754682 FA8881050 / 9772283 FA8881040 / 9752800 FA8881030 / 9751662 FA8881030 / 9773525 FA8881020 / 9832735 FA8881040 / 9757667 FA8881020 / 9774620 FA8881030 / 9834039 FA8881040 / 9758530 FA8881020 / 9774620 FA8881030 / 9834039 FA8881030 / 9758532 FA8881030 / 9783730 FA8881020 / 9836553 FA8881050 / 9760946 FA8881040 / 9786013 FA8881030 / 9834039 FA8881030 / 9761690 FA8881040 / 9787928 FA8881050 / 9848544 FA8881020 / 9761692 FA8881030 / 9791385 FA8881030 / 9848543 FA8881030 / 9758532 FA8881040 / 9793305 FA8881030 / 9853152 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9854769 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9858153 FA8881040 / 9764212 FA8881050 / 9801041 FA8881030 / 9865759 FA8881030 / 9766949 FA8881020 / 9811215 FA8881050 / 9868025 FA8881030 / 9769117 FA8881030 / 9813908",".","567 units total (323 units in US)","Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.",4/1/2014,"04/01/2014",4/23/2014,"04/23/2014"
"Devices",67893,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.","Z-1453-2014","Class I","Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.","PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888",".","32 units total (23 units in US)","Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.",4/1/2014,"04/01/2014",4/23/2014,"04/23/2014"
"Drugs",67894,"Ongoing","Hi-Tech Pharmacal Co., Inc.","Amityville","NY","US","Voluntary: Firm Initiated","Letter","nationwide","D-0048-2015","Class II","HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. ","Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966 (exp. 5/2014), Batch 610204 (exp. 5/2014), Batch 610406 (exp. 5/2014), Batch 610572 (exp. 6/2014), Batch 610575 (exp. 6/2014), Batch 610677 (exp. 6/2014), Batch 610808 (exp. 6/2014), Batch 611110 (exp. 7/2014), Batch 611201 (exp. 8/2014), Batch 611530 (exp. 8/2014), Batch 611645 (exp.9/2014), Batch 611891 (exp. 9/2014), Batch 611993 (exp. 10/2014), Batch 612328 (exp. 11/2014), Batch 612331 (exp. 11/2014), Batch No. 613050 (exp. 12/2014), Batch 613053 (exp. 12/2014), Batch 613172 (exp. 12/2014), Batch 613175 (exp. 12/2014), Batch 613738 (exp. 1/2015), Batch 613741 (exp. 1/2015), Batch 613744 (exp. 1/2015). Batch 613747 (exp. 1/2015), Batch 613852 (exp. 1/2015), Batch 613855 (exp. 2/2015), Batch 614448 (exp. 2/2015), Batch 614451 (exp. 3/2015), Batch 614914 (exp. 3/2015, Batch 614917 (exp. 3/2015), Batch 615331 (exp. 4/2015), Batch 615334 (exp. 4/2015), Batch 615797 (exp. 5/2015), Batch 615800 (exp. 5/2015), Batch 615947 (exp. 6/2015), Batch 615950 (exp. 6/2015), Batch 616356 (exp. 7/2015), Batch 616359 (exp. 7/2015), Batch 616362 (exp. 7/2015), Batch 616365 (exp. 7/2015), Batch 617066 (exp. 8/2015), Batch 617069 (exp. 8/2015), Batch 617432 (exp. 9/2015), Batch 617435 (exp. 9/2015), Batch 617951 (exp. 10/2015), Batch 617954 (exp. 11/2015), Batch 617957 (exp. 12/2015), Batch 617960 (exp. 12/2015), Batch 618918 (exp. 12/2015), Batch 618920 (exp. 12/2015), Batch 619173 (exp. 1/2016), Batch 619176 (exp. 1/2016), Batch 619543 (exp. 2/2016), Batch 619546 (exp. 2/2016), Batch 620099 (exp. 2/2016), Batch 620102 (exp. 2/2016), Batch 620338 (exp. 2/2016), and Batch 620341 (exp. 2/2016). ",".","451,916 bottles","Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.",4/1/2014,"04/01/2014",11/5/2014,"11/05/2014"
"Devices",67895,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.","Z-1497-2014","Class II","Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.","Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492.",,"3,816 ea","The products are being recalled because they did not meet minimum diameter requirements.",3/11/2014,"03/11/2014",4/30/2014,"04/30/2014"
"Devices",67896,"Ongoing","Varian Medical Systems, Inc.","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1502-2014","Class II","On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01'' elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. ","Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080749 H080944 H080003 H080066 H080127 H080188 H080252 H080315 H080379 H080442 H080504 H080608 H080673 H080753 H080947 H080004 H080068 H080128 H080189 H080254 H080316 H080380 H080443 H080506 H080609 H080674 H080754 H080948 HOSOOOS H080069 H080129 H080190 H0802SS H080317 H080381 H080444 H080507 H080610 H080675 H0807SS H080950 H080006 H080071 H080130 H080191 H080256 H080318 H080382 H080445 H080508 H080611 H080676 H080756 H080960 H080008 H080072 H080131 H080192 H080257 H080319 H080383 H080446 H080509 H080612 H080677 H080759 H080961 H080009 H080073 H080132 H080193 H080258 H080320 H080384 H080447 HOSOSlO H080613 H080678 H080760 H080962 H080010 H080074 H080133 H080194 H080259 H080321 H08038S H080448 H080511 H080614 H080679 H080761 H080969 H080011 H080075 H080134 H080195 H080260 H080322 H080386 H080449 HOSOS12 H080615 H080680 H080762 H080970 H080012 H080076 H080136 H080196 H080261 H080324 H080387 H080450 H080513 H080616 H080683 H080763 H080971 H080013 H080077 H080137 H080197 H080262 H080325 H080389 H080451 H080514 H080617 H080684 H080764 H080989 H080014 H080078 H080138 H080198 H080263 H080326 H080391 H080452 H08051S H080618 H080685 H080766 H080991 H080016 H080079 H080139 H080199 H080264 H080327 H080392 H080453 H080516 H080619 H080686 H080768 H080997 H080017 HOSOOSO H080141 H080200 H080266 H080328 H080393 H080454 H080517 H080620 H080687 H080772 H081001 H080018 HOSOOSl H080142 H080202 H080267 H080329 H080394 H080455 H080518 H080621 H080688 H080773 H081004 H080019 H080082 H080143 H080203 H080268 H080330 H080395 H080456 H080519 H080622 H080689 H080774 H081005 H080020 H080083 H080144 H080204 H080269 H080331 H080396 H080457 H080520 H080623 H080690 H080775 H081006 H080021 H080084 H080145 H080205 H080270 H080332 H080397 H080458 H080521 H080624 H080691 H080778 H081007 H080022 H080085 H080147 H080206 H080271 H080333 H080398 H080459 H080522 H080625 H080692 H080783 H081009 H080024 H080086 H080148 H080207 H080272 H080",,"2622","Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.",3/20/2014,"03/20/2014",4/30/2014,"04/30/2014"
"Devices",67897,"Ongoing","Alfa Wassermann, Inc.","West Caldwell","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1530-2014","Class II","Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.","ACE AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)",,"SA1047 lot F3609: 146; RX1047 lot F3610: 53","Extremely low absorbance readings. ",3/5/2014,"03/05/2014",5/7/2014,"05/07/2014"
"Devices",67897,"Ongoing","Alfa Wassermann, Inc.","West Caldwell","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1529-2014","Class II","Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.","ACE ALT Reagent (Product reorder number SA1046 Lot F3604)",,"731 Kits","Extremely low absorbance readings. ",3/5/2014,"03/05/2014",5/7/2014,"05/07/2014"
"Veterinary",67898,"Ongoing","SOUTHERN SEED & FEED","Macon","MS","US","Voluntary: Firm Initiated","Telephone","AL","V-061-2014","Class II","Triple Cleaned Corn, 50 LBS NET, Packaged by: Southern Seed and Feed, Macon, MS","None. Recall includes two shipments delivered 03/04/2014 and 03/07/2014",,"1250 units","Sample of product found Fumonisin above the recommended limit of 5 PPM.",4/2/2014,"04/02/2014",5/7/2014,"05/07/2014"
"Cosmetics",67899,"Ongoing","Natural Organics","Melville","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nation wide to retail stores and to the United Kingdom","F-0091-2015","Class II","Thursday Plantation Australia's Original TEA TREE MOUTHWASH, Net Wt. 8.45 fl oz/ 250 mL, UPC Code 7-17554-08057-9. Product packed in clear plastic bottles, 3 bottles per pack. Made in Australia, Distributed by Integria Healthcare (Australia) Pty Ltd., PO BOX 4854, Eight Mile Plains QLD 4113 Australia 1-866-273-0377.","1) Product No. 6710, Lot number 9810 and 2) Product No. 6710, Lot number 10952",".","2,984 bottles (994 pks)","Natural Organics Inc. has recalled Thursday Plantation TEA TREE MOUTHWASH due to potential Pseudomonas aeruginosa contamination.",4/3/2014,"04/03/2014",11/5/2014,"11/05/2014"
"Devices",67900,"Ongoing","Genesys Orthopedics Systems, LLC","Austin","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.","Z-2677-2014","Class II","Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).","The devices being recalled have a catalog number of G826 and a lot number of 11406.",,"642","The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.",4/2/2014,"04/02/2014",10/1/2014,"10/01/2014"
"Devices",67901,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.","Z-1510-2014","Class II","Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.","ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 6052, 6261, 8002, 10252, 10630, 11090, 85247, 513519, 513520, 940384, 9205345, 9408136, 9503084, 9506016, 9511123, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602254, 9603336, 9604016, 9604021, 9605024, 9605026, 9605037, 9606211, 9607015, 9607024, 9608031, 9608046, 9608049, 9608052, 9609063, 9609081, 9610058, 9611035, 9611077, 9611082, 9612072, 9702095, 9702150, 9703154, 9703165, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708076, 9708078, 9708084, 9708088, 9708227, 9709022, 9709061, 9710121, 9710127, 9710244, 9711025, 9711034, 9711036, 9711074, 9711271, 9711291, 9801047, 9801227, 9801232, 9801297, 9802050, 9802255, 9802260, 9802300, 9802306, 9802397, 9803003, 9803014, 9803067, 9803083, 9803269, 9803272, 9803288, 9803290, 9803293, 9803295, 9803303, 9803312, 9803316, 9804069, 9804330, 9804333, 9804342, 9805344, 9805350, 9805376, 9806014, 9806363, 9806377, 9806388, 9807391, 9807421, 9808036, 9808090, 9808108, 9808451, 9808452, 9808457, 9808480, 9808829, 9809067, 9809113, 9809122, 9809125, 9809498, 9809687, 9810075, 9810136, 9810551, 9810557, 9811020, 9811093, 9811569, 9811737, 9812582, 9901162, 9901597, 9901605, 9902150, 9902622, 9902630, 9903632, 9903637, 9903641, 9904089, 9905003, 9905012, 9905659, 9905667, 9906670, 9907016, 9907019, 9909011, 9909161, 9910015, 9910017, 9910031, 9911458, 9911698, 9911702, 9911711, 9912181, 9912463, 98066002, 802080322, 0002032, 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0939VM, 100098-01N, 130234-01NVERTEX, 5934V, 6090VM, 7373VM, 7376VM, 7386VM, 7560VM, 7561VM, 9054VM/V, 9056VM/V, 9130VM, 9806373A, 9810428ADAC#7973VM, 9894K, AD1261, AMT00848VM, B0006129, B0007273, B0008001, B0008003, B0008012, B0008021, B0008030, B001200212, B0102114, B0104125, B01",,"1,043 cameras","Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Devices",67902,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.","Z-1522-2014","Class II","Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.","Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014",,"3,984 devices packaged as 6 devices / box (664 boxes)","Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.",3/10/2014,"03/10/2014",5/7/2014,"05/07/2014"
"Drugs",67903,"Ongoing","Pharmakon Pharmaceuticals","Noblesville","IN","US",,"Telephone","IN","D-1362-2014","Class I","Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.","Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014 ",".","80 syringes","Superpotent Drug: Product contains twice the stated amount of midazolam.",3/26/2014,"03/26/2014",6/18/2014,"06/18/2014"
"Drugs",67904,"Completed","Unique Pharmaceutical, Ltd","Temple","TX","US","Voluntary: Firm Initiated","Letter","TN, PA, and TX","D-1587-2014","Class II","NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502","Lot # 00083844 Exp. 07/13",,"430 Bags","Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.",4/17/2013,"04/17/2013",9/24/2014,"09/24/2014"
"Devices",67905,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.","Z-1488-2014","Class II","GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.","Mfg Lot or Serial # System ID 0000000VE90667 VE9000667 0000000VE90680 VE9000680 0000000VE90878 VE9000878 0000000VE91045 VE9001045 0000000VE91821 VE9001821 0000000VE91826 VE9R001826 0000000VE92470 VE9R002470 0000000VE93780 VE9R003780 0000000VE94119 VE9R004119 0000000VE94120 VE9R004120 0000000VE94291 VE9R004291 0000000VE94521 VE9004521 0000000VE94736 VE9R004736 0000000VE94790 VE9R004790 0000000VE94876 VE9R004876 0000000VE95024 VE9R005024 0000000VE95025 VE9R005025 0000000VE95027 VE9R005027 0000000VE95028 VE9R005028 0000000VE95222 VE9R005222 0000000VE95226 VE9R005226 0000000VE95271 VE9R005271 0000000VE95302 VE9R005302 0000000VE95319 VE9R005319 0000000VE95558 VE9R005558 0000000VE95597 VE9R005597 0000000VE95599 VE9R005599 0000000VE95604 VE9R005604X 0000000VE95654 VE9005654 0000000VE95908 VE9005908 0000000VE95949 VE9005949 0000000VE95960 VE9005960 0000000VE95969 VE9005969 0000000VE96001 VE9006001 0000000VE96004 VE9006004 0000000VE96005 VE9006005 0000000VE96008 VE9006008 0000000VE96009 VE9006009 0000000VE96010 VE9006010 0000000VE96020 VE9006020 0000000VE96022 VE9006022 0000000VE96138 0000000VE96185 VE9006185 0000000VE96186 VE9006186 0000000VE96187 VE9006187 0000000VE96188 VE9006188 0000000VE96189 VE9006189 0000000VE96190 VE9006190 0000000VE96191 VE9006191 0000000VE96193 VE9006193 0000000VE96194 VE9006194 0000000VE96210 VE9006210 0000000VE96211 VE9006211 0000000VE96212 VE9006212 0000000VE96232 VE9006232 0000000VE96233 VE9006233 0000000VE96234 VE9006234 0000000VE96235 VE9006235 0000000VE96281 VE9006281 0000000VE96282 VE9006282 0000000VE96310 VE9006310 0000000VE96312 VE9006312 0000000VE96357 VE9006357 0000000VE96359 VE9006359 0000000VE96360 VE9006360 0000000VE96361 VE9006361 0000000VE96474 VE9006474 0000000VE96475 VE9006475 0000000VE96477 VE9006477 0000000VE96566 VE9006566 0000000VE96567 VE9006567 0000000VE96568 VE9006568 0000000VE96569 VE9006569 0000000VE96570 VE9006570 0000000VE96571 VE9006571 0000000VE96657 VE9006657 0000000VE96678 VE9006678 0000000VE96685 VE9006685 0000000VE96786 VE9006786 0000000VE96790 VE9006790 00",,"447 (81US, 366 OUS)","GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.",3/27/2014,"03/27/2014",4/30/2014,"04/30/2014"
"Biologics",67906,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Nebraska","B-0549-14","Class III","Red Blood Cells Leukocytes Reduced","W037914115459; ",".","1","Blood product, collected from a donor whose arm inspection was not documented, was distributed.",3/6/2014,"03/06/2014",5/14/2014,"05/14/2014"
"Biologics",67907,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","Connecticut; Pennsylvania; New York; Massachusetts; New Jersey","B-0632-14","Class III","Cryoprecipitated AHF, Pooled","W20041390225800; W20041390224800; W20041390215400; W20041390212900; W20041390223700; W20041390215200; W20041390223800; W20041390225300; W20041390216000; W20041390224400; W20041390225000; W20041390224500; W20041390215500; W20041390224200; W20041390221400; W20041390215700; W20041390213600; W20041390214600; W20041390224000; ",".","19 units","Pool Cryoprecipitated AHF, not meeting quality control specifications, were distributed. ",12/11/2013,"12/11/2013",5/28/2014,"05/28/2014"
"Biologics",67908,"Terminated","American National Red Cross ARC Blood Services N.E. Region","Burlington","VT","US","Voluntary: Firm Initiated","Telephone","Maine","B-0567-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W203414023027; W203414023027; ",".","2","Blood products, collected in a manner that compromised the sterility of the units, were distributed. ",2/21/2014,"02/21/2014",5/14/2014,"05/14/2014"
"Devices",67910,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.","Z-1540-2014","Class II","Alere Triage BNP Test For the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is a two-site immunoenzymatic (sandwich) assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate, Lumi- Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BNP in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. The Alere TriageR BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) as an aid in the assessment of severity of congestive heart failure for the risk stratification of patients with acute coronary syndromes for the risk stratification of patients with heart failure","Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14",".","12,592 kits","Alere San Diego, Inc. initiated recall of Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Lots 329599 and 331265, because these lots may not recover within range when tested using certain commercially available controls.",3/20/2014,"03/20/2014",5/14/2014,"05/14/2014"
"Food",67911,"Ongoing","Koru Pacific Packaging, Inc.","Tracy","CA","US","Voluntary: Firm Initiated","Combination ","Nationwide distribution","F-2086-2014","Class II","Ah! Laska Organic Cocoa Non Dairy Chocolate Mix; Low Fat, Vegan, USDA Organic; Net Wt. 12 oz. (340 g); UPC 7-60519-10028-7; Ingredient: Organic cane sugar, organic cocoa powder (non-alkaline) organic, rice syrup solids, xanthan gum (a natural thickener) carrageenan (a natural seaweed extract emulsifier), maltodextrin, organic vanilla powder. Made in a facility that processes peanuts, sesame, dairy, eggs, fish, and soy. This product is wheat free and gluten free. Distributed by Ah!Laska 313 Iron Horse Way Providence RI Product of USA Visit us at www.ahlaska.com","Lot 3280, Best by April 2015",,"2708 cases","Internal testing confirmed the presence of milk allergen in finished product that is labeled ''Non-Dairy''.",4/2/2014,"04/02/2014",7/16/2014,"07/16/2014"
"Devices",67912,"Ongoing","Vidacare Corporation","San Antonio","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada","Z-2672-2014","Class II","EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455","Part number 9079-VC-005; lot code 3606455",,"172 ","The voluntary recall is due to the needle set not meeting its specifications.",3/31/2014,"03/31/2014",10/1/2014,"10/01/2014"
"Devices",67913,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA,INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA.","Z-1480-2014","Class II","GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.","FMI 60865 (DV Family Gradient Connections) Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 301295MR4 00001106XF5046 301295MR5 00000301518MR7 301295MR"," LB1250MR01 00000299521MR5 MQ1000MR01 00000294156MR5 2806034DVR750 00000302922MR0 MR302922MR0 00000303872MR6 MR303872MR6 00000000HM0678 MR307145MR3 00000305378MR2 MRHM0503 00000301495MR8 MRHM0562 00000308183MR3 MR308183MR3 00001026XF5174 MRWB0632 00001234FMM0HT MRHM0828 00000307505MR8 00001308FMM062 00000000HM0397 MA1135MR02 00000304910MR3 AMS0424 00000292216MR9 RTD0125 00000293603MR7 RTD0127 00000303279MR4 RTD0156 00000000UA0080 RTD0191 00000301256MR4 RTD0422 00000304018MR5 TLB0229 00000304579MR6 UDN0120 00000000UA0095 UDN0121 00001106XF50E1 00001220FMM01F NC1028MR01 00000288409MR6 920279028 00001140FMM0G4 920279031 00000000HM0498 920279032 00001308FMM052 85092252519 00000297987MR0 NO1009MR02 00000295830MR4 NO1017MR03 00000304318MR9 NO1146MR02 00001106XF5121 OM1010MR01 00000296493MR0 PL1539MR01 00001106XF5132 PL1735MR02 00000306315MR3 PL1735MR03 00000296622MR4 PL1803MR01 00000303814MR8 PL2762MR01 00001105XF5047 PL2853MR01 00000305424MR4 PL2902MR01 00000000HM0613 PL1196MR01 00000000UA0190 600042MR02 00000000HM0809 PL1501MR03 00001308FMM05X PL3105MR01 00000307613MR0 PL3116MR01 00000305814MR6 00000305118MR2 MR16061YR4 00000298309MR6 QA1044MR01 00000000UA0221 QA1042MR01 00000000UA0079 RO1098MR02 00000300865MR3 600098MR01 00000304404MR7 RU1089MR05 00001233FMM06U RU1092MR02 00000301026MR1 RU1716MR01 00000301051MR9 RU1857MR03 00000305404MR6 RU2527MR01 00001101XF5070 RU2580MR02 00001251FMM032 RU3431MR01 00000296594MR5 RU3508MR01 00000300705MR1 RU3894MR01 00000301914MR8 RU3932MR01 00000303355MR2 RU6340MR01 00001105XF504C RU7762MR01 0000000UA0024A RU5599MR01 00000000HM0668 RU2526MR02 00000000HM0677 RU8282MR01 00000000HM0820 RU3637MR01 00000000HM0475 RU7620MR01 00000000UA0227 RU8438MR01 00000308901MR8 RU8541MR01 00001102XF500D 00000296613MR3 SA1011MR03 00000000HM0263 SA1011MR04 00000299965MR4 SA1012MR02 00000303776MR9 SA1031MR02 00000000UA0022 SA1033MR01 00000298266MR8 SA1052MR03 00000300882MR8 SA1058MR02 00000299951MR4 SA1114MR01 00000303644MR9 SA1175MR01 00000000HM0597 SA1255MR02 00000293984MR1 SA2180MR02 00000303666M","1,546 (704 US, 842 OUS).","GE Healthcare has recently become aware of a potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the Endbell. This overheating has occurred only while units were being serviced by GE service engineers during repeated evaluation scanning. However, the issue could also occur in Clinical mode.",4/2/2014,"04/02/2014",4/30/2014,"04/30/2014"
"Food",67914,"Ongoing","Sprout's Farmers Market","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","US only. Spourts Farmers Market stores in Arizona, California, Colorado, Kansas, New Mexico, Nevada, Oklahoma, Texas, and Utah.","F-1879-2014","Class I","Sprouts Farmers Market Organic Whole Black Peppercorns, 2.12oz., UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Packaged in glass jars with plastic lid. Product labeling reads in part:''SPROUTS FARMERS MARKET organic Black Peppercorns ***NET WT 2.12 OZ (60g)***Manufactured Exclusively For Sprouts Farmers Market Phoenix, Arizona 85028***www.sprouts.com***SP00056***8 74875 00425 4***''.","UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Expiration 10/2016 (Lot 3287) and 09/2016 (Lot 3246).",,"4,127 units","Sprouts Farmers Market, Inc. is recalling Organic Whole Black Peppercorns, Lot 3287 after FDA test results revealed the presence of Salmonella and Lot 3246 as precaution because it has the potential to be contaminated with Salmonella.",4/4/2014,"04/04/2014",4/30/2014,"04/30/2014"
"Food",67915,"Ongoing","Magno Humphries Laboratories, Inc","Tigard","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One consignee - Medline Industries, Inc. HQ located in IL One Medline Place, Mundelein, Illinois 60060 1-800-MEDLINE. Products distributed Nationwide (AL, CA, CO,FL, GA, IL, MA, MO, NC, NY, OH, TX, and WA) to Medline Industries distribution centers.","F-1821-2014","Class II","OPTIMUM E-1000 IU Gluten Free Dietary Supplement 100 SOFTGELS Product is packaged in a white HDPE bottle with foil cap under the white plastic cap. Bottle contains 100 softgel caps. UPC 0 43292 56291 7.","343230, 343695, 343788, 344603, and 344936.",".","2376 bottles","Magno Humphries Laboratories is recalling Vitamin E softgels because the principle display panel states the product contains 1000 IU of Vitamin E however the Supplement Facts label indicated 200 IU of Vitamin E. The supplement actually contains 1000 IU of Vitamin E.",3/25/2014,"03/25/2014",4/23/2014,"04/23/2014"
"Food",67917,"Ongoing","Frontier Natural Products Co-op","Norway","IA","US","Voluntary: Firm Initiated","Press Release","Recalled product was shipped nationwide and to Canada and Indonesia. The firm has no government or military consignees.","F-1880-2014","Class I","1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated cardboard boxes. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-82603-9.; 2) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 453 g 16 OZ. Packaged in foil pouches. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-02603-3; 3) Frontier Natural Products Co-op, Black Peppercorns Whole. Net WT. 2.12 OZ (60 g). Packaged in glass jars. Distributed by Frontier Natural Products Co-op, Norway, IA. UPC 0-89836-18435-1; 4) Simply Organic, black peppercorns. NET WT. 2.65 OZ. (75g). Packaged in glass jars. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-18524-2.; 5) Simply Organic, Adjustable Grinder Cap, daily grind. NET WT. 2.65 OZ. (75g). Packaged in glass jars with a grinder cap. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 6) Simply Organic, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19210-3.; 7) Simply Organic, Adjustable Grinder, Broyeur Rglable, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.; 8) 365, Black Peppercorns, NET WT 1.87 OZ (53g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44497-6; 9) 365, Black Peppercorns, NET WT 2.12 OZ (60g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44563-8.; 10) 365, Black Peppercorns, NET WT 8.08 OZ (229g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44511-9.; 11) 365, Organic Black Peppercorns Grains de Poivre noir biologique, 60g (2.12 OZ). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-73914-0; 12) Nature's Pla","Lot numbers: 3246, 3226, 3256, 3288, 3232, 3233, 3280, 3246, 3287, 3260, 3267, 3247, 3221, 3262, 3294, and 3261;",,"91357 units","Testing of organic whole black peppercorns revealed the presence of Salmonella",4/4/2014,"04/04/2014",4/30/2014,"04/30/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1922-2014","Class III","the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","80 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1919-2014","Class III","the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","500 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1920-2014","Class III","the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","200 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1918-2014","Class III","the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","150 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1916-2014","Class III","the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","150 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1923-2014","Class III","the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","50 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1921-2014","Class III","the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","200 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67918,"Terminated","Bread Stop Bakery, LLC","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Western Oregon and 1 consignee in Washington","F-1917-2014","Class III","the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.","This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.",".","100 loaves","An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Food",67919,"Terminated","Whole Foods Market","Emeryville","CA","US","Voluntary: Firm Initiated","Press Release","California Bay area only to 38 retail location.","F-1829-2014","Class II","The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distributed by Green Shoots Distribution' So. San Francisco, 94083","Lot code 401090104 with best by date of April 6; UPC: 046319-97076.",".","229 units","One production date of Chicken Chipotle Chicken wraps are actually filled with Chicken Caesar mix which contains a fish allergen (anchovies) that are not declared on the label.",4/4/2014,"04/04/2014",4/23/2014,"04/23/2014"
"Devices",67921,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.","Z-1571-2014","Class II","MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.","Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH, NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75, NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5, NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N, NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT, NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G ",,"90","A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. ",4/18/2014,"04/18/2014",5/21/2014,"05/21/2014"
"Devices",67921,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.","Z-1572-2014","Class II","MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. ","Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z ",,"34","A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. ",4/18/2014,"04/18/2014",5/21/2014,"05/21/2014"
"Devices",67922,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-1639-2014","Class I","Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates"," Lot Numbers (49 lots) recalled on 4/10/14: 13KMLB001 13LMLB001 14AMLB002 13KMLB002 13LMLB002 14AMLB003 13KMLB003 13LMLB003 14AMLB004 13KMLB004 13LMLB004 14AMLB005 13KMLB005 13LMLB005 14AMLB006 13KMLB006 13LMLB006 14AMLB007 13KMLB007 13LMLB007 14AMLB008 13KMLB008 13LMLB008 14AMLB009 13KMLB009 13LMLB009 14AMLB010 13KMLB010 13LMLB010 14AMLB012 13KMLB011 13LMLB011 13JMLB005 13KMLB012 13LMLB012 13JMLB008 13KMLB013 13LMLB013 13JMLB006 13KMLB014 13LMLB014 13JMLB007 13KMLB015 13LMLB015 13JMLB004 13KMLB016 13LMLB016 13KMLB017 14AMLB001 Expanded Recall (9 lots): 13LMLB005 13LMLB006 14AMLB011 14AMLB013 14AMLB014 14AMLB015 14AMLB016 14AMLB017 14BLMB001",".","672,784 units","Naturalyte Liquid Bicarbonate maybe contaminated",4/10/2014,"04/10/2014",5/28/2014,"05/28/2014"
"Devices",67923,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey.","Z-1628-2014","Class II","Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.","Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0.",".","188,520 devices","The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.",4/4/2014,"04/04/2014",5/28/2014,"05/28/2014"
"Devices",67924,"Ongoing","SCM True Air Technologies LLC","Louisville","KY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA, KY, and MI.","Z-1632-2014","Class II","MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.","Serial #'s 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2100, 2101, 2102, 2103, 2106, 2107, 2108, 2109, 2110, 2111, 2112, 2113, 2114, 2115, 2116, 2126, 2127, 2128, 2129, 2135, 2136, 2137, 2138, 2139, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2141, 2142, 2143, 2144, 2145, 2146, 2147, 2148, 2149 & 2150.",".","83 units","The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.",3/18/2014,"03/18/2014",5/28/2014,"05/28/2014"
"Devices",67924,"Ongoing","SCM True Air Technologies LLC","Louisville","KY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA, KY, and MI.","Z-1630-2014","Class II","JK Bariatric Beds, True Air Technologies, Inc.","Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735",".","24 beds","The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.",3/18/2014,"03/18/2014",5/28/2014,"05/28/2014"
"Devices",67924,"Ongoing","SCM True Air Technologies LLC","Louisville","KY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA, KY, and MI.","Z-1631-2014","Class II","ECATS E 850 Bariatric Bed, True Air Technologies, Inc. ","Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 & E9146.",".","48 beds","The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.",3/18/2014,"03/18/2014",5/28/2014,"05/28/2014"
"Devices",67925,"Completed","Terumo Cardiovascular Systems Corp","Ashland","MA","US","Voluntary: Firm Initiated","Letter","CA","Z-1465-2014","Class II","Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 ","Lot Number: RA-27",".","37 units","Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo Cardiovascular Procedure Kits",3/28/2014,"03/28/2014",4/23/2014,"04/23/2014"
"Devices",67926,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan","Z-1707-2014","Class II","ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.","ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5; 2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5; 3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5; 4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5; 5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5; 6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5; 7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5; 8) 49660A ET INFRARED SOFTWARE 5.5.5; 9) 49961 ET DATA PREP/REVIEW SYSTEM; 10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT; 11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT; 12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT; 13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT; 14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT; 15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT ",,"40 systems (worldwide)","When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.",4/15/2014,"04/15/2014",6/11/2014,"06/11/2014"
"Devices",67927,"Ongoing","Shimadzu Medical Systems","Torrance","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.","Z-1569-2014","Class II","Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.","Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001",".","685 units total (14 units in US)","Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.",4/3/2014,"04/03/2014",5/14/2014,"05/14/2014"
"Drugs",67928,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1314-2014","Class III","Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11","Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16",".","98,560 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.",4/4/2014,"04/04/2014",5/14/2014,"05/14/2014"
"Drugs",67928,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1313-2014","Class III","Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25","Lot 261983A Exp.11/15",".","8,304 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.",4/4/2014,"04/04/2014",5/14/2014,"05/14/2014"
"Food",67929,"Ongoing","Carmel Food Group, Inc.","Hayward","CA","US","Voluntary: Firm Initiated","Phone","Distributors in GA, PA, MD, IL, CA, IA, CT, TX,","F-1914-2014","Class III","RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908","LOT # 011615 UPC # 7 85030 55555 2",,"900 CASES, 6 UNITS PER CASEor 5400 TOTAL UNITS) ","Basil, Asiago & Pine Nut Pesto Ravioli is labeled with the ingredient statement for Itsy Bitsy ravioli and therefore does not include Pine Nuts in the ingredient or allergen statement.",4/4/2014,"04/04/2014",5/7/2014,"05/07/2014"
"Devices",67930,"Terminated","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Visit","US Distribution in the state of: CA.","Z-1545-2014","Class III","CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.","Serial Number: 212809",".","1 unit","Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.",2/26/2013,"02/26/2013",5/14/2014,"05/14/2014"
"Food",67931,"Terminated","Tedesco LLC","Louisville","KY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to two retailers in Kentucky.","F-1820-2014","Class II","Graeter's Ice Cream Big Scoop COOKIES AND CREAM Ingredients: cream, milk, cane sugar***locust bean gum. Manufactured Under Authority of Graeter's Inc., 1175 Regina Graeter Way Cincinnati, Ohio 45216 022715''","022715",".","120/5.1 oz cups","During an inspection on 03/04/2014 by the FDA and the Kentucky State Health Department, the firm was notified that they fail to include the allergens wheat and soy on the label.",3/4/2014,"03/04/2014",4/23/2014,"04/23/2014"
"Devices",67932,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution in the state of OH","Z-1611-2014","Class II","DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)","monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876",,"4 units","The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.",3/5/2014,"03/05/2014",5/21/2014,"05/21/2014"
"Drugs",67933,"Ongoing","Wockhardt Usa Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1300-2014","Class II","Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.","Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15",".","109,744 bottles ","Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.",4/1/2014,"04/01/2014",5/14/2014,"05/14/2014"
"Drugs",67935,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1261-2014","Class II","Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA","Lot 22-127-DK",,"255,900 vials","Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide",3/27/2014,"03/27/2014",5/7/2014,"05/07/2014"
"Drugs",67936,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1547-2014","Class I","Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30","Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015",,"844,300 vials","Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.",4/2/2014,"04/02/2014",8/27/2014,"08/27/2014"
"Biologics",67937,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-0637-14","Class II","Red Blood Cells Leukocytes Reduced","W036314102933; ",".","1","Blood product, which was labeled as leukoreduced, but failed the post filtration acceptance criteria for white blood cell count, was distributed. ",2/18/2014,"02/18/2014",6/18/2014,"06/18/2014"
"Biologics",67938,"Terminated","DCI Donor Services dba Sierra Donor Services","Sacramento","CA","US","Voluntary: Firm Initiated","Letter","California","B-0634-14","Class III","Cornea","SDS140312ODCN; SDS140312OSCN",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",4/1/2014,"04/01/2014",5/28/2014,"05/28/2014"
"Biologics",67939,"Terminated","Plasma Biological Services Inc","Johnson City","TN","US","Voluntary: Firm Initiated","E-Mail","California","B-0629-14","Class II","Source Plasma","DQ301025, DQ300353, DQ299886, DQ299192, DQ298383, DQ297813, DQ296743, DQ295827, DQ295314, DQ294975, DQ294452, DQ294076, DQ291257, DQ290037, DQ288893, DQ288190, DQ287969, DQ287306, DQ287041, DQ286455, DQ286264 ",".","21 units","Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.",1/14/2014,"01/14/2014",5/28/2014,"05/28/2014"
"Biologics",67940,"Terminated","Avera McKennan Hospital & University Health Center","Sioux Falls","SD","US","Voluntary: Firm Initiated","FAX","South Dakota, Kentucky","B-0595-14","Class II","Plasma","W116113010801",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Biologics",67940,"Terminated","Avera McKennan Hospital & University Health Center","Sioux Falls","SD","US","Voluntary: Firm Initiated","FAX","South Dakota, Kentucky","B-0594-14","Class II","Red Blood Cells Leukocytes Reduced","W116113010801",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",3/17/2014,"03/17/2014",5/7/2014,"05/07/2014"
"Biologics",67941,"Terminated","LifeSouth Community Blood Centers, Inc.","Dunwoody","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0630-14","Class II","Platelets Pheresis Leukocytes Reduced","W115114030671C",".","1 unit","Blood product, which had a low pH value, was distributed.",3/20/2014,"03/20/2014",5/28/2014,"05/28/2014"
"Biologics",67942,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0581-14","Class II","Red Blood Cells","2525365",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/18/2014,"03/18/2014",5/7/2014,"05/07/2014"
"Biologics",67942,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","FL","B-0582-14","Class II","Cryoprecipitated AHF","2525365",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",3/18/2014,"03/18/2014",5/7/2014,"05/07/2014"
"Biologics",67943,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","FAX","CA","B-0585-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W1428140047537; W142814006581K",,"2 units","Blood products, with unacceptable cell recovery rates, were distributed.",2/21/2014,"02/21/2014",5/7/2014,"05/07/2014"
"Biologics",67944,"Terminated","Gen-Probe Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","California","B-0636-14","Class III","Human Immunodeficiency Virus Type 1 and/or HCV and/or HBV (Nucleic Acid Pooled Testing/Syn)","624104; 614564",".","2 kits (Master Lot 624104) and 5 kits (Master Lot 614564)","In-vitro diagnostics, with mixed master lots, were distributed. ",1/27/2014,"01/27/2014",5/28/2014,"05/28/2014"
"Food",67945,"Ongoing","BUFFALO SAV, INC.","BUFFALO","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IN, NY, OH, MI, and IL","F-0095-2015","Class I","GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink label and contains 14 - 2 lb bags per case. Manufactured by S&A Grandma's Food Inc. 196-44 Fasken Drive Toronto, ON M9W 5M8 (416) 679-8444, www.grandmafoods.com. Product of Canada.","expiration date 040414 to 040415",,"128 cases (14 - 2 lb bags per case)","Buffalo SAV, Inc. has recalled GRANDMA'S perogies POTATO & BACON PEROGIES due to the presence of Undeclared Soy.",4/8/2014,"04/08/2014",11/12/2014,"11/12/2014"
"Food",67946,"Ongoing","H Group","Framingham","MA","US","Voluntary: Firm Initiated","Telephone","Trader Joe's Stores in Delaware, Maryland, New Jersey, New York, Northern Virginia, Pennsylvania, and Washington, DC.","F-1940-2014","Class I","TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing, NET WT. 8/5 OZ (241g).","Sell by 4/6/14, 4/7/14, and 4/8/14. ",,"509 units","Product labeling on Trader Giotto's Caesar Salad with Caesar Dressing may not list wheat, soy, egg and fish (anchovy) allergens. ",4/5/2014,"04/05/2014",5/21/2014,"05/21/2014"
"Devices",67947,"Ongoing","INO Therapeutics (dba Ikaria)","Madison","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including DC and VA.","Z-1528-2014","Class II","INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.","Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420, DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306. ",".","22","An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater than 200 ppm/25 ppm respectively over a 10 second period.",3/27/2014,"03/27/2014",5/14/2014,"05/14/2014"
"Devices",67948,"Ongoing","BD Biosciences, Systems & Reagents","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.","Z-1536-2014","Class II","Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting. ","Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.",,"12 for lot 3295974; 10 of lot 3259822","Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.",4/4/2014,"04/04/2014",5/7/2014,"05/07/2014"
"Veterinary",67949,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY)","V-143-2014","Class II","The Acclaim Infusion Pump is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.","List Number: 12237; Serial Numbers: 12670196 , 12670182 , 12670203 , 12670281 , 12671061 , 12671058 , 12671175 , 12718477 , 12672450 , 12672413 , 12716099 , 12716071 , 12671563 , 12672061 , 12672079 , 12672156 , 12718948 , 12717835 , 12716259 , 12716268 , 12671580 , 12671554 , 12716244 , 12716293 , 12671647 , 12672014 , 12672021 , 12672064 , 12672074 , 12672137 , 12672138 , 12672143 , 12672173 , 12672179 , 12672185 , 12672186 , 12672161 , 12672217 , 12716140 , 12716324 , 12716396 , 12716489 , 12716316 , 12671666 , 12672065 , 12672175 , 12716251 , 12716550 , 12716398 , 12716963 , 12716451 , 12716345 , 12716519 , 12716693 , 12716477 , 12716610 , 12716638 , 12716344 , 12716538 , 12716515 , 12716315 , 12716720 , 12716623 , 12716787 , 12716822 , 12717186 , 12716738 , 12717343 , 12716798 , 12716812 , 12716532 , 12717123 , 12716849 , 12717281 , 12717049 , 12717160 , 12717359 , 12717028 , 12717298 , 12673508 , 12673609 , 12673114 , 12673524 , 12673629 , 12673529 , 12673563 , 12673597 , 12673610 , 12673700 , 12673741 , 12673584 , 12673647 , 12673679 , 12673711 , 12672796 , 12672848 , 12672740 , 12672801 , 12673033 , 12673099 , 12671687 , 12673054 , 12673127 , 12673035 , 12673144 , 12672775 , 12673082 , 12673131 , 12673638 , 12672747 , 12672784 , 12672789 , 12673069 , 12673083 , 12673159 , 12673180 , 12673350 , 12673443 , 12718788 , 12716217 , 12672791 , 12672794 , 12672766 , 12672925 , 12672990 , 12673212 , 12673165 , 12672749 , 12672777 , 12672882 , 12672886 , 12671505 , 12673916 , 12717412 , 12673887 , 12673899 , 12673919 , 12673922 , 12673915 , 12673926 , 12673947 , 12674013 , 12674024 , 12672845 , 12673050 , 12674010 , 12673971 , 12716417 , 12717963 , 12718476 , 12672244 , 12716470 , 12671680 , 12717834 , 12718964 , 12718713 , 12673944 , 12717693 , 12671566 , 12672008 , 12674347 , 12674349 , 12674392 , 12674416 , 12671926 , 12674363 , 12674380 , 12674428 , 12674475 , 12674534 , 12674362 , 12674407 , 12674430 , 12674443 , 12716672 , 12671859 , 12717799 , 12717966 , 12674144 , 12674098 , 12674119 , 12674086 , 1267409"," , 12674533 , 12674606 , 12674611 , 12674628 , 12674636 , 12674662 , 12674676 , 12674691 , 12674702 , 12674716 , 12674743 , 12675292 , 12675414 , 12675415 , 12675471 , 12675493 , 12674751 , 12674771 , 12674901 , 12675221 , 12675351 , 12675352 , 12675381 , 12675412 , 12675418 , 12675421 , 12675458 , 12675459 , 12675791 , 12675916 , 12675921 , 12676048 , 12676070 , 12676075 , 12676133 , 12676154 , 12676159 , 12676165 , 12676190 , 12676191 , 12676671 , 12676732 , 12676741 , 12676754 , 12676769 , 12678384 , 12672205 , 12678943 , 12678993 , 12679185 , 12680019 , 12717355 , 12717713 , 12671804 , 12671567 , 12670105 , 12672289 , 12678291 , 12679842 , 12674264 , 12716347 , 12670190 , 12675271 , 12678649 , 12670041 , 12671136 , 12717443 , 12676275 , 12678849 , 12716274 , 12719188 , 12675290 , 12677011 , 12672449 , 12672087 , 12679012 , 12717258 , 12718083 , 12717347 , 12671552 , 12674802 , 12675816 , 12679659 , 12677390 , 12716946 , 12673970 , 12677308 , 12676943 , 12679425 , 12675731 , 12717522 , 12678343 , 12672930 , 12719445 , 12678897 , 12678791 , 12719238 , 12717262 , 12671523 , 12676210 , 12717375 , 12716490 , 12718537 , 12717554 , 12716636 , 12717168 , 12717402 , 12718140 , 12716923 , 12670124 , 12718484 , 12671606 , 12719451 , 12670297 , 12672983 , 12673465 , 12674529 , 12675699 , 12671707 , 12677387 , 12671585 , 12718506 , 12717889 , 12670467 , 12718089 , 12717939 , 12719069 , 12673140 , 12719342 , 12719368 , 12677464 , 12716087 , 12719317 , 12671841 , 12675237 , 12677399 , 12671364 , 12719073 , 12672928 , 12716661 , 12716369 , 12716749 , 12717818 , 12719663 , 12716854 , 12718807 , 12718260 , 12718043 , 12717445 , 12675256 , 12675845 , 12716372 , 12718585 , 12717423 , 12717079 , 12718462 , 12671177 , 12717513 , 12672081 , 12673386 , 12675817 , 12673591 , 12676591 , 12677710 , 12717573 , 12719047 , 12673439 , 12718628 , 12672102 , 12670388 , 12718403 , 12717344 , 12671219 , 12677419 , 12719297 , 12719671 , 12718247 , 12673621 , 12672083 , 12716580 , 12678869 , 12716360 , 12716146 , 12719301 , 12671974 , 1267583","11,335 infusion pumps","Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.",10/31/2013,"10/31/2013",7/30/2014,"07/30/2014"
"Veterinary",67949,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY)","V-142-2014","Class II","The Acclaim Infusion Pump is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.","List Number: 12032; Serial Numbers: 12322921 , 12323859 , 12322780 , 12322801 , 12322810 , 12322812 , 12322878 , 12322880 , 12322887 , 12322896 , 12322903 , 12322904 , 12322911 , 12322917 , 12322936 , 12322939 , 12323867 , 12322916 , 12323056 , 12321139 , 12324767 , 12324854 , 12324802 , 12322873 , 12324375 , 1231453 , 1231610",,"27 infusion pumps","Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.",10/31/2013,"10/31/2013",7/30/2014,"07/30/2014"
"Devices",67950,"Ongoing","Laurimed LLC","Redwood City","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.","Z-1527-2014","Class III","PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.","Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014. ",,"58 ","The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.",4/7/2014,"04/07/2014",5/7/2014,"05/07/2014"
"Food",67951,"Ongoing","Fong Kee Tofu Co., Inc.","San Francisco","CA","US","Voluntary: Firm Initiated","Visit","Northern CA only.","F-1938-2014","Class II","Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fong Kee Tofu Inc. 1135 Revere Ave. San Francisco, CA 94124.","No codes",,"~45 units","Soy Bean Cake products do not declare wheat, a sub ingredient of soy sauce.",4/2/2014,"04/02/2014",5/21/2014,"05/21/2014"
"Food",67952,"Ongoing","Karl Bissinger LLC","Saint Louis","MO","US","Voluntary: Firm Initiated","E-Mail","The product was distributed to AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI AND WV.","F-1924-2014","Class I","Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. ''point of purchase'' display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted Chocolatier, St. Louis, MO.","Lot Codes: 4981 Best By FEB 2015",".","10,363 individual units","Milk chocolate bunny ears are packaged in dark chocolate packaging. The ingredient statement does not list milk.",4/9/2014,"04/09/2014",5/14/2014,"05/14/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1659-2014","Class II","ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.","Kit lots ending in/Exp Date: 020 11 July 2014 021 15 December 2014 022 24 February 2015 023 25 February 2015 024 03 July 2015 ",,"16,302 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1656-2014","Class II","ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 023 07 July 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015",,"17,731 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1653-2014","Class II","ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 273 18 November 2014",,"22,770 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1658-2014","Class II","ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 050 08 August 2014 051 20 September 2014 052 11 December 2014 053 10 December 2014 054 07 March 2015 ",,"40,266 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1655-2014","Class II","ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 ",,"8,052 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1654-2014","Class II","ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 ",,"155,345 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",67953,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.","Z-1657-2014","Class II","ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. ","Kit lots ending in/Exp Date: 023 07J uly 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015 ",,"12,787 kits","Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Biologics",67954,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","NY, FL","B-0605-14","Class II","Red Blood Cells","2365399",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/31/2014,"03/31/2014",6/11/2014,"06/11/2014"
"Biologics",67954,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","NY, FL","B-0607-14","Class II","Platelets Pooled Leukocytes Reduced","2906908",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/31/2014,"03/31/2014",6/11/2014,"06/11/2014"
"Biologics",67954,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","NY, FL","B-0606-14","Class II","Fresh Frozen Plasma","2365399",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/31/2014,"03/31/2014",6/11/2014,"06/11/2014"
"Biologics",67955,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL, Switzerland","B-0584-14","Class II","Red Blood Cells","W036810197134; W036811027628 ",,"2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Biologics",67955,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","MI, FL, Switzerland","B-0583-14","Class III","Blood and Blood Products for Reprocessing","W036811027628; W036810197134",,"2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/26/2014,"03/26/2014",5/7/2014,"05/07/2014"
"Devices",67956,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.","Z-1652-2014","Class II","Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer ","material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855 ",,"9","Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models. ",4/1/2014,"04/01/2014",6/4/2014,"06/04/2014"
"Devices",67957,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","USA ( nationwide) Distribution.","Z-1645-2014","Class II","550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.","material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282 5506 3287 5527 5517 70-4378 3695 5364 5060 5205 5688 5743 70-4283 5190 5157 5343 5844 5148 5391 5300 70-4296 5474 70-4363 70-4368 3793 3817 5833 5899 5207 5355 70-4159 3524 5281 5894 5374 5558 3631 3835 5784 2765 5367 70-4354 70-4356 5540 5488 5590 5657 5350 5821 3413 5222 5843 5179 70-4129 5851 5098 5153 5700 5410 3825 5865 5118 5548 3769 5861 70-4188 5748 70-4317 5737 5830 5385 5656 3778 5088 5665 5823 5353 5630 5480 5096 5572 3873 5417 4059 5500 5388 70-4379 5226 5601 5640 5033 5177 5707 5398 4091 5532 70-4306 70-4161 5424 5755 5326 5145 5699 4079 4082 70-4077 70-4113 5525 5419 3975 5093 5481 5396 3089 5095 5154 ",".","120","Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.",4/1/2014,"04/01/2014",5/28/2014,"05/28/2014"
"Devices",67958,"Ongoing","Fujifilm Medical System USA, Inc.","Stamford","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.","Z-1642-2014","Class II","MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator","SN: MXA1170108, MXA1270262",".","14","The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.",6/29/2012,"06/29/2012",5/28/2014,"05/28/2014"
"Devices",67959,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution in the states of NY, NC, DC, FL, PA","Z-1487-2014","Class II","iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.","Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software. ",,"9 units","Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance. ",4/3/2014,"04/03/2014",4/30/2014,"04/30/2014"
"Devices",67960,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.","Z-1613-2014","Class II","Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. ","model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134 ",,"50","Siemens Medical Solutions USA, Inc. has become aware of a potential issue with the Syngo Dynamics v9.5 system with a specific set of serial numbers. Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.",4/3/2014,"04/03/2014",5/21/2014,"05/21/2014"
"Devices",67961,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution.","Z-1616-2014","Class II","ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. ","5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001",,"590,136 boxes","Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.",4/14/2014,"04/14/2014",5/21/2014,"05/21/2014"
"Food",67962,"Ongoing","Lisy Corp.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New Jersey, New York, Rhode Island, and Maryland","F-1881-2014","Class I","Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g) Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96786 30032 8 ","Item 1132 Lot #'s A013 0518 and A014 0518",,"133 six pack","FDA sample collected was found to be positive for salmonella spp.",4/4/2014,"04/04/2014",4/30/2014,"04/30/2014"
"Devices",67963,"Ongoing","Physio-Control, Inc.","Redmond","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Albania, Lebanon, Austria, Libya, Bahrain, Lithuania, Bangladesh, Barcedonia, Belgium, Maldives, Bosnia/Herzegovina, Malta, Canary Islands, Morocco, Croatia, Namibia, Cyprus, Netherlands, Czech Republic, Niger, Denmark, Norway, Egypt, Oman, Faroe Islands, Pakistan, Finland, Poland, France, Portugal, Gabon, Qatar, Georgia, Reunion, Germany, Romania, Greece, Russian Federation, Hungary, San Marino, Iceland, Saudi Arabia, India, Serbia, Iran, Slovakia, Iraq, Slovenia, Ireland, South Africa, Israel, Spain, Italy, Sweden, Ivory Coast, Switzerland, Jordan, Tunisia, Kazakhstan, Turkey, Kenya, Turkmenistan, Kuwait, Ukraine, Latvia, UAE, UK, Zambia, Asia Pacific: Australia, Korea, Brunei, Malaysia, Cambodia, Myanmar, China, New Caledonia, French Polynesia, New Zealand, Hong Kong, Philippines, Indonesia, Singapore, Sri Lanka, Taiwan, Thailand, Japan, Latin America: Argentina, Curacao, Barbados, Ecuador, Bolivia, French Guiana, Brazil, Guatemala, Cayman Islands, Honduras, Chile, Mexico, Colombia, Panama, Costa Rica, Peru, Suriname, and Uruguay.","Z-1660-2014","Class II","LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. ","Affected Part Numbers: 320371500XXX",,"96,261 total; 40,818 within the US and 55,281 outside US.","Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 1000 defibrillator causes the Readiness Display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. Batteries that are at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the ''OK'' symbol is present.",5/9/2014,"05/09/2014",6/4/2014,"06/04/2014"
"Devices",67964,"Completed","InterValve Inc","Minnetonka","MN","US","Voluntary: Firm Initiated","Visit","Distribution to TN only","Z-1621-2014","Class II","InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.","Lot numbers: 101637, 101640",,"2","InterValve V8 Transluminal Balloon Aortic Valvuloplasty Catheter Devices were retrieved after leak issues were discovered through accelerated age testing. ",3/14/2014,"03/14/2014",5/21/2014,"05/21/2014"
"Food",67965,"Ongoing","R.A.B. Food Group LLC","Newark","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2037-2014","Class III","Tam Tams Snack Crackers Onion Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box","0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a",,"29,413 total cases for all products","The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity.",10/1/2013,"10/01/2013",6/25/2014,"06/25/2014"
"Food",67965,"Ongoing","R.A.B. Food Group LLC","Newark","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2039-2014","Class III","Tam Tams Snack Crackers Everything Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box","0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a",,"29,413 total cases for all products","The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity.",10/1/2013,"10/01/2013",6/25/2014,"06/25/2014"
"Food",67965,"Ongoing","R.A.B. Food Group LLC","Newark","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2036-2014","Class III","Tam Tams Snack Crackers Unsalted Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box","0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a",,"29,413 total cases for all products","The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity.",10/1/2013,"10/01/2013",6/25/2014,"06/25/2014"
"Food",67965,"Ongoing","R.A.B. Food Group LLC","Newark","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2040-2014","Class III","Tam Tams Snack Crackers Original Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box","0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a",,"29,413 total cases for all products","The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity.",10/1/2013,"10/01/2013",6/25/2014,"06/25/2014"
"Food",67965,"Ongoing","R.A.B. Food Group LLC","Newark","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2038-2014","Class III","Tam Tams Snack Crackers Garlic Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box","0924a 0924b 0934b 0934a 0944a 0944b 1094B 1094A 1084B 1084A 1154B 1164A 1644b 1644a",,"29,413 total cases for all products","The Manischewitz Company, Newark, NJ is recalling various Tam Tam Products due to rancidity.",10/1/2013,"10/01/2013",6/25/2014,"06/25/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1912-2014","Class II","Pastene ITAL SPIRAL TRI COLOR,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7093 UPC: 066086070931 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen ''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1908-2014","Class II","Pastene ITALIAN BUCATINI,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7095 UPC: 066086070955 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1907-2014","Class II","Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7092 UPC: 066086070924 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1899-2014","Class II","Pastene ITALIAN CAPELLINI #17, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7082 UPC: 066086070825 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1891-2014","Class II","Pastene REGINE 10, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7064 UPC: 066086070641 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1905-2014","Class II","Pastene ITAL NIDI #81 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7090 UPC: 066086070900 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1906-2014","Class II","Pastene ITALIAN FARFALLE #66 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7091 UPC: 066086070917 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1911-2014","Class II","Pastene ITAL TRICOLOR FARFALLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7088 UPC: 066086070887 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen ''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1895-2014","Class II","Pastene ITALIAN SPAGHETTI #15, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7075 UPC: 066086070757 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1902-2014","Class II","Pastene ITALIAN DITALI #45 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7085 UPC: 066086070856 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1898-2014","Class II","Pastene ITALIAN FUSILLI #28, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7081 UPC: 066086070818 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1893-2014","Class II","Pastene ITAL TAGLIATELLE VERDI #80, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7070 UPC: 066086070702 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1903-2014","Class II","Pastene ITALIAN STELLINE #59 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7086 UPC: 066086070863 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1900-2014","Class II","Pastene ITALIAN RIGATONI #31 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7083 UPC: 066086070832 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1892-2014","Class II","Pastene FARFALLINE 78, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7067 UPC: 066086070672 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1904-2014","Class II","Pastene ITALIAN TRIVELLA #69 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7087 UPC: 066086070870 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1910-2014","Class II","Pastene ITAL LONG FUSILLI ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7098 UPC: 066086070986 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1894-2014","Class II","Pastene ITAL CAPELLI D'ANGELO #83, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7074 UPC: 066086070740 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1909-2014","Class II","Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7097 UPC: 066086070979 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1901-2014","Class II","Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7084 UPC: 066086070849 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1890-2014","Class II","Pastene GEMELLI 104, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7063 UPC: 066086070634 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1889-2014","Class II","Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7062 UPC: 066086070627 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1896-2014","Class II","Pastene ITALIAN LINGUINE #6, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7077 UPC: 066086070771 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Food",67966,"Ongoing","The Pastene Companies Ltd.","Canton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Nationwide","F-1897-2014","Class II","Pastene ITALIAN ZITI RIGATI #20, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7079 UPC:066086070795 ","All Lots in Commerce ",,"6,000 cases, total for all varieties","Semolina pasta fails to declare the allergen''wheat''",4/10/2014,"04/10/2014",5/7/2014,"05/07/2014"
"Devices",67967,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.","Z-1721-2014","Class II","Siemens SOMATOM Emotion 16 and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.","Material numbers: 10165977, 10045692 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 32141 32156 32159 ",,"17","The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.",3/21/2014,"03/21/2014",6/11/2014,"06/11/2014"
"Food",67968,"Ongoing","Swanson Health Products, Inc","Fargo","ND","US","Voluntary: Firm Initiated","E-Mail","nationwide","F-1936-2014","Class I","Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112","Lot 203921 and 204888 each with MFG Date 11/2013",,"3,419 bottles","The contract manufacturer has notified Swanson Health Products that Swanson Full Spectrum Cilantro (Coriander) (SW1112) is subject to a recall due to a potential risk of salmonella contamination.",3/28/2014,"03/28/2014",5/21/2014,"05/21/2014"
"Devices",67970,"Ongoing","SCC Soft Computer","Clearwater","FL","US","Voluntary: Firm Initiated","Other","Distributed in IL.","Z-1573-2014","Class II","SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.","SA HIS version 4.0.7.0",,"1","When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.",1/29/2014,"01/29/2014",5/21/2014,"05/21/2014"
"Drugs",67971,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1297-2014","Class III","Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83 ","JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15",,"47,813 bottles","Failed Impurities/Degradation Specifications: Stability testing found the product may not meet the drug release specification through expiry. ",4/9/2014,"04/09/2014",5/7/2014,"05/07/2014"
"Drugs",67971,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1296-2014","Class III","Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 ","JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15 ",,"128,363 bottles","Failed Impurities/Degradation Specifications: Stability testing found the product may not meet the drug release specification through expiry. ",4/9/2014,"04/09/2014",5/7/2014,"05/07/2014"
"Devices",67973,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.","Z-1534-2014","Class II","CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.","Product Code: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468.",,"7,380 ea (total)","The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. ",3/11/2014,"03/11/2014",5/7/2014,"05/07/2014"
"Devices",67973,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.","Z-1535-2014","Class II","Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.","Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.",,"7,380 ea (total)","The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. ",3/11/2014,"03/11/2014",5/7/2014,"05/07/2014"
"Drugs",67974,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","nationwide","D-1282-2014","Class II"," 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. ","Lot # Gl09272; Exp 09/16",,"211,752 bottles","Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.",4/21/2014,"04/21/2014",5/7/2014,"05/07/2014"
"Food",67975,"Ongoing","Natural Grocers by Vitamin Cottage","Denver","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign, govt/VA/military.","F-1882-2014","Class I","Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags.","Pack on dates: 28-14, 13-14, 351-13, 336-13, 322-13, 305-13, 290-13, 281-13, 266-13, 252-13, 245-13 ",,"7327 bags","Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling multiple lots of Natural Grocers brand Organic Black Peppercorns as the product has the potential to be contaminated with Salmonella. ",4/7/2014,"04/07/2014",4/30/2014,"04/30/2014"
"Devices",67976,"Ongoing","Altasource LLC dba Meta Labs LLC","Roswell","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.","Z-1501-2014","Class II","Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens sexual excitement and pleasure.","Lot 8-94034",,"155","Firm is not registered as a drug manufacturer.",2/3/2014,"02/03/2014",4/30/2014,"04/30/2014"
"Devices",67976,"Ongoing","Altasource LLC dba Meta Labs LLC","Roswell","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.","Z-1499-2014","Class II","Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure. ","Lot 8-94034",,"7","Firm is not registered as a drug manufacturer.",2/3/2014,"02/03/2014",4/30/2014,"04/30/2014"
"Devices",67976,"Ongoing","Altasource LLC dba Meta Labs LLC","Roswell","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.","Z-1498-2014","Class II","Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.","Lot 8-94034",,"70","Firm is not registered as a drug manufacturer.",2/3/2014,"02/03/2014",4/30/2014,"04/30/2014"
"Devices",67976,"Ongoing","Altasource LLC dba Meta Labs LLC","Roswell","GA","US","Voluntary: Firm Initiated","Letter","USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.","Z-1500-2014","Class II","Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication. ","Lot 8-94034",,"42","Firm is not registered as a drug manufacturer.",2/3/2014,"02/03/2014",4/30/2014,"04/30/2014"
"Drugs",67978,"Ongoing","Legacy Pharmaceutical Packaging","Earth City","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN","D-1363-2014","Class II","Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61","No lot or expiration date is displayed on this carton.",".","unknown","Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets",4/9/2014,"04/09/2014",6/18/2014,"06/18/2014"
"Biologics",67979,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Letter","CA","B-0079-15","Class II","Red Blood Cells Leukocytes Reduced","W128713221857",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",12/13/2013,"12/13/2013",10/29/2014,"10/29/2014"
"Devices",67983,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide, including foreign, govt/VA/Military consignees.","Z-1467-2014","Class II","Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.","DFEMII016AS - 59036042, 59213298, 59258406, 59578907; DFEMII018AS - 59176126, 59249371, 59271003, 59369527, 59374074, 59432937, 59468460, 59484133, 59585854, 59589948, 59645287 DFEMII020AS - 59036043, 59113935, 59213299, 59258407, 59320308, 59369528, 59432938, 59468461, 59484119 DIIFEMII016A- 59025196, 59069368, 59115263, 59134580, 59154519, 59218668, 59240886, 59248906, 59304339, 59342282, 59383853, 59409789, 59453487, 59473491, 59491809, 59523710, 59528324, 59555055, 59589915, 59625359, 59645284, 59651762, 59680133, 59691448 DIIFEMII018A - 59030249, 59060764, 59072416, 59093901, 59116037, 59129577, 59149668, 59176262, 59218745, 59240935, 59248907, 59304334, 59337174, 59350865, 59394866, 59431915, 59468375, 59493314, 59528325, 59555040, 59577156, 59599140, 59609142, 59625362, 59651760, 59651808, 59680241 DIIFEMII020A - 59043574, 59069369, 59082560, 59103193, 59124011, 59134578, 59149667, 59176263, 59191993, 59218735, 59229561, 59240934, 59266786, 59299945, 59318926, 59319458, 59337178, 59350871, 59404487, 59437572, 59473387, 59484151, 59516163, 59531221, 59558959, 59563837, 59585992, 59609143, 59620175, 59642447, 59651767, 59651823, 59662388, 59680247.",".","28,885","Potential for separation of dilator tips.",4/9/2014,"04/09/2014",4/23/2014,"04/23/2014"
"Devices",67983,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Nationwide, including foreign, govt/VA/Military consignees.","Z-1466-2014","Class II","Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.","FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 59176265, 59202398, 59211445, 59218739, 59229566, 59232164, 59240932, 59266788, 59276834, 59312966, 59315604, 59342283, 59369388, 59409771, 59444473, 59468377, 59477867, 59499493, 59504222, 59504265, 59509409, 59551227, 59555094, 59563825, 59563881, 59589947, 59589952, 59609154, 59627646, 59630590, 59635736, 59635737, 59651804, 59662630, 59680124, 59680182, 59684469, 59691508 FEMII016AS - 59047478, 59112421, 59183047, 59229541, 59271782, 59394860, 59463345, 59593794 FEMII018A - 59021243, 59035354, 59043578, 59060761, 59060762, 59062270, 59064759, 59070872, 59079659, 59081681, 59082564, 59092366, 59093899, 59107280, 59114713, 59118388, 59124014, 59126280, 59138577, 59142229, 59142233, 59149665, 59169476, 59173958, 59173973, 59191995, 59210228, 59211444, 59211451, 59218738, 59222629, 59229567, 59235556, 59235558, 59254373, 59261612, 59271772, 59274361, 59299840, 59304350, 59304353, 59315607, 59332980, 59350864, 59379048, 59383856, 59400071, 59437566, 59437567, 59448621, 59458038, 59468821, 59477813, 59477838, 59490065, 59509300, 59509407, 59516176, 59528326, 59546034, 59551226, 59555043, 59555095, 59568507, 59577160, 59581459, 59585855, 59593828, 59604721, 59604722, 59604768, 59615024, 59616140, 59634860, 59634914, 59640034, 59640111, 59645315, 59648786, 59651807, 59651818, 59651905, 59680127, 59680192, 59684473, 59691468, 59691497 FEMII018AS- 59442433, 59551221, 59662385, 59684809 FEMII020A - 59442434, 59444471, 59458044, 59473388, 59477822, 59484137, 59492047, 59509404, 59514153, 59518778, 59523721, 59528327, 59528328, 59551224, 59555098, 59558960, 59572973, 59581458, 59581565, 59585993, 59593791, 59593830, 59599145, 59599177, 59615023, 59616141, 59620333, 59640098, 59641413, 59641415, 59648784, 59651907, 59651909, 59662631, 59670296, 59680176, 59691467, 59702375, FEMII020AS - 59473385, 59555025, 59675123.",".","13,115","Potential for separation of dilator tips.",4/9/2014,"04/09/2014",4/23/2014,"04/23/2014"
"Drugs",67985,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1299-2014","Class III","Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.","Lot #: KD4855, Exp 06/14",,"11,422 bottles","Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.",3/20/2014,"03/20/2014",5/7/2014,"05/07/2014"
"Devices",67986,"Ongoing","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Distribution US nationwide, including Michigan and a distributor in Colorado.","Z-1562-2014","Class II","AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.","Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.",".","29","The donor was hemodiluted.",3/25/2014,"03/25/2014",5/14/2014,"05/14/2014"
"Devices",67987,"Ongoing","Abbott Laboratories, Inc","Irving","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.","Z-0131-2015","Class II","Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.","lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. ",".","11916 units","Package inserts have incorrect SmartWash parameters for Triglyceride.",4/7/2014,"04/07/2014",11/5/2014,"11/05/2014"
"Biologics",67990,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","UT","B-0609-14","Class II","Platelets Pheresis Leukocytes Reduced","W1165132064340 ",,"1 unit","Blood product, with a low platelet concentration, was distributed.",11/4/2013,"11/04/2013",6/11/2014,"06/11/2014"
"Devices",67991,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","US distribution in the state of North Carolina.","Z-1641-2014","Class I","Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage. ","Lot or Serial No: 2553426",".","100 devices","One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm. ",4/10/2014,"04/10/2014",6/18/2014,"06/18/2014"
"Food",67992,"Completed","Sinco Inc.","Belmont","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Natiowide","F-1925-2014","Class I","Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618","Printed on the edge lid code: L13-102 BEST BY: 12OCT2014 ",".","7044 units","Product contains undeclared peanut protein",4/7/2014,"04/07/2014",5/14/2014,"05/14/2014"
"Food",67993,"Completed","Brooks Tropicals, LLC","Homestead","FL","US","Voluntary: Firm Initiated","E-Mail","FL, GA, IL, NJ and NY","F-2439-2014","Class I","Avocados approximately 14-30 oz each in packed 20 units in cardboard boxes with black lettering labeled in part: in part: ''USDA/FL 2/196 LOT# 2610''. ","Code # 2610 ",,"401 boxes / 8,649 pounds","Found positive for Salmonella.",8/8/2014,"08/08/2014",9/24/2014,"09/24/2014"
"Drugs",67995,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","PA","D-1343-2014","Class II","phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02","Lot # 13064, 13065, 13066; Exp. 08/18",".","14,496 bottles","Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..",4/14/2014,"04/14/2014",5/28/2014,"05/28/2014"
"Devices",67996,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.","Z-1644-2014","Class II","Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.","Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.",".","2,461,824 units total","The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.",4/16/2014,"04/16/2014",5/28/2014,"05/28/2014"
"Devices",67996,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.","Z-1643-2014","Class II","Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.","Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.",".","2,461,824 units total","The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.",4/16/2014,"04/16/2014",5/28/2014,"05/28/2014"
"Food",67997,"Ongoing","Fernandez Chile Company, Incorporated","Alamosa","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO and NM, no foreign, military/govt/VA.","F-1930-2014","Class I","Fernandez True Chile Flavor, Mild Chile Rojo, 6 oz.","UPC 77601-10053, Lot FEB-17",,"279 cases","Fernandez Chile Company is recalling 4oz Chile Molido Puro medium hot UPC 77601-10011 and 6oz Chile Rojo mild UPC 77601-10053 due to contamination with Salmonella.",4/9/2014,"04/09/2014",5/21/2014,"05/21/2014"
"Food",67997,"Ongoing","Fernandez Chile Company, Incorporated","Alamosa","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO and NM, no foreign, military/govt/VA.","F-1929-2014","Class I","Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz.","UPC 77601-10011, Lot Code JAN-17",,"721 cases","Fernandez Chile Company is recalling 4oz Chile Molido Puro medium hot UPC 77601-10011 and 6oz Chile Rojo mild UPC 77601-10053 due to contamination with Salmonella.",4/9/2014,"04/09/2014",5/21/2014,"05/21/2014"
"Devices",67998,"Ongoing","Ivoclar Vivadent, Inc.","Buffalo","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Nationwide and the country of Canada.","Z-1740-2014","Class II","''bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241''. Ultraviolet activator for polymerization for use during dental curing.","Reference number 636241, all lots",".","241 units","Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.",4/14/2014,"04/14/2014",6/18/2014,"06/18/2014"
"Food",67999,"Ongoing","Nutri-Force Nutrition, Inc.","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","The entire lot was sold under two (2) sales orders with the final shipment taking place on 09/25/2013.","F-1913-2014","Class II","Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: ''Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***''.","Lot #107945",,"9,456","Conjugated Linoleic Acid (CLA) softgel capsules and Fish Oil capsules were found mixed together in a retail bottle labeled as1000 mg Fish Oil soft gel capsules.",3/31/2014,"03/31/2014",5/7/2014,"05/07/2014"
"Drugs",68001,"Ongoing","Pfizer Us Pharmaceutical Group","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1409-2014","Class II","Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 ","H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16 ",".","220,761 bottles","Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.",4/16/2014,"04/16/2014",7/2/2014,"07/02/2014"
"Food",68002,"Ongoing","American Pop Corn Co","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, CO, FL, GA, IA, IL, KS, KY, MA, MI, MO, NE, NJ, NY, OH, OK, OR, PA, SD, TX, WA and WI.","F-1884-2014","Class II","Jolly Time Microwave popcorn, Extra Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190008477, on the 12 count case - UPC 10028190008474 and 48 ct shipper with UPC 128190488474 American Pop Corn Company, Sioux City, IA.","Best By 03/31/15 (Julian date) 4090",,"148 cases","The product has the potential to be contaminated with stainless steel metal fragments.",4/11/2014,"04/11/2014",4/30/2014,"04/30/2014"
"Food",68002,"Ongoing","American Pop Corn Co","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, CO, FL, GA, IA, IL, KS, KY, MA, MI, MO, NE, NJ, NY, OH, OK, OR, PA, SD, TX, WA and WI.","F-1883-2014","Class II","Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA.","Best By 03/27/15 (Julian date) 4086",,"3394","The product has the potential to be contaminated with stainless steel metal fragments.",4/11/2014,"04/11/2014",4/30/2014,"04/30/2014"
"Food",68002,"Ongoing","American Pop Corn Co","Sioux City","IA","US","Voluntary: Firm Initiated","Letter","Distribution was made to CA, CO, FL, GA, IA, IL, KS, KY, MA, MI, MO, NE, NJ, NY, OH, OK, OR, PA, SD, TX, WA and WI.","F-1885-2014","Class II","Jolly Time Microwave popcorn, Homemade Classic Stovetop Flavor, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190007807, on the 12-ct case - UPC 10028190007804, 48-ct shipper UPC 128190487804 American Pop Corn Company, Sioux City, IA","Best By code of 04/01/15 (Julian date) 4091",,"103 cases","The product has the potential to be contaminated with stainless steel metal fragments.",4/11/2014,"04/11/2014",4/30/2014,"04/30/2014"
"Drugs",68003,"Ongoing","Aaron Industries Inc","Lynwood","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1286-2014","Class III","Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310. ","Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14 Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15 ",,"108,792 bottles","Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. ",4/11/2014,"04/11/2014",5/7/2014,"05/07/2014"
"Drugs",68004,"Ongoing","Piramal Critical Care, Inc.","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","To wholesale distributors and retailers located Nationwide.","D-1262-2014","Class II","Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.","Lot #: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16).",,"12,600 bottles","Failed pH Specifications: product was too acidic.",4/7/2014,"04/07/2014",5/7/2014,"05/07/2014"
"Food",68005,"Ongoing","Miami Interculinary Center, Inc. ","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL, GA, IL, MD, NC, OH, PA, VA, and WA","F-2030-2014","Class I","Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida 33155 1(800)282-8459","Lot # 07171311",".","1,164 bottles","During an FDA inspection a product was found that the label fail to declared the component ingredients of all its compound ingredients like Mayonnaise and Worcestershire sauce that contains allergens like eggs, soy, and anchovies.",4/23/2014,"04/23/2014",7/2/2014,"07/02/2014"
"Devices",68006,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, NJ and MN.","Z-1681-2014","Class II","Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).","Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689. ",,"3","Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.",4/8/2014,"04/08/2014",6/11/2014,"06/11/2014"
"Food",68007,"Ongoing","Hot Pandeyuca & Company Inc","Hialeah","FL","US","Voluntary: Firm Initiated","Visit","FL and NC Panama","F-2016-2014","Class II","El Original pa' ya To Go by hot pandeyuca brand Cheese Bread Pan de Queso Grande","Lot Codes 001 - 090",".","1,052 boxes of 14 units each","During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.",3/21/2014,"03/21/2014",6/18/2014,"06/18/2014"
"Food",68007,"Ongoing","Hot Pandeyuca & Company Inc","Hialeah","FL","US","Voluntary: Firm Initiated","Visit","FL and NC Panama","F-2015-2014","Class II","El Original pa' ya To Go by hot pandeyuca brand Soft Bread Pan Alinado","Lot Codes 001 - 090",".","56 Boxes of 14 units each","During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.",3/21/2014,"03/21/2014",6/18/2014,"06/18/2014"
"Food",68007,"Ongoing","Hot Pandeyuca & Company Inc","Hialeah","FL","US","Voluntary: Firm Initiated","Visit","FL and NC Panama","F-2017-2014","Class II","El Original pa' ya To Go by hot pandeyuca brand Small Cheese Bread Quesipan","Lot Codes 001 - 090",".","1,651 boxes of 50 units each","During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.",3/21/2014,"03/21/2014",6/18/2014,"06/18/2014"
"Drugs",68009,"Ongoing","Golden State Medical Supply Inc.","Camarillo","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1357-2014","Class II","LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 ","Lot Number GS003057. Exp Date 03/2016.",,"6,042 bottles","Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning",4/14/2014,"04/14/2014",6/11/2014,"06/11/2014"
"Food",68010,"Terminated","CJ Bakery, INC","Commerce","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: CA, TX, GA, NY, NJ, and VA.","F-1876-2014","Class II","Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:''AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. ","Production batch: 1/1/2013-03/13/2014 No codes on finished package.",,"6,355","CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat.",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Food",68010,"Terminated","CJ Bakery, INC","Commerce","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: CA, TX, GA, NY, NJ, and VA.","F-1877-2014","Class II","Chocolate Madeline, 80g Net Weight. Packaged in clear plastic bag, 4 per bag. Product package labeled in part:''AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***. ","Production batch: 1/1/2013-03/13/2014 No codes on finished package.",,"3,488","CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat.",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Food",68010,"Terminated","CJ Bakery, INC","Commerce","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: CA, TX, GA, NY, NJ, and VA.","F-1875-2014","Class II","Cinnamon Cookie Manjoo, 200g Net Weight. Packaged in clear plastic bag, 10 per bag. Product package labeled in part:''***Cinnamon Cookie (Manjoo)*** Net Wt. 200g, 7.1oz***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039219***. ","Production batch: 1/1/2013-03/13/2014. No codes on finished packaging.",,"764 ","CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat.",3/17/2014,"03/17/2014",4/30/2014,"04/30/2014"
"Devices",68011,"Ongoing","Fisher & Paykel Healthcare, Ltd.","Auckland",,"NZ","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL ITALY JAPAN LIBYA MALAYSIA NEPAL NETHERLANDS NEW ZEALAND PERU POLAND PORTUGAL QATAR ROMANIA RUSSIA RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES","Z-1539-2014","Class I","Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.","Nasal CPAP Prongs (10 pack), Lot Numbers 13060603XX through 14032503XX; 13082003XX through 14032503XX; 13091903XX through 14032503XX; 13082603XX through 14032503XX; 13091903XX through 14032503XX; 14022603XX through 14032503XX; 14022603XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX. Bubble CPAP Starter Kits, Lot No. 131007 through 140325.",".","62,063 units total (14,420 units USA)","Fisher and Paykel Healthcare is recalling the Infant Nasal CPAP Prong because it has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.",4/15/2014,"04/15/2014",5/28/2014,"05/28/2014"
"Devices",68012,"Ongoing","Microline Surgical","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.","Z-1635-2014","Class II","Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.","Lot Numbers: 00116169 and 00115866",".","540 units","Grasper jaw may break when force is applied to the jaw",4/14/2014,"04/14/2014",5/28/2014,"05/28/2014"
"Devices",68014,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.","Z-2735-2014","Class II","Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. ","Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C",".","1,660 extraction trays","There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.",6/17/2013,"06/17/2013",10/7/2014,"10/07/2014"
"Devices",68014,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.","Z-2736-2014","Class II","Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.","Part Number: 20-009-021; Lot Numbers: 052113021C",".","20 extraction trays","There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.",6/17/2013,"06/17/2013",10/7/2014,"10/07/2014"
"Devices",68015,"Ongoing","Blue Belt Technologies MN","Plymouth","MN","US","Voluntary: Firm Initiated","Visit","USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.","Z-1575-2014","Class II","NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.","SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247",,"11","Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.",4/11/2014,"04/11/2014",5/21/2014,"05/21/2014"
"Devices",68016,"Ongoing","Bio-Rad Laboratories, Inc.","Hercules","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.","Z-1537-2014","Class II","Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.","Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015",".","457 kits","There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.",4/8/2014,"04/08/2014",5/14/2014,"05/14/2014"
"Devices",68017,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.","Z-1606-2014","Class II","Tennis Elbow Support, Neoprene***LATEX FREE'' Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.","Model #: 00-3448-003-00 through 00-3448-006-00 ",,"649 units","During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Devices",68017,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.","Z-1604-2014","Class II","Cartilage Knee Brace***LATEX FREE'' Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.","Model #: 00-1747-001-00 through 00-1747-005-00",,"2,222 units","During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Devices",68017,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.","Z-1603-2014","Class II","DROP LOK'' Knee Brace***LATEX FREE'' Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction. ","Model #: 00-1746-001-00 through 00-1746-006-00",,"131 units","During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Devices",68017,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.","Z-1605-2014","Class II","Hinged Knee Support***LATEX FREE'' Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation. ","Model #: 00-1773-002-00 through 00-1773-008-00",,"546 units","During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Drugs",68018,"Ongoing","P&L Developments, LLC","Lynwood","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","D-1254-2014","Class III","Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; ","Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 ",,"2,500,510 bottles","Subpotent Drug: Phenylephrine component is subpotent.",4/14/2014,"04/14/2014",4/30/2014,"04/30/2014"
"Drugs",68019,"Ongoing","Fresenius Kabi USA LLC","Melrose Park","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0247-2015","Class III","HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01","Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106501, Exp. 12/14; Lot 6106837, Exp. 02/15",".","216,517 vials","Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.",4/14/2014,"04/14/2014",11/19/2014,"11/19/2014"
"Food",68020,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Nationwide (32 states): AK, AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, LA, MA, MD, MI, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI. Products were also sent back to Advantage Health Matters, Markham, ON, Canada.","F-1971-2014","Class I","Organic traditions DARK CHOCOLATE SACHA INCHI SEEDS***DAIRY & SUGAR FREE 80% DARK CHOCOLATE; Pack sizes: 3.5oz/100g, UPC 8 54260 00709 1; 5.3 oz (150g), UPC 8 54260 00718 3; 12kg bulk boxes.","CACAOXPSWEETZZDSIBLK001-12 and CACAOXPSWEETZZSIBLK001-13",,"2381 units 3.5oz, 822 units 5.3 oz, 3149.89lbs bulk","Undeclared milk allergen",4/14/2014,"04/14/2014",6/4/2014,"06/04/2014"
"Food",68020,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Nationwide (32 states): AK, AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, LA, MA, MD, MI, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI. Products were also sent back to Advantage Health Matters, Markham, ON, Canada.","F-1970-2014","Class I","Organic traditions DARK CHOCOLATE GOLDEN BERRIES***DAIRY & SUGAR FREE 80% DARK CHOCOLATE; Pack sizes 3.5oz/100g, UPC 8 54260 00263 8; 5.3 oz (150g), UPC 8 54260 00266 9; 12kg bulk boxes.","CACAOXPSWEETZZGBEBLK001-12 and CACAOXPSWEETZZGBEBLK001-13",,"2550 units 3.5oz., 881 units 5.3 oz, 3462lbs bulk","Undeclared milk allergen",4/14/2014,"04/14/2014",6/4/2014,"06/04/2014"
"Devices",68021,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the state of Mississippi.","Z-1629-2014","Class II","Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.","Batch G323082757.",".","150","The Irrigation Clips were assembled with the incorrect (smaller) clips.",12/3/2013,"12/03/2013",5/28/2014,"05/28/2014"
"Food",68022,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AL, AR, GA, IL, IN, KY, MI, MS, MO, OH, SC, TN & WV.","F-1926-2014","Class I","PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: ''INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA'' 0 11110 52108 8","SELL BY AUG 11 15 3948",".","1.369 cs/8/16 fl oz cartons","The firm was notified of the presence of undeclared milk in the product.",4/11/2014,"04/11/2014",5/14/2014,"05/14/2014"
"Devices",68024,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2030-2014","Class II","Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures. ","Pack Lot Nos. RA27T, RA20, RA06T, QP09A, QN18A, RA06A, QP16A, RA20A, RC03A, and RC17T. QM21, RA27, RA27R, QN07, QM28, QF13A, QM21, QN25, QP16, QM14, QN18, QN11, QN04, RA13, QF06R, RC10, QM14T, QM21A, RC24, QF06, QP09, QF20A, QF13R, QF06RT, QG03RA, QG17, QL03, QM14T, QN25A, QE29, QE29T, QL16, QM28A, QM28C, QM28T, QK05, QK05AC, QK26, QK26A, QL02, QL16, QL16A, QL23, QN11A, QF20, QH08, QP02A, QP16, RC03, RA02, RA06, RC24, QK26, QE15, QM21T, QP02A, RA27A, QM07, QL02, QH08, QN25, QG17, QF06, QF06T, QF13, QF13T, QF13TA, QN18, QA21R, QE29T, QF28, RC03, QF28, RC17, QF06, RA13, QF20, QL03, RA27A, QH22, QG10, and RC24. ",".","256 kits","During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.",4/14/2014,"04/14/2014",7/23/2014,"07/23/2014"
"Devices",68024,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2029-2014","Class II","Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures. ","Lot No. RC07, QM03, QN07, and RA09.",".",,"During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.",4/14/2014,"04/14/2014",7/23/2014,"07/23/2014"
"Devices",68024,"Ongoing","Terumo Cardiovascular Systems Corporation","Elkton","MD","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2028-2014","Class II","Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures. ","Lot No. RA07, Lot No. QP02",".",,"During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.",4/14/2014,"04/14/2014",7/23/2014,"07/23/2014"
"Drugs",68025,"Ongoing","Cubist Pharmaceuticals, Inc.","Lexington","MA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1382-2014","Class I","CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.","Lot #: 280453F, Exp 04/16",".","51,500 vials","Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.",4/17/2014,"04/17/2014",6/18/2014,"06/18/2014"
"Devices",68026,"Ongoing","RM Temena GmbH","Felsberg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution including the states of MD and IL.","Z-1609-2014","Class II","Ultrasound USB needles, with 30degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance","Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30 ",,"7370 needles","Ultra sound needles may be defective and leak at the needle hub.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Devices",68026,"Ongoing","RM Temena GmbH","Felsberg",,"DE","Voluntary: Firm Initiated","Letter","US Distribution including the states of MD and IL.","Z-1608-2014","Class II","Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.","Lot B3170005, EXP 2018-05-31",,"7370 needles","Ultra sound needles may be defective and leak at the needle hub.",3/19/2014,"03/19/2014",5/21/2014,"05/21/2014"
"Devices",68027,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Liechtenstein, Malaysia, Mauritius, Montenegro, Namibia, Nepal, Nigeria, Norway, Palestinian Ter, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Turkmenistan, U.A.E., United Kingdom.","Z-1504-2014","Class II","Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.","Model numbers: 1065844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) ",,"490","When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.",4/2/2014,"04/02/2014",4/30/2014,"04/30/2014"
"Food",68028,"Ongoing","Golub Corporation","Schenectady","NY","US","Voluntary: Firm Initiated","Telephone","132 retail supermarkets in 6 states: CT, MA, NH, NY, PA, VT","F-1972-2014","Class I","''Price Chopper Hummus***TUSCAN WHITE BEAN***NET WT 10 OZ'' labels applied to clear plastic container with black rim on lid, ''Sell By Date 5/12/14''","Sell By Date 5/12/14",,"72cs/12ct/10oz","Price Chopper, is recalling Price Chopper brand Tuscan White Bean Hummus due to undeclared milk allergen as a result of a labeling mix-up. ",4/14/2014,"04/14/2014",6/4/2014,"06/04/2014"
"Food",68028,"Ongoing","Golub Corporation","Schenectady","NY","US","Voluntary: Firm Initiated","Telephone","132 retail supermarkets in 6 states: CT, MA, NH, NY, PA, VT","F-1973-2014","Class II","''Price Chopper Hummus***ROASTED GARLIC***NET WT 10 OZ'' labels applied to clear plastic container with black rim on lid, ''Sell By Date 5/14/14''","Sell By Date 5/14/14",,"72 case/12 container/10 oz","Price Chopper, is recalling Price Chopper brand Roasted Garlic Hummus due to a mix-up in nutrition panel and ingredients labeling.",4/14/2014,"04/14/2014",6/4/2014,"06/04/2014"
"Devices",68029,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution in the states of NV, and AZ.","Z-1610-2014","Class II","PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.","Lot No. A131876",,"5","A femoral component containing pegs was found in a box for the pegless version.",4/1/2014,"04/01/2014",5/21/2014,"05/21/2014"
"Devices",68030,"Ongoing","Baxter Corporation Englewood","Englewood","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.","Z-1620-2014","Class II","RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.","Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245",,"774, 600","Baxter Corporation is recalling certain lots of RAPIDFILL Syringe Strip due to a possible breach in sterile barrier for inner and outer bags of the product.",4/16/2014,"04/16/2014",5/21/2014,"05/21/2014"
"Devices",68031,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.","Z-1568-2014","Class II","Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. ","Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.",".","13,784","Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.",4/4/2014,"04/04/2014",5/14/2014,"05/14/2014"
"Devices",68032,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,","Z-1511-2014","Class II","GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.","FMI# 60857 & Descr: CARDIAC VX Mfg Lot or Serial # System ID 00000D13194001 0000AP12171002 00000L0240862D 604682AWW4 00000287171GE3 00000322015GE9 00000287170GE5 506648AW1 00000328735GE6 00000281269GE1 604875AW1 00000LA714FC0A 562225MR2A 00000287169GE7 PASSMR1AW 00000Y13168001 M1102608 00000M13099001 RE1046AW01 00000P13074002 M4189445 00000S13081001 M4189445 00000L02687172 M2322216 00000L0240825E M2322233 00000L3A2D12BA M2322241 0000AN12171001 M155485707 0000AP12178001 M40345204 00000R13178002 M178710405 00000T13185001 M2426003 00000L13184001 M1248303 00000H13032001 A4463335 00000N13172001 M4482629 00000L13197001 00000N13030001 I9237520 00000M12341002 0000AN12171002 M2844538 0000AM12178005 C2195283 00000X12340001 C2195282 0000AM12178001 M2322247 00000M12341001 M2322247 0000AP12290001 X59655524 00000B12299001 X59655525 00000N13112001 M2148251 0000AA12213001 M4181459 0000AR12310001 M4166643 0000AD12321001 M9481854 00000R12325001 M9481855 00000M13135001 00000L020E0B14 A54013104 00000L3A3E5D1C A5624137 00000L3A5D9820 A5624137 00000H13071001 A5164528 00000LA71385A1 A5164527 0000AM12178002 A5624134 0000AA13107002 RL6035 00000P13010001 PZ0383 00000T13158001 PM0032 00000L3AB045C6 PM0278 00000X13200001 0000AM12178004 RL6025 00000V13009001 RL6059 0000AM12178003 RL6043 00000G12362001 JW0128 0000AM12178006 PMW087 0000ZA12135001 RL6009 0000AR12310002 RL6123 00000E12356001 PY0207 00000U13057001 RL6092 00000L13014001 RL6111 00000M13024001 RL6071 00000P13004001 RLW118 00000G13038001 RL6088 00000P13074001 RL6096 00000Q13092001 00000H13032002 0850270409AW1 0000AN12171003 0850270411AW1 0000AP12178002 KW1112AW03 0000AN12312001 0920499069 00000328736GE4 00000H13032003 PL1735AW08 00000L3A2CA72F PL1735AW01 00000LA71BD437 600042AW11 00000L3A2D1359 PL1751AW02 00000R12328001 PL2902AW01 00000Q13102001 PL1050AW02 00000N13022001 00000T13043001 SA1051AW03 0000AE13108001 0000AA13113001 00000R13178001 00000Z13190001 0000AF13098001 SA1255AW02 ",,"101 (1 US , 100 OUS)","GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.",4/7/2014,"04/07/2014",5/7/2014,"05/07/2014"
"Devices",68034,"Ongoing","Ev3, Inc.","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.","Z-1489-2014","Class II","ev3 EverCross 0.035'' OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035'' OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter","AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16",,"39 units (31 OUS, 8 US)","Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. ",4/9/2014,"04/09/2014",4/30/2014,"04/30/2014"
"Veterinary",68035,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, CO, FL, IA, ID, IL, IN, KS, LA, MN, MO, NC, NY, OK, PA, TN, TX, VA) + District of Columbia","V-147-2014","Class II","The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.","List Number: 60529; Serial Numbers: 14315004 , 14315005 , 14315008 , 14315009 , 14315011 , 14315012 , 14315013 , 14315014 , 14315015 , 14315017 , 14315018 , 14315019 , 14315020 , 14315022 , 14315023 , 14315025 , 14315026 , 14315027 , 14315028 , 14315029 , 14315030 , 14315031 , 14315034 , 14315035 , 14315036 , 14315037 , 14315038 , 14315040 , 14315041 , 14315043 , 14315044 , 14315045 , 14315046 , 14315047 , 14315048 , 14315049 , 14315050 , 14315051 , 14315052 , 14315053 , 14315054 , 14315055 , 14315056 , 14315057 , 14315058 , 14315059 , 14315061 , 14315062 , 14315063 , 14315064 , 14315066 , 14315067 , 14315069 , 14315070 , 14315071 , 14315072 , 14315073 , 14315074 , 14315075 , 14315076 , 14315077 , 14315078 , 14315079 , 14315080 , 14315081 , 14315082 , 14315083 , 14315084 , 14315085 , 14315086 , 14315087 , 14315088 , 14315089 , 14315090 , 14315091 , 14315092 , 14315093 , 14315094 , 14315095 , 14315096 , 14315097 , 14315098 , 14315099 , 14315100 , 14315101 , 14315103 , 14315104 , 14315105 , 14315106 , 14315109 , 14315110 , 14315111 , 14315112 , 14315113 , 14315114 , 14315116 , 14315117 , 14315118 , 14315119 , 14315120 , 14315121 , 14315123 , 14315124 , 14315125 , 14315126 , 14315127 , 14315128 , 14315129 , 14315130 , 14315131 , 14315132 , 14315133 , 14315134 , 14315135 , 14315136 , 14315137 , 14315138 , 14315139 , 14315140 , 14315141 , 14315142 , 14315143 , 14315145 , 14315146 , 14315147 , 14315148 , 14315149 , 14315150 , 14315151 , 14315152 , 14315153 , 14315154 , 14315155 , 14315156 , 14315157 , 14315158 , 14315159 , 14315160 , 14315161 , 14315162 , 14315163 , 14315164 , 14315165 , 14315166 , 14315167 , 14315168 , 14315169 , 14315170 , 14315171 , 14315172 , 14315173 , 14315174 , 14315175 , 14315176 , 14315177 , 14315178 , 14315179 , 14315180 , 14315181 , 14315182 , 14315183 , 14315184 , 14315185 , 14315186 , 14315187 , 14315188 , 14315189 , 14315190 , 14315191 , 14315192 , 14315193 , 14315194 , 14315195 , 14315196 , 14315197 , 14315198 , 14315199 , 14315200 , 14315201 , 14315202 , 14315203 , 14315204 , 1431520",,"467 pumps","The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break, which can lead to possible unrestricted flor and/or overdelivery during the removal of the IV administration set's cassette from the pump. The IV administration set's cassette contains a flow regulator designed to close upon cassette removal to prevent accidental flow. In the event the door roller assembly is broken, the regulator closer may not close properly and unrestricted flow and/or overdelivery can occur which has the potential to contribute to life-threatening adverse events.",3/20/2013,"03/20/2013",7/30/2014,"07/30/2014"
"Biologics",68036,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","E-Mail","US: CA, FL, MD, MA, MI, MS, NY,NC, PA. OUS: TAIWAN RUSSIA, JAPAN, ISRAEL, GREECE, GERMANY, FINLAND, UNITED ARAB EMIRATES.","B-0597-14","Class II","AllSet+'' Gold SSP HLA- A*23/24 High Res Kit (54160D) A*23 SSP UniTray Kit (471702) A*23 SSP UniTray Kit with Taq Polymerase (471712) ","Product Name: AllSet+'' Gold SSP HLA- A*23/24 High Res Kit 54160D Lot/serial: 002 1138827, 002 1256850, 002 1379885, 002 1504232; A*23 SSP UniTray Kit 471702 Lot.Serial: 006 1078519,006 1160463, 006 1221255, 006 1399452; A*23 SSP UniTray Kit with Taq Polymerase 471712, Lot/serial: 006 1078519. ",,"2 Kits","HLA typing assay, associated with false typing assignments, was distributed. ",4/14/2014,"04/14/2014",5/7/2014,"05/07/2014"
"Drugs",68037,"Ongoing","P&L Developments, LLC","Lynwood","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in US","D-1298-2014","Class III","Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.","Lot # (expiry): Aaron Health A) 73825 (6/14), 74141 (6/14), 74830 (6/14), 74898 (7/14), 75339 (7/14), 75455 (7/14), 78531 (9/14), 79050 (9/14), 79267 (10/14), 80017 (7/14), 80781 (7/14), 81121 (10/14), 82178 (10/14). FAMILY wellness B) 82312 (10/14), 82500 (10/15), 133197 (1/15), 140385 (1/15), 141937 (2/15), 142669 (2/15), 143201 (2/15), 143656 (2/15), 145268 (2/15), 146058 (2/15), 146406 (2/15), 146963 (2/15), 147613 (3/15), 148105 (3/15), 148297 (7/15), 148809 (3/15), 149149 (8/15), 149317 (8/15), 149411 (8/15), 149814 (8/15), 149815 (8/15), 150305 (8/15), 150673 (8/15), 151039 (9/15), 151573 (9/15), 151762 (9/15), 152798 (9/15), 153206 (9/15), 153207 (9/15), 153514 (9/15), 154024 (9/15), 155380 (1/16). Good Neighbor Pharmacy C)141202 (2/15),145249 (2/15), 146425 (2/15). Pedia Care D) 73242 (5/14), 73243 (5/14), 73244 (5/14), 73824 (6/14), 74206 (6/14), 74207 (6/14), 74303 (6/14), 74460 (6/14), 78805 (9/14), 79265 (10/14), 79266 (10/14), 79573 (9/14), 80456 (6/14), 80457 (7/14), 83746 (1/15), 133196 (1/15), 144273 (2/15), 154090 (9/15). Quality Choice E) 79355 (6/14), 133193 (1/15), 149447 (8/15), 152870 (8/15). Safeway F) 74899 (7/14), 75103 (7/14), 78803 (9/14), 79089 (9/14), 79349 (6/14), 79671 (10/14), 80599 (10/14), 81263 (7/14), 81960 (10/14), 82047 (10/14), 83726 (1/15), 133194 (1/15), 140252 (1/15), 141023 (2/15), 141692 (2/15), 142148 (2/15), 142316 (2/15), 143399 (2/15), 145170 (2/15), 145826 (1/15), 145828 (1/15), 145829 (2/15), 147961 (3/15), 150302 (2/15), 150304 (7/15), 150549 (8/15), 150866 (9/15), 151650 (8/15), 151651 (9/15), 151906 (9/15), 154922 (1/16), 154923 (1/16). Well at Walgreens G) 73671 (5/14), 73898 (6/14), 74459 (6/14), 74900 (7/14), 75306 (7/14), 75671 (7/14), 76022 (7/14), 78804 (9/14), 79264 (5/14), 79325 (6/14), 79747 (6/14), 8188401 (7/14), 8195301 (7/14), 8195401 (9/14), 8195501 (10/14), 8200601 (10/14), 8257301 (10/14), 8282601 (10/14), 8374501 (10/14), 13319201 (1/16), 13319501 (1/16), 14096601 (2/15), 14165601 (2/15), 14193601 (2/15), 14726901 (3/15), 14755501 (3/15",,"1,363,338 Bottles","Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.",4/15/2014,"04/15/2014",5/7/2014,"05/07/2014"
"Devices",68038,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1546-2014","Class I","Product Brand Name: Alere INRatio2 PT/INR Professional Test Strips Model Number: 99008G2 Product Usage: Usage: Indications for use: The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the INRatio2 Monitor and INRatio2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. The Alere INRatio2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy. ","Lot/Unit Codes: Applicable to all Alere INRatio2 PT/INR Professional Test Strips lots packaged from 8/22/13 through 3/28/14, including the following: 324810, 324811, 324812, 327543, 327544, 327549, 328109, 328705, 328707, 330238, 330852, 331340, 331916, 331922, 332841, 332842, 332843, 332959, 333362, 333654, 333655, 333864, 333865, 334572, 334575, 335552, 335553, 335796, 335797, 336426, 336668, 337350, 338965, 338966, 339257, 339707, 327856V Expiration date, or Expected shelf life: range from 4/30/14 to 1/31/15",".","Estimated 99,795 Total units","Alere San Diego is initiating a voluntary recall for the Alere INRatio2 PT/INR Professional Test Strips. This action is being initiated as a result of several complaints of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. ",4/16/2014,"04/16/2014",5/14/2014,"05/14/2014"
"Devices",68039,"Ongoing","Small Bone Innovations, Inc.","Morrisville","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.","Z-1720-2014","Class II","SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.","item #451-3004, lot V3R0R.",,"44","Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside. ",4/7/2014,"04/07/2014",6/11/2014,"06/11/2014"
"Devices",68040,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and to Canada.","Z-1666-2014","Class II","Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia","catalog no. 333740, lot no. 61358613, exp. 4/30/2015: Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% ",,"7400","B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.",4/3/2014,"04/03/2014",6/4/2014,"06/04/2014"
"Devices",68041,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.","Z-1485-2014","Class II","Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035'' (0.89mm), 260 cm (102'').","Lot No. K556399, Expires 2016-10",,"173","Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035'' 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035'' 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.",4/14/2014,"04/14/2014",4/30/2014,"04/30/2014"
"Devices",68041,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.","Z-1486-2014","Class II","Merit Laureate 0.035'' (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102'').","Lot No. K556402, Expires 2016-10",,"186","Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035'' 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035'' 260 cm Guide Wire, catalog number LWSTDA35260EX, lot number K556402 (186 units), which has an angled tip, standard shaft and Chinese unit labeling.",4/14/2014,"04/14/2014",4/30/2014,"04/30/2014"
"Devices",68042,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide) and the country of Canada.*","Z-1618-2014","Class II","Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K","Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932",,"79 units","2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump",4/25/2014,"04/25/2014",5/21/2014,"05/21/2014"
"Devices",68042,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide) and the country of Canada.*","Z-1619-2014","Class II","Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K","Revision K Actuator Test Boards ",,"39 units","2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump",4/25/2014,"04/25/2014",5/21/2014,"05/21/2014"
"Devices",68043,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.","Z-1637-2014","Class II","TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device. ","(1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188",".","1,253 units total","A manufacturing error resulted in the set screw being inserted too deep in the affected nails. ",4/4/2014,"04/04/2014",5/28/2014,"05/28/2014"
"Devices",68043,"Ongoing","Smith & Nephew Inc","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.","Z-1636-2014","Class II","TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device. ","(1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190 (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750 (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494 (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660 (5) REF 71675205, Lot Number 13LT36598 (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672 (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963 (8) REF 71675211, Lot Number 13LT36313",".","1,253 units total","A manufacturing error resulted in the set screw being inserted too deep in the affected nails. ",4/4/2014,"04/04/2014",5/28/2014,"05/28/2014"
"Food",68044,"Ongoing","Princess House Inc.","Taunton","MA","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2043-2014","Class III","Marissa Collection Tangerine Appetizer Plate Set (set of 2). distributed by Princess House Inc., Taunton, MA","All ",".","11,912 sets","Plates leaching cadmium above the specified acceptable level",5/9/2014,"05/09/2014",7/2/2014,"07/02/2014"
"Devices",68045,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution","Z-1544-2014","Class II","12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.","Model number: 0242000012; Lot/serial numbers: 021464-2, 39824-1-1, 4014, 643893-1-4, 27419, 42901-1-1, 35728-2-1, 48639-1-8, 021464-3, 40288-1-1, 43020, 43893-1-6, 27701, 43104-1-1, 36175-1-1, 48956-1-1, 23027, 40629-3-,1, 43622, 43893-1-7, 29129, 43270-1-1, 36421-1-1, 48956-1-1A, 23398, 40721-1-1, 50476, 43893-1-8, 29670, 43523-1-1, 36424-1-1, 51304-1-1, 23542, 41231-4-1, 54990, 43893-1-9, 30250, 43523-1-1A, 37251-1-1, 51304-1-1A, 23846, 41478-1-1, 7J1, 48639-1-2, 30919, 43674-1-1, 37392-1-1, 52123-1-1, 24073, 41745-1-1, 123, 48639-1-3, 3218., 43893-1-1, 37794-1-1, 52956-1-1, 24511, 42086-1-1, 28646-1-1, 48639-1-4, 33226, 43893-1-10, 38867-1-1, 54346-1-1, 26445, 42306-1-1, 29005-1-1, 48639-1-5, 33961, 43893-1-1, 1SS15327, 26843, 42526-1-1, 30384-1-1, 48639-1-7, 35933, 43893-1-12, 37991, 36610, 43893-1-13, 39219, 43893-1-2, 43893-1-14.",".","2591 trays","Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.",4/16/2014,"04/16/2014",5/14/2014,"05/14/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-2001-2014","Class II","True Liquid Hand Soap, 15 oz container. Feu de Bois Fragrance","All lot codes are included",,"433 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-2002-2014","Class II","True Liquid Hand Soap, 15 oz container. Fleurs de Baies Fragrance","All lot codes are included",,"255 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-1998-2014","Class II","True Liquid Hand Soap, 15 oz container. Chamomile Lavender Fragrance","All lot codes are included",,"1134 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-2003-2014","Class II","True Liquid Hand Soap, 15 oz container. Apricot Fragrance","All lot codes are included",,"513 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-1999-2014","Class II","True Liquid Hand Soap, 15 oz container. Gardenia Fragrance","All lot codes are included",,"518 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-2000-2014","Class II","True Liquid Hand Soap, 15 oz container. Champagne Fragrance","All lot codes are included",,"1008 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-1996-2014","Class II","True Liquid Hand Soap, 15 oz container. Redwood Fragrance","All lot codes are included",,"195 bottles","Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Cosmetics",68046,"Ongoing","Lafco Enterprises Inc","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Foreign distribution to South Korea and England","F-1997-2014","Class II","True Liquid Hand Soap, 15 oz container. Marine Fragrance","All lot codes are included",,,"Lafco Enterprises, Inc. dba LAFCO NY is recalling all lots and all varieties of its True Liquid hand soap due to a potential bacterial contamination.",4/18/2014,"04/18/2014",6/11/2014,"06/11/2014"
"Devices",68047,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.","Z-0096-2015","Class I","The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.","Desktop GemStar Power Supply List Number: 13072-05; 1) US Distribution Lot Numbers: 10115G1, 11121G1, 11122G1, 1123G1, 11124G1, 12143G1, 12144G1, 12178G1, 15185G1, 12195G1, 17214G1, 18217G1, 18219G1, 19225G1, 20233G1, 21242G1, 22251G1, 23259G1, 24271G1, 25280G1, 26289G1, 26290G1, 27293G1, 27297G1, 27300G1; 2) Foreign Distribution Lot Numbers: 11128G1, 12140G1, 12142G1, 12148G1, 14176G1, 15187G1, 15196G1, 16207G1, 16208G1, 18218G1, 19226G1, 19229G1, 20234G1, 21241G1, 22255G1, 23262G1, 24270G1, 25276G1, 26285G1, 27299G1, 27301G1",".","US Distribution: 4,709 power supplies; Foreign Distribution: 7,425 power supplies","The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.",2/3/2014,"02/03/2014",11/5/2014,"11/05/2014"
"Devices",68047,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.","Z-0095-2015","Class I","The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.","Wall Mount GemStar Power Supply List Number: 13026; Lot Numbers: 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1 ",".","978 power supplies","The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.",2/3/2014,"02/03/2014",11/5/2014,"11/05/2014"
"Drugs",68048,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide.","D-1358-2014","Class I","Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.","Lot #: 34-440-DD, Exp 10/15",,"85,680 vials","Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.",4/21/2014,"04/21/2014",6/11/2014,"06/11/2014"
"Drugs",68049,"Ongoing","Upsher Smith Laboratories, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1255-2014","Class III","Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 ","Lot #2802.042A, Exp. 10/2015",,"1,185 bottles","Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.",4/14/2014,"04/14/2014",4/30/2014,"04/30/2014"
"Food",68050,"Ongoing","Whole Foods Market Brand 365, Llc","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas, Oklahoma, Arkansas, and Louisiana","F-0001-2015","Class I","Mini Butter Croissant 6 Pack Ingredients: Wheat Flour (unbleached enriched wheat flour, malted barley flour, niacin, Iron, thiamin mononitrate, riboflavin, ascorbic acid, folic acid), Butter, Water, Sugar, Non Fat Dry Milk, Yeast, Salt, Dough Conditioner (dextrose, wheat flour, soybean oil, ascorbic acid, natural enzymes). CONTAINS: MILK, WHEAT, SOY. NET WT 9.0 oz (0.56 lb) COUNT/PACKAGES 1 SELL-BY DATE 04/22/2014 TOTAL PRICE $4.99 Dist. by Whole Foods Market 8190 Park Lane, Dallas, TX 75231","UPC 2 28719 00499 1 and PLU #8719",,"251 units","Undeclared egg allergen",4/18/2014,"04/18/2014",10/15/2014,"10/15/2014"
"Food",68051,"Ongoing","Hickory Farms Inc","Maumee","OH","US","Voluntary: Firm Initiated","Telephone","OH","F-1946-2014","Class I","Hickory Farms Farmstand Recipe Chipotle Ranch Sauce Net Weight 9 Ounces","Best if used by date of February 08, 2015 or earlier",,"282,192 units","product contains undeclared milk",4/18/2014,"04/18/2014",5/21/2014,"05/21/2014"
"Drugs",68052,"Ongoing","Konsyl Pharmaceuticals Inc","Easton","MD","US","Voluntary: Firm Initiated","Letter","USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.","D-1315-2014","Class III","PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.","Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)",,"6286 Bottles","Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. ",4/1/2014,"04/01/2014",5/21/2014,"05/21/2014"
"Biologics",68053,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","MN","B-0608-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W051513148204",,"1 unit","Blood product, labeled as leukoreduced were not tested to verify the White Blood Cell count, was distributed",3/20/2014,"03/20/2014",6/11/2014,"06/11/2014"
"Biologics",68054,"Terminated","Minnesota Lions Eye Bank, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Minnesota","B-0635-14","Class II","Cornea","111710ODC; 111710OSC",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",4/11/2014,"04/11/2014",5/28/2014,"05/28/2014"
"Biologics",68055,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","Oklahoma City","OK","US","Voluntary: Firm Initiated","FAX","TX, OK","B-0646-14","Class II","Red Blood Cells Leukocytes Reduced","W091010144602; W091009168622",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/5/2014,"03/05/2014",6/11/2014,"06/11/2014"
"Biologics",68055,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","Oklahoma City","OK","US","Voluntary: Firm Initiated","FAX","TX, OK","B-0645-14","Class II","Platelets Pheresis Leukocytes Reduced","W091010301993; W091010301993",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/5/2014,"03/05/2014",6/11/2014,"06/11/2014"
"Biologics",68055,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","Oklahoma City","OK","US","Voluntary: Firm Initiated","FAX","TX, OK","B-0647-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","4662137",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/5/2014,"03/05/2014",6/11/2014,"06/11/2014"
"Biologics",68056,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA","B-0648-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W118813535756; W118813535793; W118813555836; W118813555848; W118813555848; W118813562328; W118813575223; W118813575223",,"8 units","Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed.",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68056,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA","B-0649-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118813535445; W118813202282; W118813202282; W118813202286; W118813202286; W118813202358; W118813202358; W118813401945; W118813401945; W118813401961; W118813401961; W118813503402; W118813503415; W118813503421; W118813503502; W118813503502; W118813503531; W118813503531; W118813503539; W118813503539; W118813503552; W118813503569; W118813517689; W118813517776; W118813517777; W118813525161; W118813525161; W118813525265; W118813525282; W118813525288; W118813525310; W118813525310; W118813525351; W118813525469; W118813525488; W118813525488; W118813535458; W118813535459; W118813535459; W118813535485; W118813535485; W118813535518; W118813535554; W118813535602; W118813535649; W118813535651; W118813535651; W118813535664; W118813535768; W118813535793; W118813535823; W118813535823; W118813535833; W118813555842; W118813555851; W118813555851; W118813555857; W118813555857; W118813555893; W118813555893; W118813555926; W118813555941; W118813555961; W118813555962; W118813555994; W118813556015; W118813556015; W118813556028; W118813556048; W118813556048; W118813556058; W118813556066; W118813556106; W118813556106; W118813556135; W118813556135; W118813556145; W118813562328; W118813562392; W118813575191; W118813575191; W118813575194; W118813575194; W118813575198; W118813575208; W118813575208; W118813575229; W118813575229; W118813575301; W118813575310; W118813575371; W118813575373; ",,"92 units","Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed.",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68057,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","NJ, FL","B-0651-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118814550057; W118814550075; W118814550110; W118814550054; W118814550115; W118814550127; W118813575373; W118813575405; W118813575434; W118813575444; W118813575463; W118814200029; W118814200029; W118814200047; W118814200056; W118814200056; W118814200069; W118814200069; W118814400035; W118814500002; W118814500002; W118814500005; W118814500015; W118814500015; W118814500045; W118814500067; W118814500137; W118814500137; W118814500148; W118814500153; W118814500160; W118814500160; W118814500162; W118814500162; W118814500167; W118814500167; W118814500168; W118814500168; W118814500171; W118814500171; W118814500256; W118814500256; W118814510065; W118814510065; W118814510173; W118814510206; W118814510238; W118814510238; W118814510281; W118814510376; W118814510376; W118814510399; W118814510417; W118814510436; W118814510467; W118814510471; W118814510500; W118814510524; W118814510534; W118814510534; W118814510583; W118814510583; W118814510609; W118814510655; W118814510836; W118814510851; W118814510921; W118814520025; W118814520025; W118814520032; W118814520054; W118814520054; W118814520112; W118814520112; W118814520113; W118814520113; W118814520115; W118814520115; W118814520120; W118814520120; W118814520133; W118814520133; W118814530005; W118814530045; W118814530108; W118814530108; W118814530116; W118814530175; W118814530175; W118814530179; W118814530180; W118814530183; W118814530183; W118814530184; W118814530325; W118814550050; ",,"96 units","Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. ",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68057,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","NJ, FL","B-0650-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W118813575434; W118813575463; W118814510675; W118814530266",,"4 units","Blood products, not prepared in accordance with specifications and which failed to meet product specifications, were distributed. ",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68058,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA","B-0604-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W118814550127; W118814550163; W118814550168; W118814550169; W118814550179; W118814550181; W118814550181; W118814550199; W118814550199; W118814550203; W118814550203; W118814550204; W118814550208; W118814550210; W118814550224; W118814550225; W118814550225; W118814550229; W118814550229; W118814570094; W118814550233; W118814550239; W118814550242; W118814550242; W118814550269; W118814550272; W118814550321; W118814550415; W118814550415; W118814550420; W118814550452; W118814550466; W118814560035; W118814560035; W118814560064; W118814560064; W118814560104; W118814560105; W118814570148; W118814560126; W118814560132; W118814570052; W118814570052; W118814570074; W118814570074; W118814570088; W118814570132; W118814570132; W118814570137; W118814570138; W118814570138; W118814570141; W118814570141; W118814570174; W118814570203; W118814570210; W118814570210; W118814570249; W118814570270; W118814570284; W118814570303; W118814570317; W118814570317; W118814570434; W118814570148; W118814550224; W118813202342",,"67 units","Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68058,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA","B-0603-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W118814560070; W118814570203; W118814570204- part 1; W118814570204- part 2",,"4 units","Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.",3/3/2014,"03/03/2014",6/25/2014,"06/25/2014"
"Biologics",68059,"Terminated","Bio-Save Resources Of Albuquerque LLC","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0644-14","Class III","Source Plasma","AB1397412",,"1 unit","Blood products, collected from a donor with no arm inspection, were distributed.",3/6/2014,"03/06/2014",6/11/2014,"06/11/2014"
"Biologics",68060,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA, NJ","B-0665-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W050911075248",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Biologics",68060,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA, NJ","B-0664-14","Class II","Platelets Pheresis Leukocytes Reduced","W050911079028",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Biologics",68060,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA, NJ","B-0666-14","Class II","Red Blood Cells","W050911079014; W050911082588",".","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Biologics",68060,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA, NJ","B-0667-14","Class II","Fresh Frozen Plasma","W050911075248",".","1 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",2/19/2014,"02/19/2014",6/18/2014,"06/18/2014"
"Biologics",68061,"Terminated","CSL Plasma, Inc.","Lansing","MI","US","Voluntary: Firm Initiated","Other","US, Germany, Switzerland","B-0033-15","Class II","Source Plasma","04205025690, 04205042588, 04205058934, 04204507128, 04204764730, 04204667447, 04204782517, 04204188163, 04204253447, 04204886543, 04204899070, 04204917629, 04204995694, 04205118087, 04205150060, 04205126845, 04205244163, 04205246302, 04204664836, 04204838584, 04204904203, 04204931359, 04204957516, 04205017024, 04205035249, 04205108524, 04205198320, 04204581774, 04204600920, 04204750742, 04204761054, 04204797460, 04205047426, 04204186694, 04204255848, 04204294960, 04204316209, 04204340268, 04204375209, 04204511426, 04204801773, 04204822603, 04204840545, 04205034182, 04205057000, 04204914145, 04205089394, 04204142579, 04204166781, 04204907666, 04204937371, 04205032398, 04205056859, 04205081923, 04205092796, 04205125762, 04205177706, 04205188130, 04205192711, 04205227021, 04204841820, 04204851050, 04205160015, 04205172850, 04205213797, 04204144996, 04204385482, 04204413009, 04204422263, 04204424357, 04204205015, 04204229050, 04204211108, 04204220207, 04204287380, 04204358548, 04204819869, 04204626830, 04204649855, 04204670021, 04204744131, 04204789065, 04204836618, 04204841716, 04204864264, 04204880889, 04204892740, 04204912529, 04204935683, 04204965102, 04205046677, 04205065771, 04205077529, 04205100418, 04205187373, 04205202836, 04205237721, 04204508606, 04204521480, 04204567630, 04204599190, 04204690436, 04204718902, 04204741256, 04204779481, 04204853426, 04204897808, 04204908351, 04204912123, 04204930250, 04204953718, 04204965479, 04205007846, 04205031467, 04205061674, 04205124575, 04205145827, 04205170555, 04205172420, 04205207450, 04205212794, 04205044460, 04205054116, 04205104558, 04205114810, 04205172155, 04205190636, 04205202043, 04205216040, 04205236681, 04204856862, 04204897162, 04204898181, 04204921097, 04204941880, 04205002113, 04205024531, 04205099824, 04205105868, 04205193247, 04204051781, 04204181068, 04204215782, 04204230034, 04204263362, 04204293115, 04204309463, 04204323062, 04204372454, 04204374484, 04204384965, 04204421682, 04204443953, 04204487905, 04204521940, 04204577513, 04204646700, 0420"," 04204359090, 04204372139, 04204502933, 04204545669, 04204578620, 04204678680, 04204753396, 04205111571, 04205127768, 04205165086, 04205167428, 04204502028, 04204524462, 04204548990, 04204816975, 04204556990, 04204812405, 04204825863, 04204529730, 04204677530, 04204503872, 04204607970, 04204624607, 04204702003, 04204824465, 04204954518, 04205031811, 04205045826, 04205169335, 04205186098, 04204562696, 04204664190, 04204678349, 04204729863, 04204762920, 04204784870, 04204795748, 04204826524, 04204506740, 04204525908, 04204755252, 04204764440, 04204785312, 04204565109, 04204670371, 04204677127, 04204735438, 04204747463, 04204754639, 04204770751, 04204517094, 04204765020, 04204527911, 04204582574, 04204671518, 04204975036, 04204522491, 04204689371, 04204764116, 04204609765, 04204634506, 04204759667, 04204768740, 04204777371, 04204986077, 04205151725, 04204558523, 04204559817, 04204590910, 04204618389, 04204631268, 04204770680, 04204870285, 04204922276, 04204931789, 04204978034, 04205071178, 04205089298, 04205105850, 04205173140, 04205179605, 04205192009, 04205227187, 04205236374, 04204529773, 04204662275, 04204672801, 04204708771, 04204721888, 04204799685, 04204839595, 04204841759, 04204880256, 04204902494, 04204921599, 04204967255, 04204987360, 04205053228, 04205080322, 04205099630, 04204524075, 04204571787, 04204651429, 04204744086, 04204868880, 04204599915, 04204630370, 04204702433, 04204748052, 04204798236, 04204832553, 04204951181, 04205033008, 04205063995, 04205093537, 04205124540, 04205162379, 04204575761, 04204600470, 04204613262, 04204618928, 04204660018, 04204707162, 04204724974, 04204853485, 04204889533, 04205023942, 04205061471, 04204576051, 04204583104, 04204573352, 04204588749, 04204702660, 04204745484, 04204577089, 04204593521, 04204599421, 04204639251, 04204725678, 04204854146, 04204871325, 04204894228, 04204923789, 04204964345, 04205019775, 04205056787, 04205070458, 04205088826, 04205182804, 04204578938, 04204594751, 04204698770, 04204728270, 04204576289, 04204612358, 04204708210, 04204703161, 042","2970 units","Source Plasma units, collected from ineligible donors, were distributed. ",12/18/2013,"12/18/2013",11/12/2014,"11/12/2014"
"Food",68064,"Ongoing","Dd Foodsolutions Inc.","Tucker","GA","US","Voluntary: Firm Initiated","Telephone","FL","F-1931-2014","Class I","Frozen Corkscrew Pasta and Creamy tomato Vodka Sauce meal, Net Wt 9oz","UPC Code: 2780607001, Date Code: 00914 and 01314. ",,"1000 cases (6000 trays)","Undeclared allergen: pinenuts.",4/14/2014,"04/14/2014",5/21/2014,"05/21/2014"
"Devices",68065,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, and NY.","Z-1698-2014","Class II","Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.","Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06",,"33 units","Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.",2/26/2014,"02/26/2014",6/11/2014,"06/11/2014"
"Devices",68066,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.","Z-1567-2014","Class I","Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with ''Delay Until'' Option and ''Multidose'' Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.","Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963 14036178 14036191 14036215 14036219 14036422 12773501 13184780 13932274 13932283 13932301 13932329 13932333 13990520 13990521 13990661 13990694 13990697 13990698 13990699 13990701 13990738 13990741 13990742 13990807 13990872 13990928 13990930 13990938 13990955 13990957 13990958 13990976 13990978 13990982 13990985 13990999 13991000 13991002 13991008 13991013 13991014 13991020 13991028 13991031 13991037 13991044 13991048 13991052 13991056 13991066 13991073 13991084 13991088 13991089 13991090 13991107 13991109 13991150 13991167 13991168 13991169 13991170 13991171 13991184 13991196 13991225 13991229 13991231 13991247 13991248 13991306 13991308 13991312 13991339 13991342 13991375 13991379 13991458 13991495 13991502 13991525 13991527 13991564 13991566 13991577 13991589 13991591 13991592 13991600 13991607 13991609 13991613 13991615 13991616 13991724 13991725 13991738 13991741 13991749 13991750 13991751 13991752 13991769 13991771 13991772 13991774 13991776 13991778 13991785 13991787 13991809 13991827 13991828 13991829 13991831 13991845 13991849 13991850 13991856 13991858 13991859 13991860 13991865 13991866 13991871 13991876 13991877 13991880 13991882 13991889 13991890 13991904 13991912 13991925 13991926 13991928 13991929 13991930 13991931 13991932 13991933 13991934 13991938 13991939 13991954 13991956 13991958 13991960 13991969 13991971 13991972 13991984 13991990 13991992 13991993 13991999 13992001 13992003 13992004 13992006 13992007 13992015 13992029 13992030 13992069 13992070 13992071 13992075 13992076 13992080 13992090 13992095 13992104 13992109 13992129 13992157 13992158 13992164 13992170 13992179 13992199 13992203 13992212 13992217 13992226 13992228 13992238 13992239 13992241 13992242 13992251 13992257 13992258 13992259 13992270 13992274 13992275 13992322 13992324 13992358 13992367 "," 12383380 12383381 12383388 12383389 12383392 12383393 12383394 12383400 12383401 12383409 12383410 12383411 12383415 12383416 12383427 12383429 12383430 12383504 12383518 12383522 12383523 12383533 12383534 12383541 12383543 12383544 12383545 12383548 12383561 12383563 12383564 12383569 12383571 12383572 12383584 12383585 12383702 12383905 12384083 12384116 12384163 12384336 12384337 12384341 12384346 12384348 12384349 12384350 12384364 12384366 12384367 12384368 12384370 12384371 12384372 12384376 12384377 12384379 12384381 12384382 12384383 12384428 12384433 12384436 12384445 12384454 12384456 12384467 12384470 12384477 12384480 12384489 12384490 12384491 12384492 12384497 12384498 12384499 12384500 12384530 12384532 12384535 12384555 12384559 12384560 12384571 12384579 12384590 12384591 12384593 12384602 12384607 12384631 12384632 12384649 12384652 12384655 12384660 12384672 12384675 12384677 12384686 12384689 12384690 12384715 12384737 12384738 12384741 12384745 12384753 12384754 12384755 12384757 12384758 12384761 12384771 12384772 12384773 12384799 12384815 12384816 12384817 12384828 12384835 12384836 12384837 12384839 12384864 12384866 12384868 12384869 12384872 12384873 12384874 12384876 12384877 12384880 12384881 12384882 12384889 12384894 12384896 12384897 12384898 12384899 12384907 12384922 12385113 12385116 12385128 12385153 12385176 12385177 12385198 12385210 12385214 12385238 12385240 12385243 12385277 12386209 12386293 12386498 12386994 12389047 12389405 12389418 12389424 12389483 12389484 12389485 12389486 12389491 12389522 12389526 12389527 12389529 12389533 12391012 12391013 12391016 12391081 12391101 12391125 12391153 12391284 12391368 12391526 12391679 12391784 12391803 12391830 12391841 12391848 12392040 12392327 12392365 12392477 12393234 12393765 12393782 12396209 12418841 12419160 12425127 12425749 12425883 12425915 12426695 12426828 12426850 12426857 12426953 12427103 12427119 12427264 12427288 12427298 12427349 12427393 12427689 12427726 12428709 12428797 12428837 12428845 12428871 1","57,219 units total (55,756 units in US)","CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the ''Delay Until'' option or ''Multidose'' feature is used.",4/23/2014,"04/23/2014",5/21/2014,"05/21/2014"
"Devices",68067,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1549-2014","Class II","Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).","HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979 ",".","21 units","Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. ",4/2/2014,"04/02/2014",5/14/2014,"05/14/2014"
"Devices",68067,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1550-2014","Class II","Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).","HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804 ",".","15 units","Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. ",4/2/2014,"04/02/2014",5/14/2014,"05/14/2014"
"Devices",68067,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1547-2014","Class II","Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). ","HDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316 ",".","50 units","Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. ",4/2/2014,"04/02/2014",5/14/2014,"05/14/2014"
"Devices",68067,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1551-2014","Class II","Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).","BS9SEN BS9SES BSAVX8 BSAVX9 BSAW3A BSAY0P BSAY0U BSAY15 BSAY18 BSAY1A BSAY1E BSAY1F BSAY1N BSAY1U BSAY1X BSAY3C BSAY3F BSAY3N BSAY3V BSAY3X BSAY5D BSAY5H BSAY8S BSAY9C BSAY9G BSAY9J BSAY9R BSAYAR BSAYAU BSAYB1 BSAYBW BSAYBX BSAYC3 BSAYC9 BSAYCB BSAYCC BSAYCD BSAYGV BSAYGX BSAYGY BSAYGZ BSAYH0 BSAYH4 BSAYH6 BSAYIG BSAYJC BSAYJD BSAYOW BSAYOZ BSAYPM BSAYPU BSAYR5 BSAYSA BSAYSJ BSB993 BSB9AG BSB9AJ BSB9AR BSB9AX BSB9B9 BSB9BD BSB9BE BSB9BK BSB9D6 BSB9D7 BSB9DB BSB9DE BSB9JK BSB9JU BSB9KG BSB9KU BSB9KY BSB9NW BSB9NX BSB9NY BSB9NZ BSB9P3 BSB9P6 BSB9PA BSB9PE BSB9PG BSB9PK BSB9PL BSB9PR BSB9PY BSB9R0 BSB9R3 BSB9R5 BSB9R7 BSB9R9 BSB9RC BSB9RL BSB9RY BSB9RZ BSB9S2 BSB9S3 BSB9S5 BSB9SJ BSB9SY BSB9SZ BSB9T4 BSB9T8 BSB9TA BSB9TD BSB9TG BSB9TJ BSB9TM BSB9TS bsb9tu BSB9TX BSB9TZ BSB9U1 BSB9X6 BSB9X7 BSB9X8 BSB9X9 BSB9XA BSB9XF BSB9XG BSB9XR BSB9XX BSB9Y6 BSB9Y7 BSB9YB BSBCUJ BSBCUS BSBCV1 BSBCV2 BSBCVB BSBCWP BSBOTA BSBOTE BSBOU2 BSBOU8 BSBPTL BSBXTL BSBXTT BSBXTX BSBXU1 BSBXUO BSCE5J BSCEC4 BSCEC5 BSCEC6 BSCEE5 BSCEEC BSCEED BSCEEF BSCEEH BSCEEJ BSCEEW BSCEHH BSCEHN BSCEHR BSCEHW BSCEHX BSCEHZ BSCEKP BSCEKT BSCEKV BSCM9V BSCMA8 BSCMA9 BSCMAD BSCZPT BSCZPU BSCZPW BSCZPY BSCZR6 BSCZR7 BSCZR9 BSCZRC BSCZRO BSCZRP BSCZRW BSD0B1 BSDOAK BSDOAT BSDOAU BSDOAY BSDOAZ BSEJGJ BSA41K BSAY0K BSAY21 BSAYA0 BSAYBC BSAYBH BSAYBN BSB9PX BSB9RR BSB9SB BSB9TH BSB9SA BSB9AV BSBCV5 BSCZRJ BSCZRY ",".","301 units","Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. ",4/2/2014,"04/02/2014",5/14/2014,"05/14/2014"
"Devices",68067,"Ongoing","GE Healthcare","Laurel","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1548-2014","Class II","Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). ","HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705 HDJR57706 HDJR57707 HDJR57784 HDJR57785 HDJR57786 HDJR57787 HDJR57788 HDJR57789 HDJR57790 HDJR57791 HDJR57792 HDJR57793 HDJR57794 HDJR57795 HDJR57925 HDJR57926 HDJR57935 HDJR57936 HDJR57937 HDJR57938 HDJR57939 HDJR57944 HDJR57948 HDJR57949 HDJR57950 HDJR57951 HDJR57952 HDJR57953 HDJR57954 HDJR57955 HDJR57956 HDJR57957 HDJR57980 HDJR57981 HDJR57985 HDJR57986 HDJR57987 HDJR57988 HDJR58013 HDJR58014 HDJR58015 HDJR58039 HDJR58040 HDJR58041 HDJR58046 HDJR58047 HDJR58076 HDJR58082 HDJR58086 HDJR58087 HDJR58088 HDJR58091 HDJR58092 HDJR58093 HDJR58094 HDJR58095 HDJR58096 HDJR58097 HDJR58098 HDJR58099 HDJR58100 HDJR58101 HDJR58102 HDJR58103 HDJR58104 HDJR58105 HDJR58106 HDJR58107 HDJR58108 HDJR58109 HDJR58110 HDJR58111 HDJR58112 HDJR58113 HDJR58114 HDJR58115 HDJR58116 HDJR58117 HDJR58118 HDJR58137 HDJR58138 HDJR58156 HDJR58157 HDJR58158 HDJR58159 HDJR58160 HDJR58161 HDJR58162 HDJR58163 HDJR58164 HDJR58165 HDJR58192 HDJR58263 HDJR58264 HDJR58265 HDJR58267 HDJR58268 HDJR58269 HDJR58270 HDJR58271 HDJR58272 HDJR58273 HDJS50008 HDJS50009 HDJS50010 HDJS50011 HDJS50012 HDJS50013 HDJS50014 HDJS50015 HDJS50017 HDJS50018 HDJS50019 HDJS50020 HDJS50025 HDJS50026 HDJS50128 HDJS50129 HDJS50133 HDJS50134 HDJS50135 HDJS50136 HDJS50137 HDJS50144 HDJS50145 HDJS50146 HDJS50147 HDJS50148 HDJS50149 HDJS50150 HDJS50151 HDJS50152 HDJS50153 HDJS50154 HDJS501555 HDJS50205 HDJS50206 HDJS50238 HDJS50240 HDJS50241 HDJS50242 HDJS50243 HDJS50244 HDJS50245 HDJS50246 HDJS50247 HDJS50248 HDJS50249 HDJS50250 HDJS50251 HDJS50252 HDJS50253 HDJS50254 HDJS50337 HDJS50430 HDJS50432 HDJS50475 HDJS50476 HDJS50599 HDJS50600 HDJS50605 HDJS50606 HDJS50608 HDJS50609 HDJS50610 HDJS50611 HDJS50650 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50680 HDJS50682 HDJS50683 HDJS50684 HDJS50685 HDJS50686 HDJS50709 HDJS50710 HDJS",".","723 units","Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. ",4/2/2014,"04/02/2014",5/14/2014,"05/14/2014"
"Drugs",68069,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1324-2014","Class II","BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.","Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14 ",".","17,181 bottles","Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.",4/7/2014,"04/07/2014",5/28/2014,"05/28/2014"
"Drugs",68069,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1325-2014","Class II","BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.","34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15",".","53,452 bottles","Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. ",4/7/2014,"04/07/2014",5/28/2014,"05/28/2014"
"Food",68070,"Ongoing","Gold Medal Products","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","AZ, CA, LA, MI, NE, NJ, OH, PA, and TN. There was 1 foreign consignee in Bermuda.","F-1943-2014","Class III","2372 HOT & SPICY; 4 pound plastic gallon containers; UPC 0 9093912372 7","Interal Lot # 14012515001 and UPC-A Code 0 90939 12372 7",,"137 containers","Cajun Savory was packed in Hot & Spicy package",3/21/2014,"03/21/2014",5/21/2014,"05/21/2014"
"Devices",68071,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2148-2014","Class I","DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)","Part nos. 04.315.003, 04.315.004, 04.315.005, 04.315.006 04.315.023 04.315.024 04.315.025 04.315.026 04.315.027 04.315.028 04.315.053 04.315.054 04.315.055 04.315.056 04.315.063 04.315.064 04.315.065 04.315.066 04.315.067 04.315.068, with lot nos.: 6245205, 7129328, IS10400 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148 6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818 6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830 6393120, 7408180, 7515833 7122918, 7389333, 7422700, 7545381, IS10388 6252759, 7129331, 7155891, 7418771, 7448753 6245463, 6438376, 6981568, 6983876,7063885, 7129332,7309797, 7418772, 7418848, 7448754 6251769, 7081953, 7310030, 7365542, 7418849, 7448752, 7448758, 7556149 6245458, 6342007, 7129333, 7556150, IS10399 6245462, 6342003, 6824546, 6824551, 6883290, 6883301, 7082907, 7266972, 7476792, 7476810, 7657623 6280719, 6342004, 6394297, 6651390, 6737168, 6767617, 6824547, 6824550, 6883304, 6883305, 6961025, 6984927, 7041138, 7056051, 7111867, 7185893, 7266967, 7351857, 7351858, 7351859, 7351861, 7422701, 7545379, 7657820, IS10395, 6651389, 6702172, 6883306, 6883307, 6942444, 6984926, 7111868, 7185892, 7306562, 7306563, 7306564, 7499078, 7515834, 7657629, IS10389 6651388, 6741835, 6824553, 6883309, 6913921, 6942445, 6961024, 7082908, 7111869, 7122924, 7185888, 7515835, 7657633 6921585, 6942446, 7185887, 7306565, 7306566, 7408183, 7476791, 7567066, 7579433, 7657635, IS10390, IS10391, 6275129, 7082905, 7185890, 7266969, 7422697,",,"1499","DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.",4/16/2014,"04/16/2014",8/27/2014,"08/27/2014"
"Devices",68072,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-1833-2014","Class II","Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.","All lot numbers of multiple part numbers:293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.48L 293.48X 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.62 293.63 293.67 293.68 293.69 293.72 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.30SHA 294.43 294.43SHA 294.44 294.44SHA 294.45 294.455 294.45SHA 294.46 294.46SHA 294.48 294.52 294.52SHA 294.53SHA 294.54 294.54SHA 294.55 294.55SHA 294.56 294.56SHA 294.57 294.57SHA 294.65 294.66 294.67 294.67SHA 294.68 294.68SHA 294.71 294.72 294.73 294.73SHA 294.74 294.74SHA 294.75 294.75SHA 294.76 294.767 294.768 294.769 294.769SHA 294.76SHA 294.771 294.771SHA 294.772 294.772SHA 294.773 294.774 294.775 294.775SHA 294.776 294.776SHA 294.777 294.777SHA 294.778 294.778SHA 294.779 294.779SHA 294.782 294.782SHA 294.783 294.783SHA 294.784 294.784SHA 294.785 294.785SHA 294.786 294.786SHA 294.788 294.788SHA 294.792 294.792SHA 294.793 294.793SHA 294.794 294.794SHA 294.795 294.795SHA 294.796 294.796SHA 294.798 294.798SHA 494.769 494.771 494.771SHA 494.772 494.772SHA 494.774 494.775 494.775SHA 494.776 494.776SHA 494.777 494.777SHA 494.778 494.778SHA 494.779 494.779SHA 494.782 494.782SHA 494.783 494.783SHA 494.784 494.784SHA 494.786 494.786SHA 494.788 494.788SHA 494.792 494.793 494.794 494.795 494.796 494.798 294.950 293.790 293.840 293.890 293.940 390.002 390.003 390.004 390.005 390.006 390.007 390.008 390.009 390.010 390.011 390.012 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 494.785 494.785SHA 390.041 390.042 395.60 395.61 395.62 395.63 395.64 395.65 395.66 395.67 395.680 395.681 395.682 395.685 395.686 395.687 395.688 03.301.010s 03.301.011s 03.301.012s 03.301.013s ",,"5,114,052","Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.",4/10/2014,"04/10/2014",6/25/2014,"06/25/2014"
"Devices",68073,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-1713-2014","Class II","Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.","Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316",,"15424 ","Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.",4/14/2014,"04/14/2014",6/11/2014,"06/11/2014"
"Devices",68074,"Ongoing","Tenex Health Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.","Z-1552-2014","Class II","TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.","Lot Numbers: 00614-03, 06513-02, 24913-01, 00713-06, 06514-02, 25313-01, 00814-02, 06914-01, 25513-02, 01114-02, 07213-04, 25613-01, 01514-03, 07713-18, 26113-06, 01714-04, 08113-04, 26313-04, 01813-02, 08413-13, 26713-04, 02314-08, 09313-05, 26813-01, 02413-04, 10213-07, 27013-10, 02714-02, 10613-01, 27613-02, 02914-01, 11213-07, 28013-05, 03014-02, 11613-06, 28313-02, 03113-02, 12113-02, 29513-03, 03114-02, 12713-03, 29713-01, 03414-03, 13413-01, 30913-07, 03514-05, 14413-05, 31113-08, 03714-03, 15013-04, 31513-02, 03814-06, 15413-02, 31713-05, 04114-02, 15413-03, 32213-01, 04213-01, 16513-04, 32413-01, 04214-05, 17013-02, 32613-01, 04414-03, 17013-09, 32913-07, 04514-02, 17613-08, 33613-09, 04814-07, 17913-16, 33813-05, 05014-02, 18413-05, 34013-03, 05113-01, 18413-06, 34313-01, 05113-02, 18613-03, 34413-04, 05114-09, 19213-03, 34513-04, 05514-01, 19713-04, 34713-08, 05614-04, 20713-06, 35113-01, 05713-03, 21813-01, 35213-03, 05714-10, 23913-01, 36013-01, 06313-05, 24113-04, 36113-02, 06314-04, 24213-04, and 36413-05.",".","9,927 units","The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.",4/14/2014,"04/14/2014",5/14/2014,"05/14/2014"
"Devices",68076,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.","Z-1733-2014","Class II","Siemens Healthcare Diagnostics Vista Air Compressor Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.","Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473 International: 10488224 Dimension Vista 1500 Domestic: 10444801 International: 10444802",".","4","Siemens Healthcare Diagnostics is recalling the Vista Air Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista 500 and Dimension Vista 1500 systems because a small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. ",4/14/2014,"04/14/2014",6/18/2014,"06/18/2014"
"Food",68077,"Ongoing","Wegmans Food Markets, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to all Wegmans stores in 6 states: MA, MD, NJ, NY, PA, VA","F-1915-2014","Class II","Scale label printed with ''EASTER BREAD NET WT 17oz (1.06lb)'' UPC 0 77890 32431 8, packaged in clear plastic bag ","UPC 0 77890 32431 8 all Sell By dates (between 3/27/14 and 4/22/14)",".","29,681 units","Wegmans Food Markets, Inc. has initiated a voluntary recall of all Wegmans Easter Bread (braided loaf) 17 oz., UPC 0 77890 32431 8 (all code dates) because it contains egg, which are not declared on the label. ",4/21/2014,"04/21/2014",5/14/2014,"05/14/2014"
"Devices",68079,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.","Z-0179-2015","Class II","Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.","Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014",,"180 units","Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.",4/18/2014,"04/18/2014",11/12/2014,"11/12/2014"
"Devices",68080,"Ongoing","Cochlear Americas Inc.","Centennial ","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1699-2014","Class II","Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.","Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008",,"288","Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.",4/9/2014,"04/09/2014",6/11/2014,"06/11/2014"
"Devices",68081,"Ongoing","Sakura Finetek USA Inc","Torrance","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1748-2014","Class II","Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. ","Product Code: 7052. Lot Number: 263922.",".","115","Sakura Finetek USA, Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin because it was identified that the affected lot has variations in melting temperature.",4/16/2014,"04/16/2014",6/18/2014,"06/18/2014"
"Biologics",68082,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Georgia","B-0623-14","Class II","Platelets Pheresis Leukocytes Reduced","W115114052662T; ",".","1","Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Biologics",68083,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Puerto Rico; New Jersey","B-0702-14","Class II","Platelets Pooled Leukocytes Reduced","022LF20749; ",".","1","Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.",3/7/2014,"03/07/2014",7/2/2014,"07/02/2014"
"Biologics",68083,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Puerto Rico; New Jersey","B-0703-14","Class II","Red Blood Cells Leukocytes Reduced","022GC26953; 022GV36632; ",".","2","Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.",3/7/2014,"03/07/2014",7/2/2014,"07/02/2014"
"Biologics",68083,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Puerto Rico; New Jersey","B-0704-14","Class II","Platelets Leukocytes Reduced","022GV36632; ",".","1","Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.",3/7/2014,"03/07/2014",7/2/2014,"07/02/2014"
"Biologics",68084,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","New York; Tennessee","B-0610-14","Class II","Red Blood Cells Leukocytes Reduced","W043214017396; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/31/2014,"03/31/2014",7/2/2014,"07/02/2014"
"Biologics",68084,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","New York; Tennessee","B-0611-14","Class II","Platelets","W043214017396; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/31/2014,"03/31/2014",7/2/2014,"07/02/2014"
"Biologics",68084,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","New York; Tennessee","B-0612-14","Class III","Blood and Blood Products for Reprocessing","W043214017396; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",3/31/2014,"03/31/2014",7/2/2014,"07/02/2014"
"Biologics",68085,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","Oklahoma City","OK","US","Voluntary: Firm Initiated","Telephone","Ohio; Oklahoma","B-0617-14","Class II","Red Blood Cells Leukocytes Reduced","W091014122204; W091014116694; W091014122235; ",".","3","Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.",2/28/2014,"02/28/2014",7/2/2014,"07/02/2014"
"Biologics",68086,"Terminated","Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc","Tyler","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0622-14","Class III","Fresh Frozen Plasma","W035214047404N; W0352140284770; W035214045800V; ",".","3","Blood components, incorrectly labeled as units of Fresh Frozen Plasma, were distributed.",3/14/2014,"03/14/2014",7/2/2014,"07/02/2014"
"Biologics",68087,"Terminated","BioLife Plasma Services, LP","Green Bay","WI","US","Voluntary: Firm Initiated","Other","Austria; California","B-0621-14","Class II","Source Plasma","13GWIN5351; 13GWIN5373; 13GWIN5476; 13GWIN4893; 13GWIN5056; 13GWIN1741; 13GWIN1831; 13GWIN1868; 13GWIN1159; 13GWIN1172; 13GWIN1224; 13GWIN1263; 13GWIN0955; 13GWIN0234; 13GWIM8207; 13GWIM8308; 13GWIM8363; 13GWIM8450; 13GWIM3964; 13GWIL9929; 13GWIL9952; 13GWIM0047; 13GWIL9474; 13GWIL9503; 13GWIL8391; 13GWIL8413; 13GWIL8432; 13GWIL8443; 13GWIL6825; 13GWIL6838; 13GWIL6996; 13GWIL7012; 13GWIL6437; 13GWIL6300; 13GWIL1841; 13GWIL1869; 13GWIL0822; 13GWIL0256; 13GWIL0312; 13GWIL0374; 13GWIL0408; 13GWIL0431; 13GWIK9261; 13GWIK9002; 13GWIK9011; 13GWIK9013; 13GWIK9129; 13GWIK8230; 13GWIK8272; 13GWIK8308; 13GWIK8399; 13GWIK8445; 13GWIK7849; 13GWIK7912; 13GWIK7935; 13GWIK7340; 13GWIK7436; 13GWIK7466; 13GWIK6737; 13GWIK6889; 13GWIK6929; 13GWIK5717; 13GWIK5753; 13GWIK5189; 13GWIK5216; 13GWIK5249; 13GWIK5321; 13GWIK5322; 13GWIK5381; 13GWIK5397; 13GWIK4150; 13GWIK4235; 13GWIK4334; 13GWIK3231; 13GWIK3320; 13GWIK2641; 13GWIK2752; 13GWIK1266; 13GWIK1035; 13GWIK1099; 13GWIK1113; 13GWIJ9998; 13GWIK0005; 13GWIK0046; 13GWIK0128; 13GWIK0205; 13GWIK0240; 13GWIK0163; 13GWIJ9620; 13GWIJ9650; 13GWIJ9672; ",".","91","Blood products, collected from a donor whose physical examination was incomplete, were distributed. ",3/6/2014,"03/06/2014",7/2/2014,"07/02/2014"
"Devices",68088,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, Saudi Arabia, South Korea, Span, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.","Z-1514-2014","Class II","HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.","Serial Numbers 42188, 42246, 42106, 42153, 42107, 42068, 42012, 42013, 42062, 42009, 42224, 42126, 3005, 42222, 3019, 3000, 42058, 42059, 42057, 42187, 42129, 42159, 3022, 3017, 42189, 42213, 42202, 42212, 42004, 4220, 42113, 42178, 42216, 42207, 2982, 2986, 2991, 42102, 42000, 42032, 42145, 42174, 42008, 42048, 42064, 42070, 42074, 42084, 42115, 42134, 42118, 42152, 42137, 42146, 3008, 2987, 3010, 3018, 42069, 42036, 3029, 42162, 42139, 42011, 42007, 42173, 42109, 42193, 3006, 42053, 42015, 42105, 42124, 42085, 42065, 42094, 42198, 2998, 3003, 3033, 3024, 2980, 42121, 2999, 42027, 42061, 42075, 42079, 42214, 3020, 42192, 42247, 42202, 42155, 42025, 42021, 42127, 42151, 42239, 42033, 42035, 42089, 42204, 42200, 2995, 3030, 42266, 42197, 42077, 42001, 42037, 42147, 42186, 42016, 42028, 42029, 42050, 42042, 42054, 42047, 42051, 42055, 42049, 42262, 42080, 42076, 42063, 42103, 42087, 42117, 42083, 42166, 42101, 42227, 42150, 42156, 42163, 42179, 42180, 42140, 42165, 42157,42234, 42169, 42182, 42183, 42236, 42195, 42223, 42256, 42276, 42260, 42231, 42250, 42243, 42240, 42272, 42235, 42249, 42254, 42245, 42265, 42268, 42267, 42253, 42264, 2993, 2997, 3004, 3031, 3002, 42226, 42258, 42114, 42081, 42090, 42093, 42133, 42181, 42039, 42116, 3016, 29677, 42010, 42073, 42176, 42164, 42031, 3028, 42041, 42038, 42022, 42034, 42088, 42104, 2976, 2979, 2988, 3011, 3015, 3021, 3027, 42238, 42018, 42135, 42252, 42185, 42273, 42060, 42024, 42006, 42082, 42194, 42263, 42232, 42199, 42170, 42161, 42078, 42158, 2985, 2994, 42120, 3032, 42056, 2969, 3034, 2975, 2972, 2984, 42191, 42225, 42228, 42023, 42143, 42122, 42208, 42230, 42211, 42026, 42206, 42066, 42052, 42014, 42218, 42030, 42040, 42244, 42043, 42044, 42045, 42046, 42123, 42255, 42141, 42125, 42072, 42112, 42210, 42017, 420196, 42020, 42067, 42071, 42097, 42100, 42131, 42144, 42136, 42148, 42130, 42111, 42067, 42171, 42203, 4210, 42205, 42096, 42154, 42241, 42229, 2981, 2989, 2971, 2990, 3007, 3013, 2992, 2973, 2978, 30098, 2974, 3014, 3012, 3025, 2996, 3026, 42274 ",,"266","If screws are not properly tightened with a torque wrench they may become loose over time.",4/17/2014,"04/17/2014",5/7/2014,"05/07/2014"
"Drugs",68089,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1550-2014","Class I","0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015","Lot C931923, exp 8/31/2015",,"4,200 containers","Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes",5/12/2014,"05/12/2014",8/27/2014,"08/27/2014"
"Devices",68090,"Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom","Z-1710-2014","Class II","Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.","Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03",,"145 units","Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.",1/10/2014,"01/10/2014",6/11/2014,"06/11/2014"
"Devices",68091,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.","Z-1676-2014","Class II","Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. ","Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804 ",,"48 ","AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. ",4/21/2014,"04/21/2014",6/11/2014,"06/11/2014"
"Devices",68092,"Ongoing","GE Healthcare","Barrington","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV, and the countries of Australia, Canada, Chile, France, Germany, India, Ireland, Israel, Italy, Japan, Korea (South), Kuwait, Lebanon, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.","Z-1665-2014","Class II","The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.","Centricity PACS versions: 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 3.2 SP8; 4.0; 4.0.1; 4.0 SP3",,"297 units","It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in the exam were inadvertently rejected, the image count in the work modes palette identifies fewer images; however, all of the images remain viewable. For newly acquired exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating ''Unable to fetch this exam: No images in the exam''. The images would then need to be resent to PACS from the modality. For historical exams, if the entire exam was inadvertently rejected, the RA1000 will return a message stating ''Unable to fetch this exam: No images in the exam'', and the exam is not available on the modality, a GE Healthcare Service representative would need to be contacted to restore the exam on the database. There is a DelRejImg task in Centricity PACS versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. If the DelRejImg task runs, the inadvertently rejected images will be permanently deleted from PACS. If you do not have the DelRejImg task running, there is no potential hazard since the inadvertently rejected images remain on the system. The deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis.",4/3/2014,"04/03/2014",6/4/2014,"06/04/2014"
"Devices",68093,"Ongoing","Biorep Technologies","Miami","FL","US","Voluntary: Firm Initiated","Letter","US Distribution only to MN.","Z-1538-2014","Class II","Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.","Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03)",".","80 boxes (480 units)","The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.",3/19/2014,"03/19/2014",5/14/2014,"05/14/2014"
"Devices",68094,"Completed","Smiths Medical ASD, Inc.","Rockland","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU","Z-1650-2014","Class II","SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.","Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712",".","2120 devices","The hose could separate from the blanket. ",4/22/2014,"04/22/2014",5/28/2014,"05/28/2014"
"Devices",68095,"Ongoing","Bausch & Lomb Inc- Greenville Solutions Plant","Greenville","SC","US","Voluntary: Firm Initiated","Letter","US Nationwide.","Z-1554-2014","Class II","Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.","Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.",".","256,440 bottles","Out of specification results for one of the two disinfectants. ",4/21/2014,"04/21/2014",5/14/2014,"05/14/2014"
"Cosmetics",68096,"Ongoing","Kutol Products Co","Sharonville","OH","US","Voluntary: Firm Initiated","Letter","Product was shipped to IN & KY.","F-1928-2014","Class II","Medline Skintegrity Moisturizing Lotion, made with oatmeal, aloe & vitamin e, 2 & 4 oz btls, Manufactured in USA for Medline Industries, Inc., Mundelein, IL 60060 UPC 0 80196 75401 7","2 oz - Catalog #MSC098502, Lot #: (L)12090411 & 4 oz -Catalog #MSC098504, Lot #: (L)12120509 ",".","1,401 cs/36/2 oz bottles & 78 cs/36/4 oz bottles","Kutol Products Company is voluntarily recalling the affected products as they were found to be out of specification for Aerobic Plate Count and presence of gram negative bacteria. Specification for Aerobic Plate Count is < 100 cfu per gram with results for both affected product lots being Too Numerous To Count (TNTC). Specification for gram negative bacteria is ''negative'' with results for both affected product lots being ''positive'' for gram negative bacteria. The gram negative bacteria was identified as pseudomonas aeruginosa.",4/10/2014,"04/10/2014",5/14/2014,"05/14/2014"
"Food",68097,"Ongoing","Infinite Herbs, LLC","Doral","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Georgia","F-1939-2014","Class I","Organic Basil 2.5 oz","Lot codes: 2/21 20422",,"576","FDA (CFSAN 3rd party sampling project) sample collected was found to be positive for Salmonella ",3/7/2014,"03/07/2014",5/21/2014,"05/21/2014"
"Drugs",68098,"Ongoing","Genesis Pharmaceutical, Inc.","Henderson","NV","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1285-2014","Class III","Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2 ","Lot 54, Exp: 1/14/2016",,"461 Bottles","Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.",4/1/2014,"04/01/2014",5/7/2014,"05/07/2014"
"Devices",68099,"Ongoing","Nellcor Puritan Bennett Inc. (dba Covidien LP)","Boulder","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.","Z-1577-2014","Class II","Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. ","Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029.",,"5,765","Newport Medical Instruments, Inc. is conducting a voluntary field corrective action on specific Newport'' e360 ventilators with a particular single board computer (SBC), in response to customer reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally. ",4/18/2014,"04/18/2014",5/21/2014,"05/21/2014"
"Devices",68100,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide): All states in continental USA including DC except DE, ME, ND, RI & VT. and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GHANA, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHKSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT LEBANON, LITHUANIA, MACEDONIA, MAURITIUS,MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY,, PANAMA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and URUGUAY.","Z-1808-2014","Class II","GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.","Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262 6705263 6705264 6705266 6705271 6705274 6705276 6705277 6705278 6705279 6705280 6705282 6705283 6705284 6705287 6705313 6705316 6705327 6705328 6705329 6705333 6705334 6705336 6705337 6705338 6705339 6705340 6705341 6705348 6705352 6705360 6706475 6706477 6706478 6706479 6706480 6706485 6706487 6706489 6706490 6707891 6707892 6707893 6707894 6707896 6707897 6707899 6707901 6707902 6707904 6707906 6707908 6707909 6707911 6707912 6707913 6707914 6707916 6707917 6707918 6707920 6707921 6707922 6707924 6707926 6707928 6707929 6707932 6707933 6707934 6707936 6707939 6707940 6707941 6707943 6707944 6707946 6707948 6707949 6707950 6707951 6707953 6707955 6707956 6707960 6707962 6707967 6707968 6707971 6707974 6707975 6707976 6707978 6707980 6707981 6707985 6707986 6708993 6708994 6708995 6708996 6709002 6709003 6709004 6709006 6709170 6709171 6709172 6709173 6709176 6709179 6709180 6709181 6709221 6709230 6709232 6709235 6710264 6710271 6710274 6710280 6710281 6710282 6710283 6710284 6710285 6710286 6710287 6710289 6710543 6710545 6710562 6710565 6710566 6710567 6710568 6710569 6710570 6710574 6710575 6710576 6710579 6710580 6710581 6710583 6710588 6710590 6710591 6710599 6710600 6710602 6710604 6710606 6711237 6711246 6711249 6711253 6711256 6711259 6711261 6711262 6711266 6711271 6711277 6711278 6711280 6711282 6711284 6711641 6711642 6711644 6711651 6711668 6711669 6711685 6711687 6713073 6713077 6713079 6713080 6713082 6713083 6713084 6713088 6713089 6713093 6713095 6713100 6713101 6713102 6713103 6713107 6713109 6713111 6713113 6713114 6713116 6713121 6713122 6713124 6713125 6713135 6713139 6713140 6713142 6713143 6713148 6713150 6713152 6713154 6713155 6713156 6713159 6713160 6713162 6713163 6713166 6713169 6713172 6713173 6713174 6713175 6713176 6713180 6713186 6713188 6713191 6"," 6772988 6772990 6772995 6772996 6773005 6774138 6775819 6775821 6775824 6775825 6775832 6775833 6775846 6775848 6775871 6775877 6775893 6776030 6778742 6778751 6709225 6710587 6713195 6716710 6719465 6741037 6741051 6741053 6741062 6742483 6742511 6742514 6742527 6742534 6742536 6749444 6749447 6749460 6749487 6763408 6770713 6770720 6763589 6763593 6775056 6775947 6704125 6704145 6704155 6706472 6706488 6708999 6710544 6711654 6713192 6715909 6716721 6716723 6716728 6716729 6716741 6716742 6719524 6731851 6732836 6739588 6745028 6745043 6746310 6749415 6756017 6756635 6756941 6759665 6759681 6759696 6759715 6759717 6764647 6770702 6770705 6770721 6770725 6770738 6770740 6771923 6771925 6771928 6771931 6771940 6774072 6774075 6774084 6774146 6775046 6775052 6775055 6775064 6775933 6775950 6705285 6705286 6705361 6705362 6707900 6707905 6707919 6709222 6710255 6710258 6711661 6711663 6711665 6711672 6711673 6723138 6726727 6726759 6728294 6728301 6728319 6728322 6728336 6728340 6728341 6728381 6729670 6731854 6731878 6734875 6734911 6737541 6737544 6739468 6739470 6741039 6741069 6742287 6744851 6744852 6746470 6746497 6746509 6746537 6748834 6749355 6751191 6751196 6751204 6756667 6756679 6756904 6756906 6756916 6756919 6756921 6756925 6756928 6760437 6760445 6760459 6760470 6760478 6760487 6760507 6760508 6760510 6763158 6763170 6765847 6767954 6768529 6768564 6770400 6772944 6772948 6772987 6774074 6774076 6775842 6775845 6775876 6775900 6775901 6775928 6778659 6778660 6778662 6778665 6778667 6778670 6778704 6778706 6778711 6778723 6778724 6778726 6778732 6778738 6778743 6778753 6778755 6775909 6705315 6709182 6716638 6721434 6725498 6726724 6726803 6728356 6732765 6732775 6732802 6734888 6736719 6737255 6737534 6737583 6741047 6741090 6741179 6744026 6744854 6744995 6746311 6746444 6746713 6748787 6748805 6748815 6748824 6749104 6749497 6751836 6751842 6751844 6752926 6752954 6755479 6755481 6755482 6755490 6756685 6758928 6760428 6760432 6767945 6770421 6770750 6771444 6772903 6772904 6772909 6772911 6772","4,961 (1,946 units US, 3,015 units OUS)","Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either ''Low gas sample flow'' or ''Check sample gas out''.",5/23/2014,"05/23/2014",6/25/2014,"06/25/2014"
"Biologics",68101,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0616-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W203814018447; W203814008716; W203814008718; ",".","3","Blood products, labeled with extended expiration dates following irradiation, were distributed. ",3/10/2014,"03/10/2014",7/2/2014,"07/02/2014"
"Biologics",68101,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0615-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W2038140047151; ",".","1","Blood products, labeled with extended expiration dates following irradiation, were distributed. ",3/10/2014,"03/10/2014",7/2/2014,"07/02/2014"
"Biologics",68102,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-0658-14","Class II","Fresh Frozen Plasma","2029395",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68102,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","CA","B-0659-14","Class II","Red Blood Cells Leukocytes Reduced","2029395",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68103,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","TX","B-0655-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W035213058097J",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/25/2014,"03/25/2014",6/18/2014,"06/18/2014"
"Biologics",68104,"Terminated","American Red Cross Greater Alleghenies Region","Johnstown","PA","US","Voluntary: Firm Initiated","Telephone","Maryland","B-0614-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W203514007225; W203514010120; ",".","2","Blood products, labeled with extended expiration dates following irradiation, were distributed.",3/10/2014,"03/10/2014",7/2/2014,"07/02/2014"
"Devices",68107,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1622-2014","Class II","syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications. ","material number: 10014063, with serial numbers: 1334 1065 1351 1491 1417 1269 1076 1043 1429 1353 1392 1258 1398 1445 1496 1279 1116 1090 1229 1080 1005 1081 1310 1246 1226 1057 1379 1396 1084 1322 1107 1453 1124 1343 1198 1432 1058 1247 1278 1082 1055 1049 1329 1203 1490 1083 1316 1395 1053 1079 1387 1448 1218 1451 1389 1386 1064 1500 1436 1074 1443 1210 1408 1427 ",".","64","A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself. ",4/3/2014,"04/03/2014",5/28/2014,"05/28/2014"
"Food",68108,"Ongoing","Harvest Sensations LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA, IN, MD, MI, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA and Puerto Rico","F-1927-2014","Class III","Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala","Lot # 2161100811",".","915 Cartons","Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb",4/10/2014,"04/10/2014",5/14/2014,"05/14/2014"
"Food",68108,"Ongoing","Harvest Sensations LLC","Doral","FL","US","Voluntary: Firm Initiated","Telephone","FL, GA, IN, MD, MI, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA and Puerto Rico","F-1927-2014","Class III","Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala","Lot # 2161100811",".","915 Cartons","Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb",4/10/2014,"04/10/2014",5/28/2014,"05/28/2014"
"Devices",68109,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, TX, NC, IL, CO, and PA.","Z-1574-2014","Class II","ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.","Lot/Set/Serial: G323081803.",,"30 cutting burs affected","Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. ",1/8/2014,"01/08/2014",5/21/2014,"05/21/2014"
"Devices",68110,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ.","Z-1711-2014","Class II","AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. ","Model number: 10094200, serial numbers:4332 4291 4323 4430 3061 4331 4238 4297 4201 4024 3098 4252 4372 4354 4077 3050 3108 4327 4342 4251 3053 3114 4156 3145 3096 4043 3181 4208 3090 4143 4051 4199 4401 4405 4151 4373 4276 ",,"37","It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit. ",4/11/2014,"04/11/2014",6/11/2014,"06/11/2014"
"Devices",68111,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.","Z-1781-2014","Class II","Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.","part number: 03.503.057, lot number 8453237",".","14","It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot. ",4/22/2014,"04/22/2014",6/18/2014,"06/18/2014"
"Food",68112,"Ongoing","Woeber Mustard Manufacturing Co Inc","Springfield","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","United States including: ID, IL, NM, and UT.","F-1945-2014","Class I","Hickory Farms Chipotle Ranch Sauce; 9 oz. clear plastic pinch waist bottle","Best if used by date of February 08, 2015 or earlier",,"281796","Unlabeled milk allergen.",4/18/2014,"04/18/2014",5/21/2014,"05/21/2014"
"Devices",68113,"Ongoing","ARJOHUNTLEIGH POLSKA SP. ZO.O.","POZNAN",,"PL","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Bahrain, Canada, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom, and Uruguay.","Z-2652-2014","Class II","Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).","Model Number: KHA1000-US; Serial Numbers: P0111930 , P0112213 , P0112214 , P0117472 , P0121496 , P0123586 , P0125147 , P0127106 , P0127347 , P0127348 , P0128923 , P0128924 , P0129153 , P0129154 , P0129369 , P0129370 , P0131041 , P0131526 , P0131527 , P0131773 , P0131774 , P0133024 , P0134145 , P0134146 , P0136335 , P0137220 , P0138564 , P0139494 , P0139495 , P0139696 , P0144387 , P0148499 , P0149211 , P0149302 , P0149303 , P0162196 , P0164314 , P0165868 , P0165941 , P0166383 , P0166464 , P0167748 , P0170439 , P0172605 , P0172717 , P0179187 , P0179414 , P0180046 , P0180047 , P0180480 , P0180481 , P0180482 , P0180483 , P0183127 , P0183128 , P0183764 , P0183765 , P0183824 , P0184254 , P0186224 , P0186225 , P0187652 , P0187653 , P0188944 , P0189050 , P0189099 , P0189762 , P0192050 , P0192249 , P0208300 , P0209851 , P0210756 , P0210792 , P0210793 , P0211855 , P0211856 , P0211980 , P0211981 , P0212717 , P0217417 , P0218714 , P0220790 , P0221243 , P0221244 , TCMA0405021 , TCMNS0404E154 , TCMNS0404E155 , TCMNS0404U044 , TCMNS0404U045 , TCMNS0408E159 , TCMNS0408E160 , TCMNS0408E161 , TCMNS0409E163 , TCMNS0409G144 , TCMNS0409G145 , TCMNS0409G146 , TCMNS0409G147 , TCMNS0409U046 , TCMNS0409U047 , TCMNS0409U048 , TCMNS0409U049 , TCMNS0409U050 , TCMNS0409U051 , TCMNS0409U052 , TCMNS0409U053 , TCMNS0410G164 , TCMNS0410G165 , TCMNS0410G166 , TCMNS0410G167 , TCMNS0410G168 , TCMNS0410G169 , TCMNS0411E170 , TCMNS0412E228 , TCMNS0412E229 , TCMNS0412G171 , TCMNS0412G172 , TCMNS0412G173 , TCMNS0501G233 , TCMNS0501G234 , TCMNS0501G235 , TCMNS0501U264 , TCMNS0501U265 , TCMNS0501U274 , TCMNS0501U275 , TCMNS0501U276 , TCMNS0502A279 , TCMNS0502E288 , TCMNS0502G266 , TCMNS0502G267 , TCMNS0502G268 , TCMNS0502G269 , TCMNS0502G270 , TCMNS0502G271 , TCMNS0502U320 , TCMNS0502U321 , TCMNS0504U328 , TCMNS0504U329 , TCMNS0504U330 , TCMNS0505E333 , TCMNS0506E350 , TCMNS0507A396 , TCMNS0507A397 , TCMNS0507A398 , TCMNS0508E400 , TCMNS0508E401 , TCMNS0508E402 , TCMNS0508E403 , TCMNS0509U404 , TCMNS0509U405 , TCMNS0510E408 , TCMNS0510U407 , TCMNS0511",,"382 lifts total worldwide (160 US)","ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.",6/10/2014,"06/10/2014",9/24/2014,"09/24/2014"
"Devices",68114,"Ongoing","Mar Cor Purification","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - AL, AZ, AR, CA, CO, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI.","Z-1563-2014","Class II","Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients. ","1301273 1302515 1303486 1304517 1305636 1306626 1307463 1308631 1309375 1301350 1302516 1303487 1304571 1305711 1306666 1307536 1308665 1309437 1301453 1302600 1303559 1304660 1305782 1306666 1307758 1308666 1309532 1301456 1302634 1303560 1304662 1305840 1306718 1307759 1308722 1309566 1301514 1302655 1303680 1304750 1305907 1306722 1307841 1308799 1309589 1301580 1302675 1303722 1304794 1305953 1306810 1307842 1308821 1309592 1301682 1302703 1303728 1304851 1305954 1306834 1307857 1308830 1309613 1301705 1302714 1303776 1304962 1306107 1306844 1307897 1308833 1309647 1301751 1302791 1303839 1305045 1306108 1306897 1307904 1308981 1309662 1301898 1302809 1303840 1305108 1306110 1306913 1308035 1309027 1309717 1301966 1302852 1303876 1305142 1306225 1307022 1308052 1309029 1309743 1301972 1302933 1303943 1305176 1306228 1307041 1308059 1309120 1309765 1302063 1302934 1303977 1305193 1306299 1307041 1308201 1309123 1309807 1302074 1302993 1304027 1305234 1306307 1307042 1308202 1309139 1309860 1302115 1302994 1304112 1305303 1306308 1307095 1308217 1309206 1309890 1302195 1303055 1304158 1305341 1306377 1307219 1308279 1309227 1309904 1302266 1303144 1304176 1305342 1306411 1307230 1308294 1309241 1309923 1302269 1303178 1304235 1305379 1306465 1307276 1308335 1309280 1309926 1302319 1303231 1304286 1305472 1306467 1307317 1308384 1309283 1309983 1302337 1303232 1304428 1305523 1306544 1307391 1308443 1309327 1310113 1302461 1303322 1304440 1305632 1306599 1307413 1308520 1309364 1310147 1302485 1303391 1304454 1305633 1306610 1307418 1308533 1309374 ",".","197","Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.",4/24/2014,"04/24/2014",5/14/2014,"05/14/2014"
"Biologics",68115,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","North Carolina","B-0624-14","Class II","Platelets Pheresis Leukocytes Reduced","W333414000195; ",".","1","Blood product, with platelet concentration below the specified minimum requirement, was distributed.",3/13/2014,"03/13/2014",7/2/2014,"07/02/2014"
"Biologics",68116,"Terminated","American Natl Red Cross Mid Atlantic Region","Norfolk","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-0700-14","Class II","Red Blood Cells Leukocytes Reduced","GY933592029; ",".","1","Blood product, incorrectly identified as negative for the Jka antigen, was distributed.",3/24/2014,"03/24/2014",7/2/2014,"07/02/2014"
"Biologics",68117,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","North Carolina; Missouri; New York; New Jersey; Switzerland; California","B-0620-14","Class II","Blood and Blood Products for Reprocessing","W333614000431; W333613096101; W333613075416; W333613034870; W333613023898; W33361210579; W333612096602; W333612064894; W333612061393; W333612025384; W333612026028; W333611107126; W333611083733; W333611056590; W333611042891; W333611008496; W333610103997; W333610054350; W333610052033; W333610010309; W038309120873; W038309101325; W038308057636; ",".","23","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",3/4/2014,"03/04/2014",7/2/2014,"07/02/2014"
"Biologics",68117,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","North Carolina; Missouri; New York; New Jersey; Switzerland; California","B-0618-14","Class II","Cryoprecipitated AHF","W333613096101; ",".","1","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",3/4/2014,"03/04/2014",7/2/2014,"07/02/2014"
"Biologics",68117,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","North Carolina; Missouri; New York; New Jersey; Switzerland; California","B-0619-14","Class II","Cryoprecipitated AHF, Pooled","W333614009929; W333613078070; W333613058160; W333613041797; ",".","4","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",3/4/2014,"03/04/2014",7/2/2014,"07/02/2014"
"Food",68118,"Ongoing","Orange Peel Enterprises, Inc.","Vero Beach","FL","US","Voluntary: Firm Initiated","Letter","AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MO, MS, NC ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA WI, WY, and Hawaii Foreign: Ireland, Barbados","F-1991-2014","Class II","Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages.","Lot Codes: BB 10MAY14 F1 2883; BB 11JUN14 F2 3153; BB09JUL14 F1 3433; BB3AUG14 F1, F2 0034; BB23AUG14 F1-F2 0234; BB03OCT14 F3 0624",,"117,036 bars all Flavors","Undeclared milk protein in chocolate coating.",4/14/2014,"04/14/2014",6/11/2014,"06/11/2014"
"Food",68118,"Ongoing","Orange Peel Enterprises, Inc.","Vero Beach","FL","US","Voluntary: Firm Initiated","Letter","AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MO, MS, NC ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA WI, WY, and Hawaii Foreign: Ireland, Barbados","F-1993-2014","Class II","Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.","Lot Codes: BB 10MAY14 F1 2833; BB 11JUN14 F1 3153; BB 09JUL14 F1 3433; BB 03AUG14 F1, F2 0034; BB 03OCT14 F1-F2 0624",,"117,036 bars all Flavors","Undeclared milk protein in chocolate coating.",4/14/2014,"04/14/2014",6/11/2014,"06/11/2014"
"Food",68118,"Ongoing","Orange Peel Enterprises, Inc.","Vero Beach","FL","US","Voluntary: Firm Initiated","Letter","AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MO, MS, NC ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA WI, WY, and Hawaii Foreign: Ireland, Barbados","F-1992-2014","Class II","Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.","Lot Codes: BB 11MAY14 F2 2833; BB 11JUN14 F2 3152; BB 09JUL14 F1 3433; BB 03AUG14 F1, F1 0034; BB 23AUG14 F1-F2 0234; BB 03OCT14 F1-F2 0624",,"117,036 bars all Flavors","Undeclared milk protein in chocolate coating.",4/14/2014,"04/14/2014",6/11/2014,"06/11/2014"
"Food",68119,"Ongoing","UB Inc DBA United Bakery & Co","West Sacramento","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, HI, WA, NJ, OH,","F-2013-2014","Class I","United Bakery Grissini Parmesan Bread Sticks,; Made with Extra Virgin Olive Oil and Grano Padano Cheese; All Natural, Trans Fat Free; Packaged in 8 oz (227g) and 4.5 oz (128g) containers. Also packaged for Safeway - Safeway Select Parmesan Grissini Breadsticks, 8 oz. (227g) containers. Made in USA Ingredient: Wheat Flour, Water, Unsalted butter, yeast, Extra virgin Olive Oil, Imported Grano Padano Cheese, garlic, sea salt, malted barley, non fat milk, ascorbic acid, natural enzymes. United Bakery, W. Sacramento, CA","4.5 oz container - UPC numbers: 8-91373000762; 8-913730010769 8. oz container - UPC number - 8-91373001026; Safeway UPC - 0-21130-11823 6",".","14, 356 cases - sold in 18 pack cases and 12 pack cases","Internal label review found egg is an ingredient of Grano Padano Cheese used in Parmesan Bread Sticks, but not declared in product ingredient statement or allergen statement.",4/22/2014,"04/22/2014",6/18/2014,"06/18/2014"
"Food",68120,"Ongoing","Miravalle Foods, Inc","El Monte","CA","US","Voluntary: Firm Initiated","Letter","California, Utah, Idaho, Colorado, Nevada, Washington and Oregon.","F-1969-2014","Class I","Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz.","Lot Numbers: 0015 and 0018. UPC number: 712810005020.",,"14,299 units","Ground Annato spice has the potential to be contaminated with Salmonella.",4/22/2014,"04/22/2014",6/4/2014,"06/04/2014"
"Drugs",68121,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1341-2014","Class II","QVAR (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. ","130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations ",".","461,592 canisters","Defective Delivery System; defective valve",4/23/2014,"04/23/2014",5/28/2014,"05/28/2014"
"Drugs",68122,"Ongoing","Sung Soo Kim","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","US nationwide.","D-1535-2014","Class I","Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5. ","Lot #: L1P1-6100 (expiry 6/25/2016) and L1P2-6000 (expiry 9/16/2016). ",".","6,336 bottles","Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.",4/15/2014,"04/15/2014",8/20/2014,"08/20/2014"
"Drugs",68123,"Ongoing","SigmaPharm Laboratories LLC","Bensalem","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1344-2014","Class II","Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.","Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015 ",".","43,007 Bottles","Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.",4/22/2014,"04/22/2014",5/28/2014,"05/28/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1689-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 4.5'' Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXH0535, HUXH0696, HUXK0747",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1692-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 6''x10'' Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK0744, HUXL1004",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1694-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS TM 7''x9'' Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK0899",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1683-2014","Class II","Composix'' LP with Echo PS'' 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK1536",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1687-2014","Class II","BardVentralight'' ST Mesh with Echo PS'' 10''x13'' Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK0900, HUXK0901, HUXL1148",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1691-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 6'' CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXH0694, HUXL1149, HUXL1150, HUYA1005",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1685-2014","Class II","Bard Composix'' LIP Mesh with Echo PS'' 7''x9'' Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK1539",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1695-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 8'' Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK0058",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1696-2014","Class II"," Bard Ventralight'' ST Mesh with Echo PS'' 8''x10'' Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, HUXL 1147",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1682-2014","Class II","Composix'' LP with Echo PS'' 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","HUXH0294, HUXL0314",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1684-2014","Class II","Composix'' LP with Echo PS'' 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK0073, HUXK1537 ",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1686-2014","Class II","Bard Composix'' LIP Mesh with Echo PS'' 8''x10'' Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXK1540",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1693-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 6''x8'' Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1688-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 12''x14'' Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUYA1057",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Devices",68124,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM","Z-1690-2014","Class II","Bard Ventralight'' ST Mesh with Echo PS'' 4''x6'' Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. ","Lot Number: HUXH0695",,,"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. ",4/24/2014,"04/24/2014",6/11/2014,"06/11/2014"
"Biologics",68125,"Terminated","American National Red Cross, Northeastern Region","Hanover Township","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0613-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W200114046137; W200114043726; W200114055183; W203014000716; ",".","4","Blood products, labeled with extended expiration dates following irradiation, were distributed.",3/11/2014,"03/11/2014",7/2/2014,"07/02/2014"
"Biologics",68126,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Wisconsin","B-0701-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W20171480044400; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",3/11/2014,"03/11/2014",7/2/2014,"07/02/2014"
"Biologics",68127,"Completed","Merck Sharpe & Dohme Corp","West Point","PA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0625-14","Class II","Hepatitis B Vaccine (Recombinant)","J001183",".","1 Lot","Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed. ",6/26/2013,"06/26/2013",5/14/2014,"05/14/2014"
"Devices",68128,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Distribution to US (states: MA, NY, OH, PA & TX) and Canada.","Z-1850-2014","Class II","Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.","Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.",".","68 units","Potential for the welded seam in affected monitor spring arms to crack and/or break.",4/4/2014,"04/04/2014",7/2/2014,"07/02/2014"
"Devices",68129,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","Z-1623-2014","Class II","LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage ","List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS",".","42,292 sets (US only)","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",5/28/2014,"05/28/2014"
"Devices",68129,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","Z-1624-2014","Class II","LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures ","List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS, 35117NS",".","1,109,321 set (US); 15,113 sets (Foreign)","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",5/28/2014,"05/28/2014"
"Devices",68129,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","Z-1625-2014","Class II","LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation ","List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS",".","1,613,775 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",5/28/2014,"05/28/2014"
"Devices",68129,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","Z-1626-2014","Class II","LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems ","List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS",".","167,574 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",5/28/2014,"05/28/2014"
"Devices",68129,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","Z-1627-2014","Class II","LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures ","List No. 15239-04-01 (15239-01); Lot Numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, 31041NS",".","29,380 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",5/28/2014,"05/28/2014"
"Drugs",68130,"Ongoing","Prestige Brands Holdings","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Nationwide, and one consignee in Libya","D-1353-2014","Class III","PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523","UPC 814832013523 Lots: Expiry Date 148342 07/2015 148347 08/2015 149297 08/2015 149382 07/2015 149516 08/2015 152298 08/2015 73143 04/2014 73719 05/2014 74195 06/2014 74805 06/2014 75180 06/2014 79186 09/2014 79323 09/2014",,"17,479 cases/12 dual packs","Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution",4/25/2014,"04/25/2014",6/4/2014,"06/04/2014"
"Drugs",68130,"Ongoing","Prestige Brands Holdings","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Nationwide, and one consignee in Libya","D-1352-2014","Class III","PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544","UPC 814832013544 Lots: Expiry Date 133196 01/2015 144273 02/2015 154090 09/2015 73242 05/2014 73243 05/2014 73244 05/2014 73824 06/2014 74207 06/2014 74303 06/2014 74460 06/2014 78805 09/2014 79265 10/2014 79266 10/2014 79573 09/2014 80456 06/2014 80457 07/2014 83746 01/2015",,"12,269 cases/36 bottles","Presence of Precipitate; small amounts of diphenydramine precipitated out of solution",4/25/2014,"04/25/2014",6/4/2014,"06/04/2014"
"Veterinary",68132,"Ongoing","Piramal Critical Care, Inc.","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Nationwide to distributors and physicians in NY, PA, NC, TN, MA, ME, IA, IL, IN, MS, FL, NE, OH, OR, WI, MO, MI, MN, and NJ.","V-072-2014","Class III"," Petrem, lot S2991K16 Sevoflurane, USP , 250 mL, packaged in an amber glass vial, NDC 60307-320-25, for use in dogs, ANADA 200-438, manufactured by MINRAD, INC., Bethlehem, PA. Piramal Inc is the actual manufacturing site dba as MINRAD, INC. since 2009. "," lot S2991K16 , exp 11/2016. ",,"2052","One lot of Petrem was recalled due to retained material not meeting the Acidity/Alkalinity specifications as set forth in the USP Monograph for Sevoflurane. ",4/7/2014,"04/07/2014",6/25/2014,"06/25/2014"
"Biologics",68133,"Terminated","Genzyme, A Sanofi Company","Cambridge","MA","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico","B-0992-14","Class III","Genzyme Thymoglobulin [Anti-thymocyte Globulin (Rabbit)], 25 mg (NDC 58468-0080-01)","Lot Number C1280C01 C1286C02 ",,"62,208","Anti-Thymocyte Globulin (Rabbit) 25 mg, with a trend approaching the upper limit on the molecular size distribution tests for polymers, aggregates and fragments, was distributed. ",3/24/2014,"03/24/2014",10/1/2014,"10/01/2014"
"Food",68134,"Ongoing","H:20 Innovations LLC","Ann Arbor","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Michigan and Ohio Distribution Centers","F-1953-2014","Class II","Meijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15; 24 bottles per case, 6-4packs","Lot # P0127513",".","900 cases (21,600 bottles)","H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation.",3/26/2014,"03/26/2014",5/28/2014,"05/28/2014"
"Food",68134,"Ongoing","H:20 Innovations LLC","Ann Arbor","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Michigan and Ohio Distribution Centers","F-1952-2014","Class II","Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs","Lot # P0127413",".","720 cases (17, 280 bottles)","H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation.",3/26/2014,"03/26/2014",5/28/2014,"05/28/2014"
"Devices",68135,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Distributed in the state of MO.","Z-1739-2014","Class III","NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.","Lot Number: 14CMLB006",".","12 bottles","Container cap may contain foreign material- 0.60% - 0.80% Manganese ",5/1/2014,"05/01/2014",6/18/2014,"06/18/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1303-2014","Class II","Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.","Lot Code: 13348",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1307-2014","Class II","Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.","Lot Code: 13350",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1308-2014","Class II","Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. ","Lot Code: 13351",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1304-2014","Class II","Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .","Lot Code: 13348",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1305-2014","Class II","Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.","Lot Code: 13350",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Drugs",68136,"Ongoing","Mangiacotti","Attleboro","MA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1306-2014","Class II","Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.","Lot Code: 13350",".",,"Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.",12/27/2013,"12/27/2013",5/14/2014,"05/14/2014"
"Food",68137,"Completed","Stonyfield Farm","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","AL, DE, FL, GA, MD, NC, NJ, PA, SC, TN, VA OR, Mt, AL, CA, WA","F-1955-2014","Class II","Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178","Code Date: June 05 2014",".","427 cases","Product has elevated levels of coliforms",4/24/2014,"04/24/2014",5/28/2014,"05/28/2014"
"Food",68137,"Completed","Stonyfield Farm","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","AL, DE, FL, GA, MD, NC, NJ, PA, SC, TN, VA OR, Mt, AL, CA, WA","F-1956-2014","Class II","Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-052159701215","Code Date: June 05 2014",".","440 cases","Product has elevated levels of coliforms",4/24/2014,"04/24/2014",5/28/2014,"05/28/2014"
"Food",68137,"Completed","Stonyfield Farm","Londonderry","NH","US","Voluntary: Firm Initiated","Telephone","AL, DE, FL, GA, MD, NC, NJ, PA, SC, TN, VA OR, Mt, AL, CA, WA","F-1954-2014","Class II","Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161","Code Date: June 05 2014",".","3429 cases","Product has elevated levels of coliforms",4/24/2014,"04/24/2014",5/28/2014,"05/28/2014"
"Biologics",68138,"Terminated","American National Red Cross ARC Blood Services N.E. Region","Burlington","VT","US","Voluntary: Firm Initiated","FAX","NH","B-0708-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W203414022292",,"1 unit","Blood products, which were labeled with an incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Biologics",68138,"Terminated","American National Red Cross ARC Blood Services N.E. Region","Burlington","VT","US","Voluntary: Firm Initiated","FAX","NH","B-0707-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W203414011837; W203414020459",,"2 units","Blood products, which were labeled with an incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Biologics",68139,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","MO","B-0661-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W201114001693; W201114031135",,"2 units","Blood products, labeled with the incorrect expiration date, were distributed.",3/13/2014,"03/13/2014",6/25/2014,"06/25/2014"
"Biologics",68140,"Terminated","DCI Biologicals Orlando LLC","Orlando","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0660-14","Class III","Source Plasma","OL0389425",,"1 unit","Blood product, collected from a donor for whom there was no documentation of an arm inspection or general donor appearance, was distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Devices",68141,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.","Z-1533-2014","Class II","GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.","Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 301295MR4 00001106XF5046 301295MR5 00000301518MR7 301295MR6 00000000UA0027 3014643TMR 00000300687MR1 "," 00000294156MR5 2806034DVR750 00000302922MR0 MR302922MR0 00000303872MR6 MR303872MR6 00000000HM0678 MR307145MR3 00000305378MR2 MRHM0503 00000301495MR8 MRHM0562 00000307055MR4 0004169252XX 00000308183MR3 MR308183MR3 00001026XF5174 MRWB0632 00001234FMM0HT MRHM0828 00000307505MR8 00001308FMM062 00000000HM0397 MA1135MR02 00000304910MR3 AMS0424 00000292216MR9 RTD0125 00000293603MR7 RTD0127 00000303279MR4 RTD0156 00000000UA0080 RTD0191 00000301256MR4 RTD0422 00000304018MR5 TLB0229 00000304579MR6 UDN0120 00000000UA0095 UDN0121 00001106XF50E1 00001220FMM01F NC1028MR01 00000288409MR6 920279028 00001140FMM0G4 920279031 00000000HM0498 920279032 00001308FMM052 85092252519 00000297987MR0 NO1009MR02 00000295830MR4 NO1017MR03 00000304318MR9 NO1146MR02 00001106XF5121 OM1010MR01 00000296493MR0 PL1539MR01 00001106XF5132 PL1735MR02 00000306315MR3 PL1735MR03 00000296622MR4 PL1803MR01 00000303814MR8 PL2762MR01 00001105XF5047 PL2853MR01 00000305424MR4 PL2902MR01 00000000HM0613 PL1196MR01 00000000UA0190 600042MR02 00000000HM0809 PL1501MR03 00001308FMM05X PL3105MR01 00000307613MR0 PL3116MR01 00000305814MR6 00000305118MR2 MR16061YR4 00000298309MR6 QA1044MR01 00000000UA0221 QA1042MR01 00000000UA0079 RO1098MR02 00000300865MR3 600098MR01 00000304404MR7 RU1089MR05 00001233FMM06U RU1092MR02 00000301026MR1 RU1716MR01 00000301051MR9 RU1857MR03 00000305404MR6 RU2527MR01 00001101XF5070 RU2580MR02 00001251FMM032 RU3431MR01 00000296594MR5 RU3508MR01 00000300705MR1 RU3894MR01 00000301914MR8 RU3932MR01 00000303355MR2 RU6340MR01 00001105XF504C RU7762MR01 0000000UA0024A RU5599MR01 00000000HM0668 RU2526MR02 00000000HM0677 RU8282MR01 00000000HM0820 RU3637MR01 00000000HM0475 RU7620MR01 00000000UA0227 RU8438MR01 00000308901MR8 RU8541MR01 00001102XF500D 00000296613MR3 SA1011MR03 00000000HM0263 SA1011MR04 00000299965MR4 SA1012MR02 00000303776MR9 SA1031MR02 00000000UA0022 SA1033MR01 00000298266MR8 SA1052MR03 00000300882MR8 SA1058MR02 00000299951MR4 SA1114MR01 00000303644MR9 SA1175MR01 00000000HM0597 SA1255MR02 00000293984MR1 SA2180MR02 00000303666MR2 SA2281","1,548 units (704 US, 844 OUS).","GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.",4/23/2014,"04/23/2014",5/7/2014,"05/07/2014"
"Devices",68142,"Ongoing","Maquet Medical Systems USA","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1730-2014","Class II","Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.","Part number (begins with ALM) and associated serial numbers: ALM568300999 13, 14, 16, 19, 20, 21, 22, 23, 24, 25, 29, 30, 31, 32, 34, 35, 36, 41, 50 ALM568301999 13, 14, 16, 17, 20, 23, 24, 25, 26, 52, 54, 55, 56, 57, 60, 63, 64, 65, 66, 70, 71, 72, 74 ALM568302999 11, 43, 44, 46, 49, 50, 51, 54, 57, 58, 59, 6, 61, 63, 64, 66, 67, 71, 72, 74, 77, 78, 80, 81 ALM568303999 8, 9, 32, 52, 53, 58, 60, 61, 62, 65, 66, 69, 70, 71, 73, 74, 75, 77, 78, 79, 80, 81, 82, 85, 86, 87, 89, 91, 92, 94, 95, 96, 97, 99, 100, 105, 106, 108, 111, 118, 120, 121, 122, 159 ALM568320901 12012, 40015, 40017, 40018, 40019, 40020, 40021, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 50022, 50023, 50024, 50025, 50026, 50027, 50028, 50030, 50031, 50032, 50033, 50034, 50035, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50047, 50048, 50050, 50051, 50052, 50053, 50054, 50055, 50056, 50058, 50059, 50060, 50061, 50064, 50066, 50067, 50068, 50069, 50070, 50071, 50072, 70033, 70034, 70035 ALM568320905 40003, 40004, 40005, 40006, 40007, 40008, 40009, 40010, 40011, 40012, 40013, 40014, 40015, 40016, 50003, 50004, 50005, 50006, 50008, 50009, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 60003, 60004, 70001, 70002, 70003, 70004, 70005, 70006, 70007, 70009, 70010, 70011, 70012, 70013, 70014, 70015, 70016, 70017, 70018, 70019, 70020, 70021, 70022, 70024, 70025, 70027, 70028, 70029, 70030, 70031, 70032, 70033, 70034, 70035, 70036, 70037, 70038, 70039, 70040, 70041, 70042, 70043, 70044, 70045, 70046, 70047, 70048, 70049, 70050, 70051, 70052, 70053, 70054, 70055, 70056, 70057, 70058, 70059, 70060, 70061, 70063, 70064, 70066, 70068, 70069 ALM568370900 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20039, 20040, 20041, 20042, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 30038, 30039, 30053, 30054, 40006, 40010, 40012, 40013, 40014, 40015, 40016, 40018, 40019, 40020, 40027, 40028, 40029, 400",".","United States 1169 units","Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.",4/16/2014,"04/16/2014",6/18/2014,"06/18/2014"
"Devices",68143,"Ongoing","William C. Domb, D.M.D., A Professional Corporation","Upland","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.","Z-1576-2014","Class II","Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.","Lot # 10BT-091237",,"16 units","William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.",4/23/2014,"04/23/2014",5/21/2014,"05/21/2014"
"Devices",68144,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.","Z-1615-2014","Class II","ExploR 7x26mm Modular Radial Stem, Product Usage: Biomet manufactures a variety of elbow joint Radial Head and Modular Radial Head prostheses intended for primary and revision joint athroplasty for use in cemented and uncemented press fit applications. Page 5 of the surgical technique states Once the radial head has been fully seated on the radial stem, place the set screw packaged with the stem to secure the head to the stem.","Catalog Number: 11-210062 Lot Number Identification: 972230",,"8 devices","This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.",4/22/2014,"04/22/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1602-2014","Class II","UPGRD PRGM 9734638 ADD AxiEM NAVIGATION","Lot No.: 6148186",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1595-2014","Class II","SPHERES 8801071 1/TRAY 12PK","Lot No.: 1203122 1205291 1206251 1306081 1309101 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1598-2014","Class II","TRAJ GUIDE KIT, 9733066, BIOPSY, INT","Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1601-2014","Class II","TUMOR RESECTION KIT 9733608 SKULL MOUNT","Lot No.: 120725D 130404B ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1588-2014","Class II","MOUSE 9732721 STERILE O-ARM 10PK","Lot No.: 5051140611 5336060213 5162060112 4734921009 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1594-2014","Class II","SHUNT KIT 9733605 NON-INVASIVE","Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1597-2014","Class II","TRAJ GUIDE KIT, 9733065, BIOPSY, EXT","Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1589-2014","Class II","PACK 9731975 TUMOR RESECTION AXIEM CR","Lot No.: 0006922410",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1583-2014","Class II","DRAPE 9732722 TUBE STERILE O-ARM 20PK","Lot No.: D120065 D121495 D121515 D120175 D122611 D101555 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1596-2014","Class II","SPHERES 8801075 5/TRAY 12PK","Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1578-2014","Class II","BAG 9732315 MOUSE STERILE 15 PK","Lot No.: 5246110712 5316560113 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1593-2014","Class II","PIN, 9733236, 150MM, STERILE, PERC REF","Lot No.: 2013041109",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1584-2014","Class II","ENT PRGM 9734636 ADD FUSION NAV AxiEM","Lot No.: 6917614",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1587-2014","Class II","KIT, 9731427, THORACIC TACTILE PROBES","Lot No.: 6688089 6095124 6095129 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1579-2014","Class II","BIOPSY NEEDLE KIT, 9733068, PASSIVE","Lot No.: 66516213 66501413 66518413 66507713 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1582-2014","Class II","DISP 9730951 STRL SPHERE, 5PK INSERT","Lot No.: B155300281",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1590-2014","Class II","PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT","Lot No.: 121130B",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1599-2014","Class II","TUMOR RES. PACK 9733553 AxiEM S.M.","Lot No.: 6402019 6402024 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1580-2014","Class II","BIT 9733516 2.9mm DRILL STERILE","Lot No.: 130204G",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1600-2014","Class II","TUMOR RESECTION KIT 9733607 NON-INVASIVE","Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1586-2014","Class II","INSTRUMENT TRACKER 9733533XOM ENT 1PK","Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1592-2014","Class II","PIN, 9733235, 100MM, STERILE, PERC REF","Lot No.: 2012110744 2013010347 2012081458 ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1591-2014","Class II","PATIENT TRACKER 9733534XOM ENT 1PK","Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G ",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1585-2014","Class II","INST 9731132 KIT CR REF FRAME DRIVER 5PK","Lot No.: r683",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1581-2014","Class II","DISP 9730950 STRL SPHERE, 1 PK INSERT","Lot No.: B135276281",,"26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",5/21/2014,"05/21/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1590-2014","Class II","PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT","Lot No.: 121130B",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1581-2014","Class II","DISP 9730950 STRL SPHERE, 1 PK INSERT","Lot No.: B135276281",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1582-2014","Class II","DISP 9730951 STRL SPHERE, 5PK INSERT","Lot No.: B155300281",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1598-2014","Class II","TRAJ GUIDE KIT, 9733066, BIOPSY, INT","Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1583-2014","Class II","DRAPE 9732722 TUBE STERILE O-ARM 20PK","Lot No.: D120065 D121495 D121515 D120175 D122611 D101555 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1594-2014","Class II","SHUNT KIT 9733605 NON-INVASIVE","Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1595-2014","Class II","SPHERES 8801071 1/TRAY 12PK","Lot No.: 1203122 1205291 1206251 1306081 1309101 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1588-2014","Class II","MOUSE 9732721 STERILE O-ARM 10PK","Lot No.: 5051140611 5336060213 5162060112 4734921009 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1596-2014","Class II","SPHERES 8801075 5/TRAY 12PK","Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1585-2014","Class II","INST 9731132 KIT CR REF FRAME DRIVER 5PK","Lot No.: r683",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1599-2014","Class II","TUMOR RES. PACK 9733553 AxiEM S.M.","Lot No.: 6402019 6402024 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1602-2014","Class II","UPGRD PRGM 9734638 ADD AxiEM NAVIGATION","Lot No.: 6148186",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1597-2014","Class II","TRAJ GUIDE KIT, 9733065, BIOPSY, EXT","Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1600-2014","Class II","TUMOR RESECTION KIT 9733607 NON-INVASIVE","Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1601-2014","Class II","TUMOR RESECTION KIT 9733608 SKULL MOUNT","Lot No.: 120725D 130404B ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1589-2014","Class II","PACK 9731975 TUMOR RESECTION AXIEM CR","Lot No.: 0006922410",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1593-2014","Class II","PIN, 9733236, 150MM, STERILE, PERC REF","Lot No.: 2013041109",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1580-2014","Class II","BIT 9733516 2.9mm DRILL STERILE","Lot No.: 130204G",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1578-2014","Class II","BAG 9732315 MOUSE STERILE 15 PK","Lot No.: 5246110712 5316560113 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1591-2014","Class II","PATIENT TRACKER 9733534XOM ENT 1PK","Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1584-2014","Class II","ENT PRGM 9734636 ADD FUSION NAV AxiEM","Lot No.: 6917614",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1592-2014","Class II","PIN, 9733235, 100MM, STERILE, PERC REF","Lot No.: 2012110744 2013010347 2012081458 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1586-2014","Class II","INSTRUMENT TRACKER 9733533XOM ENT 1PK","Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1587-2014","Class II","KIT, 9731427, THORACIC TACTILE PROBES","Lot No.: 6688089 6095124 6095129 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Devices",68145,"Ongoing","Medtronic Navigation, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1579-2014","Class II","BIOPSY NEEDLE KIT, 9733068, PASSIVE","Lot No.: 66516213 66501413 66518413 66507713 ",".","26,674 total","Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",4/24/2014,"04/24/2014",11/26/2014,"11/26/2014"
"Biologics",68146,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","Mississippi","B-0602-14","Class III","Bone","84320180; 84320181; 84320182; 84320184; 84320185; 84320186; 84320194; 84320195; 84320196; 84320197; 84320198; 84320199; 84320200; 84320201; 84320202; 84320203; 84320204; 84320205; 84320206; 84320207; 84320208; 84320209; 84320210; 84320211; 84320212; 84320213; 84320214; 84320215; 84320216; 84320217; 84320218; 84320219; 84320220; 84320221; 84320222; 84320223; 84320224; 84320225; 84320226; 84320227; 84320228; 84320229; 84320187; 84320188; 84320189; 84320190; 84320191; 84320192; 84320193; 84320158; 84320167; 84320175; 84320183; 84320150; 84320131; 84320132; 84320133; 84320134; 84320135; 84320136; 84320137; 84320138; 84320139; 84320140; 84320141; 84320142; 84320143; 84320144; 84320145; 84320146; 84320147; 84320148; 84320149; 84320151; 84320152; 84320153; 84320154; 84320155; 84320156; 84320157; 84320159; 84320160; 84320161; 84320162; 84320163; 84320164; 84320165; 84320166; 84320168; 84320169; 84320170; 84320171; 84320172; 84320173; 84320174; 84320176; 84320177; 84320178; 84320179",,"99 bone allografts","Human bone allografts, mislabeled with an extended expiration date, were distributed. ",3/7/2014,"03/07/2014",5/7/2014,"05/07/2014"
"Biologics",68147,"Terminated","Community Blood Council of New Jersey, Inc.","Ewing","NJ","US","Voluntary: Firm Initiated","FAX","PA, NJ","B-0657-14","Class III","Fresh Frozen Plasma","W126213008846 ",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/9/2014,"04/09/2014",6/25/2014,"06/25/2014"
"Biologics",68147,"Terminated","Community Blood Council of New Jersey, Inc.","Ewing","NJ","US","Voluntary: Firm Initiated","FAX","PA, NJ","B-0656-14","Class III","Red Blood Cells Leukocytes Reduced","W126213008846",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/9/2014,"04/09/2014",6/25/2014,"06/25/2014"
"Biologics",68148,"Terminated","American Red Cross Blood Services","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","MS","B-0662-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W2041140102461",,"1 unit","Blood products, labeled with the incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Biologics",68148,"Terminated","American Red Cross Blood Services","Birmingham","AL","US","Voluntary: Firm Initiated","Telephone","MS","B-0663-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W204114008316",,"1 unit","Blood products, labeled with the incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Biologics",68149,"Terminated","American Natl Red Cross Mid Atlantic Region","Norfolk","VA","US","Voluntary: Firm Initiated","Telephone","VA","B-0706-14","Class III","Red Blood Cells Leukocytes Reduced","W20291403103000; W20291400499100",,"2 units","Blood products, which were labeled with an incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Devices",68150,"Ongoing","CryoLife, Inc.","Kennesaw","GA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.","Z-1674-2014","Class II","BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries). ","12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046, 12MUV047, 12MUV048, 12MUV049, 12MUV050, 12MUV051, 12MUV052, 12MUV053, 12MUV054, 12MUV055, 12MUV056, 12MUV057, 12MUV058, 12MUV059, 12MUV060, 12MUV061, 12MUV062, 12MUV063, 12MUV064, 12MUV065, 12MUV067, 12MUV068, 12MUV069, 12MUV070, 12MUV071, 12MUV072, 12MUV073, 12MUV074, 12MUV075, 12MUV076, 13MUV001, 13MUV002, 13MUV003, 13MUV004, ",,"6190 units","Serum albumin component monomer failed to meet internally established end of shelf-life specification.",4/25/2014,"04/25/2014",6/11/2014,"06/11/2014"
"Veterinary",68151,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","V-126-2014","Class II","LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544- 01; Hospira","List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS",".","1,613,775 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Veterinary",68151,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","V-124-2014","Class II","LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U- R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira","List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS",".","42,292 sets (US only)","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Veterinary",68151,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","V-125-2014","Class II","LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira","List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS, 35117NS",".","1,109,321 set (US); 15,113 sets (Foreign)","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Veterinary",68151,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","V-128-2014","Class II","LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira","List No. 15239-04-01 (15239-01); Lot Numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, 31041NS",".","29,380 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Veterinary",68151,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; *** FOREIGN: Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates","V-127-2014","Class II","LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira","List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS",".","167,574 sets","The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.",3/25/2014,"03/25/2014",7/2/2014,"07/02/2014"
"Drugs",68152,"Ongoing","Fresenius Kabi USA, LLC","Melrose Park","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1429-2014","Class II","Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10 ","Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15",,"728,880 vials","Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.",5/2/2014,"05/02/2014",7/16/2014,"07/16/2014"
"Drugs",68152,"Ongoing","Fresenius Kabi USA, LLC","Melrose Park","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1428-2014","Class II","Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 ","Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15",,"2,070,500 vials","Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.",5/2/2014,"05/02/2014",7/16/2014,"07/16/2014"
"Devices",68153,"Ongoing","C P Medical Inc.","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide","Z-1708-2014","Class II","Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle","Lot 130826-08, expiration 2015-07.",,"US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).","CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength. ",4/23/2014,"04/23/2014",6/11/2014,"06/11/2014"
"Biologics",68154,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","SC","B-0722-14","Class III","Red Blood Cells","W121614121670",,"1 unit","Blood product, collected from a donor without documenting the body temperature, was distributed. ",4/17/2014,"04/17/2014",6/25/2014,"06/25/2014"
"Biologics",68155,"Terminated","American National Red Cross","Columbus","OH","US","Voluntary: Firm Initiated","Telephone","OH","B-0726-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W201614019112; W201614014541",,"2 units","Blood product, which was labeled with an incorrect expiration date, was distributed.",3/11/2014,"03/11/2014",6/25/2014,"06/25/2014"
"Biologics",68156,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-0716-14","Class II","Red Blood Cells","W036810058843; W036811019309 ",,"2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68156,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-0717-14","Class II","Platelets Pooled Leukocytes Reduced","W036811802914",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68156,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-0718-14","Class II","Fresh Frozen Plasma","W036811019309",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68156,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; FL","B-0715-14","Class III","Blood and Blood Products for Reprocessing","W036810058843",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68157,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","TN","B-0725-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W201914016019",,"1 unit","Blood product, which was labeled with an incorrect expiration date, was distributed.",3/10/2014,"03/10/2014",6/25/2014,"06/25/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1320-2014","Class II","Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533","Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty. ",,"unknown","Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1316-2014","Class II","Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357*","Lot #: F040, Exp 08/16",,"unknown","Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1318-2014","Class II","Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 ","Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015 ",,"unknown","Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1319-2014","Class II","Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302","Lot #: 130616, Exp 06/16",,"unknown","Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1317-2014","Class II","Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576","Lot #: UB302, Exp 05/12/15",,"unknown","Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Drugs",68158,"Ongoing","Flawless Beauty LLC","Asbury Park","NJ","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1321-2014","Class II","Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219","Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16 ",,"unknown","Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.",4/29/2014,"04/29/2014",5/21/2014,"05/21/2014"
"Devices",68159,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Illinois, Florida, Maryland, Massachusetts, North Carolina, Pennsylvania, South Dakota and Internationally to Australia, Austria, Belgium, Chile, Finland, Germany, Great Britain, Greece, Israel, Italy and Russia.","Z-1675-2014","Class II","Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor. ","Catalog Number BC10R Lot Nos: 051113, 100913, 140513, 161013, 25013",,"49 test probes","Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous ''calibration test failure'' message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor (AC31).",4/16/2014,"04/16/2014",6/11/2014,"06/11/2014"
"Food",68160,"Ongoing","HK GALLERIA WHOLESALE L.P","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","California","F-5060-2014","Class II","Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case ","Lot#: 2015-01-24",,"460 cases","HK Galleria Wholesale is recalling Rice Porridge with Abalone because it may be contaminated with Clostridium botulinum.",4/29/2014,"04/29/2014",7/9/2014,"07/09/2014"
"Devices",68161,"Ongoing","Greatbatch Medical","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the state of UT.","Z-1614-2014","Class II","Coaxial Micro-Introducer Kit, Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard; 10636-002 8005011 Kit Coax 10 Pack 5FR Bard; 10636-007 8004012 Kit Coax 10 Pack 4FR Bard; 10636-008 8005012 Kit Coax 10 Pack 5FR Bard; 10636-009 8004022 Kit Coax 10 Pack 5FR Bard; 10636-010 8005022 Kit Coax 10 Pack 5FR Bard. The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.","W1190519 W1190532 W1190532 W1190514 W1190517 W1190517 W1190516 W1266849 W1266851 W1266850 W1266848 W1298418 W1300005 W1298419 W1298425 W1298426 W1362771 W1362772 W1362773 W1362775 W1383678 W1362774 W1420240 W1420241 W1420242 W1434887 W1434888 W1464513 W1464514 W1464516 W1464511 W1464512 W1464515 W1466090 W1466092 W1466093 W1466091 W1467421 W1477933 W1467420 W1477935 W1477932 W1477934 W1490379 W1477937 W1490378 W1490380 W1490377 W1477936 W1509174 W1509175 W1532502 W1532501 W1509173 W1599234 W1629461 W1661254 W1688745 W1720426 W1746962 W1720428 W1792523 W1786461 W1788967 W1770099 W1807382 W1807383 W1807378 W1872468 W1872469 W1872470 W1927797 W1872468 W1927798 W1927799 W1963380 W2012849 W2012851 W2012850 W2047027 W2058073 W2047028 W2073401 W2047030 W2047031 W2094903 W2110798 W2170053 W2155950 W2170050 W2170052 W2192990 W2211695 W2211696 W2211697 W2268277 W2268271 W2315849 W2315850 W2315845 W2315846 W2315848 W2357893 W2357894 W2371770 W2371771 W2392043 W2357895 W2357896 W2397846 W2371772 W2386295 W2451688 W2451690 W2451691 W2451692 W2451693 W2461057 W2461056 W2461058 W2513845 W2561761 W2561762",,"6,642 sets (66,420 devices)","Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.",4/28/2014,"04/28/2014",5/21/2014,"05/21/2014"
"Devices",68162,"Ongoing","RAYSEARCH LABORATORIES AB","Stockholm",,"SE","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.","Z-1806-2014","Class II","RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.","Software version 4.0.3.4",,"25 sites/245 units (US), 25 sites/124 units (foreign)","This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution. ",4/25/2014,"04/25/2014",6/25/2014,"06/25/2014"
"Food",68163,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.","F-1941-2014","Class I","Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton. Product labeled in part, ''PRIVATE SELECTION'' CHOCOLATE HAZELNUT MASCARPONE ICE CREAM chocolate covered hazelnuts folded into creamy mascarpone ice cream***INGREDIENTS: ICE CREAM MILK, CREAM SUGAR***MASCARPONE CHEESE (MILK, CREAM, CITRIC ACID)***CONTAINS: MILK, SOY, HAZELNUT***DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC: 0 11110 52101 9","ALL CODES",,"39,588 cs/8/16 fl oz cartons","The firm discovered that the label for two of their products did not declare eggs in the ingredient statement.",4/25/2014,"04/25/2014",5/21/2014,"05/21/2014"
"Food",68163,"Ongoing","Kroger Co","Cincinnati","OH","US","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.","F-1942-2014","Class I","Private Selection Caramel Hazelnut Fudge Truffle Ice Cream, 16 fl oz lamented carton. Product labeled in part, ''PRIVATE SELECTION'' CARAMEL HAZELNUT FUDGE TRUFFLE ICE CREAM caramel, hazelnuts and fudge truffles folded into chocolate ganache ice cream***INGREDIENTS: ICE CREAM - MILK, CREAM SUGAR***CARAMEL VARIEGATE***CHOCOLATE TRUFFLES***CONTAINS: MILK, HAZELNUT, SOY. MAY ALSO CONTAIN: PEANUTS, WHEAT, TREE NUTS.***DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC: 0 11110 52100 2''","SELL BY AUG 02 14 and SELL BY DEC 13 14",,"3,341 cs/8/16 fl oz cartons","The firm discovered that the label for two of their products did not declare eggs in the ingredient statement.",4/25/2014,"04/25/2014",5/21/2014,"05/21/2014"
"Food",68164,"Ongoing","Prep Enterprises Llc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","The products were sold to wholesale distributors in the following states: Alabama, Arizona, California, Texas, Washington, Nevada, New York, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio. Wordwide to Canada.","F-1988-2014","Class II","CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS CAPTAIN KRATOM PREMIUM THAI LEAF 15 Grams CAPTAIN KRATOM 30 grams Thai Capsules XL CAPTAIN KRATOM PREMIUM THAI CAPSULES 8 Grams MINI CAPTAIN KRATOM PREMIUM THAI RESIN 6 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 30 GRAMS","UPC 42008 06908",,"155,470 units","Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa). ",5/1/2014,"05/01/2014",6/11/2014,"06/11/2014"
"Food",68164,"Ongoing","Prep Enterprises Llc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","The products were sold to wholesale distributors in the following states: Alabama, Arizona, California, Texas, Washington, Nevada, New York, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts, and Ohio. Wordwide to Canada.","F-1989-2014","Class II","Arena Ethnobotanicals and Kratom Pro, sizes: 1oz, 4oz, and 8oz.","n/a",,"4,505 units","Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals and Kratom Pro products because they may be contain Kratom (mitragyna speciosa). ",5/1/2014,"05/01/2014",6/11/2014,"06/11/2014"
"Devices",68165,"Ongoing","Medtronic Inc. Cardiac Rhythm Disease Management","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.","Z-1661-2014","Class II","Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).","serial numbers: PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K, PEP001013P, PEP001014K, PEP001014P, PEP001015K, PEP001015P, PEP001016K, PEP001016P, PEP001017K, PEP001017P, PEP001018K, PEP001018P, PEP001019K, PEP001019P, PEP001020K, PEP001020P, PEP001021K, PEP001021P, PEP001022K, PEP001022P, PEP001023K, PEP001023P, PEP001024K, PEP001024P, PEP001025K, PEP001025P, PEP001026K, PEP001026P, PEP001027K, PEP001027P, PEP001028K, PEP001028P, PEP001029K, PEP001029P, PEP001030K, PEP001030P, PEP001031K, PEP001031P, PEP001032K, PEP001032P, PEP001033K, PEP001033P, PEP001034K, PEP001034P, PEP001035K, PEP001035P, PEP001036K, PEP001036P, PEP001037K, PEP001037P, PEP001038K, PEP001038P, PEP001039K, PEP001039P, PEP001040K, PEP001040P, PEP001041K, PEP001041P, PEP001042K, PEP001042P, PEP001043K, PEP001043P, PEP001044K, PEP001044P, PEP001045K, PEP001045P, PEP001046K, PEP001046P, PEP001047K, PEP001047P, PEP001048K, PEP001048P, PEP001049K, PEP001049P, PEP001050K, PEP001050P, PEP001051K, PEP001051P, PEP001052K, PEP001052P, PEP001053K, PEP001053P, PEP001054K, PEP001054P, PEP001055K, PEP001055P, PEP001056K, PEP001056P, PEP001057K, PEP001057P, PEP001058K, PEP001058P, PEP001059K, PEP001059P, PEP001060K, PEP001060P, PEP001061K, PEP001061P, PEP001062K, PEP001062P, PEP001063K, PEP001063P, PEP001064K, PEP001064P, PEP001065K, PEP001065P, PEP001066K, PEP001066P, PEP001067K, PEP001067P, PEP001068K, PEP001069K, PEP001069P, PEP001070K, PEP001070P, PEP001071K, PEP001071P, PEP001072K, PEP001072P, PEP001073K, PEP001073P, PEP001074K, PEP001074P, PEP001075K, PEP001075P, PEP001076K, PEP001076P, PEP001077K, PEP001077P, PEP001078K, PEP001078P, PEP001079K, PEP001079P, PEP001080K, PEP001080P, PEP001081K, PEP001081P, PEP001082K, PEP001082P, PEP001083K, PEP001083P, PEP001084K, PEP001084P, PEP001085K, PEP001085P, P"," PEP002974P, PEP002975P, PEP002976P, PEP002977P, PEP002978P, PEP002979P, PEP002980P, PEP002981P, PEP002982P, PEP002983P, PEP002984P, PEP002985P, PEP002986P, PEP002987P, PEP002988P, PEP002989P, PEP002990P, PEP002991P, PEP002992P, PEP002993P, PEP002994P, PEP002995P, PEP002996P, PEP002997P, PEP002998P, PEP002999P, PEP003000P, PEP003001P, PEP003002P, PEP003003P, PEP003004P, PEP003005P, PEP003006P, PEP003007P, PEP003008P, PEP003009P, PEP003010P, PEP003011P, PEP003012P, PEP003013P, PEP003014P, PEP003015P, PEP003016P, PEP003017P, PEP003018P, PEP003019P, PEP003020P, PEP003021P, PEP003022P, PEP003023P, PEP003024P, PEP003025P, PEP003026P, PEP003027P, PEP003028P, PEP003029P, PEP003030P, PEP003031P, PEP003032P, PEP003033P, PEP003034P, PEP003035P, PEP003036P, PEP003037P, PEP003038P, PEP003039P, PEP003040P, PEP003041P, PEP003042P, PEP003043P, PEP003044P, PEP003045P, PEP003046P, PEP003047P, PEP003048P, PEP003049P, PEP003050P, PEP003051P, PEP003052P, PEP003053P, PEP003054P, PEP003055P, PEP003056P, PEP003057P, PEP003058P, PEP003059P, PEP003060P, PEP003061P, PEP003062P, PEP003063P, PEP003064P, PEP003065P, PEP003066P, PEP003067P, PEP003068P, PEP003069P, PEP003070P, PEP003071P, PEP003072P, PEP003073P, PEP003074P, PEP003075P, PEP003076P, PEP003077P, PEP003078P, PEP003079P, PEP003080P, PEP003081P, PEP003082P, PEP003083P, PEP003084P, PEP003085P, PEP003086P, PEP003087P, PEP003088P, PEP003089P, PEP003090P, PEP003091P, PEP003092P, PEP003093P, PEP003094P, PEP003095P, PEP003096P, PEP003097P, PEP003098P, PEP003099P, PEP003100P, PEP003101P, PEP003102P, PEP003103P, PEP003104P, PEP003105P, PEP003106P, PEP003107P, PEP003108P, PEP003109P, PEP003110P, PEP003111P, PEP003112P, PEP003113P, PEP003114P, PEP003115P, PEP003116P, PEP003117P, PEP003118P, PEP003119P, PEP003120P, PEP003121P, PEP003122P, PEP003123P, PEP003124P, PEP003125P, PEP003126P, PEP003127P, PEP003128P, PEP003129P, PEP003130P, PEP003131P, PEP003132P, PEP003133P, PEP003134P, PEP003135P, PEP003136P, PEP003137P, PEP003138P, PEP003139P, PEP003140P, PEP003141P, PEP003142P, PEP003143P, PEP0","16,337 (8,989 US; 7,348 OUS)","Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.",4/29/2014,"04/29/2014",6/4/2014,"06/04/2014"
"Food",68166,"Completed","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","CT, MA, NJ, NY, RI","F-1951-2014","Class II","Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated","Sell By : 05/02/2014",".","190 lbs.","Potential for foreign material -glass ",4/29/2014,"04/29/2014",5/28/2014,"05/28/2014"
"Food",68167,"Ongoing","Mercola Group","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI); *** FOREIGN: Australia, Canada, China, Hong Kong, Iceland, Mexico, Netherlands, New Zealand, United Kingdom","F-1979-2014","Class II","Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail locations in display cases containing 12 bars per display case. 12 display cases are packaged in each master case.","UPC Code: 8 13006 01142 6; Lot Numbers and Best By Dates: CD2601MC01, 04/27/14; 2313, 08/19/14; 2323, 08/20/14; 3503, 12/16/14; 3513, 12/16/14; 3523, 12/16/14; 3533, 12/16/14",,"98,698 boxes (1,184,376 bars)","This voluntary recall has been initiated because the Dr. Mercola Organic Cocoa Cassava bars may contain undeclared milk protein.",4/29/2014,"04/29/2014",6/4/2014,"06/04/2014"
"Food",68168,"Terminated","T.H. Seafood Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Product was sold to 2 distributors in Washington State.","F-2021-2014","Class II","Raw, frozen, vacuum-packaged halibut (portions, fillets, and whole fish of various sizes). ","No code.",".","Approximately 2,050 lbs.","T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed halibut due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control the hazard of Clostridium botulinum.",4/25/2014,"04/25/2014",6/18/2014,"06/18/2014"
"Food",68168,"Terminated","T.H. Seafood Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Product was sold to 2 distributors in Washington State.","F-2020-2014","Class II","Raw, frozen, vacuum-packaged black cod (portions, fillets, and whole fish, various sizes). ","No code.",".","Approximately 2100 lbs.","T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed black cod due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control the hazard of Clostridium botulinum.",4/25/2014,"04/25/2014",6/18/2014,"06/18/2014"
"Food",68168,"Terminated","T.H. Seafood Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Product was sold to 2 distributors in Washington State.","F-2022-2014","Class II","Raw, frozen, vacuum-packaged salmon (portions, fillets, and whole fish, various sizes). ","No code.",".","Approximatley 2,000 lbs.","T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed salmon due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control the hazard of Clostridium botulinum.",4/25/2014,"04/25/2014",6/18/2014,"06/18/2014"
"Food",68168,"Terminated","T.H. Seafood Inc.","Seattle","WA","US","Voluntary: Firm Initiated","Telephone","Product was sold to 2 distributors in Washington State.","F-2019-2014","Class II","Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes). ","No code.",".","Approximately 2,000 lbs","T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed rockfish due to labeling instructions that do not direct the consumer to ''Keep Frozen-Thaw Under Refrigeration'' to control the hazard of Clostridium botulinum.",4/25/2014,"04/25/2014",6/18/2014,"06/18/2014"
"Drugs",68170,"Ongoing","Bacai Inc. Dba Ky Duyen House","Fountain Valley","CA","US","Voluntary: Firm Initiated","Letter","Worldwide via internet sales","D-1534-2014","Class I","Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com ","Lot #13165; Exp. 05/17 ",".","14,040 softgel capsules","Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.",4/30/2014,"04/30/2014",8/20/2014,"08/20/2014"
"Drugs",68171,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0293-2015","Class II","Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. ","Lot #: NC082768, Exp 12/23/2014",".","19,152 Containers","Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.",4/24/2014,"04/24/2014",12/17/2014,"12/17/2014"
"Biologics",68172,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","NV","B-0723-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W041913042347D-part 1; W041913042347D- part 2",,"2 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",4/22/2014,"04/22/2014",6/25/2014,"06/25/2014"
"Biologics",68173,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0724-14","Class II","Platelets Pheresis Leukocytes Reduced","W120613405578 ",,"1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",2/27/2014,"02/27/2014",6/25/2014,"06/25/2014"
"Biologics",68175,"Terminated","Delta Blood Bank","Stockton","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0812-14","Class II","Red Blood Cells Leukocytes Reduced","W128713068798",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",2/15/2014,"02/15/2014",9/10/2014,"09/10/2014"
"Drugs",68176,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines","D-1359-2014","Class II","CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18","4451B; 4451GL ",,"2,443,500 scrub brushes","Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. ",12/20/2013,"12/20/2013",6/11/2014,"06/11/2014"
"Drugs",68176,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines","D-1360-2014","Class II","CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15. ","4452B ",,"1,662,000 Surgical Scrub Brushes","Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. ",12/20/2013,"12/20/2013",6/11/2014,"06/11/2014"
"Devices",68177,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI","Z-2170-2014","Class II","Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngal swab, depending on the test, through automated nucleic acid extraction and hybridization. ","VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14",".","155 test cartridges","Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as ''IVD''. Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Cartridge Lot: 040214021A, Identification Numbers: 02148613 through 02148832.",4/17/2014,"04/17/2014",8/20/2014,"08/20/2014"
"Food",68178,"Ongoing","E & M Corporation, Dba Noh Foods International Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","Press Release","US distribution - HI, CA, FL, VA, ID, UT, NV, IL OR, WI, WA. Also Australia, French Polynesia. Mail order sales to FL, CA, MI, NM, WA, NY, NJ, TN, OR, MN, IA, ID and Canada.","F-1986-2014","Class I","Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 kg. Ingredients: Sugar, coconut ''powder, corn starch, locust bean gum, carrageenan, maltodextrin. 2 oz UPC 073562000504; 4 oz UPC 073562000559; 3 lb UPC 073562000511, NOH Foods of Hawaii, Honolulu, HI","All codes 2 oz UPC 073562000504; 4 oz UPC 073562000559; 3 lb UPC 073562000511,",,"25458 - 3lb cases, 13,337- 2 oz cases, 4103 4 oz cases ","Consumer complaint initiated testing of the product by University of Nebraska who found >5000 ppm of milk allergen.",5/1/2014,"05/01/2014",6/11/2014,"06/11/2014"
"Devices",68179,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution, including US nationwide, Argentina, Australia, Austria, Canada, Cayman Islands, Chile, Denmark, Finland, France, Germany, India, Iraq, Israel, Italy, Latvia, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Turkey and United Kingdom.","Z-1678-2014","Class II","IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.","ISP DX/HX/EX; Model number 881001, Serial numbers 35033, 85298, 80861, 81017, 81021, 81191, 82085, 82124, 82144, 82148, 82242, 85029, 85030, 85033, 85164, 85166, 85183, 85247, 85302, 85324, 85337, 85353, 85357, 85359, 85397, 85401, 85402, 87004, 87014, 87158, 87176, 87177, 87182, 87200, 92003, 95043, 95044, 95045, 95046, 95047, 95048, 95049, 95050, 95051, 95052, 95054, 850001, 870030, 870071, 870073, 870076, 920007, 920008, 950006, 950023, 950031, 950039, 950041, 950045, 950052, 950071, 950084, 950085, 950087, 950106, 950119, 950120, 950121, 950129, 950137, 950143 and 950146. ISP IX; Model number 881030, Serial numbers 40024, 40021, 40031, 40036, 40044, 40061, 40082, 40088, 40096, 40145, 40146, 40148, 40150, 40155, 40158, 40160, 40169 and 600003. ISP LX SPECT; Model number 881035, Serial numbers 40001, 40003, 40033, 40084, 40087, 40093, 40133, 40134 and 40141.",,"157 units","During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.",3/11/2014,"03/11/2014",6/11/2014,"06/11/2014"
"Biologics",68180,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Telephone","Texas","B-0668-14","Class II","Platelets Pheresis Leukocytes Reduced","W03651400894; ",,"1 unit","Blood product, in which Quality Control Distribution/Distribution of product did not meet specifications, was distributed.",3/25/2014,"03/25/2014",6/4/2014,"06/04/2014"
"Biologics",68181,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0669-14","Class II","Red Blood Cells Leukocytes Reduced","W118813612226; ",,"1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/27/2014,"03/27/2014",6/4/2014,"06/04/2014"
"Biologics",68182,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0670-14","Class II","Platelets Pheresis Leukocytes Reduced","W115914110486 ",,"1 unit","Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed.",4/17/2014,"04/17/2014",6/4/2014,"06/04/2014"
"Biologics",68183,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0672-14","Class II","Platelets Pheresis Leukocytes Reduced","W115914110414; W115914110414; ",,"2 units","Blood products, in which platelet units failed residual white blood cell counts, were distributed.",3/29/2014,"03/29/2014",6/4/2014,"06/04/2014"
"Biologics",68183,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0671-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W115914110414; ",," 1unit","Blood products, in which platelet units failed residual white blood cell counts, were distributed.",3/29/2014,"03/29/2014",6/4/2014,"06/04/2014"
"Biologics",68184,"Terminated","DCI Biologicals Orlando LLC","Orlando","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0705-14","Class III","Source Plasma","OL0390791; ",,"1 unit","Blood product, collected from a donor taking the medication Accutane, was distributed.",3/14/2014,"03/14/2014",6/25/2014,"06/25/2014"
"Biologics",68185,"Terminated","American National Red Cross","San Juan","PR","US","Voluntary: Firm Initiated","FAX","Puerto Rico","B-0641-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W20171401320400; ",".","1","Blood product, labeled with an extended expiration date following irradiation, was distributed.",3/11/2014,"03/11/2014",7/2/2014,"07/02/2014"
"Biologics",68186,"Terminated","DCI Biologicals, Orlando LLC","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0683-14","Class II","Source Plasma","GN0423685, WN0424245",".","2 units","Blood products, which were not quarantined after receiving post donation information concerning receipt of a tattoo, were distributed.",2/15/2014,"02/15/2014",5/28/2014,"05/28/2014"
"Biologics",68187,"Terminated","LifeShare Blood Centers","Beaumont","TX","US","Voluntary: Firm Initiated","Letter","Texas","B-0642-14","Class II","Red Blood Cells Leukocytes Reduced","W036513065139; ",".","1","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",2/27/2014,"02/27/2014",6/18/2014,"06/18/2014"
"Biologics",68188,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","Letter","Arkansas; Switzerland","B-0653-14","Class II","Red Blood Cells Leukocytes Reduced","W036513104300; ",".","1","Blood product, for which documentation of the donor history was incomplete, was distributed.",1/21/2014,"01/21/2014",6/18/2014,"06/18/2014"
"Biologics",68188,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","Letter","Arkansas; Switzerland","B-0654-14","Class III","Blood and Blood Products for Reprocessing","W036513104300; ",".","1","Blood product, for which the documentation of the donor history was incomplete, was distributed. ",1/21/2014,"01/21/2014",6/18/2014,"06/18/2014"
"Food",68189,"Ongoing","Six Dog, LLC","Wellington","CO","US","Voluntary: Firm Initiated","Press Release","Product was distributed in Colorado; some may have gone to Idaho, Kansas, New Mexico, and Utah. No military/govt/VA or foreign consignees.","F-2176-2014","Class I","Certified Organic, Owl Canyon Whole Eggs, packed in one dozen and half-dozen cardstock packages, with a packing date of 93, 94, 97, or 98. ","Expiration date of 5/18/14, 5/19/14, 5/22/14, or 5/23/14; location code of 1 or 3",".","220","Eggs have the potential to be contaminated with Salmonella Enteritidis",5/5/2014,"05/05/2014",7/23/2014,"07/23/2014"
"Devices",68190,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1669-2014","Class II","Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.","part number: 03.820.161s, with lot numbers: 5742507,5755970,5755971,5755972, 5755973,5755974,5828298,6336115, 6338099,6338100,6340029,6340030, 6344199,6344200,6363601,6385892, 6407046,6431260,6431261,6460402, 6503360,6526127,6571070,6571073, 6571074,6601985,6636946,6636947, 6636948,6653819,6653820,6670383, 6691341,6691342,6718933,6718934, 6718935,6740611,6794651,6794652, 6794653,6794654,6794655 part number: 03.820.1638 with lot numbers: 5742506,5755978,5755979,5755980, 5755981,5755982,5828299,5828300, 6320586,6336108,6336110,6336111, 6340033,6344201,6344202,6363602, 6385893,6431262,6431263,6460403, 6503361,6571075,6601986,6601987, 6636949,6636950,6636951,6653810, 6653818,6670382,6691343,6691344, 6718938,6740615,6740616,6745821, 6770474,6770475,6770476,6770477, 6770478,6794657,6794658 part number: 03.820.167S with lot numbers: 5755983,5755984,5755987,5755988, 5755989,5755985,5755986,5755990, 5828302,6338101,6338102,6338103, 6338104,6338106,6338107,6338108, 6338109,6344205,6471089,6670381, 6718939,6718940,6718941,6843907, 6843906,6856252,6856253,6867662, 6867661,6901712,6901713,6919726, 6919727,6919728,6901710,6901711, 6921717,6921718,6940357,6960192, 6960193,6983033,7006496,7055427 part number: 03.820.169S with lot numbers: 6066520,6113671,6113633,6159883, 6180175,6338068,6338098,6344206, 6363603,6407047,6431264,6460404, 6526128,6571078,6670384,6745820, 6770479,6770480 ",,"6690","Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.",4/29/2014,"04/29/2014",6/4/2014,"06/04/2014"
"Drugs",68191,"Ongoing","Pharmakon Pharmaceuticals","Noblesville","IN","US",,"Telephone","United States: TX, IL, MD, IN","D-1565-2014","Class I","Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.","Lot #: E21294K3C Exp Date: 6/29/2014",".","20 vials","Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.",4/21/2014,"04/21/2014",9/3/2014,"09/03/2014"
"Drugs",68191,"Ongoing","Pharmakon Pharmaceuticals","Noblesville","IN","US",,"Telephone","United States: TX, IL, MD, IN","D-1566-2014","Class I","Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.","A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014",".","10/50 mL bags, 40/100 mL bags","Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.",4/21/2014,"04/21/2014",9/3/2014,"09/03/2014"
"Drugs",68191,"Ongoing","Pharmakon Pharmaceuticals","Noblesville","IN","US",,"Telephone","United States: TX, IL, MD, IN","D-1567-2014","Class II","Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.","Lot #: E131210.212 Exp: 07/14/2014",".","200 Syringes","Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.",4/21/2014,"04/21/2014",9/3/2014,"09/03/2014"
"Drugs",68191,"Ongoing","Pharmakon Pharmaceuticals","Noblesville","IN","US",,"Telephone","United States: TX, IL, MD, IN","D-1568-2014","Class I","Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.","Lot #: E0333282R; Exp: 7/13/2014",".","5 Syringes","Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.",4/21/2014,"04/21/2014",9/3/2014,"09/03/2014"
"Food",68192,"Ongoing","Anhing Corporation","Los Angeles","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide in US","F-2029-2014","Class I","Caravelle CHILI POWDER HOT Net Weight 8 oz. (227G), plastic tub, UPC 080736115551. 24 units/case","Lot Code# 560916, 570115",,"83 cartons","Anhing Corporation is recalling Caravelle Brand Chili Powder because it has the potential to be contaminated with Salmonella.",5/2/2014,"05/02/2014",6/25/2014,"06/25/2014"
"Devices",68193,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.","Z-1719-2014","Class II","MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.","Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift). ",,"Domestic - 12,600 units, Foreign - 44,280 units","ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. ",5/8/2014,"05/08/2014",6/11/2014,"06/11/2014"
"Food",68194,"Ongoing","Pacific Organic Produce","San Francisco","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, AZ, TX, NJ, CO.","F-1948-2014","Class I","Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12. Product of Mexico, Pacific.com distributed by: Pacific Organic Produce, San Francisco, CA 94080","PLU 94051 and 94959; Lot 00017954 (not a retail pack)",,"1400 cases","IEH sample had positive result for Listeria Monocytogenes of Purity Brand Organic Fresh Mango.",5/3/2014,"05/03/2014",5/21/2014,"05/21/2014"
"Devices",68195,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed, Saudi Arabia, Sweden, Switzerland, Turkey, U.A.E. and United Kingdom.","Z-1667-2014","Class II","ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.","Model number 10433816; Serial numbers: US: 400290 400425 400439 400441 400443 400447 401176 401591 400763 400787 400789 400790 400791 400792 400794 400797 400063 400860 400868 400872 400873 400877 401041 401187 401441 401540 401590 401602 401662 401696 401638 401641 400174 400882 401612 401501 401507 401561 401378 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400803 400821 400570 401010 401020 401235 401252 401564 401611 400998 400999 401601 401648 400979 401625 401631 400234 400312 400972 401433 400336 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400782 400887 400889 401043 401554 400067 401257 401320 401559 401576 401633 401583 400875 400912 400925 400474 400902 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 401608 401618 401669 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 401596 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401188 401191 401650 400546 400945 401506 401371 401325 401393 401403 401543 401571 401580 401581 401613 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401288 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 401630 401676 400125 400200 401434 401658 401661 401626 401435 401498 401217 401389 401431 401563 401585 401605 401687 400155 400180 400307 400704 401428 401451 401541 401521 401582 401594 401595 401624 401632 401637 401640 401666 401688 401689 401695 401004 401508 401546 401519 401627 400247 400263 400511 401045 400497 401664 400284 400252 401566 401502 400655 400214 401394 401367 401617 401634 401651 401652 401657 401659 401663 401665 401681 401685 401686 401694 401698 4002",,"257 units","Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.",4/23/2014,"04/23/2014",6/4/2014,"06/04/2014"
"Devices",68196,"Ongoing","DIABETIC SUPPLY OF SUNCOAST, INC.","Dorado","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam","Z-2021-2014","Class I","ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.","All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.",,"1,852,800 cases (50 strips ea)","''Advocate Redi-Code + BMB-BA006A Blood Glucose test strips'' are inappropriately labeled and marketed as ''Advocate Redi-Code + Blood Glucose test strips''.",5/5/2014,"05/05/2014",7/30/2014,"07/30/2014"
"Devices",68197,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.","Z-1668-2014","Class II","ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.","ACUSON SC2000 model number: 10433816; Stress Echo Feature model number: 1044966 Serial numbers - USA: 400290 400425 400439 400441 400443 400447 401176 400787 400789 400790 400791 400792 400794 400797 400063 400877 401187 401441 401590 401602 401638 400174 401612 401501 401507 401561 400297 401423 401429 401550 401491 401494 401562 401572 401584 401621 400570 401010 401020 401235 401252 401564 401611 400998 400999 400979 401625 401631 400234 400312 400972 401645 400108 400177 400203 400313 400650 400663 400664 400176 400712 400716 401565 400128 400142 400887 400889 401043 401257 401559 401576 400474 400902 400860 400875 400912 400925 401387 401476 401477 401547 401496 401567 401569 401570 401597 401607 400630 401558 401587 401644 400227 400473 400577 400649 401294 401600 ROW: 400652 400733 400737 400746 401437 401443 401478 401495 401650 400546 401506 401371 401325 401581 401620 401623 400302 400348 400347 400553 400558 400726 400995 400996 401120 401123 401209 401260 401338 401344 401442 401452 401551 401555 401556 401522 401560 401577 401579 401588 401589 401603 401604 401606 401643 401699 400125 400200 401434 401626 401615 400155 400180 400307 400704 401428 401541 401624 401004 401546 401519 401627 400247 400263 400511 401045 400497 400284 400252 401502 400655 400214 400253 400836 400840 401118 400218 400990 401127 401180.",,"177 units","Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.",4/23/2014,"04/23/2014",6/4/2014,"06/04/2014"
"Food",68198,"Ongoing","Wells Enterprises, Inc.","Le Mars","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to KS, IN and IA.","F-1961-2014","Class I","Blue Bunny Premium Ice Cream, Bordeaux Cherry Chocolate, 1.75 quart. Packaged in 4/56-oz carton cases. Item # 745152, UPC 070640034123. Manufactured by Wells Enterprises, Inc., Le Mars, IA.","Lot 40010 TTT 19115 4100, Best Used by 10/9/15",".","87/4/56-oz carton cases","The product may contain egg which is not listed on the ingredient label.",5/2/2014,"05/02/2014",5/28/2014,"05/28/2014"
"Drugs",68199,"Ongoing","Independent Nutrition Center, Inc.","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1349-2014","Class II","Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.","Lot #: 1402009; 1312008; 1309017; and 1308009 ",".","a) 209 bottles and b) 8 bottles","Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.",4/29/2014,"04/29/2014",5/28/2014,"05/28/2014"
"Devices",68200,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide in the state of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela","Z-2031-2014","Class II","GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.","1) List Number: 13000; Serial Numbers: 9221423 , 12470045 , 12470063 , 12470085 , 12470109 , 12470130 , 12470133 , 12470135 , 12470138 , 12470144 , 12470145 , 12470147 , 12470152 , 12470153 , 12470154 , 12470156 , 12470157 , 12470158 , 12470160 , 12470162 , 12470163 , 12470164 , 12470165 , 12470167 , 12470168 , 12470169 , 12470171 , 12470172 , 12470173 , 12470174 , 12470177 , 12470180 , 12470207 , 12470208 , 12470209 , 12470220 , 12470225 , 12470239 , 12470243 , 12470244 , 12470257 , 12470258 , 12470259 , 12470262 , 12470268 , 12470273 , 12470279 , 12470281 , 12470283 , 12470285 , 12470290 , 12470294 , 12470299 , 12470301 , 12470303 , 12470304 , 12470305 , 12470319 , 12470320 , 12470321 , 12470332 , 12470335 , 12470337 , 12470338 , 12470340 , 12470341 , 12470346 , 12470347 , 12470350 , 12470354 , 12470357 , 12470360 , 12470361 , 12470362 , 12470365 , 12470366 , 12470367 , 12470369 , 12470370 , 12470375 , 12470378 , 12470381 , 12470383 , 12470385 , 12470386 , 12470387 , 12470389 , 12470390 , 12470391 , 12470392 , 12470393 , 12470395 , 12470396 , 12470397 , 12470399 , 12470402 , 12470408 , 12470411 , 12470412 , 12470413 , 12470416 , 12470417 , 12470418 , 12470424 , 12470425 , 12470428 , 12470433 , 12470434 , 12470435 , 12470439 , 12470440 , 12470441 , 12470442 , 12470444 , 12470447 , 12470448 , 12470449 , 12470452 , 12470453 , 12470455 , 12470457 , 12470458 , 12470459 , 12470464 , 12470465 , 12470470 , 12470472 , 12470473 , 12470477 , 12470479 , 12470487 , 12470489 , 12470492 , 12470496 , 12470500 , 12470501 , 12470503 , 12470505 , 12470506 , 12470511 , 12470513 , 12470514 , 12470516 , 12470518 , 12470519 , 12470520 , 12470521 , 12470526 , 12470528 , 12470529 , 12470531 , 12470532 , 12470539 , 12470540 , 12470541 , 12470543 , 12470545 , 12470549 , 12470550 , 12470552 , 12470553 , 12470557 , 12470561 , 12470562 , 12470567 , 12470569 , 12470570 , 12470571 , 12470576 , 12470577 , 12470578 , 12470579 , 12470581 , 12470583 , 12470588 , 12470589 , 12470590 , 12470591 , 12470594 , 12470598 , 12470600 , 12470602 , 12470"," 13430895 , 13430896 , 13430897 , 13430898 , 13430900 , 13430902 , 13430903 , 13430905 , 13430906 , 13430909 , 13430911 , 13430913 , 13430916 , 13430917 , 13430918 , 13430919 , 13430921 , 13430922 , 13430923 , 13430926 , 13430928 , 13430929 , 13430931 , 13430932 , 13430934 , 13430936 , 13430938 , 13430939 , 13430940 , 13430941 , 13430942 , 13430943 , 13430944 , 13430945 , 13430946 , 13430948 , 13430949 , 13430950 , 13430952 , 13430953 , 13430954 , 13430955 , 13430957 , 13430958 , 13430960 , 13430961 , 13430962 , 13430964 , 13430965 , 13430970 , 13430971 , 13430972 , 13430973 , 13430974 , 13430976 , 13430979 , 13430980 , 13430983 , 13430985 , 13430989 , 13430990 , 13430992 , 13430993 , 13430994 , 13430995 , 13430996 , 13430997 , 13430999 , 13431000 , 13431001 , 13431002 , 13431004 , 13431005 , 13431008 , 13431009 , 13431010 , 13431011 , 13431012 , 13431013 , 13431014 , 13431015 , 13431016 , 13431019 , 13431020 , 13431021 , 13431023 , 13431024 , 13431026 , 13431027 , 13431028 , 13431029 , 13431031 , 13431032 , 13431033 , 13431034 , 13431035 , 13431038 , 13431039 , 13431040 , 13431041 , 13431043 , 13431044 , 13431046 , 13431048 , 13431049 , 13431050 , 13431052 , 13431053 , 13431054 , 13431055 , 13431056 , 13431059 , 13431060 , 13431061 , 13431062 , 13431063 , 13431064 , 13431066 , 13431067 , 13431068 , 13431069 , 13431070 , 13431071 , 13431073 , 13431074 , 13431075 , 13431078 , 13431079 , 13431080 , 13431081 , 13431083 , 13431084 , 13431085 , 13431086 , 13431088 , 13431089 , 13431090 , 13431091 , 13431092 , 13431093 , 13431094 , 13431095 , 13431096 , 13431098 , 13431099 , 13431100 , 13431101 , 13431102 , 13431103 , 13431104 , 13431105 , 13431106 , 13431107 , 13431108 , 13431109 , 13431110 , 13431112 , 13431113 , 13431114 , 13431115 , 13431116 , 13431117 , 13431118 , 13431119 , 13431120 , 13431121 , 13431122 , 13431123 , 13431124 , 13431127 , 13431128 , 13431129 , 13431130 , 13431131 , 13431132 , 13431133 , 13431134 , 13431136 , 13431138 , 13431140 , 13431141 , 13431143 , 13431144 , 13431145 , 13431146 , 13431149 ","36,881 infusion pumps","Through customer complaints, Hospira has become aware that in GemStar (Phase 3) infusion pumps, list numbers 13000, 13100, and 13150, the connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the ''self-test'' while powering up which will result in a Beeper Error (''code 10/001/000''). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.",1/31/2014,"01/31/2014",7/16/2014,"07/16/2014"
"Devices",68201,"Ongoing","Abbott Laboratories","Abbott Park","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.","Z-0135-2015","Class II","HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.","List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014",".","183 calibrator kits","HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.",4/30/2014,"04/30/2014",11/5/2014,"11/05/2014"
"Food",68202,"Ongoing","Aqua Filter Fresh, Inc.","Pittsburgh","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA, WV","F-1949-2014","Class II","On cap 100% Spring Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Source Boiling Spring, Oakland, MD 21550 On bottle side: Tyler Mountain Water & Coffee In 3 gallon and 5 gallon plastic bottles","MFG 041714 EXP 041715 MFG 041814 EXP 041815",".","6961 bottles","For Spring Water and Purified Water bottled 4/17 - 18/2014, Outside lab results were positive for Coliforms non-speciated E. coli.",4/23/2014,"04/23/2014",5/28/2014,"05/28/2014"
"Food",68202,"Ongoing","Aqua Filter Fresh, Inc.","Pittsburgh","PA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA, WV","F-1950-2014","Class II","On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 15239 Processed by Reverse Osmosis, Steam Distillation, Micro-filtration, Ozonation, UV *Minerals added for taste On Bottle side: Tyler Mountain Water & Coffee In 4 gallon and 5 gallon plastic bottles","MFG 041714 EXP 041715 MFG 041814 EXP 041815",".","2436 bottles","For Spring Water and Purified Water bottled 4/17 - 18/2014, Outside lab results were positive for Coliforms non-speciated E. coli.",4/23/2014,"04/23/2014",5/28/2014,"05/28/2014"
"Biologics",68203,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Mississippi","B-0682-14","Class II","Red Blood Cells Leukocytes Reduced","W043213105076",".","1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",4/24/2014,"04/24/2014",5/28/2014,"05/28/2014"
"Biologics",68204,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","Telephone","Michigan","B-0638-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W201314035722; W201314029759; ",".","2","Blood products, labeled with extended expiration dates following irradiation, were distributed.",3/13/2014,"03/13/2014",7/2/2014,"07/02/2014"
"Biologics",68205,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0681-14","Class II","Platelets Pheresis Leukocytes Reduced","W050914007799",".","1 unit","Blood products, which were not tested for pH and platelet count, were distributed.",2/4/2014,"02/04/2014",5/28/2014,"05/28/2014"
"Biologics",68205,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0680-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W050914007799",".","1 unit","Blood products, which were not tested for pH and platelet count, were distributed.",2/4/2014,"02/04/2014",5/28/2014,"05/28/2014"
"Biologics",68206,"Terminated","American National Red Cross Southeastern Michigan Region","Detroit","MI","US","Voluntary: Firm Initiated","Telephone","Michigan","B-0640-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W2013140135461; W2013140135462; ",".","2","Blood products, labeled with extended expiration dates following irradiation, were distributed.",3/10/2014,"03/10/2014",7/2/2014,"07/02/2014"
"Biologics",68207,"Terminated","American National Red Cross The","Pomona","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0639-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W20061403227700; ",".","1","Blood product, labeled with an extended expiration date following irradiation, was distributed.",3/11/2014,"03/11/2014",7/2/2014,"07/02/2014"
"Devices",68208,"Ongoing","Mckesson Medical Immaging","Richmond","BC","CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, and the countries of Canada and France.","Z-1617-2014","Class II","McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.","Model MR 12.0",,"45","High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.",4/17/2014,"04/17/2014",5/21/2014,"05/21/2014"
"Drugs",68209,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Telephone","OH","D-1407-2014","Class II","Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 ","JKM7188A",".","200 vials","Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.",4/9/2014,"04/09/2014",7/2/2014,"07/02/2014"
"Biologics",68210,"Completed","Citra Labs LLC.","Braintree","MA","US","Voluntary: Firm Initiated","Letter","NY, MA","B-0698-14","Class II","Rejuvesol Red Blood Cell Processing Solution, 50 ml. Sterile Rx Intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC}. Part Number: 7012","Lot Code/Exp. Date: J13026A December 31, 2015; ",".","1 Lot","Rejuvesol Red Blood Cell Processing Solution, with a potentially compromised container closure seal, was distributed. ",4/24/2014,"04/24/2014",8/13/2014,"08/13/2014"
"Devices",68211,"Completed"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Distribution to SC only","Z-1662-2014","Class II","IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.","Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service",,"One","Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.",4/30/2014,"04/30/2014",6/4/2014,"06/04/2014"
"Biologics",68212,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","HI","B-0743-14","Class II","Fresh Frozen Plasma (Apheresis)","W088414200619",,"1 unit","Blood products, collected from a donor who was taking the medication Proscar, were distributed.",5/1/2014,"05/01/2014",6/25/2014,"06/25/2014"
"Biologics",68213,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0710-14","Class II","Platelets Pheresis Leukocytes Reduced","W117014118965; W117014118965",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/25/2014,"03/25/2014",6/25/2014,"06/25/2014"
"Biologics",68213,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0711-14","Class II","Fresh Frozen Plasma (Apheresis)","W117014118965",,"1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",3/25/2014,"03/25/2014",6/25/2014,"06/25/2014"
"Biologics",68214,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0721-14","Class II","Red Blood Cells Leukocytes Reduced","W036812565452",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/16/2014,"04/16/2014",6/25/2014,"06/25/2014"
"Biologics",68214,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0719-14","Class II","Platelets Pooled Leukocytes Reduced","W036812845144",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/16/2014,"04/16/2014",6/25/2014,"06/25/2014"
"Biologics",68214,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0720-14","Class III","Blood and Blood Products for Reprocessing","W036812565452",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",4/16/2014,"04/16/2014",6/25/2014,"06/25/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1965-2014","Class II","Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 12 Pack","Item # 134073 (12 pk) with codes: XXXXGG03034, XXXXGG03044,and XXXXGG03064. Manufactured on: 03/03/14, 03/04/14, and 03/06/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ","."," 20,064 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1966-2014","Class II","Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack","Item # 137642 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Jun 30 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ","."," 11,880 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1967-2014","Class II","Lipton Pure Leaf Iced NTS Peach Tea 12 Pack","Item # 137643 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Sept 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ","."," 7,656 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1963-2014","Class II","Lipton Pure Leaf Iced Tea Sweet Tea 18.5OZ PL 6 Pack","Item # 133245 (6 pk) with codes: XXXXGG03064 Manufactured on: 03/06/14 BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ","."," 40,524 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1964-2014","Class II","Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 6 Pack","Item # 133246 (6 pk) with codes: XXXXGG03034 and XXXXGG03044 Manufactured on: 03/03/14 03/04/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ","."," 5,808 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Food",68215,"Ongoing","Pepsi Beverages Company","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Domestic Distribution centers in ID, MI, OH, PA, IL, KY, MD, VA, TN, WV, SD, ND, MN, IA, NE, KS, MO, and WI.","F-1962-2014","Class II","Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack","Item # 133244 (6 pk) and Item # 134072 (12 pk) with codes: XXXXGG03034, XXXXGG03044, and XXXXGG03054. Manufactured on: 03/03/14, 03/04/14, and 03/05/14. BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) ",".","57,552 pks","Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. ",5/1/2014,"05/01/2014",5/28/2014,"05/28/2014"
"Devices",68216,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1802-2014","Class II","EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.","Part numbers 110007379 Lot 060830 and 258920,",,"100 units","The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.",4/15/2014,"04/15/2014",6/25/2014,"06/25/2014"
"Devices",68216,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1803-2014","Class II","EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.","Part # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and M060890.",,"102","The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.",4/15/2014,"04/15/2014",6/25/2014,"06/25/2014"
"Devices",68216,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1801-2014","Class II","EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.","Part numbers 110007380 Lot 223570 and 803860",,"100 units","The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.",4/15/2014,"04/15/2014",6/25/2014,"06/25/2014"
"Veterinary",68217,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV); *** FOREIGN: Bahrain, Germany, Mexico, Philippines","V-074-2014","Class II","CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 15% Povidone-iodine (USP) Surgical Hand Scrub; NDC 57613-013-15. Packaged 30 scrub brushes per carton and 10 cartons per corrugate box.","Catalog Code: 4452B; Lot Numbers and Expiry Dates: 0000503811 , Expires 2013-11 ; 0000506220 , Expires 2013-11 ; 0000510765 , Expires 2013-11 ; 0000512732 , Expires 2013-12 ; 0000515174 , Expires 2013-12 ; 0000517445 , Expires 2013-12 ; 0000521711 , Expires 2014-01 ; 0000524276 , Expires 2014-01 ; 0000526895 , Expires 2014-01 ; 0000529735 , Expires 2014-01 ; 0000531478 , Expires 2014-02 ; 0000535989 , Expires 2014-02 ; 0000538326 , Expires 2014-03 ; 0000540593 , Expires 2014-03 ; 0000542887 , Expires 2014-03 ; 0000547433 , Expires 2014-03 ; 0000549925 , Expires 2014-04 ; 0000549925 , Expires 2014-04 ; 0000553601 , Expires 2014-04 ; 0000554836 , Expires 2014-04 ; 0000560448 , Expires 2014-05 ; 0000562704 , Expires 2014-05 ; 0000564521 , Expires 2014-05 ; 0000566812 , Expires 2014-06 ; 0000568882 , Expires 2014-06 ; 0000568884 , Expires 2014-06 ; 0000575375 , Expires 2014-06 ; 0000586422 , Expires 2014-08 ; 0000588544 , Expires 2014-08 ; 0000592583 , Expires 2014-08 ; 0000601033 , Expires 2014-09 ; 0000602709 , Expires 2014-09 ; 0000604892 , Expires 2014-09 ; 0000607062 , Expires 2014-10 ; 0000607064 , Expires 2014-10 ; 0000612904 , Expires 2014-11 ; 0000615357 , Expires 2014-11 ; 0000615359 , Expires 2014-11 ; 0000617388 , Expires 2014-11",,"1,662,000 hand scrubs","CareFusion is conducting a voluntary recall regarding the CareFusion Scrub Care Surgical Scrub Brush- Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label and therefore does not meet the label claim for free iodine concentration.",12/20/2013,"12/20/2013",6/25/2014,"06/25/2014"
"Veterinary",68217,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV); *** FOREIGN: Bahrain, Germany, Mexico, Philippines","V-073-2014","Class II","CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner with 9% Povidone-iodine (USP) Surgical Hand Scrub; NDC 57613-003-18. Packaged 30 scrub brushes per carton and 10 cartons per corrugate box.","1) Catalog Code: 4451B; Lot Numbers and Expiry Dates: 0000503318 , Expires 2013-12 ; 0000506214 , Expires 2013-11 ; 0000508533 , Expires 2013-11 ; 0000510764 , Expires 2013-11 ; 0000510935 , Expires 2013-11 ; 0000512731 , Expires 2013-12 ; 0000515176 , Expires 2013-12 ; 0000519658 , Expires 2013-12 ; 0000520682 , Expires 2014-01 ; 0000524275 , Expires 2014- 01 ; 0000526893 , Expires 2014-01 ; 0000526894 , 2014-01 ; 0000529734 , Expires 2014-01 ; 0000531474 , Expires 2014-02 ; 0000535988 , Expires 2014-02 ; 0000538311 , Expires 2014-02 ; 0000545246 , Expires 2014-03 ; 0000549924 , Expires 2014-04 ; 0000552624 , Expires 2014-04 ; 0000553607 , Expires 2014-04 ; 0000556017 , Expires 2014-04 ; 0000558355 , Expires 2014-05 ; 0000560447 , Expires 2014-05 ; 0000562700 , Expires 2014-05 ; 0000564519 , Expires 2014-05 ; 0000566810 , Expires 2014-05 ; 0000568880 , Expires 2014-06 ; 0000568881 , Expires 2014-06 ; 0000575374 , Expires 2014-06 ; 0000577556 , Expires 2014-07 ; 0000577571 , Expires 2014-07 ; 0000590828 , Expires 2014-08 ; 0000590828 , Expires 2014-08 ; 0000592582 , Expires 2014-08 ; 0000597039 , Expires 2014-09 ; 0000602710 , Expires 2014-09 ; 0000604890 , Expires 2014-10 ; 0000607065 , Expires 2014-10 ; 0000612905 , Expires 2014-11 ; 0000615356 , Expires 2014-11 ; 0000615762 , Expires 2014-11 ; 2) Catalog Code: 4451GL; Lot Numbers: 0000511784 , Expires 2013-12 ; 0000514626 , Expires 2013-12 ; 0000521710 , Expires 2014-01 ; 0000531476 , Expires 2014-02 ; 0000552036 , Expires 2014-04 ; 0000552623 , Expires 2014-04 ; 0000558356 , Expires 2014-05 ; 0000566811 , Expires 2014-05 ; 0000583939 , Expires 2014-07 ; 0000601031 , Expires 2014-09 ; 0000611309 , Expires 2014-10",,"1) Catalog Code 4451B: 1,939,500 hand scrubs; 2) Catalog Code 4451GL: 504,000 hand scrubs","CareFusion is conducting a voluntary recall regarding the CareFusion Scrub Care Surgical Scrub Brush- Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label and therefore does not meet the label claim for free iodine concentration.",12/20/2013,"12/20/2013",6/25/2014,"06/25/2014"
"Drugs",68218,"Ongoing","Eugene Oregon, Inc.","Levittown","PA","US","Voluntary: Firm Initiated","Letter","To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC","D1612-2014","Class I","AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. ","All lots",".","460 boxes","Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. ",5/5/2014,"05/05/2014",10/7/2014,"10/07/2014"
"Drugs",68218,"Ongoing","Eugene Oregon, Inc.","Levittown","PA","US","Voluntary: Firm Initiated","Letter","To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC","D-1614-2014","Class I","MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 ","All lots",".","57 boxes","Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. ",5/5/2014,"05/05/2014",10/7/2014,"10/07/2014"
"Drugs",68218,"Ongoing","Eugene Oregon, Inc.","Levittown","PA","US","Voluntary: Firm Initiated","Letter","To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC","D-1613-2014","Class I","Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd. ","All lots ",".","136 boxes","Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. ",5/5/2014,"05/05/2014",10/7/2014,"10/07/2014"
"Devices",68219,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, VENEZUELA, VIETNAM, and YEMEN.","Z-1706-2014","Class II","Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. ","Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV 00000063736YY3 MCTHKGMN 00000416503WK1 1222 00000299868WK0 215662C3 00000312304WK9 215770C1 00000367696WK2 215861LC 00000312714WK9 301891LC 00000321508WK4 313421LC 00000309562WK7 317818MDI120 00000438039WK0 317818MDI905 00000503165WK3 318462BCL 00000505246WK9 318473RCATH4 00000281715WK3 318494LC1 00000405780WK8 318494LC2 00000405779WK0 401729PCL 00000455944WK9 402280P1 00000492511WK1 407646CL1 00000314328WK6 407896CCCATH 00000378033WK5 480474LC3 00000314429WK2 607763CL1 00000469188WK7 610250SC 00000399463WK9 615778ECL1 00000431048WK8 615781SHCV1 00000466434WK8 617340LC 00000280718WK8 618242GSLC 00000323794WK8 619543UC5 00000409286WK2 636933JMLC 00000320222WK3 708383OPLC 00000506007WK4 801350LC1 00000508243WK3 801350LC2 00000309699WK7 815963LC 00000285416WK4 817548ALC 00000273308BU7 901384LCA 00000399610WK5 909824LC2 00000421718WK8 909824LC3 00000475337WK2 910343NHC1 00000373273WK2 941475CL 00000504090WK2 DLPGMH1 00000283982WK7 E16327 00000432874WK6 LIJ201178 00000484098WK9 M27036 00000336973WK3 MCTH050 FMI12209DUM168 NSCXR 00000387613WK3 215221CL3 00000423269WK0 215785SCA 00000500248WK0 813462ADV1 00000215082WK9 316268SFCL 00000249758WK4 713791SCL3X 00000470720WK4 305395B44 00000319310WK9 313745CATH2 00000414277WK4 415428OCCL2 00000459249WK9 507255CC101 00000409553WK5 602258LC1 00000450389WK2 619552VLC 00000293241WK6 808547QRM8A 00000496418WK5 912633MCL1 00000495821WK1 916734XR 00000289981WK3 M27037 00000497122WK2 215221CL1 00000143391WK1 0837YX0037 00000298765WK9 203872LUA 00000389718WK8 404422NR5 00000305860WK9 619421XSP 00000287562WK3 704255MMS2 00000315705WK4 714824LUA 00000227510WK5 714887LU 00000295578WK9 7186155N47 FMI12198DUM051 801566SPC 00000450489WK0 810664LUA 00000071592WK0 919748B10 00000286172WK2 214872NSP 00000251371WK1 301368LUB 00000313685WK0 401274MA1 00000340"," EG1168VA02 00000590866BU0 EG1843VA01 00000558464BU4 EG1794VA01 00000272431BU8 EG1914VA01 00000342292BU0 EG3000VA01 00000011686GP3 EG1021VA03 00000569579BU6 EG1000VA01 00000004306GP7 EG1112VA02 00000409406WK6 EG1006VA01 00000524177BU3 FI1017VA02 00000537029BU1 FI1017VA03 00000549714BU4 FI1025VA01 00000593473BU2 FI1126VA02 00000582042BU8 FI1153VA01 00000633447BU8 FI1128VA03 00000600318BU0 FI1023VA03 00000576357BU8 FI1314VA02 00000464655BU0 FI1064VA01 00000004095GQ6 FI1021VA01 00000002407GP5 FI1023VA01 00000456800BU2 FI1015VA01 00000457205BU3 FI1015VA02 00000577356BU9 FI1031VA01 00000403124BU1 A4213138 00000434042BU8 B4498640 00000434772BU0 B4498642 00000430906BU8 E4167627 00000380585BU0 M1754003 00000420032BU5 M2030707 00000374276BU4 M2052042 00000418416BU4 M23864601 00000435104BU5 M4046541 00000442837BU1 M4159626 00000438344BU4 M4163751 00000428406BU3 S4160056 00000424701BU1 X100378801 00000520965BU5 A4166952 00000516767BU1 B1650215 00000552737BU9 B4192944 00000564219BU4 B4192946 00000543077BU2 B5483438 00000577023BU5 G4191715 00000554735BU1 M181374801 00000489550BU4 M2569315 0000009C2M0011 M2569317 00000547031BU5 M2710101 00000543168BU9 M4176519 00000534726BU5 M4183841 00000467360BU4 M4198195 00000516954BU5 M4200108 00000577527BU5 M4202928 00000573955BU2 M4484974 00000530416BU7 M4496941 00000565930BU5 M9164780 00000499002BU4 X4211036 00000581570BU9 A4199383 00000576750BU4 C4193339 00000590863BU7 M1327508 00000618485BU7 M2148245 00000598340BU8 M23864608 00000604271BU7 M2505305 00000583669BU7 M2812105 00000605184BU1 M4169342 00000590317BU4 M4171816 00000576358BU6 M4434869 00000577025BU0 M9162730 00000602672BU8 R4211494 00000592451BU9 X76305707 FMI12209DUMM41 A4166971 00000618938BU5 B5483447 00000620712BU0 E4167648 00000633457BU7 M1830304 00000631423BU1 M2208719 00000632175BU6 M2621513 FMI12209DUMM42 M4478227 00000618484BU0 M5484989 00000623161BU7 C4193347 FMI12209DUMM59 M5484990 00000452928BU5 N4192939 00000609125BU0 A9190167 00000611020BU9 A9862607 00000601499BU7 B1650224 00000579010BU0 M1076854 00000615923BU0","3221 (108 US, 3113 OUS).","GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury. ",5/2/2014,"05/02/2014",6/11/2014,"06/11/2014"
"Devices",68221,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MN, CA, CO, TX, and IA.","Z-1663-2014","Class II","MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.","model # 10432914 with serial numbers: 52126 52135 52108 52025 52101 ",,"5","Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals. ",4/24/2014,"04/24/2014",6/4/2014,"06/04/2014"
"Drugs",68222,"Ongoing","Thorne Research Inc","Sandpoint","ID","US","Voluntary: Firm Initiated","Visit","Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.","D-1383-2014","Class II","Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 ","All lot codes",,"unknown","Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.",6/12/2014,"06/12/2014",6/25/2014,"06/25/2014"
"Drugs",68222,"Ongoing","Thorne Research Inc","Sandpoint","ID","US","Voluntary: Firm Initiated","Visit","Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.","D-1384-2014","Class II","Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1","All lot codes",,"unknown","Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.",6/12/2014,"06/12/2014",6/25/2014,"06/25/2014"
"Devices",68224,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of GA, FL, NY, NV, and MA.","Z-1638-2014","Class II","MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. ","(Material number 10549894) with serial numbers 5000 through 5029.",".","5","There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury. ",4/25/2014,"04/25/2014",5/28/2014,"05/28/2014"
"Drugs",68225,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1408-2014","Class II","Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. ","Lot # 34013122A, Exp 11/15",".","9,882 bottles","Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. ",5/1/2014,"05/01/2014",7/2/2014,"07/02/2014"
"Devices",68226,"Ongoing","Childrens Medical Ventures","Monroeville","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.","Z-1789-2014","Class II","Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.","989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384",,"112","The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.",4/29/2014,"04/29/2014",6/25/2014,"06/25/2014"
"Food",68227,"Ongoing","Middle East Bakery, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Press Release","C&S Wholesale, VT distributed the product to Market Basket Stores in NH and MA.","F-2025-2014","Class I","Market Basket, Dairy-Free, Gluten-Free Pancakes. Each package contains 12 pancakes in a 14.4 oz. (408 g) box with UPC 4970571120","All lots",,"1089 cases","Undeclared milk in Dairy-Free, Gluten-Free Market Basket Pancakes",5/19/2014,"05/19/2014",6/25/2014,"06/25/2014"
"Devices",68229,"Ongoing","Gen-Probe Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).","Z-1793-2014","Class III"," APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.","Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.",,"4,740 units","Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as ''APTIMA Urine Collection Kits''; however, the inner pouches are incorrectly labeled as ''APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens.''",4/17/2014,"04/17/2014",6/25/2014,"06/25/2014"
"Devices",68230,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution only.","Z-1727-2014","Class II","Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.","PN 98100, Lot W53884B.",".","373 kits","Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result. ",5/2/2014,"05/02/2014",6/18/2014,"06/18/2014"
"Food",68231,"Ongoing","Asian Bakery","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Cakes were sold to two retail stores in Portland, OR and one retail store in Vancouver, WA","F-1975-2014","Class II","Chernosliv cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code","No code.",,"1 or 2 cakes","Cakes are being recalled due to undeclared milk, wheat and soy lecithin.",5/5/2014,"05/05/2014",6/4/2014,"06/04/2014"
"Food",68231,"Ongoing","Asian Bakery","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Cakes were sold to two retail stores in Portland, OR and one retail store in Vancouver, WA","F-1977-2014","Class II","Bells cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 13oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code","No code.",,"3 or 4 cakes","Cakes are being recalled due to undeclared wheat and soy lecithin.",5/5/2014,"05/05/2014",6/4/2014,"06/04/2014"
"Food",68231,"Ongoing","Asian Bakery","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Cakes were sold to two retail stores in Portland, OR and one retail store in Vancouver, WA","F-1978-2014","Class II","Velvet cake; Round 8 cake packaged in plastic dome. Net Weight: 3lb 10oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code","No code.",,"1 or 2 cakes","Cakes are being recalled due to undeclared wheat and soy lecithin.",5/5/2014,"05/05/2014",6/4/2014,"06/04/2014"
"Food",68231,"Ongoing","Asian Bakery","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Cakes were sold to two retail stores in Portland, OR and one retail store in Vancouver, WA","F-1976-2014","Class II","Marquiz cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code","No code.",,"1 or 2 cakes","Cakes are being recalled due to undeclared milk, wheat and soy lecithin.",5/5/2014,"05/05/2014",6/4/2014,"06/04/2014"
"Food",68232,"Ongoing","American Spoon Foods, Inc.","Petoskey","MI","US","Voluntary: Firm Initiated","Letter","Sales to retail stores are located in MI, MN, IL, ID, MT, NC, GA, PA, OK, TX, KY, MA, FL, and NY. The one wholesale customer is in MI.","F-2007-2014","Class II","American Spoon Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and tree nuts. Refrigerate after opening American Spoon Foods PETOSKEY, MICHIGAN 49770 800 222 5886 UPC 0 19363 01010 6 ","code 3322 The code is a 12 digit code printed on the side of the jar as: 3322000*** and with a Best Flavor by date of 11/2016. The missing digits include the sequential batch number for the day and a sequential jar number for each jar in the batch. ",,"2,887 glass jars","American Spoon, Sour Cherry Preserves, 9.5 oz (UPC 019363010106) may contain mold.",4/30/2014,"04/30/2014",6/11/2014,"06/11/2014"
"Food",68233,"Ongoing","American Licorice Company","LaPorte","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI, IL, MA, TX, OR, CO, NJ, CA, KY","F-1994-2014","Class III","REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9","BEST BEFORE 11/23/14 2",,"455cs/12 caddies/12/2 oz bags","The nutritional panel on the packaging incorrectly states the sodium content as 35g, when it should read 35mg. ",4/25/2014,"04/25/2014",6/11/2014,"06/11/2014"
"Food",68233,"Ongoing","American Licorice Company","LaPorte","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI, IL, MA, TX, OR, CO, NJ, CA, KY","F-1995-2014","Class III","REDVINES FRUIT VINES Bites Strawberry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82006 4","BEST BEFORE 11 24 14 3",,"97 cs/12 caddies/12/2 oz bags","The nutritional panel on the packaging incorrectly states the sodium content as 35g, when it should read 35mg. ",4/25/2014,"04/25/2014",6/11/2014,"06/11/2014"
"Devices",68234,"Ongoing","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1980-2014","Class II","Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.","Model AFC-330: Serial numbers: 380034 380021 380035 380061 380060 380013 380011 380069 380073 380053 380055 380067 380077 380078 380017 380075 380032 380080 380081 380092 380116 380120 380237 380238 380239 380240 380241 380122 380121 380014 380211 380125 380126 380127 380124 380215 380214 380188 380221 380187 380190 380189 380212 380062 380038 380128 380223 380224 380076 380216 380213 380222 380243 380054 380042 380225 380244 380251 380252 380256 380015 380250 380074 380018 380012 380258 380068 380260 380186 380037 380253 380264 380242 380261 380262 380123 380255 380016 380052 380033 380257 380259 380004 380009 380019 380023 380027 380029 380099 380101 380103 380108 380118 380131 380134 380139 380144 380146 380147 380148 380152 380153 380155 380156 380157 380159 380160 380162 380164 380175 380177 380178 380185 380196 380198 380201 380203 380207 380208 380218 380219 380236 380008 380020 380043 380056 380058 380063 380066 380070 380071 380088 380090 380098 380102 380105 380106 380107 380111 380112 380115 380117 380119 380129 380130 380136 380140 380141 380142 380143 380145 380150 380158 380163 380176 380179 380180 380181 380182 380183 380184 380199 380200 380202 380205 380209 380210 380226 380227 380228 380230 380232 380233 380234 380235 380265 380267 380268 380269 380270 380271 380272 380273 380274 380275. ",,"185 cameras","Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.",6/16/2014,"06/16/2014",7/9/2014,"07/09/2014"
"Devices",68237,"Ongoing","Cenorin, LLC","Kent","WA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution","Z-1729-2014","Class II","HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5'' (67 cm); Depth: 33'' (83 cm); Height: 46.5'' (118 cm) to top of control panel; 64'' (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes. ","610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits (6 refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.",".","25 HLD systems ","Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.",4/24/2014,"04/24/2014",6/18/2014,"06/18/2014"
"Food",68238,"Completed","Lily Bloom's Kitchen","Fridley","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota","F1990-2014","Class I","Lily Bloom's Kitchen Chocolate Coconut Poparoons","Poparoons do not contain a lot number or code",,"1,000 individual pieces","Lily Bloom's Kitchen Poparoon flavors that contain milk which was not listed on the label include lemon, key lime, strawberry, blueberry and chocolate dipped in a white chocolate coating.",5/1/2014,"05/01/2014",6/11/2014,"06/11/2014"
"Food",68239,"Ongoing","STE FROMAGERE DU LIVRADOIS","Fournols",,"FR","Voluntary: Firm Initiated","Press Release","CA, IL, MI, OH, NJ, & WI","F-2005-2014","Class I","Raclette du Haut Livradois Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated","lot #350",,"168 cases (1 per case)","Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.",5/7/2014,"05/07/2014",6/11/2014,"06/11/2014"
"Food",68239,"Ongoing","STE FROMAGERE DU LIVRADOIS","Fournols",,"FR","Voluntary: Firm Initiated","Press Release","CA, IL, MI, OH, NJ, & WI","F-2006-2014","Class I","Montboissie du haut- Livradois Manufactured by Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrapped in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated","lot #350",,"46 cases (1 per case)","Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.",5/7/2014,"05/07/2014",6/11/2014,"06/11/2014"
"Devices",68240,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Telephone","one customer in IA","Z-1634-2014","Class II","CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)","Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)",".","1","There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing acceptance criteria for a required drift test.",5/9/2014,"05/09/2014",5/28/2014,"05/28/2014"
"Biologics",68241,"Terminated","International Sight Restoration, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","E-Mail","United Arab Emirates; Egypt","B-0643-14","Class III","Cornea","20140084OD; 20140084OS",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",4/24/2014,"04/24/2014",5/28/2014,"05/28/2014"
"Devices",68242,"Ongoing","Ventlab LLC","Grand Rapids","MI","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,","Z-1948-2014","Class I","Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.","Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.",,"251,384","The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.",5/16/2014,"05/16/2014",7/9/2014,"07/09/2014"
"Devices",68243,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC","Z-1997-2014","Class II","Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.","14085, 14086, 14092, 14095, 14101, 14106 *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission. ",,"264 devices","Straps may separate from the foam pad. ",5/8/2014,"05/08/2014",7/16/2014,"07/16/2014"
"Devices",68244,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.","Z-2018-2014","Class II","Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)","Catalog Number 801763",,"1713 units","An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.",6/17/2014,"06/17/2014",7/16/2014,"07/16/2014"
"Devices",68244,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.","Z-2019-2014","Class II","Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)","Catalog Number 801764",,"1713 units","An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.",6/17/2014,"06/17/2014",7/16/2014,"07/16/2014"
"Devices",68245,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide distribution. US Nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Herzegovina, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, LAO People's Dem, Rep., Latvia, Lebanon, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nahar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam and Yemen.","Z-1722-2014","Class II","Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)","Brilliance CT 6: M/N: 728256; S/N: 3001, 3002, 3005, 3007, 3014, 3016, 3019-3021, 3025, 3026, 3028, 3032-3036, 3045, 3046, 3049, 3051, 3052, 3057, 3058, 3060, 3062, 3064-3066, 3068, 3071, 3073, 3074, 3076-3081, 3083, 3084, 3090, 3093-3095, 3097, 3101, 3102, 3104, 3106-3108, 3112-3115, 3118-3121, 3124, 3126, 3128, 3129, 3131, 3132, 3134, 3136, 3137, 3139-3141, 3143-3145, 3147, 3148, 3151-3158, 3162, 3165-3169, 3171, 3173-3177, 3180, 3181, 3184-3190, 3192, 3193, 3196, 3200, 3201, 3203, 3204, 3207, 3208, 3210-3218, 3220, 3221, 3225, 3226, 3228, 3229, 3232, 3235, 3237, 3240, 3241, 3243-3245, 3248, 3249, 3253-3257, 3260-3264, 3266-3272, 3275-3282, 3284, 3285, 3287, 3290, 3292, 3296, 3299, 3301, 3303-3305, 3307-3311, 3313, 3315, 3317-3323, 3325-3328, 3332-3334, 3336, 3338, 3339, 3341, 3343-3345, 3347-3349, 3351, 3352, 3354, 3357-3364, 3366-3368, 3370-3374, 3377-3384, 3386, 3388-3391, 3394, 3396-3400, 3402-3404, 3408, 3409, 3412, 3413, 3415-3418, 3423-3426, 3428-3432, 3434-3437, 3439, 3443, 3444, 3447, 3449, 3451-3453, 3455, 3457, 3459, 3460, 3461, 3463, 3465, 3467-3475, 3477-3483, 3485, 3486, 3488, 3489, 3491-3506, 3508-3511, 3513, 3515, 3517-3519, 3522-3524, 3526, 3527, 3532-3535, 3537-3549, 3551-3553, 3556-3559, 3562, 3564, 3566, 3568, 3570, 3571, 3573-3575, 3577, 3578, 3580, 3582-3588, 3590-3595, 3597-3608, 3611-3616, 3618-3622, 3625-3632, 3634-3637, 3639-3646, 3648, 3649, 3651-3661, 3663-3665, 3667-3670, 3672, 3674-3677, 3679-3693, 3695-3698, 3703-3712, 3714, 3715, 3717-3720, 3722, 6039, 6040, 30003, 30005, 30007-30009, 30011-30018, 30021, 30022, 30024, 30026-30031, 30033-30040, 30042, 30043, 30045-30048, 30050, 30052-30054, 30056-30062, 30064-30066, 30068, 30069, 30072, 30073, 30075, 30077-30080, 30082-30090, 30092, 30094, 30100, 30101, 30104-30108, 30111, 30113, 30117-30119, 30121-30131 & 300043. Brilliance CT 10: M/N: 728251; S/N: 3008, 3098, 4001, 4003, 4005, 4006, 4009-4012, 4014, 4016, 4020, 4021, 4023, 4026, 4027, 4029-4031, 4035, 4040, 4041, 4044, 4047-4050, 4052-4054, 4058, 4059, 4061, 4063-4067, 30099,",,"6, 839 units","A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.",4/1/2014,"04/01/2014",6/11/2014,"06/11/2014"
"Drugs",68246,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1348-2014","Class II","Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30 ","Lot: A287945, Exp: 08/2015",".","21,875 bottles","Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.",5/12/2014,"05/12/2014",5/28/2014,"05/28/2014"
"Biologics",68248,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0753-14","Class III","Red Blood Cells Leukocytes Reduced","W117014372289",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",4/2/2014,"04/02/2014",7/23/2014,"07/23/2014"
"Biologics",68248,"Terminated","Blood Centers of the Pacific - Irwin Center","San Francisco","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0754-14","Class III","Plasma Frozen","W117014372289",".","1 unit","Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.",4/2/2014,"04/02/2014",7/23/2014,"07/23/2014"
"Biologics",68249,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","NV","B-0768-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W041914003163D; W041914007490U",".","2 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",4/17/2014,"04/17/2014",7/23/2014,"07/23/2014"
"Biologics",68249,"Terminated","Blood Systems, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Telephone","NV","B-0767-14","Class II","Platelets Pheresis Leukocytes Reduced","W041914003163D; W041914007490U",".","2 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",4/17/2014,"04/17/2014",7/23/2014,"07/23/2014"
"Biologics",68250,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM","B-0751-14","Class II","Platelets Pheresis Leukocytes Reduced","W041214008850U",".","1 unit","Platelets, with a low platelet count, were distributed. ",4/25/2014,"04/25/2014",7/23/2014,"07/23/2014"
"Biologics",68251,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","E-Mail","DE","B-0752-14","Class III","Whole Blood","W036914204019; W036914203649; W036914203652; W036914400826; W036914204033; W036914203102; W036914300433; W036914203747; W036914203765; W036914203653; W036914203353; W036914900835; ",".","12 units","Whole Blood, collected in misbranded collection sets, were distributed.",3/17/2014,"03/17/2014",7/23/2014,"07/23/2014"
"Biologics",68252,"Terminated","American National Red Cross Great Lakes Region","Lansing","MI","US","Voluntary: Firm Initiated","Telephone","Michigan","B-0761-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W201614025133; W201614021528; ",".","2","Blood products, labeled with extended expiration dates, were distributed.",3/11/2014,"03/11/2014",7/2/2014,"07/02/2014"
"Biologics",68253,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota; Pennsylvania; Arkansas; District of Columbia; Puerto Rico; New Jersey; Wisconsin; Maryland","B-0763-14","Class II","Red Blood Cells Leukocytes Reduced","W201714002238; W201714002285; W201714002302; W201714033688; W201714063660; W201714063679; W201714007695; W201714011356; W201714095155; W201714095285; W201714097435; W201714097483; W201714085287; W201714085316; W201714005926; W201714002059; W201714002068; W201714002133; W201714002155; W201714002157; W201714001659; ",".","21","Blood products, collected from a donor whose health history screening was not adequately performed, were distributed. ",3/14/2014,"03/14/2014",7/2/2014,"07/02/2014"
"Biologics",68253,"Terminated","American National Red Cross (The) - North Central Region","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota; Pennsylvania; Arkansas; District of Columbia; Puerto Rico; New Jersey; Wisconsin; Maryland","B-0762-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W2017140103561; W2017140103562; W2017140022701; W2017140022702; W2017140103482; W2017140926511; W2017140103481; ",".","7","Blood products, collected from a donor whose health history screening was not adequately performed, were distributed. ",3/14/2014,"03/14/2014",7/2/2014,"07/02/2014"
"Biologics",68254,"Terminated","Gulf Coast Regional Blood Center","Houston","TX","US","Voluntary: Firm Initiated","FAX","Texas; Tennessee","B-0728-14","Class III","Red Blood Cells Leukocytes Reduced","9782524; W044609227288; W044610307374; W044611400719; W044610338880; W044608220474; ",,"6 units","Blood products, collected from a donor with a history of polycythemia, were distributed. ",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Biologics",68254,"Terminated","Gulf Coast Regional Blood Center","Houston","TX","US","Voluntary: Firm Initiated","FAX","Texas; Tennessee","B-0727-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W044613208896; W044613317945; ",,"2 units","Blood products, collected from a donor with a history of polycythemia, were distributed. ",4/1/2014,"04/01/2014",6/25/2014,"06/25/2014"
"Devices",68255,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.","Z-1724-2014","Class II","Synergy XVI Intended for radiation therapy treatment.","XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1 ",,"380 US","XVI can incorrectly calculate the target position of the treatment table.",4/23/2014,"04/23/2014",6/25/2014,"06/25/2014"
"Veterinary",68257,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + US Virgin Islands; *** FOREIGN: Australia, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, Yemen","V-139-2014","Class II","The LifeCare 5000 Pump (Plum 1.6) is indicated for accurate, volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.","List Number: 02507; Serial Numbers: All.",,"List Number 02507: 132,889 pumps","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",7/30/2014,"07/30/2014"
"Veterinary",68257,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + US Virgin Islands; *** FOREIGN: Australia, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, Yemen","V-141-2014","Class II","The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.","List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.",,"List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846:","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",7/30/2014,"07/30/2014"
"Veterinary",68257,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + US Virgin Islands; *** FOREIGN: Australia, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, Yemen","V-140-2014","Class II","The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.","List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All.",,"List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859:","There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing.",1/24/2014,"01/24/2014",7/30/2014,"07/30/2014"
"Devices",68259,"Ongoing","LAP of America Laser Applications, LLC","Boynton Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","North Carolina","Z-1866-2014","Class II","LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.","Product Code: 0007569-0001 ",".","1 system","While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm. ",3/21/2014,"03/21/2014",7/2/2014,"07/02/2014"
"Food",68260,"Ongoing","Nutrition Center, Inc. dba Nutri-West","Douglas","WY","US","Voluntary: Firm Initiated","E-Mail","NATIONWIDE, ENGLAND, no military/govt/VA consignees.","F-2031-2014","Class II","Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule ","TOTAL ENZYMES Product # 2404 LOT#S 302152, 303083, 306046, 308044(PARTIAL)",,"8,414 bottles","Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol.",10/10/2013,"10/10/2013",6/25/2014,"06/25/2014"
"Food",68260,"Ongoing","Nutrition Center, Inc. dba Nutri-West","Douglas","WY","US","Voluntary: Firm Initiated","E-Mail","NATIONWIDE, ENGLAND, no military/govt/VA consignees.","F-2032-2014","Class II","Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule","TOTAL PROBIOTICS Product # 2405, 2405A LOT#S 305002, 305001, 305036, 306015, 306045, 306109, 306110, 307018, 307019, 307065, 307066, 308009, 308010, 308121, 308122, 309063(PARTIAL)",,"13,864 bottles","Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol.",10/10/2013,"10/10/2013",6/25/2014,"06/25/2014"
"Devices",68261,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.","Z-1715-2014","Class II","The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures. ","Stryker Product Number: 7700-800-000 Stryker Serial Numbers: 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, 15118",,"20","The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints ",5/13/2014,"05/13/2014",6/11/2014,"06/11/2014"
"Devices",68261,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.","Z-1716-2014","Class II","The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor). ","Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004",,"20","The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints ",5/13/2014,"05/13/2014",6/11/2014,"06/11/2014"
"Devices",68262,"Ongoing","Philips Healthcare Informatics, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.","Z-1646-2014","Class II","Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.","Model XIRIS 8.1 version XIRIS 8.1.50.0",".","5 units","When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed",5/5/2014,"05/05/2014",5/28/2014,"05/28/2014"
"Devices",68263,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1677-2014","Class II","enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. ","enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below",,"Domestic: 20 units, Foreign: 61 units","Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.",3/20/2014,"03/20/2014",6/11/2014,"06/11/2014"
"Food",68264,"Terminated","Kodiak Wild Alaska Seafood","Kodiak","AK","US","Voluntary: Firm Initiated","Telephone","Product was distributed to customers in Alaska, Virgina, and New Jersey,","F-2041-2014","Class II","Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this product.","Product is not coded.",,"25 lbs","Firm has been cold smoking, vacuum packaging, and distributing frozen seafood products without the required operating permit and without HACCP controls in place. ",4/23/2014,"04/23/2014",6/25/2014,"06/25/2014"
"Food",68264,"Terminated","Kodiak Wild Alaska Seafood","Kodiak","AK","US","Voluntary: Firm Initiated","Telephone","Product was distributed to customers in Alaska, Virgina, and New Jersey,","F-2042-2014","Class II","Pacific halibut, skin-on boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on the product..","Product is not coded.",,"42 pounds","Firm has been cold smoking, vacuum packaging, and distributing frozen seafood products without the required operating permit and without HACCP controls in place. ",4/23/2014,"04/23/2014",6/25/2014,"06/25/2014"
"Food",68265,"Terminated","Domega NY International Co Ltd","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City area","F-2422-2014","Class I","YF brand CRACKER (SESAME), Net Wt. 14 oz. (400g), UPC 6 920580 733416 --- The product is packed in a plastic package.","Code: PRD: 12/20/2013, EXP 6/30/2015",".","UNKNOWN","The product was found to contain undeclared peanuts based on sampling and analysis by New York State Department of Agriculture & Markets.",4/11/2014,"04/11/2014",9/17/2014,"09/17/2014"
"Devices",68266,"Ongoing","LAP of America Laser Applications, LLC","Boynton Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.","Z-1709-2014","Class II","CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.","CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002 ",,"280 Manuals","Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)",10/7/2013,"10/07/2013",6/11/2014,"06/11/2014"
"Devices",68267,"Completed","Summit Medical, Inc.","Eagan","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including CA, and country of: GERMANY.","Z-1731-2014","Class II","Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane. ","Lot #: 147809",".","9 boxes","One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.",5/12/2014,"05/12/2014",6/18/2014,"06/18/2014"
"Food",68268,"Terminated","Domega NY International Co Ltd","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City area (Manhattan, Brooklyn and Queens)","F-0003-2015","Class I","Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a plastic wrapped package.","MFD: 10.17.2013, EXP: 07.18.2014 ",,"150 cases (12 x 13.9 oz. packages per case)","The product was found to contain undeclared eggs plus unapproved colors Ponceau 4R (E124, Acid Red 18) and Acid Yellow 73 (uranine) based on sampling and analysis by New York State Department of Agriculture & Markets.",4/24/2014,"04/24/2014",10/15/2014,"10/15/2014"
"Devices",68269,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.","Z-1741-2014","Class II","enGen (TM) Laboratory Automation System Configured with TCAutomation'' Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). ---The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be gen","enGen (TM) Laboratory Automation Systems configured with TCAutomation'' Software version 3.5",".","Domestic: 6 units, Foreign: 3 units","Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5. ",4/17/2014,"04/17/2014",6/18/2014,"06/18/2014"
"Devices",68270,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela","Z-1738-2014","Class II","enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.","TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems ",".","Domestic - 31 units; Foreign - 77 units","Software anomaly: potential for delay in the reporting of patient sample test results when using enGen (TM) Laboratory Automation Systems with TCAutomation (TM) Software v2.6, v3.2 and v3.5. ",4/10/2014,"04/10/2014",6/18/2014,"06/18/2014"
"Devices",68271,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US Nationwide including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1734-2014","Class II","VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.","Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403",".","Domestic - 82, Foreign - 213 units","Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH",4/10/2014,"04/10/2014",6/18/2014,"06/18/2014"
"Devices",68271,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1735-2014","Class II","VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.","Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912",".","Domestic - 835 units, Foreign - 921 units","Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH",4/10/2014,"04/10/2014",6/18/2014,"06/18/2014"
"Devices",68271,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US Nationwide including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1736-2014","Class II","VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.","Software Version 2.7 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000102 through J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000337, 34001840, 34000316, 34001389, 34001317, 34000538, 34000552, 34000360, 34000451, 34000833, 34001572, 34000193, 34001633, 34000851, 34001345, 34001396, 34001809, 34001897, 34001240, 34001612, 34001311, 34000212, 34001472, 34001172, 34001390, 34000557, 34000893, 34001297, 34001378, 34001218, 34000318, 34000596, 34000497, 34000495, 34000529, 34000478, 34001569, 34001243, 34001504, 34000947, 34001422, 34000805, 34000631, 34001248, 34001251, 34000601, 34001274, 34001668, 34001850, 34001379, 34000133, 34000642, 34001626.",".","Domestic - 597 units, Foreign - 1381 units","Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH",4/10/2014,"04/10/2014",6/18/2014,"06/18/2014"
"Biologics",68273,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-0766-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W041013144667G; W041013144667G; ",".","1","Blood products, positive for the M-antigen but labeled negative for the M-antigen, were distributed.",3/26/2014,"03/26/2014",7/2/2014,"07/02/2014"
"Biologics",68274,"Terminated","The Blood Connection, Inc.","Piedmont","SC","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0764-14","Class III","Red Blood Cells","W121614125163; ",".","1","Blood product, collected from a donor with an unacceptable temperature, was distributed.",4/18/2014,"04/18/2014",7/2/2014,"07/02/2014"
"Biologics",68275,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; Illinois","B-0785-14","Class III","Red Blood Cells Leukocytes Reduced","W287814000681; W288014001185; ",,"2","Blood product, collected from a donor with polycythemia vera, was distributed. ",3/26/2014,"03/26/2014",7/9/2014,"07/09/2014"
"Biologics",68275,"Terminated","LifeSource","Rosemont","IL","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; Illinois","B-0784-14","Class III","Red Blood Cells","W084214000622; ",,"1","Blood product, collected from a donor with polycythemia vera, was distributed. ",3/26/2014,"03/26/2014",7/9/2014,"07/09/2014"
"Drugs",68276,"Ongoing","Bristol-Meyers Squibb","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide, Canada","D-1595-2014","Class I","COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96","Lot 00201125, Exp. 09/14; 00201126 Exp.11/14; 00201127, Exp.12/14; 00201228 Exp.06/15; 00201229 Exp. 07/15; 00201230, Exp. 09/15",,"50,724 Vials ","Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials",5/12/2014,"05/12/2014",9/24/2014,"09/24/2014"
"Devices",68277,"Ongoing","Medtronic MiniMed Inc.","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-Nationwide in US","Z-2544-2014","Class II","Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.","Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.",".","559,374 units total (444,374 units in US)","Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.",3/13/2014,"03/13/2014",9/3/2014,"09/03/2014"
"Food",68278,"Terminated","Surma Distributors Llc","Brooklyn","NY","US","Voluntary: Firm Initiated","Press Release","boroughs of Manhattan and Queens, NY","F-2170-2014","Class I","HAQUE brand GOLDEN RAISINS, WT 7 OZ. --- SURMA DISTRIBUTORS LLC Brooklyn, NY 11237 --- Nutrition Facts: Serving Size 1/4 tsp (0.5 g), Servings 204","No codes",,"UNKNOWN","The product was found to contain undeclared sulfites (1329.2 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.",5/8/2014,"05/08/2014",7/16/2014,"07/16/2014"
"Devices",68279,"Ongoing","NEO METRICS, INC.","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.","Z-1747-2014","Class II","Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.","MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899 ",".","1256 boxes ( 2 wires/box)","Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury. ",3/31/2014,"03/31/2014",6/18/2014,"06/18/2014"
"Veterinary",68280,"Terminated","Dogswell Llc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US. No international.","V-070-2014","Class III","HAPPY HIPS TILAPIA WITH GLUCOSAMINE & CHONDROITIN, 15 oz.","All Lot with Best Before date of December 26th, 2014 or earlier, based on last lot code produced. UPC 84244115184. Product Code 11518.",,"unknown","Dogswell LLC initiated this market withdrawal due to undeclared vegetable glycerin.",4/18/2014,"04/18/2014",6/25/2014,"06/25/2014"
"Devices",68281,"Ongoing","Beaver-Visitec International Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.","Z-1664-2014","Class II","Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth","Lot number: 3079324",,"9970 units","Contains a sharp tip needle when the product should contain a blunt tip cannula.",5/6/2014,"05/06/2014",6/4/2014,"06/04/2014"
"Drugs",68282,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1387-2014","Class III","Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01 ","Lot F0067 exp. 06/14, F0079 exp. 04/15 ",,"Lot F0067: 45,834 units; Lot F0079: 63,321 units","Failed Stability Specification; out of specification result for particle size distribution during stability testing.",5/28/2014,"05/28/2014",6/25/2014,"06/25/2014"
"Drugs",68283,"Completed","Abrams Royal Pharmacy","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","Two hospitals in Dallas, TX","D-0250-2015","Class I","Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.","Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13",".","1,100 vials","Non-Sterility: The firm's contract testing laboratory found sterility failures.",5/31/2013,"05/31/2013",11/26/2014,"11/26/2014"
"Devices",68284,"Ongoing","Integra LifeSciences Corporation","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.","Z-1697-2014","Class II","Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.","SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6; SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL",,"417 units","New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).",3/28/2014,"03/28/2014",6/11/2014,"06/11/2014"
"Drugs",68285,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1342-2014","Class II","PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01","Lot #: MN9081, Expiry: 09/2015",".","10,200 bottles","Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.",5/8/2014,"05/08/2014",5/28/2014,"05/28/2014"
"Devices",68286,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1805-2014","Class II","VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016) ",,"Domestic - 464 units; Foreign - 361 units ","Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28. ",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Devices",68286,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1804-2014","Class II","VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.","Lots 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), 1764 (31-Jul-2015)",,"Domestic - 612 units, Foreign - 461 units","Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28. ",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Biologics",68287,"Terminated","Kentucky Blood Center Inc","Lexington","KY","US","Voluntary: Firm Initiated","Telephone","Kentucky","B-0765-14","Class II","Red Blood Cells Leukocytes Reduced","W038214022806; ",,"1","Blood product, possibly contaminated with air during collection, was distributed.",4/17/2014,"04/17/2014",7/9/2014,"07/09/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0741-14","Class II","Red Blood Cells Leukocytes Reduced","W1428140102631; W142814007828R; W142814010193Y; W142814010197Q; W142814007544E; W142814007371O; W142814007318Y; W142814005611J; W142814010278O; W142814007275O; W142814010267U; W142814010453Q; W142814004463R; W142814011086O; W1428140013559; W142814005756M; W142814007946F; W1428140031988; W14281401301400O",,"19 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0738-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W142814010039H; W142814010039H; ",,"2 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0742-14","Class II","Fresh Frozen Plasma (Apheresis)","W142814004689S; W142814004689S; W142814004689S; W142814004689S; W1428140017103; W1428140017103; W1428140017103; W142813038174D; W142813038174D; W142813038174D; W142813038174D; W142813038002G; W142813038002G; W142813038002G; W142813038002G; W142813038002G; W1428130377209; W1428130377209; W1428130377209; W1428130377209; W1428130377209; W142813037427J; W142813037427J; W142813037427J; W142813037427J; W142813037427J; W142814010913002; W142814010913002; W142814010913002 ",,"29 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0736-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W1428140056521; W1428140056521; ",,"2 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0737-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W142814010295M; W142814008359000",,"2 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0740-14","Class II","Platelets Pheresis Leukocytes Reduced","W142814005824U; W142814005824U; ",,"2 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68288,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0739-14","Class II","Plasma Frozen","W1428140102631; W142814007828R; W1428140106636; W142814001338B; W142814005611J; W142814010278O; W142814010295M; W1428140031988; W142814004463R; W142814001994L; W1428140019428; W142814001592K; W1428140011967; W1428140003402; W14281400166200O; W14281304582200Y; W14281400326800C; W14281400244400S",,"18 units","Blood products, collected from an ineligible donor, were distributed. ",3/28/2014,"03/28/2014",6/25/2014,"06/25/2014"
"Biologics",68289,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; New York; Florida; Texas","B-0732-14","Class II","Red Blood Cells","W036809309525; 2601294; 2548618; 2416053; 2441866; 2375673; 2219900; 2219323; 2163158; 1465285; ",,"10 units","Blood products, collected from an unsuitable donor, were distributed. ",4/9/2014,"04/09/2014",7/9/2014,"07/09/2014"
"Biologics",68289,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; New York; Florida; Texas","B-0731-14","Class II","Platelets Pooled Leukocytes Reduced","W036810806232; W036809820278; 2936933; 2928314; 2916439; 2913066; 2906808; ",,"7 units","Blood products, collected from an unsuitable donor, were distributed. ",4/9/2014,"04/09/2014",7/9/2014,"07/09/2014"
"Biologics",68289,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; New York; Florida; Texas","B-0729-14","Class II","Red Blood Cells Leukocytes Reduced","W036810045282; 2636839; ",,"2 units","Blood products, collected from an unsuitable donor, were distributed. ",4/9/2014,"04/09/2014",7/9/2014,"07/09/2014"
"Biologics",68289,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; New York; Florida; Texas","B-0730-14","Class II","Cryoprecipitated AHF","2441866",,"1 unit","Blood products, collected from an unsuitable donor, were distributed. ",4/9/2014,"04/09/2014",7/9/2014,"07/09/2014"
"Biologics",68289,"Terminated","OneBlood, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Michigan; New York; Florida; Texas","B-0733-14","Class II","Fresh Frozen Plasma","W036810045282; W036809309525; 2601294; 2548618; 2375673; 1465285; ",,"6 units","Blood products, collected from an unsuitable donor, were distributed. ",4/9/2014,"04/09/2014",7/9/2014,"07/09/2014"
"Food",68290,"Ongoing","American Waffle","Clayton","DE","US","Voluntary: Firm Initiated","Telephone","Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Texas, West Virginia and Wisconsin","F-2024-2014","Class I","liveGfree Gluten Free Blueberry Pancakes NET WT 14.4 OZ, 12 pancakes Keep Frozen Distributed By Aldi, Inc., Batavia, IL 60510","Best By: 07/31/2015, UPC code 041498151485 ",,"480 cases, 2880 units ","American Waffle Company of Clayton, Delaware is voluntarily recalling one lot of Gluten Free Blueberry Pancakes because the product contains undeclared milk. ",5/14/2014,"05/14/2014",6/25/2014,"06/25/2014"
"Food",68291,"Ongoing","Us Tov, Inc. Dba U.s. Trading Company","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","Retail locations in MN,OH, KY, NY, CO, WA, CA, MO, IN, MI","F-2004-2014","Class I","Dragonfly Brand Crushed Chili Powder, Net Wt. 6.3 oz plastic tubs. Product of Thailand UPC 7 21557-53317 8 Packed for: U.S. Trading Co., 21118 Cabot Blvd., Hayward, CA 94545","Lot 359XP",,"44 cartons (48 x 6.3 0z tubs per carton)","IEH sample of Crushed Chili Powder collected at retail was positive for Salmonella Ba reilly.",5/13/2014,"05/13/2014",6/11/2014,"06/11/2014"
"Devices",68292,"Ongoing","Convatec Inc.","Skillman","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide","Z-1785-2014","Class I","Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.","13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM513636 13VM513642 13VM516733 13VM520039 13VM521731 13VM521733 13VM524363 13VM524364 13VM527149 13VM527150 13VM528992 13VM528994 13VM531214 14FM0301 14VM531935 14VM532098 ",,"73,021 units US; 24,866 units OUS","Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative to the inflation and deflation of the device's retention balloon. ",4/29/2014,"04/29/2014",6/25/2014,"06/25/2014"
"Devices",68293,"Ongoing","Bayer Corp","Warrendale","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.","Z-1673-2014","Class II","Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff. ","catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656 300010 100066 14498 100087 200305 200663 200248 200606 300047 1040 100182 100187 200442 200037 200716 200111 300051 1041 100428 100128 200479 200586 200648 200009 300045 100107 100037 100213 200665 200034 200722 200134 300027 100272 100457 100215 200601 200109 200298 200135 100220 100273 100482 100141 200615 200121 200558 200593 300036 100401 11210 100488 200117 200313 200618 200465 300033 100409 10328 100129 200540 200515 200187 1045 300034 100404 15187 100083 200401 200119 20398 200045 300042 100299 10407 100006 200115 1068 200051 14857 300026 100300 100233 100188 200432 200267 1073 200557 300049 100399 100266 100226 200497 200689 200022 200322 30020 100400 14076 100271 200200 200771 200089 200346 300013 100184 100265 100069 200012 200075 200090 200655 300012 100185 1033 1047 200706 200076 200091 200509 300000 100405 100316 100098 200707 1047 200344 1006 200004 100173 100356 100051 200493 200031 200337 200175 300001 100174 10810 100148 200419 200512 200644 200103 300002 100259 100144 100297 200597 200430 200579 200436 300003 100283 100105 100449 100122 200348 200580 200104 300028 100375 14163 100452 200393 200276 200463 200105 300055 1000 11159 100454 200392 200205 200079 200204 300032 100517 100027 100458 200674 200469 200328 200443 300031 100518 100279 100072 200193 200268 200040 200444 300044 100521 100139 100084 200324 200000 200030 200225 300015 100212 100175 11132 200289 200627 200395 200421 1021 100284 14246 100304 200415 200583 200388 200396 300037 100036 100443 100257 200416 200087 200682 200047 300025 100545 100492 100447 200448 200136 200164 1020 300016 100433 100497 100529 200482 200137 200778 1012 300017 100434 100170 100487 200483 200270 200568 200124 300019 1019 100019 100537 200574 200581 200185 1008 300006 100296 14464 100515 200587 200641 200043 1064 300029 100135 10387 10213 200598 200213 200160 200049 300062 1038 14846 11179 200614 200186 200161 200450 300043 100354 100342 11",,"1347","There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. ",4/3/2014,"04/03/2014",6/11/2014,"06/11/2014"
"Devices",68294,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US",,"Letter","US Nationwide Distribution","Z-1792-2014","Class II","cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.","1125-07,1017-06,1021-03,1021-05,1016-05,1017-01,1124-05,1124-06,1128-02,1132-03,1132-04,1131-08,1132-01,1132-02,1128-05,1128-06,2374-11,1132-05,1132-10,1137-02,1139-08,1139-10,1140-07,1140-10,1140-08,1146-01,1146-02,1146-03,1139-06,1139-07,1139-09,1142-09,1145-10,1138-10,1139-01,1127-08,1138-08,1146-05,1146-06,1147-04,1156-04,1140-01,1147-05,1149-01,1149-07,1149-08,1167-02,1156-06,1158-09,1156-05,1158-10,1139-02,1139-03,1139-04,1139-05,1160-01,1160-05,1171-07,1171-08,1171-09,1173-10,1156-01,1160-04,1156-07,1156-02,1156-09,1160-06,1171-10,1173-01,1169-06,1169-08,1169-09,1172-09,1182-08,1211-15,1211-14,1174-08,1160-08,1171-06,1174-06,1174-07,1211-13,1211-06,1183-04,1217-09,1225-11,1211-16,1211-17,1211-18,1224-10,1156-08,1156-10,1225-14,1331-13,1338-15,1338-16,1211-19,1211-04,1211-05,1211-20,1208-08,1208-09,1211-02,1211-03,1338-12,1338-13,1338-14,1208-05,1211-07,1211-08,1458-04,1331-10,1331-11,1331-12,1334-15,1335-13,1344-02,1344-03,1344-04,1344-05,1344-06,1357-07,1357-08,1357-09,1357-10,1357-19,1357-20,1334-12,1334-13,1334-14,1459-12,1459-13,1357-15,1357-16,1357-17,1357-18,1335-08,1335-09,1335-10,1335-11,1344-01,1344-07,1344-08,1461-01,1461-02,1344-09,1459-14,1459-10,1459-11,, , ",,"149","Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.",5/21/2014,"05/21/2014",6/25/2014,"06/25/2014"
"Devices",68294,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US",,"Letter","US Nationwide Distribution","Z-1791-2014","Class II","cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. ","1848-01, 1848-03, 1848-04, 185503, 1845-15, 186211, 1857-12, 186225, 1862-16, 1862-10, 185715, 185817, 1865-05, 1862-27, 1858-35, 1859-30, 1859-33, 1863-05, 1867-14, 1844-16, 1868-14, 1844-15, 1870-06, 1870-14, 1857-13, 1870-05, 1868-08, 1867-16, 1868-02, 1865-04, 1867-13, 1862-24, 1872-14, 1872-15, 1871-05, 1873-05, 1871-12, 1871-14, 1873-10, 1872-01, 1871-09, 187015, 1873-01, 1871-04, 187113, 187202, 1871-07, 1873-02, 1866-13, 185731, 1867-20, 1868-01, 01873-03, 1874-06, 1872-12, 1867-19, 1985-08, 1872-07, 1874-05, 1983-10, 1983-09, 1872-03, 1871-01, 1867-06, 1844-14, 1985-10, 187102, 1988-08, 1872-06, 1871-03, 1988-02, 1984-05, 1985-07, 1987-14, 1871-11, 187018, 198703, 1990-04, 1987-04, 1983-08, 199902, 1870-16, 1990-02, 1991-08, 1852-15, 1984-01, 198803, 199110, 198711, 1987-10, 199010, 1988-11, 1991-18, 1990-05, 1988-14, 1991-09, 1991-11, 199112, 1991-13, 1991-14, 1988-10, 1910-02, 1909-09, 1909-10, 1991-15, 1910-03, 1910-05, 190914, 1991-17, 1991-16, 1985-06, 1919-05, 1909-08, 1983-06, 1924-11, 0761-08, 1912-20, 198709, 191007, 1911-11, 1924-12, 0756-30, 1908-03, 1910-06, 1909-13, 1907-02, 1901-15, 1913-03, 1913-04, 1909-01, 1988-06, 1925-07, 192506, 1928-02, 190515, 1905-16, 1924-17, 1924-15, 1905-17, 1924-14, 1927-19, 1907-01, 1931-09, 190520, 1923-17, 1919-07, 1919-08, 1925-11, 1990-08, 1926-04, 2039-11, 2037-08, 1925-12, 1926-02, 0753-22, 1905-11, 1905-18, 1905-19, 1935-17, 1927-09, 2037-13, 1935-16, 1926-03, 190703, 1871-06, 2037-14, 1936-14, 1928-19, 192418, 1936-09, 1936-08, 1991-07, 1919-03, 1911-15, 1935-14, 1927-15, 1924-16, 1924-13, 2039-07, 1928-01, 2037-03, 191305, 1927-16, 2039-12, 192707, 2039-13, 2041-16, 2037-11, 1927-03, 1935-19, 1931-11, 2039-09, 2037-19, 2037-07, 2049-21, 2047-10, 2041-12, 2047-07, 2049-16, 2054-11, 192509, 2041-18, 2047-06, 2049-15, 2051-33, 2051-34, 2049-28, 0763-03, 1914-14, 192717, 2049-14, 2048-31, 2051-32, 2056-09, 2056-12, 2048-05, 2048-32, 2050-31, 2050-32, 2058-22, 2056-14, 2054-06, 2050-29, 2054-10, 1935-18, 2042-01, 2052-05, 2055-30, 2059-11, 2047-09, 2055",,"1147","Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.",5/21/2014,"05/21/2014",6/25/2014,"06/25/2014"
"Devices",68294,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US",,"Letter","US Nationwide Distribution","Z-1790-2014","Class II","Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. "," 1305-31, 1305-21, 1305-22, 1308-35, 1308-36, 130833, 130834, 1308-44, 1310-20, 1418-12, 1307-33, 1421-11, 1417-20, 1423-16, 143115, 1428-07, 1430-16, 1430-17, 1423-15, 1429-15, 1305-40, 1541-05, 1539-15, 1548-15, 1544-11, 1431-14, 1548-17, 1545-03, 1547-20, 1557-12, 1544-06, 1548-08, 1429-13, 1303-31, 1303-32, 1556-16, 1549-04, 1548-16, 1540-20, 1538-10, 1563-06, 1556-17, 1539-13, 1539-14, 1571-12, 1572-19, 1684-05, 1570-14, 1571-13, 1679-13, 1684-06, 1683-17, 1570-17, 1684-07, 1684-08, 1685-16, 1572-20, 1673-01, 1691-17, 1691-19, 1691-18, 1698-05, 1698-06, 1691-14, 1728-10, 1694-19, 1711-17, 1708-20, 1709-03, 1601-01, 1698-03, 1601-03, 1705-20, 1714-18, 1714-19, 1847-02, 1686-01, 1733-17, 1733-19, 1733-16, 1736-06, 1843-02, 1570-15, 1849-01, 1855-15, 1857-22, 1860-10, 1691-20, 1696-05, 1567-01, 1860-24, 1853-02, 1855-10, 1855-11, 1858-02, 1858-03, 1860-12, 1860-13, 1860-14, 1736-04, 1849-02, 1853-01, 1860-11, 1857-23, 1857-24, 1739-19, 1857-25, 1857-26, 1861-18, 1861-19, 1861-23, 1853-03, 1860-16, 1860-23, 1860-15, 1864-16, 1860-19, 1985-13, 1989-19, 1996-02, 1861-20, 1865-19, 1307-34, 1992-19, 1999-16, 1999-17, 1864-19, 1980-15, 1535-09, 1999-20, 1993-01, 1996-01, 1999-18, 1905-05, 1905-03, 1921-03, 1925-03, 1860-22, 1860-20, 1905-01, 1921-01, 1858-04, 1860-17, 1905-02, 1921-02, 1418-03, 1418-04, 1925-04, 1905-06, 1999-19, 2050-04, 2050-03, 2050-06, 2050-07, 2050-05, 1537-15, 2052-01, 2052-02, 2050-08, 1725-18, 1694-20, 1733-18, 2056-22, 2056-23, 1419-12, 1422-17, 1307-41, 1536-04, 2065-12, 1905-07, 1905-08, 1864-17, 1864-18, 2061-20, 2065-06, 1736-03, 2065-13, 2076-18, 2068-24, 2080-02, 2071-24, 2071-23, 2068-23, 2081-05, 2081-06, 2070-01, 2079-19, 2080-01, 2081-04, 2070-02, 2086-14, 2086-20, 2084-16, 2084-17, 2084-18, 2085-09, 2086-17, 2086-18, 2082-39, 2084-05, 2084-12, 2084-13, 2084-14, 2084-15, 2085-05, 2085-07, 2085-08, 2188-05, 2188-06, 2188-07, 2086-15, 2086-16, 2086-19, 2188-08, 2188-09, 2188-10, 2084-06, 2084-07, 2071-22, 2084-08, 2084-09, 2084-10, 2084-11, 2085-04, 2085-10, 2188-04, 2084-19, 2084",,"462","Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.",5/21/2014,"05/21/2014",6/25/2014,"06/25/2014"
"Devices",68295,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Distributed in the state of CT.","Z-1723-2014","Class II","Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.","N457062003",,"1","Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. ",5/2/2014,"05/02/2014",6/11/2014,"06/11/2014"
"Drugs",68296,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1424-2014","Class II","Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20 ","Lot 36225DD, exp 12/01/2015",,"45,448 vials","Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution",5/16/2014,"05/16/2014",7/16/2014,"07/16/2014"
"Devices",68298,"Ongoing","Hologic, Inc.","Danbury","CT","US","Voluntary: Firm Initiated","Letter","Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.","Z-1701-2014","Class II","Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.","Serial Numbers: 1800314 7263, 180031472, 18002023051PR",,"3 units","Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury",5/13/2014,"05/13/2014",6/11/2014,"06/11/2014"
"Devices",68298,"Ongoing","Hologic, Inc.","Danbury","CT","US","Voluntary: Firm Initiated","Letter","Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.","Z-1700-2014","Class II","Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.","Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W ",,"11 units","Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury",5/13/2014,"05/13/2014",6/11/2014,"06/11/2014"
"Drugs",68299,"Ongoing","Oasis Medical Inc","Glendora","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","D-1347-2014","Class III","Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.","Lot #: OTM-07, Expiry: 12/2015.",".","10,549 Bottles","Labeling: Missing Label; The label on the immediate bottle is missing.",5/14/2014,"05/14/2014",5/28/2014,"05/28/2014"
"Veterinary",68300,"Ongoing","Oxbow Enterprises","Murdock","NE","US","Voluntary: Firm Initiated","Telephone","Distribution was made to AZ, CA, GA, IN, KS, MD, PA, RI, VA, WA, and WI. Foreign distribution was made to Canada. There was no military/government distribution.","V-071-2014","Class III","Essentials Mouse & Young Rat Food, packaged in 2.5-lb. flexible plastic bags (12/case), UPC 744845404042, and 25-lb. flexible plastic bags, UPC 744845404035. Manufactured by Oxbow Animal Health, Oxbow Enterprises, Inc., Murdock, NE.","Best by dates: Jan 10 2016, Jan 25 2016, Feb 28 2016, Mar 14 2016, and Apr 04 2016.",,"8,616/2.5-lb. bags and 4,208/25-lb. bags","Some of the bags of product contain mold",5/5/2014,"05/05/2014",6/25/2014,"06/25/2014"
"Food",68301,"Ongoing","F. Gavina & Sons Inc.","Vernon","CA","US","Voluntary: Firm Initiated","Letter","CA and NE","F-1985-2014","Class III","Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb, Product label reads in part ''***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***''","Lot No. 85895",,"29 units","F. Gavina and Sons Inc. is recalling Gavina Northwest Blend Dark whole beans because it was mislabeled as decaffeinated product.",5/14/2014,"05/14/2014",6/11/2014,"06/11/2014"
"Devices",68302,"Ongoing","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution","Z-2120-2014","Class II","GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.","Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063 10064 10066 10067 10068 10072 10073 10074 10075 10079 10080 10081 10082 10083 10084 10085 10086 10087 10088 10108 10109 10110 10111 10112 10113 10114 10115 10116 10117 10146 10147 10148 10149 10150 10151 10152 10153 10154 10155 10162 10208 10209 10212 10213 10222 10225 10226 10238 10239 10242 10243 10244 10245 10272 10273 10274 10275 10276 10295 10296 10297 10298 10299 10300 10301 10302 10303 10304 10328 10329 10330 10331 10332 10333 10334 10335 10336 10337 10356 10357 10358 10359 10360 10361 10362 10363 10364 10365 10366 10367 10400 10401 10402 10403 10404 10405 10406 10429 10430 10431 10432 10433 10459 10461 10464 10465 10466 10491 10492 10493 10494 10537 10538 10539 10540 10541 10542 10543 10544 10545 10546 10547 10548 10549 10550 10566 10567 10568 10569 10570 10571 10572 10573 10594 10595 10596 10597 10598 10599 10600 10608 10609 10610 10611 10612 10613 10614 10615 10616 10651 10652 10653 10654 10655 10673 10674 10675 10676 10677 10678 10679 10680 10696 10697 10732 10766 10767 10768 10769 10770 10771 10772 10773 10798 10799 10800 10801 10802 10821 10822 10823 10824 10825 10826 10827 10828 10854 10855 10856 10857 10858 10859 10860 10904 10905 10906 10907 10908 10909 10910 10911 10912 10913 10957 10958 10959 10960 10992 10993 10994 11080 11081 11082 11083 11084 11119 11120 11121 11122 11123 11155 11156 11157 11192 11193 11194 11195 11196 11197 11198 11199 11236 11237 11238 11239 11240 11241 11242 11243 11244 11245 11261 11262 11263 11270 11271 11272 11273 11310 11311 11312 11313 11314 11315 11316 11317 11318 11319 11367 11368 11369 11370 11371 11372 11373 11406 11407 11408 11409 11410 11411 11412 11449 11450 11451 11568 11",".","567 units","Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,",5/16/2014,"05/16/2014",8/20/2014,"08/20/2014"
"Food",68303,"Ongoing","Rockman Company Usa Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US. No International. US States: CA, HI, MO, FL, MN, MS, MN, NC, NE.","F-2009-2014","Class II","Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Packaged in plastic pouch. 12oz/60bags/carton. Product labeling reads in part: ''ROCKMAN***SKINLESS PEANUT 12 0Z (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (U.S.A.) INC.***COMMERCE, CA***PRODUCT OF CHINA***''.","No codes.",,"approximately 22 cartons","Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling and blanched peanuts due to mis-labeling.",5/19/2014,"05/19/2014",6/11/2014,"06/11/2014"
"Food",68303,"Ongoing","Rockman Company Usa Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US. No International. US States: CA, HI, MO, FL, MN, MS, MN, NC, NE.","F-2008-2014","Class II","Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as ''PEANUT'' on packaging. Product labeling reads in part: ''ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (USA) INC.***COMMERCE, CA***PRODUCT OF CHINA***''.","No codes. ",,"approximately 47 cartons","Rockman Company USA, Inc. inititated the recall of raw peanuts due to mold and mis-labeling: missing Allergen Statement, missing Nutrition Facts Information, missing List of Ingredients, and inaccurate Distributor address and phone number. ",5/19/2014,"05/19/2014",6/11/2014,"06/11/2014"
"Drugs",68304,"Completed","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas","D-1422-2014","Class II","BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.","Lot #: 6156-0, Exp 03/07/14",,"10 bags","Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial. ",2/13/2014,"02/13/2014",7/16/2014,"07/16/2014"
"Devices",68305,"Terminated","Bacterin International, Inc.","Belgrade","MT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to one foreign consignee in Lebanon.","Z-1680-2014","Class II","Wound Drain - Label reads in part ''Elutia ***Hubless Coated Silicone Surgical Wound Drain***'' Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.","19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..",,"390","The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized",5/15/2014,"05/15/2014",6/11/2014,"06/11/2014"
"Food",68306,"Ongoing","Diamond Crystal Brands, Inc.","Duluth","GA","US","Voluntary: Firm Initiated","Letter","AR, CA, CO, FL, GA, IA, IN, KS, KY, MN, MS, NJ, NY, OH, OK, OR, TX, UT and VA.","F-2018-2014","Class I","Poco Pac Salad Dressing, Distributed by Diamond Crystal Brands, Inc., Savannah, GA 31405, and packaged in single serve packets of 9 or 12 grams (g) of product. Product is packed as follows: 500 ct-9g (Product Code: 86251), 200ct-9g (Product Code: 86242) and 200 ct-12g (Product Code: 86228).","Product Code: 86251, Lot numbers: D009E, D022E, D027E, D030E, D031E, D037E, D038E, D048E, D056E, D057E, D058E, D093E, D105E, D136D, D150D, D156D, D162D, D163D, D171D, D172D, D178D, D190D, D193D, D199D, D204D, D213D, D220D, D224D, D227D, D228D, D229D, D234D, D235D, D241D, D248D, D249D, D252D, D254D, D255D, D266D, D267D, D274D, D275D, D281D, D282D, D295D, D298D, D302D, D315D, D316D, D318D, D322D, D329D, D338D, D339D, D344D, D345D, D361D; Product Code: 86242, Lot number: D022E, D037E, D065E, D105E, D169D, D171D, D184D, D189D, D193D, D199D, D203D, D204D, D220D, D233D, D234D, D240D, D256D, D269D, D274D, D280D, D283D, D294D, D315D, D329D, D331D, D351D, D358D, D360D; Product Code: 86228, Lot numbers: D009E, D022E, D027E, D038E, D048E, D058E, D136D, D162D, D184D, D193D, D199D, D204D, D220D, D224D, D227D, D228D, D235D, D241D, D248D, D249D, D254D, D266D, D267D, D280D, D283D, D298D, D315D, D316D, D322D, D329D, D345D, D346D.",".","48,143 cases/200 ct/9 gram pack per case","Undeclared Allergen: Egg",5/14/2014,"05/14/2014",6/18/2014,"06/18/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0578-2015","Class I","Item Number 717548.01, Kerry 96002542, Sage Sausage Seasoning, 50 Lb (22.68 KG), Lots: 0329460107, 0428424311 ","Lots: 0329460107, 0428424311 ",".","201 bags (10,050 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0576-2015","Class II","Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01. ","lot 0505460103",".","12,548.9 lbs","Kerry Ingredients is recalling two products, Italian Pork and Beef Meatball Seasoning, and Beef and Chicken Meatball Seasoning, because they were processed on the same equipment as Breakfast Sausage Seasoning which tested positive for Salmonella. Kerry determined that the source of the Salmonella was an ingredient used in the Breakfast Sausage Seasoning.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0581-2015","Class I","Item Number B18780.01, Kerry Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0407424305"," Lot: 0407424305",".","148 bags (7,400 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0587-2015","Class I","Item Number 721698.01, Kerry, Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0417424307","Lot: 0417424307",".","40 bags (2,000 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0583-2015","Class I","Item Number 30511785.01, Kerry Breakfast Sausage Seas, Net Wt 50 Lb (22.68 Kg), Lot Number: 0329460108 ","Lot: 0329460108 ",".","79 bags (3,950 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0579-2015","Class I","Item Number 30499117.0, Kerry CI 96004320, Sausage Crumble 30499117, 40.05 lbs (18.16 KG) Lot Number : 0401423904 "," Lot: 0401423904 ",".","32 bags ( 1,281.6 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0582-2015","Class I","Item Number 723297.01,Kerry 80529TR PC NEW ENGLISH BANG, Net WT 6.7 KG, Lot Number: 0402437604, 0403437502, 0430437506, 0506437603. "," Lot: 0402437604, 0403437502, 0430437506, 0506437603. ",".","160 bags (2,358.4 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0588-2015","Class I","Item Number 30600397.01, 96005094, Kerry, Chicken Noodle Soup Seasoning, Net WT 40 Lb (18.18 KG), Lot Number: 0418409102","Lot: 0418409102",".","6 bags (240 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0577-2015","Class II","Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01. ","lot 0505460104",".","8727.42 lb.","Kerry Ingredients is recalling two products, Italian Pork and Beef Meatball Seasoning, and Beef and Chicken Meatball Seasoning, because they were processed on the same equipment as Breakfast Sausage Seasoning which tested positive for Salmonella. Kerry determined that the source of the Salmonella was an ingredient used in the Breakfast Sausage Seasoning.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0585-2015","Class I","Item Number B00584.01, Kerry, Breakfast Sausage Seasoning, Net WT 50 lb (22.68 KG), Lot Number: 0417424306","Lot: 0417424306",".","40 bags (2,000 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0586-2015","Class I","Item Number B17416.01, Kerry, Rosemary & Olive Oil Seas Baptistas Item # 00391, Net WT 50.0 lb (22.68 KG), Lot Number: 0416424101, 0501424101","Lot: 0416424101, 0501424101",".","259 bags ( 12,950 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0580-2015","Class I"," Item Number B17017.02, 96051707, Kerry Chicken Noodle Soup Seas 17017, 29.0 LB ( 13.18 KG), Lot Number : 0402409101 "," Lot: 0402409101 ",".","18 bags (522 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Food",68307,"Ongoing","Kerry Foods","Beloit","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, WI, KY, PA, AR, KS. CANADA","F-0584-2015","Class I","Item Number 30590439.01, Kerry, Brown Butter 30590439.01, Net WT 50 lb (22.68 KG), Lot Number: 0416424102","Lot: 0416424102",".","61 bags (3,050 lbs)","Kerry determined that eleven products they manufactured contained an ingredient which was found positive for Salmonella.",5/12/2014,"05/12/2014",12/2/2014,"12/02/2014"
"Biologics",68308,"Ongoing","Pall Corporation","Port Washington","NY","US","Voluntary: Firm Initiated","Letter","CA, NC, IL, MD, FL, MA","B-0699-14","Class II","Sterile Cord Blood Collection Unit, Anticoagulant Citrate Phosphate Dextrose Solution (CPD), Code 791-08 (PALL Medical label) and 791-09V (ViaCord label), UPC code for Pall product code: 791-08: (Case box): (01) 30636207307966 There is no UPC code issued to the ViaCord product. --- The systems are packaged STERILE within a ''sterilization pouch'' (1 system/pouch) and placed within a foil envelope (1 pouch/ envelope). There are 24 units packaged per case box.","Pall Sterile Cord Blood Collection System Code 791-08: Lot number 1356443 (Expiry Date 10/2016); ViaCord's Sterile Cord Blood Collection System, Code 791-09V: Lot numbers 1356441 and 1356442 (Expiry Date 10/2016)",,"3 Lots","Sterile Cord Blood Collection Systems, with a limited number of reports of a blood leaks, were distributed. ",1/14/2014,"01/14/2014",6/11/2014,"06/11/2014"
"Devices",68309,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.","Z-1737-2014","Class II","Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. ","Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.",".","82 units","Beckman Coulter is initiating a field action for the Access Family of Immunoassay Systems because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.",5/14/2014,"05/14/2014",6/18/2014,"06/18/2014"
"Devices",68310,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.","Z-1838-2014","Class II","G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis PN 110003500.","PN: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.",,"1047 total","Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. ",5/7/2014,"05/07/2014",6/25/2014,"06/25/2014"
"Devices",68310,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.","Z-1837-2014","Class II","G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN:110003458","PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.",,"1047 total","Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. ",5/7/2014,"05/07/2014",6/25/2014,"06/25/2014"
"Devices",68311,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Canada, Mexico, Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-1827-2014","Class II","Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.","Model Number: 9896 030 1929.1",,"5","Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68311,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Canada, Mexico, Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-1826-2014","Class II","Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.","Model Numbers: 9896 030 1929.2, 9896 030 1929.3 ",,"420","Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68312,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide","Z-1717-2014","Class II","Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.","Model nos. 10281013,10281163 with serial nos. 30080 23071 20045 31072 22523 22776 22787 31137 23021 20034 20112 22775 22279 22283 22280 22875 22290 22576 22848 31060 31136 31064 31138 22326 23068 22288 22114 22714 21100 22960 23082 22169 22601 21065 21205 31017 31135 31040 21086 22972 30038 30047 23029 22538 22658 21088 21103 31120 21224 21221 21223 21085 31122 22597 22388 22391 20115 22104 22583 23097 22943 22942 22585 22781 21089 20093 20110 21066 22404 22796 22506 21031 30040 22119 22599 22844 22148 22880 21139 21006 20155 30055 30024 21114 21112 21122 31069 21185 30051 31078 30076 31012 22429 22190 31010 31011 22146 22527 22520 22126 22128 23138 31018 22836 23083 23036 22163 20089 20107 20088 20106 21052 22727 23098 22135 22737 22872 22542 22549 22551 22567 22500 31075 22449 30032 22350 31128 22389 31004 22984 30028 23020 31026 31134 21213 22247 22347 30078 22428 22137 22917 22873 31115 20167 31053 31081 21174 22029 22725 22724 31094 22286 31019 22093 22933 22920 22895 22681 22676 22682 22019 22020 21098 31077 31119 30062 31054 22080 31121 30050 21057 22833 22840 22955 31093 22058 31046 22931 22847 22852 22309 21101 22612 21120 21117 21116 21118 22367 22600 22946 30021 22655 22705 23016 22699 22192 22251 22899 31028 21091 31071 22928 22275 21092 22254 21037 21077 21076 22839 22117 22609 22543 22821 30029 23118 22838 22842 21200 21209 21203 20149 21163 22708 21172 21171 21173 22248 31067 31066 23053 30066 30067 30063 22789 22857 22055 22050 22038 22051 22056 22037 22060 22242 22071 22208 22073 22632 22683 22666 22541 22537 22364 23127 23129 20094 22132 22026 22027 22225 23024 23022 30052 23130 23132 22092 21115 22456 22441 22021 22730 22743 22851 21113 22175 31003 22584 20047 21194 22786 31117 31145 23018 23019 22166 22170 ",,"433","Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.",5/9/2014,"05/09/2014",6/11/2014,"06/11/2014"
"Devices",68313,"Completed","BioDerm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.","Z-1744-2014","Class II","BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. ","Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.",".","26,040 units.","On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers. ",5/31/2011,"05/31/2011",6/18/2014,"06/18/2014"
"Devices",68313,"Completed","BioDerm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.","Z-1742-2014","Class II","BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. ","Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.",".","26,040 units.","On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. ",5/31/2011,"05/31/2011",6/18/2014,"06/18/2014"
"Devices",68313,"Completed","BioDerm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.","Z-1743-2014","Class II","BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. ","Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.",".","26,040 units.","On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination. ",5/31/2011,"05/31/2011",6/18/2014,"06/18/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2289-2014","Class I","KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 5.","Lot Codes: TC14034A, TC14034B, TC14035A, TC14035B, TC14036A, TC14036B, TC14088A, TC14088B, TC14088C, TC14090A, TC14090B, TC14090C",".","16,002 cases","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2292-2014","Class I","STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.","Lot Codes: TC14049A1, TC14049B1, TC14070B1, TC14070C1, TC14071A1, TC14071B1, TC14105B1, TC14105C1, TC14106A1, TC14106B1, TC14106C1, TC14107A1",".","16,869 bars","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2294-2014","Class I","STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.","Lot Codes: TC14049B1, TC14049C1, TC14071C1, TC14072A1, TC14072B1, TC14072C1, TC14100A1, TC14100B1, TC14100C1, TC14101A1",".","14,300 cases","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2290-2014","Class I","STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.","Lot Codes: TC14048B1, TC14048C1, TC14069A1, TC14069B1, TC14069C1, TC14070A1, TC14070B1, TC14101A1, TC14101B1, TC14101C1, TC14102A1, TC14102B1, TC14102C1",".","3,494 cases","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2293-2014","Class I","STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.","Lot Codes: TC14048A1, TC14048B1, TC14074A1, TC14074B1, TC14074C1, TC14076A1, TC14102C2, TC14104A1, TC14104B1, TC14104C1, TC14105A1",".","3,525 cases","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68315,"Ongoing","KIND, LLC","New York","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Mexico","F-2291-2014","Class I","STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.","Lot Codes: TC14049C1, TC14050A1, TC14072C1, TC14073A1, TC14073B1, TC14073C1, TC14099A1, TC14099B1, TC14099C1",".","12,190 cases","The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars",5/21/2014,"05/21/2014",8/13/2014,"08/13/2014"
"Food",68316,"Ongoing","Bazzini Holdings L.L.C.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Nationwide, excluding Pacific States","F-2171-2014","Class II","Barricini Milk Chocolate Peanut Butter Pretzels in Net Wt 6.5 oz. plastic tub, UPC 075655235181 Back Panel: Milk Chocolate Peanut Butter Cups Barricini Manufactured by Bazzini Holdings, LLC Allentown, PA 18106","Lot 1E083 ",,"1000 cases, 12,000 units","Undeclared wheat. The back panel applied to some containers of milk chocolate peanut butter pretzels was for milk chocolate peanut butter cups, which does not declare wheat.",5/2/2014,"05/02/2014",7/16/2014,"07/16/2014"
"Devices",68317,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.","Z-1782-2014","Class II","Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005","Lot 141525",".","1180 units","Sterility of the device may be compromised due to unsealed pouch",5/13/2014,"05/13/2014",6/18/2014,"06/18/2014"
"Food",68319,"Ongoing","Mandelin Inc","Wasco","CA","US","Voluntary: Firm Initiated","Letter","CA, KY, CO","F-2010-2014","Class II","Marzipan - Pink, Orange and Green; Packed in 1 lb, (16 oz.) plastic containers and and 10.5 lb. 4.76 kg) pails. Ingredient: Sugar, almonds, potassium sorbate, oil of bitter almonds. Mandelin: California Almonds and Almond Pastes, Wasco California 93280","Codes: 1 Lb. packages: 2234, 91469FY; 10.5 lb packages: 133, 233, 336, 390, 509, 878, 995, 1071, 1608, 1617, 1634, 1677, 1691, 2529, 91276, 91714, 91755, 91786, 91113YF, and 91276YF",".","~5500-6000 lbs","Undeclared Yellow #5 & 6 in Marzipan (Pink, Green, Orange).",5/16/2014,"05/16/2014",6/18/2014,"06/18/2014"
"Devices",68320,"Ongoing","Siemens Medical Solutions Diagnostics","Flanders","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy. Malaysia, Peru, Korea, and the United Kingdom.","Z-1832-2014","Class III","VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.","Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528",,"19 units","The keyboard and monitor may not be properly secured to the monitor arm.",4/25/2014,"04/25/2014",6/25/2014,"06/25/2014"
"Biologics",68321,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-0749-14","Class III","Red Blood Cells Leukocytes Reduced","W071213017758; ",,"1 unit","Blood product, which failed to meet the minimum specification for red blood cell percent recovery, was distributed.",4/8/2014,"04/08/2014",7/9/2014,"07/09/2014"
"Biologics",68322,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-0709-14","Class II","Platelets Pheresis Leukocytes Reduced","W1151140597688; W1151140597688; ",,"2 units","Blood products, for which the monthly product quality control was outside the acceptable range, were distributed.",4/18/2014,"04/18/2014",7/9/2014,"07/09/2014"
"Biologics",68323,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Texas","B-0750-14","Class II","Red Blood Cells Leukocytes Reduced","W035213079119X; ",,"1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",5/5/2014,"05/05/2014",7/9/2014,"07/09/2014"
"Biologics",68324,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0712-14","Class III","Cryoprecipitated AHF","1500157; W280313100569; W280313100571; W280313301453; W280313401141; W280313501433; W280313501435; W280313604358; W280313604371; W280310402161; W280310600246; W280310600268; W280310600287; W280310600288; W280311300170; W280312202000; W280312401013; W280312501718; W280312501719; W280312501720; W280312501721; W280313600506; 1500156; 2006316; 2006318; 2006391; 2006593; 2006594; 3501868; 3501869; 3501870; 3502243; 3502244; 3503146; 3504714; ",,"35 units","Blood products, processed more than eight hours after collection, were distributed.",3/27/2014,"03/27/2014",7/9/2014,"07/09/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0775-14","Class II","Cryoprecipitated AHF","W115912047510; 3429940; ",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0774-14","Class II","Plasma Frozen within 24 hours (FP24)","W115912046083; W115912042988; W115912020691; W115911027043; ",".","4 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0776-14","Class II","Fresh Frozen Plasma","W115913040228; 3527550; 3679362; 3651875; ",".","4 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0773-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W115912046083; W115912020691; ",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0778-14","Class II","Blood and Blood Products for Reprocessing","W115912047510; 3429940; 3811696; 3639252; 3634924; ",".","5 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Biologics",68325,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; Massachusetts; California; Florida","B-0777-14","Class II","Red Blood Cells Leukocytes Reduced","W115913040228; W115912047510; W115912042988; W115911027043; 3429940; 3527550; 3811696; 3679362; 3651875; 3639252; 3634924; ",".","11 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. ",4/11/2014,"04/11/2014",7/23/2014,"07/23/2014"
"Devices",68326,"Ongoing","Microport Orthopedics INC.","Arlington","TN","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution.","Z-1712-2014","Class II","PATH THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.","Lot Number(s): 1153896, 1279714, 1288604, and 1314793",,"140 units","Difficulty removing the cup adaptor from the impaction handle during surgery",4/30/2014,"04/30/2014",6/11/2014,"06/11/2014"
"Food",68327,"Ongoing","White Wave Foods, Inc","Broomfield","CO","US","Voluntary: Firm Initiated","Press Release","Product was distributed in the following states: Alabama, Arizona, Colorado, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Texas, Utah, Washington, Wisconsin, and Wyoming","F-2237-2014","Class I","Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Colorado 80021, UPC 0 25293 60101 7","Use by dates of 06/22/14 and 06/23/14 will be found on the carton's gable top. 06/22 or 23/14 hh:mm 48-0994 EH3-5 1; 06/22 or 23/14 hh:mm 48-0994 EH3-5 2; 06/22 or 23/14 hh:mm 48-0994 EH3-4 3; and 06/22 or 23/14 hh:mm 48-0994 EH3-4 4. Code breakdown as follows: 6/22/14 and 6/23/14 are the expiration dates; hh:mm is the manufacturing time stamp and varies across the run; 48-0994 is the manufacturing plant code; EH3 is the filler model generation; and the Remaining numbers are filling machine and lane designations",,"20,442 half gallon cartons","The product has the potential to contain undeclared almondmilk.",5/19/2014,"05/19/2014",8/6/2014,"08/06/2014"
"Cosmetics",68328,"Ongoing","Kutol Products Co","Sharonville","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was shipped nationwide, including: AL, AR, AZ, CA, CO, GA, IL, KS, KY, MA, MD, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, and WI. The product was also shipped to Canada and Australia.","F-2023-2014","Class II","KLM Hand & Body Moisturizing Lotion with oatmeal, aloe, and vitamin E sold in 800 mL bags, 1000 mL bottles, and 1 gallon bottles. Manufactured in the USA in a LEED Silver certified facility Kutol Products Co. Cincinnati, OH 45241. The product was also distributed under the Dominant 4 Protection brand name in Australia in 750 mL bags.","1 gallon - Kutol Catalog # 6207, Lot (L) 13020804; 800 mL bag - Kutol Catalog # 6265, Lot (L) 13062710; 1000 mL bottle - Kutol Catalog # 66236, Lot (L) 13062710; Dominant 750 mL bag - Kutol Catalog # 6226, Dominant Catalog # 15248, Lot (L) 13062710.",".","Catalog # 6207 - 240 units; Catalog # 6265 - 1392 units; Catalog # 66236 - 432 units; Catalog # 6226 - 1008 units.","Product has been found to contain Pseudomonas aeruginosa and Pseudomonas putida.",5/2/2014,"05/02/2014",6/18/2014,"06/18/2014"
"Devices",68329,"Ongoing","KCI USA, Inc.","San Antonio","TX","US","Voluntary: Firm Initiated",,"US Nationwide Distribution","Z-2717-2014","Class II","CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50","Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000. Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000, 3247170000, 3247250000, 3247310000, 3247470000, 324780000, 3247810000, 3247820000, 3247960000, 3247970000, 3248080000, 3248190000, 3248230000, 3248300000, 3248380000, 3248960000, 3248970000, 3248980000, 3248990000, 3249000000, 3249010000, 3249020000, 3249030000, 3249040000, 3249050000, 3249060000, 3249070000, 3249080000, 3249090000, 3249100000, 3249110000, 3249390000, 3249580000. ",".","1,331 units","Blade can shift during shipping which makes the product ineffective.",5/19/2014,"05/19/2014",10/7/2014,"10/07/2014"
"Devices",68330,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1868-2014","Class II","Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. ","Model Number: 02-6000-050 , Lot Number: 132160.",".","61","This lot (132160) of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.",5/19/2014,"05/19/2014",7/2/2014,"07/02/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1760-2014","Class II","Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-260, Lot Numbers 13346017",".","301","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1773-2014","Class II","Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-103-15, Lot Number 14004017",".","246","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1761-2014","Class II","Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-320, Lot Numbers 14009017",".","6","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1763-2014","Class II","Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-650, Lot Number 14005027",".","4","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1756-2014","Class II","Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-230, Lot Number 13343017",".","285","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1762-2014","Class II","Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-635, Lot Numbers 13354017",".","39","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1769-2014","Class II","Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-30-50, Lot Number 13347017",".","71","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1779-2014","Class II","Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-017-050S1, Lot Number 14015017",".","1","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1777-2014","Class II","Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-430, Lot Number 13350017",".","497","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1772-2014","Class II","Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-103-13, Lot Number 14004017",".","176","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1776-2014","Class II","Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-40, Lot Number 13339017",".","188","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1766-2014","Class II","Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-15-50, Lot Number 13343017",".","144","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1755-2014","Class II","Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-155, Lot Number 13346017",".","99","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1774-2014","Class II","Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-25, Lot Number 13346017",".","41","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1750-2014","Class II","Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. ","Part Number 5820-10-10, Lot Number 14005017",".","72","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1765-2014","Class II","Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-920, Lot Number 13344017",".","4","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1757-2014","Class II","Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-245, Lot Number 13350017",".","62","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1754-2014","Class II","Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-130, Lot Numbers 13346017, 13346027",".","609","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1752-2014","Class II","Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-40, Lot Numbers 13344017",".","281","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1770-2014","Class II","Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-30-60, Lot Number 13353017",".","59","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1775-2014","Class II","Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-30, Lot Number 13351017, 14007017",".","802","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1753-2014","Class II","Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-60, Lot Numbers 13343017",".","256","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1758-2014","Class II","Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017",".","1537","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1771-2014","Class II","Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-102-16, Lot Number 14006017",".","12","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1751-2014","Class II","Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-20, Lot Numbers 13347017,14010017",".","252","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1768-2014","Class II","Stryker 5.0mm Barrel Bur Sterile","Part Number 5820-17-50, Lot Number 13345017",".","15","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1749-2014","Class II","Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-5, Lot Number 13354017",".","27","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1780-2014","Class II","Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-430S1, Lot Number 14003017,14005017",".","916","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1759-2014","Class II","Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-255, Lot Numbers 13354017, 14013017",".","84","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1764-2014","Class II","Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-10-660, Lot Number 13352017",".","107","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1778-2014","Class II","Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017",".","6481","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68331,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (nationwide)","Z-1767-2014","Class II","Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.","Part Number 5820-15-60, Lot Number 14002017",".","65","There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite'' Attachments. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68332,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.","Z-1786-2014","Class II","Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.","Product Code 18400, Lot No. 01A1400037",".","450","Several complaints were received for the metal support tube missing from the cholangiogram catheter.",5/16/2014,"05/16/2014",6/18/2014,"06/18/2014"
"Devices",68333,"Ongoing","Global Cooling Inc","Athens","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Australia, Brazil, Canada, China, India, Indonesia, Japan, Korea, Kuwait, Mexico, Netherlands, Pakistan, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.","Z-1940-2014","Class II","Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.","Codes: ULT-25-255 & ULT-25-713",,"413 units","The external power supply input is overheating at the connection to the freezer.",3/20/2014,"03/20/2014",7/9/2014,"07/09/2014"
"Biologics",68334,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0747-14","Class II","Red Blood Cells Leukocytes Reduced","W045214000785",".",,"Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",5/1/2014,"05/01/2014",7/23/2014,"07/23/2014"
"Biologics",68334,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0748-14","Class II","Plasma Frozen within 24 hours (FP24)","W045214000785",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",5/1/2014,"05/01/2014",7/23/2014,"07/23/2014"
"Devices",68335,"Ongoing","Alcon Research, Ltd.","Fort Worth","TX","US","Voluntary: Firm Initiated",,"Nationwide Distribution including North Carolina and Maine","Z-1947-2014","Class II","Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.","Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H. ",,"684 total (525 units in US)","Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle",5/16/2014,"05/16/2014",7/9/2014,"07/09/2014"
"Drugs",68336,"Ongoing","US Compounding Inc","Conway","AR","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1548-2014","Class II","ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588","Lot# 20142104@30 USE BY: 10/18/2014",,"762 Syringes","Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.",5/16/2014,"05/16/2014",8/27/2014,"08/27/2014"
"Food",68337,"Ongoing","La Terra Fina Inc.","Union City","CA","US","Voluntary: Firm Initiated","Letter","3 distributors in CA, NJ and NC.","F-2014-2014","Class III","La Terra Fina All Natural Spinach & Kale Dip and Spread; Made with Greek Yogurt; Net Wt. 10 oz. (.625 lb) 284 g UPC 6 40410 51350 1; La Terra Fina, Union City, CA.","Item number: 4303501; Lot 20140421, Expiration Date: 5/31/2014; Lot 20140428, Expiration Date: 6/14/2014. Lot 20140505, Expiration Date: 6/6/2014",".","59 cases (6 containers per case)lot 2014021, 57 cases lot 20140438, 126 cases Lot 2014505","Ingredient statement for one lot of Greek Yogurt Spinach Kale dip contains the ingredient statement for spinach dip.",5/19/2014,"05/19/2014",6/18/2014,"06/18/2014"
"Food",68338,"Terminated","Annie Mac's Baking Company","Applegate","OR","US","Voluntary: Firm Initiated","Telephone","Oregon","F-2197-2014","Class I","Label reads in part ''Annie Mac's Baking Co. Coconut Macaroon, ''The coconut macaroon is dipped in chocolate, heat sealed in plastic.'' Net Wt. 12 oz. Product is wrapped in cellophane","Product does not contain any lot code ",,"1 dozen cookies per week","Ingredient statement for the Coconut Macaroon Cookie does not declare chocolate and its sub-ingredients, including soy lecithin and milk plus does not declare the sulfur dioxide in the coconut.",5/19/2014,"05/19/2014",7/30/2014,"07/30/2014"
"Devices",68341,"Ongoing","Exactech, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including Spain, Greece and Japan","Z-2086-2014","Class II","NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.","Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252",,"10","The femoral stem is lacking specified plasma coating.",3/7/2014,"03/07/2014",7/30/2014,"07/30/2014"
"Drugs",68342,"Completed","Abrams Royal Pharmacy","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","Texas","D-0251-2015","Class I","Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX","Lot# 041013-13 (also been written as ''041013@13'') Exp: 06/09/2013 ",".","50 syringes","Non-Sterility",4/19/2013,"04/19/2013",11/26/2014,"11/26/2014"
"Devices",68343,"Ongoing","JAS Diagnostics Inc.","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.","Z-1873-2014","Class II","Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. ","LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K. ",".","407","JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.",4/7/2014,"04/07/2014",7/2/2014,"07/02/2014"
"Devices",68344,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BRAZIL, CANADA, CHILE, CHINA, Croatia, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, MALAYSIA, NETHERLANDS, NEW ZEALAND, OMAN, PERU, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,VENEZUELA, LEBANON, REPUBLIC OF MALDOVIA, COSTA RICA, GABON, INDONESIA, JAMAICA, NIGERIA, NORWAY, NEPAL, PAKISTAN, PANAMA, PHILIPPINES, SENEGAL, SOUTH AFRICA, THAILAND TUNISIA, and CAMBODIA.","Z-2068-2014","Class I","DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.","Serial # Model # 6837005 E-MINIC-00 6838210 E-MINIC-00 6845207 E-MINIC-00 6845218 E-MINIC-00 6845228 E-MINIC-00 6845248 E-MINIC-00 6860768 E-MINIC-00 6860858 E-MINIC-00 6876048 E-MINIC-00 6876050 E-MINIC-00 6876052 E-MINIC-00 6876054 E-MINIC-00 6878048 E-MINIC-00 6888716 E-MINIC-00 6888726 E-MINIC-00 6888755 E-MINIC-00 6889935 E-MINIC-00 6889950 E-MINIC-00 6891094 E-MINIC-00 6891114 E-MINIC-00 6891115 E-MINIC-00 6891116 E-MINIC-00 6891117 E-MINIC-00 6891121 E-MINIC-00 6891130 E-MINIC-00 6891137 E-MINIC-00 6891139 E-MINIC-00 6892616 E-MINIC-00 6892626 E-MINIC-00 6827924 E-MINIC-00 6829318 E-MINIC-00 6829321 E-MINIC-00 6832785 E-MINIC-00 6832787 E-MINIC-00 6832788 E-MINIC-00 6832789 E-MINIC-00 6832791 E-MINIC-00 6832795 E-MINIC-00 6832796 E-MINIC-00 6832797 E-MINIC-00 6832802 E-MINIC-00 6832803 E-MINIC-00 6832804 E-MINIC-00 6832805 E-MINIC-00 6832813 E-MINIC-00 6832815 E-MINIC-00 6832824 E-MINIC-00 6832825 E-MINIC-00 6832831 E-MINIC-00 6834874 E-MINIC-00 6834877 E-MINIC-00 6834880 E-MINIC-00 6834883 E-MINIC-00 6834884 E-MINIC-00 6834885 E-MINIC-00 6834886 E-MINIC-00 6834887 E-MINIC-00 6834888 E-MINIC-00 6834889 E-MINIC-00 6834890 E-MINIC-00 6834891 E-MINIC-00 6834892 E-MINIC-00 6834893 E-MINIC-00 6834894 E-MINIC-00 6834895 E-MINIC-00 6834896 E-MINIC-00 6834898 E-MINIC-00 6834899 E-MINIC-00 6834902 E-MINIC-00 6834903 E-MINIC-00 6834904 E-MINIC-00 6834907 E-MINIC-00 6834909 E-MINIC-00 6834910 E-MINIC-00 6834911 E-MINIC-00 6834913 E-MINIC-00 6834914 E-MINIC-00 6834915 E-MINIC-00 6834916 E-MINIC-00 6834917 E-MINIC-00 6834918 E-MINIC-00 6834919 E-MINIC-00 6834920 E-MINIC-00 6834921 E-MINIC-00 6834922 E-MINIC-00 6836999 E-MINIC-00 6837002 E-MINIC-00 6837003 E-MINIC-00 6837010 E-MINIC-00 6837011 E-MINIC-00 6837013 E-MINIC-00 6838187 E-MINIC-00 6838196 E-MINIC-00 6838197 E-MINIC-00 6838198 E-MINIC-00 6842192 E-MINIC-00 6842196 E-MINIC-00 6842198 E-MINIC-00 6842212 E-MINIC-00 6842221 E-MINIC-00 6848886 E-MINIC-00 6848887 E-MINIC-00 6848888 E-MINIC-00 6852650 E-MINIC-00 6852655 E-MINIC-00 6855674 E-MINIC-00 6860683 E-MINI"," E-MINIC-00-EN 6827911 E-MINIC-00-EN 6827915 E-MINIC-00-EN 6827917 E-MINIC-00-EN 6827923 E-MINIC-00-EN 6834875 E-MINIC-00-EN 6834876 E-MINIC-00-EN 6834878 E-MINIC-00-EN 6834879 E-MINIC-00-EN 6834881 E-MINIC-00-EN 6834882 E-MINIC-00-EN 6834905 E-MINIC-00-EN 6834906 E-MINIC-00-EN 6834908 E-MINIC-00-EN 6834912 E-MINIC-00-EN 6838220 E-MINIC-00-EN 6838221 E-MINIC-00-EN 6838225 E-MINIC-00-EN 6838229 E-MINIC-00-EN 6838230 E-MINIC-00-EN 6838248 E-MINIC-00-EN 6838250 E-MINIC-00-EN 6838260 E-MINIC-00-EN 6838264 E-MINIC-00-EN 6842166 E-MINIC-00-EN 6842168 E-MINIC-00-EN 6842169 E-MINIC-00-EN 6842170 E-MINIC-00-EN 6842171 E-MINIC-00-EN 6842173 E-MINIC-00-EN 6842178 E-MINIC-00-EN 6842179 E-MINIC-00-EN 6842184 E-MINIC-00-EN 6842185 E-MINIC-00-EN 6842186 E-MINIC-00-EN 6842187 E-MINIC-00-EN 6842194 E-MINIC-00-EN 6842199 E-MINIC-00-EN 6842200 E-MINIC-00-EN 6842201 E-MINIC-00-EN 6842210 E-MINIC-00-EN 6842211 E-MINIC-00-EN 6842213 E-MINIC-00-EN 6842214 E-MINIC-00-EN 6845202 E-MINIC-00-EN 6845209 E-MINIC-00-EN 6845211 E-MINIC-00-EN 6845213 E-MINIC-00-EN 6845241 E-MINIC-00-EN 6845243 E-MINIC-00-EN 6845245 E-MINIC-00-EN 6845247 E-MINIC-00-EN 6848872 E-MINIC-00-EN 6848873 E-MINIC-00-EN 6848874 E-MINIC-00-EN 6848875 E-MINIC-00-EN 6848876 E-MINIC-00-EN 6848879 E-MINIC-00-EN 6848882 E-MINIC-00-EN 6848893 E-MINIC-00-EN 6848894 E-MINIC-00-EN 6848903 E-MINIC-00-EN 6848904 E-MINIC-00-EN 6848906 E-MINIC-00-EN 6848910 E-MINIC-00-EN 6848918 E-MINIC-00-EN 6848929 E-MINIC-00-EN 6848935 E-MINIC-00-EN 6848939 E-MINIC-00-EN 6848941 E-MINIC-00-EN 6848943 E-MINIC-00-EN 6848944 E-MINIC-00-EN 6848947 E-MINIC-00-EN 6848948 E-MINIC-00-EN 6848951 E-MINIC-00-EN 6852603 E-MINIC-00-EN 6852604 E-MINIC-00-EN 6852605 E-MINIC-00-EN 6852608 E-MINIC-00-EN 6852610 E-MINIC-00-EN 6852628 E-MINIC-00-EN 6852632 E-MINIC-00-EN 6852638 E-MINIC-00-EN 6852643 E-MINIC-00-EN 6852645 E-MINIC-00-EN 6852649 E-MINIC-00-EN 6852659 E-MINIC-00-EN 6852671 E-MINIC-00-EN 6852683 E-MINIC-00-EN 6852687 E-MINIC-00-EN 6852688 E-MINIC-00-EN 6852699 E-MINIC-00-EN 6855650 E-MINIC-00-EN 685566","2,948 (761 units US, 2,187 units OUS)","Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et/Fi CO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.",6/11/2014,"06/11/2014",7/30/2014,"07/30/2014"
"Drugs",68345,"Completed","Abrams Royal Pharmacy","Dallas","TX","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-0252-2015","Class I","Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX","Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013",".","21 vials","Non-Sterility; contract laboratory identified Staphylococcus warneri in the product",5/13/2013,"05/13/2013",11/26/2014,"11/26/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2285-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311 1004991311 1005001311 1005021311 1005041311 1005061311 1005071311 1005091311 1005111311 1005121311 1005151311 1005161311 1005171311 1005181311 1005191311 1005201311 1005211311 1005221311 1005231311 1005241311 1005251311 1005291311 1005331311 1005351311 1005521311 1005531311 1005541311 1005551311 1005561311 1005571311 1005591311 1005611311 1005651311 1005711311 1005731311 1005751311 1005771311 1005791311 1005811311 1005831311 1005841311 1005851311 1014291310 1014301310 1014311310 1014411310 1014421310 1014431310 1014451310 1014511310 1014521310 1014531310 1014541310 1014561310 1014581310 1014591310 1014601310 1014611310 1014641310 1014661310 1014671310 1014701310 1014721310 1014781310 1014801310 1014811310 1014831310 1014861310 1014881310 1014891310 1014911310 1014921310 1014931310 1014951310 1014971310 1014981310 1014991310 1015001310 1015011310 1015021310 1015031310 1015051310 1015061310 1015071310 1015081310 1015091310 1015101310 1015111310 1015131310 1015141310 1015151310 1015171310 1015181310 1015191310 1015211310 1015231310 1015251310 1015271310 1015291310 1015311310 1015331310 1015341310 1020841310 1020851310 1020861310 1020871310 1020881310 1020891310 1020901310 1020911310 1020921310 1020931310 1020941310 1020951310 1020961310 1020971310 1020981310 1020991310 1021001310 1021021310 1021031310 1021041310 1021051310 1021061310 1021071310 1021081310 1021091310 1021101310 1021111310 1021121310 1021131310 1021141310 1021151310 1021161310 1021171310 1021181310 1021191310 1021201310 1021211310 1021221310 1021231310 1021241310 1021251310 1021261310 1021271310 1021281310 1021291310 1021301310 1021311310 1021321310 1021331310 1021341310 1021351310 1021361310 1021371310 1021381310 1021391310 1021401310 1021411310 1021421310 1021431310 1021441310 1021451310 1021461310 1021471310 1021481310",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2286-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309 1007571309 1007581309 1007591309 1007601309 1007611309 1007621309 1007631309 1007641309 1007651309 1007661309 1007671309 1007681309 1007691309 1007701309 1007711309 1007721309 1007731309 1007741309 1007751309 1007761309 1007771309 1007791309 1007801309 1007811309 1007821309 1007831309 1007841309 1007851309 1007861309 1007871309 1007881309 1007891309 1007901309 1007911309 1007921309 1007931309 1007941309 1007951309 1007961309 1007971309 1007981309 1007991309 1008001309 1008011309 1008021309 1008031309 1008041309 1008051309 1008061309 1008101309 1008121309 1008141309 1008161309 1008171309 1008181309 1008191309 1008201309 1008211309 1008221309 1008231309 1008241309 1008251309 1008261309 1008271309 1008281309 1008291309 1008301309 1008311309 1008321309 1008331309 1008341309 1008361309 1008381309 1008401309 1104951312 1119291309 1119311309 1119321309 1119331309 1119341309 1119351309 1119361309 1119371309 1119381309 1119391309 1119401309 1119411309 1119421309 1119431309 1119451309 1119461309 1119471309 1119481309 1119491309 1119501309 1119511309 1119521309 1119531309 1119541309 1119551309 1119561309 1119571309 1119581309 1119591309 1119601309 1119611309 1119621309 1119631309 1119641309 1119651309 1119661309 1119671309 1119681309 1119691309 1119701309 1119711309 1119721309 1119731309 1119741309 1119751309 1119771309 1119811309 1119831309 1119851309 1119871309 1119901309 1119921309 1119931309 1119941309 1119951309 1119971309 1119991309 1120001309 1120021309 1120041309 1120061309 1120081309 1120101309 1120121309 1120141309 1120161309 1120181309 1120201309 1120221309 1120251309 1120261309 1120271309 1120281309 1120331309 1120361309 1120371309 1120381309 1120391309 1120411309 1120421309 1217951310 1217971310 1217991310 1218011310 1218031310 1218051310 1218071310 1218091310 1218111310 1218131310",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2272-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309 1004501311 1042861309 1166871309 1004521311 1042881309 1166881309 1004561311 1042901309 1166891309 1004581311 1042941309 1166901309 1004601311 1042961309 1166911309 1004621311 1043061309 1166921309 1004631311 1043081309 1166941309 1004641311 1043121309 1166961309 1004661311 1043141309 1166971309 1004671311 1043161309 1166981309 1004681311 1166391309 1166991309 1042091309 1166431309 1167001309 1042111309 1166441309 1167021309 1042191309 1166451309 1167041309 1042271309 1166471309 1167051309 1042291309 1166481309 1167061309 1042311309 1166511309 1167081309 1042331309 1166531309 1167101309 1042351309 1166561309 1167111309 1042391309 1166581309 1167131309 1042481309 1166601309 1167141309 1042571309 1166621309 1167151309 1042581309 1166631309 1167161309 1042591309 1166641309 1167171309 1042601309 1166661309 1167181309 1042611309 1166671309 1167201309 1042621309 1166681309 1167221309 1042631309 1166691309 1167241309 1042641309 1166701309 1167251309 1042651309 1166711309 1167261309 1042671309 1166721309 1167271309 1042681309 1166731309 1167281309 1042691309 1166741309 1167291309 1042701309 1166751309 1167301309 1042711309 1166761309 1167311309 1042721309 1166771309 1167321309 1042731309 1166781309 1167331309 1042741309 1166791309 1167351309 1167371309 1167391309 1167411309 1167431309 1167441309 1167451309 1167461309 1013301309 1014161309 1013311309 1014171309 1013331309 1014191309 1013351309 1014231309 1013391309 1014251309 1013411309 1014261309 1013431309 1014281309 1013451309 1014301309 1013511309 1014321309 1013531309 1014341309 1013551309 1014351309 1013561309 1083721309 1013571309 1083731309 1013581309 1083751309 1013601309 1083851309 1013611309 1083871309 1013621309 1083881309 1013641309 1083891309 1013661309 1083901",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2284-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310 1006351310 1006371310 1006371312 1006391310 1006391312 1006411310 1006411312 1006431310 1006431312 1006451310 1006451312 1006471310 1006471312 1006481310 1006491310 1006491312 1006501310 1006511310 1006511312 1006521310 1006531310 1006531312 1006541310 1006551310 1006561310 1006571310 1006591310 1006601310 1006611310 1006621310 1006631310 1006641310 1006651310 1006661310 1006671310 1006681310 1006691310 1006701310 1006711310 1006721310 1006731310 1006741310 1006751310 1006761310 1006771310 1006781310 1006791310 1006801310 1006811310 1006821310 1006831310 1006841310 1006851310 1006871310 1006881310 1006891310 1006901310 1006911310 1006921310 1006931310 1006931312 1006941310 1006951310 1006951312 1006961310 1006971310 1006981310 1007001310 1007221312 1007241312 1007261312 1007281312 1007301312 1007321312 1007341312 1007351312 1007361312 1007371312 1007381312 1007401312 1007421312 1007441312 1008211310 1008231310 1008351310 1008371310 1008391310 1008411310 1008431310 1008451310 1008471310 1008491310 1008511310 1008531310 1008541310 1008551310 1008561310 1008571310 1008581310 1008591310 1008601310 1008611310 1008621310 1008631310 1008641310 1008651310 1008661310 1008681310 1008701310 1008721310 1008741310 1008761310 1008781310 1008801310 1008821310 1008841310 1008861310 1008881310 1009001310 1009021310 1009041310 1009311309 1009391309 1009411309 1009431309 1009451309 1009521309 1009541309 1009551309 1009571309 1009591309 1009611309 1009631309 1009641309 1009651309 1009661309 1009671309 1009681309 1009701309 1009721309 1009771309 1009791309 1009811309 1009831309 1009851309 1009871309 1009891309 1009911309 1009941309 1009961309 1010011309 1010021309 1010031309 1010041309 1010051309 1010061309 1010071309 1010081309 1010091309 1010101309 1010111309 1010131309 1010151309 1010171309 1010181309 1010201309 1010211309 1010221309 1010231309 1010241309 1010251309 1010271309 1010281309 1010291309 1010301309 1010311309"," 1230881309 1230891309 1230901309 1237801311 1237811311 1237821311 1237831311 1237841311 1237851311 1237861311 1237871311 1237891311 1237911311 1237931311 1237951311 1237971311 1237991311 1238011311 1238031311 1238051311 1238071311 1238081311 1238101311 1238121311 1238131311 1238141311 1238151311 1238161311 1238171311 1238181311 1238201311 1238211311 1238221311 1238231311 1238241311 1238251311 1238261311 1238271311 1238281311 1238291311 1238301311 1238311311 1238321311 1238331311 1238341311 1238351311 1238361311 1238371311 1238381311 1238391311 1238401311 1238411311 1238421311 1238431311 1238441311 1238451311 1238461311 1238471311 1238481311 1238491311 1238501311 1238511311 1238521311 1238531311 1238541311 1238551311 1238561311 1238571311 1238581311 1238591311 1238601311 1238611311 1238621311 1238641311 1238661311 1238681311 1238701311 1238721311 1238741311 1238761311 1238781311 1238801311 1238821311 1238831311 1238841311 1238851311 1238861311 1238871311 1238881311 1238891311 1238901311 1238911311 1238921311 1248291309 1248301309 1248311309 1248321309 1248331309 1248341309 1248351309 1248361309 1248371309 1248381309 1248391309 1248401309 1248411309 1248421309 1248431309 1248441309 1248451309 1248461309 1248471309 1248481309 1248491309 1248501309 1248511309 1248521309 1248531309 1248541309 1248551309 1248561309 1248571309 1248581309 1248591309 1248611309 1248631309 1248651309 1248671309 1248691309 1248711309 1248731309 1248751309 1248771309 1248791309 1248801309 1248811309 1248821309 1248831309 1248841309 1248851309 1248861309 1248871309 1248881309 1248891309 1248901309 1248911309 1248921309 1248931309 1248941309 1248951309 1248971309 1248991309 1249011309 1249031309 1249051309 1249071309 1249091309 1249111309 1249131309 1249151309 1249161309 1249171309 1249191309 1249201309 1249211309 1249221309 1249231309 1249241309 1249251309 1249261309 1249271309 1249281309 1249291309 1249301309 1249311309 1249321309 1249331309 1249341309 1249351309 1249361309 1249371309 1249381309 1249391309 1249401309 1249411309 124942130",,"Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2273-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309 1229261309 1177621309 1229271309 1177681309 1229281309 1177751309 1229291309 1177771309 1229301309 1177791309 1229311309 1177811309 1229321309 1177821309 1229331309 1177831309 1229341309 1177841309 1229351309 1177861309 1229381309 1177881309 1229401309 1177901309 1229501309 1177921309 1229521309 1178041309 1229541309 1178061309 1229551309 1178081309 1229561309 1178101309 1229571309 1178121309 1229581309 1178141309 1229591309 1178151309 1229601309 1178161309 1229611309 1178181309 1229621309 1178201309 1229631309 1178211309 1229651309 1178221309 1229671309 1228801309 1229681309 1228821309 1229691309 1228851309 1229701309 1228861309 1229721309 1228881309 1229741309 1228901309 1229761309 1228921309 1229771309 1228941309 1229781309 1228961309 1229811309 1229831309 1229841309 1229871309 1229881309 1177291309 1228871309 1228891309 1228911309 1229451309 1229511309 1107621309 1107721309 1107741309 1107801309 1108041309 1215161310 1224661309 1225081309 1293581308 1293621308 1294031308 1294091308 1294111308 1294251308 1107431309 1108051309 1215071310 1224861309 1293691308 1107441309 1108061309 1215091310 1224871309 1293751308 1107451309 1108071309 1215111310 1224881309 1293761308 1107471309 1108081309 1215131310 1224891309 1293771308 1107481309 1108091309 1215151310 1224911309 1293781308 1107491309 1108101309 1215171310 1224921309 1293791308 1107511309 1108111309 1215191310 1224931309 1293801308 1107521309 1108131309 1215211310 1224941309 1293811308 1107531309 1108151309 1215221310 1224951309 1293821308 1107551309 1108161309 1215241310 1224961309 1293831308 1107561309 1108171309 1215251310 1224971309 1293841308 1107571309 1108181309 1215261310 1224981309 1293851308 1107591309 1108201309 1215271310 1225001309 1293871",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2282-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311 1000721311 1000741311 1000761311 1000781311 1000801311 1000821311 1000841311 1000861311 1000881311 1000891311 1000901311 1000911311 1000921311 1000931311 1000941311 1000951311 1000961311 1000971311 1000981311 1000991311 1001001311 1001011311 1001021311 1001031311 1001041311 1001051311 1001061311 1001071311 1001081311 1001091311 1001101311 1001111311 1001121311 1001131311 1001141311 1001151311 1001161311 1001171311 1001181311 1001191311 1001201311 1001211309 1001211311 1001221311 1001231309 1001231311 1001241311 1001251309 1001251311 1001261311 1001271309 1001271311 1001281311 1001291309 1001291311 1001301311 1001311309 1001311311 1001321311 1001331311 1001341311 1001351311 1001361311 1001371311 1001381311 1001391311 1001401309 1001401311 1001411309 1001411311 1001421311 1001431309 1001431311 1001441311 1001451309 1001451311 1001461311 1001471309 1001471311 1001481309 1001481311 1001491309 1001491311 1001501309 1001501311 1001511311 1001521309 1001521311 1001531309 1001531311 1001541309 1001541311 1001551309 1001551311 1001561309 1001561311 1001571311 1001581309 1001581311 1001591311 1001601309 1001601311 1001611311 1001621309 1001621311 1001631311 1001641309 1001641311 1001651311 1001661309 1001671311 1001681309 1001691311 1001711311 1001721309 1001731311 1001741309 1001751311 1001761309 1001771311 1001781309 1001791311 1001801309 1001811311 1001821309 1001821311 1001831311 1001841309 1001841311 1001851311 1001861309 1001861311 1001871311 1001881309 1001881311 1001891311 1001901309 1001901311 1001911311 1001921311 1001931311 1001941311 1001951311 1001961311 1001971311 1001981311 1001991311 1002001311 1002011311 1002021311 1002031311 1002041311 1002051311 1002061311 1002071311 1002081311 1002091311 1002101311 1002111311 1002121309 1002121311 1002131311 1002141309 1002141311 1002151311 1002161309 1002161311 1002171311 1002181309 1002181311 1002191311 1002201311 1002211311 1002221311 1002231311 1002241311"," 1185581311 1185601311 1185621311 1185641311 1185661311 1185681311 1185701311 1185721311 1185741311 1185761311 1185781311 1185801311 1185821311 1185841311 1185861311 1185881311 1185901311 1185921311 1185941311 1185961311 1185981311 1186001311 1186021311 1186041311 1186061311 1186081311 1186101311 1186121311 1186141311 1186161311 1186181311 1186201311 1186331311 1186351311 1186371311 1186391311 1186531311 1186551311 1186561311 1186571311 1186581311 1186591311 1186601311 1186611311 1186621311 1186631311 1186651311 1186661311 1186671311 1186681311 1186691311 1186701311 1186711311 1186721311 1186731311 1186741311 1186751311 1186761311 1186771311 1186781311 1186791311 1186801311 1186811311 1186821311 1186831311 1186841311 1186851311 1186861311 1186871311 1186881311 1186891311 1186911311 1186921311 1186931311 1186951311 1186961311 1186971311 1186981311 1186991311 1187011311 1187031311 1187051311 1187071311 1187091311 1187111311 1187131311 1187151311 1187171311 1187191311 1187211311 1187231311 1187251311 1187271311 1187291311 1187311311 1187331311 1187351311 1187371311 1187391311 1187411311 1187431311 1187441311 1187451311 1187461311 1187471311 1187481311 1187491311 1187501311 1187511311 1187521311 1187531311 1187541311 1187551311 1187561311 1187571311 1187581311 1187591311 1199021310 1199031310 1199041310 1199051310 1199061310 1199071310 1199081310 1199091310 1199101310 1199111310 1199121310 1199131310 1199141310 1199151310 1199161310 1199171310 1199181310 1199191310 1199201310 1199211310 1199221310 1199231310 1199241310 1199251310 1199261310 1199271310 1199281310 1199291310 1199301310 1199311310 1199321310 1199331310 1199341310 1199351310 1199361310 1199371310 1199381310 1199391310 1199401310 1199411310 1199421310 1199431310 1199441310 1199451310 1199461310 1199481310 1199501310 1199521310 1199531310 1199541310 1199561310 1199571310 1199581310 1199591310 1199601310 1199611310 1199621310 1199631310 1199641310 1199651310 1199661310 1199671310 1199681310 1199691310 1199701310 1199711310 1199721310 1199731310 119974131","77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2277-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5, 16.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 1023001309 1023511309 1023981309 1097141310 1124811310 1125331310 1014381309 1014871309 1023011309 1023521309 1023991309 1097161310 1124821310 1125351310 1014391309 1014881309 1023021309 1023531309 1024011309 1097181310 1124831310 1125361310 1014401309 1014891309 1023031309 1023541309 1024031309 1097201310 1124841310 1125371310 1014411309 1014901309 1023041309 1023551309 1096541310 1097221310 1124851310 1125381310 1014421309 1014911309 1023051309 1023561309 1096561310 1097241310 1124861310 1125391310 1014431309 1014921309 1023061309 1023571309 1096581310 1097251310 1124871310 1125401310 1014441309 1014931309 1023071309 1023581309 1096591310 1097261310 1124881310 1125411310 1014451309 1014941309 1023081309 1023591309 1096601310 1097271310 1124891310 1125421310 1014461309 1014951309 1023111309 1023601309 1096611310 1097281310 1124901310 1125431310 1014471309 1014961309 1023131309 1023611309 1096621310 1097301310 1124911310 1125441310 1014481309 1014971309 1023151309 1023621309 1096631310 1097321310 1124921310 1125451310 1014491309 1014981309 1023171309 1023631309 1096641310 1097341310 1124931310 1125471310 1014501309 1014991309 1023191309 1023641309 1096651310 1097361310 1124941310 1125491310 1014511309 1015001309 1023201309 1023651309 1096661310 1097381310 1124951310 1125501310 1014521309 1015011309 1023211309 1023661309 1096671310 1097401310 1124961310 1125511310 1014531309 1015021309 1023221309 1023671309 1096681310 1097441310 1124971310 1125521310 1014541309 1015031309 1023231309 1023681309 1096691310 1097461310 1124981310 1125541310 1014551309 1015041309 1023241309 1023691309 1096701310 1097481310 1124991310 1125561310 1014561309 1015051309 1023251309 1023701309 1096711310 1097501310 1125001310 1125581310 1014571309 1015061309 1023261309 1023711309 1096721310 1097521310 1125011310 1125601310 1014581309 1015071309 1023271309 1023721309 1096731310 1097541310 1125021310 1125611310 1014591309 1015081309",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2278-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309 1031881311 1032441311 1041231312 1041771312 1042221312 1048421311 1006381309 1006961309 1031891311 1032461311 1041241312 1041781312 1042231312 1048441311 1006391309 1006981309 1031901311 1032481311 1041251312 1041791312 1042241312 1048461311 1006401309 1007001309 1031911311 1032501311 1041261312 1041801312 1042251312 1048481311 1006411309 1007021309 1031921311 1032521311 1041271312 1041811312 1047821311 1048501311 1006421309 1007031309 1031931311 1032541311 1041281312 1041821312 1047841311 1048511311 1006431309 1007041309 1031941311 1032561311 1041291312 1041831312 1047861311 1048521311 1006441309 1007061309 1031951311 1032581311 1041301312 1041841312 1047881311 1048531311 1006451309 1007071309 1031961311 1032591311 1041311312 1041851312 1047901311 1048541311 1006471309 1007081309 1031971311 1032601311 1041321312 1041861312 1047911311 1048551311 1006491309 1007091309 1031981311 1032611311 1041331312 1041871312 1047931311 1048561311 1006511309 1007101309 1031991311 1032621311 1041341312 1041881312 1047951311 1048571311 1006561309 1007111309 1032001311 1032631311 1041351312 1041891312 1047971311 1048581311 1006571309 1007121309 1032011311 1032641311 1041361312 1041901312 1047991311 1048591311 1006581309 1007131309 1032021311 1032651311 1041371312 1041911312 1048011311 1048601311 1006601309 1007151309 1032031311 1032661311 1041381312 1041921312 1048051311 1048611311 1006621309 1007161309 1032041311 1032671311 1041391312 1041931312 1048061311 1048621311 1006631309 1007171309",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2279-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5, 18.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 1012521311 1013101311 1027661310 1028141310 1031871309 1032401309 1004291312 1004851312 1012541311 1013121311 1027671310 1028151310 1031881309 1032411309 1004301312 1004861312 1012601311 1013141311 1027691310 1028161310 1031891309 1032421309 1004311312 1004871312 1012621311 1013161311 1027701310 1028171310 1031901309 1032431309 1004321312 1004881312 1012641311 1013181311 1027711310 1028181310 1031921309 1032441309 1004331312 1004891312 1012661311 1013201311 1027721310 1028191310 1031941309 1032451309 1004341312 1004901312 1012681311 1013221311 1027731310 1028201310 1031951309 1032461309 1004351312 1004911312 1012701311 1013241311 1027741310 1028211310 1031961309 1032471309 1004361312 1004921312 1012711311 1013261311 1027751310 1028221310 1031981309 1032481309 1004371312 1004931312 1012721311 1013281311 1027761310 1028231310 1032001309 1032491309 1004381312 1004941312 1012731311 1013291311 1027771310 1028241310 1032021309 1032501309 1004391312 1004951312 1012741311 1013311311 1027781310 1028251310 1032041309 1032521309 1004401312 1004961312 1012751311 1013331311 1027791310 1028261310 1032051309 1032531309 1004411312 1004971312 1012761311 1013341311 1027801310 1028271310 1032061309 1032551309 1004421312 1004981312 1012771311 1013351311 1027811310 1028281310 1032071309 1032561309 1004431312 1004991312 1012781311 1013361311 1027821310 1028291310 1032081309 1032571309 1004441312 1005001312 1012791311 1013371311 1027831310 1028301310 1032091309 1032591309 1004451312 1005011312 1012801311 1013381311 1027841310 1028311310 1032101309 1032601309 1004461312 1005021312 1012821311 1013391311 1027851310 1028321310 1032111309 1032611309 1004471312 1005031312 1012841311 1013401311 1027861310 1028331310 1032121309 1032621309 1004491312 1005041312 1012851311 1013411311 1027871310 1028341310 1032131309 1032661309 1004511312 1005051312 1012861311 1013421311 1027881310 1028351310 1032141309 1032711309 1004531312 1005061312"," 1183541310 1196181310 1196651310 1145661310 1146111310 1165741309 1166281309 1183091310 1183561310 1196191310 1196661310 1145671310 1146121310 1165761309 1166291309 1183101310 1183571310 1196201310 1196671310 1145681310 1146131310 1165771309 1166301309 1183111310 1183581310 1196211310 1196681310 1145691310 1146141310 1165781309 1166311309 1183121310 1183591310 1196221310 1196691310 1145701310 1146151310 1165791309 1166321309 1183131310 1183601310 1196231310 1196701310 1145711310 1146161310 1165801309 1166331309 1183141310 1183611310 1196241310 1196721310 1145721310 1146171310 1165831309 1166341309 1183151310 1183621310 1196251310 1196741310 1145731310 1146181310 1165851309 1166361309 1183161310 1195761310 1196261310 1196761310 1145741310 1146191310 1165891309 1166371309 1183171310 1195771310 1196271310 1196781310 1145751310 1146201310 1165901309 1166381309 1183181310 1195781310 1196281310 1207951309 1145761310 1146211310 1165911309 1182691310 1183191310 1195791310 1196291310 1207971309 1145771310 1146221310 1165921309 1182701310 1183211310 1195801310 1196301310 1207991309 1145781310 1146231310 1165931309 1182711310 1183221310 1195811310 1196311310 1208071309 1145791310 1146241310 1165941309 1182721310 1183231310 1195821310 1196321310 1208111309 1145801310 1146251310 1165951309 1182731310 1183241310 1195831310 1196331310 1208151309 1145811310 1146261310 1165961309 1182741310 1183251310 1195841310 1196341310 1208171309 1145821310 1146271310 1165971309 1182751310 1183261310 1195851310 1196351310 1208191309 1145831310 1146281310 1165981309 1182761310 1183271310 1195861310 1196361310 1208211309 1145841310 1165321309 1165991309 1182771310 1183281310 1195871310 1196371310 1208231309 1145851310 1165331309 1166001309 1182781310 1183291310 1195881310 1196381310 1208251309 1145861310 1165351309 1166011309 1182791310 1183301310 1195891310 1196391310 1208271309 1145871310 1165371309 1166021309 1182801310 1183311310 1195901310 1196401310 1208291309 1145881310 1165391309 1166031309 1182811310 1183321310 1195911310 119641131","77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2275-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310 1214401310 1262721310 1290531308 1030831310 1031351310 1113031309 1113561309 1213891310 1214421310 1262731310 1290541308 1030841310 1031361310 1113051309 1113571309 1213911310 1214441310 1262751310 1290551308 1030861310 1031371310 1113071309 1113581309 1213921310 1214461310 1262771310 1290561308 1030871310 1031381310 1113091309 1113601309 1213941310 1214481310 1262781310 1290571308 1030881310 1031391310 1113101309 1113621309 1213951310 1214491310 1262791310 1290581308 1030891310 1031401310 1113111309 1113661309 1213961310 1214501310 1262801310 1290591308 1030901310 1031411310 1113121309 1113681309 1213971310 1214511310 1262811310 1290601308 1030911310 1031421310 1113131309 1113701309 1213981310 1214521310 1262821310 1290611308 1030921310 1031431310 1113141309 1113711309 1213991310 1214531310 1262831310 1290621308 1030931310 1031451310 1113151309 1113721309 1214001310 1214541310 1262851310 1290631308 1030941310 1031471310 1113161309 1113731309 1214011310 1214561310 1262871310 1290641308 1030951310 1031491310 1113171309 1113741309 1214021310 1214571310 1262891310 1290651308 1030961310 1031511310 1113181309 1113761309 1214031310 1214581310 1262911310 1290661308 1030971310 1031521310 1113191309 1113781309 1214041310 1214591310 1262931310 1290671308 1030981310 1031531310 1113201309 1113791309 1214051310 1214601310 1262951310 1290681308 1030991310 1031541310 1113211309 1113801309 1214061310 1214611310 1262971310 1290701308 1031001310 1031551310 1113221309 1113811309 1214071310 1214621310 1262991310 1290721308 1031011310 1031561310 1113231309 1113821309 1214081310 1214641310 1263011310 1290741308 1031021310 1031571310 1113241309 1113831309 1214101310 1214661310 1263031310 1290761308 1031041310 1031581310 1113251309 1113841309 1214121310 1214671310 1263051310 1290781308 1031051310 1031591310",,,"Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2283-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310 1002041310 1002051310 1002061310 1002071310 1002081310 1002091310 1002101310 1002111310 1002121310 1002131310 1002141310 1002151310 1002161310 1002171310 1002181310 1002191310 1002201310 1002221310 1002241310 1002281310 1002301310 1002321310 1002341310 1002361310 1002381310 1002391310 1002411310 1002431310 1002451310 1002471310 1002491310 1002511310 1002531310 1002551310 1002571310 1002591310 1002611310 1002621310 1002631310 1002641310 1002651310 1002661310 1002671310 1002681310 1002691310 1002701310 1002711310 1002721310 1002731310 1002741310 1002751310 1002761310 1002771310 1002781310 1002791310 1002801310 1002811310 1002821310 1002831310 1002841310 1002851310 1002861310 1002871310 1002881310 1002891310 1002901310 1002911310 1002921310 1002931310 1002941310 1002951310 1002961310 1002971310 1002981310 1002991310 1003001310 1003011310 1003021310 1003031310 1003041310 1003051310 1003061310 1003071310 1003081310 1003091310 1003101310 1003111310 1003121310 1003131310 1003141310 1003151310 1003161310 1003171310 1003181310 1003191310 1003201310 1003211310 1003221310 1003231310 1003241310 1003251310 1003261310 1003271310 1003281310 1003291310 1003301310 1003311310 1003321310 1003331310 1003341310 1003351310 1003361310 1003371310 1003381310 1003391310 1003401310 1003411310 1003421310 1003431310 1003441310 1003451310 1003461310 1003471310 1003481310 1003491310 1003501310 1003511310 1003521310 1003531310 1003541310 1003551310 1003561310 1003571310 1003581310 1003591310 1003601310 1003611310 1003621310 1003631310 1003641310 1003651310 1003661310 1003671310 1003681310 1003691310 1003701310 1003711310 1003721310 1003731310 1003741310 1003751310 1003761310 1003771310 1003781310 1003791310 1003801310 1003811310 1003821310 1003831310 1003841310 1003851310 1003861310 1003871310 1003881310 1003891310 1003901310 1003911310 1003921310 1003931310 1003941310 1003951310 1003961310 1003971310 1003981310 1003991310 1004001310"," 1179011311 1179021311 1179031311 1179041311 1179051311 1179061311 1179071311 1179081311 1179091311 1179101311 1179111311 1179121311 1179131311 1179141311 1179151311 1179161311 1179171311 1179181311 1179191311 1179201311 1179211311 1179221311 1179241311 1179261311 1179281311 1179301311 1179321311 1179341311 1179361311 1179381311 1179401311 1179421311 1179441311 1179461311 1179481311 1179501311 1179521311 1179541311 1179561311 1179581311 1179601311 1179621311 1179641311 1179841311 1179861311 1179881311 1179901311 1179921311 1179991311 1180001311 1180011311 1180021311 1180031311 1180041311 1180051311 1180061311 1180071311 1180081311 1180101311 1180121311 1180141311 1180181311 1180201311 1180221311 1180241311 1180261311 1180281311 1180301311 1180321311 1180341311 1180361311 1180381311 1180401311 1180421311 1180441311 1180461311 1180481311 1180501311 1180521311 1180541311 1180561311 1180581311 1180601311 1180621311 1180641311 1180661311 1180681311 1180701311 1180721311 1180741311 1180761311 1180781311 1180801311 1180821311 1180841311 1180861311 1180881311 1180901311 1180921311 1180941311 1180961311 1188691311 1188701311 1188711311 1188721311 1188731311 1188741311 1188751311 1188761311 1188771311 1188791311 1188801311 1188811311 1188821311 1188831311 1188841311 1188851311 1188861311 1188871311 1188881311 1188891311 1188911311 1188931311 1188951311 1189031311 1189051311 1189061311 1189071311 1189081311 1189091311 1189101311 1189111311 1189121311 1189131311 1189141311 1189201311 1189221311 1189241311 1189261311 1189281311 1189301311 1189321311 1189341311 1189361311 1189381311 1189401311 1189421311 1189441311 1189461311 1189481311 1189501311 1189521311 1189541311 1189561311 1189581311 1189601311 1189621311 1189641311 1189661311 1189671311 1189681311 1189691311 1189701311 1189711311 1189721311 1189731311 1189741311 1189751311 1193081311 1193101311 1193121311 1193141311 1193161311 1193181311 1193201311 1193221311 1193241311 1193261311 1193281311 1193301311 1193321311 1193341311 1193361311 1193381311 1193401311 119342131","77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2287-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309 1102221309 1102231309 1102241309 1102261309 1102271309 1102291309 1102301309 1102311309 1102321309 1102331309 1102351309 1102371309 1102381309 1102391309 1102401309 1102411309 1102431309 1102461309 1102481309 1102501309 1102551309 1102621309 1102641309 1102651309 1102661309 1102681309 1102811309 1102831309 1102851309 1102871309 1102911309 1102941309 1289831308 1289841308 1289851308 1289861308 1289871308 1289881308 1289891308 1289901308 1289911308 1289921308 1289931308 1289941308 1289961308 1290001308 1290021308 1290041308 1290061308 1290071308 1290081308 1290091308 1290101308 1290111308 1290121308 1290141308 1290161308 1290171308 1290181308 1290191308 1290201308 1290211308 1290231308 1290251308 1290271308 1290281308 1290291308 1290311308 1290321308 1290331308 1290341308 1290351308 1290361308 1290371308 1290381308 1039861309 1039881309 1039901309 1039961309 1039981309 1040011309 1040021309 1040041309 1040121309 1040151309 1040161309 1040171309 1040181309 1040191309 1040201309 1040211309 1040231309 1040251309 1040271309 1040291309 1040311309 1040331309 1040351309 1040371309 1040391309 1040471309 1040501309 1040551309 1040571309 1040591309 1040671309 1040711309 1040771309 1048531309 1048541309 1048551309 1048561309 1048571309 1048591309 1048601309 1048611309 1048621309 1048631309 1048641309 1048661309 1048671309 1048681309 1048691309 1048701309 1048711309 1048721309 1048731309 1048741309 1048751309 1048761309 1048771309 1048781309 1048801309 1048811309 1048841309 1048911309 1048921309 1048931309 1048941309 1048951309 1048971309 1048981309 1048991309 1049001309 1049021309 1049031309 1049041309 1049051309 1049071309 104910",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2280-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312 1001241312 1001251312 1001261312 1001271312 1001291312 1001301312 1001311312 1001321312 1001331312 1001341312 1001351312 1001361312 1001371312 1001381312 1001391312 1001401312 1001411312 1001421312 1001431312 1001441312 1001451312 1001461312 1001471312 1001481312 1001491312 1001501312 1001511312 1001521312 1001531312 1001541312 1001551312 1001571312 1001591312 1001611312 1001631312 1001651312 1001671312 1001691312 1001711312 1001731312 1001751312 1001771312 1001811312 1001831312 1001851312 1001871312 1001891312 1001911312 1001931312 1001951312 1001971312 1001991312 1002001312 1002021312 1002041312 1002061312 1002081312 1002101312 1002121312 1002131312 1002141312 1002151312 1002161312 1002171312 1002181312 1002201312 1002221312 1002231312 1005251309 1005261309 1005271309 1005281309 1005291309 1005301309 1005321309 1005341309 1005361309 1005381309 1005401309 1005421309 1005431309 1005441309 1005451309 1005461309 1005471309 1005491309 1005501309 1005511309 1005521309 1005531309 1005551309 1005561309 1005571309 1005581309 1005591309 1005601309 1005611309 1005621309 1005631309 1005641309 1005651309 1005671309 1005681309 1005691309 1005701309 1005711309 1005721309 1005731309 1005751309 1005771309 1005791309 1005811309 1005831309 1005851309 1005871309 1005891309 1005911309 1005931309 1005951309 1005971309 1005991309 1006011309 1006031309 1006051309 1006061309 1006071309 1006081309 1006091309 1006101309 1006111309 1006121309 1006131309 1006151309 1006171309 1006211309 1006231309 1006241309 1006251309 1006261309 1006271309 1006281309 1006291309 1006301309 1009131311 1009141311 1009151311 1009161311 1009171311 1009181311 1009191311 1009201311 1009211311 1009221311 1009231311 1009241311 1009251311 1009261311 1009271311 1009281311 1009291311 1009301311 1009321311 1009331311 1009341311 1009351311 1009361311 1009371311 1009381311 1009391311 1009401311 1009411311 1009421311 1009431311 1009441311 1009451311 1009461311"," 1028591311 1028601311 1028611311 1028621311 1028631311 1028641311 1028651311 1028661311 1028671311 1028681311 1028691311 1028701311 1028711311 1028721311 1028731311 1028741311 1028751311 1028761311 1028771311 1028791311 1028801311 1028811311 1028821311 1028831311 1028841311 1028851311 1028861311 1028871311 1028881311 1028891311 1028901311 1028911311 1028921311 1028931311 1028941311 1028951311 1028961311 1028971311 1028981311 1028991311 1029001311 1029011311 1029021311 1029031311 1029041311 1029051311 1029061311 1029071311 1029081311 1029091311 1029101311 1029111311 1029121311 1029131311 1029141311 1029151311 1029161311 1029171311 1029181311 1029191311 1029201311 1029211311 1029221311 1029231311 1029241311 1029251311 1029261311 1029271311 1029281311 1029291311 1029301311 1029311311 1029321311 1029331311 1029341311 1029351311 1029361311 1029371311 1029381311 1029391311 1029401311 1029411311 1029421311 1029431311 1029441311 1029451311 1029461311 1029471311 1029481311 1029491311 1029501311 1029521311 1032841311 1032851311 1032861311 1032871311 1032881311 1032891311 1032901311 1032911311 1032921311 1032931311 1032941311 1032951311 1032961311 1032971311 1032981311 1032991311 1033001311 1033011311 1033021311 1033031311 1033041311 1033061311 1033081311 1033101311 1033121311 1033141311 1033161311 1033181311 1033191311 1033201311 1033211311 1033221311 1033231311 1033241311 1033251311 1033261311 1033271311 1033281311 1033291311 1033301311 1033311311 1033321311 1033331311 1033341311 1033351311 1033361311 1033371311 1033381311 1033391311 1033401311 1033411311 1033421311 1033431311 1033441311 1033451311 1033461311 1033471311 1033481311 1033491311 1033501311 1033511311 1033521311 1033531311 1033541311 1033551311 1033561311 1033571311 1033581311 1033591311 1033601311 1033611311 1033621311 1033631311 1033641311 1033651311 1033661311 1033671311 1033681311 1033691311 1033701311 1033711311 1033721311 1033731311 1033741311 1033751311 1033771311 1033791311 1033811311 1033831311 1033851311 1033861311 1033871311 1033881311 103389131","77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2274-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871311 1036351309 1190491309 1191431309 1221481309 1016891311 1036371309 1190501309 1191441309 1221491309 1016911311 1036381309 1190511309 1191461309 1221501309 1016931311 1036401309 1190521309 1191471309 1221521309 1016951311 1036421309 1190531309 1191481309 1221531309 1016971311 1036431309 1190541309 1220991309 1221541309 1016991311 1036451309 1190551309 1221011309 1221551309 1017011311 1036461309 1190561309 1221021309 1221561309 1017031311 1036471309 1190571309 1221031309 1221571309 1017051311 1036491309 1190581309 1221041309 1221581309 1017071311 1036511309 1190591309 1221051309 1221591309 1017091311 1036521309 1190601309 1221061309 1221601309 1017111311 1036531309 1190611309 1221071309 1221611309 1017131311 1036541309 1190621309 1221081309 1221621309 1017151311 1036561309 1190631309 1221091309 1221631309 1017171311 1036581309 1190641309 1221111309 1221641309 1017191311 1036591309 1190661309 1221151309 1221651309 1017211311 1036601309 1190681309 1221171309 1221661309 1017231311 1036611309 1190701309 1221181309 1221671309 1020891311 1036621309 1190721309 1221191309 1221681309 1020901311 1036631309 1190751309 1221201309 1221691309 1021091311 1036641309 1190761309 1221211309 1221701309 1021201311 1036651309 1190771309 1221221309 1221721309 1021221311 1036671309 1190781309 1221231309 1221741309 1021241311 1036691309 1190791309 1221241309 1221761309 1021261311 1036751309 1190891309 1221251309 1221801309 1021281311 1036871309 1190931309 1221261309 1221821309 1021301311 1036951309 1191031309 1221271309 1221841309 1021321311 1036981309 1191061309 1221281309 1221861309 1021341311 1037001309 1191081309 1221291309 1221871309 1021361311 1037021309 1191101309 1221311309 1221881309 1021381311 1037041309 1191171309 1221331309 1221901309 1021401311 1037061309 1191181309 1221351309 1221921309 1021421311 1037071309 1191191309 1221361309 1221941309 1036181309 1037091309 1191211309 1221371309 1221951309 1036201309",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2276-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 1025131309 1025581309 1028511309 1039921310 1040371310 1093811310 1019741311 1020221311 1025141309 1025591309 1028521309 1039931310 1040381310 1093821310 1019751311 1020231311 1025151309 1025601309 1028531309 1039941310 1040391310 1093831310 1019761311 1020241311 1025161309 1025611309 1028541309 1039951310 1040401310 1093841310 1019771311 1020251311 1025171309 1025621309 1028551309 1039961310 1040411310 1093851310 1019781311 1020261311 1025181309 1025631309 1028561309 1039971310 1040421310 1093861310 1019791311 1020271311 1025191309 1025641309 1028571309 1039981310 1040431310 1093871310 1019801311 1020281311 1025201309 1025651309 1028581309 1039991310 1040441310 1093881310 1019811311 1020291311 1025211309 1025661309 1028591309 1040001310 1040451310 1093891310 1019821311 1020301311 1025221309 1025671309 1028601309 1040011310 1040461310 1093911310 1019831311 1020311311 1025231309 1025681309 1028611309 1040021310 1040471310 1093941310 1019841311 1020321311 1025241309 1025691309 1028621309 1040031310 1040481310 1093961310 1019851311 1020341311 1025251309 1027941309 1028631309 1040041310 1040491310 1093981310 1019861311 1020361311 1025261309 1027971309 1028641309 1040051310 1040501310 1094001310 1019871311 1020381311 1025271309 1027991309 1028651309 1040061310 1040511310 1094011310 1019881311 1020401311 1025281309 1028011309 1028671309 1040071310 1040521310 1094021310 1019891311 1020421311 1025291309 1028031309 1028691309 1040081310 1040531310 1094031310 1019901311 1020441311 1025301309 1028051309 1039601310 1040091310 1040541310 1094041310 1019911311 1020461311 1025311309 1028071309 1039621310 1040101310 1040551310 1094051310 1019921311 1020481311 1025321309 1028091309 1039631310 1040111310 1040561310 1094061310 1019931311 1020501311 1025331309 1028111309 1039641310 1040121310 1040571310 1094071310 1019941311 1020521311 1025341309 1028141309 1039651310 1040131310 1040581310 1094081310 1019951311 1020541311",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2281-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","Serial Num 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311 1014711311 1014721311 1014731311 1014741311 1014751311 1014761311 1014771311 1014781311 1014791311 1014801311 1014811311 1014821311 1014831311 1014841311 1014851311 1014861311 1014871311 1014881311 1014891311 1014901311 1014911311 1014921311 1014931311 1014941311 1014951311 1014961311 1014971311 1014981311 1014991311 1015001311 1015011311 1015021311 1015031311 1015041311 1015051311 1015061311 1015071311 1015081311 1015091311 1015101311 1015111311 1015121311 1015131311 1015141311 1015151311 1015161311 1015171311 1015181311 1015191311 1015201311 1015211311 1015221311 1015231311 1015241311 1015251311 1015261311 1015271311 1015281311 1015291311 1015301311 1015311311 1015321311 1015331311 1015341311 1015351311 1015361311 1015371311 1015381311 1015391311 1015401311 1015411311 1015421311 1015431311 1015441311 1015451311 1015461311 1015471311 1015481311 1015491311 1015501311 1015511311 1015521311 1015531311 1015541311 1015551311 1015561311 1015571311 1015581311 1015591311 1015601311 1015611311 1016501310 1016521310 1016541310 1016561310 1016581310 1016601310 1016621310 1016641310 1016661310 1016671310 1016681310 1016691310 1016701310 1016711310 1016721310 1016731310 1016741310 1016751310 1016761310 1016771310 1016781310 1016791310 1016801310 1016811310 1016821310 1016831310 1016841310 1016851310 1016861310 1016871310 1016881310 1016891310 1016901310 1016911310 1016921310 1016931310 1016941310 1016951310 1016961310 1016971310 1016981310 1016991310 1017001310 1017011310 1017021310 1017031310 1017041310 1017051310 1017061310 1017071310 1017081310 1017091310 1017101310 1017111310 1017121310 1017131310 1017141310 1017151310 1017161310 1017171310 1017191310 1017211310 1017231310 1017241310 1017251310 1017261310 1017271310 1017281310 1017291310 1017301310 1017311310 1017321310 1017331310 1017341310 1017351310 1017371310 1017391310 1017411310 1017431310 1017451310 1017471310 1017491310 1017511310 1017531310 1017551310"," 1189531309 1189541309 1189551309 1189561309 1189571309 1189581309 1189591309 1189601309 1189611309 1189621309 1189631309 1189641309 1189651309 1189661309 1189671309 1189681309 1189691309 1189701309 1189711309 1189721309 1189731309 1189741309 1189751309 1189761309 1189781309 1189801309 1189821309 1189881309 1189941309 1189991309 1190011309 1190031309 1190051309 1190071309 1190131309 1190151309 1190171309 1190191309 1190271309 1190291309 1190311309 1190331309 1190351309 1201731311 1201741311 1201751311 1201761311 1201771311 1201781311 1201791311 1201801311 1201811311 1201821311 1201831311 1201841311 1201851311 1201861311 1201871311 1201881311 1201891311 1201901311 1201911311 1201921311 1201931311 1201941311 1201951311 1201961311 1201971311 1201981311 1201991311 1202001311 1202011311 1202021311 1202031311 1202041311 1202051311 1202061311 1202071311 1202081311 1202091311 1202101311 1202111311 1202121311 1202131311 1202141311 1202151311 1202161311 1202171311 1202181311 1202191311 1202201311 1202211311 1202221311 1202231311 1202241311 1202251311 1202261311 1202271311 1202281311 1202291311 1202301311 1202311311 1202321311 1202331311 1202341311 1202351311 1202361311 1202371311 1202381311 1202391311 1202401311 1202411311 1202421311 1202431311 1202441311 1202451311 1202461311 1202471311 1202481311 1202491311 1202501311 1202511311 1202521311 1202531311 1202541311 1202551311 1202561311 1202571311 1202581311 1202591311 1202601311 1202611311 1202621311 1202631311 1202641311 1202651311 1202661311 1202671311 1202681311 1202691311 1202701311 1202711311 1202721311 1202731311 1202741311 1202751311 1202761311 1202771311 1202781311 1202791311 1208771311 1208781311 1208791311 1208801311 1208811311 1208821311 1208831311 1208841311 1208851311 1208861311 1208881311 1208901311 1208921311 1208941311 1208961311 1208981311 1209001311 1209041311 1209061311 1209081311 1209101311 1209121311 1209141311 1209161311 1209181311 1209201311 1209221311 1209241311 1209261311 1209281311 1209301311 1209321311 1209341311 1209361311 1209381311 120940131","77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68346,"Ongoing","AMO Puerto Rico Manufacturing, Inc.","Anasco","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.","Z-2271-2014","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. ","1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309 1039641309 1114081309 1114411309 1114431309 1114621309 1114841309 1114861309 1114871309 1114881309 1114891309 1114921309 1297261308 1297361308 1297411308 1297491308 1297511308 1297561308 1297571308 1297581308 1297601308 1297801308 1169561309 1169601309 1169641309 1169681309 1169691309 1169721309 1169731309 1169761309 1169791309 1169801309 1169831309 1169841309 1169871309 1169891309 1169911309 1169931309 1169971309 1170011309 1170051309 1170091309 1170131309 1170171309 1170211309 1170411309 1170431309 1170451309 1170491309 1170501309 1170511309 1170551309 1170581309 1170591309 1032921309 1032941309 1033101309 1033141309 1033161309 1033181309 1033261309 1033281309 1033301309 1033341309 1033361309 1033381309 1033401309 1033441309 1033461309 1033471309 1033481309 1033491309 1033511309 1033521309 1033531309 1033541309 1033561309 1033571309 1033581309 1033591309 1033601309 1033611309 1033621309 1033631309 1033641309 1033651309 1033661309 1033671309 1033681309 1033691309 1033701309 1033721309 1033731309 1033751309 1033811309 1037161309 1037181309 1037211309 1037231309 1037251309 1037271309 1037321309 1037341309 1037351309 1037361309 1037371309 1037381309 1037391309 1037401309 1037411309 1037421309 1037431309 1037441309 1037451309 1037461309 1037471309 1037481309 1037491309 1037511309 1037531309 1037551309 1037571309 1037581309 1037591309 1037601309 1037621309 1037641309 1037651309 1037661309 1037671309 1037681309 1037691309 1037751309 1037771309 1037861309 1037871309 1037891309",,"77,055 IOLs in total","Units may be labeled with the incorrect diopter power.",5/13/2014,"05/13/2014",8/27/2014,"08/27/2014"
"Devices",68347,"Ongoing","Focus Diagnostics Inc","Cypress","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution","Z-1958-2014","Class II","Simplexa'' Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa'' Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. ","Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015. ",,"614 kits","Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa'' Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.",5/15/2014,"05/15/2014",7/9/2014,"07/09/2014"
"Drugs",68348,"Ongoing","Bausch & Lomb, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Canada, and Hong Kong.","D-1410-2014","Class II","Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.","Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16 ",".","a) 4,165 tubes; b) and c) 844,879 tubes","Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.",4/10/2014,"04/10/2014",7/2/2014,"07/02/2014"
"Drugs",68348,"Ongoing","Bausch & Lomb, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Canada, and Hong Kong.","D-1411-2014","Class II","Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.","Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 ",".","35,253 tubes","Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.",4/10/2014,"04/10/2014",7/2/2014,"07/02/2014"
"Devices",68349,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon","Z-1746-2014","Class II","IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352","Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431 ",".","42,600","IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. ",5/22/2014,"05/22/2014",6/18/2014,"06/18/2014"
"Devices",68350,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, FL, OH and OK.","Z-1732-2014","Class II","RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.","Product Code: ECK103, Lot number: 02A1402484",".","1000 eaches","Product was packaged with a straight catheter rather than the correct coude (curved) catheter.",5/21/2014,"05/21/2014",6/18/2014,"06/18/2014"
"Food",68351,"Ongoing","Sherman Produce Co","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","The products were distributed in MO and IL.","F-2027-2014","Class I","Bulk shelled walnuts packaged in 25 lb. cardboard boxes labeled with GSF LLC, Combo Halves and Pieces, Visalia, CA. 4024 CHP, also labeled California Walnut Board 40242096","Lot # 129498",,"2/25-lb boxes","The products are potentially contaminated with Listeria monocytogenes",5/20/2014,"05/20/2014",6/25/2014,"06/25/2014"
"Food",68351,"Ongoing","Sherman Produce Co","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","The products were distributed in MO and IL.","F-2028-2014","Class I","Schnucks walnuts packaged in 10 oz. plastic trays. IPC 003383900325 Packed by Sherman Produce Company, St. Louis, MO.","Lot # 129498 , best by dates 03/15 and 04/15",,"359/12/10-oz/cases","The products are potentially contaminated with Listeria monocytogenes",5/20/2014,"05/20/2014",6/25/2014,"06/25/2014"
"Devices",68353,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.","Z-2071-2014","Class III","Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,","Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194",".","6 systems","RAPIDComm 5.0 Screen Layout will display incorrect test names",5/22/2014,"05/22/2014",7/23/2014,"07/23/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1857-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot code: 40179091 40179069 40179068 40179029 40179019 31279094 3067901 3057932 3057919 3057918 3057909 3057908",".","16,625 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1859-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot codes: 31279092 3047917 3047916",".","2711 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1860-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927 ",".","8683 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1856-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot codes: 40179030 3067904 3067902 3057925 3057924 3047934 3047929",".","5488 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1855-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, Batch Size (liters): 60 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot codes: 40179127 40179107 40179109 40179105 40179093 40179034 31279120 31279118 3057921 3057920 3057915 3057914 3057906 3057905 3047924 3047923",".","19423 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1854-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStages PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStages PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.","Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928",".","13474 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1858-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40 ","Lot codes: 40179026 3057901 3047930",".","2839 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68354,"Ongoing","NxStage Medical, Inc.","Lawrence","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.","Z-1861-2014","Class II","NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlowTM SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 ","Lot code: 40179074 ",".","91 cases"," SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification",5/14/2014,"05/14/2014",7/2/2014,"07/02/2014"
"Devices",68355,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Honduras, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine and Venezuela.","Z-1800-2014","Class II","MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.","N/A - Software versions 1.40 through 2.50, inclusive",,"723","When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.",5/23/2014,"05/23/2014",6/25/2014,"06/25/2014"
"Devices",68356,"Terminated","Cincinnati Sub-Zero Products Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","The product was distributed to one customer in MI, and internationally (Taiwan)","Z-1679-2014","Class II","115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.","Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165",,"7 units","The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but no alarms will alert the user of the loss of therapy condition.",1/8/2014,"01/08/2014",6/11/2014,"06/11/2014"
"Devices",68357,"Terminated","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Visit","US Distribution to GA.","Z-1705-2014","Class II","Spacelabs Medical Ultraview SL'' Command Module, Model 91496. Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.","Listing Number: D145750 Model: 91496.",,"64 devices","A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.",5/8/2014,"05/08/2014",6/11/2014,"06/11/2014"
"Devices",68358,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Other","Medical facilities in TX and FL","Z-1718-2014","Class II","Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.","lot 380652-20",,"2","Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.",5/9/2014,"05/09/2014",6/11/2014,"06/11/2014"
"Food",68359,"Terminated","Royal Rye LLC","Hillsboro","OR","US","Voluntary: Firm Initiated","Telephone","Bread was distributed to 16 retail makets in Oregon and 1 retail market in Washington.","F-1984-2014","Class II","KrustaVita Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6.","Best By: MAY 28, 2014",,"128 loaves","Royal Rye LLC is recalling their KrustaVita Bread of Life rye bread due to undeclared soy.",5/20/2014,"05/20/2014",6/11/2014,"06/11/2014"
"Drugs",68360,"Ongoing","Sandoz, Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico.","D-1350-2014","Class II","Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.","Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016",,"22,818 Bottles","Presence of Particulate Matter: Presence of stainless steel particles.",5/22/2014,"05/22/2014",6/4/2014,"06/04/2014"
"Food",68361,"Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","MA,NY,NJ,CT,RI","F-2033-2014","Class I","Whole Foods Thai Soba Noodle Salad , 9 oz. refrigerated plastic container UPC Code: 36406304107 ","Use By; 05/25/14",,"140 units","Thai Soba Noodle Salad contains undeclared soy",5/22/2014,"05/22/2014",6/25/2014,"06/25/2014"
"Devices",68363,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CA and IN","Z-1714-2014","Class II","Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.","Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.",,"2","Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been found that although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, and does not stop.",5/12/2014,"05/12/2014",6/11/2014,"06/11/2014"
"Biologics",68364,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0755-14","Class II","Red Blood Cells Leukocytes Reduced","W127014612174; ",,"1 unit","Blood product, contaminated with air was distributed.",4/28/2014,"04/28/2014",7/9/2014,"07/09/2014"
"Biologics",68365,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","Hawaii","B-0756-14","Class II","Red Blood Cells Leukocytes Reduced","W088414514031; ",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",4/17/2014,"04/17/2014",7/9/2014,"07/09/2014"
"Biologics",68366,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee; Georgia","B-0757-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W043211032426; W043211032426; ",,"2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/2/2014,"05/02/2014",7/9/2014,"07/09/2014"
"Biologics",68367,"Terminated","Cangene Plasma Resources, Inc.","Frederick","MD","US","Voluntary: Firm Initiated","FAX","California","B-0758-14","Class III","Source Plasma","9160122331; 9160123078; ",,"2 units","Blood products, collected from a donor who did not have a complete medical history interview, were distributed.",5/15/2014,"05/15/2014",7/9/2014,"07/09/2014"
"Biologics",68368,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0759-14","Class II","Red Blood Cells Leukocytes Reduced","W202213011188; ",,"1 unit","Blood product, which tested positive for Fyb red cell antigen, but was previously typed as negative for Fyb antigen, was distributed.",2/11/2014,"02/11/2014",7/9/2014,"07/09/2014"
"Biologics",68369,"Completed","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0745-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W202213019658, W202213005900",".","2 units","Blood products, incorrectly labeled as negative for the Jka red cell antigen, were distributed.",4/3/2014,"04/03/2014",7/2/2014,"07/02/2014"
"Biologics",68369,"Completed","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0744-14","Class II","Red Blood Cells Leukocytes Reduced","W202213017749, W202213005882",".","2 units","Blood products, incorrectly labeled as negative for the Jka red cell antigen, were distributed.",4/3/2014,"04/03/2014",7/2/2014,"07/02/2014"
"Biologics",68370,"Terminated","Cangene Plasma Resources, Inc.","Frederick","MD","US","Voluntary: Firm Initiated","FAX","California","B-0760-14","Class III","Source Plasma","9160120103; 9160128389; ",,"2 units","Blood products, collected from a donor who did not have a complete medical history interview, were distributed.",5/15/2014,"05/15/2014",7/9/2014,"07/09/2014"
"Biologics",68371,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0746-14","Class II","Red Blood Cells Leukocytes Reduced","022GH85329",".","1 unit","Blood product, which was incorrectly labeled as negative for the S red cell antigen, was distributed.",2/12/2014,"02/12/2014",7/2/2014,"07/02/2014"
"Biologics",68372,"Terminated","Central Jersey Blood Center, Inc.","Eatontown","NJ","US","Voluntary: Firm Initiated","FAX","New Jersey","B-0713-14","Class II","Red Blood Cells Leukocytes Reduced","W053514000339; ",,"1","Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed.",4/8/2014,"04/08/2014",7/9/2014,"07/09/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1794-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.","Catalog Number: PM4500; Material Number: M004PM45000; Serial numbers: 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, 16872836. Expiry Dates: May 7, 2014 to January 13, 2017 ",,"968 units - all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1796-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. ","Catalog Number: PM4500N4; Material Number: M004PM45000N40; Serial numbers: 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, 16872124. Expiry Dates: May 11, 2014 to January 13, 2017 ",,"968 units total all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1798-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.","Catalog Number: PM4790K2; Material Number: M004PM47900K2; Serial numbers: 16739673, 16739674, 16739675, 16739676, 16739677, 16739678, 16739679, 16739860, 16872121, 16872935 Expiry Dates: May 11, 2014 to January 13, 2017 ",,"968 units total all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1795-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.","Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017 ",,"968 units total all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1797-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.","Catalog Number: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 Expiry Dates: May 11, 2014 to January 13, 2017 ",,"968 units total all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68373,"Ongoing","Boston Scientific Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1799-2014","Class II","IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. ","Catalog Number: PM4790N4; Material Number: M004PM47900N4; Serial numbers: 16743269, 16872007; Expiry Dates: May 11, 2014 to January 13, 2017 ",,"968 units - all models","Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68374,"Ongoing","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.","Z-1824-2014","Class II","Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07","Serial Numbers Distributed in the US: 436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283, 436A03237 and 436A03238. Serial Numbers Distributed Outside the US: 436A003628, 436A003629, 436A003630, 436A003631, 436A003632, 436A003633, 436A003634, 436A003635, 436A003636, 436A003637, 436A003638, 436A003639, 436A003640, 436A003644, 436A003645, 436A003646, 436A003647, 436A004162, 436A004166, 436A004197, 436A004198, 436a005205, 436a005471, 436a005472, 436A005638, 436A005641, 436A005642, 436A006087, 436A006088, 436A006151, 436A006193, 436A006248, 436A006249, 436A006250, 436A006262, 436A006389, 436A006390, 436A006397, 436A006445, 436A006446, 436A006522, 436A006523, 436A006524, 436A006570, 436A006571, 436A006572, 436A006609, 436A006610, 436A006611, 436A006612, 436A006613, 436A006614, 436A006616, 436A006617, 436A006618, 436A006619, 436A006620, 436A006621, 436A006624, 436A006625, 436A006950, 436A006951, 436A01023, 436A01094, 436A01095, 436A01096, 436A01097, 436A01098, 436A01099, 436A01100, 436A01101, 436A01102, 436A01103, 436A01104, 436A01105, 436A01106, 436A01107, 436A01108, 436A01129, 436A01152, 436A01190, 436A01191, 436A01192, 436A01193, 436A01194, 436A01195, 436A01197, 436A01199, 436A01200, 436A01212, 436A01213, 436A01217, 436A01298, 436A02023, 436A02024, 436A02025, 436A02026, 436A02027, 436A02188, 436A02233, 436A02262, 436A02264, 436A02590, 436A02591, 436A02592, 436A03193, 436A03239, and 436A03500. ",,"46 units distributed within the US; 108 units distributed outside the US.","Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.",5/9/2014,"05/09/2014",6/25/2014,"06/25/2014"
"Drugs",68375,"Ongoing","Aidarex Pharmaceuticals LLC","Corona","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS","D-0042-2015","Class II","Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India","Lot 39661-3 Exp. 07/15",,"531 bottles","Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg ",5/22/2014,"05/22/2014",10/29/2014,"10/29/2014"
"Food",68376,"Ongoing","GSF Nut Company LLC","Orosi","CA","US","Voluntary: Firm Initiated","Telephone","One customer in AZ","F-2026-2014","Class I","GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces","4024CHP",,"440 x 25 lb. cases","FDA sample found positive for Listeria monocytogenes.",5/22/2014,"05/22/2014",6/25/2014,"06/25/2014"
"Food",68376,"Ongoing","GSF Nut Company LLC","Orosi","CA","US","Voluntary: Firm Initiated","Telephone","One customer in AZ","F-2026-2014","Class I","GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs. GSF LLC, Visalia, CA 93290","4024CHP",".","440 x 25 lb. cases","FDA sample found positive for Listeria monocytogenes.",5/22/2014,"05/22/2014",7/2/2014,"07/02/2014"
"Food",68377,"Ongoing","Brunkow Cheese of Wisconsin, Inc.","Darlington","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","sold to distributors in IL, MN, and WI and believe product was sold in retail stores located in CO, IA, IL,KS, MI, MN, MO, MT, NE, NM, OH, TX, WI","F-2035-2014","Class II","Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), UPC 09513-00008","Sell by Dates: 05211411, 04051408, 06191415, 06191416, 06191417, 06261411, 06261412, 07071413, 07071414, 08061410, 08121406, 08121407, 08281413, 08281414, 08281415, 08281416, 09201411, 10031410, 10111404, 10171408, 10171409, 10251413, 11011406, 11151409.",,"4160 units","8 oz tubs of Fayette Creamery brand Jalapeno Raw Milk Cheddar Cold Pack Cheese contains an undeclared soy ingredient.",5/23/2014,"05/23/2014",6/25/2014,"06/25/2014"
"Devices",68378,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FDRATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY,PANAMA, PAKISTAN, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLAND, NAMIBIA, MYANMAR, MOROCCO, MEXICO, MAURITIUS, MALAYSIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JORDAN, Italy, JAPAN, JAMAICA, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GREECE, GERMANY, GEORGIA, FRANCE, FINLAND, ESTONIA, EL SALVADOR, Egypt, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRUNEI, BRAZIL, BOLIVIA, BERMUDA, BELGIUM, BANGLADESH, BAHRAIN, BAHAMAS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA.","Z-2114-2014","Class II","GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",,"21,799 (7,635 units US, 14,164 units OUS)","GE Healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.",7/7/2014,"07/07/2014",7/30/2014,"07/30/2014"
"Veterinary",68380,"Ongoing","Norbrook Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide.","V-131-2014","Class II","Hexasol (tm) Injection, 300 mg oxytetracycline and 20 mg flunixin meglumine per mL, 500 mL, Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian, Norbrook Laboratories Limited, NDC 55529-016-05. Hexasol (tm) (oxytetracycline and flunixin) Injection is a sterile preconstituted solution of the broad-spectrum antibiotic oxytetracycline and the NSAID flunixin meglumine.","Lot number 3403-91, Exp: Oct 2015",,"5,720 500 mL vials","Crystallization; Crystals observed suspended in the injectable solution.",5/30/2014,"05/30/2014",7/16/2014,"07/16/2014"
"Veterinary",68381,"Ongoing","Norbrook Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distribution was made to KS and MO.","V-132-2014","Class III","VetOne Vetrimycin 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL Sterile, 500 mL, ANDA 200-452, Distributed by: MWI, Meridian, ID. Made in UK","Lot 3431-91; exp 10/31/2016",".","4800/500 ml vials","The product appears cloudy when it should be a clear amber solution.",5/20/2014,"05/20/2014",7/23/2014,"07/23/2014"
"Veterinary",68381,"Ongoing","Norbrook Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distribution was made to KS and MO.","V-133-2014","Class III","Terra-Vet 100, Oxytetracycline Hydrochloride Injection, 100 mg/mL, Multiple Dose Sterile Vial, 500 mL, ANDA 200-452, Veterinary Resources, LTD. Manufactured for: Aspen Veterinary Resources, Ltd., Liberty, MO.","Lot 3431-91; exp 10/31/2016",".","2770/500 ml vials","The product appears cloudy or milky when it should be a clear amber solution.",5/20/2014,"05/20/2014",7/23/2014,"07/23/2014"
"Devices",68382,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.","Z-1985-2014","Class II","Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.","model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022 ",,"10","There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.",5/9/2014,"05/09/2014",7/9/2014,"07/09/2014"
"Devices",68383,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distributed in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.","Z-1984-2014","Class II","Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.","All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.",,"44","All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. ",5/15/2014,"05/15/2014",7/9/2014,"07/09/2014"
"Food",68385,"Ongoing","Suntree LLC","Phoenix","AZ","US","Voluntary: Firm Initiated","Press Release","KS","F-2048-2014","Class I","California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806 46 cases, 24 count, 12 oz packages.","Lot 42720 Best By 12/11/14",".","1,104 units","Sun Tree is recalling California Grown Shelled Walnuts because they may be contaminated with Listeria monocytogenes.",5/23/2014,"05/23/2014",7/2/2014,"07/02/2014"
"Devices",68386,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, VT, VA and WA,. and the countries of Australia, Canada, New Zealand and United Kingdom.","Z-1869-2014","Class II","MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.","Released builds 2.50.04D5 and higher",".","101","MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.",5/29/2014,"05/29/2014",7/2/2014,"07/02/2014"
"Devices",68387,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution and the country of Colombia.","Z-1851-2014","Class II","RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.","Product Code: 102004040, Lot #13371, 13381, 13291, 13281, 13251 & 13231; Product Code: 102004050, Lot #13461, 13441, 13401, 13431, 13421, 13381, 13371, 1329, 13301, 13311, 13361, 13261, 13231, 13251 & 13241; Product Code: 102004060, Lot #13441, 13451, 13431, 13411, 13381, 13361, 13311, 13301, 13281, 13271, 13261, 13241 & 13231; Product Code: 102004070, Lot #13441, 13421, 13381, 13351, 13291, 13311, 13271 & 13261; Product Code: 102004070, Lot #13251 & 13241; and Product Code: 102004080, Lot #13371, 13301 & 13251.",".","1658 ea","Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement ''Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions'' was not printed on the product label. ",5/23/2014,"05/23/2014",7/2/2014,"07/02/2014"
"Food",68388,"Ongoing","Rome Packing Co., Inc.","E Providence","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, MA, ME, MO, NY, RI","F-2080-2014","Class I","Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container Ingredients; Contains Jonah Rock Crab Meat, Salt","8oz :containers: lot number 101372 with a sell by date before 5/14/14; lot number 101432 with a sell by date before 5/19/14; lot number 101474 with a sell by date before 5/20/14; 16 oz containers: ''lot number 101372 with a sell by date before 5/14/14; ''lot number 101391 with a sell by date before 5/16/14; ''lot number 101407 with a sell by date before 5/16/14; ''lot number 101432 with a sell by date before 5/19/14; ''lot number 101474 with a sell by date before 5/20/14; ''lot number 101539 with a sell by date before 5/21/14. ",,"802 lbs.","Product contaminated with Listeria monocytogenes",5/22/2014,"05/22/2014",7/9/2014,"07/09/2014"
"Food",68388,"Ongoing","Rome Packing Co., Inc.","E Providence","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, MA, ME, MO, NY, RI","F-2081-2014","Class I","Ocean's Catch Jonah Crab Minced Meat Crabmeat , Net WT. 10 lb. plastic bag","Lot 101450",,"300 lbs.","Product contaminated with Listeria monocytogenes",5/22/2014,"05/22/2014",7/9/2014,"07/09/2014"
"Food",68388,"Ongoing","Rome Packing Co., Inc.","E Providence","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, MA, ME, MO, NY, RI","F-2079-2014","Class I","Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat","lot number 101366 with a sell by date before 5/14/14; lot number 101507 with a sell by date before 5/20/14; lot number 101540 with a sell by date before 5/21/14 ",,"262.5 lbs","Product contaminated with Listeria monocytogenes",5/22/2014,"05/22/2014",7/9/2014,"07/09/2014"
"Drugs",68389,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated",,"Nationwide","D-1427-2014","Class II","Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.","Lot # 360122A, EXP Date: MAY 2015",,"5364 bottles","Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point",5/1/2014,"05/01/2014",7/16/2014,"07/16/2014"
"Devices",68390,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.","Z-2033-2014","Class II","Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.","Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057. Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752. Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100. Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004. Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62101438, 621",,"1487 units","Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.",5/23/2014,"05/23/2014",7/16/2014,"07/16/2014"
"Devices",68390,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.","Z-2035-2014","Class II","Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS , Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components. ","Product ID: 00771300500, Lot #: 61694618, 61743290, 61812682, 61845568, 61845569, 61972395, 61972396, 61978915, 62030113, 62044919, 62118875, 62134957, 62163650, 62169474, 62225879, 62225880, 62354721, 62418036, 62418040, 62460390, 62478289, 62586736 & 62687940. Product ID: 00771300600, Lot #: 60958672, 61468347, 61768416, 61945209, 62071403, 62179055, 62198165, 62238299, 62243210, 62361446, 62422692, 62425093, 62425097, 62430583, 62460385, 62478293, 62484262, 62528055, 62554084, 62616549, 62667448, 62681512 & 77002699. Product ID: 00771300700, Lot #: 61856468, 61950857, 61985935, 62118858, 62153527, 62163657, 62247195, 62275860, 62361448, 62361449, 62414878, 62414882, 62418044, 62454089, 62454091, 62454093, 62489358, 62521396, 62528063, 62554092, 62578361, 62614850, 62652926, 62659300 & 62681516. Product ID: 00771300900, Lot #: 61548886, 62225891, 62282073, 62335405, 62335409, 62356148, 62361455, 62367790, 62414880, 62417690, 62472139, 62484266, 62489363, 62496069, 62521565, 62530628, 62540514, 62554103, 62564692, 62578368, 62578370, 62652933, 62667455 & 62700933. Product ID: 00771301000, Lot #: 61356738, 61796994, 61850999, 62030070, 62124949, 62169497, 62198185, 62253484, 62288848, 62342743, 62342963, 62342967, 62367798, 62367799, 62443121, 62443123, 62503161, 62560129, 62564694, 62564698, 62578377, 62594161, 62652941, 62652942, 62667463, 62694065 & 77003232. Product ID: 00771301100, Lot #: 61576325, 61786474, 61909829, 61950874, 62066981, 62163668, 62201722, 62207778, 62253492, 62417698, 62428479, 62432955, 62432959, 62450085, 62496079, 62521571, 62521572, 62540529, 62554121, 62564702, 62578385, 62616557, 62647175, 62647178, 62659302, 62667466 & 62667469. Product ID: 00771301200, Lot #: 60898841, 61300903, 61409710, 62030078, 62041818, 62163670, 62198191, 62207784, 62253638, 62270938, 62282101, 62356206, 62418052, 62428484, 62428488, 62432966, 62478323, 62484283, 62496086, 62503168, 62521407, 62546967, 62546968, 62546975, 62564705, 62578401, 62659306 & 62687964. Product ID: 00771301300,",,"315 units","Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.",5/23/2014,"05/23/2014",7/16/2014,"07/16/2014"
"Devices",68390,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.","Z-2033-2014","Class II","Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.","Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057. Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752. Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100. Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004. Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62",,"1487 units","Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.",5/23/2014,"05/23/2014",7/16/2014,"07/16/2014"
"Devices",68390,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.","Z-2034-2014","Class II","Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components. ","Product ID: 00771100410, Lot #: 60876583, 61098988, 61158127, 61230791, 61542496, 61548105, 61702995, 61729254, 61904645, 61957233, 61963047, 61998392, 62004467, 62067479, 62078278, 62096889, 62107667, 62145541, 62153634, 62184289, 62246880, 62246881, 62253651, 62265027, 62283066, 62316369, 62343031, 62356431, 62361531, 62380986, 62390746, 62445410, 62459360, 62472165, 62495527, 62528301, 62529331, 62529334, 62529335, 62529341, 62577926, 62577929 & 62630007. Product ID: 00771100440, Lot #: 60500974, 60597171, 60824961, 61040634, 61510553, 61601757, 61703092, 61796656, 61870553, 61880423, 61904646, 61963030, 61967702, 62101479, 62135089, 62153635, 62158616, 62176234, 62179221, 62202469, 62239214, 62253653, 62253654, 62275332, 62275333, 62302332, 62309445, 62316374, 62342712, 62405371, 62410988, 62472168, 62521896, 62554173, 62571801, 62577931, 62601210 & 62645212. Product ID: 00771100510, Lot #: 61098989, 61158128, 61595675, 61734799, 61791458, 61870554, 61919455, 61967734, 61985992, 62023864, 62059114, 62085023, 62135094, 62135095, 62143027, 62145548, 62145549, 62145551, 62169649, 62198214, 62238349, 62243359, 62243360, 62302339, 62302341, 62342714, 62367890, 62445414, 62458976, 62459363, 62509237, 62529278, 62529353, 62529362, 62537985, 62540589 & 62554177. Product ID: 00771100540, Lot #: 60659250, 61030264, 61085549, 61098994, 61595699, 61690452, 61749176, 61765962, 61796657, 61845539, 61865602, 61966525, 62004475, 62078283, 62096893, 62130151, 62143029, 62153639, 62158620, 62207884, 62258663, 62271060, 62275338, 62323507, 62335521, 62335522, 62361538, 62445416, 62452735, 62489955, 62503202, 62540593, 62594190 & 62615704. Product ID: 00771100610, Lot #: 61030252, 61416334, 61523437, 61894915, 61894916, 61966499, 62085032, 62114298, 62158626, 62207887, 62219914, 62226003, 62236540, 62238352, 62243369, 62243372, 62243373, 62275343, 62289018, 62302344, 62309453, 62335525, 62356440, 62379097, 62393282, 62405381, 62409688, 62410998, 62411003, 62423064, 62423065, 62445419, 62452741, 62478872, 62478874, 62488298, 6",,"852 units","Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.",5/23/2014,"05/23/2014",7/16/2014,"07/16/2014"
"Food",68391,"Ongoing","Physique Enhancing Science","Clearwater","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: USA including states of: FL, IL, CA, CT, NC, OH, TX, WA, NH, PA, MI, IN, GA, IA, LA, MS, AZ, SC, NV, and NY.","F-2054-2014","Class II","Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors. ","For Both Flavours the Lot #s are: N09474, N08447-B, N08448, N08447-A, N07398, and N07397. For Both Flavours the UPC #'s are: 793573113870 and 793573113801.",,"12,363 units","Products contain ''Aegeline'' an unapproved New Dietary Ingredient.",11/15/2013,"11/15/2013",7/9/2014,"07/09/2014"
"Food",68391,"Ongoing","Physique Enhancing Science","Clearwater","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: USA including states of: FL, IL, CA, CT, NC, OH, TX, WA, NH, PA, MI, IN, GA, IA, LA, MS, AZ, SC, NV, and NY.","F-2055-2014","Class II","Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch flavors","For Both Flavors the Lot #s are: N01046, N01047, M11588, and M11589. For Both Flavours the UPC #s are: 793573173171, 793573221834, and 793573173140.",,"28,804 units","Products contain ''Aegeline'' an unapproved New Dietary Ingredient.",11/15/2013,"11/15/2013",7/9/2014,"07/09/2014"
"Devices",68393,"Ongoing","DeVilbiss Healthcare LLC","Somerset","PA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.","Z-1949-2014","Class III","DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.","Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154 HD071278 HD070474 HD070736 JD034560 JD034566 HD070219 HD070162 HD070172 HD070174 HD070178 HD070182 HD070827 HD070961 HD071003 HD071004 HD071007 HD071009 HD071020 HD071021 HD071022 HD071030 HD071032 HD071033 HD071040 HD071043 HD071045 HD071048 HD071057 HD071058 HD071059 HD071062 HD071063 HD071064 HD071065 HD071069 HD071072 JD034492 JD034497 JD034504 JD034506 JD034507 JD034540 JD034543 JD034553 JD034554 JD034555 HD071068 JD034316 JD034317 JD034327 JD034328 JD034329 JD034330 JD034331 JD034332 JD034333 JD034334 HD070167 HD070171 HD070177 HD070190 HD070191 HD070198 HD070206 HD070212 HD070223 HD070225 HD070248 HD070249 HD070279 HD069902 HD069903 HD069906 HD069907 HD070533 HD070534 HD070545 HD070548 HD070563 HD070598 HD070605 JD034598 JD034599 JD034601 JD034603 JD034604 HD070724 HD070749 HD070756 HD070758 HD070760 HD070763 HD070767 HD070779 HD070781 HD070783 HD070787 HD070797 JD034569 JD034571 JD034576 JD034578 JD034586 JD034588 JD034591 JD034592 JD034597 HD069969 HD070722 HD070728 HD070733 HD070761 HD070784 JD034519 JD034602 JD034609 JD034613 JD034614 kd014347 HD069922 HD069905 HD069916 HD069917 JD034156 JD034158 JD034159 JD034163 JD034165 JD034185 JD034186 KD014349 KD014350 JD034209 JD034212 JD034231 JD034235 JD034239 JD034242 JD034584 JD034587 JD034589 JD034568 JD034581 JD034582 HD070283 HD070301 JD034161 JD034171 HD069927 HD069929 HD069930 HD069932 HD069949 HD069951 JD034211 JD034226 KD014329 HD070482 HD070483 HD070500 HD070556 HD070719 HD070720 HD070791 HD070800 HD070828 ID039134 ID039150 ID039167 KD014117 JD034402 KD014229 JD034154 JD034155 JD034160 JD034183 JD034188 JD034189 JD03",,"1809","A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as ''RUN-TEST''. ",5/13/2014,"05/13/2014",7/9/2014,"07/09/2014"
"Devices",68394,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.","Z-1944-2014","Class II","syngo Lab Data Manager ","syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B",,"336","Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.",5/20/2014,"05/20/2014",7/9/2014,"07/09/2014"
"Devices",68395,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.","Z-2075-2014","Class II","Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.","material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272 ",".","7","An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DICOM data failed because the loaded CD was not recognized by the system. ",5/15/2014,"05/15/2014",7/23/2014,"07/23/2014"
"Devices",68396,"Terminated","Meridian Bioscience Inc","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.","Z-1941-2014","Class II","illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.","Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706.",,"35 instruments","Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.",4/22/2014,"04/22/2014",7/9/2014,"07/09/2014"
"Biologics",68397,"Terminated","American National Red Cross","Cleveland","OH","US","Voluntary: Firm Initiated","FAX","Ohio; California","B-0769-14","Class III","Platelets Pooled Leukocytes Reduced","W204214003913; ",,"1","Blood products, collected from a donor who reported a post donation illness, were distributed.",4/16/2014,"04/16/2014",7/9/2014,"07/09/2014"
"Biologics",68397,"Terminated","American National Red Cross","Cleveland","OH","US","Voluntary: Firm Initiated","FAX","Ohio; California","B-0770-14","Class III","Blood and Blood Products for Reprocessing","W204214003913; ",,"1","Blood products, collected from a donor who reported a post donation illness, were distributed.",4/16/2014,"04/16/2014",7/9/2014,"07/09/2014"
"Devices",68398,"Completed","Atrium Medical Corporation","Hudson","NH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.","Z-1959-2014","Class II","Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.","Lot Number: 10906458",,"195 Cases; Total 1170 units","Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.",4/28/2014,"04/28/2014",7/9/2014,"07/09/2014"
"Devices",68399,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Distributed in PA and Canada.","Z-2023-2014","Class II","Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.","Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).",,"465 units","The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.",6/25/2014,"06/25/2014",7/16/2014,"07/16/2014"
"Devices",68400,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","FL LA AR IA OH OH WI IL LA KS MT","Z-2133-2014","Class III","Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. ","DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX ",,"15","There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.",5/27/2014,"05/27/2014",8/6/2014,"08/06/2014"
"Drugs",68401,"Ongoing","Alexion Pharmaceuticals, Inc.","Cheshire","CT","US","Voluntary: Firm Initiated","Press Release","Nationwide and Puerto Rico","D-1512-2014","Class I","Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.","Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15",".","96,506 vials","Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. ",6/2/2014,"06/02/2014",8/13/2014,"08/13/2014"
"Drugs",68402,"Ongoing","Wockhardt Usa Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1355-2014","Class II","Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.","Lot #: LN11423, Expiry: 8/15/15",,"8712 Bottles","Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.",4/10/2014,"04/10/2014",6/4/2014,"06/04/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2098-2014","Class II","Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8'' flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Part No. 16094, Lot #: 655235 ",,"20 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2094-2014","Class II","Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.",,"7,460 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2096-2014","Class II","Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2'' connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.","Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 4935, Lot #: 0655206, 0656923, 0682315, 0685669, 0696718; Part No. 4936, Lot #: 0655292, 0665320, 0684443, 0684444, 0687492, 690459R & Part No. 4936X, Lot #: 0656438, 0661606, 683308R.",,"7,190 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2106-2014","Class II","CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. ","Part No. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09",,"125 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2105-2014","Class II","Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Part No. 7071, Lot #: 0658575, 0662312, 0666660, 0670324, 0670948, 0682566, 0686889, 0689725, 0695466, 0702123, 689725R; Part No. 7072, Lot #: 0658572, 0662311, 0670325, 0686126, 0687466, 0694421, 0702124, 694421R, 694445R; Part No. 7072X, Lot #: 0662871, 662871R, 684785R; Part No. 7080, Lot #: 0661085, 0670671, 0675676, 0687168, 0694423, 0696700, 0702127, 0711833, 694423R; Part No. 5767, Lot #: 0652211, 0661105, 0664361, 0670323, 0675826, 0677192, 0684996, 0685122, 0685123, 0689787, 0697471, 0708188, 0708770, 667914N, 689787R, 695467R; Part No. 5761, Lot #: 0650494, 0653427, 0661106, 0667066, 0668960, 0670940, 0672074, 0677795, 0678216, 0683309, 0685666, 0687798, 0689724, 0694428, 0696206, 0698338, 0703836, 0704646, 0708187, 0708767, 694428R; Part No. 5761X, Lot #: 0653824, 0660674, 0668570, 0674464, 0683051, 0686891, 686891R; Part No. 5767X, Lot #: 0662430, 0670967, 670967R; Part No. 6392, Lot #: 0648090, 0653418, 0659107, 0661101, 0664539, 0676371, 0677191, 0677794, 0685662, 0685663, 0685664, 0689718, 685664R, 689718R, 697473R; Part No. 6394, Lot #: 0650838, 0659106, 0661098, 0670945, 0674474, 0678011, 0685489, 0689720, 0696207, 0702122, 689720R; Part No. 5842, Lot #: 0654074, 0656644, 0671750, 0681809, 0688003, 0695986, 0710040, 688003R; Part No. 5798, Lot #: 0649217, 0656439, 0660663, 0662070, 0670425, 0677301, 0686890, 0688490, 0711274, 0711827, 688490R; Part No. 6393, Lot #: 684774R; Part No. 5768, Lot #: 0649874, 0654075, 0659017, 0662733, 0669800, 0670941, 0675738, 0677971, 0685665, 0687801, 0695468, 0708190, 687801R; Part No. 5762, Lot #: 0647163, 0650493, 0653424, 0659018, 0668571, 0670937, 0673175, 0674263, 0677300, 0678059, 0686324, 0689721, 0694413, 0702121, 0708189, 0708776, 694413R, 696147R; Part No. 5762X, Lot #: 0649168, 0661605, 696146R; Part No. 5768X, Lot #: 0661175, 0673743, 0677012, 677012R, 695469R; Part No. 6384, Lot #: 0649216, 0658580, 0666662, 0670943, 0674472, 0680716, 0687537, 0709686; Part No. 6386, Lot #: 0649585, 0653419, 0666613, 0668004, 0670938, 0676537, 0681103, 0687538, 06",,"132, 250 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2099-2014","Class II","Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ","Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876, 0649394, 0653430, 0660668, 0661526, 0667894, 0668979, 0674463, 0675778, 0677306, 0678217, 0681808, 0686128, 0687960, 0694412, 0696144, 0696612, 0698299, 0702118, 0708768, 0710037, 0711275, 0713301, 0722066, 696144R & Part No. 4951X, Lot #: 0668569, 0677303, 0696145, 0712873, 696145R.",,"135,340 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2097-2014","Class II","Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8'' & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.","Part No. 4881, Lot #: 0646527, 0652247, 0655237, 0657761, 0659431, 0663547, 0666625, 0674022, 0676975, 0678722, 0681793, 0693318, 0695683, 0697379; Part No. 4881X, Lot #: 684032; Part No. 4882, Lot #: 0646526, 0649165, 0650782, 0653857, 0657248, 0662811, 0668349, 0673863, 0676584, 0678953, 0682571, 0683601, 683601R; Part No. 4882X, Lot #: 0651693, 0656946, 0668566, 0683306, 683306R; Part No. 4883, Lot #: 0647472, 0653433, 0658525, 0659432, 0662541, 0673755, 0676593, 0681816, 0691567, 0696613; Part No. 4883X, Lot #: 0649154, 0653823, 0675680; Part No. 4884, Lot #: 0646143, 0647046, 0649882, 0652246, 0654605, 0662807, 0667262, 0670484, 0674103, 0677804, 0683383, 0683605, 0692771, 0696611; Part No. 4884X, Lot #: 0649169, 0653445, 0683608; Part No. 4885, Lot #: 0647474, 0652803, 0655236, 0662804, 0670673, 0675804, 0677976, 0681127, 0695872, 0698980; Part No. 4885X, Lot #: 0652526, 0662887; Part No. 4886, Lot #: 0659433, 0661555, 0667893, 0669797, 0681817; Part No. 4886X, Lot #: 652528 & Part No. 4887, Lot #: 0661530, 0668567, 0672138.",,"32,880 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2095-2014","Class II","Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8'' connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. ",", Part No. 144936, Lot #: 653821",,"120 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2104-2014","Class II","Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8'' flare, 30 Fr with 3/8'' connector and 30 Fr with 3/8'' flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. ","28 Fr with 3/8'' flare , Part No., 816460, Lot #:, 0645280, 0649157, 0654734, 0666686, 0674810, 0678724, 0682221, 0684790, 0698319, 0698910; 30 Fr with 3/8'' connector , Part No., 820732, Lot #:, 646450 & 30 Fr with 3/8'' flare , Part No., 820731, Lot #:, 0689843, 0698323",,"2,290 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2103-2014","Class II","Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4'' & 3/8'' flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava ","Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697, AM006020, AM007724; Part No. 813550, Lot #: AM001312, AM004268, AM007732, AM018316; Part No. 813549, Lot #: AM002717, AM006052, AM007637; Part No. 813552, Lot #: AM003778, AM007725; Part No. 813554, Lot #: AM001309; Part No. 813551, Lot #: AM002702, AM007635; Part No. 813553, Lot #: AM002708; Part No. 813556, Lot #: AM007733; Part No. 813555, Lot #: AM002719; Part No. 813557, Lot #: AM007726; Part No. 813560, Lot #: AM018160; Part No. 813559, Lot #: AM008235; Part No. 813561, Lot #: AM007639; Part No. 813566, Lot #: AM004227, AM017924 & Part No. 813565, Lot #: AM001315, AM006072.",,"14,380 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2101-2014","Class II","Sarns Venoatrial Cannulae 36/46 Fr with 1/2'' flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. ","Part No. 4440, Lot #: 0646496, 0650492, 0659856, 0666657, 0674751, 0677190, 0686887, 0690546; Part No. 164525, Lot #: 0646401, 0652209, 0656640, 0662516, 0674459, 0678212",,"3,040 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2100-2014","Class II","Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2'' & 3/8'' flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. ","Part No. 4442, Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729; Part No. 14992, Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885; Part No. 4443, Lot #: 0649883, 0660672 & Part No. 15949, Lot #: 0646530, 0661896, 0667259, 0674784, 0683631.",,"6,720 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68404,"Ongoing","Terumo Cardiovascular Systems Corporation","Ann Arbor","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.","Z-2102-2014","Class II","Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2'' flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava ","Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165; Part No. 813582, Lot #: AM001293, AM017320; Part No. 813581, Lot #: AM002694, AM003543, AM006059, AM017959; Part No. 813584, Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639; Part No. 813583, Lot #: AM002729, AM006054, AM016187, AM016638, AM018071; Part No. 813586, Lot #: AM001303, AM005726, AM006061, AM008349; Part No. 813585, Lot #: AM002473, AM002728, AM006056, AM010935, AM017208; Part No. 813588, Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477; Part No. 813587, Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297; Part No. 813590, Lot #: AM016920 & Part No. 813589, Lot #: AM002720, AM004287.",,"34,470 units","During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Devices",68405,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1872-2014","Class II","Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.","Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329. ",".","1992 trays","STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.",5/19/2014,"05/19/2014",7/2/2014,"07/02/2014"
"Devices",68406,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.","Z-2137-2014","Class II","KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator. ","Service Code 1534 ",".","Domestic: 100 units; Foreign: 46 units","A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the ''Up'' or ''Down'' control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.",5/30/2014,"05/30/2014",8/13/2014,"08/13/2014"
"Drugs",68407,"Ongoing","Ferring Pharmaceuticals Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1385-2014","Class II","TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46","Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16 ",,"129,060 cartons","Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.",4/28/2014,"04/28/2014",6/25/2014,"06/25/2014"
"Food",68408,"Completed","American Importing Co, Inc","Minneapolis","MN","US","Voluntary: Firm Initiated","Press Release","NY, ND, MN, WI, CA.","F-2034-2014","Class II","Product label: Amport Foods, Granola, Cinnamon Crunch, 22 oz (1 lb, 6 0z), UPC 0 71725 72511 0, Best BY 03-26-15, Ingredients: wheat flakes, oat flakes , brown sugar, sugar, coconut oil, coconut, wheat flour, cinnamon, honey, natural vanilla, sea salt. Allergy Information: This product is produced on packaging equipment shared with peanut and tree nut products. Case label: Stock No. 3250420 8/22 oz, Amport Vanilla Almond Granola, Best by 3-26-15, 085X418, UPC 3 00 71725 72512 8.","Best By 03-26-15. Lot Code: 085x418.",,"229 cases","American Importing Co, Inc is voluntarily recalling a limited number of packages of a single lot of Cinnamon Crunch Granola because they may contain undeclared almonds. People who have an allergy or sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product. No adverse reactions or illnesses have been reported to date.",5/2/2014,"05/02/2014",6/25/2014,"06/25/2014"
"Biologics",68409,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","Hawaii","B-0771-14","Class II","Platelets Pheresis Leukocytes Reduced","W088414201425; ",,"1","Blood product, collected from a donor whose health history was not adequately performed, was distributed. ",4/17/2014,"04/17/2014",7/9/2014,"07/09/2014"
"Biologics",68410,"Terminated","Saving Sight","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0734-14","Class II","Cornea","PH116682OS; PH116682OD; PH116909OD; PH116965OS; PH116979OS; PH116877OD; PH117171OS; ",,"7 corneas","Human Corneas, processed using an expired viewing chamber, were distributed. ",4/23/2014,"04/23/2014",6/25/2014,"06/25/2014"
"Biologics",68411,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0772-14","Class II","Platelets Pheresis Leukocytes Reduced","W398514024786A; W398514024786A; ",,"2","Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.",4/11/2014,"04/11/2014",7/9/2014,"07/09/2014"
"Biologics",68412,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","NJ","B-0786-14","Class II","Platelets Pheresis Leukocytes Reduced","W333514007688",".","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed.",4/14/2014,"04/14/2014",7/23/2014,"07/23/2014"
"Food",68414,"Ongoing","Navitas, LLC., dba Navitas Naturals","Novato","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution and to Bahrain Costa Rica, Estonia, Goias, Iceland, Israel, New Zealand, Bermuda, China, Jamaica, Lebanon, Netherlands, Slovenia, Singapore","F-2046-2014","Class I","Navitas Naturals Omega Blend Sprouted Smoothie Mix, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted. UPC 858847000314; Also packaged for Williams Sonoma Omega Smoothie Mixer; SKU 506436 Navitas Naturals, Novato, CA","All best buy dates up to and including 11/05/2015 Navitas Brand and All best buy datess up to and including OC 2015. for Williams Sonoma brand. ",".","25,663 8-oz bags","Data obtained from interviews of patients in a multistate outbreak of Salmonella Newport show Chia Products as the common food consumed",5/28/2014,"05/28/2014",7/2/2014,"07/02/2014"
"Food",68414,"Ongoing","Navitas, LLC., dba Navitas Naturals","Novato","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution and to Bahrain Costa Rica, Estonia, Goias, Iceland, Israel, New Zealand, Bermuda, China, Jamaica, Lebanon, Netherlands, Slovenia, Singapore","F-2045-2014","Class I","Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, Protein, dietary Fiber. UPC 858847000369; Navitas Naturals, Novato, CA 94949","All Best buy dates up to and including 11/22/2015. ","."," 120,275 8-oz bags","Data obtained from interviews of patients in a multistate outbreak of Salmonella Newport show Chia Products as the common food consumed",5/28/2014,"05/28/2014",7/2/2014,"07/02/2014"
"Food",68414,"Ongoing","Navitas, LLC., dba Navitas Naturals","Novato","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution and to Bahrain Costa Rica, Estonia, Goias, Iceland, Israel, New Zealand, Bermuda, China, Jamaica, Lebanon, Netherlands, Slovenia, Singapore","F-2047-2014","Class I","William & Sonoma Navitas Naturals brand Omega 3 Smoothie Mixer, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted.","All best buy dates up to and including OC 2015 ",".","19,354 8-oz bags","Data obtained from interviews of patients in a multistate outbreak of Salmonella Newport show Chia Products as the common food consumed",5/28/2014,"05/28/2014",7/2/2014,"07/02/2014"
"Devices",68415,"Ongoing","3M Company - Health Care Business","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.","Z-2002-2014","Class II","3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.","All serial numbers.",,"5343 (2621 USA, 2722 OUS)","The purpose of this communication is to inform you of a correction needed to the labeling of 3M Attest Auto-readers 390, 390G, & 490. Labeling on units shipped prior to May 16th, 2014 did not contain the statement ''This product contains dry natural rubber'' as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.",6/9/2014,"06/09/2014",7/16/2014,"07/16/2014"
"Biologics",68416,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","IN","B-0793-14","Class III","Plasma Frozen","W040713435414",".","1 unit","Blood products, collected from a donor with an invalid result for body temperature, were distributed.",4/21/2014,"04/21/2014",7/23/2014,"07/23/2014"
"Biologics",68416,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","IN","B-0794-14","Class III","Red Blood Cells Leukocytes Reduced","W040713138655; W040713435414; W040713461246 ",".","3 units","Blood products, collected from a donor with an invalid result for body temperature, were distributed. ",4/21/2014,"04/21/2014",7/23/2014,"07/23/2014"
"Food",68417,"Ongoing","Bar Harbor Jam Company","Bar Harbor","ME","US","Voluntary: Firm Initiated","Letter","Product was distributed in ME, NH, and MA.","F-2538-2014","Class II","BAR HARBOR JAM COMPANY Maine Old Fashioned Popover Mix; Net Wt 1 lb 5 oz (624g)","UPC Code: 892845001621",".","132 units total for all varieties","Label does not declare wheat. ",5/19/2014,"05/19/2014",10/7/2014,"10/07/2014"
"Food",68417,"Ongoing","Bar Harbor Jam Company","Bar Harbor","ME","US","Voluntary: Firm Initiated","Letter","Product was distributed in ME, NH, and MA.","F-2536-2014","Class II","BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g) ","UPC Code: 892845001 607",".","132 units total for all varieties","Label does not declare wheat. ",5/19/2014,"05/19/2014",10/7/2014,"10/07/2014"
"Food",68417,"Ongoing","Bar Harbor Jam Company","Bar Harbor","ME","US","Voluntary: Firm Initiated","Letter","Product was distributed in ME, NH, and MA.","F-2537-2014","Class II","BAR HARBOR JAM COMPANY Maine Wild Blueberry Muffin Mix; Net Wt. 1 lb 6 oz (624 g) ","UPC Code: 892845001 614",".","132 units total for all varieties","Label does not declare wheat. ",5/19/2014,"05/19/2014",10/7/2014,"10/07/2014"
"Devices",68418,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the state of California","Z-1925-2014","Class II","DISCOVERY ELBOW, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Product Usage: Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances,hinge components. Components are available in a variety of surface finished including bone coat (a thin layer of titanium plasma spray), porous titanium plasma spray and lnterlok finish. ","Catalog/REF #: 114905, Lot #: M846640",".","1","Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.",5/15/2014,"05/15/2014",7/2/2014,"07/02/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0119-2015","Class II","Good Herbs, Inc., BEE PROPOLIS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0116-2015","Class II","Good Herbs, Inc., BAYBERRY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0112-2015","Class II","Good Herbs, Inc., BACK HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0141-2015","Class II","Good Herbs, Inc., BUPLEURUM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0173-2015","Class II","Good Herbs, Inc., DANDELION LEAF, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0210-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CHERRY PLUM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0203-2015","Class II","Good Herbs, Inc., FEVERFEW, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0105-2015","Class II","Good Herbs, Inc., ALUM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0202-2015","Class II","Good Herbs, Inc., FENUGREEK, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0118-2015","Class II","Good Herbs, Inc., BEE POLLEN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0111-2015","Class II","Good Herbs, Inc., ASTRAGALUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0168-2015","Class II","Good Herbs, Inc., CRAMP BARK FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0211-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CHESTNUT BUD, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0131-2015","Class II","Good Herbs, Inc., BODY HEALTH, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0104-2015","Class II","Good Herbs, Inc., ALLERGY SUPPORT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0193-2015","Class II","Good Herbs, Inc., EUROPEAN MISTLETOE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0159-2015","Class II","Good Herbs, Inc., CHINESE SALVIA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0138-2015","Class II","Good Herbs, Inc., BUCHU, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0192-2015","Class II","Good Herbs, Inc., EUROPEAN ELDER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0127-2015","Class II","Good Herbs, Inc., BLUE COHOSH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0145-2015","Class II","Good Herbs, Inc., CALENDULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0137-2015","Class II","Good Herbs, Inc., BRAIN SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0122-2015","Class II","Good Herbs, Inc., BLACK COHOSH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0114-2015","Class II","Good Herbs, Inc., BACK HEALTH PLUS & PEPPERMINT OIL, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0102-2015","Class II","Good Herbs, Inc. ADRENAL HEALTH, Capsules, 1 & 4 oz bottles, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0117-2015","Class II","Good Herbs, Inc., BEE FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0165-2015","Class II","Good Herbs, Inc., COMPLETE INTERNAL CLEANSE, kit, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0185-2015","Class II","Good Herbs, Inc., ENT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0189-2015","Class II","Good Herbs, Inc., EQUILIBRIUM HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0187-2015","Class II","Good Herbs, Inc., EP-2-M, 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0218-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE GORSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0156-2015","Class II","Good Herbs, Inc., CHICORY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0207-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE BEECH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0140-2015","Class II","Good Herbs, Inc., BUGLEWEED, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0149-2015","Class II","Good Herbs, Inc., CELERY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0184-2015","Class II","Good Herbs, Inc., ENDOMETRIAL SUPPORT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0147-2015","Class II","Good Herbs, Inc., CAT'S CLAW, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0135-2015","Class II","Good Herbs, Inc., BOWEL EXTRACT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0107-2015","Class II","Good Herbs, Inc., AQUAACTIVE, powder, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0148-2015","Class II","Good Herbs, Inc., CAYENNE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0166-2015","Class II","Good Herbs, Inc., CONCENTRATION & ENERGY HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0130-2015","Class II","Good Herbs, Inc., BMN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0172-2015","Class II","Good Herbs, Inc., DAMIANA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0214-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE COMBINATION-L, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0205-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE AGRIMONY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0125-2015","Class II","Good Herbs, Inc., BLESSED THISTLE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0103-2015","Class II","Good Herbs, Inc., ALFALFA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works,","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0129-2015","Class II","Good Herbs, Inc., BLUE VERVAIN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0113-2015","Class II","Good Herbs, Inc., BACK HEALTH PLUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0143-2015","Class II","Good Herbs, Inc., BUTCHER'S BROOM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0186-2015","Class II","Good Herbs, Inc., ENVIRONMENTAL FORMULA, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0208-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CENTAURY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0121-2015","Class II","Good Herbs, Inc., BILBERRY LEAF, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0194-2015","Class II","Good Herbs, Inc., EYE & EAR HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0146-2015","Class II","Good Herbs, Inc., CASCARA SAGRADA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0134-2015","Class II","Good Herbs, Inc., BORAGE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0196-2015","Class II","Good Herbs, Inc., EYEBRIGHT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0180-2015","Class II","Good Herbs, Inc., ECHINACEA ANGUSTIFOLIA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0133-2015","Class II","Good Herbs, Inc., BONE HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0199-2015","Class II","Good Herbs, Inc., FEMALE HORMONE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0152-2015","Class II","Good Herbs, Inc., CHAPARRAL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0201-2015","Class II","Good Herbs, Inc., FENNEL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0154-2015","Class II","Good Herbs, Inc., CHASTE TREE FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0124-2015","Class II","Good Herbs, Inc., BLADDERWRACK, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0144-2015","Class II","Good Herbs, Inc., C&F, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0178-2015","Class II","Good Herbs, Inc., DONG QUAI, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0215-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CRAB APPLE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0164-2015","Class II","Good Herbs, Inc., CLOVE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0174-2015","Class II","Good Herbs, Inc., DANDELION ROOT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0195-2015","Class II","Good Herbs, Inc., EYE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0209-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CERATO, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0139-2015","Class II","Good Herbs, Inc., BUCKTHORN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0179-2015","Class II","Good Herbs, Inc., DULSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0191-2015","Class II","Good Herbs, Inc., ESSENTIAL DAILY HERBAL FORMULA, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0120-2015","Class II","Good Herbs, Inc., BILBERRY FRUIT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0155-2015","Class II","Good Herbs, Inc., CHICKWEED, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0175-2015","Class II","Good Herbs, Inc., DI-ZYME, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0106-2015","Class II","Good Herbs, Inc., APRICOT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0197-2015","Class II","Good Herbs, Inc., FAVA BEAN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0169-2015","Class II","Good Herbs, Inc., CRANBERRY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0108-2015","Class II","Good Herbs, Inc., ARNICA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0162-2015","Class II","Good Herbs, Inc., CINNAMON, capsules, 1 & 4 oz bottles, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0132-2015","Class II","Good Herbs, Inc., BONE & TISSUE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0212-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CHICORY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0188-2015","Class II","Good Herbs, Inc., EPAZOTE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0176-2015","Class II","Good Herbs, Inc., DIGESTIVE KIT, kit, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0126-2015","Class II","Good Herbs, Inc., BLOOD PRESSURE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0213-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE CLEMATIS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0182-2015","Class II","Good Herbs, Inc., ELECAMPANE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0160-2015","Class II","Good Herbs, Inc., CHROMIUM PICOLINATE, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0123-2015","Class II","Good Herbs, Inc., BLACK WALNUT HULL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0171-2015","Class II","Good Herbs, Inc., CT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0142-2015","Class II","Good Herbs, Inc., BURDOCK, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0200-2015","Class II","Good Herbs, Inc., FEMALE REPRODUCTIVE HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0190-2015","Class II","Good Herbs, Inc., ESSENTIAL DAILY GREENS, powder, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0150-2015","Class II","Good Herbs, Inc., CELL SALTS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0109-2015","Class II","Good Herbs, Inc., ASHWAGANDHA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0217-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE GENTIAN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","GHAll lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0128-2015","Class II","Good Herbs, Inc., BLUE FLAG, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0177-2015","Class II","Good Herbs, Inc., DISC & VERTABRA HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0206-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE ASPEN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0204-2015","Class II","Good Herbs, Inc., FLAX, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0181-2015","Class II","Good Herbs, Inc., EH FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0161-2015","Class II","Good Herbs, Inc., CILANTRO, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0136-2015","Class II","Good Herbs, Inc., BOWEL SUPPORT 2, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0153-2015","Class II","Good Herbs, Inc., CHASTE TREE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0170-2015","Class II","Good Herbs, Inc., CRANESBILL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0183-2015","Class II","Good Herbs, Inc., ELEUTHERO, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0216-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE ELM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0151-2015","Class II","Good Herbs, Inc., CHAMOMILE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0158-2015","Class II","Good Herbs, Inc., CHINESE LICORICE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0115-2015","Class II","Good Herbs, Inc., BARBERRY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0167-2015","Class II","Good Herbs, Inc., CRAMP BARK, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0163-2015","Class II","Good Herbs, Inc., CIRCULATORY FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0198-2015","Class II","Good Herbs, Inc., FEMALE HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0157-2015","Class II","Good Herbs, Inc., CHINESE ASPARAGUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68420,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0110-2015","Class II","Good Herbs, Inc., ASIAN GINSENG, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All lots distributed on or after October 17, 2013. ",".","Approximately 1099 total units for all products","Products not manufactured under GMP's",3/25/2014,"03/25/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0322-2015","Class II","Good Herbs, Inc., KIDNEY & BLADDER SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0291-2015","Class II","Good Herbs, Inc., GRAVEL ROOT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0237-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE VINE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0311-2015","Class II","Good Herbs, Inc., J&B, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0332-2015","Class II","Good Herbs, Inc., LUNG SUPPORT 1, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0289-2015","Class II","Good Herbs, Inc., GOTU KOLA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0270-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & PINE, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0220-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE HOLLY, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0285-2015","Class II","Good Herbs, Inc., GINGER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0239-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE WATER VIOLET, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0288-2015","Class II","Good Herbs, Inc., GOLDENSEAL & ECHINACEA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works,","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0271-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & RED CHESTNUT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0321-2015","Class II","Good Herbs, Inc., KIDNEY & BLADDER FOUNDATION, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0279-2015","Class II","Good Herbs, Inc., FOCUS & LEARNING HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0305-2015","Class II","Good Herbs, Inc., HYPOTHALAMUS SUPPORT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0226-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE MUSTARD, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0316-2015","Class II","Good Herbs, Inc., KAVA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0256-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & WILD OAT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0327-2015","Class II","Good Herbs, Inc., LILY & THISTLE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0261-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & CLEMATIS, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0240-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE WHITE CHESTNUT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0241-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE WILD OAT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0277-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & WILD OAT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0300-2015","Class II","Good Herbs, Inc., HMC, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0287-2015","Class II","Good Herbs, Inc., GOLDENSEAL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0313-2015","Class II","Good Herbs, Inc., JOINT HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0282-2015","Class II","Good Herbs, Inc., GARLIC, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0243-2015","Class II"," Good Herbs, Inc., FLOWER ESSENCE WILLOW, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0308-2015","Class II","Good Herbs, Inc., IMMUNE SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0246-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & CHESTNUT BUD, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0245-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & CERATO, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0248-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & HORNBEAM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0303-2015","Class II","Good Herbs, Inc., HORSETAIL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0268-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & MUSTARD, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0301-2015","Class II","Good Herbs, Inc., HOLY BASIL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0318-2015","Class II","Good Herbs, Inc., KELP, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0249-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & IMPATIENS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0225-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE MIMULUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0267-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & MIMULUS, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0298-2015","Class II","Good Herbs, Inc., HEALTHY VEIN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0266-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & LARCH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0250-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & MIMULUS, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0275-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & WATER VIOLET, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0324-2015","Class II","Good Herbs, Inc., KUDZU, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0260-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & BEECH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0307-2015","Class II","Good Herbs, Inc., IMMUNE PLUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0296-2015","Class II","Good Herbs, Inc., HEALTHY BLOOD, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0294-2015","Class II","Good Herbs, Inc., HAWTHORN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0325-2015","Class II","Good Herbs, Inc., LEMON BALM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0232-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE ROCK WATER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0263-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & GORSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0304-2015","Class II","Good Herbs, Inc., HYDRANGEA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0252-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & STAR OF BETHLEHEM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0334-2015","Class II","Good Herbs, Inc., LVGL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0299-2015","Class II","Good Herbs, Inc., HEART SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0255-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & WHITE CHESTNUT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0264-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & HORNBEAM, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0227-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE OAK, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0230-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE RED CHESTNUT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0284-2015","Class II","Good Herbs, Inc., GENTIAN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0317-2015","Class II","Good Herbs, Inc., KAVA & ST. JOHN'S WORT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0295-2015","Class II","Good Herbs, Inc., HEAL ALL, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0292-2015","Class II","Good Herbs, Inc., GYMNEMA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0274-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & VERVAIN, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0244-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0323-2015","Class II","Good Herbs, Inc., KND, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0286-2015","Class II","Good Herbs, Inc., GINKGO, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0330-2015","Class II","Good Herbs, Inc., LIVER HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0247-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & GORSE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0328-2015","Class II","Good Herbs, Inc., LINDEN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0276-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & WHITE CHESTNUT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0272-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & ROCK ROSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0336-2015","Class II","Good Herbs, Inc., LYCIUM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0236-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE VERVAIN, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0229-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE PINE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0333-2015","Class II","Good Herbs, Inc., LUNG SUPPORT 2, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0280-2015","Class II","Good Herbs, Inc., FORSYTHIA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","6","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0222-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE HORNBEAM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0231-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE ROCK ROSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0224-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE LARCH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0254-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & WATER VIOLET, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0302-2015","Class II","Good Herbs, Inc., HORSE CHESTNUT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0251-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & ROCK WATER, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0312-2015","Class II","Good Herbs, Inc., JAPANESE HONEYSUCKLE & FORSYTHIA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0253-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & SWEET CHESTNUT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0233-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE SCLERANTHUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0331-2015","Class II","Good Herbs, Inc., LOBELIA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0235-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE SWEET CHESTNUT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0242-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE WILD ROSE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0293-2015","Class II","Good Herbs, Inc., HAIR, SKIN, & NAILS SUPPORT, 1, 4 & 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0238-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE WALNUT, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0320-2015","Class II","Good Herbs, Inc., KIDNEY & ADRENAL HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0269-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & OAK, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0278-2015","Class II","Good Herbs, Inc., FO-TI, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0310-2015","Class II","Good Herbs, Inc., IRISH MOSS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0265-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & IMPATIENS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0319-2015","Class II","Good Herbs, Inc., KIC & CAT'S CLAW, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0314-2015","Class II","Good Herbs, Inc., JUJUBE SEED, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0315-2015","Class II","Good Herbs, Inc., JUNIPER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0326-2015","Class II","Good Herbs, Inc., LICORICE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0297-2015","Class II","Good Herbs, Inc., HEALTHY DIGESTION, capsules, 1 & 4 oz bottles, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0329-2015","Class II","Good Herbs, Inc., LIVER & GALLBLADDER HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0283-2015","Class II","Good Herbs, Inc., GAS FORMULA, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0221-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE HONEYSUCKLE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0281-2015","Class II","Good Herbs, Inc., GALLBLADDER HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0290-2015","Class II","Good Herbs, Inc., GRAPE, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0228-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE OLIVE, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0234-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE STAR OF BETHLEHEM, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0223-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE IMPATIENS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0335-2015","Class II","Good Herbs, Inc., LVGL CAPSULES, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0259-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & ASPEN, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0306-2015","Class II","Good Herbs, Inc., HYSSOP, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0262-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & ELM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0258-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0219-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE HEATHER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0257-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R & WILD ROSE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0273-2015","Class II","Good Herbs, Inc., FLOWER ESSENCE-R PLUS & SWEET CHESTNUT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68421,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0309-2015","Class II","Good Herbs, Inc., INTESTINAL HEALTH, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 901 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0404-2015","Class II","Good Herbs, Inc., SARSAPARILLA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0346-2015","Class II","Good Herbs, Inc., MOOD SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0428-2015","Class II","Good Herbs, Inc., SUNFLOWER, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0379-2015","Class II","Good Herbs, Inc., PERFORMANCE PLUS, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0362-2015","Class II","Good Herbs, Inc., OLIVE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0398-2015","Class II","Good Herbs, Inc., RHODIOLA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0383-2015","Class II","Good Herbs, Inc., POKE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0382-2015","Class II","Good Herbs, Inc., PLEURISY ROOT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0422-2015","Class II","Good Herbs, Inc., STEVIA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0433-2015","Class II","Good Herbs, Inc., TURMERIC, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0369-2015","Class II","Good Herbs, Inc., PANCREAS SUPPORT 3, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0438-2015","Class II","Good Herbs, Inc., VEIN & JOINT SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0359-2015","Class II","Good Herbs, Inc., NEEM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0355-2015","Class II","Good Herbs, Inc., MUSCLE & NERVE HEALTH 2, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0367-2015","Class II","Good Herbs, Inc., PANCREAS SUPPORT 1, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0378-2015","Class II","Good Herbs, Inc., PEPPERMINT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0429-2015","Class II","Good Herbs, Inc., THYME, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0354-2015","Class II","Good Herbs, Inc., MUSCLE & NERVE HEALTH 1, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0417-2015","Class II","Good Herbs, Inc., SLEEP SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0448-2015","Class II","Good Herbs, Inc., WORMWOOD, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0351-2015","Class II","Good Herbs, Inc., MULLEIN, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0368-2015","Class II","Good Herbs, Inc., PANCREAS SUPPORT 2, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0376-2015","Class II","Good Herbs, Inc., PASSIONFLOWER, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0426-2015","Class II","Good Herbs, Inc., STONEROOT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0361-2015","Class II","Good Herbs, Inc., OATSTRAW, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0420-2015","Class II","Good Herbs, Inc., SPLEEN SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0352-2015","Class II","Good Herbs, Inc., MULTI-HERBAL, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0348-2015","Class II","Good Herbs, Inc., MOTHERWORT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0454-2015","Class II","Good Herbs, Inc., YUCCA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0449-2015","Class II","Good Herbs, Inc., YARROW, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0397-2015","Class II","Good Herbs, Inc., RESPIRATORY SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0339-2015","Class II","Good Herbs, Inc., MACA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0356-2015","Class II","Good Herbs, Inc., MUSCLE SUPPORT, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0401-2015","Class II","Good Herbs, Inc., ROSEMARY, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0357-2015","Class II","Good Herbs, Inc., MUSCULAR HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0451-2015","Class II","Good Herbs, Inc., YERBA SANTA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0366-2015","Class II","Good Herbs, Inc., OSHA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0412-2015","Class II","Good Herbs, Inc., SILVER PRIME, 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0406-2015","Class II","Good Herbs, Inc., SCHISANDRA, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0388-2015","Class II","Good Herbs, Inc., PROSTATE FOUNDATION, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0414-2015","Class II","Good Herbs, Inc., SKC, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0358-2015","Class II","Good Herbs, Inc., MYRRH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0380-2015","Class II","Good Herbs, Inc., PERIWINKLE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0347-2015","Class II","Good Herbs, Inc., MORINDA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0371-2015","Class II","Good Herbs, Inc., PARA FORMULA, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0338-2015","Class II","Good Herbs, Inc., LYMPHATIC HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0386-2015","Class II","Good Herbs, Inc., PRO VITALITY MAX, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0349-2015","Class II","Good Herbs, Inc., MPA, powder, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0364-2015","Class II","Good Herbs, Inc., OREGANO, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0395-2015","Class II","Good Herbs, Inc., REISHI, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0345-2015","Class II","Good Herbs, Inc., MILK THISTLE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0407-2015","Class II","Good Herbs, Inc., SHATAVARI, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0450-2015","Class II","Good Herbs, Inc., YELLOW DOCK, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0439-2015","Class II","Good Herbs, Inc., VH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0372-2015","Class II","Good Herbs, Inc., PARA FORMULA 1, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0437-2015","Class II","Good Herbs, Inc., VALERIAN, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0421-2015","Class II","Good Herbs, Inc., ST. JOHN'S WORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0444-2015","Class II","Good Herbs, Inc., WILD LETTUCE, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0435-2015","Class II","Good Herbs, Inc., USNEA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0440-2015","Class II","Good Herbs, Inc., WELLNESS FORMULA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0411-2015","Class II","Good Herbs, Inc., SICKLE-POD SENNA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0394-2015","Class II","Good Herbs, Inc., RED ROOT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0446-2015","Class II","Good Herbs, Inc., WOOD BETONY, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0341-2015","Class II","Good Herbs, Inc., MALE HORMONE SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0377-2015","Class II","Good Herbs, Inc., PAU D'ARCO, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0425-2015","Class II","Good Herbs, Inc., STOMACH SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0442-2015","Class II","Good Herbs, Inc., WHITE OAK, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0373-2015","Class II","Good Herbs, Inc., PARA FORMULA 2, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0396-2015","Class II","Good Herbs, Inc., RESPIRATORY PLUS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0343-2015","Class II","Good Herbs, Inc., MEADOWSWEET, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0390-2015","Class II","Good Herbs, Inc., PS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0427-2015","Class II","Good Herbs, Inc., SUMA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0360-2015","Class II","Good Herbs, Inc., NERVE SUPPORT, 8 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0344-2015","Class II","Good Herbs, Inc., MENTAL ALERTNESS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0365-2015","Class II","Good Herbs, Inc., OREGON GRAPE, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0453-2015","Class II","Good Herbs, Inc., YOHIMBE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0434-2015","Class II","Good Herbs, Inc., URINARY HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0410-2015","Class II","Good Herbs, Inc., SHIITAKE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0408-2015","Class II","Good Herbs, Inc., SHEEP SORREL, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0409-2015","Class II","Good Herbs, Inc., SHEPHERD'S PURSE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0389-2015","Class II","Good Herbs, Inc., PROSTATE SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0416-2015","Class II","Good Herbs, Inc., SKUNK CABBAGE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0418-2015","Class II","Good Herbs, Inc., SLIPPERY ELM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0405-2015","Class II","Good Herbs, Inc., SAW PALMETTO, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0415-2015","Class II","Good Herbs, Inc., SKULLCAP, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0340-2015","Class II","Good Herbs, Inc., MALE & FEMALE HORMONE HEALTH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0387-2015","Class II","Good Herbs, Inc., PRO VITALITY PLUS, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0363-2015","Class II","Good Herbs, Inc., OLIVE & OREGANO, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0370-2015","Class II","Good Herbs, Inc., PAPAYA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0431-2015","Class II","Good Herbs, Inc., TIENCHI GINSENG, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0402-2015","Class II","Good Herbs, Inc., ROYAL JELLY, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0393-2015","Class II","Good Herbs, Inc., RED CLOVER, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0445-2015","Class II","Good Herbs, Inc., WILD YAM, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0392-2015","Class II","Good Herbs, Inc., RASPBERRY, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0400-2015","Class II","Good Herbs, Inc., ROSE HIPS, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0391-2015","Class II","Good Herbs, Inc., PUMPKIN, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0452-2015","Class II","Good Herbs, Inc., YERBA SANTA FORMULA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0443-2015","Class II","Good Herbs, Inc., WHITE WILLOW, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0399-2015","Class II","Good Herbs, Inc., RICE, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0423-2015","Class II","Good Herbs, Inc., STILLINGIA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0337-2015","Class II","Good Herbs, Inc., LYMPH HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0413-2015","Class II","Good Herbs, Inc., SINUS HEALTH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0374-2015","Class II","Good Herbs, Inc., PARA FORMULA 3, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0384-2015","Class II","Good Herbs, Inc., PRICKLY ASH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0441-2015","Class II","Good Herbs, Inc., WELLNESS PLUS, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0424-2015","Class II","Good Herbs, Inc., STINGING NETTLE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0375-2015","Class II","Good Herbs, Inc., PARSLEY, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0385-2015","Class II","Good Herbs, Inc., PRO VITALITY, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0381-2015","Class II","Good Herbs, Inc., PLANTAIN, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0342-2015","Class II","Good Herbs, Inc., MARSHMALLOW, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0430-2015","Class II","Good Herbs, Inc., THYROID HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0403-2015","Class II","Good Herbs, Inc., SAGE, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0419-2015","Class II","Good Herbs, Inc., SPIRULINA, capsules, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0350-2015","Class II","Good Herbs, Inc., MPA SET, kit, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0447-2015","Class II","Good Herbs, Inc., WORKOUT SUPPORT, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0353-2015","Class II","Good Herbs, Inc., MUSCLE & JOINT HEALTH, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0436-2015","Class II","Good Herbs, Inc., UVA-URSI, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68422,"Ongoing","Good Herbs, Inc.","Troy","MI","US","Voluntary: Firm Initiated","Letter","National: AZ, CA, CT, FL, IN, ME, MI, MO, MS, NC, NH, NY, OH, OR, RI, TX, VA & WY International: None reported","F-0432-2015","Class II","Good Herbs, Inc., TRIPHALA, 1 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works","All Lots distributed on or after October 17, 2013",".","Approximately 1204 total units for all products2","Products not manufactured under GMP's",5/5/2014,"05/05/2014",11/5/2014,"11/05/2014"
"Food",68423,"Ongoing","Dot Foods Inc.","Mount Sterling","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide in the states WI, NC, FL, IL, TX, NC, CO, GA, and PA","F-2052-2014","Class II","Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg)","Lot Code: SIRA D 0224, UPC: 6 84476 03790 8",,"720 cases (4 plastic barrels per case), 2,880 plastic barrels","This voluntary recall has been initiated because Savor Brands Large Pitted Kalamata Olives may contain glass.",5/27/2014,"05/27/2014",7/9/2014,"07/09/2014"
"Devices",68424,"Ongoing","Pall Corporation","Port Washington","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.","Z-2038-2014","Class II","PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.","REF BB50T: Lots 326902, 402802, 405002; REF BB50T-BULK: Lots 228702, 229902, 328202",,"24,650 units domestically","Pall Corporation is recalling several lots of its Pall Breathing Circuit Filters due to a possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection. ",6/4/2014,"06/04/2014",7/16/2014,"07/16/2014"
"Devices",68426,"Ongoing","Kerr Corporation","Romulus","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.","Z-1788-2014","Class II","Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries. ","Part Number 29948, Lot Number 3-1294. Expires October 2016",,"2,030 units","Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.",5/29/2014,"05/29/2014",6/25/2014,"06/25/2014"
"Biologics",68427,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX; NY","B-0787-14","Class II","Red Blood Cells Leukocytes Reduced","W140913328204",".","1 unit","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",4/4/2014,"04/04/2014",7/23/2014,"07/23/2014"
"Biologics",68427,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX; NY","B-0788-14","Class II","Platelets Irradiated","W140913328204",".","1 unit","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",4/4/2014,"04/04/2014",7/23/2014,"07/23/2014"
"Biologics",68428,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","NJ; Switzerland","B-0790-14","Class III","Blood and Blood Products for Reprocessing","W051513131786",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/21/2014,"04/21/2014",7/23/2014,"07/23/2014"
"Biologics",68428,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Other","NJ; Switzerland","B-0789-14","Class II","Red Blood Cells Leukocytes Reduced","W051513131786",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",4/21/2014,"04/21/2014",7/23/2014,"07/23/2014"
"Biologics",68429,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX; NY","B-0792-14","Class II","Platelets Irradiated","W140914119101",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/3/2014,"03/03/2014",7/23/2014,"07/23/2014"
"Biologics",68429,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","FAX","TX; NY","B-0791-14","Class II","Red Blood Cells Leukocytes Reduced","W140914119101",".","1 unit","Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.",3/3/2014,"03/03/2014",7/23/2014,"07/23/2014"
"Devices",68430,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam","Z-1807-2014","Class II","iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.","Software Versions 2.0.0, 2.0.1 and 2.0.2",,"224","A bug in the software prevents the iGUIDE software from logging off.",5/29/2014,"05/29/2014",6/25/2014,"06/25/2014"
"Devices",68431,"Ongoing","Mckesson Medical Immaging","Richmond","BC","CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.","Z-1728-2014","Class II","Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. ","HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0",".","659","Firm received a complaint that an unreported study performed that day could not be opened from the archive.",5/29/2014,"05/29/2014",6/18/2014,"06/18/2014"
"Food",68432,"Completed","Oceans Cuisine, LTD.","Farmingdale","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY and TX","F-2044-2014","Class I","Oceans Cuisine brand CRAB STUFFING WITH REAL CRABMEAT, NET WEIGHT 3 LBS. (48 oz.) UPC 7 30692 00031 5, PRODUCT OF USA --- PACKED BY: OCEANS CUISINE LTD. FARMINGDALE, NY 11735 --- The product is packaged in plastic tub containers, 2 x 3 lb. containers per case ","051516 (Use By 05/15/2016) ",".","96 cases (2 x 3 lb. tubs per case)","The crab stuffing is potentially contaminated with Listeria monocytogenes from the raw material (frozen minced crab meat).",5/23/2014,"05/23/2014",7/2/2014,"07/02/2014"
"Food",68434,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.","F-2394-2014","Class I","ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548","All lot codes ",".","9,650 bags","HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Food",68434,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.","F-2396-2014","Class I","ORGANIC TRADITIONS ULTIMATE SUPERFOOD TRAILMIX; NET WT. 3.5 oz UPC 854260010701 ","All lots ending in 003-13 to 005-14.",".","Unknown","HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Food",68434,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.","F-2392-2014","Class I","ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546","All codes starting with BIO13 and ending with 269 up to and including 365; All codes starting with BIO14 and ending with 001 up to and including 156",".","1,818 packages","HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella Contamination.",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Food",68434,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.","F-2395-2014","Class I","ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb. ","For 8 oz. & 16 oz., all codes starting with ASCBO13. For 50 lb., all lot codes.",".","Unknown","HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Food",68434,"Ongoing","Health Matters America Inc.","Cheektowaga","NY","US","Voluntary: Firm Initiated","Letter","Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Tennessee, Virginia and Wisconsin.","F-2393-2014","Class I","ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item number AHM547 and item number BLK622","For 8 oz. & 16 oz., all codes starting with BIO13 and ending with 269 up to and including 365 and all codes starting with BIO14 and ending with 001 up to and including 156. For bulk 50 lb., all lot codes",".","17,907 packages","HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Biologics",68436,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","HI","B-0823-14","Class II","Red Blood Cells Leukocytes Reduced","W088414514645",,"1 unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ",5/14/2014,"05/14/2014",8/6/2014,"08/06/2014"
"Devices",68437,"Ongoing","Siemens Healthcare Diagnostics Inc","Norwood","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan","Z-2079-2014","Class II","RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813 ","Serial Numbers: 2334500011 through 2412705915",,"20,507 cartridges","RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)",5/23/2014,"05/23/2014",7/30/2014,"07/30/2014"
"Food",68438,"Ongoing","Mt. Olive Pickle Company Inc","Mount Olive","NC","US","Voluntary: Firm Initiated","E-Mail","FL and NY.","F-2184-2014","Class III","Mt. Olive, PepperPAK Jalapeno Slices, 4-3.7fl oz cups, Net fl oz 14.8 (438 ml), Mt Olive Pickled Co., Inc., Corner of Cucumber and Vine, P.O. Box 609, Mt. Olive, NC 28365-0609. ","Case UPC = 0930010016 Jalapeno PepperPak code date 1FI1114A and 1FI1114B; Sleeve UPC = 0930010015 Hamburger Dill Chips code date 1FI1114A and 1FI1114B ",".","840 cases/6-4-pack units per case","Undeclared Non-Allergen: Sulfites.",5/30/2014,"05/30/2014",7/23/2014,"07/23/2014"
"Devices",68440,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.","Z-2082-2014","Class II","RECLAIM TAPER PROTECTOR SLEEVE To ensure the locking taper surface of the Distal Stem is protected during proximal preparation.","Product #297500110; Lot #: 126559, 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.",,"814 units","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.",6/3/2014,"06/03/2014",7/30/2014,"07/30/2014"
"Devices",68440,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.","Z-2084-2014","Class II","RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.","Product # 197614140; Lot # 107310, 107311, 107313, 107314, 107315, 136244, 136247, 136251, 136252, 136256, 136257, 136262, 136268, 136271, 136276, 136286, 196221, 196222, 196225, 225871, 225872, 225873, 228185, 228187, 228188, 235886, 235887, 240634, 240635, 246147, 246179, 254812, 254814, 260373, 260374, 264629, 264630, 281910, 281911, 281912, 281915, 288356, 288359, 288361, 288363, 442821, 451586, 452549, 453409, 455523, 455524, 456513, 456514, 456515, 457650 & 457651. Product # 197614190; Lot # 290958, 290959, 290960, 310940, 310941, 310942, 310947, 310948, 327468, 327469, 327475, 327477, 327478, 327480, 365792, 365793, 365794, 365795, 365796 & 365797. Product # 197615140; Lot # 107320, 107323, 107325, 107328, 107330, 107331, 136369, 136370, 136371, 136372, 136373, 136374, 136375, 136376, 136377, 136377A, 136378, 136380, 136381, 196227, 196228, 225874, 225875, 225876, 228196, 228197, 228198, 231202, 235888, 235890, 239254, 239255, 251499, 251500, 251502, 251504, 254817, 254818, 260375, 260377, 264633, 264638, 383749, 393633, 405087, 420828, 421141, 432535, 442823, 451846, 457652, 465564, 465565, 480737, 482786, 491057, 497256, 503931, 518456, 523799 & 526931. Product # 197615190; Lot # 290964, 290966, 290967, 290969, 311800, 311802, 311804, 311806, 311808, 323743, 323744, 323746, 323748, 323750, 323754, 387702, 387703, 387704, 387705 & 387706. Product # 197616140; Lot # 136419, 136420, 136454, 136455, 136456, 136457, 136459, 136460, 136467, 136478, 136480, 136481, 225877, 225878, 225879, 225880, 225881, 228126, 228127, 228128, 228129, 228130, 239256, 239257, 240636, 246148, 246149, 246180, 254822, 254825, 260378, 260379, 264639, 264640, 264641, 281918, 281922, 281923, 281924, 288366, 288367, 288368, 288370, 288374, 405088, 405089, 415495, 418748, 421512, 422731, 461416, 461417, 461418, 461419, 461420, 461421, 466522, 466523, 466524, 466525, 472003, 475333, 482787, 493055, 499964, 503926, 516019, 518462, 520979, 523800, 526933 & FH1PH1. Product # 197616190; Lot # 290971, 290972, 290975, 290977, 314437, 31443",,"3,623","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.",6/3/2014,"06/03/2014",7/30/2014,"07/30/2014"
"Devices",68440,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.","Z-2083-2014","Class II","RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.","Product # 197714190; Lot # 107342, 107343, 107346, 107347, 138357, 138358, 138359, 138360, 138361, 138362, 138363, 163354, 163356, 163357, 190780, 190783, 190784, 211757, 211758, 225886, 225887, 228150, 228153, 231204, 235931, 235932, 235935, 246196, 246197, 251519, 251520, 254838, 254839, 264816, 264817, 282507, 282509, 282511, 282512, 288712, 288713, 288714, 288715, 288716 & 288717. Product # 197715190; Lot # 107603, 107605, 107607, 107610, 107612, 138364, 138365, 138366, 138367, 138368, 138369, 138370, 138373, 138374, 163358, 211759, 211760, 211761, 225888, 225889, 228160, 228162, 228164, 228165, 228166, 235939, 235941, 239345, 254840, 254842, 260398, 260401, 264818, 264819, 282513, 282514, 282516, 288718, 288719, 288720, 288721, 288722, 288723 & 288725. Product # 197716190; Lot # 136503, 136515, 136517, 136518, 136519, 136521, 136522, 136524, 136525, 136535, 190767, 190769, 190772, 190775, 190776, 196006, 196007, 196008, 196009, 226259, 226260, 226261, 228211, 228212, 228214, 231210, 235942, 235944, 239348, 246198, 246199, 246200, 260404, 260406, 264820, 264821, 264822, 282517, 282518, 282519, 288727, 288729, 288731, 288734 & 288736. Product # 197716240; Lot # 107616, 107618, 107620, 107623, 150282, 150286, 150291, 150292, 151020, 151022, 151031, 151032, 151051, 196002, 196004, 196005, 211768, 211769, 226262, 226263, 231181, 231182, 231183, 231184, 231186, 231187, 231189, 239350, 246201, 246202, 260407, 260408, 264823, 264824, 282520, 282521, 282522 & 282524. Product # 197717190; Lot # 107635, 107639, 107641, 107642, 107646, 150312, 150313, 150314, 150315, 150317, 150318, 151060, 151061, 151065, 151066, 151068, 152323, 152324, 152325, 152328, 152330, 152332, 152333, 231205, 231211, 239352, 239355, 239359, 246203, 246204, 260409, 260410, 264825, 264826, 264828, 316404, 316405, 316406, 316408, 372515, 415503, 422253, 428484, 451588, 452551, 452552, 453414, 453415, 454332, 455528, 493028, 493029, 493030 & 499967. Product # 197717240; Lot # 110419, 110423, 110424, 110425, 110426, 152336, 152337, 152338, 152740",,"10,467 units","DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.",6/3/2014,"06/03/2014",7/30/2014,"07/30/2014"
"Drugs",68441,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands","D-1430-2014","Class II","Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56","Lot #: F47008, Exp. 7/2015 ",,"8,472 Bottles","Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage. ",5/29/2014,"05/29/2014",7/16/2014,"07/16/2014"
"Devices",68442,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Bermuda.","Z-2087-2014","Class II","Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.","part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147",,"180","The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.",5/29/2014,"05/29/2014",7/30/2014,"07/30/2014"
"Devices",68443,"Ongoing","Childrens Medical Ventures","Monroeville","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the country of Canada.","Z-2192-2014","Class I","Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.","All lots of models: 92025-A, 92025-B, 92025-C, 91033-2",,"332,649","The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.",5/28/2014,"05/28/2014",8/27/2014,"08/27/2014"
"Devices",68445,"Ongoing","Small Bone Innovations","Morrisville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.","Z-2127-2014","Class II","Small Bone Innovations 3.0/4.0mm AutoFIX'' Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX'' cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.","All lots",,"506","Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX'' Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.",5/19/2014,"05/19/2014",8/6/2014,"08/06/2014"
"Food",68446,"Ongoing","Brunkow Cheese of Wisconsin, Inc.","Darlington","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, MN","F-2059-2014","Class III","Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion."," Lot numbers: 112014 010114 010414 042914 060314 080314 090514 100514 111214 ",,"18,800 pounds.","Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom Cheese because the product is mislabeled. The product contains other type of mushroom instead of Morel Mushrooms as listed on the label.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Devices",68447,"Ongoing","Zynex Medical, Inc.","Lone Tree","CO","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1874-2014","Class II","IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.","Serial No: 2483901,2484006,2484014,2484036,2484007,2484018,2484048,2484090,2484041,2483985,2484079,2484077,2483964,2789203,2484071,2484138,2484109,2484070,2483950,2484161,2483965,2484172,2484004,2484164,2484183,2484196,2484115,2484343,2484228,2484267,2484284,2484193,2484336,2484272,2484238,2484409,2483929,2484441,2484399,2484318,2484478,2484422,2484491,2484402,2484415,2484425,2484204,2484300,2484458,2484528,2484567,2484464,2484557,2484519,2484593,2484602,2484645,2484246,2484608,2484714,2484541,2484539,2484571,2484564,2484373,2484494,2484507,2484420,2484393,2484219,2484582,2484605,2484307,2484268,2484626,2484396,2484681,2484659,2484610,2484720,2484653,2484662,2484727,2484656,2484531,2780167,2783057,2784884,2484770,2484798,2484879,2784905,2784918,2784908,2784939,2784974,2784980,2784901,2784919,2784935,2785070,2784969,2784971,2784943,2784944,2785155,2785127,2785170,2785165,2785200,2484869,2785103,2785205,2483935,2484442,2785102,2785107,2785323,2785352,2785163,2484778,2785062,2785156,2785176,2785213,2785236,2785243,2785256,2785332,2785438,2784890,2785034,2785039,2785110,2785353,2785427,2785435,2484628,2785263,2785282,2785291,2785476,2785418,2785121,2785321,2785429,2785470,2785024,2785030,2785214,2785274,2785369,2785371,2785503,2785661,2785264,2785303,2785500,2787841,2785174,2785484,2785488,2785564,2785490,2785524,2785535,2785556,2484838,2785004,2785232,2785474,2785610,2785148,2785152,2785308,2785608,2484733,2484821,2484862,2785480,2785414,2785645,2785479,2785673,2785179,2785680,2785022,2785252,2785433,2785586,2785594,2785687,2785689,2484365,2785130,2785322,2785570,2785580,2785685,2785706,2785548,2785450,2785829,2785830,2785079,2785341,2785572,2785759,2785762,2785765,2785776,2483944,2484570,2785775,2785822,2484369,2785378,2785485,2785798,2785656,2785915,2785858,2484866,2785113,2785234,2785365,2785886,2785986,2784904,2785571,2785871,2484800,2785944,2785951,2786201,2484663,2484741,2785658,2784997,2785150,2785801,2785930,2785957,2785972,2785988,2785261,2785933,2785994,2786001,2786009,2786014,2785129,2785217,2785233,27",".","1,461","Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.",1/25/2009,"01/25/2009",7/2/2014,"07/02/2014"
"Food",68448,"Ongoing","Baptista's Bakery, Inc","Franklin","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, IL, IN, MD, MN, NJ, PA, UT, WA","F-2053-2014","Class I","Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC 41498-20371","Lot Code 11914 / Best ByDate 10-26-14, and Lot Code 14314 / Best By Date 11-24-14",,"28,916 cases","A seasoning supplier is recalling its rosemary and olive oil seasoning blend, which potentially may be contaminated with Salmonella. ",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68449,"Ongoing","Estee Lauder Inc","New York","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1452-2014","Class III","DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France","All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000",,"3,791 tubes","Stability Data Does Not Support Expiry",6/6/2014,"06/06/2014",7/30/2014,"07/30/2014"
"Biologics",68450,"Terminated","Southern California Permanente Medical Group","San Diego","CA","US","Voluntary: Firm Initiated","FAX","CA","B-0821-14","Class II","Platelets Pheresis Leukocytes Reduced","W072114000066",," 1 unit","Blood products, which did not meet the acceptable product specifications for release, were distributed.",4/10/2014,"04/10/2014",8/6/2014,"08/06/2014"
"Biologics",68451,"Terminated","Minnesota Lions Eye Bank, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Minnesota; Kentucky","B-0735-14","Class III","Cornea","140304ODC; 140304OSC; ",,"2 corneas","Human Corneas, processed with a corneal preservation media that was not verified to meet specification for use, were distributed. ",5/20/2014,"05/20/2014",6/25/2014,"06/25/2014"
"Biologics",68452,"Terminated","American National Red Cross SW Region - HT","Tulsa","OK","US","Voluntary: Firm Initiated","Telephone","Oklahoma","B-0795-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W200214020078; ",,"1 unit","Blood product, which was labeled with an incorrect expiration date, was distributed.",4/4/2014,"04/04/2014",7/30/2014,"07/30/2014"
"Drugs",68453,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1386-2014","Class II","Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15. ","Lot #: 3100135, Expiry: 05/2014",,"6913 packages","Subpotent Drug.",5/16/2014,"05/16/2014",6/25/2014,"06/25/2014"
"Devices",68454,"Ongoing","Nellcor Puritan Bennett Inc. (dba Covidien LP)","Boulder","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.","Z-1809-2014","Class II","Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities","Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L,",,"7371","In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.",6/4/2014,"06/04/2014",6/25/2014,"06/25/2014"
"Drugs",68455,"Ongoing","Nature's Universe","Nashville","TN","US","Voluntary: Firm Initiated","Press Release","U.S. Nationwide and Canada","D-1594-2014","Class I","THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.","None Available. All lots distributed prior to 02/06/2014 are being recalled.",,"Unknown","Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.",4/9/2014,"04/09/2014",9/24/2014,"09/24/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1931-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1932-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 2, includes the following Lot numbers: 37214650 61417415 61417416 61442278 61459938 61459939 61459940 61488069 61497510 61497511 61518148 61518149 61538023 61543972 61543973 61543974 61567335 61592049 61592050 61627189 61627190 61672554 61672555 61672556 61672557 61672558 61682128 61682129 61721665 61721666 61721667 61774118 61774119 61774120 61827109 61827110 61827111 61863080 61863081 61863083 61863084 61863085 61912434 61915370 61915371 61979021 61979022 61979023 62016175 62020276 62041296 62060610 62069533 62091728 62141255 62141256 62141257 62155305 62155306 62155307 62177111 62214660 62214661 62214662 62214663 62214664 62251565 62251566 62271420 62298567 62315723 62319301 62326315 62337922 62337923 62345561 62345562 62377649 62383365 62411732 62411733 62411735 62411736 62411737 62586465 62586467 62610913 62610914 62640980 62646141 62646142 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1934-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208 61488209 61488210 61488211 61518162 61518163 61518164 61526401 61538046 61543975 61543976 61558363 61567340 61567341 61567342 61567343 61592088 61592089 61627203 61627204 61627205 61627206 61643933 61643934 61658878 61658879 61658880 61658881 61658882 61678232 61678233 61682153 61682154 61682155 61692238 61692240 61721671 61721672 61721673 61774143 61774144 61774145 61774146 61774147 61774148 61827117 61827118 61827119 61863112 61863113 61863114 61863115 61863116 61912438 61914866 61914867 61914868 61914869 61934684 61934685 61934686 61934687 61958859 61958860 61958861 61979028 61979029 61979030 62016156 62016157 62016158 62022554 62022555 62029928 62029929 62029930 62041303 62041304 62060613 62060614 62064935 62064936 62077849 62077850 62077851 62143194 62143195 62143196 62143197 62143604 62143605 62143606 62143607 62168183 62168184 62193304 62193305 62193306 62200285 62200286 62214670 62214671 62214672 62227418 62227419 62261960 62261961 62261962 62261963 62261964 62261966 62315724 62319295 62319296 62319297 62326311 62326312 62332564 62332565 62345558 62345559 62358488 62358490 62363649 62377650 62383363 62383364 62390066 62390067 62390068 62454576 62454577 62454578 62465724 62465725 62465726 62473212 62473213 62473215 62528582 62528583 62586506 62586507 62586509 62586510 62586518 62610915 62610916 62640976 62640977 62640978 62640979 62646146 62646147 62649656 62649658 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1939-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1936-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 5, includes the following Lot numbers: 370318 37214652 61424997 61442318 61442319 61442320 61451223 61454955 61454956 61459968 61459969 61459970 61475130 61475131 61475132 61488234 61518182 61518183 61518184 61526402 61543977 61567344 61567345 61592091 61592092 61627258 61627260 61643935 61643936 61658884 61658885 61658886 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 62377651 62423843 62455679 62460240 62460242 62460243 62525441 62525442 62586581 62586582 62610910 62610911 62610912 62640982 62646149 62646150 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1937-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1935-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1938-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.","Size 7, includes the following Lot Numbers: 370320 37214653 61424998 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62383359 62383362 62401016 62401017 62602812 62602813 62640983 ",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Devices",68457,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.","Z-1933-2014","Class II","NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis."," Size 3, includes the following Lot numbers: 370316 37214039 61414610 61414611 61442294 61442295 61442296 61442297 61450963 61450964 61450965 61454951 61454952 61454953 61459941 61459942 61475123 61475124 61488064 61488065 61488066 61488067 61488068 61497512 61497513 61507223 61507224 61518151 61518153 61518154 61526398 61526399 61558358 61558359 61558360 61558361 61567336 61567337 61567338 61567339 61592084 61592085 61592086 61592087 61627191 61627192 61627193 61627194 61627195 61627196 61627197 61627198 61627199 61627201 61627202 61643928 61643929 61643930 61643931 61643932 61658872 61658873 61658874 61658875 61658876 61658877 61672561 61672562 61672563 61672564 61672565 61672566 61721668 61721669 61721670 61774134 61774135 61774136 61774137 61774140 61774141 61774142 61827112 61827113 61827114 61827115 61827116 61863088 61863090 61863091 61863093 61863094 61898777 61898778 61898779 61898780 61898781 61912437 61914863 61914864 61914865 61934678 61934679 61934680 61934681 61934682 61958855 61958856 61958857 61958858 61979024 61979025 61979026 61979027 61993771 61993773 61993774 61993775 61993776 62022557 62029925 62029926 62029927 62037892 62041300 62041301 62041302 62060611 62060612 62064931 62064932 62064933 62069538 62077846 62077847 62077848 62080358 62080359 62080360 62143198 62143199 62143201 62143601 62143602 62143603 62168181 62168182 62193299 62193301 62193302 62193303 62200277 62200278 62200279 62214665 62214666 62214667 62214668 62214669 62227415 62227416 62227417 62271422 62271423 62271424 62271425 62271426 62284606 62284607 62284608 62298568 62298569 62319299 62326502 62326503 62332546 62332547 62335852 62335864 62345560 62352633 62352634 62357204 62357205 62377654 62377655 62383356 62383357 62389590 62389591 62389592 62423838 62423839 62423840 62454586 62454587 62460233 62460234 62462894 62462895 62",,"41180 total","Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. ",5/19/2014,"05/19/2014",7/9/2014,"07/09/2014"
"Food",68458,"Ongoing","Ocean Spray Cranberries Inc.","Lakeville","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, North Dakota, New York, North Carolina, Ohio, Oklahoma, Texas, Virginia and Wisconsin","F-2067-2014","Class I","Ocean Spray Greek Yogurt Covered Craisins Dried Cranberries , 8 oz Resealable Pouch UPC: #23719 ","Best By Dates: Feb 10, 2015 and Feb 11, 2015 ",,"12,585 cases (12/case)","Product contains undeclared peanuts",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Devices",68459,"Ongoing","Nihon Kohden America Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.","Z-1979-2014","Class II","CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.","Model Number: CNS-6201 Software Version 02-26 only. Serial Numbers: 00485, 00488, 00489, 00490, 00491, 00361, 00429, 00430, 00432, 00436, 00443, 00447, 00478, 00486, 00546, 00564, 00573, 00574, 00575, 00576, 00592, 00626, 00638, 00643, 00651, 00674, 00675, 00677, 00678, 00679, 00687.",,"430","Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.",6/3/2014,"06/03/2014",7/9/2014,"07/09/2014"
"Biologics",68460,"Terminated","American National Red Cross SW Region - HT","Tulsa","OK","US","Voluntary: Firm Initiated","Letter","California","B-0714-14","Class III","Blood and Blood Products for Reprocessing","W204913020188; ",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.",5/12/2014,"05/12/2014",7/9/2014,"07/09/2014"
"Biologics",68461,"Terminated","Central Blood Bank","Pittsburgh","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0779-14","Class II","Red Blood Cells","W085114000397; ",,"1 unit","Blood product, which failed the residual white blood cell count and labeled as leukoreduced, was distributed. ",4/10/2014,"04/10/2014",7/9/2014,"07/09/2014"
"Biologics",68462,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0780-14","Class II","Red Blood Cells Leukocytes Reduced","W039414106570; ",,"one unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Biologics",68463,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0781-14","Class II","Red Blood Cells Leukocytes Reduced","W039414106569; ",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Food",68464,"Ongoing","Maui Soda & Ice Works Ltd/dba Roselani Ice Cream","Wailuku","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MAUI, HI only","F-2058-2014","Class II","Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI","Lot/Expiration date: 05/08/2015",,"2045 cartons - 1.75 QT each ","Complaint received of a carton of Roselani Tropics Kona Mud Pie Ice Cream that was filled with chocolate Macadamia Nut Ice Cream.",6/2/2014,"06/02/2014",7/9/2014,"07/09/2014"
"Food",68465,"Ongoing","Rite Aid HDQTRS. Corp.","Camp Hill","PA","US","Voluntary: Firm Initiated","Telephone","CA Rite Aid stores","F-2068-2014","Class I","waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327 ","Expiration Date: October 28 2015 Lot #24273 ",,"560 pints","Pistachio flavored ice cream was inadvertently packed into 16 oz. (Pint) containers labeled as Thrifty Ice Cream Mint 'N' Chip. Ingredient statement does not declare pistachio. ",6/3/2014,"06/03/2014",7/9/2014,"07/09/2014"
"Food",68467,"Ongoing","National Vitamin Co Inc","Casa Grande","AZ","US","Voluntary: Firm Initiated","Letter","Nationwide in US","F-2061-2014","Class II","Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5","Lot No. 3KB01 and 3LB72",,"13,240 units","National Vitamin is recalling Nature's Blend Ferrous Gluconate Tablets because they are mislabeled on the front panel with 65 mg of elemental iron. The side panel and the tablets inside the bottle have the correct label with 36mg of elemental iron per tablet.",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Devices",68468,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.","Z-2041-2014","Class III","BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.","Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09",".","18.210","A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct. ",5/21/2014,"05/21/2014",7/23/2014,"07/23/2014"
"Devices",68469,"Ongoing","Alere San Diego, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide and the countries of Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.","Z-1928-2014","Class III","Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) as an aid in the assessment of severity of congestive heart failure for the risk stratification of patients with acute coronary syndromes for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.","Lot #328163",".","3,121 kits","Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.",5/30/2014,"05/30/2014",7/2/2014,"07/02/2014"
"Devices",68470,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.","Z-2122-2014","Class II","InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.","Model 2130 T01168 T01723 T01331 T02213 T02554 T01544 T01167 T01722 T01330 T02212 T02553 T01609 T01166 T01721 T01329 T02211 T02552 T01608 T01165 T01310 T01328 T02210 T02551 T01543 T01164 T02089 T01327 T02209 T02550 T02515 T01163 T01967 T01326 T02208 T02549 T02514 T01162 T01966 T01325 T02207 T02173 T02513 T01161 T01965 T01324 T02206 T02172 T01613 T01160 T01964 T01323 T02205 T02171 T01612 T02644 T01963 T01322 T02204 T02170 T01611 T02068 T01962 T01321 T02203 T02169 T01610 T02067 T01961 T01699 T02202 T02168 T02174 T02066 T01960 T01698 T02201 T02167 T02180 T02512 T01959 T01697 T02200 T02166 T02179 T02511 T01958 T01696 T02199 T01931 T02178 T02510 T01957 T01695 T02198 T01930 T02177 T02509 T01956 T01665 T02197 T01929 T02176 T02508 T01955 T01664 T02196 T01928 T02175 T02507 T01954 T01663 T02152 T01927 T01572 T02506 T01953 T01662 T01369 T01926 T01548 T01388 T01952 T01661 T01368 T01925 T01547 T01387 T01951 T02237 T01377 T01924 T01526 T01386 T01950 T02236 T01376 T01923 T01525 T01385 T01949 T02235 T01375 T01922 T02660 T01384 T01948 T02234 T01374 T01921 T02659 T02077 T02239 T02233 T01373 T01920 T02090 T02076 T02256 T02232 T01372 T01919 T02088 T02075 T02255 T02231 T01371 T01918 T01971 T01720 T02087 T02230 T01370 T01917 T01970 T01719 T02086 T02229 T01689 T01916 T01933 T01718 T01348 T02228 T01688 T01915 T01419 T02065 T01347 T02227 T01687 T01914 T01418 T02064 T01346 T02226 T01686 T01913 T01417 T02063 T01345 T02225 T01685 T01912 T01416 T02062 T01344 T02224 T01684 T01911 T01415 T02061 T01343 T02223 T01683 T01910 T01414 T02060 T01342 T02222 T01682 T01909 T01413 T02059 T01341 T02221 T02564 T01908 T01412 T02058 T01340 T02220 T02563 T01907 T01411 T02016 T01339 T02219 T02090 T01906 T01410 T02015 T01338 T02218 T02088 T01905 T01409 T02014 T01337 T02217 T01555 T01551 T01408 T02013 T01336 T02216 T01554 T01550 T01407 T02012 T01335 T02215 T01553 T01546 T01406 T02011 T01332 T02214 T01552 T01545 T01405 T01401 T02566 T02565 T01404 Model 2131 U04413 U03329 U08829 U51367 U06561 U01013 U04412 U03328 U03872 U51366 U06560 U01012 U04411 U50318 U03871 "," U02999 U05824 U08826 U06979 U01139 U07541 U02998 U05647 U08825 U06978 U03299 U07540 U02997 U05521 U08824 U06977 U08401 U07539 U02996 U05452 U08823 U06976 U08400 U07538 U02995 U04770 U08822 U06975 U08399 U07537 U02994 U08846 U08821 U06974 U08398 U07536 U02993 U08845 U08820 U06973 U08397 U07535 U02252 U06783 U08819 U06972 U08396 U50491 U51149 U51564 U08818 U06971 U08395 U50490 U51148 U51563 U03067 U06970 U08390 U50489 U51147 U51562 U03066 U06969 U01504 U50488 U51146 U51561 U03065 U06968 U50376 U50487 U51145 U51560 U03064 U06009 U50375 U50486 U51144 U51559 U03063 U06008 U50374 U50485 U51143 U51558 U02414 U06007 U50373 U50484 U51142 U51557 U02413 U06006 U50372 U50483 U51141 U51556 U02412 U06005 U50371 U50482 U51140 U51555 U02383 U06004 U50370 U50481 U51139 U51554 U02382 U06003 U50369 U04683 U51138 U51553 U02381 U06002 U50368 U51274 U51137 U51304 U02380 U06001 U50367 U51273 U51136 U51303 U02379 U06000 U50366 U51223 U51135 U51302 U02378 U05999 U50365 U51222 U51134 U51301 U02377 U05998 U50364 U51221 U51133 U51300 U02376 U05997 U50363 U51220 U51132 U51299 U02375 U05996 U50362 U51219 U51131 U51298 U02374 U05995 U50361 U51218 U51130 U51297 U02373 U05994 U50360 U51217 U51129 U51296 U02372 U05993 U50359 U51216 U51128 U51295 U02371 U05992 U50358 U51215 U51127 U51294 U02370 U05991 U50357 U51214 U51126 U08892 U02369 U05990 U50356 U51213 U51125 U06822 U02368 U05989 U50355 U51212 U51124 U04140 U02367 U05988 U50354 U51211 U51123 U04139 U02366 U05987 U50353 U51210 U51122 U08891 U50953 U05986 U50352 U51209 U51121 U06821 U05097 U05985 U50351 U51201 U51120 U51101 U05096 U05984 U50350 U51200 U51119 U51100 U05095 U05983 U50349 U51199 U51118 U05012 U05094 U05982 U50348 U51198 U04486 U05011 U05093 U50206 U01138 U51197 U03260 U01867 U05092 U50205 U01137 U51196 U08415 U01866 U05091 U50204 U01136 U51195 U08394 U01865 U05090 U50203 U01135 U51194 U08393 U01864 U05089 U06828 U01134 U51193 U08392 U06162 U05088 U06827 U01133 U50893 U08391 U06161 U05087 U06826 U01132 U50892 U06776 U06160 U05086 U06825 U01131 U50891 U06775 U06159 U02254 U06824 ","11,632 units","Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affected by having a reduced holding force",6/4/2014,"06/04/2014",8/6/2014,"08/06/2014"
"Food",68471,"Ongoing","Olde Thompson, Inc.","Oxnard","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US: UT, CA , AZ, NJ, MD, FL, GA, IL, TX Worldwide to: Canada","F-2077-2014","Class I","Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998. Packaging includes a PET bottle. The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and back) information is superimposed over an antique map in various shades of brown.","Lot #: OT 065099, OT 065169, OT 065254, OT 065255, OT 065256, and OT 065284.",,"103,060 units","Olde Thompson is recalling Kirkland Signature Coarse Ground Malabar Black Pepper because it may be contaminated with Salmonella.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1968-2014","Class II","Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 550986",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1966-2014","Class II","Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 550866",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1975-2014","Class II","Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 551997.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1970-2014","Class II","Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 551182",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1969-2014","Class II","Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System","Part number 551027",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1973-2014","Class II","Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System","Part number 551992.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1971-2014","Class II","Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 551184 - US Manual; Part number 550965 - OUs manuals.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1964-2014","Class II","System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part numbers 550120 for standard; 550516 for S system and 550650 for Si System.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1974-2014","Class II","Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 551993.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1967-2014","Class II","Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 550973",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1965-2014","Class II","Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.","Part number 550675",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Devices",68472,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.","Z-1972-2014","Class II","IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System","Part number 551979 - da Vinci S, Si and SI-e Part number 551980 - da Vinci Standard.",,"All distributed prior to June 2014","Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Biologics",68473,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; California","B-0783-14","Class II","Red Blood Cells Leukocytes Reduced","W115913271239; W115912235161; ",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Biologics",68473,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","E-Mail","Austria; California","B-0782-14","Class II","Blood and Blood Products for Reprocessing","W115913271239; W115912235161; ",,"2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD) were distributed.",5/21/2014,"05/21/2014",7/9/2014,"07/09/2014"
"Biologics",68474,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0816-14","Class II","Red Blood Cells Leukocytes Reduced","W036813221954; ",".","1","Blood product, incorrectly determined to be negative for the Jk(a) antigen, was distributed.",4/21/2014,"04/21/2014",8/13/2014,"08/13/2014"
"Biologics",68475,"Terminated","DCI Biologicals LLC","Farmington","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0818-14","Class III","Source Plasma","FD0841959; ",".","1 Unit","Blood product, collected from a donor who had no responses to medical history questions documented, was distributed.",5/9/2014,"05/09/2014",8/13/2014,"08/13/2014"
"Biologics",68476,"Terminated","DCI Biologicals, LLC","Beaumont","TX","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0817-14","Class II","Source Plasma","NG0327471; NG0328013; NG0328785; NG032890; NG0329572; NG0330684; ",".","6","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.",5/3/2014,"05/03/2014",8/13/2014,"08/13/2014"
"Biologics",68477,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-0820-14","Class III","Blood and Blood Products for Reprocessing","W069113102395; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",4/15/2014,"04/15/2014",8/13/2014,"08/13/2014"
"Biologics",68477,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Mississippi; Switzerland","B-0819-14","Class II","Red Blood Cells Leukocytes Reduced","W069113102395; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",4/15/2014,"04/15/2014",8/13/2014,"08/13/2014"
"Biologics",68478,"Terminated","BioLife Plasma Services L.P.","Broken Arrow","OK","US","Voluntary: Firm Initiated","E-Mail","Product was distributed in CA and NY","B-0990-14","Class II","SOURCE PLASMA CAUTION: FOR MANUFACTURING USE ONLY PLASMA SEPARATED FROM WHOLE BLOOD CONTAINING APPROXIMATELY 50-120 mL OF ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USING AN AUTOMATED PROCEDURE 1. Store at -20C or colder. 2. Plasma collected from a normal donor. BioLife Plasma Services L.P. One Baxter Parkway","13BOKC7112 13BOKC6840 13BOKC5654 13BOKB8431 13BOKB4062 13BOKB3793 13BOKB2336 13BOKB1805 13BOKB1966 13BOKB1783 13BOKB1891 13BOKB1844 13BOKB2016 13BOKB1922 13BOKB1899 13BOKB1632 13BOKB1522 13BOKB1665 13BOKB1764 13BOKB1646 13BOKB1652 13BOKB1758 13BOKB1526 13BOKB1686 13BOKB1574 13BOKB1678 13BOKB1671 13BOKB1384 13BOKB1501 13BOKB1442 13BOKB1331 13BOKB1367 13BOKB1494 13BOKB1327 13BOKB1425 13BOKB1270 13BOKB1131 13BOKB1027 13BOKB1013 13BOKB1040 13BOKB1033 13BOKB1290 13BOKB1214 13BOKB0842 13BOKB0775 13BOKB1007 13BOKB0845 13BOKB0808 13BOKB0955 13BOKB0851 13BOKB0792 13BOKB0784 13BOKB1003 13BOKB0816 13BOKB0804 13BOKB0994 13BOKB0607 13BOKB0619 13BOKB0570 13BOKB0631 13BOKB0479 13BOKB0505 13BOKB0671 13BOKB0553 13BOKB0472 13BOKB0443 13BOKB0173 13BOKB0256 13BOKB0186 13BOKB0304 13BOKB0202 13BOKB0233 13BOKB0182 13BOKB0197 13BOKB0341 13BOKB0376 13BOKB0350 13BOKB0274 13BOKA9912 13BOKB0122 13BOKB0010 13BOKA9877 13BOKA9884 13BOKB0135 13BOKA9900 13BOKB0112 13BOKB0127 13BOKB0143 13BOKA9880 13BOKB0144 13BOKA9879 13BOKA9882 13BOKB0078 13BOKA9931 13BOKA9903 13BOKB0115 13BOKA9629 13BOKA9662 13BOKA9638 13BOKA9743 13BOKA9742 13BOKA9706 13BOKA9823 13BOKA9761 13BOKA9744 13BOKA9550 13BOKA9536 13BOKA9370 13BOKA9400 13BOKA9595 13BOKA9546 13BOKA9533 13BOKA9611 13BOKA9570 13BOKA9466 13BOKA9448 13BOKA9157 13BOKA9339 13BOKA9125 13BOKA9072 13BOKA9242 13BOKA9117 13BOKA9204 13BOKA9286 13BOKA8842 13BOKA8832 13BOKA8757 13BOKA8926 13BOKA8827 13BOKA9047 13BOKA8882 13BOKA8771 13BOKA8980 13BOKA8810 13BOKA8863 13BOKA9044 13BOKA8759 13BOKA8798 13BOKA8795 13BOKA8816 13BOKA8792 13BOKA8914 13BOKA9035 13BOKA8780 13BOKA8437 13BOKA8531 13BOKA8646 13BOKA8455 13BOKA8611 13BOKA8430 13BOKA8533 13BOKA8539 13BOKA8534 13BOKA8553 13BOKA8701 13BOKA8664 13BOKA8565 13BOKA8551 13BOKA8613 13BOKA8630 13BOKA8528 13BOKA8128 13BOKA8135 13BOKA8171 13BOKA8419 13BOKA8165 13BOKA8142 13BOKA8261 13BOKA8129 13BOKA8108 13BOKA8183 13BOKA8127 13BOKA8398 13BOKA8249 13BOKA7896 13BOKA8037 13BOKA8101 13BOKA7917 13BOKA7958 13BOKA8033 13BOKA8035 13BOKA8092 13BOKA7901 13BOKA7994 13BOKA7843 13BOKA7730"," 12BOKD7089 12BOKD7290 12BOKD7398 12BOKD7042 12BOKD7102 12BOKD6890 12BOKD6813 12BOKD7017 12BOKD6912 12BOKD7026 12BOKD6883 12BOKD6850 12BOKD6937 12BOKD6602 12BOKD6505 12BOKD6760 12BOKD6642 12BOKD6560 12BOKD6717 12BOKD6688 12BOKD6768 12BOKD6456 12BOKD6719 12BOKD6785 12BOKD6472 12BOKD6496 12BOKD6539 12BOKD6544 12BOKD6591 12BOKD6243 12BOKD6339 12BOKD6269 12BOKD6420 12BOKD6397 12BOKD6234 12BOKD6311 12BOKD6292 12BOKD5974 12BOKD6105 12BOKD6145 12BOKD6185 12BOKD6183 12BOKD6038 12BOKD6094 12BOKD6186 12BOKD5898 12BOKD5720 12BOKD5878 12BOKD5814 12BOKD5891 12BOKD5781 12BOKD5705 12BOKD5924 12BOKD5481 12BOKD5510 12BOKD5567 12BOKD5676 12BOKD5645 12BOKD5549 12BOKD5408 12BOKD5565 12BOKD5661 12BOKD5432 12BOKD5599 12BOKD5590 12BOKD5400 12BOKD5414 12BOKD5587 12BOKD5611 12BOKD5545 12BOKD5212 12BOKD5261 12BOKD5089 12BOKD5199 12BOKD5116 12BOKD5296 12BOKD4879 12BOKD4782 12BOKD4918 12BOKD4785 12BOKD4954 12BOKD4916 12BOKD4955 12BOKD4755 12BOKD4777 12BOKD4880 12BOKD4898 12BOKD4970 12BOKD4787 12BOKD4851 12BOKD4924 12BOKD5028 12BOKD4573 12BOKD4607 12BOKD4692 12BOKD4524 12BOKD4560 12BOKD4703 12BOKD4494 12BOKD4539 12BOKD4527 12BOKD4670 12BOKD4533 12BOKD4696 12BOKD4523 12BOKD4310 12BOKD4331 12BOKD4345 12BOKD4325 12BOKD4388 12BOKD4434 12BOKD4412 12BOKD4339 12BOKD4360 12BOKD4379 12BOKD4129 12BOKD4025 12BOKD4167 12BOKD4133 12BOKD4095 12BOKD4086 12BOKD4082 12BOKD4076 12BOKD4101 12BOKD4125 12BOKD4161 12BOKD4139 12BOKD3803 12BOKD3827 12BOKD3823 12BOKD3825 12BOKD3836 12BOKD3887 12BOKD3891 12BOKD3710 12BOKD3944 12BOKD3858 12BOKD3809 12BOKD3865 12BOKD3745 12BOKD3704 12BOKD3909 12BOKD3463 12BOKD3416 12BOKD3411 12BOKD3546 12BOKD3506 12BOKD3632 12BOKD3505 12BOKD3267 12BOKD3163 12BOKD3284 12BOKD3305 12BOKD3259 12BOKD3131 12BOKD3265 12BOKD3234 12BOKD3311 12BOKD2963 12BOKD3044 12BOKD3035 12BOKD3109 12BOKD3078 12BOKD3114 12BOKD2941 12BOKD3099 12BOKD2915 12BOKD2924 12BOKD2985 12BOKD2925 12BOKD2959 12BOKD3012 12BOKD2948 12BOKD2877 12BOKD2673 12BOKD2716 12BOKD2802 12BOKD2787 12BOKD2875 12BOKD2554 12BOKD2499 12BOKD2614 12BOKD2639 12BOKD2594 12BOKD2579 12BOKD260","4026 units","Source Plasma, collected from ineligible donors, were distributed. ",8/30/2013,"08/30/2013",10/1/2014,"10/01/2014"
"Biologics",68479,"Ongoing","Olerup SSP AB","Stockholm",,"SE","Voluntary: Firm Initiated","Letter","US distribution was made to end users in: TX, CA, FL, PA, Washington, DC, MO, RI, AZ, HI, and GA, and Internationally to distributors in Mexico, Canada, and Venezuela.","B-0815-14","Class II","Olerup SSP HLA Typing Kits The kit contains dried primer solutions are pre-aliquoted into cut PCR trays with 0.2 ml wells. These trays, one for each test, are packaged in inner boxes of paper and then together with mastermix vials in outer paper boxes. The kits are available in two formats, kits containing PCR Master Mix including Taq polymerase respective kits containing PCR Master Mix without Taq polymerase. ","Olerup SSP HLA Typing Kits ALow: Lot 44V, exp. September 1, 2015; ALow Screening: Lot 28V, exp. July 1, 2016; A-B-C: Lots 64S, exp. March 1, 2016, and 63V, exp. September 1, 2016; A-B-DR: Lot 63S, exp. March 1, 2016; A-B-DR-DQ: Lot 70S, exp. March 1, 2016 ",".","6 kits","HLA typing assay, associated with false negative results, were distributed. ",5/26/2014,"05/26/2014",7/23/2014,"07/23/2014"
"Devices",68480,"Ongoing","Axcentria Pharmaceuticals, LLC","Telford","PA","US","Voluntary: Firm Initiated","Letter","US distribution to NY and CA","Z-2069-2014","Class II","Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.","lot # H13136, exp. August 2014. ",".","528","One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use. ",6/5/2014,"06/05/2014",7/23/2014,"07/23/2014"
"Drugs",68481,"Ongoing","Axcentria Pharmaceuticals, LLC","Telford","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1434-2014","Class II","Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA ","G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015 ",".","20,369 bottles","Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number",5/5/2014,"05/05/2014",7/23/2014,"07/23/2014"
"Devices",68482,"Ongoing","Blue Belt Technologies MN","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, PA, and TX","Z-1942-2014","Class II","Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.","Lot C785231, Exp 5-2015",,"2","Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Devices",68482,"Ongoing","Blue Belt Technologies MN","Plymouth","MN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, PA, and TX","Z-1943-2014","Class II","Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.","Lot C785241, Exp 4-2015",,"2","Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Food",68483,"Ongoing","Frito-Lay, Inc","Plano","TX","US","Voluntary: Firm Initiated","Other","Distributed nationwide","F-2513-2014","Class II","Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189","Best Before Dates of July 15, July 29, Aug 12, and Aug 26, 2014",,"1,757,772 units","Printing error by the packaging manufacturer erroneously added a ''GF'' symbol to the packages.",6/2/2014,"06/02/2014",10/1/2014,"10/01/2014"
"Food",68484,"Ongoing","Green Smoothie Girl","Orem","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, no foreign/miitary/govt/VA consignees.","F-2050-2014","Class I","GreenSmoothieGirl TriOmega Superfood, GreenSmoothieGirl Sprouted Ground TriIOmega Superfood, Packaged in metalized resealable standup pouches in 1-pound units","Lot numbers: BIO13TOP300 Exp 10/2015, no UPC, AC030141, Exp. 01/2016, UPC 5381100503.",".","1232 Units","The products contain Organic Sprouted Chia Powder that may be contaminated with Salmonella.",6/6/2014,"06/06/2014",7/2/2014,"07/02/2014"
"Devices",68485,"Ongoing","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US distribution only.","Z-1853-2014","Class II","RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.","RT-5100 and RT-3100, various serial numbers.",".","~4,285 units RT-5100; 167 units of RT-3100","Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.",6/9/2014,"06/09/2014",7/2/2014,"07/02/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2147-2014","Class II","S'mores Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"8 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2154-2014","Class II","Tiramisu Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","1aTRM022014",,"1 - 7qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2160-2014","Class II","Shirley's Red Velvet Cake with White Chocolate Icing Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2138-2014","Class II","Java Chip Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2133-2014","Class II","Fudgesicle Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2124-2014","Class II","Candy Cane Lane Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2148-2014","Class II","Watermelon Mint Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2139-2014","Class II","Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2158-2014","Class II","Cookie Monster Dough Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"17 - 3gal units; 1 - 7qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2109-2014","Class II","Ginger 2 Snaps Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","1aG2S120613.",,"3gal - 1 unit, 7qt - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2169-2014","Class II","Ze German Chocolate Cake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"7 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2116-2014","Class II","Arnold Palmer Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2126-2014","Class II","Chatty Cathy Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2146-2014","Class II","Shorty's Strawberry Shortcake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2162-2014","Class II","Sunnyside Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch numbers: 1bMBE031914, 1aMBE032814",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2127-2014","Class II","Cherry Amaretto Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2117-2014","Class II","Aww Shucks Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2140-2014","Class II","Peaches and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2105-2014","Class II","The Doctor's Cure Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","1aTDC030314, 1bTDC030314, 1dTDC030314, 1bTDC033114, and 1dTDC021914.",,"5.2qt - 5 units.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2125-2014","Class II","Caramel Apple Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2131-2014","Class II","Coconut Almond White Chocolate Dream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2144-2014","Class II","Raspberry Lemonade Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1- 3 gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2111-2014","Class II","Lemon Cream Raspberry Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 7 units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2112-2014","Class II","Old 502 Sangria Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2107-2014","Class II","Freshly Roasted Coffee Ice Cream and Policeman's Special Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 12 units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2106-2014","Class II","Egg Noggin' Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","1aEGG121113",,"7qt - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2149-2014","Class II","Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2143-2014","Class II","Raspberry Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2094-2014","Class II","Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"3 gal - 3 units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2153-2014","Class II","Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Bath Numbers: 1aDLS020714; 1bDLS020714; 2aDLS022414; 2bDLS012014; 1bDLS111413",,"17 - 3gal units; 1 - 1.5gal unit; 1 - 5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2119-2014","Class II","Banana Walnut Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2100-2014","Class II","Blue Cheese Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1bBLE030514",,"3gal - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2168-2014","Class II","Sister Bean's White Chocolate Mocha Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Number: 1aSBWCM22614",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2103-2014","Class II","Caramel Mocha Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"3gal - 2 units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2130-2014","Class II","Chocolate Peanut Butter Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2096-2014","Class II","Erica's PB&J Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 3aPBJ021713",,"3 gal - 2 units, 5.2qt - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2099-2014","Class II","Black Raspberry Chip Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1bBRC120313, 2aBRC121513, and 1aBRC010714.",,"3gal - 13 units, 7qt - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2101-2014","Class II","Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"5.2qt - 3 units.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2114-2014","Class II","Sorghum & Grits Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 3 units.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2156-2014","Class II","Bourbon Ball Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 3bBOUR032314; 1aBOUR030414; 1aBOUR020614",,"17 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2161-2014","Class II","Green Tea Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 5.2qt units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2120-2014","Class II","Blackberry Cobbler Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2097-2014","Class II","Say ''Cheeeeeesecake'' Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: Say Cheeeeeesecake 1aCHZ031914. ",,"3gal - 1 unit, 5.2qt - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2134-2014","Class II","Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2095-2014","Class II","Peanut Butter Cow Tracks Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 3aCTRX110913, 5aCTRX112413, and 2bCTRX022714.",,"3gal - 18 units, 5.2qt - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2102-2014","Class II","Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"1.5gal - 3 units.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2108-2014","Class II","Georgia Butter Pecan Ice Cream and Simply Southern Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Georgia Butter Pecan: 1aGBP011914.",,"3gal - 14 units, 5.2qt - 1 unit, ","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2128-2014","Class II","Chocolate Bourbon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2104-2014","Class II","Coconut Almond Bliss Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"3gal - 9 units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2164-2014","Class II","Chocolate ''Chip Off the Old Block'' Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"12 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2093-2014","Class II","Cinnamon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked. ",,"3 gal - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2137-2014","Class II","Jack and Cola Float Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2157-2014","Class II","Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Number: 1aSRVCCSS031114",,"1 - 1.5gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2142-2014","Class II","Pretzel Logic Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"9 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2115-2014","Class II","Strawberry Fields Forever Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","1aSFF022714, 4bSFF032714, 2bSFF032714, 2bSFF022714",,"19 - 3gal units, 1 - 5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2152-2014","Class II","Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit; 1 - 5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2145-2014","Class II","Rocky Road Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2121-2014","Class II","Blueberry French Toast with Bacon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2136-2014","Class II","Hazelnut Crunch Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"2 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2123-2014","Class II","Brown Butter Peanut Brittle Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2092-2014","Class II","Chocolate Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1aCHOC030314, 3aCHOC030314, 2cCHOC030814. ",,"16 - 3gal units, 1 - 5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2167-2014","Class II","Minty Chocolate Chippy Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Number: 1aMCC111713",,"12 - 3gal units; 1 - 5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2118-2014","Class II","Banana Nana Fofana Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2135-2014","Class II","Green Apple Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2163-2014","Class II","Vanilla Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1aVAN022614, 1aVAN030714, 1bVAN030714, 2cVAN031214, 2bVAN031214, 2bVAN032314, 2aVAN032314, 1dVAN032314, 1aVAN032414, 2aVAN031714, 2aVAN031114, 1cVAN022614, and 1bVAN032614.",,"20 - 3gal units; 1 - 1.5gal unit; 8 - 5.2qt units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2110-2014","Class II","Key To My Heart Lime Pie Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 4 units.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2166-2014","Class II","Hey Jude Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"4 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2132-2014","Class II","CooCoo for Coconut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2150-2014","Class II","Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"14 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2151-2014","Class II","Policeman's Special Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"7 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2129-2014","Class II","Chocolate Coconut Almond Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 1 unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2165-2014","Class II","Chocolate Squared Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1aCSD030414",,"2 - 3gal units, 1 - 1.5gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2141-2014","Class II","Pistachio Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2122-2014","Class II","Bonjour Toast Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"1 - 3gal unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2113-2014","Class II","Raspberry Sorbet. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Codes on the products distributed to Comfy Cow retail locations are not tracked.",,"3gal - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2155-2014","Class II","Vermont Maple Walnut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Number: 1bVMW031014",,"13 - 3gal units","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2098-2014","Class II","Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1aBANP103113",,"3gal - 1 unit, 5.2qt - 1 unit.","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Food",68486,"Ongoing","Koogee-Queen Anne, LLC","Louisville","KY","US","Voluntary: Firm Initiated","Combination ","Distributed in the states of Indiana and Kentucky","F-2159-2014","Class II","Cookies and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.","Batch Numbers: 1aCAC040214, 1bCAC032814",,"22 - 3gal units, 1 -5.2qt unit","During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.",4/10/2014,"04/10/2014",7/16/2014,"07/16/2014"
"Devices",68487,"Ongoing","Alcon Research, Ltd.","Fort Worth","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.","Z-2694-2014","Class II","eye-pak 7407 Tray Support Cover REF 8065740745 ","Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.",,"2462","The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.",6/3/2014,"06/03/2014",10/1/2014,"10/01/2014"
"Devices",68488,"Ongoing","Kova Laboratories, Inc.","Margate","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of FL and NJ.","Z-1993-2014","Class II","Amerigel Wound Dressing 55 gallons/drum","Lot #3WD05.",,"3 drums","Product may not have been manufactured pursuant to a validated process protocol and CGMP.",3/21/2014,"03/21/2014",7/16/2014,"07/16/2014"
"Devices",68488,"Ongoing","Kova Laboratories, Inc.","Margate","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of FL and NJ.","Z-1992-2014","Class II","Amerigel Wound Dressing 1 oz. tube","Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.",,"122,396 / 1oz. tubes","Product may not have been manufactured pursuant to a validated process protocol and CGMP.",3/21/2014,"03/21/2014",7/16/2014,"07/16/2014"
"Devices",68489,"Ongoing","Vascular Solutions, Inc.","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.","Z-1981-2014","Class I","Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.","Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.",,"8,580 total (US 5714)","The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.",5/27/2014,"05/27/2014",7/9/2014,"07/09/2014"
"Devices",68490,"Ongoing","BD Biosciences, Systems & Reagents","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.","Z-1977-2014","Class II","BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.","FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.",,"35 installed devices","Laser cooling fans and internal fan of the associated fluidics cart are not operational.",6/6/2014,"06/06/2014",7/9/2014,"07/09/2014"
"Devices",68491,"Ongoing","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.","Z-1852-2014","Class II","Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.","n/a",".","3383 in the USA; 1459 outside the USA","Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.",6/6/2014,"06/06/2014",7/2/2014,"07/02/2014"
"Food",68492,"Ongoing","Dole Packaged Foods, Llc","Westlake Village","CA","US","Voluntary: Firm Initiated","Letter","TX, TN, NV, PA","F-2078-2014","Class I","Dole Garden Soup ''Roasted Garlic Tomato Basil'', Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case","Lot No. WF14113 and WF14114, Best By Oct 23 2015 and Oct 24 2015",,"604 cases","Dole Packaged Foods is recalling Dole Garden Soup Roasted Garlic Tomato Basil because it contains undeclared milk.",6/8/2014,"06/08/2014",7/9/2014,"07/09/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2015-2014","Class II","Adaptor, 040 Hum, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 4000040, Lot number: AG14.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2010-2014","Class II","Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 005-40, Lot numbers: 001125, 002125, 003125, 004125, 005125, 006125, 007125, 008125, 009125, 010125, 011125, 012125, 013125, 014125, 015125, 016125, 017125, 019125, 020125, 021125, 022125, 023125, 024125, 025125, 026125 & 032125.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2013-2014","Class II","Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 006-40F, Lot numbers: 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126 & 115126.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2016-2014","Class II","Humidifier Adaptor 040, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 000-40, Lot numbers: AA19, AB12, AC20, AE03, AE18, AE21, AF09, AF16, AG10, AG12 & AH11.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2012-2014","Class II","Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 006-40, Lot numbers: 041126, 042126, 043126, 044126, 053126, 054126, 055126, 056126, 057126, 058126, 068126, 069126, 070126, 075126, 077126, 078126, 079126, 086126, 087126, 088126, 089126, 090126, 097126, 111126, 120126, 121126, 122126, 123126, 128126, 155126 & 156126.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2011-2014","Class II","Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 006-40C, Lot numbers: 029126, 036126, 065126, 071126, 076126 & 091126.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2003-2014","Class II","Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 400340, Lot numbers: 082127, 085127, 088127, 092127, 094127, 097127, 100127, 102127, 104127, 106127, 108127, 137127, 141127, 145127, 148127, 154127, 156127, 159127, 161127, 163127, 194127, 198127, 200127, 204127, 207127, 209127, 223127, 224127, 226127, 228127, 230127, 232127, 239127, 241127, 243127, 245127, 246127, 248127, 250127, 252127, 256127, 259127, 263127, 266127, 269127, 289127, 290127, 292127, 307127, 309127, 312127, 314127, 316127, 318127, 320127, 322127, 338127, 340127, 345127, 350127, 353127, 356127, 359127, 386127, 388127, 390127, 392127, 395127, 399127, 403127, 406127, 410127, 414127, 419127, 421127, 430127, 432127, 447127, 450127, 453127, 456127, 459127, 462127, 465127, 467127, 477127, 478127, 481127, 483127, 486127, 487127, 489127, 491127, 493127, 496127, 516127, 577127 & 580127.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2005-2014","Class II","Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 001-40J, Lot numbers: 001129 & 002129.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2014-2014","Class II","Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 006-40J, Lot numbers: 028126, 035126, 045126, 063126, 098126, 105126 & 106126.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2004-2014","Class II","Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 400640, Lot numbers: 021126, 022126, 030126, 031126, 032126, 033126, 034126, 037126, 038126, 039126, 040126, 047126, 048126, 049126, 050126, 051126, 052126, 059126, 060126, 061126, 066126, 067126, 072126, 073126, 074126, 081126, 082126, 083126, 084126, 085126, 093126, 094126, 095126, 096126, 100126, 101126, 102126, 103126, 104126, 109126, 110126, 116126, 117126, 118126, 119126, 125126, 126126, 127126 & 151126.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2009-2014","Class II","Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 003-40J, Lot numbers: 177127, 181127, 184127, 225127, 227127, 229127, 231127, 254127, 287127, 291127, 293127, 363127, 364127, 365127, 366127, 367127, 385127, 387127, 389127, 391127, 393127, 423127, 424127, 429127, 431127, 434127, 436127, 437127 & 445127.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2007-2014","Class II","Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 003-40C, Lot numbers: 109127, 155127, 157127, 174127, 195127, 222127, 277127, 335127, 337127, 384127, 422127, 425127, 497127 & 500127.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2006-2014","Class II","Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.","Product Code: 003-40, Lot numbers: 088137, 093127, 095127, 096127, 098127, 099127, 101127, 103127, 105127, 107127, 111127, 112127, 113127, 114127, 115127, 116127, 117127, 118127, 119127, 120127, 121127, 122127, 123127, 124127, 125127, 126127, 127127, 128127, 129127, 130127, 131127, 132127, 133127, 134127, 135127, 136127, 138127, 140127, 143127, 144127, 146127, 147127, 149127, 150127, 151127, 152127, 153127, 158127, 160127, 162127, 164127, 165127, 166127, 167127, 168127, 169127, 170127, 171127, 172127, 173127, 175127, 176127, 178127, 179127, 180127, 182127, 183127, 185127, 186127, 187127, 188127, 189127, 190127, 191127, 192127, 193127, 196127, 197127, 199127, 201127, 202127, 203127, 205127, 206127, 208127, 210127, 212127, 214127, 216127, 218127, 219127, 220127, 221127, 234127, 235127 , 237127, 240127, 242127, 258127, 262127, 265127, 268127, 271127, 273127, 275127, 278127, 279127, 280127, 281127, 282127, 283127, 284127, 285127, 286127, 294127, 295127, 296127, 297127, 298127, 299127, 301127, 302127, 303127, 305127, 306127, 308127, 310127, 311127, 319127, 321127, 323127, 324127, 325127, 326127, 327127, 328127, 329127, 330127, 331127, 332127, 342127, 344127, 346127, 348127, 349127, 351127, 352127, 354127, 355127, 357127, 358127, 360127, 361127, 369127, 370127, 372127, 373127, 374127, 375127, 377127, 378127, 380127, 381127, 383127, 394127, 397127, 400127, 402127, 407127, 408127, 409127, 411127, 412127, 416127, 418127, 420127, 439127, 440127, 441127, 442127, 443127, 444127, 446127, 448127, 449127, 451127, 452127, 454127, 455127, 457127, 460127, 461127, 463127, 469127, 472127, 475127, 476127, 479127, 480127, 482127, 484127, 494127, 498127, 499127, 501127, 502127, 503127, 504127, 505127, 506127, 507127, 508127, 510127, 546127, 547127 & 548127..",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2008-2014","Class II","Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 003-40F, Lot numbers: 046127, 049127, 052127, 053127, 055127, 056127, 058127, 059127, 061127, 062127, 065127, 066127, 068127, 069127, 071127, 072127, 074127, 211127, 213127, 215127, 217127, 233127, 236127, 238127, 244127, 247127, 249127, 251127, 253127, 257127, 260127, 261127, 264127, 267127, 270127, 272127, 274127, 276127, 288127, 300127, 304127, 313127, 315127, 317127, 333127, 334127, 336127, 339127, 341127, 343127, 368127, 371127, 376127, 379127, 382127, 396127, 398127, 401127, 405127, 433127, 435127, 438127, 464127, 466127, 468127, 470127, 471127, 473127, 474127, 485127, 488127, 490127, 492127, 495127, 513127 & 518127.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Devices",68493,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.","Z-2017-2014","Class II","Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.","Product Code: 000-40F, Lot numbers: AA05 & AC01.",,"7,758,650 ea. (total for all types listed)","The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Food",68494,"Ongoing","Caromont Farm","Esmont","VA","US","Voluntary: Firm Initiated","E-Mail","DISTRIBUTION PATTERN: Is as follows - The total number of consignees (customers) that received the recall product as per Company Response: 25 Sales by Customer Detail Sheet List: 37 (including one retail customer) The total number of wholesaler dealers that received the recall product as per company's response, 2 The total number of distributors that received the recall product as per company's response - 2 The total number of retailers that received the recall product as per company's response - 23 The total number of consumers / users that received the recall product as per company's response - 25","F-2174-2014","Class II","Chevre (Pasteurized Goats Milk Cheese) .-Four oz. cups Fresh Chevre / Bulk Chevre - One, two, and five pound sizes ","Lot # 937 - Chevre, Production Date : 05/12/14",".","Lot 937 - waiting on a figure","Failure to achieve proper pasteurization due to one or more of the following critical factors: Improper Air space temperature, Pasteurization time, and/or Milk Temperature.",5/30/2014,"05/30/2014",7/23/2014,"07/23/2014"
"Food",68494,"Ongoing","Caromont Farm","Esmont","VA","US","Voluntary: Firm Initiated","E-Mail","DISTRIBUTION PATTERN: Is as follows - The total number of consignees (customers) that received the recall product as per Company Response: 25 Sales by Customer Detail Sheet List: 37 (including one retail customer) The total number of wholesaler dealers that received the recall product as per company's response, 2 The total number of distributors that received the recall product as per company's response - 2 The total number of retailers that received the recall product as per company's response - 23 The total number of consumers / users that received the recall product as per company's response - 25","F-2173-2014","Class II","Plank Road Round (Pasteurized Cows Milk Cheese), 4 ounce plastic cups are sealed with a protective band.","Lot # 922 - Plank Road Round, Production Date : 04/16/14",".","Lot 922 - 131.95 lbs","Failure to achieve proper pasteurization due to one or more of the following critical factors: Improper Air space temperature, Pasteurization time, and/or Milk Temperature.",5/30/2014,"05/30/2014",7/23/2014,"07/23/2014"
"Devices",68495,"Ongoing","Microline Surgical, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.","Z-1987-2014","Class II","Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222","Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278 ",,"6290 units","Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw",5/12/2014,"05/12/2014",7/9/2014,"07/09/2014"
"Devices",68495,"Ongoing","Microline Surgical, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.","Z-1986-2014","Class II","Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221","Lot Numbers: 00115342",,"150 units","Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw",5/12/2014,"05/12/2014",7/9/2014,"07/09/2014"
"Devices",68496,"Ongoing","The Anspach Effort, Inc.","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.","Z-1983-2014","Class II","Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.","DFU: 18-0047: Revisions A & B 18-0074: Revision A; and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A, and 19-0013: Revisions A, B, & C.",,"115,988 units","Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.",5/8/2014,"05/08/2014",7/9/2014,"07/09/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1463-2014","Class II","Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14","Rx # 29082 Exp. 5/19/14 ",,"60 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1478-2014","Class II","Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14","Rx # 29083, Exp 05/21/14",,"7 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1454-2014","Class II","Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14","Rx # 28289, Exp 02/5/14; Rx # 29189, Exp 05/23/14",,"22 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1482-2014","Class II","Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14","Rx # 29190, Exp 05/23/14; Rx # 29068, Exp 05/18/14",,"12 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1453-2014","Class II","Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14","Rx 29184 Exp 5/28/14",,"7 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1460-2014","Class II","Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14","Rx # 29157, Exp 5/19/14; Rx # 29097, Exp 5/20/14",,"12 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1456-2014","Class II","Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14","Rx 28314 Exp 5/22/2014 ",,"6 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1471-2014","Class II","Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14","Rx # 28503, Exp 02/27/14",,"14 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1457-2014","Class II","Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14","Rx # 28288, Exp 02/4/14; Rx # 29176, Exp 05/21/14; Rx # 28829, Exp 05/17/14",,"24 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1459-2014","Class II","Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014","Rx # 29038, Exp 05/20/14 ",,"7","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1469-2014","Class II","Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14","Rx # 28300, Exp 02/7/14",,"7 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1474-2014","Class II","Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14","Rx # 28878, Exp 05/16/14",,"16 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1461-2014","Class II","Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14","Rx # 29087 Exp. 5/28/2014 ",,"42 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1479-2014","Class II","Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14","Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14",,"52 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1481-2014","Class II","Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14","Rx # 28879, Exp 05/21/14",,"11 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1480-2014","Class II","Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14","Rx # 29150, Exp 05/17/14",,"5 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1458-2014","Class II","Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14","Rx # 29039, Exp 05/05/14 & 05/20/14; Rx # 29204, Exp 05/23/14; Rx # 29161, Exp 05/19/14",,"31 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1473-2014","Class II","Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14","Rx # 29140, Exp 05/23/14",,"14 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1472-2014","Class II","Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14","Rx # 29186, Exp 05/22/14; Rx # 29010, Exp 05/22/14",,"21 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1462-2014","Class II","Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14","Rx 29162 Exp. 5/21/2014 ",,"5 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1467-2014","Class II","Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14","Rx # 29114, Exp 05/13/14",,"1 unit","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1475-2014","Class II","Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14","Rx # 29185, Exp 05/23/14",,"14 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1476-2014","Class II","Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14","Rx # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14",,"10 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1464-2014","Class II","Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14","Rx # 27767, Exp 05/23/14",,"2 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1468-2014","Class II","Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15","Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15",,,"Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1477-2014","Class II","Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14","Rx # 29096, Exp 05/20/14",,"8 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1455-2014","Class II","Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14","Rx 29183 Exp, 5/21/2014 ",,"7 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1470-2014","Class II","ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15","Rx # 28838, Exp 03/4/15",,"1 unit","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1465-2014","Class II","Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14","Rx #28694, Exp 05/22/14",,"21 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Drugs",68497,"Ongoing","Franck's Lab Inc dba Trinity Care Solutions","Ocala","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","D-1466-2014","Class II","Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14","Rx # 28837, Exp 04/11/14",,"21 units","Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.",5/15/2014,"05/15/2014",7/30/2014,"07/30/2014"
"Devices",68498,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.","Z-1961-2014","Class II","MIS Rod 2, a component of the NewPort System Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws.","Lot No. Z21781A (45mm NewPort MIS Rod, 2) Z21956A (50mm NewPort MIS Rod, 2) Z21782A (55mm NewPort MIS Rod, 2) Z21957A (60mm NewPort MIS Rod, 2) Z21784A (75mm NewPort MIS Rod, 2) Z21958A (80mm NewPort MIS Rod, 2) ",,"94 units","Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Food",68499,"Ongoing","The Coca-Cola Company","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","CO, KS, NM, SD, UT and WY.","F-2088-2014","Class III","Coca Cola Vanilla, 12 pack/12 fl oz cans, UPC: 49000 03124, Canned under authority of the Coca Cola Company, Atlanta, GA 30313 By a member of the Coca Cola Bottlers Association, Atlanta, GA. ","Date Code: JAN192055CC",,"Total 3606 cases (24/12oz cans/case)","The product contains undeclared aspartame.",5/29/2014,"05/29/2014",7/16/2014,"07/16/2014"
"Devices",68500,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.","Z-1978-2014","Class II","Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol. ","Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.",,"22 Units","Tritanium Patella Inserter Instrument fracture during implantation. .",5/1/2014,"05/01/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2073-2014","Class II","Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid.","Sell by Date: 9/19/2014",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2074-2014","Class II","Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid.","Sell by Date: 9/19/2014",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2076-2014","Class II","Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid.","Sell by Date: 9/19/2014",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2070-2014","Class II","Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), and 5 lb. (11951) white tub with snap on lid; 2. 150+Central Markets in 8 oz cups with snap on lid (27057). 3. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 4. Dierks Waukesha in 5 lb. pail with snap on lid (11952). ","Sell by Date: 2/17/2015, 5/20/2015, and 5/21/2015",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2075-2014","Class II","Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid.","Sell by Date: 9/19/2014",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2069-2014","Class II","Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2. Central Markets in 8 oz cups with snap on lid (27056). 3. Cobblestone Market in 5 lb. pail (42403) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442) ","Sell by Date: 2/17/2015, 5/20/2015, and 5/21/2015",,"1264 cases total ","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2071-2014","Class II","Olivia Swan Cheddar Cold Pack Cheese 10 lb. pail with snap on lid (12341os) ","Sell by Date: 2/17/2015",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Food",68501,"Ongoing","Parkers Farm Inc","Coon Rapids","MN","US","Voluntary: Firm Initiated","E-mail","WI, IN, TX, IL, MN.","F-2072-2014","Class II","Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid (42550); 2. Cobblestone Market in 5 lb. pail pails with snap on lid (42603). ","Sell by Date: 2/17/2015",,"1264 cases total","Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.",6/5/2014,"06/05/2014",7/9/2014,"07/09/2014"
"Drugs",68502,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1414-2014","Class II","Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.","Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14 ",,"a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles","Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.",5/20/2014,"05/20/2014",7/9/2014,"07/09/2014"
"Devices",68503,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1922-2014","Class I","Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.","Lot No. 206923344 206986678 207096628 207565426 207659574 207945035 207982846 208031201 208055143 ",,"760 units","Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Devices",68503,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1921-2014","Class I","Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.","Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802",,"5,744 units","Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Devices",68503,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1920-2014","Class I","Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.","Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847",,"3,026 units","Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Devices",68503,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1923-2014","Class I","Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.","Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202",,"1,187 units","Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Devices",68503,"Ongoing","Medtronic Neurosurgery","Goleta","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.","Z-1924-2014","Class I","Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.","Lot No. 208031203",,"35 units","Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.",6/9/2014,"06/09/2014",7/9/2014,"07/09/2014"
"Food",68504,"Terminated","Sunrise Meats, Inc.","Port Angeles","WA","US","Voluntary: Firm Initiated","Telephone","Product was distributed to five Washington state retail accounts.","F-2084-2014","Class II","Hot smoked Coho salmon; Gold foiled, vacuum packaged units, approximately pounds each. Adhesive label affixed to front or back of package. Label reads in part, ''**Smoked Coho INGREDIENTS, SALMON CURED WITH WATER, DEXTROSE, FLAVORING, SODIUM NITRITE. PROCESSED BY SUNRISE MEATS***PORT ANGELES WASHINGTON***REFRIGERATE BELOW 38 DEGREE***''","PACKED ON 08.30.13",,"Approximately 55.5 pounds","Sunrise Meats is voluntarily recalling one batch of refrigerated, vacuum-packaged hot smoked salmon due to inadequate water phase salt content to control the hazard of Clostridium botulinum growth and toxin formation.",6/9/2014,"06/09/2014",7/16/2014,"07/16/2014"
"Food",68505,"Ongoing","Eillien's Candies, Inc.","Green Bay","WI","US","Voluntary: Firm Initiated","Telephone","AL, CO, IA, IL, IN, MI, MN, WI","F-2051-2014","Class I","Dark Old Fashioned Sponge Candy, sold under the following brand and sizes: 1. Eillien's in Net Wt. 6 oz (170g) UPC 34952-12994, 10 oz. (284g) UPC 34952-56927, 12 oz. (340g) UPC 34952-57307. 2. Blain's Farm & Fleet Net Wt. 14oz. (397g), UPC 34952-81171 3. Mae's Corner Market Net Wt. 14oz. (397g) UPC 34952-41075, 1 lb. 8 oz. (680g) UPC 34952-41098, and Premium Party Tray, Net Wt. 58.5 oz.(1687g) UPC 34952-41324. 5. Mrs. Kimball's Candy Shoppe, Net Wt 13 oz(369g) PCA3-13956. 6. Piggly Wiggly Net Wt. 10 oz. (284g) UPC 34952-58138, and 12 oz. (340g) 34952-57477","Best By date prior to 06-01-15",".","78,584 lbs.","Eillien's Candies is recalling Dark Old Fashioned Sponge Candy because it contains undeclared milk.",6/5/2014,"06/05/2014",7/2/2014,"07/02/2014"
"Devices",68506,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide","Z-1963-2014","Class II","EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.","model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX",,"1758","If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.",6/10/2014,"06/10/2014",7/9/2014,"07/09/2014"
"Devices",68507,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide and ROW, including Canada and Mexico.","Z-2174-2014","Class II","Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.","material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094. ",".","160","The issue affects certain serial numbers of digital linear accelerators (LINAC) of type ARTISTE, ONCOR, and PRIMUS with automatic sequenced treatment delivery option. The safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient. ",5/28/2014,"05/28/2014",8/20/2014,"08/20/2014"
"Biologics",68508,"Terminated","Innovasis, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Telephone","California","B-0802-14","Class III","Bone","THB0108643; THB0108617; THB0108648; THB0108661; THB0108794",".","5 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ",1/9/2014,"01/09/2014",7/23/2014,"07/23/2014"
"Biologics",68509,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","New Jersey; Wyoming; Maryland","B-0801-14","Class III","Bone","0098360048; 0098360049; 0098360050",".","3 allografts","Human bone allografts, mislabeled with an incorrect expiration date, were distributed. ",5/21/2014,"05/21/2014",7/23/2014,"07/23/2014"
"Biologics",68510,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0814-14","Class II","Red Blood Cells Leukocytes Reduced","W270114502680; ",,"1","Blood product, collected from a donor who reported travel to an area possibly endemic for malaria, was distributed.",5/2/2014,"05/02/2014",8/27/2014,"08/27/2014"
"Biologics",68511,"Terminated","Coastal Bend Blood Center","Corpus Christi","TX","US","Voluntary: Firm Initiated","E-Mail","Texas","B-0796-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W230813623755; ",,"1 unit","Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.",5/9/2014,"05/09/2014",7/30/2014,"07/30/2014"
"Devices",68512,"Ongoing","Vascular Technology, Inc.","Nashua","NH","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.","Z-1998-2014","Class II","07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.","LOT NUMBER 11798-37631",,"164","Report of the product penetrating the sterile barrier; this could render the product unsterile.",5/28/2014,"05/28/2014",7/16/2014,"07/16/2014"
"Devices",68512,"Ongoing","Vascular Technology, Inc.","Nashua","NH","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.","Z-1999-2014","Class II","07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.","LOT NUMBER 11802-37667",,"147","Report of the product penetrating the sterile barrier; this could render the product unsterile.",5/28/2014,"05/28/2014",7/16/2014,"07/16/2014"
"Devices",68512,"Ongoing","Vascular Technology, Inc.","Nashua","NH","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.","Z-2001-2014","Class II","VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.","LOT NUMBER 11786-37683",,"25","Report of the product penetrating the sterile barrier; this could render the product unsterile.",5/28/2014,"05/28/2014",7/16/2014,"07/16/2014"
"Devices",68512,"Ongoing","Vascular Technology, Inc.","Nashua","NH","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.","Z-2000-2014","Class II","07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.","LOT NUMBER 1516-37698",,"34","Report of the product penetrating the sterile barrier; this could render the product unsterile.",5/28/2014,"05/28/2014",7/16/2014,"07/16/2014"
"Drugs",68513,"Ongoing","Dr. Reddy's Laboratories, Inc.","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1381-2014","Class II","Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01","Lot # C206578 Exp. 05/14 Lot # C207415 Exp. 06/14",".","13560 bottles","Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.",5/23/2014,"05/23/2014",6/18/2014,"06/18/2014"
"Veterinary",68514,"Ongoing","Huvepharma Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","The product was distributed to MO. The firm's consignee reports distributing the recalled product to two customers, one in OR and one in GA.","V-134-2014","Class II","Huvepharma Amprol 25% (amprolium), Type A medicated article, NADA 012-650, Manufactured by: Huvepharma, Inc., St. Louis, MO, Distributed by: Huvepharma, Inc., Peachtree City, GA.","Lot # HSC119; expiration date: February 2017",".","115/50-lb. bags","The product may contain broken glass.",6/5/2014,"06/05/2014",7/23/2014,"07/23/2014"
"Food",68515,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","E-Mail","US: (IL)","F-2082-2014","Class I","Egg White Salad with Chives, 6 oz., packaged in round plastic containers with film seals and snap lids under the Trader Joe's brand. This is a ready-to-eat refrigerated deli salad sold at retail locations.","The lot code is SELL BY JUN 10 2014 The UPC code is 00666695",,"304 - 6oz. containers","This voluntary recall has been initiated because the Trader Joe's Egg White Salad with Chives tested positive for Listeria monocytogenes.",6/6/2014,"06/06/2014",7/16/2014,"07/16/2014"
"Biologics",68516,"Completed","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Greece.","B-0003-15","Class II","Bone","87260172; 87260069; 87260056; 87260064; 87260150; 87260151; 87260154; 87260155; 87260156; 87260157; 87260138; 87260070; 87260111; 87260112; 87260113; 87260114; 87260127; 87260128; 87260129; 87260130; 87260131; 87260132; 87260133; 87260134; 87260065; 87260067; 87260116; 87260117; 87260118; 87260119; 87260120; 87260121; 87260123; 87260124; 87260125; 87260126; 87260115; 87260099; 87260100; 87260101; 87260102; 87260103; 87260104; 87260105; 87260106; 87260107; 87260108; 87260109; 87260110; 87260080; 87260081; 87260082; 87260083; 87260084; 87260085; 87260086; 87260087; 87260088; 87260089; 87260090; 87260091; 87260092; 87260093; 87260094; 87260095; 87260096; 87260097; 87260098; 87260077; 87260122; 87260076; 87260163; 87260164; 87260165; 87260166; 87260167; 87260152; 87260061; 87260149; 87260153; 87260137; 87260140; 87260141; 87260142; 87260143; 87260145; 87260146; 87260144; 87260147; 87260062; 87260170; 87260173; 87260148; 87260057; 87260181; 87260075; 87260179; 87260183; 87260185; 87260186; 87260189; 87260187; 87260188; 87260190; 87260191; 87260074; 87260161; 87260162; 87260066. ",".","109 allografts ","Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.",8/6/2013,"08/06/2013",11/5/2014,"11/05/2014"
"Biologics",68516,"Completed","University of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide and Greece.","B-0004-15","Class II","Tendon","87260047; 87260048; 87260049; 87260050; 87260051; 87260054; 87260055; 87260058. ",".","8 allografts ","Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.",8/6/2013,"08/06/2013",11/5/2014,"11/05/2014"
"Devices",68519,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.","Z-1976-2014","Class II","Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures ","Lot Numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010",,"1250 battery chargers","LED battery chargers may prematurely fail and will not charge the LED battery as intended",6/11/2014,"06/11/2014",7/9/2014,"07/09/2014"
"Devices",68520,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.","Z-1991-2014","Class II","ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790","Kit Lots Ending In: 078, 079, 082, 083, 084",,"34,283 kits","The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Devices",68521,"Ongoing","Argon Medical Devices, Inc","Athens","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2696-2014","Class II","The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. ","Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm)",,"3,783 units","UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Devices",68521,"Ongoing","Argon Medical Devices, Inc","Athens","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2697-2014","Class II","The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. ","Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm)",,"3,783 units","UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Devices",68521,"Ongoing","Argon Medical Devices, Inc","Athens","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2698-2014","Class II","UltraStream Peel Away Kit The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. ","Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm)",,"3,783 units","UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Drugs",68522,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1538-2014","Class II","Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10 ","lot 29C220, Exp. 11/15 ",".","3881bottles","Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.",6/5/2014,"06/05/2014",8/20/2014,"08/20/2014"
"Food",68523,"Terminated","Wegmans Food Markets, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","E-Mail","reatil stores located in NJ, MD, VA, and PA.","F-2205-2014","Class II","WEGMANS ICE in plastic bags; NET WT. 7 LBS (UPC 77890 29197) and NET WT 18 LBS (UPC 77890 29200) --- WEGMANS FOOD MARKETS INC. ROCHESTER, NEW YORK ","All codes sold between 1/1/2014 and 6/10/2014",,"7 lbs: 13,440 bags; 18 lbs.: 61,920 bags","Product may contain metal pieces from a broken part in the ice machine.",6/10/2014,"06/10/2014",7/30/2014,"07/30/2014"
"Devices",68524,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.","Z-1990-2014","Class II","MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic.","WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284. ",,"WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.","Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.",6/2/2014,"06/02/2014",7/9/2014,"07/09/2014"
"Food",68525,"Ongoing","Oregon Freeze Dry, Inc.","Albany","OR","US","Voluntary: Firm Initiated","Telephone","Product was distributed in the United States to: AL, AR ,AZ, CA, CO, CT ,DE, FL, ID, IL, IN, KY, MI, MN, MO, MS, NC, NE, NV, NY, OH, OR, PA, SC, RI, TN, TX, UT, VA, and WV. No foreign distribution.","F-2087-2014","Class II","Mountain House Freeze-Dried Precooked Scrambled Eggs with Ham and Red & Green Peppers, 19.4 oz 1 LB 3.4 oz), packed in #10 metal can. Product is labeled in part ''***INGREDIENTS: Precooked Scrambled Eggs* (whole eggs, egg yolk, nonfat dry milk, modified corn starch, corn oil, salt, yeast extract, sunflower oil, smoke flavoring, xanthan gum). Ham* (ham, salt, dextrose, sodium tripolyphosphate, sodium erythorbate, smoke flavor, sodium nitrite), Red and Green Peppers*. *Freeze Dried CONTAINS: Milk, Egg.***OREGON FREEZE DRY, INC***ALBANY, OR***''","Two codes are being recalled: BEST USED BY MAR 2039 14082 BEST USED BY FEB 2039 14042 Codes are stamped on bottom of can. The affected cans were sold in cases labeled as Granola with Milk and Blueberries, which can be identified by Lot Number 1141144 and Lot 1140585 -on the side of the case. Product Code 30-449.",,"248 cans (Mixture of correctly and incorrectly labeled cans)","Oregon Freeze Dry, Inc. is voluntarily recalling Mountain House Scrambled Eggs with Ham and Red & Green Peppers due to undeclared wheat, soy and coconut. Canned product has the potential to be mislabeled and actually contain Mountain House Granola with Milk and Blueberries.",6/11/2014,"06/11/2014",7/16/2014,"07/16/2014"
"Devices",68526,"Ongoing","Ebi, Llc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the country The Netherlands.","Z-1811-2014","Class II","Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.","Catalog Number 14-501669; Lot Number 006731",,"32 units (30 domestic and 2 international)","The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.",5/15/2014,"05/15/2014",6/25/2014,"06/25/2014"
"Devices",68527,"Terminated","Omnilife Science Inc.","East Taunton","MA","US","Voluntary: Firm Initiated","Letter","US: CA, OK, VA, FL, MA, NY, TX","Z-2241-2014","Class II","Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA","Lot: 17284",,"13 devices","Staining on hip implant.",5/9/2014,"05/09/2014",8/27/2014,"08/27/2014"
"Devices",68528,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.","Z-1988-2014","Class II","GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.","Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 00000030772HL8 201291PROTEUS 00000018574HL4 201358ER1 00000018682HL5 201358ER2 00000023348HL6 201418RAD1 00000021851HL1 201418RAD3 00000030395HL8 201599PRO 00000100468HL8 201795ER 00000032859HL1 202269PRO 00000013889HL1 202715PRO 00000016974HL8 203679RAD 00000078697HL0 203688PROTLW2 00000021322HL3 203797PROT1 00000022725HL6 203797PROT2 00000028953HL8 203797PROT3 00000027089HL2 203852ED1 00000030390HL9 203852RM1 00000028277HL2 203852RM5 00000023570HL5 205387PRO 00000044402HL6 205750RAD 00000013259HL7 206215RM1 00000037711HL9 206248RAD1 00000034679HL1 206302XRM1 00000013114HL4 206543HECED 00000016238HL8 207454CRAD1 00000080456HL7 207664PROTEUS 00000039888HL3 207795CM3 00000018794HL8 208227RM1 00000019521HL4 208227RM5 00000040501HL9 208265PROT 00000020176HL4 208359RM2 00000020667HL2 208373RAD2 00000023516HL8 208373RAD3 00000019212HL0 208381ED1 00000103408HL1 208402RAD1 00000042856HL5 208455RAD3 00000041973HL9 208455RAD4 00000035259HL1 208463RAD1 00000015447HL6 208463RAD2 00000029208HL6 208476CRAD 00000037477HL7 208524ROOM2 00000013648HL1 208529ER 0000"," 718262RAD1 00000023154HL8 718267ER 00000047493HL2 718470XRA 00000023149HL8 718567ER 00000034297HL2 718567RM3 00000032757HL7 718567RM4 00000029670HL7 718604ER1 00000028954HL6 718604PROTEUS1 00000046869HL4 718604PROTEUS2 00000014705HL8 718830PROTEUS 00000095417HL2 718960PROT1 00000021849HL5 719560GD1 00000037942HL0 719560GR2 00000047952HL7 719846XR 00000031529HL1 724230PROT1 00000012541HL9 724537ER 00000019374HL8 724537PROT1 00000013106HL0 724543R1 00000022721HL5 724627PROT2 00000041177HL7 724779PROT 00000049583HL8 724779PROT2 00000025536HL4 724MTVXR 00000037813HL3 727341PPER1 00000037337HL3 727341RAD1 00000017647HL9 727521ER 00000041854HL1 727528RAD1 00000042164HL4 727588XRA5 00000046507HL0 731422RM2 00000023882HL4 731425RS 00000031014HL4 731425TRAUMA2 00000027819HL2 731425TRAUMA3 00000031016HL9 731584RAD 00000040832HL8 731659RF1 00000028269HL9 731784RM1 00000037943HL8 732223PRO 00000019742HL6 732294ER 00000034665HL0 732321ERP2 00000021004HL7 732321ERPRO 00000017434HL2 732360ER 00000034930HL8 732360PAT 00000034437HL4 732499PROT5 00000032864HL1 732499PROT7 00000021003HL9 732505RAD 00000028760HL7 732530ERP1 00000028762HL3 732530ERP2 00000048251HL3 732840PRO4OP 00000039694HL5 732840PROER1 00000041122HL3 732840PROER2 00000045425HL6 732840PROER3 00000015855HL0 732970RAD 00000046739HL9 734246PROT 00000020748HL0 734254PROT 00000015854HL3 734434PROT 00000043483HL7 734446PROT 00000016643HL9 734475ORTHO 00000088062HL5 734712AABJ 00000021170HL6 734712PROT1 00000028156HL8 734930UMED 00000079516HL1 740351PROT 00000018797HL1 740356PROT 00000038342HL2 740356PROT2 00000023520HL0 740368PR2 00000021850HL3 740368PR4 00000020840HL5 740369PR3 00000041963HL0 740393PROT1 00000041611HL5 740393PROT3 00000048066HL5 740420PRO 00000037713HL5 740454BHER 00000031132HL4 740454BHRM6 00000013274HL6 740454PROT 00000042836HL7 740454SZUC 00000028271HL5 740474R2 00000092085HL0 740506PROT 00000033491HL2 740592PROD 00000044644HL3 740779PRO1 00000045206HL0 740779PRO3 00000049926HL9 740941WRM1 00000014157HL2 740HOCPRO 00000029943HL8 757398PRO1 000000","3460","GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Devices",68528,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.","Z-1989-2014","Class II","GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. ","Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 00000030772HL8 201291PROTEUS 00000018574HL4 201358ER1 00000018682HL5 201358ER2 00000023348HL6 201418RAD1 00000021851HL1 201418RAD3 00000030395HL8 201599PRO 00000100468HL8 201795ER 00000032859HL1 202269PRO 00000013889HL1 202715PRO 00000016974HL8 203679RAD 00000078697HL0 203688PROTLW2 00000021322HL3 203797PROT1 00000022725HL6 203797PROT2 00000028953HL8 203797PROT3 00000027089HL2 203852ED1 00000030390HL9 203852RM1 00000028277HL2 203852RM5 00000023570HL5 205387PRO 00000044402HL6 205750RAD 00000013259HL7 206215RM1 00000037711HL9 206248RAD1 00000034679HL1 206302XRM1 00000013114HL4 206543HECED 00000016238HL8 207454CRAD1 00000080456HL7 207664PROTEUS 00000039888HL3 207795CM3 00000018794HL8 208227RM1 00000019521HL4 208227RM5 00000040501HL9 208265PROT 00000020176HL4 208359RM2 00000020667HL2 208373RAD2 00000023516HL8 208373RAD3 00000019212HL0 208381ED1 00000103408HL1 208402RAD1 00000042856HL5 208455RAD3 00000041973HL9 208455RAD4 00000035259HL1 208463RAD1 00000015447HL6 208463RAD2 00000029208HL6 208476CRAD 00000037477HL7 208524ROOM2 00000013648HL1 208529ER 0000"," 718262RAD1 00000023154HL8 718267ER 00000047493HL2 718470XRA 00000023149HL8 718567ER 00000034297HL2 718567RM3 00000032757HL7 718567RM4 00000029670HL7 718604ER1 00000028954HL6 718604PROTEUS1 00000046869HL4 718604PROTEUS2 00000014705HL8 718830PROTEUS 00000095417HL2 718960PROT1 00000021849HL5 719560GD1 00000037942HL0 719560GR2 00000047952HL7 719846XR 00000031529HL1 724230PROT1 00000012541HL9 724537ER 00000019374HL8 724537PROT1 00000013106HL0 724543R1 00000022721HL5 724627PROT2 00000041177HL7 724779PROT 00000049583HL8 724779PROT2 00000025536HL4 724MTVXR 00000037813HL3 727341PPER1 00000037337HL3 727341RAD1 00000017647HL9 727521ER 00000041854HL1 727528RAD1 00000042164HL4 727588XRA5 00000046507HL0 731422RM2 00000023882HL4 731425RS 00000031014HL4 731425TRAUMA2 00000027819HL2 731425TRAUMA3 00000031016HL9 731584RAD 00000040832HL8 731659RF1 00000028269HL9 731784RM1 00000037943HL8 732223PRO 00000019742HL6 732294ER 00000034665HL0 732321ERP2 00000021004HL7 732321ERPRO 00000017434HL2 732360ER 00000034930HL8 732360PAT 00000034437HL4 732499PROT5 00000032864HL1 732499PROT7 00000021003HL9 732505RAD 00000028760HL7 732530ERP1 00000028762HL3 732530ERP2 00000048251HL3 732840PRO4OP 00000039694HL5 732840PROER1 00000041122HL3 732840PROER2 00000045425HL6 732840PROER3 00000015855HL0 732970RAD 00000046739HL9 734246PROT 00000020748HL0 734254PROT 00000015854HL3 734434PROT 00000043483HL7 734446PROT 00000016643HL9 734475ORTHO 00000088062HL5 734712AABJ 00000021170HL6 734712PROT1 00000028156HL8 734930UMED 00000079516HL1 740351PROT 00000018797HL1 740356PROT 00000038342HL2 740356PROT2 00000023520HL0 740368PR2 00000021850HL3 740368PR4 00000020840HL5 740369PR3 00000041963HL0 740393PROT1 00000041611HL5 740393PROT3 00000048066HL5 740420PRO 00000037713HL5 740454BHER 00000031132HL4 740454BHRM6 00000013274HL6 740454PROT 00000042836HL7 740454SZUC 00000028271HL5 740474R2 00000092085HL0 740506PROT 00000033491HL2 740592PROD 00000044644HL3 740779PRO1 00000045206HL0 740779PRO3 00000049926HL9 740941WRM1 00000014157HL2 740HOCPRO 00000029943HL8 757398PRO1 000000","1053","GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.",6/4/2014,"06/04/2014",7/9/2014,"07/09/2014"
"Devices",68529,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.","Z-1962-2014","Class II","ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.","10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590 208609 210104 210121 210187 210103 201296 201355 202477 206011 208663 210186 210172 210173 210178 210188 210257 200379 201754 202985 206249 206592 206715 206746 207626 207735 207737 207755 207940 207944 208654 208668 208718 208772 208775 208790 208903 208912 208913 210112 210229 210260 201382 206829 208902 208908 202372 202373 210119 210677 202063 203127 206492 207586 207613 208637 208701 208867 210361 201186 208554 210018 210039 210058 210227 201216 201186 208142 208153 210128 210179 210181 210183 210185 210191 210258 210268 210334 210451 208606 210149 210212 210236 210357 200128 210536 210565 210189 210170 202133 210166 210171 210310 210352 210485 210552 210559 200620 203593 200360 203253 203552 207041 210159 208733 210235 210242 210124 210474 210299 210329 208029 208047 208082 208527 207324 210285 208610 208807 208843 210233 210234 210246 206629 210157 205322 206538 208052 208825 208834 208838 202862 208752 210010 210176 210264 210269 210277 210304 210312 210414 210479 210487 207616 207648 207649 208010 208159 210385 201141 201210 203247 208984 210337 210348 210355 210495 210539 203414 210062 201430 210035 200113 207270 207276 207279 210034 210118 210184 210205 210298 210301 210311 210319 201350 205489 206529 208919 208920 210096 210195 207522 207647 210371 210254 210263 207272 207280 207287 207294 210470 200327 210308 210531 201125 208941 200319 202832 207609 210665 210679 207258 207296 207435 207467 207749 207952 210163 210164 210321 210383 210392 210433 210439 210664 207348 208603 210036 210152 210270 210326 210347 210397 207600 207697 207699 210134 210135 210255 210402 207674 201433 205152 207658 208072 208905 210046 210053 210055 210061 210063 210143 210153 210199 210204 210209 210215 210240 210241 210265 210274 210295 210324 210343 210667 201351 201354 202978 210026 210248 210300 208330 208376 210032 210038 210042 210044 210162 210203 210207 210213 210214 210217 210223 210379 210388 208959",,"790 units","There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.",6/3/2014,"06/03/2014",7/9/2014,"07/09/2014"
"Food",68530,"Ongoing","Naturex Inc.","S Hackensack","NJ","US","Voluntary: Firm Initiated","Telephone","TN, TX, & WA","F-2179-2014","Class III","Echinacea Angustifolia Root PE 4: The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.","EC330955, Lot#C073/050/A14",".","25 kg","Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507.",6/9/2014,"06/09/2014",7/23/2014,"07/23/2014"
"Food",68530,"Ongoing","Naturex Inc.","S Hackensack","NJ","US","Voluntary: Firm Initiated","Telephone","TN, TX, & WA","F-2177-2014","Class III","Echinacea Agustifolia Root PE 4:1 The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.","EC330955, Lot #C133/068/A13",".","9 boxes (25 kg each) ","Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507.",6/9/2014,"06/09/2014",7/23/2014,"07/23/2014"
"Food",68530,"Ongoing","Naturex Inc.","S Hackensack","NJ","US","Voluntary: Firm Initiated","Telephone","TN, TX, & WA","F-2178-2014","Class III","Echinacea Agustifolia PE 4& echinosides The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.","ED161322, Lot #C129/081/A13",".","4 boxes (each 25 kg)","Products contain Azoxystrobin for which no tolerance is allowed per 40 CFR 180.507.",6/9/2014,"06/09/2014",7/23/2014,"07/23/2014"
"Devices",68531,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, TX, and NY.","Z-1871-2014","Class II","IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope Intuitive Surgical Inc.","470026-18",".","19 units","In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue",6/11/2014,"06/11/2014",7/2/2014,"07/02/2014"
"Devices",68531,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, TX, and NY.","Z-1870-2014","Class II","IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope Intuitive Surgical Inc.","470027-20",".","20 units","In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue",6/11/2014,"06/11/2014",7/2/2014,"07/02/2014"
"Drugs",68532,"Ongoing","Central Admixture Pharmacy Services, Inc.","Livonia","MI","US","Voluntary: Firm Initiated","Telephone","Michigan and Wisconsin","D-1560-2014","Class I","del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150","Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014 ",".","31 doses","Non Sterility; microbial contamination identified as Aspergillus species",5/28/2014,"05/28/2014",9/3/2014,"09/03/2014"
"Drugs",68532,"Ongoing","Central Admixture Pharmacy Services, Inc.","Livonia","MI","US","Voluntary: Firm Initiated","Telephone","Michigan and Wisconsin","D-1561-2014","Class I","adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 ","Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 2014",".","5 doses","Non Sterility; microbial contamination identified as Aspergillus species",5/28/2014,"05/28/2014",9/3/2014,"09/03/2014"
"Drugs",68532,"Ongoing","Central Admixture Pharmacy Services, Inc.","Livonia","MI","US","Voluntary: Firm Initiated","Telephone","Michigan and Wisconsin","D-1562-2014","Class I","LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 ","Lot # 13-920739-01 through Lot # 13-920739-04 (4 total doses) EXP 21 Jun 2014",".","4 doses","Non Sterility; microbial contamination identified as Aspergillus species",5/28/2014,"05/28/2014",9/3/2014,"09/03/2014"
"Drugs",68532,"Ongoing","Central Admixture Pharmacy Services, Inc.","Livonia","MI","US","Voluntary: Firm Initiated","Telephone","Michigan and Wisconsin","D-1559-2014","Class I","PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 ","Lot # 13-920741-0-1 EXP 21 JUN 2014",".","1 dose","Non Sterility; microbial contamination identified as Aspergillus species",5/28/2014,"05/28/2014",9/3/2014,"09/03/2014"
"Food",68533,"Ongoing","Oaxaca Mexican Products","Passaic","NJ","US","Voluntary: Firm Initiated","Telephone","NY, NJ, & PA","F-2195-2014","Class II","Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055","No codes or dates",".","10 cases with 12 packages 1.5 oz each","Mango Enchilado contains undeclared colors and sulfites. It is also contaminated with lead.",4/16/2014,"04/16/2014",7/23/2014,"07/23/2014"
"Food",68534,"Ongoing","Oaxaca Mexican Products","Passaic","NJ","US","Voluntary: Firm Initiated","Letter","CT, DE, NJ & NY","F-2091-2014","Class II","Oaxaca brand of Anelina in 1/2 oz plastic bags with paper label reading in part: ''Oaxaca Mexican Products 100 8th Street Passaic New Jersey 07055 UPC 807310007466 ***''","None ",,"approximately 8 cases (24 plastic bags per case)","Anelina contains undeclared and unapproved colors.",2/6/2014,"02/06/2014",7/16/2014,"07/16/2014"
"Devices",68535,"Ongoing","Ability Dynamics LLC","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and in the countries of Australia and Canada.","Z-1825-2014","Class II","RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use","Serial Numbers: B1400045 B1400085 B1400272 B1400352 B1400101 B1400344 B1300083 B1400133 B1400114 B1300030 B1400290 B1400297 B1400197 B1400305 B1300043 B1400264 B1300080 B1400024 B1400087 B1300073 B1400108 B1400330 B1400138 B1300056 B1400261 B1400210 B1400321 B1400337 B1400300 B1400323 B1400351 B1400103 B1400104 B1400156 B1400173 B1400202 B1400222 B1400232 B1400253 B1400269 B1300062 B1400296 B1400258 B1400083 B1400111 B1300084 B1400135 B1400294 B1400031 B1400036 B1400162 B1300082 B1400102 B1400050 B1400051 B1400076 B1400084 B1300038 B1300025 B1400288 B1400280 B1400281 B1400312 B1400018 B1400252 B1400245 B1400260 B1400128 B1400201 B1400215 B1400308 B1400071 B1400033 B1400058 B1400213 B1400196 B1400214 B1400203 B1400204 B1400115 B1400212 B1400144 B1400319 B1400238 B1300072 B1300074 B1400336 B1400335 B1300061 B1400174 B1400175 B1400171 B1400194 B1300050 B1400059 B1400025 B1300036 B1400074 B1400089 B1400234 B1400346 B1400010 B1300065 B1400055 B1400064 B1300048 B1400151 B1400066 B1400090 B1400118 B1400119 B1400147 B1300029 B1300064 B1400227 B1400230 B1400231 B1400152 B1400153 B1300032 B1400216 B1400239 B1400241 B1400242 B1300075 B1400020 B1400298 B1400311 B1300023 B1400338 B1400340 B1400134 B1400143 B1400005 B1400289 B1300060 B1400105 B1400225 B1400332 B1400141 B1400154 B1400043 B1400098 B1400181 B1400318 B1400223 B1400220 B1400339 B1400182 B1400268 B1400334 B1300026 B1400049 B1400046 B1400047 B1400052 B1400249 B1400027 B1300047 B1300051 B1300053 B1400155 B1400310 B1400160 B1300079 B1300066 B1400015 B1400350 B1400273 B1400185 B1400250 B1400322 B1400061 B1300035 B1400168 B1300004 B1300005 B1300009 B1300010 B1300014 B1300015 B1300016 B1300020 B1400270 B1400271 ",,"175 units","Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.",6/2/2014,"06/02/2014",6/25/2014,"06/25/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2480-2014","Class I","Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN MARKER WITH RULER (1) TUBE SUCTION CONNECT Y4'' X 12' ( 1) CAST PADDING SOFT ROLL 4'' X 4yds (10) GAUZE SPONGE 4'' X 4'' 16PLY ( 1) MERLING SKIN PREP APPLIC 39ML (1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50'' X 90'' (2) DRAPE SHEET 42'' X 55'' ( 1) STOCKINETTE 9'' x 48'' (1) CAUTERY PENCIL ROCKER SWITCH (2) LITE GLOVE ( 1) BANDAGE ESMARK 6'' X 9yds ( 1) SHEET EXTREMITY ABS SMS 125'' X 85'' ( 1) UTILITY BOWL QUART 32oz Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2615, 6 lots: 113099520 131110253 131210797 140211867 140312138 140412662 ",,"6 lots (272 packed units, multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2337-2014","Class I","LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44'' X 78'' (1) LAPAROSCOPY SHEET ''T'' SMS (3) TOWELS ABSORBENT 15'' X 20'' (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7'' CUFF 30'' x 42'' (1) UNDERBUTTOCK DRAPE WITH POUCH 44'' X 35'' (4) DRAPE UTILITY WITH TAPE (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) CONNECTING TUBING 3/16'' X 12'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-618, 24 lots: 109010109 109030609 109040846 109051047 109061208 109071536 109071688 109092073 109102337 112020491 112030732 112051999 112062499 112083436 112093647 113036805 113057495 113057617 113078338 113088878 113099446 113109861 140211734 140312178 ",,"24 lots; 648 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2408-2014","Class I","CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41'' X 58'' SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%'' X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15'' LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4'' X 14'' (1) DRAPE C-SECTION WITH POUCH 102'' X 121'' X 78'' (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50'' X 90'' L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24'' X 24'' L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 112062447 112125292 113015635 113026050 113036756 113057398 113067894 113078273 113088759 113099390 113109748 131210760 140111171 140211792 140312084 140412458 ",,"23 lots; 804 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2530-2014","Class I","Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15'' X 20'' LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X'' X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50'' X 90'' LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5''X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18'' X 18'' XRD LIF (1) SHEET DRAPE 42'' X 57'' SMS LIF (1) SHEET DRAPE 70'' x 100'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3431, 1 lot: 140513333 ",,"1 lot/ 45 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2443-2014","Class I","NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15'' X 20'' LIF ( I ) BAG BI OH AZARD 30'' X 37'' (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4'' X 4'' 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79'' X 110'' HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8'' X 1 8'' XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8'' STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53'' X 77'' LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02'' X 78'' X 1 21 '' STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2256, 12 lots 112041300 113026058 113047204 113057738 113078309 113088794 113109793 131110244 131110291 140111095 140412649 140513128 ",,"12 lots/256 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2352-2014","Class I","FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15'' X 20'' UF (1) DRAPE ANGlO 75'' X 145'' (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06'' LONG LIF (20) GAUZE SPONGE 4'' X 4'' 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5'' LIF (1) MOSQUITO HALSTED CVD 5'' LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035'' X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-796, 14 lots: 113047032 113057507 113067965 113078346 113088892 113109873 131110279 131210842 140111251 140211700 140311949 140312388 140513145 140513340 ",,"14 lots; 580 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2487-2014","Class I","Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50'' X 90'' LIF (4) (1) PVP PAINT 8'' STICK SPONGE (2) DRAPESHEET 41X AMED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2)DRAPE UTILITY Rape LIF (1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y (20) APPLICATOR COTOIN 6 WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2582, 2 lots: 112030835 112041310 ",,"2 lots/ 140 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2534-2014","Class I","Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15'' X 20'' (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7'' CUFF 30'' X 42'' (1) DRAPE UNDERBUTTOCK WITH POUCH 44'' X 35'' (1) DRAPE ABDOMINAL WITH TAPE 40'' X 54'' (1) DRAPE UTILITY WITH TAPE (1) COVER TABLE REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","code 900-2487, 1 lot: 113078525 ",,"0 distributed; 300 packed units manufactured under firm's control","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2378-2014","Class I","LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41'' X 58'' SMS LIF (4) ABSORBENT TOWELS 15'' x 20'' LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6'' X 96'' (1) TUBE SUCTION CONNECT.%'' X 12' LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TABLE COVER 44'' X 78'' REINFORCED LIF (1) TEGADERM TRANS DRESSING 6'' X 8'' (2) LEGGINS WITH 7'' CUFF 30'' X 42'' (10) GAUZE SPONGES 4'' X 4'' 12PLY XRD (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) TUR CYSTO IRRIGATION SET 79'' (1) FOLEY CATHETER 16FR 2WAY, 5CC (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (2) GOWN IMPERVIOUS EXTRA REINF XLG LIF (1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT) (1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF (1) CEFAZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1192, 10 lots: 113057752 113067947 113078458 113078680 113099381 140211710 140312054 140412584 140513072 140513334 ",,"10 lots; 345 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2515-2014","Class I","Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINFORCED 44 X 90 (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (2) TOWEL ABSORBENT 15 X 20 (1) MINDE KNIFE 1.0MM, WIDE, 40 DEGREE ANGLE, 6.0MM IN LENGTH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2966, 2 lots: 131210948 140613794 ",,"2 lots, 72 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2469-2014","Class I","TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE LAP TRANSVERSE (1) TABLE COVER REINFORCED 50'' X 90'' (1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP (1) GOWN XL SMS IMPERVIOUS REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2491 , 4 lots 112031036 112072729 113078526 140513220 ",,"4 lots/654 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2388-2014","Class I","PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102'' X 121'' X 78'' ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50'' X 90'' LIF (2) DRAPE SHEET 41 '' X 58'' SMS (2) TOWELS ABSORBENT 15'' x 20'' LIF (I ) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1383, 32 lots: 109010046 109020262 109030545 109061169 109061419 109071711 109071724 109091995 109102264 109122744 110010037 110020306 110081959 110092383 110123086 111010040 111030570 111051156 111061493 111061849 111071888 111082185 112051750 112093869 112104143 112114938 113067949 113068039 113099302 113109721 140412844 140613591 ",,"32 lots; 984 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2381-2014","Class I","PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6'' WOOD LIF (1 0) GAUZE SPONGES 4''X 4'' 12PL Y (2) TOWELS ABSORBENT 15'' x 20'' LIF (1) COVER MAYO STAND REINFORCED LIF (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF (1) COVER TABLE REINFORCED 50'' x 90'' LIF (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1293, 7 lots: 110092130 111041087 112020325 112051676 112051745 112062348 112083385 ",,"7 lots; 720 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2383-2014","Class I","PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) TUR Y SET 81 ''2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1295, 2 lots: 111030561 112031009 ",,"2 lots; 258 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2422-2014","Class I","ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4'' X 4'' 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44'' X 90'' (4) DRAPE UTILITY WITH TAPE L/F ( 1) DENTURE CUP WITH LID ( 1) UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( 1) NEEDLE HYPODERMIC 27G X 1 Y..'' ( 1) SHEET SPLIT WITH ADHESIVE 108'' X 77'' STD SMS LIF (3) CAP NURSE 21 '' GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( 1) PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( 1) SCALPEL WEIGHTED SAFETY # 11 ( 1) PROBE DRAPE ST 6'' X 96'' NO GEL LIF ( 1) WRAPPER 30'' X 30'' (3) TOWELS ABSORBENT 15'' X 20'' L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1937, 12 lots: 111082312 111113057 112020431 112051902 112062289 113025829 113026168 113067902 113088773 131210660 140211699 140312423 ",,"12 lots; 190 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2390-2014","Class I","VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36'' X 36'' (1) IMP. STOCKINETTE 14'' X 48'' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1401, 3 lots: 109050994 110020540 110081960 ",,"3 lots; 48 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2444-2014","Class I","LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15'' X 20'' (2) LEGGINS W/7'' CUFF 30'' X 42'' (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (2) UTILITY BOWL 16oz (2) STERI STRIP CLOSURE W' X 4'' (1) ACTIFOG W/FOAM PAD SOLUTION (1) TABLE COVER REINFORCED 50'' X 90'' (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM (1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON (1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES (1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE (1) DRAPE LAP. ABDO W/POUCH 102'' X 122'' X 78'' STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501 ",,"17 lots/626 units,(multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2460-2014","Class I","BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53'' X 77'' (1) DRAPE SHEET 41'' X 58'' SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44'' X 78'' (2) GOWN SOFT SMS STD, XLGE SET IN SLEEVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2469 ,3 lots 112020350 112052029 112072722 ",,"3 lots/1300 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2316-2014","Class I","LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15'' x 20'' ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50'' X 90'' ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42'' X 55'' SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-281A, 3 lots: 140312027 140412669 140412796 ",,"3 lots; 1941 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2373-2014","Class I","FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24'' X 24'' (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PLY POLY 17'' X 18'' (2) SWABSTICK DRY COTTON (1) DRAPE 4'' FENESTRATED 18'' X 26'' (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated (1) SYRINGE 10cc WATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1127, 27 lots: 111082044 111092578 111102824 111112983 111123318 112020311 112030602 112041178 112072767 112083205 112093744 113015572 113025906 113036449 113047145 113068141 113088830 113099339 131110626 131210624 140111138 140211532 140211883 140412442 140412828 140513066 140513253 ",,"27 lots; 67410 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2349-2014","Class I","CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44'' X 90'' LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41'' X 58'' SMS LIF (2) TOWELS ABSORBENT 15'' X 20'' LIF (1) BANDAGE GAUZE STRETCH 4'' (1) NEEDLE HYPODERMIC 25G X 5/8 (2) BLADE SURGICAL #15 STAINLESS STEEL (2) TOWEL CLOTH HUCK BLUE LIF (1) PADDING CAST COTTON ROLL 2'' X 4yds (1) STOCKINETTE 6'' X 48'' L/F (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (4) DRAPE UTILITY LIF (1) GOWN SURG. FABRIC REINFORCED X-LARGE AAMI Ill LIF (1) TIME OUT BEACON NON WOVEN (1) HAND DRAPE ORTHOARTSO 76'' X 150'' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) BAG SUTURE FLORAL L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGEL TOWEL/WRAP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-742A, 4 lots: 140312026 140412702 140513380 140513481 ",,"4 lots; 360 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2366-2014","Class I","C-SECTION PACK - (1) TABLE COVER REINFORCED 50'' X 90'' L/F (3) TOWELS ABSORBENT 15'' X 20'' L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41'' X 69'' MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102'' X 121'' X 78'' (1) FEEDING TUBE 8FR. 15'' LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y.'' X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-998, 30 lots: 110102460 110112688 110123134 111010177 111020380 111040983 111051307 111061695 111071843 111082122 111092412 111092562 111102894 111123312 111123473 112020498 112030759 112041367 112072882 112083446 112093766 112114689 112125126 113026063 113036770 113078482 113109886 140111264 140311950 140412910 ",,"30 lots; 1392 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2380-2014","Class I","OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4'' X 4'' 12PL Y (2) LEGGINS W/ 7'' CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8'' STICK SPONGES (1) MEASURE DISP. PAPER TAPE 24'' (1) IMP .REINFORCED GOWN XLge. SMS STERILE (1) TABLE COVER Reinf. L/Free (1) SYRINGE 1cc W/NDL. 25G X 5/8 SLIP TIP L/Free (2) PAD OBSTETRICAL XLGE ST. (1) UNDERBUTTOCK DRAPE W/POUCH (1) SYRINGE 10cc W/0 NDL. L/Free (1) SYRINGE 20cc W/ONDL. L/Lock L/Free (1) FEEDING TUBE 8 Fr. 15'' LONG (1) BABY BLANKET IMP. POLY ABS. (1) NEEDLE HYPODERMIC 23GA X 1'' (6) ABSORBENT TOWELS L/Free (1) WRAPPER 24'' X 24'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1238, 1 lots: 109071538 ",,"1 lot; 30 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2434-2014","Class I","NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77'' x 110'' HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I'' 60'' X 77'' DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) CUP MEDICINE 2oz UF (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL (20) GAUZE SPONGE 4'' X 4'' 16ply XRD UF (5) SPONGE LAP PREWASH 18''X 18'' XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF (1) YANKAUER SUCT. TUBE W/0 VENT LIF (1) DRAPE INCISE ANTIMICROBIAL 23'' X 17'' LIF (1) POLISHER CAUTERY TIP LIF (2) PENCIL CAUTERY HAND SWITCHING LIF (1) DRAPE T LAPAROTOMY 102'' X 78'' X 121'' STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP (2) BLADE SURG #15 CARBON STEEL (1) PK.STRIP SURGICAL %'' X 6'' COTTON (1) PK.STRIP SURGICAL Y4'' X 6'' COTTON (10) GAUZE SPONGE 4'' X 4'' 16ply (1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt (4) SHEET DRAPE 42'' X 57'' SMS LIF (2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz. (2) SYRINGE EAR/ULCER 2oz LIF (2) BLADE EXTENDED ELECTRODE (2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR (1) STRIP SURGICAL 'I''X 6'' (2) GOWN XL SMS IMPERV. REINFORCED UF (1) CORD BIPOLAR FIRCEPS (4) TOWEL CLOTH HUCK (WHITE) (2) DRESSING OPSITE POST PO 2%'' x 2'' (2) POUCH INSTRUMENT 7 X 11 (1) MAYO TRAY LARGE (1) MAYO STAND COVER REINFORCED UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2122, 1 lot: 112124868 ",,"1 lot/15 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2484-2014","Class I","HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12'' X 48'' (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89'' X 128'' REINFORCED WITH ADHESIVE (1) COVER TABLE REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2504, 4 lots: 112020358 112052030 112072733 113078529 ",,"4 lots, 336 units, muliple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2330-2014","Class I","LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44'' X 78'' LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15'' X 20'' UF (1 0) GAUZE SPONGES XRD 4'' X 4''-12PL Y (2) DRAPE SHEET 41 '' X 58'' SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-547, 19 lots: 109010180 109030602 110020394 110041044 110061584 110071846 110112813 111030690 111102881 112020520 112030884 112051719 112083433 113025793 113036491 113046966 113057746 140111076 140312175 ",,"19 lots; 550 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2428-2014","Class I","GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15'' x 20'' LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF ( 1) LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41'' X 58'' SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 0) GAUZE 4''X 4'' X 4 PLY ( 1) CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( 1) CAUTERY PENCIL ROCKER SWITCH LIF (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF ( 1) TUBE SUCTION CONNECT. 3/16'' X 12' LIF ( 1) SURGICAL BLADE# 15 CARBON STEEL ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-2003, 29 lots: 112030702 112041277 112062472 112093923 112103923 112114386 112114472 112125311 113015438 113025954 113026205 113036457 113047011 113047156 113057447 113057696 113057814 113068159 113078779 113089205 113099569 131110221 131110405 131110582 140211725 140211874 140312378 140312461 140412832 ",,"29 lots; 2144 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2454-2014","Class I","TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02'' X 1 22'' X 78'' STD SMS (2) LEGGINGS W/7'' CUFF 30'' X 42'' ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50'' X 90'' LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42'' X 57'' SMS (I) TUBE SUCTION CONNECT Y.'' X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5'' X 20'' LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144'' X 35'' (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8'' XRD LIF ( I ) PVP PAINT 8'' STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2'' ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17'' X 18'' (I) DRAPE 4'' FENESTRATED 18'' X 26'' (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( I ) WRAPPER 24'' X 24'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2415 ,1 lots 140412654 ",,"1 lot ,6 units placed on hold at the firm","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2514-2014","Class I","Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2942: 113067718 113078516 113088808 ",,"3 lots/ 5460 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2419-2014","Class I","AV FISTULA PACK- (1) DRAPE T LAPAROT 102'' X 78'' X121 '' STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42'' X 57'' SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCTION CONNECT ''Y-1'' X 12' LIF (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF (2) LITE GLOVE LIF (1) BOWL UTILITY 32oz LIF (2) BOWL UTILITY 16oz LIF (10) LAP SPONGE PREWASH XRD LIF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 18G X 1 % (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF (1) COVER MAYO STAND REINFORCED LIF (1) COVER TABLE 44'' X 90'' (1) MAYO TRAY SMALL (2) ABSORBENT TOWEL 15'' X 20'' UF (1) BOWL WITH LID PLASTIC 80oz EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1922, 21 lots: 110112626 112010102 112030659 112041213 112051899 112062468 112081922 113025826 113036785 113057439 113078286 113088772 113089202 113109767 131110213 140111080 140111186 140211803 140312097 140312460 140412890 ",,"21 lots; 684 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2482-2014","Class I","Open Heart Pack, code 900-2618, contains: (9) DRAPE 60'' X 76'' REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15'' X 20'' L/F ( 1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REINFORCED 44'' X 78'' LIF (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP ( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS ( 1) SHEET SPLIT BILATERAL 84'' X 80'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2618, 7 lots: 113078598 113099489 113109819 131110407 140211729 140412561 140513137 ",,"7 lots, 259 packed units, multiple units for lot.","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2320-2014","Class I","CESAREAN PACK - - (7) TOWELS ABSORBENT 15'' X 20'' (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30'' X 30'' POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15'' LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST. (1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz. (1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST. (1) COVER TABLE REINFORCED 50'' X 90'' (1) SYRINGE 10CC W/0 NEEDLE L/LOCK (1) BOWL PLASTIC W/LID 80oz (2) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET DRAPE 41'' X 58'' SMS (1) DRAPE C SECTION W/POUCH 102'' X 121'' X 78'' (1) YANKAUER SUCTION TUBE W/0 VENT (1) WRAPPER 30'' X 30'' (15) SPONGE LAP PREWASH 18'' X 18'' XRD (1) TIME OUT BEACON NON WOVEN ST. (1) TUBE SUCTION CO NN ECT~'' X 12' (2) LIGHT SHIELD (1) GOWN SURG REINF LARGE T/WRAP (2) PK. STRIP STERI CLOSURE W' X 4'' (1) POLISHER CAUTERY TIP (1) DRESSING COMP OP 4'' X 14'' (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246 ",,"30 lots; 4396 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2371-2014","Class I","ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6'' X 5yrd. LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16'' X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) BAG SUTURE FLORAL LIF (1) BLADE SURGICAL #11 CARBON STEEL (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SYRINGE 30cc SLIP TIP LIF (1) TABLE COVER 44'' x 90'' (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15'' X 20'' LIF (5) LAP SPONGES PRE-WASH XRD UF (1) DRAPE SHEET 41 '' x 58'' SMS UF (1) NEEDLE HYPODERMIC 22G X 1 Y:z (1) NEEDLE HYPODERMIC 18G X 1 Y:z (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (10) GAUZE SPONGES 4'' X 4'' 16PL Y EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390 ",,"16 lots; 512 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2315-2014","Class I","LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15'' x 20'' (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50'' X 90'' ( I) MAYO STAND COVER REINFORCED ( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH (2) DRAPE SHEET 42'' X 55'' SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-281, 20 lots: 111061489 112093652 112104098 112114587 112125082 113015512 113015694 113036462 113036731 113057616 113057845 113068168 113078603 113089070 113109824 131110075 131110408 131110585 131210969 140111451 ",,"20 lots; 3576 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2311-2014","Class I","OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18'' X 18'' XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF (1) NEEDLE HYPODERMIC 27G X 'h'' (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF (1) JAR 16oz 500cc GRADUATE MEASURE (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (2) PENCIL CAUTERY HAND SWITCHING LIF (1) MARKER SKIN RULER (2) BANDAGE ELASTIC 4'' X 5yds LIF (2) POLISHER CAUTERY TIP LIF (2) BANDAGE ELASTIC 6'' X 5yds LIF (2) SYRINGE BULB 60cc CLEAR (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF (1) NEEDLE BLADE/KNIFE 3.0mm (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL (1) BLADE SHARP ALL ARROUND (1) BASIN EMESIS 10 IN 700cc (3) CATHETER 20FR ROB NEL RED RUB (3) BOWL UTILITY QUART 32oz LIF (2) CATHETER THORACIC 32FR STRAIGH (1) LABELS SET, HEPARINE, SALINE, ETC. (2) SAFETY SCALPEL #10 DISP (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP (2) BOWL UTILITY 16oz L/F (1) WRAPPER 54'' X 54'' L/F (1) CONNECTOR Y 3/8'' X 3/8'' X 3/8'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245 ",,"45 lots; 1292 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2334-2014","Class I","LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINFORCED (3) TOWEL ABSORBENT 15'' X 20'' UF (1) TUBBING INSUFFLATION SET WITHOUT RING (1) MAYO STAND COVER REINFORCED UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER (1) DRAPE SHEET 41 '' X 58'' SMS UF (1) BAG SUTURE FLORAL (4) DRAPE UTILITY UF (1) TUR CYSTO IRRIGATION SET 79'' SINGLE UF (1) TUBE SUCTION CONNECT. 3/16 '' x 12' UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-576A, 2 lots: 140312024 140513373 ",,"2 lots; 40 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2325-2014","Class I","CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4'' X 4'' 12PL Y LIF (4) ABSORBENT TOWELS 15'' X 20'' LIF (1) CYSTOSCOPY 'T' DRAPE 60'' X 87'' X 35'' SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7'' CUFF 30'' X 42'' LIF (1) TABLE COVER REINFORCED 44'' X 78'' LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44'' X 35'' LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 ''2.1 M REGULAR CLAM (4) GAUZE SPONGES 4'' X 4'' 12 PLY XRD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-430, 29 lots: 110020453 110030667 110051146 111030671 111040897 111061672 111071814 111082217 111092389 111102877 111113116 111123253 112010174 112030874 112041411 112072872 112083431 113015513 113015697 113036365 113047211 113057626 113078328 113088864 113109841 131110304 140111229 140312164 140412467 ",,"29 lots; 870 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2494-2014","Class I","Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY TIP POLISHER (20) GAUZE SPONGE 4X 4 12PL Y (4) TOWEL CLAMP (1) Y CONNECTOR (1) CAUTERY PENCIL PUSH BOTTOM (3) DRAPE SHEET 98 X 63 STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2681, 1 lot: 112093711 ",,"1 lot/80 packed units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2435-2014","Class I","KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15'' X 20'' L/F (10) GAUZE SPONGE 4'' X 4'' 16PLY (1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION CONNECT. W X 12' LIF (1) CAST PADDING SOFT ROLL 6 X 4yds L/F (2) BANDAGE ELASTIC 6'' X 5yds L/F (4) STRIP TAPE 24'' X 4'' LIF (1) Pk. STERI STRIP CLOSURE Y:z'' X 4'' LIF (1) SHEET ARTHROSCOPY ''T'' STD SMS W/POUCH L/F (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) NEEDLE SPINAL ANESTHESIA 18G X 3% LIF (1) SYRINGE 10cc W/0 NDL L/LOCK LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) GOWN IMPERV. XTRA REINF. LGE TIWRAP (1) MAYO STAND COVER REINFORCED LIF (2) NEEDLE HYPODERMIC 25 X 1Y:z LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) STOCKINETTE IMPERV. 14'' X 48'' LIF (1) TABLE COVER REINF. 50'' X 90'' LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) SAFETY GLIDE NEEDLE 21G X 1% (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2123, 22 lots 112041293 112041377 112051685 112083162 112093925 112104110 112114603 113015564 113026273 113036460 113036691 113078467 113088788 113109787 131110236 131210645 140111094 140211658 140312117 140412557 140513124 140613657 ",,"22 lots/784 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2528-2014","Class I","Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15'' X 20'' LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (3) LITE GLOVE LIF (1) DRAPE LAP ABDOMINAL W/POUCH 102'' X 122'' X 78'' (1) BLADE SURGICAL# 11 (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SUTURE BAG FLORAL L/F (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF (1) CABLE LAP 10FR 4MM MALE MONOP. LIF (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) SHEET% 60'' X 77'' DRAPE REINFORCED LIF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (1) WRAPPER 24'' X 24'' LIF (1) ULTRA VERES NEEDLE 120MM LIF (1) TROCAR ENDO.XCELL DILATING TIP 11 MM (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF (1) CANNULA 5MM XCEL SLEEVES LIF (2) DENTURE CUP 8oz W/LID (2) DRESSING NON ADH TELFA 4'' X 3'' (1) CHLORAPREP 26ML APPLICATOR TEAL LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3178, 4 lots: 131210899 140211837 140312152 140513143 ",,"4 lots/ 154 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2407-2014","Class I","O.B. PACK - (I) TABLE COVER REINFORCED 50'' X 90'' LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44'' X 35'' (2) LEGGINS W/7'' CUFF 30'' X 42'' (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15'' X 20'' LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4'' X 36'' 8PL Y XRD (10) GAUZE SPONGES 4'' X 4'' 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42'' X 75'' CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41'' X 58'' SMS LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626 ",,"49 lots; 1804 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2310-2014","Class I","Universal Pack- - (1) TABLE COVER REINFORCED 50'' X 90'' LIF (3) TOWEL ABSORBENT 15'' X 20'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X'' X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100'' X 53'' LIF (1) DRAPE BOTTOM ASS REINFORCED 71'' X 71'' WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36'' X 77'' (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24'' X 24'' (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753 ",,"8 lots; 120 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2527-2014","Class I","Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15'' X 20'' (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~'' X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER WITH RULER (2) RULER (1) COVER TABLE REINFORCED 50'' X 90'' (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST SMS (10) SPONGE LAP PREWASH 18'' X 18'' XRD (1) SHEET% DRAPE REINFORCED 60'' X 77'' (4) DRAPE UTILITY WITH TAPE (1) BLADE SURG. #15 CARBON STEEL (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE (10) GAUZE SPONGE 4'' X 4'' 16PLY (1) PK. STRIP STERI CLOSURE W' X 4'' (1) NEEDLE SPINAL ANESTH 22G X 3Y2 (1) NEEDLE HYPODERMIC 22G X 1Y2 (1) IV PRIMARY ADD ADMINISTRAT SET (1) STOPCOCK 3WAY WSWIVEL MALE (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3118; 2 lots: 131210806 140111440 ",,"2 lots/ 36 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2318-2014","Class I","OPHTALMIC PACK- (3) ABSORBENT TOWELS 15'' X 20'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6'' WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y.'' (1) NEEDLE HYPODERMIC 25G X 5/8'' (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106'' LONG L/F (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8'' STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-357, 2 lots: 113099550 113109831 ",,"2 lots; 60 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2395-2014","Class I","E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %'' X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15'' X 20'' L/F (1) DRAPE SHEET 41 '' X 58'' SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1482, 39 lots: 110102428 110112608 110123088 111010049 111020265 111030581 111040888 111051317 111061497 111071865 111082190 111092354 111102683 111113009 111123347 112010050 112020371 112030620 112041188 112051766 112062419 112083396 112093898 112124950 112125282 113025940 113036669 113047197 113067888 113068256 113078256 113109732 131210747 140111083 140211641 140312070 140312453 140513090 140613609 ",,"39 lots; 1771 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2470-2014","Class I","LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15'' X 20'' (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41'' X 58'' SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102'' X 78'' X 121'' STD SMS (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2492 , 12 lots 112020347 112051967 112072730 113099518 131110113 131110247 131110500 131211018 140211827 140312132 140412656 140513131 ",,"12 lots/2233 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2519-2014","Class I","Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15'' X 20'' (1 ) DRAPE INSTRUMENT MAGNETIC 10'' X 16'' (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT 110'' X 77'' (1 ) COVER TABLE REINFORCED 44'' X 78'' (20) GAUZE SPONGES 4'' X 4'' 12PLY (6) TOWELS CLOTH HUCK C BLUE (1 ) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3027, 1 lot: 113099552 ",,"1 lot/12 units ","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2396-2014","Class I","ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48'' M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15'' X 20'' LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4'' X 4'' 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5'' SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1488, 16 lots: 111123348 112010051 112020372 112030619 112041075 112072775 112104146 112124636 112124951 113025839 113026046 113036412 113078257 131210748 140211642 140412601 ",,"16 lots; 570 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2448-2014","Class I","LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50'' X 90'' UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17'' X 23'' UF (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30'' X 30'' WITH RUBBER BAND UF (1) DRAPE CHEST 100'' X 142'' X 72'' (1) RULER FLEXIBLE PLASTIC (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60'' X 77'' DRAPE REINFORCED UF (1) STRIP STERI CLOSURE%'' X 4'' UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8'' X 3'' NON ADH UF (1) DRESSING TEGADERM 4 X 4%'' UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727 ",,"5 lots/280 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2533-2014","Class I","LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15'' X 20'' LIF (2) LEGGINS W/7'' CUFF 30'' X 42'' LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4'' L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (1 0) LAP SPONGES PREWASH 18'' X 18'' XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2259A, 3 lots: 140312025 140412651 140612902 ",,"3 lots, 280 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2481-2014","Class I","Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y.''X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60'' X 70'' WIT APE UF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4''X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81'' 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50'' X 90'' UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2616, 4 lots: 112083077 113109907 131110339 140312139 ",,"4 lots, 114 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2499-2014","Class I","Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2718: 3 lots 113026299 113068033 113078728 ",,"3 lots/ 84 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2496-2014","Class I","Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2684, 2 lots: 112093646 113057473 ",,"2 lots/ 75 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2479-2014","Class I","Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y.'' X 12' UF (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15'' X 20'' UF (2) DRAPE SHEET 70'' X 100'' L/F (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100'' X 50'' SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23'' X 17'' (1) SKIN MARKER WITH RULER (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108'' X 77'' UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4'' X4'' 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6'' X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12'' X 48'' (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6'' X 9yds UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2614, 1 lot: 140312137 ",,"1 lot (30 packed units)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2302-2014","Class I","Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,& Guidewire EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-002, 26 lots: 112020289 112030605 112041383 112051709 112061653 112062296 112072757 112093974 112104120 112124901 113015421 113015629 113026199 113036745 113057404 113057683 113068134 113078451 113078655 113099260 131110394 131110574 140211618 140211908 140513048 140613547 ",,"26 lots, 1536 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2344-2014","Class I","ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) STOCKINETTE IMPERVIOUS 14'' X 48'' LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81'' 2.1M REGULAR CLAM (1) NEEDLE HYPODERMIC 18G X 1 ~ (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y (1) SHEET DRAPE 70'' X 100'' LIF (1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF (1 ) TUBE SUCTION CONNECT. X'' X 12' LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6'' X 21'' (1 ) DURAPREP SURGICAL SOLUTION 26ML LIF (1 ) NEEDLE SPINAL ANEST. 18G X 3 %'' LIF (2) ELASTIC BANDAGE 6'' X 5YRD. LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) PAD ABDOMINAL 8'' X 7.5'' (1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-740, 20 lots: 112030744 112041351 112052010 112062505 112072876 112093641 112104101 112114588 112125111 113015457 113025967 113036380 113057877 113088887 113099452 113099576 131110272 131210839 140111248 140211735 ",,"20 lots; 1356 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2365-2014","Class I","PERl GYN PACK (1) TABLE COVER 44'' x 90'' (2) LEGGINS W/7'' CUFF 30'' x 42'' (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15'' X 20'' (10) GAUZE SPONGE 4'' X 4'' 16PLY (2) DRESSING NON ADH TELFA 4'' X 3'' (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-997, 54 lots: 109010132 109020292 109061223 109061459 109081892 109092100 109102355 109112608 109122830 110010122 110030692 110030798 110061476 110071720 110081986 110092293 110092410 110112818 111010176 111020308 111030676 111041119 111051306 111061572 111071842 111082121 111082231 111092411 111102790 111113148 111123310 112020497 112030758 112041366 112052028 112072881 112083445 112093959 112104309 112125125 113015522 113025975 113026120 113036394 113057518 113078481 113088901 113099461 113109885 140111263 140211865 140312193 140412708 140513386 ",,"54 lots; 2965 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2372-2014","Class I","PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15'' X 20'' UF (2) LEGGINGS W/7'' CUFF 30'' X 42'' (1) TABLE COVER REINFORCED 44'' X 78'' UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451 ",,"56 lots; 5040 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2445-2014","Class I","LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15'' X 20'' LIF (2) LEGGINS W/7'' CUFF 30'' X 42'' LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4'' L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) NEEDLE ULTRA VERES 120MM LIF (1) STAPLE ARTICULATING ECHEL 60MM LIF (1) RELOAD WHITE 60MM ECHELON L/F (2) CANNULA 5MM XCEL SLEEVES LIF (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF (10) LAP SPONGES PREWASH 18'' X 18'' XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (2) LITE GLOVE (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (1) ELECTRODE DUAL DEPRES (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF (1) POLISHER CAUTERY TIP LIF (1) BAG GLASSINE (1) RELOAD BLUE 60MM LIF (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2259A, 3 lots 140312025 140412651 140612902 ",,"3 lots/280 units,(multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2394-2014","Class I","IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50'' X 90'' REINFORCED LIF ( I) MAYO STAND COVER REINFORCED LIF (5) TOWEL ABSORBENT 15'' X 20'' LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 70'' X I 00'' LIF (5) LAP SPONGES PRE-WASH 18'' X 18'' XRD L/F ( I) MAYO TRAY LARGE LIF ( I) DRAPE TOP WITH ADHESIVE LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) BULB SYRINGE 60cc LIF ( I) UTILITY BOWL 16oz L/F (2) UTILITY BOWL 32oz L/F ( I) INCISION DRAPE 23'' X I 7'' L/F (I) SKIN MARKER WITH RULER LIF ( I) U-DRAPE 54'' X 72'' W/TAPE SPLIT 6'' X 2 1'' LIF (2) ABDOMINAL PAD 8'' X 7.5'' L/F ( I) YANKAUER SUCTION TUBE W/0 VENT L/F (I) DURAPREP SURGICAL SOLUTION 26ML LIF ( I) SURGICAL BLADE # 10 STAINLESS STEEL (I) SPLIT SHEET W/ADH 108'' X 77'''' STD SMS LIF ( I) IMP. STOCKINETTE LIF (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF (2) IMP. GOWN REINFORCED X-LARGE SMS LIF (I) PENCIL CAUTERY ROCKER SWITCH LIF (I) SURGICAL BLADE #20 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1476, 12 lots: 112030618 112072885 112104097 112114378 112114555 112124949 113015689 113047329 113078255 113088832 113089191 121104357 ",,"12 lots; 399 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2364-2014","Class I","LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18'' X 18'' XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44'' X 90'' L/F (2) DRAPE SHEET 41 '' X 58'' SMS (1) LAPAROTOMY DRAPE ''T'' 102'' X 78'' X 121'' STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15'' X 20'' LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-996, 34 lots: 111040982 111051305 111061694 111071947 111082120 111092410 111092465 111102789 111113147 111123308 112010213 112020496 112030757 112041365 112052027 112072880 112083444 112093958 112114585 112125124 113025974 113036393 113057517 113057612 113057822 113078480 113078577 113099300 113099581 131110081 131110607 140111262 140211738 140513485 ",,"34 lots; 3603 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2431-2014","Class I","ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50'' x 90'' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15'' x 20'' LIF (1) MOSQUITO HALSTED (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE (1) SCALPEL SAFETY #11 (3) LABELS FOR SKIN MARKER (1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2 (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz (4) BAND BAG WITH RUBBAND & TAPE LIF (20) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH (1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE (2) NEEDLE HYPODERMIC 23GA X 1'' (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2038, 21 lots: 112114658 112125063 113026054 113036790 113047157 113057456 113067865 113068044 113078304 113078602 113099284 113109785 131110231 131110604 131211016 131211023 140111450 140311934 140412464 140412897 140513123 ",,"21 lots/ 1196 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2488-2014","Class I","Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44'' X 78'' LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2654, 2 lots: 112062214 112093599 ",,"2 lots/ 112 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2389-2014","Class I","OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53'' X 77'' LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9'' X 48'' LIF (1) SPLIT SHEET BILATERAL 84'' X 80'' LIF (3) DRAPE SHEET 41'' X 58'' SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12'' LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6'' X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4'' X 4'' 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4'' X 5 yds. LIF (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8'' X 3/8'' X 3/8'' LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718 ",,"6 lots; 127 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2476-2014","Class I","Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44'' X 90'' ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15'' X 20'' L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) COUNTER NDL /BLADE IOc MAG/CLEAR ( I) GOWN XL SMS IMPERV. REINFORCED LIF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF ( I) TUBE SUCTION CONNECT W' X 12' LIF (2) LITE GLOVE LIF ( 10) GAUZE SPONGE4'' X 4'' 16PLY XRD LIF (2) DRAPE SHEET 41'' X 58'' SMS LIF ( I) CAUTERY TIP POLISHER LIF ( I) MERLING SKIN PREP APPLIC. 39ML LIF ( I) UTILITY BOWL PINT 16oz LIF ( I) SKIN STAPLE 35 WIDE LIF ( I) UTILITY BOWL QUART 32oz LIF ( I) BLADE SURGICAL II CARBON STEEL ( I) TRAY MAYO SMALL ( I) BLADE SURGICAL 20 CARBON STEEL ( I) MAYO STAND COVER REINFORCED LIF ( I) DRAPE LAPAROTOMY 100'' X 72'' X 124'' W/POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2516, 2 lots: 131110250 131210792 ",,"2 lots, 93 units, multiple packed units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2439-2014","Class I","SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70'' X 100'' (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48'' (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18'' X 18'' XRD (2) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (2) DRAPE SHEET 41'' X 58'' SMS (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) TABLE COVER REINFORCED 50'' X 90'' (1) COBAN WRAP TAN 4'' X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X'' X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2193, 28 lots 111082204 111092380 111113084 111123219 111123426 112041379 112083164 112093928 113015445 113026056 113036438 113036728 113046937 113057461 113067867 113078470 113078790 113099287 113109790 131110074 131110499 131210647 131210968 140111415 140311935 140312380 140412834 140513127 ",,"28 lots/1707 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2335-2014","Class I","LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15'' X 20'' LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY BOWL 32oz (2) LEGGINS WITH 7'' CUFF 30'' X 42'' LIF (1) EMESIS BASIN 10in 700cc (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGES 4'' X 4'' 16PLY XRD LIF (2) TUBE SUCTION CONNECT 114'' X 12' LIF (1) TABLE COVER REINFORCED 44'' X 78'' UF (1) DRAPE LAP. PERINEAL 102'' X 97'' WITH POUCH (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-605, 34 lots: 110092266 110102447 110112666 110123109 111010142 111020291 111030694 111040908 111061557 111071939 111082104 111092395 111102768 111113129 111123270 112010189 112020490 112030886 112051997 112062497 112072807 112083435 112093728 112124593 112125104 113078336 113088877 113099445 113109859 131110267 131210832 140111091 140312177 140412696 ",,"34 lots; 1136 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2457-2014","Class I","CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41'' X 58'' SMS L/Free (1) CAP NURSE 21'' GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44'' X 31'' REINFORCED CIRC/ FENE (1) WRAPPER 24'' X 24'' GOWN LGE STANDARD SMS VELCRO NECK TOWELS ABSORBENT 15'' X 20'' L/Free Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2455 ,6 lots 111123428 112010145 112020523 112030832 112041305 112051957 ",,"6 lots/420 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2426-2014","Class I","SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50'' x 90'' LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (4) TOWELS ABSORBENT 15'' X 20'' LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70'' X 100'' SMS LIF (1) CUP SPECIMEN WITH CAP 4oz (1) TUBE SUCTION CONNECT. Y.'' X 12' LIF (1) SKIN MARKER WITH RULER (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) BAG SUTURE FLORAL LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 21G X 1% LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF (1) STOCKINETIE IMPERVIOUS 14'' X 48'' LIF (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC. (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (2) GAUZE SPONGE 4'' X 4'' 16PL Y XRD L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1985, 16 lots: 112030698 112041408 112083418 112093632 112114384 112114490 112125051 113025843 113026052 113026108 113036788 113057730 113078294 113088775 113099406 140111191 ",,"16 lots; 327 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2510-2014","Class I","BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15'' X 20'' LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt'' X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%'' X 4'' L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24'' X 24'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2915, 4 lots 113026307 113047021 113068035 113078731 ",,"4 lots, 168 units ( multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2368-2014","Class I","ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6'' X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125'' X 85'' SMS (1) DRAPE LASER CAMERA W/EL (3) TOWELS ABSORBENT 15'' X 20'' LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4'' X 4'' 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42'' X 55'' LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045 ",,"12 lots; 432 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2319-2014","Class I","ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035'' X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44'' X 90'' (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15'' X 20'' UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4'' X 4'' 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-366, 5 lots: 113026100 113057477 113078475 113088811 113109832 ",,"5 lots; 180 units (multiple lots per unit)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2506-2014","Class I","LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15'' X 20'' (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102'' X 78'' X 121'' STD SMS (1) COVER TABLE REINFORCED 50'' X 90'' (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) TIME OUT BEACON NON WOVEN (1) COUNTER NDUBLADE 20C FOAM/MAG (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2829, 4 lots 140111331 140211831 140312145 140412671 ",,"4 lots, 360 units ( multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2526-2014","Class I","Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15'' X 20'' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0'' X 77'' SMS (1) COVER TABLE REINFORCED 44'' X 78'' (20) GAUZE SPONGE 4'' X 4'' 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4'' (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60'' X 77'' REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3116, 1 lot: 131210805 ",,"1 lot/ 16 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2401-2014","Class I","DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4'' X 4'' 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON FENESTR. 18'' X 26'' UF ( I) TAPE TRANSPORE :Y. X 18 LIF ( I) WRAPPER 20'' X 20'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1538, 12 lots: 113078261 113088739 113089084 113109657 131110181 131210634 140111156 140211646 140312073 140412553 140412914 140613614 ",,"12 lots; 2950 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2326-2014","Class I","MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15'' X 20'' LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) DRAPE% ECONOMY 53'' X 77'' LIF (1) CAUTERY PENCIL ROCKER SWITCH (1) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-450, 60 lots: (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9'' X 96'' LIF (5) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50'' X 90'' (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41'' X 58'' SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4'' X 4%'' (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %''X 12' (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST",,"60 lots; 6200 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2367-2014","Class I","OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) LEGGINS W/7'' CUFF 30'' X 42'' LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44'' X 35'' LIF (3) TOWEL ABSORBENT 15'' X 20'' LIF (1) DRAPE SHEET 41 '' X 58'' SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING BLANKET 100% COTTON (1) PVP SCRUB 8'' STICK SPONGE (1) FEEDING TUBE BFR, 15'' LONG LIF (1) BOWL PLASTIC 80oz WITH LID (1) CORD UMBILICAL CLAMP (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 20cc SLIP TIP LIF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) NEEDLE HYPODERMIC 22G X 1% (20) GAUZE SPONGE 4'' X 4'' 16PL Y (1) EAR ULCER SYRINGE 2oz LIF (1) DRAPE ABDOMINAL WITH TAPE 40'' X 54'' LIF (2) GLOVE MED FREETOUCH VYNIL POWDER FREE (1) WRAPPER 24'' X 24'' L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1030, 18 lots: 112041230 112072809 112093846 112104130 112114918 113026212 113036313 113047310 113057379 113067853 113078668 113109703 131110148 131210674 140111136 140211630 140311913 140513060 ",,"18 lots; 1580 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2374-2014","Class I","FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24'' X 24'' (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17'' X 18'' (2) SWABSTICK DRY COTTON (1) DRAPE 4'' FENESTRATED 18'' X 26'' (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED m SYRINGE 10ccWATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1)SPECIMEN CONTAINER 4oz W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1139, 13 lots: 111112985 111123474 112010023 112041179 112072768 112083208 112093742 112103742 112114377 113015573 113109708 140211533 140412580 ",,"13 lots; 12820 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2423-2014","Class I","HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 '' X 58'' SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50'' X 90'' (1) DRAPE INCISE ANTIMICROBIAL 23'' X 17'' (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18'' X 18'' XRD (1) STRIP STERI CLOSURE W X 4'' (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15'' X 20'' (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y.'' X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1966, 18 lots: 113025951 113026188 113036672 113047210 113067907 113078582 113099405 113109642 113109776 131110111 131110333 131210639 140111088 140211806 140312102 140412625 140412892 140513119 ",,"18 lots; 738 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2363-2014","Class I","ARHTROSCOPY PACK- (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) TOWEL ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50'' X 90'' (1) BAG SUTURE FLORAL (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (4) STRIPS TAPE 24'' X 4'' (1) SHEET EXTREMITY ABS. 125'' X 85'' (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-982, 11 lots: 112093957 112114688 112125123 113025981 113067944 113078479 113088900 113109884 131110285 140111261 140412707 ",,"11 lots; 540 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2502-2014","Class I","REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15'' X 20'' (I) PK. STRIP STERICLOSURE Y,'' X 4'' (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14'' X 48'' (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60'' X 70''WI TAPE SPLIT 6'' X 21 '' (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23'' X 17'' (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24'' X 4'' (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4'' X 4'' 16PLY (3) DRAPE '!. ECONOMY 53'' X 77'' (I) DRAPE UNDERBUTTOCK W/POUCI-1 44'' X 35'' (I) DRAPE TOP WIADHESIVE 108'' X 50'' STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36'' X 77'' W/ADl-1. (I) SHEET SPLIT W/ADHES 108'' X 77'' STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77'' X I I 0''l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18'' X 18'' XRD (I) COVER MAYO STAND W/CSR 23'' X 54'' (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6'' X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2726: 7 lots 131110255 131210799 140111086 140211664 140312141 140412664 140512992 ",,"7 lots,208 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2495-2014","Class I","Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) YANKAUER SUCTION TUBE W/O VENT ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2682, 1 lot: 112093710 ",,"1 lot/ 120 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2347-2014","Class I","ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6'' X 21'' (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8'' X 7 Y:z'' (1) TUBE SUCTION CONNECT. }4'' X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT (2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08'' X 77'' STD SMS (2) COVER TABLE BTC 77'' X 86'' HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23'' X 17'' (5) ABSORBENT TOWELS 15'' X 20'' (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV (4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH (5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE (2) DRAPE SHEET 70'' X 100'' STD SMS (1) TIME OUT BEACON NON WOVEN (1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG (1) TOP DRAPE W/ADHES. 100'' X 53'' SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP (2) BANDAGE ELASTIC 6'' X 5''yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK (1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2 (2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-741A, 2 lots: 140412701 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736 ",,"2 lots; 153 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2525-2014","Class I","Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15'' X 20'' LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4'' X 4'' 16PLY LIF (1) COVER TABLE REINFORCED 44'' X 78'' LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60'' X 77'' LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108'' X 50'' STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71'' X 62'' STD SMS WITH TAPE L/F (2) DRAPE SIDE 42'' X 76'' WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8'' ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2'' X 4'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3115, 2 lots: 131211011 140111439 ",,"2 lots/ 35 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2361-2014","Class I","CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44'' X 78'' L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15'' X 20'' LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-944, 63 lots: 110010120 110010151 110020418 110020489 110020494 110040959 110040961 110041046 110041047 110061499 110061544 110071716 110071717 110071807 110071808 110092290 110092318 110092409 110092412 110112786 110112787 110122904 110122905 111010173 111010179 111020306 111030826 111040980 111051219 111061648 111071971 111082117 111092408 111102641 111102787 111123307 112010211 112020471 112030755 112030944 112041363 112052025 112062574 112083442 112104089 112114686 113025972 113036598 113047119 113047149 113057515 113057821 113068182 113078576 113099299 113099580 131210848 131210975 140111456 140211881 140312387 140412843 140513353",,"63 lots; 20094 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2393-2014","Class I","REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4'' X 4'' 16PLY ( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E ( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL (5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE ( I} TUR Y SET, 2LEAD UF ( I} DRAPE LITHO 11 0'' X 63'' WI POUCH WILEGGING ( I} ROUND WASH BASIN 6QT. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1460, 29 lots: 109050945 111123344 112010046 112020337 112041074 112051759 112062229 112062272 112083031 112083391 112093722 112114564 112124948 113015428 113036592 113047001 113047147 113057686 113067887 113078253 113078702 113089190 131110174 131210632 140111081 140211866 140311920 140312391 140513089 ",,"29 lots; 1521 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2345-2014","Class I","ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~'' X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14'' X 48'' LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8'' X 7.5'' LIF (2) ELASTIC BANDAGE WITH VELCRO 6'' X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44'' X 90'' LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70'' X 1 00'' SMS LIF (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81''2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6'' X 21'' UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-740A, 1 lots: 140312021 ",,"1 lot; 120 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2355-2014","Class I","UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4'' X 4'' 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44'' X 78'' LIF (1) DRAPE LITHO 110'' X 63'' SMS WITH LEGGINS (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) TUR Y SET 81''2.1m REGULAR CLAM ST. (1) TUBE SUCTION CONNECT Y4'' X 12' LIF (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-868, 36 lots: 111030667 111040921 111051390 111061692 111071970 111082114 111092560 111102783 111123143 111123300 112010206 112020509 112030750 112041359 112052020 112083060 112093955 112114402 112114485 112114583 112125119 113015518 113015570 113036769 113057511 113078350 113088896 113099297 113109649 113109878 131210844 140111254 140211858 140412476 140412909 140513484 ",,"36 lots; 1900 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2350-2014","Class I","NEURO PACK- (1)TABLE COVER 44'' x 90'' (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15'' X 20'' LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 14'' X 48'' L/F (1) SHEET SPLIT WITH ADHESIVE 1 08'' X 77'' STD SMS LIF (1) TOP DRAPE WITH ADHESIVE 1 08'' X 50'' STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-752, 37 lots: 109020288 109040862 109051218 109081882 109112704 110010111 110020448 110041015 110061538 110071775 110081984 110122945 111010161 111020378 111030658 111040919 111051388 111061566 111071943 111082111 111092403 111092464 111102780 111123294 112020512 112030745 112093950 112124705 112125113 113036768 113078345 113088889 113099454 113099588 113109872 120141354 131110277 ",,"37 lots; 858 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2467-2014","Class I","LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15'' X 20'' LIF (2) LEGGINGS W/7'' CUFF 30'' X 42'' LIF (1) DRAPE UTILITY WITAPE L/F (1) SUTURE BAG FLORAL LIF (1) SHEET T LAPAROSCOPY SOFT 97'' X 96'' X 36 LIF'' (1) TABLE COVER REINFORCED 44'' X 78'' L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2485 ,2 lots 112051964 113078524 ",,"2 lots/612 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2442-2014","Class I","EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h'' X 4'' ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110'' X 77'' SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50'' X 90'' ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6'' WOOD (2) STRJPS TAPE 24'' X 4'' ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4'' X 4'' 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30'' X 30'' (2) COTTON TIP APPLICATOR 6'' WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5'' X 20'' (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2234, 8 lots 112030726 113088792 113109792 131110112 131110338 140211660 140412835 140512993 ",,"8 lots/123 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2351-2014","Class I","GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4'' X 4'' 16PLY XRD LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (1) TUBE SUCTION CO NNECTING ~'' X 12' LIF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (2) LITE GLOVES LIF (1) DRAPE LAPAROTOMY WITH POUCH 102'' X 121'' X 78'' STD SMS (4) DRAPE UTILITY WITH TAPE LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) BLADE SURGICAL #15 CARBON STEEL (2) SHEET DRAPE 41'' X 69'' MEDIUM LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-787, 25 lots: 109010128 112030747 112052015 112062577 112093733 112114397 112114483 112125114 113015516 113025969 113036383 113047206 113057819 113068181 113078606 113099296 113099577 131110278 131110606 131210973 140111454 140211879 140312331 140412842 140513251 ",,"25 lots; 4275 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2427-2014","Class I","O.B. PACK - ( I) PVP SCRUB 8'' STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7'' CUFF 30'' x 42'' ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS (I) CORD UMBILICAL CLAMP (4) TOWELS ABSORBENT 15'' x 20'' LIF ( I) UTILITY BOWL 16oz. (2) TRAY ORGANIZER FULL DEEP (3) T IP ABSORBENT APPLICATOR (2) GLOVES EXAM MEDIUM (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (10) GAUZE SPONGE 4'' X 4'' 12PLY (2) PAD OBSTETRJCAL X-LARGE ST. (I) EAR ULCER SYRINGE 2oz. LIF (I) BABY BEANNIES (2) SHEET DRAPE 4 1'' x 58'' SMS LIF (I) SCISSORS UMBILICAL (I) TABLE COVER REINFORCED 50'' x 90'' LIF (2) WRAPPER 24'' X 24'' L/f Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2002, 23 lots: 111113064 111123196 111123470 112010109 112041220 112051915 112062471 112083419 112093922 112104298 112114657 112125310 113015054 113015437 113067910 113088778 113089204 113099408 131110220 140111321 140211502 140211932 140312439 ",,"23 lots; 1396 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2375-2014","Class I","NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6'' (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 '' X 69'' MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102'' X 121'' X 78'' (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30'' X 42'' (1) DRAPE% ECONOMY 53'' X 77'' LIF (1) Pk. SURGICAL STRIP 'X'' X 6'' (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %''X 4'' LIF (1) TUBE SUCTION CONNECT. 'X'' X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475 ",,"36 lots; 936 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2492-2014","Class I","Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2660, 2 lots: 112062218 112093621 ",,"2 lots/ 54 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2486-2014","Class I","Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15'' X 20'' (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24'' X 4'' (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08'' X 77'' STD SMS (1) DRAPE SHOULDER SPLIT W/ADHESIVE (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2515, 2 lots: 112104283 113078531 ",,"2 lots, 354 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2321-2014","Class I","MAJOR LAP PACK - (1) TABLE COVER REINF. 50'' X 90'' 10) GUZE SPONGE 4'' X 4'' 16PLY XRD (1) DRAPE T LAPAROT 102'' X 78'' X 121'' SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED (4) ABSORBENT TOWELS 15'' X 20'' (2) DRAPE SHEET 41'' X 58'' SMS (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-404, 35 lots: 102030840 111030924 111041044 111051296 111061668 111123243 112010164 112020524 112041317 112041373 112041448 112062487 112083429 112114599 112125087 112125314 113025961 113036355 113036763 113047220 113057480 113057846 113068046 113078323 113078574 113089071 113099290 113099572 131110410 131110587 131210971 140111452 140211742 140412837 140513247 ",,"35 lots; 11472 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2489-2014","Class I","Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2656, 1 lot: 140111441 ",,"1 lot / 25 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2522-2014","Class I","Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110'' X 77'' LIF (I) COVER TABLE REINFORCED 50'' X 90'' LIF (I) DRAPE HEAD WITH TAPE 44'' X 26'' LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15'' X 20'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3083, 5 lots: 113109930 131210851 131210953 140111437 140312196 ",,"5 lots/ 32 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2415-2014","Class I","HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15'' X 20'' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41'' X 58'' SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4'' X 4'' 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18'' X 18'' XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16'' X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23'' X 33'' (2) SHEET DRAPE 70'' X 100'' LIF (1) DRAPE TOP WITH ADHESIVE 108'' X 50'' STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108'' X 77'' STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1835, 3 lots: 113109763 131210771 140412619 ",,"3 lots; 36 units (multiple lots per unit)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2478-2014","Class I","Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24'' X 4'' (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (4) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4'' X 12' (2) ELASTIC BANDAGE WITH VELCRO 6'' X 5yds (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2'' X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON STEEL (1) GOWN SURG REINFORCED LGE TOWEL WRAP (2) GOWN XL SMS IMPERVIOUS REINFORCED (2) LITE GLOVE (1) STOCKINETTE IMPERVIOUS 12'' X 48'' (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2609, 7 lots: 131210795 140111213 140211829 140312136 140412660 140513133 140513402 ",,"7 lots (9 packs per lot, 63 packs)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2497-2014","Class I","Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY KUTIER (1) SCALPEL W/HANDLE 20 (1 i WRAPPER 24 X 24 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2702, 4 lots: 131110501 140111072 140211830 140312140 ",,"4 lots/100 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2323-2014","Class I","LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4'' LIF ( 1) TABLE COVER REINFORCED 50'' X 90'' LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102'' X 122'' X 78'' LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15'' X 20'' LIF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (4) DRAPE UTILITY WIT APE LIF ( 1) COVER CAMERA W/ELAST LIF (2) GAUZE SPONGE 4'' X 4'' 12PL Y LIF ( 1) NEEDLE ULTRA VERES 120mm LIF (2) DRAPE SHEET 41 '' X 58'' SMS LIF ( 1) SCALPEL WEIGHTED SAFETY #11 ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF ( 1) DRESSING TEGADERM 4'' X 4 %'' LIF ( 1) TUBE SUCTION CONNECT X'' X 12' LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) SUTURE BAG FLORAL LIF ( 1) Pk. STERI STRIP LAP SET LATEX ( 1) CORD LAPAROSCOPY MONOPOLAR LIF ( 1) MAYO TRAY SMALL LIF ( 1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF ( 1) BAG ZIP LOCK PLASTIC 6'' X 10'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-414, 26 lots: 112030868 112041328 112051656 112062284 112072802 112093940 112104108 112114600 113015696 113025963 113036361 113036800 113057485 113068047 113068170 113088863 113089072 113099574 131110261 131210813 140111100 140211669 140311938 140412466 140412887 140513363 ",,"26 lots; 2192 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2391-2014","Class I","PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4'' X 4'' 16 PLY LIF (1) TABLE COVER 44'' X 90'' (1) DRAPE SHEET 70'' X 100'' LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44'' X 26'' LIF (30) COTION TIP APPLIC 6'' WOOD LIF (1) PVP PAINT 8'' STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1402, 14 lots: 112041394 112051751 112072866 112093870 112124944 113036451 113046933 113057834 113088696 113088831 131110172 140111093 140412599 140513083 ",,"14 lots; 295 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2312-2014","Class I","LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42'' X 57'' (1) TABLE COVER REINFORCED 50'' X 90'' (4) DRAPE UTILITY WITH TAPE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112 ",,"48 lots; 15008 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2472-2014","Class I","ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15'' X 20'' LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60'' X 70'' W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53'' X 77'' LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08'' X 77'' LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2503, 3 lots 112051970 112072732 113078528 ",,"3 lots/600 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2400-2014","Class I","UROLOGY PACK- (10) GAUZE SPONGE 4'' X 4'' 16PLY (1) TUBE SUCTION CONNECT Y.'' X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0'' x 63'' (2) SHEET DRAPE 41 '' X 58'' SMS (1) COVER TABLE REINF 50'' X 90'' (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15'' X 20'' (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1521, 27 lots: 111102904 112041376 112041452 112062286 112104149 112114602 112124957 113015430 113015690 113025942 113026048 113036739 113046934 113047002 113047332 113057836 113078260 113088737 113088931 113089193 131110180 131110598 131210962 140211645 140211922 140412884 140513346 ",,"27 lots; 1884 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2309-2014","Class I","Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44'' x 90'' (2) LEGGINS WITH/7'' CUFF 30'' x 42'' (5) ABSORBENT TOWELS 15'' x 20'' LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15'' LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 '' X 58'' SMS (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV (1) VAGINAL SPONGE XRD (1) UMBILICAL CORD CLAMP LIF (2) CLOTH HUCK TOWELS BLUE (1 0) GAUZE SPONGE 4'' X 4''16 PLY XRD LIF (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 (1) MUCUSTRAP 20cc 1 OFr. (1) BOWL PLASTIC 80oz WITH LID (1) WRAPPER 24'' X 24'' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-168, 34 lots: 110061523 110092042 110092166 110092388 110112612 110123053 111010060 111020331 111041058 111051332 111061506 111071775 111082059 111102842 111113023 111123371 112072440 112083401 112114642 112125025 113026049 113036454 113036752 113057838 113078270 113088750 113089158 113109744 131110336 140111166 140211649 140211925 140513102 140513461 ",,"34 lots; 2648 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2357-2014","Class I","CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4'' X 4'' 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24'' X 24'' UF (1) PACKING TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-913, 16 lots: 112093762 112114486 112114882 113015699 113026117 113036390 113057375 113057513 113067943 113088899 113099460 113109881 131110318 140111257 140211861 140312190 ",,"16 lots; 910 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2402-2014","Class I","UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1) SHEET SPLIT WITH ADHESIVE 108'' X 77'' STD SMS LIF (1) SHEET% 57'' X 63'' REINFORCED SMS LIF (2) TOWELS ABSORBENT 15'' X 20'' LIF (4) DRAPE UTILITY LIF (1 0) GAUZE SPONGES 4'' X 4'' 12PL Y LIF (4) CLOTH HUCK TOWELS BLUE LIF (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) SCALPEL WITH HANDLE #11 (1) DENTURE CUP WITH LID (1) TRAY 2 COMPARTMENT (2) ABSORBENT TIP APPLICATOR (1) IMPERVIOUS STOCKINETIE 14'' X 48'' LIF (1) TAPE TRANSPORE 1'' X 36'' (1) DIISP NEEDLE 30 X ~ (1) PROBE DRAPE 6'' X 96 WITH GEL (1) ARTERIAL NEEDLE 18 X 2 % (1) CATHETER INTRODUCER 7FR (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1587, 36 lots: 102030623 110082155 110082298 110102430 110112610 110122922 111010202 111020362 111030586 111040993 111051366 111061501 111071771 111082193 111092502 111102687 111113016 111123356 112010065 112020382 112041190 112051845 112062430 112072709 112083158 112083400 113015504 113025773 113036453 113036751 113067890 113089195 113099383 131110184 140111159 140312077 ",,"36 lots; 888 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2516-2014","Class I","Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50'' X 90'' (10) GAUZE SPONGE 4'' X 4'' 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15'' X 20'' (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24'' X 24'' (8) LABELS FOR SKIN MARKERS 1.25'' X %'' (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18'' X 18'' XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2969: 131110592 131210949 131211012 140111325 140111436 140211730 ",,"6 lots/ 1140 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2327-2014","Class I","LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9'' X 96'' LIF (5) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50'' X 90'' (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41'' X 58'' SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4'' X 4%'' (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %''X 12' (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480 ",,"19 lots; 1168 units (multiple lots per unit)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2359-2014","Class I","CESAREAN PACK- (1) COVER TABLE REINFORCED 50'' X 90'' (2) TOWELS ABSORBENT 15'' X 20'' (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102'' X 121'' X 78'' (1) TUBE SUCTION CONNECT. ~''X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES PREWASH 18'' X 18'' XRD (1) BAG GLASSINE (2) SURGICAL BLADE #10 STAINLESS STEEL (1) EAR ULCER SYRINGE 2oz. (2) LIGHT GLOVE (1) BOWL UTILITY 16oz (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41 '' X 58'' SMS (1) ELECTRODE DUAL DEPRES./GROUNDPAD EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-921, 16 lots: 110061474 112114590 113026118 113036391 113057414 113057820 113078478 113078607 113099298 113099579 131110080 131110413 131110590 131210974 140111455 140211743 ",,"16 lots; 1784 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2332-2014","Class I","PERY GYN PACK - (1) TABLE COVER REINFORCED 44'' X 78'' (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15'' X 20'' (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44'' X 35'' (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE FLORAL (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD (1) GOWN IMPERV. EXTRA REINF LGE AAMI LEVEL Ill T/WRAP (1) CATHETER 16'' 18FR MALE PVC (2) LEGGINS W/7'' CUFF 30'' X 44'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-548A, 2 lots: 140312022 140412694 ",,"2 lots; 48 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2384-2014","Class I","PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102'' X 78'' X 121'' (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50'' X 90'' LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15'' X 20'' LIF (5) SPONGE LAP PRE-WASH 18'' X 18'' XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4'' X 4'' 16PL Y XRD LIF (2) DRAPE SHEET 42'' X 55'' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP ","Product code 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344 ",,"51 lots; 11070 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2343-2014","Class I","CESAREAN PACK- - (3) ABSORBENT TOWELS 15'' x 20'' LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18'' x 18'' XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41'' x 58'' SMS LIF (2) TUBE SUCTION CONNECT. Y..'' X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4'' X 1 0'' (1) C-SECTION DRAPE WITH POUCH 102'' X 121'' X 78'' (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-660, 47 lots: 110061532 110071635 110071853 110102449 110112671 110122899 111010148 111020375 111030650 111040914 111051212 111061560 111071832 111082224 111092400 111102775 111112949 111123281 112010195 112020516 112030737 112041345 112052004 112062504 112083440 112093591 112093732 112114595 112125107 113015698 113025966 113036597 113036730 113057500 113057875 113068179 113088883 113099295 113109867 131110270 131110412 131110589 131210972 140111453 140211677 140211945 140513352 ",,"47 lots; 5560 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2509-2014","Class I","ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60'' X 70'' WITAPE SPLIT 6'' X 21'' (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8'' X 7.5'' (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50'' X 90'' LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108'' X 77'' STD SMS L/F (5) TOWELS ABSORBENT 15'' X 20'' UF (1) STOKINETIE IMPERVIOUS 14'' X 48'' LIF (2) DRAPE SHEET 70'' X 100'' LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108'' X 50'' STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF (1) DRAPE INCISION 23'' X 17'' UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2903, 4 lots 113026303 113057705 113068034 113088858 ",,"4 lots, 180 units ( multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2348-2014","Class I","CARPALTUNNELLARGE - (1) TABLE COVER 50'' X 90'' REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 '' X 58'' SMS (1) BANDAGE GAUZE 4'' STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8'' (1) STOCKINETTE 6'' X 48'' LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %'' (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15'' X 20'' LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125'' x 85'' SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-742, 38 lots: 110092282 110112680 110122944 111010190 111020296 111041070 111061687 111071387 111071969 111082110 111092402 111102779 111113140 111123292 112010203 112020493 112030743 112041353 112052012 112062507 112093642 112104103 112114589 112125112 113015460 113025776 113025985 113036767 113067963 113068180 113088888 113099453 113109871 131110275 131210841 140111250 140211737 140311948 ",,"38 lots; 3066 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2513-2014","Class I","Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) OB PAD WRAP OVERNIGHT (1) TABLE COVER REINFORCED 50X90 LIF (1) DRAPE UNDERBUTTOCK W/POUCH 44X35'' (1) CLAMP UMBILICAL CORD LIF (1) BOWL PLASTIC 80oz. LIF (1) LID FOR BOWL 80oz. CLEAR LIF (1) BEANNIES BABY (5) LAP SPONGE PREWASH 18X18XRD (1) MAYO TRAY SMALL (1) DRAPE SHEET 41X58 SMS LIF (1) UNDERPAD 36X36 BEIGE (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON (10) GAUZE SPONGE 4X4 16PLY LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2940, 1 lot",,"1 lot/ 76 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2468-2014","Class I","LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE T LAPAROT 102'' X 78'' X 121'' STD SMS (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2490 ,3 lots 112020346 112051965 112072728 ",,"3 lots/790 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2398-2014","Class I","CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (INDUCCION) (1) OPEN HEART TRAY EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1500, 7 lots: 110061567 131211069 140211907 140312371 140412630 140412871 140613717 ",,"7 lots; 49 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2453-2014","Class I","VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110'' X 63'' W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50'' X 90'' LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8'' STICK SPONGE (1) PVP SCRUB 8'' STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15'' X 20'' LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4'' X 36'' 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2385 ,7 lots 112041304 112093771 113057712 113078586 113099428 120051955 140613805 ",,"7 lots/96 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2461-2014","Class I","BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44'' X 78'' (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15'' X 20'' (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42'' X 57'' SMS (1) SHEET :X 57'' X 63'' REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2471 ,5 lots 112041034 112051959 112072723 113078521 140513219 ",,"5 lots/1110 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2437-2014","Class I","LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15'' X 20'' (2) LEGGINGS W/7'' CUFF 30'' X 42'' CSR (1) DRAPE UNDERBUTTOCK WITH POUCH 44'' x 35'' (1) DRAPE ABDOMINAL WITH TAPE 40'' X 54'' (1) DRAPE UTILITY WITH TAPE (1) TABLE COVER REINFORCED 50'' X 90'' (1) TIME OUT BEACON NON WOVEN ST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2167, 29 lots 111041037 111051291 111061531 111102864 112010130 112020462 112030812 112041223 112051942 112062480 112072798 112083163 112083421 112093927 113057460 113067915 113078469 113088789 113089024 113109643 113109789 131110238 131210786 140111203 140312119 140412646 140513126 140513397 140613659 ",,"29 lots/2675 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2429-2014","Class I","LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15'' X 20'' LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102'' X 122'' X 78'' (2) DRAPE SHEET 41'' X 58'' SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6'' X 96'' LIF (1) TUBE SUCTION CONNECT. 3/16'' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-2004, 11 lots: 112030703 112061278 112114387 112114491 112114877 113068160 113078570 113089022 113099283 131110222 140613472 ",,"11 lots; 681 units (multiple units per lots)","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2500-2014","Class I","Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2719: 3 lots 113047020 113068032 113078729 ",,"3 lots/ 74 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2485-2014","Class I","Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42'' X 76'' WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71'' X 62'' STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08'' X 50'' STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50'' X 90'' (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2509, 3 lots: 112020357 112051971 113078530 ",,"3 lots, 612 units, multiple units per pack","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2324-2014","Class I","LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15'' X 20'' ( 1) FEEDING TUBE 8FR, 15'' LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7'' CUFF 30'' X 42'' ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4'' X 4'' 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50'' X 90'' ( 1) DRAPE ABDOMINAL WITH TAPE 40'' X 54'' (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8'' STICK SPONGES ST. ( 1) EAR ULCER SYRINGE 2oz. ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30'' X 30'' ( 1) PVP PAINT 8'' STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-419, 16 lots: 112041449 112093941 112114601 113025847 113026169 113036364 113047313 113067871 113078327 113089073 113099292 131110077 131210815 140111228 140211670 140311939 ",,"16 lots; 1852 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2471-2014","Class I","EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110'' X 77'' SMS (1) TABLE COVER REINFORCED 50'' X 90'' (1) DRAPE HEAD W!TAPE 44'' X 26'' (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2498 , 4 lots 112020356 112051968 112072870 113078527 ",,"4 lots/700 units(multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2386-2014","Class I","PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24'' X 4'' (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15'' X 20'' LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4'' X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6'' X 5 YRD. L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1298, 15 lots: 112041185 112062555 112072865 113015632 113026067 113026165 113026272 113036748 113047122 113057832 113078568 113089184 113109720 140111149 140211639 ",,"15 lots; 860 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2411-2014","Class I","UROLOGY PACK - (3) TOWELS ABSORBENT 15'' X 20'' UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44'' X 90'' UF (2) DRAPE SHEET 42'' X 55'' SMS UF (1) TUBE SUCTION CONNECT. Y.'' X 12' UF (1) MAYO STAND COVER REINFORCED UF (10) GAUZE SPONGE 4'' X 4'' 16PLY (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) TUR Y SET TWO LEAD ST. UF (1) DRAPE LITHO 110'' X 63'' SMS WITH LEGGINS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1742, 14 lots: 111113032 111123382 112010089 112020407 112041202 112051876 112083407 112093915 112125157 113015435 113036757 140412562 140513111 140513393 ",,"14 lots; 325 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2412-2014","Class I","OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15'' x 20'' UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6'' WOOD (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4'' X 4'' 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX (1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE) (1) EYE DRAPE (1) GOWN LARGE STANDARD SMS (1) TRAY 3/COMPART (1) BAG ZIP LOCK (1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1780, 25 lots: 112010094 112020415 112041205 112051885 112072786 112083376 112083453 112104301 112114612 112125037 113015436 113036758 113057839 113068042 113078279 113088764 113099281 113109757 131110203 131110602 140111178 140211654 140312436 140513114 140513454 ",,"25 lots; 2382 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2475-2014","Class I","Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) DRAPE LAPAROTOMY W/POUCH 100'' x 72'' x 124'' (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41'' X 69'' MEDIUM ( 1) MAYO STAND COVER REINFORCED ( 1) GOWN SURG XLGE REINFORCED TOWEL & WRAP AAMIIII ( 1) BLADE SURGICAL STAINLESS STEEL# 10 (2) LIGHT SHIELD ( 1) CAUTERY PENCIL ROCKER SWITCH ( 1) TABLE COVER REINFORCED 50'' X 90'' ( 1) UTILITY BOWL BLUE 16oz ( 1) TOWELS ABSORBENT 15'' X 20'' ( 1) SOLUTION SURGICAL DURAPREP 6ML Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2511, 10 lots: 112083072 113099519 113109796 131110292 131210659 140111323 140211706 140211936 140412903 140513479 ",,"10 lots (2018 packaged units, multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2333-2014","Class I","LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 '' X 58'' SMS UF (10) GAUZE SPONGE 4'' X 4'' 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16'' x 12' UF (3) TOWEL ABSORBENT 15'' X 20'' UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP (1) TABLE COVER REINFORCED 50'' X 90'' UF (2) GOWN LARGE SMS IMPERV. REINFORCED (4) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-576, 26 lots: 109020368 109030605 109040844 109051043 109061293 109071535 109081864 109092110 109102391 112030885 112041338 112051871 112062293 112072806 112114577 112125102 113025987 113036372 113078334 113088940 113099442 113109857 131210829 140111239 140211732 140211941 ",,"26 lots; 1412 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2307-2014","Class I","Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo Cover, & lite gloves. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-149, 32 lots: 111113165 111123349 112010052 112010280 112030621 112041077 112051768 112062421 112083062 112093900 112104147 112114637 112114952 113015429 113025941 113026204 113036749 113047333 113057861 113078258 113078600 113089192 113109733 131110083 131110399 131110578 131210961 140111409 140211872 140312328 140412830 140513345 ",,"32 lots; 8954 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2317-2014","Class I","BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50'' X 90'' UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15'' x 20'' L/F (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42'' X 57'' SMS g~ SHEET o/. 57'' X 63'' REINFORCED SMS UF MAYO STAND COVER REINFORCED UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-345, 38 lots: 109122917 110020470 110030770 110040936 110071690 110092240 110112640 111010116 111030655 111051294 111051326 111071845 111082215 111092537 111102740 111113101 111123239 112010162 112030866 112051977 112093937 112104306 112124703 112124858 113025959 113036353 113046956 113067922 113088810 113089162 113109830 131210950 140211466 140312155 140412559 140513144 140513338 140613746 ",,"38 lots; 2442 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2385-2014","Class I","PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50'' X 90'' LIF (10) GAUZE SPONGES 4'' X 4'' 12PLY LIF (2) LEGGINS WITH 7'' CUFF 30'' x 42'' LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42'' X 55'' LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40'' X 54'' WITH TAPE LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BOWL PLASTIC 80oz WITH LID (1) EAR ULCER SYRINGE 2oz LIF (1) CORD UMBILICAL CLAMP LIF (1) BABY BLANKET IMP. 30'' X 30'' POLY ABS. LIF (1) TOWELS ABSORBENT 15'' X 20'' LIF (1) LAP SPONGE PRE-WASH 18'' X 18'' XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1297, 44 lots: 109030542 110061517 110071663 110081957 110082065 110082132 110112605 110112866 110123051 110123066 111030563 111071760 111082184 111082268 111092487 111102647 111102672 111112928 111112962 111123334 112010034 112020327 112041184 112062405 112062406 112062582 112062620 112083387 112114633 112124935 113015426 113025935 113036315 113036450 113047324 113068144 113078692 113109719 131110167 131110596 131210959 140111406 140412596 140513080 ",,"44 lots; 4670 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2462-2014","Class I","ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15'' X 20'' (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (1) U - DRAPE 60'' X 70'' WITAPE SPLIT 6 X 21 (1) SHEET SPLIT W/ADHESIVE 108'' X 77'' STD SMS (1) STOCKINETTE IMPERVIOUS 12'' X 48'' (4) STRIPS TAPE 24'' X 4'' (1) SUTURE BAG FLORAL (1) SHEET ARTHROSCOPY T STD SMS W/ POUCH (1) TABLE COVER REINFORCED 44'' X 78'' (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2473 ,4 lots 112020354 112051960 112072724 113057469 ",,"4 lots/972 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2304-2014","Class I","Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052 ",,"30 lots, 6977 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2532-2014","Class I","Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA) (1) OPEN HEART TRAY Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-1415A, 7 lots: 109102236 140211906 140312233 140412870 140412872 140513354 140613716 ",,"7 lots/48 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2452-2014","Class I","ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50'' X 90'' (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) U-DRAPE 60'' X 70'' WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125'' X 85'' (1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE (1) WRAPPER 24'' X 24'' (1) TOWELS ABSORBENT 15'' X 20'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2356 ,3 lots 112010142 112010284 112020522 ",,"3 lots/240 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2342-2014","Class I","0.B. PACK - - (1) TABLE COVER 44'' x 90'' (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7'' CUFF 30'' x 42'' (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15'' x 20'' (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4'' X 4'' 12PLY XRD (1) CORD UMBILICAL CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz (1) SET UP COVER CLEAR POLY (1) BASIN WASH 7QT. (1) ABDOMINAL DRAPE WITH TAPE LIF (2) KELLY FORCEP STRAIGHT 5 % (1) MAYO SCISSOR STRAIGHT 6% (1) BABY BEANNIES EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-645, 51 lots: 109030612 109030699 109051050 109051212 110061464 110071705 110081981 110082075 110092405 110112816 110122898 111010147 111020295 111030648 111041071 111051300 111061559 111071831 111092556 111102774 111112951 111112964 111123280 112010194 112010255 112030736 112052003 112083214 112093731 112104256 112114396 112125106 112125305 113015456 113025965 113036376 113047028 113057498 113078339 113078575 113099294 113099575 131110079 131110411 131110588 140111243 140211676 140211878 140412472 140412889 140513351 ",,"51 lots; 5574 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2369-2014","Class I","LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15'' X 20'' LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 ''2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6'' X 96'' (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44'' X 90'' (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4'' X 4'' 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1059, 16 lots: 112030823 113047111 113057410 113057823 113078454 113078566 113099561 113109983 131110149 131110397 131110577 131210955 140211914 140312430 140513062 140513474 ",,"16 lots; 1671 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2446-2014","Class I","CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30'' X 30'' (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21'' GREEN BOUFFANT (2) TOWELS ABSORBENT 15'' X 20'' (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41'' X 58'' SMS (1) DRAPE BRACHIAL ANGlO 44'' X 31'' REINFORCED 3'' ADHESIVE CIRCULAR FENESTRATION Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128 ",," 8 lots/1232 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2521-2014","Class I","Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15'' X 20'' (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%'' X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50'' X 90'' (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3029, 3 lots: 113099554 140312149 140613789 ",,"3 lots/ 60 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2455-2014","Class I","EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4'' LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!.'' X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50'' X 90'' LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6'' WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20'' LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4'' X 4'' 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24'' X 24'' WET SKIN PACK CONTA INING: ( I ) WRAPPER 30'' X 30'' ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15'' X 20'' L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6'' WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2423 ,3 lots 131010019 140111210 140312131 ",,"3 lots/27 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2305-2014","Class I","Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343 ",,"34 lots, 5556 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2524-2014","Class I","Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15'' X 20'' (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50'' X 90'' (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X'' X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60'' X 77'' (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18'' X 18'' XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108'' X 50'' STD SMS (2) DRAPE SIDE 42'' X 76'' WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71'' X 62'' STD SMS WITH TAPE (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY (1) PK. STRIP STERI CLOSURE W X 4'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3114, 2 lots: 131210804 140111438 ",,"2 lots/48 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2341-2014","Class I","PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15'' x 20'' UF (2) LEGGINS W/7'' CUFF 30'' X 42'' (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD UF (1) PAD OBSTETRICAL XL LIF (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL (1 ) SYRINGE 1 Occ PREFILLED W/GEL (1 ) DRAPE SHEET 41 '' X 69'' MEDIUM UF (1 ) CATHETER 14FR. ROB. NELAT (1) NON-ADHESIVE TELFA DRESSING (2) GOWN IMP. REINFORCED LGE SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-635, 42 lots: 110040968 110051274 110051406 110092404 110112815 110112897 111020476 111030646 111041113 111051299 111061558 111071830 111082247 111092399 111102773 111112950 111123278 112020492 112041343 112083439 112093730 112125105 112125304 113015514 113036673 113036736 113047027 113057609 113067934 113068178 113088881 113099448 113109866 113507497 131110310 131210835 140111242 140211675 140211944 140312385 140412840 140513250 ",,"42 lots; 4790 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2459-2014","Class I","08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15'' X 20'' (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44'' X 65'' (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30'' X 30'' POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4'' X 36'' 8PLY (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40'' X 54'' (2) LEGGINS W/7'' CUFF 30'' X 42'' (1) TABLE COVER REINFORCED 44'' X 78'' (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2464 ,3 lots 112020343 112051958 112083317 ",,"3 lots/567 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2424-2014","Class I","LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18'' X 18'' XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6'' X 96'' LIF (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15'' X 20'' LIF (1) DRAPE ENDOSCOPY 100'' X 123%'' X 77'' WITH TROUGHS L/F (2) SHEET DRAPE 42'' X 57'' SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2'' X 2'' 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50'' X 90'' L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1967, 19 lots: 111123453 112030696 112041219 112041457 112051908 112062470 112083417 112125164 113015692 113025952 113026107 113026233 113047010 113057694 113078292 140211807 140312103 140412626 140412893 ",,"19 lots; 351 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2425-2014","Class I","TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15'' X 20'' LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y..'' X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53'' X 77'' LIF ( 1) SHEET SPLIT W/ADHESIVE 77'' x 146'' (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1983, 1 lots: 131110141 ",,"1 lot; 50 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2517-2014","Class I","Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24'' X 24'' UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53'' X 77'' UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18'' X 18'' XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-3025, 1 lot: 131110114 ",,"1 lot/ 20 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2358-2014","Class I","PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4'' X 4'' 4PL Y (1) COVER TABLE REINFORCED 50'' X 90'' LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) PENCIL CAUTERY HANDSWITCHING L/F (1) TUBE SUCTION CONNECT. ~, X 12' LIF (1 0) LAP SPONGE PRE-WASH XRD LIF (2) LITE GLOVE LIF (4) HUCK CLOTH TOWEL BLUE (2) DRAPE SHEET MEDIUM 41'' X 69'' LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS (5) Pk. STERI STRIP CLOSURE %''X 4'' L/F (1) MAGNETIC INST. DRAPE (3) SKIN MARKER WITH RULER LIF (1) EXTENDED ELECTRODE BLADE (2) ABSORBENT TOWEL 15'' X 20'' LIF (4) UTILITY BOWL 32 oz (2) SURGEON GLOVES #8 BIOGEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-920, 21 lots: 111051217 111092406 112030888 112052022 112093734 112114584 112125309 113015700 113036806 113057750 113078593 113089210 113099376 113099582 131010028 131110283 140111258 140211862 140312427 140412918 140513470 ",,"21 lots; 680 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2503-2014","Class I","MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15'' X 20'' (1) WRAPPER 24'' X 24'' (16) GAUZE SPONGES 2'' X 2'' 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6'' WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4'' X 4'' 12PLY (1) SMALL DRAPE W/ADH APERTURE POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2727: 3 lots 112093757 113025895 113078730 ",,"3 lots, 200 units ( multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2376-2014","Class I","PHACO PACK - (10) GAUZE SPONGE 4'' X 4'' 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %'' (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44'' X 90'' (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15'' x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1156, 12 lots: 109122834 110010026 110020379 110020559 110040869 110041086 110051182 110061483 110071624 110081995 110092119 110102582 ",,"12 lots; 1775 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2370-2014","Class I","PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15'' X 20'' UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7'' CUFF 30'' X 42'' (1) TABLE COVER REINFORCED 44'' X 78'' UF (1 0) GAUZE SPONGES 4'' X 4'' 16PL Y XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1061, 43 lots: 110051144 110061480 110071614 110082107 110102421 110112595 110123081 111010014 111020502 111030541 111030814 111040868 111061579 111071751 111082041 111082267 111092342 111102654 111112942 112020305 112051670 112062315 112072764 112083153 112093849 113025926 113026038 113036447 113046995 113047194 113057377 113057824 113068139 113078455 113099265 113099585 131110150 131210675 131211024 140311916 140312431 140412826 140513473 ",,"43 lots; 3201units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2338-2014","Class I","ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4'' X 4'' 16PL Y (1) TUBE SUCTION CONNECTING X'' X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF (2) ELASTIC BANDAGE 6'' X 5yrd LIF (1) TUR Y SET 81 ''2.1m REGULAR CLAM (2) NEEDLE HYPODERMIC 18G X 1 ~ (1) TABLE COVER 50'' X 90'' REINFORCED LIF (5) TOWEL ABSORBENT 15'' X 20'' LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT (1) Pr. NEUTRALON SURGEON GLOVES #7.5 (1) Pr. NEUTRALON SURGEON GLOVES #8 (1) Pr. NEUTRALON SURGEON GLOVES #8.5 (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (10) GAUZE SPONGES 4'' X 4'' 16PLY XRD (2) STRIPS TAPE (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) DRAPE VIDEO CAMERA LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456 ",,"28 lots; 2620 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2306-2014","Class I","Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558 ",,"37 lots, 2360 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2392-2014","Class I","UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24'' (1) FENESTRATED DRAPE 18'' x 26'' LIF (1) NEEDLE HOLDER BAUMGARTNER 5'' (2) HALSTED MOSQUITO CVD 5'' SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2'' X 2'' 8PL Y (6) GAUZE 4'' X 4'' 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4'' WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30'' X 30'' L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6'' WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5'' (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6'' 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1408, 7 lots: 113015546 113057835 140211780 140412600 140513084 113047152 112051753 ",,"7 lots; 176 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2436-2014","Class I","FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15'' X 20'' LIF (2) DRAPE SHEET 42'' X 57'' SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE (1) SUTURE AID BOOT STD YELLOW ST. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD (1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF (1) DRAPE T LAPAROT 102'' X 78'' X 121'' SMS STD LIF (10) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14'' X 48'' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF (2) UTILITY BOWL 16oz. L/F (1) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (4) DRAPE UTILITY WITH TAPE LIF (1) MAYO TRAY SMALL (1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11 (2) TUBE SUCTION CONNECT X'' x 12' LIF (2) NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2164, 11 lots 112041224 112083167 113036762 113047217 113067914 113078468 113088852 131210646 140312118 140412645 140513125 ",,"11 lots/432 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2505-2014","Class I","SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4'' X 5YD WRAP TAN LATEX (2) U-DRAPE 60'' X 70'' WITAPE SPLIT 6'' X 21'' (1) TABLE COVER 44'' X 90'' (4) TOWELS ABSORBENT 15'' X 20'' LIF (2) TUBE SUCTION CONNECT'' X 12' LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) NEEDLE SPINAL ANESTH 18G X 3% LIF (1) DRAPE INCISE ANTIMICROBIAL 23'' X 17'' LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF (2) ATTACHABLE POUCH BEACH CHAIR 35'' X 43'' WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F (4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17'' X 11'' LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6'' X 48'' L/F (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) WRAPPER 24'' X 24'' (1) NEEDLE HYPODERMIC 22G X 1 % (1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT (1) MAYO STAND COVER REINFORCED LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666 ",,"6 lots, 171 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2377-2014","Class I","LAP AROSCOPY PACK - (10) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%'' X 3'' ST. LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15'' X 20'' LIF (1) DRAPE LASER CAMERA W/EL 6'' X 96'' LIF (2) LITE GLOVE LIF (1) TUBE SUCTION CONNECTING W X 12' LIF (1) DRAPE LAP WITH POUCH 102'' X 121 '' X 78'' STD SMS (1) BLADE SURGICAL #11 STAINLESS STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) BAG SUTURE FLORAL (1) TUR Y SET, 2 LEAD L/F (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) GOWN STANDARD LARGE SMS VELCRO NECK (1) TUBE SUCTION CONNECT 3/16'' X 12' LIF (1) Pk. STERI STRIP LAP. LATEX (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL ROCKER SWITCH LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1176, 21 lots: 112051673 112051735 112062336 112083210 112093723 112114597 112114925 113025928 113036747 113078239 113078679 113089017 113099562 140111074 140211461 140211717 140312052 140312421 140412913 140513071 140513476 ",,"21 lots; 690 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2329-2014","Class I","LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53'' X 77'' LIF (1) TUBE SUCTION CONNECT. v.i'' X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02'' X 122'' X 78'' LIF (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD LIF (8) TOWEL ABSORBENT 15'' X 20'' L/F (1) TABLE COVER REINFORCED 50'' X 90'' L/F (1) *LAPAROSCOPIC WOUND CLOSURE LATEX (1) DRAPE LASER CAMERA WITH/EL 6'' X 96'' LIF (4) DRAPE UTILITY WITH TAPE L/F (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-486, 39 lots: 109102328 109112574 109122809 110010090 110020385 110030671 110030811 110051245 110071697 110102446 110112662 111010131 111020373 111030681 111041112 111113120 111123259 111123435 112020536 112030844 112051987 112093629 112114394 112114481 112114571 113015453 113025988 113036367 113057489 113067929 113099436 113109846 131110263 131210820 140111233 140312167 140412470 140412907 140513249 ",,"39 lots; 1712 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2483-2014","Class I","LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102'' X 122'' X 78'' (1) WRAPPER 30'' X 30'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-2619, 2 lots: 131211019 140312150 ",,"2 lots, 288 packed units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2493-2014","Class I","Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL CARBON STEEL 10 (1) BLADE SURGICAL CARBON STEEL 11 (4) PAD ABDOMINAL 8 X 7.5 ( 1) CAUTERY TIP POLISHER (2) LITE GLOVES ( 1) YANKAUER SUCTION TUBE WITHOUT VENT (20) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER (1) UNDERPAD 23 X 36 ( 1) TUBE SUCTION CONNECT 1/4 X 12 (1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2661, 1 lot: 140312417",,"1 lot/12 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2430-2014","Class I","CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15'' x 20'' LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102'' X 121 '' X 78'' (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41'' X 58'' SMS LIF (1) TUBE SUCTION CONNECT. X'' X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20''X 20'' (1) DRESSING ISLAND 4'' X 10'' (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50'' X 90'' L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462 ",,"14 lots; 420 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2520-2014","Class I","Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15'' X 20'' L/F (1) NEEDLE HYPODERMIC 27G X 1 %'' LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUTION 4oz (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) COVER TABLE REINFORCED 44'' X 78'' LIF (1) CUP DENTURE 8oz TEAL WITH LID (12) TOWEL CLOTH HUCK C BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) TUBING INFILTRATION PERISTALTIC PUMPS (4) CLAMP TOWEL LIF (3) SHEET DRAPE 70'' X 100'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3028, 2 lots: 113099553 140613790 ",,"2 lots/30 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2508-2014","Class I","CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30'' X 42'' (1) COVER TABLE REINFORCED 44'' X 78'' (2) TOWELS ABSORBENT 15'' X 20'' (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79'' SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2899, 2 lots 140111333 140412673 ",," 2 lots,128 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2387-2014","Class I","NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44'' X 90'' (4) ABSORBENT TOWELS 15'' X 20'' UF (1) LAPAROTOMY T DRAPE 102'' X 78'' X 121'' STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23'' x 17'' (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y..'' X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23''x17'' LIF (1) Pk SURGICAL STRIP W'X 6'' (5) LAP SPONGES PRE-WASH 18'' X 18'' XRD L/F (20) GAUZE SPONGE 4''X 4'' 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53'' X 77'' LIF (2) TABLE COVER HD 77'' X 110'' L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082 ",,"20 lots; 800 units (multiple lots per unit)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2336-2014","Class I","ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44'' X 78'' LIF (30) GAUZE SPONGES 4'' X 4'' 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( 1) GUIDEWIRE .035'' X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( 1) NEEDLE HYPODERMIC 18G X 1 % ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( 1) UTILITY BOWL 16oz. LIF ( 1) SCALPEL WITH HANDLE # 11 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-610, 26 lots: 111123130 111123272 112010190 112030731 112041339 112051998 112062498 112093947 112114578 112125303 113025825 113026192 113036373 113036696 113047161 113057494 113067874 113078337 113089077 113109860 131110268 131210661 140111087 140211673 140311942 140513221 ",,"26 lots; 1305 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2328-2014","Class I","LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15'' x 20'' LIF (2) LEGGINS WITH 7'' CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6'' X 96'' LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) TABLE COVER 44'' X 90'' (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4'' X 3'' (1) TUBE SUCTION CONNECT Y4'' X 12' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845 ",,"25 lots; 552 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2501-2014","Class I","Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15'' X 20'' (1) WRAPPER 24'' X 24'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2725: 2 lots 112093989 113057519 ",,"2 lots (1500 units)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2382-2014","Class I","PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30'' X 30'' POLY ABSORBENT (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 '' X 58'' SMS LIF (1) TUBE SUCTION CONNECT. X'' X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4'' X 10'' (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477 ",,"18 lots; 730 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2362-2014","Class I","STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44'' X 78'' UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15'' X 20'' UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE SHEET 41'' X 58'' SMS (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-946, 46 lots: 109010131 109020438 109030630 109030725 109061221 109061458 109081891 109102354 109112606 109122828 110010121 110020416 110030690 110041052 110071718 110092291 110092375 110112686 110122949 111010174 111020307 111040981 111051220 111061571 111071946 111082118 111092409 111102788 112010212 112020507 112030756 112041364 112052026 112072879 112083443 112093956 112114687 112125122 113025973 113036807 113057516 113089090 113109650 113109883 140111260 140111318 ",,"46 lots; 1240 units (multiple units per lot)manufactured","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2463-2014","Class I","C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15'' X 20'' LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30'' X 30'' POLYABS IMPERVIOUS LIF (1) SYRINGE EAR/ULCER 2oz LIF (2) PAD OBSTETRICAL X-LARGE (1) BOWL WITH/LID PLASTICS 80oz LIF (1) CLAMP UMBILICAL CORD LIF (1) BAG SUTURE FLORAL LIF (1) DRAPE C-SECTION W/POUCH 102'' X 121'' X 78'' LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2476 ,3 lot 112020348 112051961 112072725 ",,"3 lots/604 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2303-2014","Class I","Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549 ",,"24 lots, 904 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2421-2014","Class I","UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108'' X 77'' SMS STD LIF (1) DRAPE % ECONOMY 53'' X 77'' UF (2) TOWEL ABSORBENT 15'' X 20'' UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4'' X 4'' 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50'' X 90'' UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4'' STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1) RULER L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 111041100 111051372 111061520 111071785 111113056 111123422 112010103 112041214 112062469 112083415 113109769 131210637 140111090 140312098 140412891 ",,"22 lots; 312 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2433-2014","Class I","OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15'' X 20'' LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) SPLIT SHEET BILATERAL 84'' X 80'' (12) % SHEET 60'' X 77'' DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14'' X 48'' LIF (30) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) WRAPPER 54'' X 54'' (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) BANDAGE ELASTIC 6'' X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %'' ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15'' LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54'' X 54'' UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15'' X 20'' UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44'' X 78'' UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2114, 12 lots 112030719 112041222 112051939 112083124 112093924 112125069 113025796 113026055 113026076 113036761 113057459 113088787 ",,"12 lots/88 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2379-2014","Class I","LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50'' X 90'' LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4'' X 4'' 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5'' X 20'' LIF ( I) DRAPE LAP 102'' X 121'' X 78'' W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41'' X 69'' MEDIUM LIF (2) LEGGING W/7'' CUFF 30'' X 42'' LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8'' STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8'' STICK SPONGE ( I) SURGICAL STRIP W' X 6'' COTTON (2) LITE GLOVES LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1202, 12 lots: 112051738 113078681 113099269 113109712 131110160 131210629 140111078 140211462 140211633 140311918 140412586 140513335",,"12 lots; 450 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2418-2014","Class I","LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00'' X 123W' X 77'' WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15'' X 20'' LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2'' X 2'' 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42'' X 57'' SMS (1) DRAPE LASER CAMERA W/EL 6'' X 96'' LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18'' X 18'' XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1913, 18 lots: 112030657 112041913 112051896 112062467 112114653 112125043 113026231 113036784 113057438 113078284 113088771 113099399 113109766 131110211 131210772 140311185 140412620 140412878 ",,"18 lots; 882 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2416-2014","Class I","PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7'' CUFF (1) DRAPE TOP WI ADHESIVE (1) TABLE COVER REINF. L/Free (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) CATHETER 14FR ROBIN NELAT PVC (2) GOWN LGE SMS IMPERVIOUS REINF. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1871, 1 lots: 111072025 ",,"1 lot; 12 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2438-2014","Class I","HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15'' X 20'' (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14'' X 48'' (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89'' X 128'' WITH POUCH TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents ","Product code 900-2184, 4 lots 111041038 111071378 111082085 112062292 ",,"4 lots/110 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2440-2014","Class I","LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4'' X 4'' 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50'' X 90'' LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5'' X 20'' LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102'' X 122'' X 78'' ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60'' X 77'' DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24'' X 24'' (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2204, 5 lots 112050723 112062283 112083422 112093930 112125070 ",,"5 lots/214 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2531-2014","Class I","Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54'' X 54'' (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24'' X 24'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-1196C, 25 lots: 109081948 111020513 111040952 111041136 111051468 111112924 111113162 112010244 112020547 112020554 112051555 112062220 112082996 112083217 112093966 112114785 113015636 113036439 113078353 113109656 131210739 140111446 140312370 140513169 140613799 ",,"25 lots/ 493 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2441-2014","Class I","SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30'' X 30'' (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT (5) LAP SPONGE PREWASH 18'' X 18'' XRD (1) BLADE SURG. #15 CARBON STEEL (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR (1) CAUTERY TIP POLISHER (1) BLADE SURG. #10 CARBON STEEL (2) LITE GLOVE (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) CAUTERY PENCIL ROCKER SWITCH (1) TIME OUT BEACON NON WOVEN ST Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2224, 31 lots 111030809 111040974 111051186 111051439 111061657 111123221 112010132 112020464 112030725 112041296 112083423 112093932 112114389 112114662 113015447 113025955 113026235 113036792 113057462 113067868 113078471 113088791 113099288 113109791 131110239 140111204 140211659 140312122 140312381 140412899 140513478 ",,"31 lots/5900 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2512-2014","Class I","TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15'' X 20'' LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60'' X 76'' REINFORCED L/F (1) DRAPE CHEST 100'' X 142'' X 72'' LIF (1) FLUORO COVER 30'' X 30'' WITH RUBBBAND LIF (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. Y.'' X 12' UF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD UF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF (1) STERI STRIP DRAPE LARGE 17'' X 23'' LIF (1) SKIN MARKER WITH RULER UF (9) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (4) NEEDLE HYPODERMIC 18G X 1Y2 UF (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE SPINAL 18G X 6'' LONG LENGTH LIF (1) BLADE SURGICAL # 10 CARBON STEEL (1) BLADE SURGICAL # 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN UF (2) DRESSING TEGADERM 4'' X 4% ''UF (2) MEDICINE CUP 2oz (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23'' X 23'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795 ",,"8 lots, 273 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2413-2014","Class I","LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50'' x 90'' UF (4) TOWEL ABSORBENT 15'' x 20'' UF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1) BLADE SURGICAL #11 S/STEEL (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH (4) DRAPE UTILITY WITH TAPE UF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F (1) TROCAR DILATING XCEL 5MM x 100 (D5LT) (1) TROCAR ENDO.XCEL DILATING TIP 11MM (1) SUTURE BAG FLORAL UF (1) CLOSURE SKIN W' X 4'' STERI STRIP LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1803, 7 lots: 112114857 112125169 113026230 113036759 140312276 140412556 140513115 ",,"7 lots; 128 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2331-2014","Class I","PERY GYN PACK - (1) TABLE COVER REINFORCED 44'' X 78'' UF (2) TOWEL ABSORBENT 15'' X 20'' LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4'' X 4'' 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE SHEET 41 '' X 58'' SMS (2) LEGGINS WITH 7'' CUFF 30'' X 42'' (1) DRAPE UTILITY WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-548, 60 lots: 109010181 109030603 109051042 109061206 109071558 109081861 109092069 109102334 109112579 109122695 110010096 110020395 110030677 110040948 110051248 110051360 110061461 110071847 110082073 110092262 110092399 110112663 110123108 111010139 111020289 111030691 111040905 111051209 111061555 111071826 111082102 111092553 111102766 111123268 112010186 112020489 112030845 112041337 112051995 112062490 112072805 112083434 112093640 112104099 112114678 113015454 113036442 113047025 113047205 113057493 113057747 113068175 113088875 113099441 113109856 131110266 131210828 140111238 140211731 140211940 ",,"60 lots; 4896 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2507-2014","Class I","ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15'' X 20'' (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53'' X 77'' (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108'' X 77'' STD SMS (1) COVER TABLE REINFORCED 50'' X 90'' (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2830, 3 lots 140111332 140211832 140412672 ",,"3 lots, 402 units ( multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2313-2014","Class I","ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15'' X 20'' LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8'' STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4'' X 4'' 16PL Y XRD LIF (1) DRAPE ANGlO 75'' X 145'' (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1'' (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8'' STICK SPONGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-210, 30 lots: 112030717 112041290 112041446 112051934 112072622 112093725 112114388 112114598 113015442 113015630 113036436 113036760 113047216 113057458 113057699 113057816 113068045 113068165 113078572 113089023 113099285 113109786 131110235 131110605 131210967 140111414 140211876 140312332 140412833 140513348 ",,"30 lots; 6500 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2314-2014","Class I","0.B. PACK - HSCH- (1) PVP SCRUB 8'' STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7'' CUFF 30'' X 42'' (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18'' X 18'' XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15'' X 20'' LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP (10) GAUZE SPONGE 4'' X 4'' 12PLY (2) PAD OBSTETRICAL X-LARGE ST. LIF (1) EAR ULCER SYRINGE 2oz UF (1) BABY BEANNIES (2) DRAPE SHEET 41 '' X 58'' SMS (1) SCISSORS UMBILICAL (1) TABLE COVER REINFORCED 44'' X 78'' L/F (2) WRAPPER 24'' X 24'' LI EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-254, 22 lots: 111113093 111123230 112030815 112041318 112051972 112093935 112114665 113026059 113026113 113036348 113036461 113047019 113047218 113057472 113088799 113089161 113109797 131110249 131210793 140312134 140412465 140412904 ",,"22 lots; 1485 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2447-2014","Class I","LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60'' X 77'' DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y.'' X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102'' X 122'' X 78'' LIF (1) PK. STRIP STERI CLOSURE W' X 4'' LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15'' X 20'' LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2270,1 lot 112125073 ",,"1 lot/60 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2474-2014","Class I","Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0'' X 63'' W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4'' X 4'' 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 '' 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRAP (1) TUBE SUCTION CONNE 1/4 X 12' UF (3) GEL SYRINGE 10cc PREFILLED (1) TABLE COVER REINFORCED 44 X 78 (1) SYRINGE 60ML LUER LOCK W/O NDL UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2510, 10 lots: 113046981 113057471 113078312 113088798 113099429 131110251 131210649 140111211 140312133 140412657 ",,"10 lots, 612 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2406-2014","Class I","PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15'' x 20'' UF (2) LEGGINS W/7'' CUFF 30'' X 42'' (1 ) TABLE COVER REINFORCED 50'' X 90'' UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1716, 53 lots: 109061244 109071562 109081820 109092024 109102291 109122762 110020332 110040902 110051214 110061438 110071671 110081969 110082177 110112616 110123093 111010064 111020274 111030598 111041097 111051278 111061509 111071907 111082062 111092362 111102697 111123377 112010084 112020402 112030640 112041197 112051869 112062445 112072783 112083403 112093912 112114382 112125030 113015433 113025947 113036671 113036754 113047005 113057396 113057862 113088757 113089198 113109747 131110329 131210758 140111169 140211650 140312082 140412456 ",,"53 lots; 1800 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2404-2014","Class I","LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6'' X 96'' LIF (2) SHEET DRAPE 42'' X 57'' SMS (1) TUBE SUCTION CONNECT. %'' X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44'' X 78'' LIF (1) DRAPE LAPAROSC. ABD 102'' X 122'' X 78'' WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %'' (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15'' X 20'' L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8'' STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8'' STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1688, 16 lots: 112114380 112114643 113036740 113047004 113057426 113068154 113088751 113099276 131110193 140211464 140211704 140311926 140312434 140412555 140513103 140513462 ",,"16 lots; 843 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2405-2014","Class I","CESAREAN PACK - (1) BABY BLANKET IMP. 30'' X 30'' POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4'' x 10'' (1) CESAREAN DRAPE 71'' x 125'' LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42'' X 57'' SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15'' X 20'' L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44'' x 78'' LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30'' X 30'' LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y.'' X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1689, 20 lots: 111113026 111123373 112051861 112083402 112114645 113015432 113036419 113036729 113047214 113057427 113068155 113088752 113099277 131110194 131210755 140111165 140211884 140312435 140513104 140513464 ",,"20 lots; 1095 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2523-2014","Class I","General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50'' X 90'' LIF (2) TOWEL ABSORBENT 15'' X 20'' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) SYRINGE BULB 60CC LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE HYPODERMIC 18G X 1% LIF (6) TOWEL CLOTH HUCK BLUE LIF (4) DRAPE UTILITY WITH TAPE L/F (1) NEEDLE HYPODERMIC 25 X 1% L/F (1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF (2) NEEDLE SPINAL ANESHT 20G X 3%'' LIF (1) SKIN MARKER WITH RULER LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) LITE GLOVE (1) DRAPE BREAST/CHEST SMS LIF (1) TUBE SUCTION CONNECT%'' X 12' LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY L/F (2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE (1) TRAY 3/COMPARTMENT (1) WRAPPER 24'' X 24'' L/F (2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEX Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3113, 2 lots: 131110435 131210803 ",,"2 lots/ 18 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2403-2014","Class I","RETINA PACK - (1) TABLE COVER REINFORCED 44'' X 78'' LIF (50) COTTON TIP APPLICATOR 6'' WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (2) MEDECINE CUP 2oz LIF (5) TOWELS ABSORBENT 15'' X 20'' LIF ( 1) UNIVERSAL EYE SHIELD (1) EYE DRAPE (1) BIPOLAR CABLE DISPOSABLE ( 1) OPHTALMIC BIPOLAR PENCIL (10) GAUZE SPONGE 4'' X 4'' 16PLY (2) EYE PAD 2 1/8 X 2 5/8 ST. ( 1) MAYO STAND COVER REINFORCED LIF ( 1) KNIFE 15 5.0 CONTROLLED DEPTH. (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) SURGICAL BLADE #15 STAINLESS STEEL (3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1611, 10 lots: 111123361 112030624 112051849 112072779 112114640 112124965 113078268 113088833 140412455 140513000 ",,"10 lots; 336 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2397-2014","Class I","D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X'' X 12' LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) LEGGINGS WITH 7'' CUFF 30'' X 42'' LIF (1) UTILITY BOWL 32oz. UF (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX (2) DRESSING NON ADH TELFA 4 X 3 ST. UF (1) JELLY LUBRICATING FIVE GRAM (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) *Pk. STERI STRIP LAP SET LATEX (1) COVER CAMERA W/ELAST UF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF (4) TOWELS ABSORBENT 15'' X 20'' UF (1) DRAPE LAP. PERINEAL WITH POUCH 102'' X 97'' SOFT SMS UF (2) LIGHT SHIELD (1) DRESSING TEGADERM 4'' X 4 %'' LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD UF (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (1) SCALPEL WEIGHTED SAFETY #11 (1) BAG ZIP LOCK (1) Pk. STRIP STERI CLOSURE W' X 4'' LIF (1) TIME OUT BEACON NON WOVEN ST. UF (1) BANDAGE GAUZE STRETCH 4'' (1) NEEDLE ULTRA VERES 120MM UF (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391 ",,"22 lots; 968 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2432-2014","Class I","ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77'' X 11 0'' HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5'' X 20'' LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70'' X 100'' L/ F (5) LAP SPONGE PREWASH 18'' X 1 8'' XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108'' X 50'' STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23'' X 1 7'' LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6'' X 2 1 '' LIF (1 ) PAD ABDOM INAL 8'' X 7''h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108'' X 77'' STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2039, 7 lots: 112062199 113026170 113057698 113099418 131110232 140311817 140312114 ",,"7 lots/236 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2498-2014","Class I","Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF (2) SOLUTION SURGICAL DURAPREP 6ML LIF ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF (4) TOWELS CLOTH HUCK BLUE LIF (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF (I) COYER TABLE 44 X 90 LIF ( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF (2) CLAMP TOWEL (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF ( I) NEEDLE HYPODERMIC 18G X I Y, LIF ( I) SHARP STOP NEEDLE HOLDER LIF ( I) TRAY ORGANIZER FULL DEEP ( I) NEEDLE 18G X 23 (I) BOWL UTILITY BLUE 16oz LIF ( I) WRAPPER 24X 24 LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2715, 1 lot: 113099591 ",,"1 lot/ 12 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2518-2014","Class I","Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50 X 90 (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER ACCU-6 (6) TOWELS CLOTH HUCK C BLUE (1) TUBE SUCTION CONNECT (1) DRAPE BREAST/CHEST (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-3026: , 2 lots: 113099551 140312148 ",,"2 lots/ 24 units, 12 units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2449-2014","Class I","CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50'' X 90'' (1) COVER FLUORO 30'' X 30'' WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60'' X 77'' DRAPE REINFORCED (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100'' X 142'' X 72'' (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2'' X 2'' 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4'' (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17'' X 23'' (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2286 ,2 lots 112082968 113057620 ",,"2 lots/160 units,(multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2456-2014","Class I","EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) GOBAN SELF-ADHERENT WRAP 6'' X 5yds (3) BANDAGE ELASTIC 4'' X 5yds (1) BANDAGE ESMARK 6'' X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4'' X 4'' 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23'' X 17'' (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60''X 70'' WITH TAPE SPLIT 6'' X 21'' (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15'' X 20'' (3) DRAPE % ECONOMY 53'' X 77'' (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146'' X 104'' X 91'' (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2438 ,4 lots 140211465 140211702 140412558 140512912 ",,"4 lots/112 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2339-2014","Class I","O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20'' X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-629, 26 lots: 109061450 109102339 110030682 110041125 110071851 110123058 111020294 111020444 111040911 111051251 111092555 111113133 112010193 112030734 112072918 112124704 113036701 113046967 113047229 113057748 113088880 131110309 131110345 140312179 140513154 140613796 ",,"26 lots; 3875 units (multiple units per lots)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2399-2014","Class I","LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4'' X 4'' 16 PLY XRD UF (2) ABSORBENT TOWELS 15'' X 20'' UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3'' L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50'' x 90'' UF (3) DRAPE SHEET 41 '' x 58'' SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1515, 2 lots: 110061486 111030825 ",,"2 lots; 148 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2511-2014","Class I","ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15'' X 20'' UF (1) TABLE COVER REINFORCED 50'' X 90'' L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60'' X 76'' REINFORCED LIF (1)DRAPE THYROID 100'' X 142'' X 72'' LIF (1) FLUORO COVER 30'' X 30'' W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13'' X 13'' (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 ''X 2 o/.. ''L/F (2) MEDICINE CUP 2oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146 ",,"6 lots, 180 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2340-2014","Class I","FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42'' X 57'' SMS (1) WRAPPER 24'' X 24'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-633, 56 lots: 109020284 109040849 109051210 109071550 109092075 109102340 109112583 109122699 110010102 110010242 110020460 110030683 110030781 110041029 110051365 110071704 110082030 110092351 110102554 110102670 110122940 111010146 111020229 111030685 111040913 111051394 111051461 111061682 111061683 111071941 111071967 111082323 111092606 111102772 112041342 112052001 112062213 112062502 112083438 112093948 113036375 113036674 113036735 113047026 113057496 113068177 113078605 113089078 113099293 113109865 131110269 131210834 140211674 140412471 140412797 140513350 ",,"56 lots; 60820 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2451-2014","Class I","FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6'' WOOD (60) GAUZE SPONGE 4'' X 4'' 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBON RIB (1) SHEET ENT SPLIT 110'' X 77'' SMS L/F (3) *Pr. GLOVE PERRY SURG # 7.5 LATEX (5) SPONGE LAP PREWASH 18'' X 18'' XRD LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF (2) COTTON BALL MED (3) *Pr. GLOVE PERRY SURG # 7 LATEX (1) DRAPE INST. MAGNETIC 10'' X 16'' L/F (2) NEEDLE 30G X 1 DISP LIF (1) MARKER SKIN WITH RULER LIF (4) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) COUNTER NEEDLE AND BLADE 15C FOAM I MAG STRIP LIF (2) GOWN SOFT SMS STD X-LGE SET IN SLEEVE LIF (1) RULER 6'' FLEXIBLE (1) BAG ZIP LOCK 6'' X 10'' PLASTIC Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2291 ,2 lots 112010139 112020467 ",,"2 lots/96 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2346-2014","Class I","IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!'' X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14'' X 48'' LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108'' X 77'' STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15'' X 20'' LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70'' X 100'' STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108'' X 50'' STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6'' X 5''yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23'' X 17'' LIF (2) ABDOMINAL PAD 8'' X 7 W (1) U-DRAPE 60'' X 70'' WIT APE SPLIT 6'' X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77'' X 86'' HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-741, 16 lots: 112041352 112072877 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736 ",,"16 lots; 1041 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2353-2014","Class I","LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58'' SMS L/F ( 1) TABLE COVER 50'' X 90'' LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) BLADE SURGICAL# 10 CARBON STEEL (5) LAP SPONGE PREWASH 18'' X 18' XRD LIF (6) TOWELS ABSORBENT 15'' X 20'' LIF ( 1) CAUTERY TIP POLISHER L/F (2) UTILITY BOWL 16oz LIF (1) TUBE SUCTION CONNECT%'' X 12' LIF (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF (1) DRAPE T LAPAROTOMY 102'' X 78'' 121'' SMS STD LIF ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF ( 1) TIME OUT BEACON NON WOVEN LIF ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-848, 23 lots: 112041259 112072813 112072916 112114685 112124855 112125308 113015569 113047034 113047207 113057642 113067938 113068189 113078590 113099301 113109648 113109876 131110346 140111253 140211856 140312186 140412473 140513146 140513482 ",,"23 lots; 1966 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2354-2014","Class I","CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50'' X 90'' LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 '' X 58'' SMS LIF (5) TOWEL ABSORBENT 15'' X 20'' LIF (15) SPONGE LAP PREWASH 18'' X 18'' XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) SYRINGE EAR/ULCER 2oz. L/F (1) BLANKET BABY PRINTED (1) TUBE SUCTION CONNECT Y-1'' X 12' LIF (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) BLANKET RECEIVING 100% COTTON (1) BOWL W/LID PLASTIC 80oz. (1) UMBILICAL CORD CLAMP (1) TUBE FEEDING PVC 8FR 15'' LONG (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BAG SUTURE FLORAL (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE (1) SCALPEL W/HANDLE #1 0 (1) SCALPEL W/HANDLE #20 (2) BOWL UTILITY 16oz. LIF (1) PVP PAINT 8'' STICK SPONGE LIF (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) SCISSOR UMBILICAL 4.5'' STRAIGHT (1) WRAPPER 24'' X 24'' LIF (1) PVP SCRUB 8'' STICK SPONGE LIF (1) DRAPE C-SECTION W/POUCH 102'' X 121'' X 78'' LIF (1) TIME OUT BEACON NON WOVEN LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-851, 19 lots: 112093954 112114401 112125118 113015517 113046987 113047162 113057510 113067939 113078349 113088895 113099457 113109877 131110317 140111098 140211857 140312187 140412474 140513147 140513483 ",,"19 lots; 968 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2420-2014","Class I","OPHTALMIC PACK- (1) TABLE COVER REINF. 44'' X 78'' UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15'' X 20'' LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6'' WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4'' X 4'' 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1933, 20 lots: 112114613 112125046 113015506 113025815 113036476 113046936 113047008 113057440 113057613 113057842 113078288 113078581 113089021 113099282 113109641 131110072 131110603 131210966 140412831 140513465 ",,"20 lots; 1812 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2450-2014","Class I","LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18'' X 18'' XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50'' X 90'' LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4) DRAPE SHEET 44'' X 58'' SMS LIF (1) TRAY ORGANIZER FULL DEEP (3) SHEET% 53'' X 77'' REINF. LIF (2) TOWELS ABSORBENT 15'' X 20'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2290 ,2 lots 112030728 112041301 ",,"2 lots/32 units, (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2360-2014","Class I","C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50'' X 90'' (2) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18'' X 18'' XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CORD UMBILICAL CLAMP (2) LIGHT GLOVE (1) BOWL UTILITY 32oz (1) BOWL UTILITY 16oz (4) DRAPE UTILITY (1) TUBE SUCTION CONNECT. 1!4'' X 12' (1) TIP CAUTERY POLISHER (1) MUCUSTRAP 20cc, 10FR. (2) DRAPE SHEET 41'' X 58'' SMS (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) PENCIL CAUTERY ROCKER SWITCH (1) ELECTRODE DUAL DEPRES./GROUNDPAD (1) C-SECTION DRAPE WITH POUCH 102'' X 121'' X 78'' (1) EAR ULCER SYRINGE 2oz (1) BABY BEANNIES (1) RECEIVING BLANKET 100% COTTON (2) SURGICAL BLADE #10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-921A, 4 lots: 140312028 140412706 140513148 140513469 ",,"4 lots; 600 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2490-2014","Class I","Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1'' (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG ( 1) BOWL UTILITY QUART 32oz (1 ) MAYO STAND COVER REINFORCED (1 ) TABLE COVER REINFORCED 50'' X 90'' (1 ) DRAPEBREASTICHEST SMS ( 1) RULER 6'' CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWELS ABSORBENT 15'' X 20'' ( 1) TUBE SUCTION CONNECT ~'' X 12' ( 1) DENTURE CUP 8oz WITH LID (2) SKIN MARKER INK WITH 8 LABEL (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2657, 3 lots: 112062216 112093596 112093902 ",,"3 lots, 272 units multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2491-2014","Class I","Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50 X 90 ( 1) DRAPE BREAST/CHEST SMS ( 1) YANKAUER SUCTION TUBE W/0 VENT ( 1) TUBE SUCTION CONNECT Y ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( 1) DENTURE CUP 8oz W/LID (2) LITE GLOVES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2658, 3 lots 112062217 112093595 112093720 ",,"3 lots, 306 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2504-2014","Class I","NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23'' X 1 7'' (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6'' (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23'' X 1 7'' LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77'' X 110'' HD FULL L/F (20) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5'' X 20'' LIF ( I ) DRAPE T LAPAROTOMY 102'' X 78'' X 1 21'' STD SMS (5) LAP SPONGE PREWASH 18'' X 18'' XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53'' X 77'' LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Code 900-2765, 6 lots 112124939 113036441 113056798 113057644 113078320 113088806 ",,"6 lots,132 units (multiple units per package)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2473-2014","Class I","ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108'' X 50'' STD SMS (1) DRAPE ORTHOPEDIC SPLIT (1) U- DRAPE 60'' X 70'' WffAPE SPLIT 6 X 21 (1) TABLE COVER REINFORCED 50'' X 90'' (1) GOWN SURG REINFORCED XLGE TOWEL I WRAP (1) STOCKINETIE IMPERVIOUS 12'' X 48'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2499 , 4 lots 112020344 112051969 112072731 113057470 ",,,"Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2414-2014","Class I","ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50'' X 90'' (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X'' X 12' (1) STOCKINETTE IMPERVIOUS 14'' X 48'' (1) U-DRAPE 60'' X 70'' WITH TAPE SPLIT 6'' x 21 '' (1) SHEET ARTRHOSCOPY ''T'' W/POUCH STD SMS (1) SUTURE BAG FLORAL (3) ABSORBENT TOWEL 15'' X 20'' EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1832, 39 lots: 109122842 110010063 110020346 110030645 110051220 110071773 110082195 110092199 110102436 110112622 110122927 111010075 111030627 111041079 111051370 111071782 111082071 111092368 111102709 111113047 111123182 112020420 112030819 112041405 112051890 112072788 112083304 112083409 113026166 113036456 113036733 113047115 113047200 113078282 113088768 113099486 113099587 131010209 140111184 ",,"39 lots; 600 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2409-2014","Class I","MINOR LAPAROTOMY PACK - (1) TABLE COVER 50'' X 90'' REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15'' X 20'' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~'' X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4'' X 4'' 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41'' X 69'' LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347 ",,"50 lots; 9749 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2308-2014","Class I","Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453 ",,"14 lots; 855 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2466-2014","Class I","LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15'' X 20'' (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50'' X 90'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2483 ,5 lots 112020352 112051963 112072727 113078523 140513401 ",,"5 lots/1269 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2465-2014","Class I","CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44'' X 78'' (2) TOWELS ABSORBENT 15'' X 20'' (2) LEGGINGS W/7'' CUFF 30'' X 42'' (1) DRAPE CYSTOSCOPY T 60'' X 87'' 35'' SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2482 ,2 lots 112072726 113078522 ",,"2 lots/600 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2464-2014","Class I","MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15'' X 20'' (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44'' X 65'' (1) DRAPE% ECONOMY 53'' X 77'' (1) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET EXTREMITY ABS 125'' X 85'' SMS (1) TABLE COVER REINFORCED 50'' X 90'' (1) GOWN XL SMS IMPERVIOUS REINFORCED Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2477 ,1 lots 112104281 ",,"1 lot/102 units","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2410-2014","Class I","UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 ''2 .1M REGULAR CLAM (1) TABLE COVER 44'' x 90'' (1) DRAPE LITHO 11 0'' X 63'' WITH POUCH /LEGGING FEN (1) TUBE SUCTION CONNECT. Y.'' X 12' LIF (1) WASH BASIN ROUND 6QT (1 0) GAUZE SPONGE 4'' X 4'' 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF (1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF (1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20'' X 20'' L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1738, 20 lots: 111030607 111051369 111061590 111071991 111082066 111102866 111113031 111123419 112010088 112020406 112030643 112041201 112051875 112083056 112093914 112114648 113088760 113089083 140211651 140312085 ",,"20 lots; 440 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2322-2014","Class I","CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50'' X 90'' LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X- LARGE LIF (5) TOWEL ABSORBENT 15'' X 20'' LIF (1) DRAPE SHEET 41'' X 58'' SMS LIF (1) TUBE SUCTION CONNECT. Y..'' X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE (1) RECEIVING BLANKET 100% COTTON (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents","Product code 900-410, 24 lots: 112020166 112020534 112030841 112041322 112051983 112062488 112072871 112083430 112093939 112114673 112125090 113025992 113036358 113036764 113078476 113078814 113099291 113099573 131110300 140111223 140211668 140312159 140412838 140513349 ",,"24 lots; 2564 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2477-2014","Class I","Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24'' X 24'' (1) TOWELS ABSORBENT 15'' X 20'' LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2592, 20 lot: 112020341 112041064 112041312 112051974 112062485 112062496 112124666 112125076 113057401 113067920 113078313 113088800 113089085 113099304 113109818 131110252 131210794 140111212 140312135 140412659 ",,"20 lots (1656 packed units, multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2458-2014","Class I","KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50'' X 90'' (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BAG SUTURE FLORAL (1) SHEET SPLIT WITH/ADHESIVE 108'' X 77'' STD SMS (1) STOCKINETTE IMPERVIOUS 12'' X 48'' (4) STRIPS TAPE 24'' X 4'' (1) DRAPE ARTHROSCOPY W/POUCH (1) TOWEL ABSORBENT 15'' X 20'' Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","Product code 900-2463 ,1 lot 113078520 ",,"1lot/ 300 units ","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2529-2014","Class I","Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. ","900-3190, 5 lots: 140111070 140211868 140312153 140412677 140513356 ",,"5 lots/312 units, multiple units per lot","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2356-2014","Class I","ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15'' x 20'' LIF (1) TUBE SUCTION CONNECT Y..'' X 12' LIF (1) ELASTIC BANDAGE 6'' X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14'' X 48'' (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60'' X70'' WITH TAPE SPLIT (4) STRIPS TAPE 24'' X 4'' L/F (1) STOCKINETTE 6'' X 48'' LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125'' x 85'' SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30'' X 37'' (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77'' X 110'' HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342 ",,"11 lots; 273 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68536,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.","Z-2417-2014","Class I","BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4'' X 4'' 12PLY (2) DRAPE SHEET 41'' X 58'' SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.","Product code 900-1880, 1 lots: 109010222 ",,"1 lot; 40 units (multiple units per lot)","Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",5/20/2014,"05/20/2014",9/10/2014,"09/10/2014"
"Devices",68537,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.","Z-1927-2014","Class II","Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments","Kit Lot Number: 454779 Exp. Date: 28 February, 2015",".","3,839 kits","Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles",6/2/2014,"06/02/2014",7/2/2014,"07/02/2014"
"Food",68538,"Ongoing","Fish Family Farm","Bolton","CT","US","Voluntary: Firm Initiated","Press Release","Shadow Valley Farm product distributed to retail stores in CT and MA. Fish Family Farm Brand Products were only sold at the firm's retail store.","F-2345-2014","Class II","FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container ","Sell by 6/23/14",,"92 half-gallons","Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Food",68538,"Ongoing","Fish Family Farm","Bolton","CT","US","Voluntary: Firm Initiated","Press Release","Shadow Valley Farm product distributed to retail stores in CT and MA. Fish Family Farm Brand Products were only sold at the firm's retail store.","F-2348-2014","Class II","FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homogenized in a glass half-gallon container ","Sell by 6/23/14",,"162 half-gallons","Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Food",68538,"Ongoing","Fish Family Farm","Bolton","CT","US","Voluntary: Firm Initiated","Press Release","Shadow Valley Farm product distributed to retail stores in CT and MA. Fish Family Farm Brand Products were only sold at the firm's retail store.","F-2347-2014","Class II","FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized and Homogenized in a glass half-gallon container ","Sell by 6/23/14",,"120 half-gallons","Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Food",68538,"Ongoing","Fish Family Farm","Bolton","CT","US","Voluntary: Firm Initiated","Press Release","Shadow Valley Farm product distributed to retail stores in CT and MA. Fish Family Farm Brand Products were only sold at the firm's retail store.","F-2349-2014","Class II","FISH FAMILY FARM INC. GRADE A PASTEURIZED HEAVY CREAM in glass pints, quarts, half-gallons ","Sell by 6/23/14",,"12 quarts, 10 pints, 33 half-gallons","Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Food",68538,"Ongoing","Fish Family Farm","Bolton","CT","US","Voluntary: Firm Initiated","Press Release","Shadow Valley Farm product distributed to retail stores in CT and MA. Fish Family Farm Brand Products were only sold at the firm's retail store.","F-2346-2014","Class II","FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized and Homogenized in a glass half-gallon container ","Sell by 6/23/14",,"126 half-gallons","Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Biologics",68539,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","Letter","Colorado","B-0797-14","Class III","Red Blood Cells Leukocytes Reduced","W290614053856; ",,"1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.",6/2/2014,"06/02/2014",7/30/2014,"07/30/2014"
"Biologics",68540,"Terminated","Bergen Comm Reg Blood Center","Montvale","NJ","US","Voluntary: Firm Initiated","Telephone","New Jersey","B-0798-14","Class II","Platelets Pheresis Leukocytes Reduced","W065614021981; ",,"1 unit","Blood product, which did not meet the acceptable product specification, was distributed.",4/26/2014,"04/26/2014",7/30/2014,"07/30/2014"
"Biologics",68541,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0799-14","Class II","Platelets Pheresis Leukocytes Reduced","W398514024761S; ",,"1 unit","Blood product, in which quality control on a platelet apheresis product was found to be unacceptable, was distributed.",4/8/2014,"04/08/2014",7/30/2014,"07/30/2014"
"Food",68542,"Completed","La Finquita","Stamford","CT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed through retail stores in Connecticut, New Jersey and New York","F-2404-2014","Class II","La Finquita Quesito Fresco Campesino / Fresh Farmers Cheese. The product is packaged in a 14.11oz. plastic container, UPC Code: 0 94922 76809 4","Use by 6/28/14. ",".","1171 units","The milk used to manufacture the cheese may be contaminated with peanuts and tree nuts (pistachios). ",6/12/2014,"06/12/2014",9/3/2014,"09/03/2014"
"Food",68543,"Ongoing","Smith's Country Cheese, Inc.","Winchendon","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA","F-2049-2014","Class I","Gouda Cheese wheels, Whole Wheels 10 lbs and Half Wheels 5 lbs., packaged under the the brand names: Mountain Gouda and Smiths Farmstand","Julian date Code: 4037",".","21 wheels","Product contaminated with Listeria monocytogenes",6/12/2014,"06/12/2014",7/2/2014,"07/02/2014"
"Food",68544,"Ongoing","Interbake Foods Llc","Front Royal","VA","US","Voluntary: Firm Initiated","Telephone","OH, IA, AL","F-2314-2014","Class II","Mrs. Fields Milk Cholate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a case. UPC 8-86002-50651-7.","Lot BB 1-29-15 (with time stamp 9:46 am - 9:49 am). Item 60332.","."," 16 cases","Undeclared Walnuts. Some cartons labelled as Chocolate Chip cookies actually contain Oatmeal Raisin with Walnut cookies. ",5/24/2014,"05/24/2014",8/20/2014,"08/20/2014"
"Veterinary",68545,"Ongoing","Boehringer Ingelheim Vetmedica Inc","Saint Joseph","MO","US","Voluntary: Firm Initiated","Letter","Distribution has been made to AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MN, MO, MS, NE, NJ,NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WY.","V-135-2014","Class III","Surpass (1% diclofenac sodium) Topical Anti-Inflammatory Cream, 124 g tube, UPC 012313449810, NADA 141-186. Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO. ","Lot # 130502, expiration date 05/2015",".","16,633 tubes","During stability testing, the product was found out of specification. ",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Devices",68546,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.","Z-2022-2014","Class II","STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches","Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.",,"10,835","Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.",5/29/2014,"05/29/2014",7/16/2014,"07/16/2014"
"Devices",68547,"Ongoing","Zimmer Manufacturing B.V.","Mercedita","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.","Z-2032-2014","Class II","Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.","Lot No. 62629432 Lot No. 62628759",,"496","Zimmer recently received a complaint regarding a screw that did not correspond to the part number and lot number information on the package label. Zimmer determined that two lots of screws were commingled. Specifically, screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.",6/12/2014,"06/12/2014",7/16/2014,"07/16/2014"
"Drugs",68548,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico.","D-1412-2014","Class II","Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.","Lot # A308879, Expiry: 09/2015",,"92,544 Bottles","Failed Dissolution Specifications: Drug failed stage III dissolution testing.",6/19/2014,"06/19/2014",7/9/2014,"07/09/2014"
"Food",68550,"Ongoing","U-Can Food Trading Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","FAX","US.","F-2083-2014","Class II","The Cookies Cottage (Brand) Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits), 180g. Packaged in 24packets per carton.","UPC Code: 9556995 121059. Lot D11M.",,"82 cartons","U-Can Food Trading, Inc. initiated a voluntary recall of The Cookies Cottage brand, Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits) due to undeclared FD&C Blue #1, Yellow #5, and Carmoisine, a dye not permitted for use.",6/5/2014,"06/05/2014",7/16/2014,"07/16/2014"
"Food",68551,"Terminated","Wegmans Food Markets, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York, Pennsylvania, New Jersey, Massachusetts, Virginia, and Maryland","F-2190-2014","Class I","Wegmans Cinnamon Raisin Buns, NET WT. 12 OZ (340g), UPC 77890 92218 ---Baked by Wegmans Food Markets Inc. - Rochester, NY 14603 ","BEST IF USED BY 6/19 TU (stamped on top of package)",".","1,315 units","The Raisin Cinnamon Buns contain undeclared eggs which may also be raw. This poses a potential health risk to consumers if the product is consumed.",6/14/2014,"06/14/2014",7/23/2014,"07/23/2014"
"Devices",68552,"Ongoing","RGI Medical Manufacturing, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.","Z-1996-2014","Class II","Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures. ","Lot numbers 102131 and 110531. ",,"19,200 units.","Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. ",3/28/2014,"03/28/2014",7/16/2014,"07/16/2014"
"Devices",68553,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-2020-2014","Class II","Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086","All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06; Batch numbers: M10131018 M10131022 M10131025 M10131105 M10131108 M10131112 M10131115 M10131122 M10131123 M10131126 M10131211 M10131218 M10140109 M10140113 M10140204 M10140224 M10140313 M10140509 M11140224 N10140117 N10140121 N10140227 N10140319 N10140325 N10140403 N10140429 N10140515. Part number 420230-04, Batch numbers: M10120516 M10120523 M10120529 M10120530 M10120607 M10120615 M10120627 M10120628 M10120629 M10120702 M10120704 M10120706 M10120712 M10120716 M10120718 M10120724 M10120727 M10120731 M10120803 M10120807 M10120813 M10120817 M10120827 M10120830 M10120911 M10120918 M10120925 M10121001 M10121009 M10121015 M10121025 M10121030 M10121105 M10121113 M10121116 M10121126 M10121128 M10121203 M10121205 M10121207 M10121213 M10130103 M10130109 M10130115 M10130122 M10130129 M10130131 M10130207 M10130212 M10130215 M10130225 M10130228 M10130305 M10130307 M10130314 M10130315 M10130321 M10130401 M10130403 M10130416 M10130418 M10130423 M10130429 M10130501 M10130508 M10130517 M10130521 M10130528 M10130529 M10130530 M10130606 M10130608 M10130627 M10130702 M10130724 M10130725 M10130806 M10130809 M10130819 M10130827 M10130904 M10130906 M10130918 M10130925 M10131002 M10131004 M10131010 N10130919 N11130925 S10121108 S10130109 S10130722. ",,"5290 for part 420230-04; 1964 for part 420240-06","Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..",6/13/2014,"06/13/2014",7/16/2014,"07/16/2014"
"Food",68554,"Ongoing","Schnucks Markets Inc","Saint Louis","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to MO, IL, IN, IA and WI.","F-2192-2014","Class II","Schnucks Bakery 8'' Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078 Schnuck Markets, Inc., St. Louis, MO.","8'' Devil's Food Cake: Item: 31-40080; Half Devil's Food Cake: Item: 31-40503.",".","179 units","The product contains pecan pieces as a top garnish and the product label does not include pecan or tree nuts. ",6/13/2014,"06/13/2014",7/23/2014,"07/23/2014"
"Food",68555,"Completed","Plaze Inc","Saint Clair","MO","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to MO. There was no government/military/foreign distribution.","F-2236-2014","Class II","Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz. aerosol cans.","4135 1 CAKE 1800 thru 2100 (1800-2100 = military times affected)",,"130/6/14-oz. can cases","The product contains undeclared wheat.",6/9/2014,"06/09/2014",8/6/2014,"08/06/2014"
"Devices",68556,"Completed","Wellspring Pharmaceutical Corporation","Sarasota","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.","Z-2112-2014","Class I","IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing. ","Lot #3P3446",,"3,135 cartons of 4/10g tubes ","Potential for microbial contamination of the product. ",3/25/2014,"03/25/2014",8/6/2014,"08/06/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1398-2014","Class II","B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot # 2095, Use by 8/17/14",,"30 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1395-2014","Class II","Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot: 1731, Use by 7/01/14; Lot: 2190, Use by 8/24/14",,"1750 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1390-2014","Class II","CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot # 940, Best used by 08/01/14; Lot # 1090, Best used by 08/29/14; Lot # 1533, Best used by 05/24/14; Lot # 1838, Best used by 07/15/14; Lot# 2755, Best used by 10/06/14",,"2650 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1394-2014","Class II","Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14",,"2250 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1392-2014","Class II","Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","lot# 1157, Use by 09/16/14; lot# 2357, use by 06/01/14",,"50 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1391-2014","Class II","Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14",,"550 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1388-2014","Class II","Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15",,"300 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. ",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1406-2014","Class II","Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234","Lot 2868, Best used by 3/15/15",,"100 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1401-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot: 2187, best used by 05/26/14",,"10 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1400-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","a) 5 mL: Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14; Lot: 2672, best used by 7/03/14; Lot: 3022, best used by 7/28/14; b) 10 mL: Lot: 2166, best used by 5/26/14; Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14",,"170 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1393-2014","Class II","MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14",,"210 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1404-2014","Class II","LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234","lot: 2571, use by 9/23/14",,"80 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1403-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234","a) 5 mL: Lot: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14; ",,"40 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1389-2014","Class II","Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot# 938, Use by 08/17/14, Lot #1370; Use by Lot# 1818; Use by 11/08/14, 1/30/15; Lot# 2664, Use by 4/18/15",,"1560 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1402-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","a) 5 mL: Lot: 2488, best used by 6/19/14; b) 10 mL: Lot: 2264, best used by 06/03/14; Lot: 2295, best used by 06/04/14",,"25 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1396-2014","Class II","METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot # 1862, used by 7/20/14",,"60 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1397-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; b) 10 mL: Lot 2084, best used by 5/19/14; Lot 2318, best used by 6/04/14; Lot: 2369, best used by 6/10/04; Lot: 2396, best used by 6/11/14; Lot: 2576, best used by 6/25/14; Lot: 2744, best used by 7/08/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; Lot: 3123, best used by 8/10/14 ",,"365 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1405-2014","Class II","PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","Lot: 2789, Best used by: 7/10/14",,"30 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Drugs",68557,"Completed","John W Hollis Inc","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1399-2014","Class II","Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234","a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14 ",,"45 mL","Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.",5/12/2014,"05/12/2014",6/25/2014,"06/25/2014"
"Biologics",68558,"Terminated","Donor Network of Arizona","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","B-0800-14","Class III","Cornea","1405303ODC; 1405303OSC",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",6/10/2014,"06/10/2014",7/23/2014,"07/23/2014"
"Biologics",68559,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0803-14","Class II","Platelets Pheresis Leukocytes Reduced","W120614005600; W120614005600; ",,"2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.",5/2/2014,"05/02/2014",7/30/2014,"07/30/2014"
"Biologics",68560,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0857-14","Class III","Red Blood Cells Leukocytes Reduced","W120614003490",,"1 unit","Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.",4/28/2014,"04/28/2014",8/6/2014,"08/06/2014"
"Biologics",68560,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0858-14","Class III","Platelets Pooled Leukocytes Reduced","W120614180789",,"1 unit","Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.",4/28/2014,"04/28/2014",8/6/2014,"08/06/2014"
"Biologics",68560,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0856-14","Class III","Fresh Frozen Plasma","W120614003490",,"1 unit","Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.",4/28/2014,"04/28/2014",8/6/2014,"08/06/2014"
"Biologics",68561,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA","B-0825-14","Class II","Red Blood Cells","W050911075480",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/7/2014,"03/07/2014",10/1/2014,"10/01/2014"
"Biologics",68561,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","PA","B-0826-14","Class II","Red Blood Cells Irradiated ","W0050911079224",,"1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",3/7/2014,"03/07/2014",10/1/2014,"10/01/2014"
"Biologics",68562,"Terminated","Michigan Blood","Saginaw","MI","US","Voluntary: Firm Initiated","FAX","MI","B-0822-14","Class III","Red Blood Cells Leukocytes Reduced","W120614330943",,"1 unit","Blood product, manufactured without the entire quantity of additive solution, was distributed.",5/12/2014,"05/12/2014",8/6/2014,"08/06/2014"
"Biologics",68563,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0829-14","Class II","Platelets Pheresis Leukocytes Reduced","W038114062255",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",5/7/2014,"05/07/2014",8/20/2014,"08/20/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1950-2014","Class II","Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.","Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018. ",,"474 cs (9,480 ea) total for all kits involved. ","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1954-2014","Class II","Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1952-2014","Class II","Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1953-2014","Class II","Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1957-2014","Class II","Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1951-2014","Class II","Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015. ",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1956-2014","Class II","McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228","Model number: 25-2685, Lot number: 187211, Exp. Date: 12/1/2016.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68564,"Ongoing","Medical Action Industries Inc","Arden","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.","Z-1955-2014","Class II","Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.","Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.",,"474 cs (9,480 ea) total for all kits involved","Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Devices",68565,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.","Z-2048-2014","Class II","SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue","Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589",".","1086 untis","Sterility of device is compromised due to breach in sterile barrier",6/2/2014,"06/02/2014",7/23/2014,"07/23/2014"
"Devices",68565,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.","Z-2046-2014","Class II","SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue","Lot Numbers: 50477397, 50481448",".","136 units","Sterility of device is compromised due to breach in sterile barrier",6/2/2014,"06/02/2014",7/23/2014,"07/23/2014"
"Devices",68565,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.","Z-2049-2014","Class II","SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue","Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684",".","763 units","Sterility of device is compromised due to breach in sterile barrier",6/2/2014,"06/02/2014",7/23/2014,"07/23/2014"
"Devices",68565,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.","Z-2047-2014","Class II","SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue","Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899",".","907 units","Sterility of device is compromised due to breach in sterile barrier",6/2/2014,"06/02/2014",7/23/2014,"07/23/2014"
"Devices",68565,"Ongoing","Smith & Nephew, Inc. Endoscopy Division","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.","Z-2045-2014","Class II","SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue","Lot Numbers: 50476555, 50481446 ",".","259 units","Sterility of device is compromised due to breach in sterile barrier",6/2/2014,"06/02/2014",7/23/2014,"07/23/2014"
"Drugs",68566,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide in U.S.","D-1442-2014","Class II","ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. ","Lot #: 71132, Expiry: 02/2017",".","23,000 Applicators","Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.",6/13/2013,"06/13/2013",7/23/2014,"07/23/2014"
"Devices",68567,"Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.","Z-2081-2014","Class II","AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography. ","Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000315, A5411000331, A5411000332, A5411000141, A5411000144, A5411000038, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000333, A5411000334, A5410000038, A5411000019, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5410000016, A5410000039, A5410000021, A5410000023, A5411000074, A5411000080, A5411000024, A5411000184, A5411000193, A5411000196, A5410000100, A5410000114, A5410000115, A5410000116, A5410000117, A5411000342, A5411000343, A5411000344, A5411000366, A5411000368, A5411000237, A5411000027, A5411000020, A5411000021, A5411000132, A5411000070, A5411000078, A5411000082, A5411000154, A5411000156, A54110000107, A5410000082, A5410000066, A5411000236, A5411000155, A5411000151, A5411000148, A5411000149, A5411000134, A5411000120, A5411000125, A5411000147, A5410000079, A5411000185, A5411000191, A5411000192, A5411000194, A5411000239, A5411000052, A5411000030, A5411000314, A5411000348, A5411000268, A5411000347, A5411000349, A5411000140, A5411000142, A5411000097, A5410000022, A5411000017, A5410000027, A5411000153, A5411000233, A5411000234, A5411000235, A5411000318, A5410000044, A5411000037, A5410000043, A5411000181, A5411000158, A5411000152, A5411000263, A5411000309, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000159, A5411000041, A5411000050, A5411000088, A5411000247, A5411000079, A5411000040, A5411000240, A5411000085, A5411000277, A5411000278, A5411000279, A5411000280, A5411000281, A5411000282, A5411000245, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000039, A5411000032, A5411000083, A5411000122, A5411000108, A5411000110, A5411000241, A5411000246, A5411000114, A541100",,"216 units","When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.",6/6/2014,"06/06/2014",7/30/2014,"07/30/2014"
"Food",68568,"Terminated","Domega NY International Co Ltd","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City","F-2423-2014","Class I","GONG XIFACAI GIFT CHOCOLATES, 238 grams, UPC 6 934169 900335 --- MANUFACTURER: JIANGXI GOLDEN EAGLE FOOD CO. LTD, ADD: NO. 188, YONGQIANG ROAD (NORTH), WANGCHENG TOWN, XINJIAN COUNTY, JIANGXI, CHINA 330100 --- The product is packed in a plastic tray with a plastic overwrap package.","UPC 6 934169 900335 and no other coding",".","189 cases (40 x 238 grams packages)","The product contained undeclared peanuts and milk based on sampling and analysis by New York State Department of Agriculture & Markets.",6/17/2014,"06/17/2014",9/17/2014,"09/17/2014"
"Devices",68569,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH, REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.","Z-2085-2014","Class II","GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.","Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report.",,"41,992 (20,509 US; 21,483 OUS)","GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.",6/13/2014,"06/13/2014",7/30/2014,"07/30/2014"
"Devices",68570,"Ongoing","MTI Precision Products LLC.","Lakewood","NJ","US","Voluntary: Firm Initiated","E-Mail","Distributed in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.","Z-2044-2014","Class II","Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products","P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002, T41203003, T41203010, T41204001 to T41204006 P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001 P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as ''Meditorque I 20 K'' with serial numbers M21203001 to M21203025. P/N Lynx distirbuted to Medidenta private labeled as ''Meditorque I 20 K'' with serial numbers M21203026 to M21203055. P/N Lynx TM20-4H-01 distributed to Johnson-Promident with serial numbers T41204001-T41204020 P/N Lynx TM20-2H-01 distirbuted to Johnson-Promident with serial numbers T21204001-T21204020. ",".","134 devices","MTI Precision Products LLC received a complaint regarding a sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.",5/7/2012,"05/07/2012",7/23/2014,"07/23/2014"
"Food",68571,"Ongoing","New B.C.N. Trading Inc","South Plainfield","NJ","US","Voluntary: Firm Initiated","Letter","MA, MD, NJ, NY, & PA","F-2172-2014","Class II","CTF Brand Tapioca Pearl Net Wt: 14 oz. (400G.) Exporter: Combine Thai Foods Co., Ltd. 359/716-17 Spot Chalaem Nimit, Chalaem Nimit Rd. (Pradu 1) Bangkro, Bangkholaem, Bangkok 10120 Thailand Product of Thailand UPC 8851381560506","no codes",".","30 cartons (50 packages per case)","Tapioca pearl contains unapproved and undeclared colors.",3/10/2014,"03/10/2014",7/23/2014,"07/23/2014"
"Drugs",68572,"Ongoing","Valeant Pharmaceuticals North America LLC ","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0018-2015","Class III","Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada","VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015 ",".","205,853 bottles","Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset",5/21/2014,"05/21/2014",10/22/2014,"10/22/2014"
"Drugs",68572,"Ongoing","Valeant Pharmaceuticals North America LLC ","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0019-2015","Class III","Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles ","VASOTEC 2.5MG TAB 30CT 12K015P exp. 9/30/2014 VASOTEC 2.5MG TAB 30CT 13G048P exp. 07/31/2015 VASOTEC 2.5MG TAB 30CT 14A065P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 13G020P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 12K020P exp. 9/30/2014 VASOTEC 2.5MG TAB 90CT 13B016P exp. 9/30/2014 VASOTEC 5MG TAB 30CT 13B022P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13B023P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13C015P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 13E002P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 14A002P exp. 11/30/2015 VASOTEC 5MG TAB 30CT 13L066P exp. 11/30/2015 VASOTEC 5MG TAB 90CT 13B018P exp. 2/28/2015 VASOTEC 5MG TAB 90CT 13G015P exp. 06/30/2015 VASOTEC 10MG TAB 90CT 12M017P exp. 11/30/2014 VASOTEC 10MG TAB 1000CT 12L105P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 12M016P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 13G013P exp. 06/30/2015 VASOTEC 10MG TAB 30CT 13J081P exp. 9/30/2015 VASOTEC 10MG TAB 90CT 12M025P exp. 11/30/2014 VASOTEC 10MG TAB 90CT 13J082P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J085P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J094P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13J098P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13G011P exp. 06/30/2015 VASOTEC 10MG TAB 1000CT 13J097P exp. 09/30/2015 VASOTEC 20MG TAB 30CT 12J017P exp. 5/31/2014 VASOTEC 20MG TAB 30CT 13C016P exp. 2/28/2015 VASOTEC 20MG TAB 30CT 13E003P exp. 02/28/2015 VASOTEC 20MG TAB 30CT 13L068P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J086P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J087P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 12M029P exp. 11/30/2014 VASOTEC 20MG TAB 90CT 12M030P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 12J023P exp. 5/31/2014 VASOTEC 20MG TAB 1000CT 12L108P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 13C088P exp. 02/28/2015 VASOTEC 20MG TAB 1000CT 13J099P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M054P exp. 09/30",".","205,853 bottles ","Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.",5/21/2014,"05/21/2014",10/22/2014,"10/22/2014"
"Devices",68573,"Ongoing","Excelsior Medical Corp","Neptune","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada.","Z-2070-2014","Class II","Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer","Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513",".","4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))","There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.",6/5/2014,"06/05/2014",7/23/2014,"07/23/2014"
"Food",68574,"Ongoing","Vita Food Products, Inc.","Chicago","IL","US","Voluntary: Firm Initiated","E-Mail","US: Nationwide (NY, MA, VM, NH, TX, AL, FL, GA, and SC)","F-2175-2014","Class I","Vita Classic Premium Sliced Smoked Atlantic Nova Salmon, packaged in a black vacuum-sealed, plastic film package for retail sale. Product is labeled ''ready to serve'' and each package contains 4 ounces of product.","UPC: Case (12/4oz. packages), 10022635700381 *** Package (4 oz), 22635 70038 ****** ITEM NO: 140490 ****** SELL BY AUG 17 2014 ****** LOT: 00764B",".","626 cases, each case contains 12/4 ounce packages, TOTAL PACKAGES = 7,512 packages ","This voluntary recall is being initiated due to a positive Listeria monocytogenes sample taken by the Florida Department of Agriculture and Consumer Services.",6/13/2014,"06/13/2014",7/23/2014,"07/23/2014"
"Biologics",68575,"Terminated","Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0875-14","Class III","Blood and Blood Products for Reprocessing","W035212339643K; ",".","1 unit","Blood products, collected from a donor whose health history was inadequately determined, were distributed. ",6/10/2014,"06/10/2014",8/13/2014,"08/13/2014"
"Biologics",68575,"Terminated","Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0873-14","Class II","Red Blood Cells Leukocytes Reduced","W035212339643K; ",".","1 unit","Blood products, collected from a donor whose health history was inadequately determined, were distributed. ",6/10/2014,"06/10/2014",8/13/2014,"08/13/2014"
"Biologics",68575,"Terminated","Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0874-14","Class II","Cryoprecipitated AHF","W035212339643K; ",".","1 unit","Blood products, collected from a donor whose health history was inadequately determined, were distributed. ",6/10/2014,"06/10/2014",8/13/2014,"08/13/2014"
"Food",68576,"Ongoing","Crown Food Distribution Inc","North Bergen","NJ","US","Voluntary: Firm Initiated","Letter","NJ and NY","F-2407-2014","Class I","Golden Natural Mix Party Net Wt 23.00 oz. in a plastic round tub Product of Crown Food North Bergen, NJ 07047 UPC 098346021049","Sell By: 11/15/2014",,"142 cases (12 packages per case)","'Golden Natural' Mix Party contains undeclared sulfites.",3/4/2014,"03/04/2014",9/10/2014,"09/10/2014"
"Drugs",68577,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1413-2014","Class II","Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61. ","Lot #: C926923, Exp 01/16",,"20,810 containers","Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.",6/16/2014,"06/16/2014",7/9/2014,"07/09/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2062-2014","Class II","ACL TOP CTS, automated coagulation laboratory instrument.","Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010",".","572","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2066-2014","Class II","ACL TOP 300 CTS, automated coagulation laboratory instrument.","Start SN and Date: 11110101 Nov 2011End SN and Date 14051302 May 2014",".","1201","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2065-2014","Class II","ACL TOP 700 CTS, automated coagulation laboratory instrument.","Start SN and Date: 09120101 Dec 2009 End SN and Date 14050368 May 2014",".","266","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2061-2014","Class II","ACL TOP 700, automated coagulation laboratory instrument.","Start SN and Date: 09080100 Aug 2009 and End SN and Date 14050732 May 2014",".","633","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2063-2014","Class II","ACL TOP 700 LAS, automated coagulation laboratory instrument.","Start SN and Date: 08120100 Dec 2008 End SN and Date 14050198 May 2014",".","99","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2060-2014","Class II","ACL TOP (Base), automated coagulation laboratory instrument.","Start SN and Date: 03110101 Nov 2003 and End SN and Date 11111174 Nov 2011",".","1074","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Devices",68578,"Ongoing","Instrumentation Laboratory Co.","Bedford","MA","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal,Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.","Z-2064-2014","Class II","ACL TOP 500 CTS, automated coagulation laboratory instrument.","Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014",".","2802","Potential for sample misidentification. ",6/3/2014,"06/03/2014",7/23/2014,"07/23/2014"
"Drugs",68579,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-0002-2015","Class I","Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29","Lot # 33-545-DD, Exp. 09/15",".","40,730 vials","Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.",6/17/2014,"06/17/2014",10/7/2014,"10/07/2014"
"Devices",68580,"Completed","Cenorin, LLC","Kent","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.","Z-1995-2014","Class II","HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.","610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.",,"25 HLD systems ","The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water. ",1/24/2013,"01/24/2013",7/16/2014,"07/16/2014"
"Devices",68581,"Ongoing","Shape Medical Systems, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution","Z-2051-2014","Class II","Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.","DPIs with Lot Number 1405006 and higher. ",".","800","Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.",5/28/2014,"05/28/2014",7/23/2014,"07/23/2014"
"Devices",68582,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.","Z-2059-2014","Class II","V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.","Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.",".","113 units (57 United States; 56 International)","Several issues with the V-Series Monitoring System 12-lead ECG interpretation feature. These issues impact the 12-lead ECG feature only; standard 12-lead ECG monitoring is not affected. (1) The 12-lead Standard and Extended Measurement Report will include false measurements when the P wave or QRS axis cannot be accurately determined by the algorithm. (2) The Median Complex and Extended Measurement Report will display the representative beat as 25% larger than actual signal input. (3) When a patient date of birth is imported into the V Series from an external source, such as Mindray's Gateway, e-Gateway, Panorama Central Station or Panorama Workstation, the age will not pass into the 12-lead ECG interpretation algorithm. The algorithm analysis will use the default adult criteria of ''50 year adult'' in which case the interpretive statements may be incorrect, depending on the actual age of the patient. Note: when the patients date of birth is manually entered into the V-Series the correct age is accepted and the appropriate interpretation algorithm is applied.",5/19/2014,"05/19/2014",7/23/2014,"07/23/2014"
"Devices",68583,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Telephone","Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.","Z-2057-2014","Class II","Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.","Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10",".","76/50-bottle boxes","Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.",6/11/2014,"06/11/2014",7/23/2014,"07/23/2014"
"Devices",68584,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2050-2014","Class II","Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006","Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.",".","129 units","Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.",6/25/2014,"06/25/2014",7/23/2014,"07/23/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2629-2014","Class II","BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. ","Lot::3319877",,"3 boxes","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2634-2014","Class II","BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. ","Lot: B011403",,"13 Each","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2633-2014","Class II","BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.","Lot: 4007362",,"2 each","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2632-2014","Class II","BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.","Lot: 4007096",,"2 each","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2631-2014","Class II","BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.","Lot(s): 3305588 and 4006903",,"9 boxes","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68585,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of LA, OK, and TX.","Z-2630-2014","Class II","BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.","Lot: 3343067",,"26 boxes","Products were held at improper storage temperature",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Devices",68586,"Ongoing","Pentax Medical Company","Montvale","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2116-2014","Class II","EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.","Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140 E110188 E110285 E010064 E01039 E110141 E110193 E110287 E010066 E01042 E110144 E110195 E110289 E010069 E01043 E110145 E110202 E110290 E010070 E01046 E110146 E110205 E110306 E010075 E01054 E110147 E110208 E110307 E010077 E01061 E110156 E110210 E110308 E010078 E01062 E110157 E110219 Model: EG-3830UT E110067 E110160 E110204 E110275 E110374 E110070 E110163 E110206 E110277 E110377 E110074 E110165 E110212 E110286 E110379 E110079 E110168 E110214 E110289 E110426 E110082 E110171 E110224 E110292 E110428 E110093 E110172 E110228 E110295 E110433 E110095 E110174 E110230 E110309 E110439 E110108 E110183 E110243 E110310 E110442 E110126 E110186 E110255 E110323 E110444 E110142 E110189 E110263 E110331 E110454 E110152 E110195 E110265 E110340 E110517 E110153 E110196 E110268 E110341 Model: FG-36UX A01014 A01049 A01079 A01100 A01166 A01019 A01053 A01080 A01104 A01168 A01020 A01054 A01081 A01105 A01174 A01029 A01055 A01082 A01116 A01183 A01030 A01056 A01084 A01122 A01184 A01033 A01057 A01086 A01126 A01186 A01036 A01068 A01092 A01131 A110260 A01040 A01070 A01096 A01137 A110268 A01046 A01074 A01098 A01142 Model: EG-3870UTK A110013 A110060 A110095 A110125 A110154 A110021 A110061 A110096 A110126 A110155 A110022 A110062 A110098 A110127 A110156 A110024 A110063 A110099 A110128 A110161 A110025 A110065 A110100 A110129 A110162 A110026 A110067 A110101 A110130 A110163 A110028 A110068 A110104 A110133 A110164 A110029 A110069 A110105 A110134 A110165 A110031 A110070 A110106 A110135 A110166 A110033 A110071 A110107 A110138 A110167 A110038 A110073 A110108 A110139 A110168 A110040 A110076 A110110 A110140 A110169 A110041 A110077 A110111 A110141 A110172 A110042 A110078 A110112 ",,"531 units","Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.",6/12/2014,"06/12/2014",7/30/2014,"07/30/2014"
"Devices",68588,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.","Z-1865-2014","Class II","Ingenia 1.5T, magnetic resonance imaging system.","Model Number: 781396",".","24","For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.",6/13/2014,"06/13/2014",7/2/2014,"07/02/2014"
"Devices",68588,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.","Z-1864-2014","Class II","Ingenia 3.0T, magnetic resonance imaging system.","Model Number: 781377",".","18","For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.",6/13/2014,"06/13/2014",7/2/2014,"07/02/2014"
"Devices",68588,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.","Z-1863-2014","Class II","Ingenia 1.5T R5, magnetic resonance imaging system.","Model Number: 781341",".","33","For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.",6/13/2014,"06/13/2014",7/2/2014,"07/02/2014"
"Devices",68588,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.","Z-1862-2014","Class II","Ingenia 3.0T R5, magnetic resonance imaging system.","Model Numbers: 781342",".","21","For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.",6/13/2014,"06/13/2014",7/2/2014,"07/02/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2200-2014","Class III","YES Green Tea Gelato ","no code",,,"Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2202-2014","Class III","YES Peanut Butter Cup Gelato","no code ",,,"Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2201-2014","Class III","YES Sea Salt Caramel Gelato ","No code",,,"Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2203-2014","Class III","YES Mocha Gelato ","no code ",,,"Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2199-2014","Class III","YES Raspberry Lemonade Sorbetto ","No code",,"193 Pints remain in commerce subject to recall / all product is at firm in a segreated area waiting to be destroyed.","Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Food",68589,"Ongoing","Dolci Gelati LLC.","Washington","DC","US","Voluntary: Firm Initiated","E-Mail","The recalled product was made only for Yes Organic Market in the MD/DC area. None of this product was made for other distributors or retail groceries. 193 Pints remain at Yes Organic Markets subject to recall.","F-2204-2014","Class III","YES Mango Agave Sorbetto","no code ",,,"Mislabeling of product as ''Organic''",4/1/2014,"04/01/2014",7/30/2014,"07/30/2014"
"Devices",68590,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Distributed USA (nationwide) and Canada.","Z-2074-2014","Class II","Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. ","GD895771",".","585,360 units","Inadequate iodine and packaging related defects.",6/17/2014,"06/17/2014",7/23/2014,"07/23/2014"
"Devices",68591,"Terminated","Codan Us Corporation","Santa Ana","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.","Z-2040-2014","Class II","ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets","Lot No. 71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.",,"7250 units","CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.",8/17/2011,"08/17/2011",7/16/2014,"07/16/2014"
"Devices",68592,"Ongoing","ORIGIO, Inc","Charlottesville","VA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.","Z-1946-2014","Class II","Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL","CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.",,"Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511 ","Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration",6/20/2014,"06/20/2014",7/9/2014,"07/09/2014"
"Devices",68593,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution.","Z-1994-2014","Class II","Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086","Material number 371268-02 - al lots.",,"2606","Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.",4/27/2012,"04/27/2012",7/16/2014,"07/16/2014"
"Devices",68594,"Ongoing","ARJOHUNTLEIGH POLSKA Sp. z.o.o.","KOMORNIKI",,"PL","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.","Z-2693-2014","Class II"," Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.","Model Numbers: HMA0002 and HMB002-US; Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531",,"18 Lifts","ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the spreader bar can eventually fully unscrew and become detached from the scale and the lift arm, and drop to the floor. Consequently, the person suspended in the sling that is hooked up to the spreader bar could also drop, and/or the spreader bar could drop onto the person, causing serious injury.",7/28/2014,"07/28/2014",10/1/2014,"10/01/2014"
"Devices",68595,"Ongoing","Siemens Healthcare Diagnostics Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay","Z-2058-2014","Class II","Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics","Lot No. TKAN1 batch 587 TKAN1 batch 588 TKAN1 batch 589 TKAN1 batch 590 TKAN1 batch 591 TKAN1 batch 592 TKAN1 batch 593 TKAN1 batch 594 TKAN1 batch 595 TKAN1 batch 596 TKAN1 batch 597 TKAN1 batch 598 TKAN1 batch 599 TKAN1 batch 600 ",".","1,164 units","The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.",6/9/2014,"06/09/2014",7/23/2014,"07/23/2014"
"Devices",68596,"Ongoing","Enhancement Medical, LLC","Wauwatosa","WI","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.","Z-2135-2014","Class I","Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.","Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203. RECALL EXPANDED 7-8-2014 to include ALL LOTS.",".","17,875","Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product. ",8/7/2013,"08/07/2013",8/20/2014,"08/20/2014"
"Food",68597,"Ongoing","Country Life","Hauppauge","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Kenya","F-2196-2014","Class II","Country Life TARGET MINS CALCIUM MAGNESIUM With Vitamin D3 Complex, WILD BLUEBERRY FLAVOR, LIQUID Dietary Supplement, 16 FL. OZ. (1 PINT) (472 mL), Product No. 2523, Bar Code 015794025238, and 32 FL. OZ. (1 QT) (944 mL), Product No. 2522, Bar code 015794025221 --- Manufactured for Country Life, LLC 180 Vanderbilt Motor Parkway, Hauppauge, NY 11788 ","Code 2523: Lot 1112H6-G16 (16 fl. oz), Code 2522: Lot 1112H6-G32 (32 fl. oz.)",,"Lot 1112H6-G16: 2,902 bottles; Lot 1112H6-G32: 4,932 bottles","The affected lots do not meet quality standards due to insoluble particulates. ",6/19/2014,"06/19/2014",7/30/2014,"07/30/2014"
"Biologics",68598,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","FL","B-0830-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W036813313820- part 1; W036813313820- part 2",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",2/19/2014,"02/19/2014",8/20/2014,"08/20/2014"
"Biologics",68600,"Terminated","American Red Cross Blood Services","Birmingham","AL","US","Voluntary: Firm Initiated","E-Mail","AL","B-0831-14","Class II","Red Blood Cells Leukocytes Reduced","W204114011757",,"1 unit","Misbranded RBCs were distributed. ",5/8/2014,"05/08/2014",10/1/2014,"10/01/2014"
"Biologics",68602,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Michigan","B-0806-14","Class II","Platelets Irradiated","W035213116849U; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/9/2014,"06/09/2014",8/20/2014,"08/20/2014"
"Biologics",68602,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Michigan","B-0804-14","Class II","Red Blood Cells Leukocytes Reduced","W035213116849U; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/9/2014,"06/09/2014",8/20/2014,"08/20/2014"
"Biologics",68602,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Michigan","B-0805-14","Class II","Fresh Frozen Plasma","W035213116849U; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",6/9/2014,"06/09/2014",8/20/2014,"08/20/2014"
"Biologics",68603,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","Tennessee","B-0807-14","Class II","Plasma Frozen within 24 hours (FP24)","W071213048844; W071213054234; ",".","2 units","Blood products, possibly contaminated with air, were distributed.",5/7/2014,"05/07/2014",8/20/2014,"08/20/2014"
"Biologics",68604,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","TN","B-0868-14","Class II","Red Blood Cells Leukocytes Reduced","W071214005836",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",5/8/2014,"05/08/2014",8/20/2014,"08/20/2014"
"Biologics",68606,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0869-14","Class II","Blood and Blood Products for Reprocessing","W071212064099",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",5/16/2014,"05/16/2014",8/20/2014,"08/20/2014"
"Devices",68607,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of IL, NY, GA, and RI.","Z-2024-2014","Class II","Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures","Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055 ",,"11","Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile. ",6/13/2014,"06/13/2014",7/16/2014,"07/16/2014"
"Devices",68608,"Ongoing","CareFusion 303, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, NM, WA, WI, and TX.","Z-2025-2014","Class II","SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 ","Lot No. 14035485 14046894 14035458 14035457 ",,"5,600 units","CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber.",6/17/2014,"06/17/2014",7/16/2014,"07/16/2014"
"Devices",68609,"Ongoing","Dental EZ Group Star Dental Division","Lancaster","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of : IN, TN, and WA.","Z-2078-2014","Class II","Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability. ","Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 ",".","25","The housing of 5K motor was laser marked incorrectly as a 20K motor.",6/13/2014,"06/13/2014",7/23/2014,"07/23/2014"
"Drugs",68610,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1438-2014","Class III","Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58","Lot 33805325A, Exp.11/14",".","1125 blister packs","Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Kariva tablets due to out of specification impurity test results. ",6/18/2014,"06/18/2014",7/23/2014,"07/23/2014"
"Drugs",68610,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1436-2014","Class III","Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 ","Lot 3805324A Exp. 11/14",".","1104 blister packs","Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Aprif tablets due to out of specification impurity test results. ",6/18/2014,"06/18/2014",7/23/2014,"07/23/2014"
"Drugs",68610,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1437-2014","Class III","Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 ","Lot 33805507A, Exp. date 11/14 ",".","984 blister packs ","Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Mircette tablets due to out of specification impurity test results. ",6/18/2014,"06/18/2014",7/23/2014,"07/23/2014"
"Drugs",68610,"Ongoing","Teva Pharmaceuticals USA","North Wales","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1439-2014","Class III","Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67","Lot 33805449A, Exp. 12/14 ",".","5265 blister packs"," Failed Impurities/Degradation Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Velivet distributed by Barr Laboratories, Inc. due to out of specification impurity test results. ",6/18/2014,"06/18/2014",7/23/2014,"07/23/2014"
"Devices",68611,"Ongoing","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.","Z-2077-2014","Class II","Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.","Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209 ",".","8 units total (3 units in US)","With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.",6/18/2014,"06/18/2014",7/23/2014,"07/23/2014"
"Food",68612,"Ongoing","Pearl Valley Cheese Inc","Fresno","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: OH and WI","F-2180-2014","Class II","Walnut Creek Farmers Cheese- 6lbs in plastic bags- 4 per case","PLU: 4030 Lot 06111",".","3310.94 lbs","Milk used in the products tested positive for antibiotics.",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Food",68612,"Ongoing","Pearl Valley Cheese Inc","Fresno","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: OH and WI","F-2181-2014","Class II","Walnut Creek Marble Cheese-- 6lbs of cheese in plastic bags; 4 per case","PLU: 6030 Lot: 06112",".","6747.12 lbs","Milk used in the products tested positive for antibiotics",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Food",68612,"Ongoing","Pearl Valley Cheese Inc","Fresno","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: OH and WI","F-2182-2014","Class II","Whey Protein Concentrate -- No labeling sold in bulk tanker","None - ship date: 06/12/13 Load # 36866",".","38865 lbs","Milk used in the products tested positive for antibiotics ",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Food",68612,"Ongoing","Pearl Valley Cheese Inc","Fresno","OH","US","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: OH and WI","F-2183-2014","Class II","Cream; Sold in bulk; No labeling","None- Ship date 6/13/2014",".","9804 lbs","Milk used in the products tested positive for antibiotics",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Veterinary",68613,"Terminated","Steve Pritchett Farms LLC","Henderson","KY","US","Voluntary: Firm Initiated","Telephone","The firm distributed to one firm in Indiana","V-129-2014","Class II","Frozen mice in ziplock bags","There is no code information. The package shows the type of mice and the quantity. ",,"Unknown","The firm imitated a voluntary recall of frozen mice intended for use as reptile feed because of possible human exposure to Lymphocytic Choriomeningitis Virus from handling the mice.",6/18/2014,"06/18/2014",7/9/2014,"07/09/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2295-2014","Class I","Traditional Hummus sold under the Archer Farms brand and packaged in either a transparent plastic tub or a white plastic tub with a net weight respectively of 10 oz (283 g) or 2 lb.","All products with the ''Use By'' date of JUN/11/2014",".","1,438 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2298-2014","Class I","Chipotle Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).","All products with the ''Use By'' dates of MAY/7/2014 and MAY/14/14",".","552 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2296-2014","Class I","Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).","All products with the ''Use By'' dates of JUN/9/2014 and JUN/12/14",".","360 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2301-2014","Class I","5 Layer Fiesta Dip sold under the Trader Joe's brand and packaged in a transparent plastic tub with a net weight of 11.5 oz (326 g) or 24 oz.","All products with the ''Use By'' dates of APRIL/15/2014, ",".","2,344 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2302-2014","Class I","Spicy Yellow Lentil Hummus sold under the Eat Well Embrace Life brand and packaged in a transparent plastic tub with a net weight of 10 oz.","All products with the ''Use By'' dates of JUN/10/14 E and JUN/12/14 E ",".","3,073 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2297-2014","Class I","Roasted Red Pepper Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).","All products with the ''Use By'' date of JUN/12/2014",".","480 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2299-2014","Class I","Garlic Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).","All products with the ''Use By'' dates of MAY/7/2014 and MAY/14/14",".","1,548 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Food",68614,"Ongoing","Hot Mama's Foods","Wheeling","IL","US","Voluntary: Firm Initiated","Telephone","US: Nationwide","F-2300-2014","Class I","Edamame Hummus sold under the Trader Joe's brand and packaged in a transparent plastic tub with a white lid and with a net weight of 8 oz (227 g).","All products with the ''Use By'' dates of APRIL/28/2014, APRIL/29/14, and MAY/9/14",".","14,232 containers","Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.",5/15/2014,"05/15/2014",8/13/2014,"08/13/2014"
"Devices",68615,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including MT, OR, LA, NE, NC, MN, UT, FL, KY, IL, CA, VA, TX, CO, KS and Internationally to UNITED KInGDOM, CANADA, and SPAIN.","Z-2118-2014","Class II","Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.","Lot numbers: 082605614, 082601414, 082602014, 082634313,082630913,082629713,082629613, 082626913, 082623113,082621413,082618213",,"300","Medtronic is initiating a voluntary recall for the Nexdrive Micropositioning Drive (model Ml-1000 and Ml-2000) due to the potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.",6/11/2014,"06/11/2014",8/6/2014,"08/06/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1420-2014","Class II","HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 ","Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14; 04232014@2 / BUD 06/22/14; 04252014@27 / BUD 06/24/14; 04162014@33 / BUD06/15/14; 05132014@2 / BUD 07/12/14; 05092014@39 BUD 7-8-14",,"55 mL","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1421-2014","Class II","HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045","Lot # / Beyond Use Date: 04302014@21 / BUD 06/29/14",,"8 mL","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1416-2014","Class II","Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045","Lot # / Beyond Use Date: 04282014@11 / BUD 05/28/14; 04212014@4 / BUD 05/21/2014",,"6000 mL","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1419-2014","Class II","HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045","Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14; 04032014@7 / BUD 06/02/14; 04092014@16 / BUD06/08/14; 04142014@51 / BUD 06-13-14; 04152014@48 / BUD 06/14/14; 04172014@42 / BUD 06-06-14; 04182014@45 / BUD 6-17-14; 05162014@41 / BUD 07/15/14; 04172014@44 / BUD 06/16/14; 04212014@37 / BUD 6/20/14; 04222014@10 / BUD 06/21/14; 04232014@30 / BUD 06/22/14; 05072014@37 / BUD 07-06-14; 04292014@31 / BUD 06/28/14; 04302014@9 / BUD 06/29/14; 04252014@43 / BUD 06/24/14; 04222014@28 / BUD 6 -21-14",,"850 tablets","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1418-2014","Class II","HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045","Lot # / Beyond Use Date: 05192014@15 / BUD 07/18/14; 04142014@39 / BUD 6-13-14; 04182014@4 / BUD 6-17-14; 04162014@12 / BUD 06/15/14; 05092014@34 / BUD 07/08/14; 04162014@35 / BUD 06/15/14; 05232014@33 / BUD 07/22/14; 05022014@36 / BUD 7/1/14; 04292014@13 / BUD 06/28/14; 04282014@43 / BUD 06/27/14; 05212014@5 / BUD 07/20/14; 04292014@13 / BUD 06/28/14; 05062014@42 / BUD 07/05/14; 05022014@36 / BUD 07/01/14; 05062014@45 / BUD 07/05/14; 05082014@2 / BUD 07/07/14, 05152014@36 / BUD 7/14/14; 05212014@5 / BUD 07/20/14; 05082014@2 / BUD 07/07/14; 05132014@37 / BUD 07/12/14; 05082014@2 / BUD 07/07/14; 05132014@38 / BUD 07/12/14; 04242014@14 / BUD 6-23-14; 04162014@12 / BUD 6-15-14; 04212014@27 / BUD 6-20-14; 04292014@13 / BUD 6-28-14; 05092014@34 / BUD 7-8-14; 05212014@5 / BUD 7-20-14; 05272014@58 / BUD 7-26-14; 05222014@27 / BUD 07/21/14",,"184 mL","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Drugs",68616,"Completed","Brookfield Prescription Center Inc. dba MD Custom Rx","Brookfield","WI","US","Voluntary: Firm Initiated","Telephone","WI only","D-1417-2014","Class II","Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045","Lot # / Beyond Use Date: 05012014@36 / 05/15/14",,"30 mL","Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.",5/30/2014,"05/30/2014",7/9/2014,"07/09/2014"
"Devices",68617,"Ongoing","Abbott Molecular","Des Plaines","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: AUSTRALIA AUSTRIA BELGIUM BENIN CAMEROON CHINA ETHIOPIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND ISRAEL ITALY KENYA MALAYSIA MALAWI MALI NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PHILIPPINES POLAND PORTUGAL RUSSIA SENEGAL SINGAPORE SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE UNITED KINGDOM VIETNAM","Z-2169-2014","Class II","5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.","Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001",".","1,688,000 reaction vessels","Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Devices",68618,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-2587-2014","Class II","AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures","material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959 ",,"1067","There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image. ",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Devices",68619,"Ongoing","PIONEER SURGICAL TECHNOLOGY, INC.","Marquette","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution in the states of TX and FL","Z-2076-2014","Class II","Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.","Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018",".","5","Lack of Sterility Assurance",6/11/2014,"06/11/2014",7/23/2014,"07/23/2014"
"Food",68620,"Ongoing","CT Concerns, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US: CA.","F-2420-2014","Class II","Fresh Wild Tuna. No finished packaging. Fresh Tuna is placed in white styrofoam box and delivered to area restaurants. ","No codes. Production date from 05/27/14 to 05/28/2014.",".","1590 lbs total","Firm is initiating a voluntary recall of Fresh Farmed Atlantic Salmon and Fresh Wild Tuna because it has the potential to be contaminated with Listeria monocytogenes. Firm was notified that FDA environmental swab samples had a positive result for Listeria monocytogenes.",6/19/2014,"06/19/2014",9/17/2014,"09/17/2014"
"Food",68620,"Ongoing","CT Concerns, Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","US: CA.","F-2419-2014","Class II","Fresh Atlantic Salmon. No finished packaging. Fresh Salmon is placed in white styrofoam box and delivered to area restaurants. ","No codes. Production date from 05/27/14 to 05/28/2014.",".","1590 lbs total","Firm is initiating a voluntary recall of Fresh Farmed Atlantic Salmon and Fresh Wild Tuna because it has the potential to be contaminated with Listeria monocytogenes. Firm was notified that FDA environmental swab samples had a positive result for Listeria monocytogenes.",6/19/2014,"06/19/2014",9/17/2014,"09/17/2014"
"Biologics",68621,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0835-14","Class III","Cryoprecipitated AHF, Pooled","W045214003586; ",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Biologics",68621,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0834-14","Class III","Red Blood Cells Leukocytes Reduced","W045214004581; ",".","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Devices",68622,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distriution: CA, SC, IL, UT, TN, KS, HI, NJ, LA, TX,FL, IN, AL, AZ, MN, WI, MN, MI, AR,MA, GA, MS, NJ, NM, OK, ME, PA, NY, NC, OK, MO, WA, IA, OR,KY, MD, NE, ID, VA, WA, ND, MT, OH, NH, CT. Also shipped to Canada","Z-2091-2014","Class II","MK5 NX Controller--Wheelchair controller","P/N 1143839",,"819","M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control. ",6/24/2014,"06/24/2014",7/30/2014,"07/30/2014"
"Food",68623,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: IN, MO, NE, WI","F-2194-2014","Class II","Velveeta Original Pasteurized Ripe Cheese Product sold under the Kraft brand and individually wrapped in plastic and sold in a card stock carton with a net weight of 2 lb. (32 oz.).","Consumer Package Code: 17 DEC 2014 09:34 - 13:35",".","270 cases (3,240 cartons)","Kraft Foods is recalling part of one sku of Velveeta Original Pasteurized Recipe Cheese Product because a preservative ingredient was found to be present at levels below specification.",6/19/2014,"06/19/2014",7/23/2014,"07/23/2014"
"Devices",68624,"Ongoing","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.","Z-2080-2014","Class II","Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution.","P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.",,"496 boxes (6 tips per box)","Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.",6/20/2014,"06/20/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2207-2014","Class II","Fat free cottage cheese sold under the Knudsen or Kraft brand and packaged in a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, or a plastic container with a net weight of 32 oz. (2 lb.) 907 g.","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"1) Knudsen: 186,612 containers; 2) Kraft: 284,736 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2217-2014","Class II","Low fat cottage cheese, 1.5% milkfat, with pineapple sold under the Knudsen brand packaged in plastic containers with a net weight of 16 oz. (1 lb.) 453 g.","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"187,968 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2212-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with pineapple topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"413,796 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2209-2014","Class II","Cottage cheese, 4% milkfat, sold under the Daily Chef, Knudsen, or Kraft brand and packaged in a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, a plastic container with a new weight of 32 oz. (2 lb.) 907 g, or a plastic container with a net weight of 5 lb. (2.27 kg).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"1) Daily Chef: 59,826 containers; 2) Knudsen: 754,602 containers; 3) Kraft.: 545,028 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2213-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with blueberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"34,068 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2216-2014","Class II","Cottage cheese, 2% milkfat, with pineapple sold under the Breakstone's brand or Knudsen brand and packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"1) Breakstone's: 101,552 trays; 2) Knudsen: 2,344 trays","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2208-2014","Class II","Low fat cottage cheese, 2% milkfat, sold under the Breakstone's brand, Daily Chef brand, Knudsen brand, or Kraft brand packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g), a tray of 8 plastic containers each with a net weight of 4 oz. (113 g), a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, a plastic container with a net weight of 32 oz. (2 lb.) 907 g, or a 3 lb. plastic container with a net weight of 48 oz. (3 lb.) 1.36 kg.","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"1) Breakstone's: 1,039,484 trays; 2) Daily Chef: 194,526 containers; 3) Knudsen: 2,313,098 containers and trays; 4) Kraft: 613,138 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2210-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with peach topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"129,696 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2215-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with mango topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"59,292 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2211-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with strawberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"281,856 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Food",68625,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY) + Puerto Rico","F-2214-2014","Class II","Cottage Doubles - cottage cheese, 2% milkfat, with raspberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).","Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014",,"169,560 containers","Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness.",5/16/2014,"05/16/2014",7/30/2014,"07/30/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1523-2014","Class II","Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1529-2014","Class II","Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1531-2014","Class II","G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1521-2014","Class II","BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1527-2014","Class II","Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1525-2014","Class II","MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1528-2014","Class II","B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1524-2014","Class II","Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1533-2014","Class II","Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1530-2014","Class II","Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1520-1014","Class II","Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1519-2014","Class II","Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1526-2014","Class II","Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1532-2014","Class II","L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer ",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Drugs",68626,"Ongoing","Medical Supply Liquidators Llc","Clive","IA","US","Voluntary: Firm Initiated","E-Mail","Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.","D-1522-2014","Class II","Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us","All lot numbers and exp dates",".",,"Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer",6/25/2014,"06/25/2014",8/13/2014,"08/13/2014"
"Devices",68627,"Ongoing","Varian Medical Systems, Inc.","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.","Z-2567-2014","Class II","C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.","Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014 H272181 H272354 H272820 H140018 H140202 H140727 H140793 H140859 H140926 H140987 H271293 H271759 H272015 H272187 H272359 H272822 H140025 H140203 H140728 H140795 H140860 H140927 H140988 H271308 H271762 H272016 H272188 H272362 H272824 H140026 H140204 H140729 H140796 H140861 H140928 H140989 H271330 H271763 H272018 H272195 H272365 H272825 H140027 H140206 H140730 H140797 H140863 H140930 H140990 H271334 H271773 H272022 H272197 H272370 H272826 H140029 H140207 H140732 H140799 H140864 H140931 H140991 H271385 H271783 H272023 H272198 H272377 H272828 H140036 H140208 H140733 H140800 H140865 H140932 H140992 H271400 H271785 H272024 H272201 H272382 H272834 H140038 H140209 H140734 H140801 H140866 H140933 H140993 H271407 H271787 H272027 H272202 H272388 H272837 H140039 H140210 H140735 H140802 H140867 H140934 H140994 H271413 H271802 H272029 H272204 H272391 H272841 H140045 H140211 H140736 H140803 H140868 H140935 H140995 H271414 H271809 H272032 H272209 H272394 H272846 H140046 H140213 H140737 H140804 H140869 H140936 H140996 H271420 H271815 H272035 H272212 H272397 H272847 H140047 H140214 H140738 H140805 H140870 H140937 H140997 H271438 H271825 H272038 H272216 H272401 H272848 H140048 H140215 H140742 H140806 H140871 H140938 H140998 H271439 H271828 H272043 H272219 H272405 H272849 H140058 H140216 H140743 H140807 H140872 H140939 H140999 H271443 H271833 H272045 H272220 H272408 H272851 H140062 H140217 H140744 H140808 H140874 H140940 H141000 H271452 H271834 H272049 H272223 H272410 H272852 H140067 H140218 H140745 H140809 H140875 H140941 H141002 H271459 H271835 H272050 H272226 H272413 H272854 H140070 H140219 H140747 H140810 H140876 H140942 H141003 H271490 H271838 H272051 H272231 H272415 H272856 H140071 H140220 H140748 H140811 H140877 H140943 H141004 H271497 H271843 H272052 H272235 H272418 H272857 H140072 H140221 H14",,"2572 ","Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.",6/17/2014,"06/17/2014",9/24/2014,"09/24/2014"
"Biologics",68628,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","E-Mail","Indiana; Virginia","B-0808-14","Class II","Red Blood Cells Leukocytes Reduced","W089813410351; ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/14/2014,"05/14/2014",8/20/2014,"08/20/2014"
"Biologics",68628,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","E-Mail","Indiana; Virginia","B-0809-14","Class III","Blood and Blood Products for Reprocessing","W089813410351; ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/14/2014,"05/14/2014",8/20/2014,"08/20/2014"
"Biologics",68628,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","E-Mail","Indiana; Virginia","B-0810-14","Class II","Cryoprecipitated AHF","W089813410351; ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/14/2014,"05/14/2014",8/20/2014,"08/20/2014"
"Biologics",68629,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","Hawaii","B-0811-14","Class II","Red Blood Cells Leukocytes Reduced","W088414515528; W088414516606; ",".","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",5/16/2014,"05/16/2014",8/20/2014,"08/20/2014"
"Biologics",68630,"Terminated","Grifols PlasmaCare, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","E-Mail","CA","B-0887-14","Class II","Source Plasma","2820768357",," 1 unit","Blood product, collected from a donor who had been incarcerated, was distributed. ",5/28/2014,"05/28/2014",10/1/2014,"10/01/2014"
"Drugs",68631,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1425-2014","Class II","Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62","Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16",,"142,152 bags","Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.",6/6/2014,"06/06/2014",7/16/2014,"07/16/2014"
"Devices",68632,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-*** US: Nationwide (AK ; AL ; AR ; AZ ; CA ; CO ; CT ; DE ; FL ; GA ; HI ; IA ; ID ; IL ; IN ; KS ; KY ; LA ; MA ; MD ; ME ; MI ; MN ; MO ; MS ; MT ; NC ; ND ; NE ; NH ; NJ ; NM ; NV ; NY ; OH ; OK ; OR ; PA ; RI ; SC ; SD ; TN ; TX ; UT ; VA ; VT ; WA ; WI ; WV ; WY) + District of Columbia + Puerto Rico; *** FOREIGN: Albania ; Algeria ; Angola ; Argentina ; Australia ; Austria ; Azerbaijan ; Bahrain ; Bangladesh ; Belarus ; Belgium ; Botswana ; Brazil ; Bulgaria ; Canada ; Chile ; China ; Colombia ; Costa Rica ; Croatia ; Cuba ; Czech Republic ; Dominican Rep. ; Ecuador ; Egypt ; El Salvador ; Finland ; France ; Georgia ; Germany ; Ghana ; Greece ; Hong Kong ; India ; Indonesia ; Iran ; Iraq ; Ireland ; Israel ; Italy ; Jamaica ; Japan ; Jordan ; Kazakhstan ; Kuwait ; Macedonia ; Malaysia ; Mexico ; Morocco ; Myanmar ; Netherlands ; New Zealand ; Niger ; Nigeria ; Norway ; Oman ; Pakistan ; Palestinian Territory ; Peru ; Philippines ; Poland ; Portugal ; Qatar ; Romania ; Russia ; Saudi Arabia ; Serbia ; Singapore ; Slovakia ; Slovenia ; South Africa ; South Korea ; Spain ; Sri Lanka ; Sweden ; Switzerland ; Syria ; Taiwan ; Thailand ; Trinidad and Tobago ; Tunisia ; Turkey ; Ukraine ; United Arab Emirates ; United Kingdom ; Uruguay ; Vietnam ; Yemen.","Z-2042-2014","Class II","e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.","9073 ; 11779 ; 9180 ; 9293 ; 11527 ; 10074 ; 9046 ; 9027 ; 9033 ; 9155 ; 9206 ; 10195 ; 10129 ; 10302 ; 10083 ; 10304 ; 10219 ; 11096 ; 11211 ; 11176 ; 11723 ; 11729 ; 11791 ; 10017 ; 10336 ; 9126 ; 9252 ; 9276 ; 10054 ; 11076 ; 11252 ; 11372 ; 11371 ; 11476 ; 11478 ; 11498 ; 9152 ; 11710 ; 10314 ; 9090 ; 9037 ; 9169 ; 9190 ; 10030 ; 10301 ; 9189 ; 9083 ; 9116 ; 9150 ; 9104 ; 9273 ; 9281 ; 9200 ; 9172 ; 9149 ; 9292 ; 9249 ; 9239 ; 9310 ; 9294 ; 10018 ; 10046 ; 11250 ; 10220 ; 10232 ; 10279 ; 11012 ; 11063 ; 11029 ; 11069 ; 11535 ; 11536 ; 11169 ; 11350 ; 11231 ; 11316 ; 11555 ; 11566 ; 11341 ; 11342 ; 11419 ; 11682 ; 11683 ; 11460 ; 11473 ; 11516 ; 9185 ; 11748 ; 9203 ; 11431 ; 11587 ; 10229 ; 11692 ; 11693 ; 11595 ; 9001 ; 9089 ; 9110 ; 9008 ; 9052 ; 9137 ; 9025 ; 9098 ; 9163 ; 9023 ; 9147 ; 9198 ; 10029 ; 10185 ; 11078 ; 11079 ; 10361 ; 11228 ; 11054 ; 11093 ; 11092 ; 11178 ; 11134 ; 11227 ; 11210 ; 11326 ; 11517 ; 10052 ; 11105 ; 9197 ; 10173 ; 10221 ; 10305 ; 10355 ; 11339 ; 11518 ; 11625 ; 11746 ; 11783 ; 9061 ; 9130 ; 10073 ; 10050 ; 11042 ; 11137 ; 11266 ; 11571 ; 11462 ; 11402 ; 11501 ; 11511 ; 11630 ; 11711 ; 11741 ; 10327 ; 11520 ; 11375 ; 11500 ; 11650 ; 10136 ; 9016 ; 9156 ; 9148 ; 10048 ; 10126 ; 11098 ; 11253 ; 11532 ; 11513 ; 9194 ; 10002 ; 9019 ; 9080 ; 9232 ; 9268 ; 10023 ; 10349 ; 10347 ; 11101 ; 11638 ; 11641 ; 11335 ; 9144 ; 11015 ; 11022 ; 11567 ; 11570 ; 11598 ; 9067 ; 9031 ; 9029 ; 11087 ; 9118 ; 9071 ; 9248 ; 9124 ; 10024 ; 10179 ; 10159 ; 10243 ; 11038 ; 11081 ; 11401 ; 11312 ; 11422 ; 11303 ; 11299 ; 11320 ; 11465 ; 11503 ; 11523 ; 11505 ; 11631 ; 11019 ; 11158 ; 9041 ; 9069 ; 10339 ; 10340 ; 9259 ; 10070 ; 11380 ; 10231 ; 11198 ; 9035 ; 10094 ; 10039 ; 10208 ; 10230 ; 10222 ; 11225 ; 11256 ; 11287 ; 11484 ; 11486 ; 11529 ; 11554 ; 11654 ; 11123 ; 9087 ; ",".","2,458 systems","Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.",4/23/2014,"04/23/2014",7/23/2014,"07/23/2014"
"Devices",68632,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-*** US: Nationwide (AK ; AL ; AR ; AZ ; CA ; CO ; CT ; DE ; FL ; GA ; HI ; IA ; ID ; IL ; IN ; KS ; KY ; LA ; MA ; MD ; ME ; MI ; MN ; MO ; MS ; MT ; NC ; ND ; NE ; NH ; NJ ; NM ; NV ; NY ; OH ; OK ; OR ; PA ; RI ; SC ; SD ; TN ; TX ; UT ; VA ; VT ; WA ; WI ; WV ; WY) + District of Columbia + Puerto Rico; *** FOREIGN: Albania ; Algeria ; Angola ; Argentina ; Australia ; Austria ; Azerbaijan ; Bahrain ; Bangladesh ; Belarus ; Belgium ; Botswana ; Brazil ; Bulgaria ; Canada ; Chile ; China ; Colombia ; Costa Rica ; Croatia ; Cuba ; Czech Republic ; Dominican Rep. ; Ecuador ; Egypt ; El Salvador ; Finland ; France ; Georgia ; Germany ; Ghana ; Greece ; Hong Kong ; India ; Indonesia ; Iran ; Iraq ; Ireland ; Israel ; Italy ; Jamaica ; Japan ; Jordan ; Kazakhstan ; Kuwait ; Macedonia ; Malaysia ; Mexico ; Morocco ; Myanmar ; Netherlands ; New Zealand ; Niger ; Nigeria ; Norway ; Oman ; Pakistan ; Palestinian Territory ; Peru ; Philippines ; Poland ; Portugal ; Qatar ; Romania ; Russia ; Saudi Arabia ; Serbia ; Singapore ; Slovakia ; Slovenia ; South Africa ; South Korea ; Spain ; Sri Lanka ; Sweden ; Switzerland ; Syria ; Taiwan ; Thailand ; Trinidad and Tobago ; Tunisia ; Turkey ; Ukraine ; United Arab Emirates ; United Kingdom ; Uruguay ; Vietnam ; Yemen.","Z-2043-2014","Class II","Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.","1) Symbia E Dual Head System; Model Number: 10275879; Serial Numbers: 1066 ; 1090 ; 1184 ; 1185 ; 1552 ; 1443 ; 1442 ; 1479 ; 1500 ; 1505 ; 1519 ; 1534 ; 1535 ; 1539 ; 1546 ; 1554 ; 1559 ; 1562 ; 1064 ; 1060 ; 1520 ; 1042 ; 1127 ; 1553 ; 1225 ; 1228 ; 1488 ; 1446 ; 1461 ; 1232 ; 1480 ; 1494 ; 1029 ; 1292 ; 1234 ; 1106 ; 1014 ; 1329 ; 1027 ; 1324 ; 1072 ; 1319 ; 1487 ; 1462 ; 1538 ; 1339 ; 1200 ; 1213 ; 1345 ; 1241 ; 1142 ; 1557 ; 1273 ; 1124 ; 1101 ; 1216 ; 1532 ; 1337 ; 1013 ; 1131 ; 1367 ; 1468 ; 1026 ; 1043 ; 1056 ; 1107 ; 1108 ; 1111 ; 1133 ; 1211 ; 1217 ; 1271 ; 1277 ; 1311 ; 1312 ; 1333 ; 1356 ; 1392 ; 1451 ; 1454 ; 1455 ; 1467 ; 1471 ; 1491 ; 1540 ; 1541 ; 1004 ; 1248 ; 1055 ; 1048 ; 1434 ; 1236 ; 1238 ; 1235 ; 1237 ; 1208 ; 1363 ; 1341 ; 1412 ; 1464 ; 1435 ; 1453 ; 1199 ; 1075 ; 1198 ; 1197 ; 1161 ; 1162 ; 1041 ; 1040 ; 1050 ; 1394 ; 1207 ; 1146 ; 1218 ; 1139 ; 1151 ; 1145 ; 1282 ; 1091 ; 1077 ; 1081 ; 1206 ; 1175 ; 1239 ; 1120 ; 1281 ; 1280 ; 1247 ; 1347 ; 1109 ; 1150 ; 1550 ; 1542 ; 1484 ; 1068 ; 1284 ; 1015 ; 1156 ; 1242 ; 1073 ; 1147 ; 1485 ; 1067 ; 1327 ; 1326 ; 1501 ; 1083 ; 1518 ; 1268 ; 1361 ; 1517 ; 1087 ; 1249 ; 1224 ; 1070 ; 1059 ; 1246 ; 1533 ; 1537 ; 1144 ; 1143 ; 1222 ; 1342 ; 1005 ; 1299 ; 1129 ; 1251 ; 1358 ; 1082 ; 1190 ; 1503 ; 1205 ; 1348 ; 1427 ; 1528 ; 1038 ; 1078 ; 1189 ; 1186 ; 1001 ; 1011 ; 1116 ; 1306 ; 1128 ; 1012 ; 1183 ; 1117 ; 1100 ; 1071 ; 1371 ; 1063 ; 1202 ; 1231 ; 1318 ; 1157 ; 1428 ; 1173 ; 1166 ; 1527 ; 1404 ; 1259 ; 1355 ; 1314 ; 1210 ; 1267 ; 1194 ; 1303 ; 1444 ; 1492 ; 1498 ; 1436 ; 1458 ; 1507 ; 1504 ; 1529 ; 1506 ; 1296 ; 1177 ; 1309 ; 1244 ; 1130 ; 1016 ; 1021 ; 1135 ; 1382 ; 1243 ; 1094 ; 1076 ; 1136 ; 1102 ; 1201 ; 1274 ; 1095 ; 1497 ; 1514 ; 1561 ; 1560 ; 1490 ; 1521 ; 1160 ; 1093 ; 1047 ; 1297 ; 1079 ; 1226 ; 1349 ; 1227 ; 1441 ; 1003 ; 1449 ; 1141 ; 1148 ; 1182 ; 1196 ; 1203 ; 1219 ; 1252 ; 1283 ; 1288 ; 1270 ; 1302 ; 1304 ; 1310 ; 1328 ; 1331 ; 1340 ; 1334 ; 1343 ; 1362 ; 1452 ; 1496 ; 1510 ; 1513 ; 1486 ; 1545 ; 1522 ; 1044 ; 1045 ; 1429 ; 1344 ; 1321 ; 1",".","531 systems","Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.",4/23/2014,"04/23/2014",7/23/2014,"07/23/2014"
"Devices",68633,"Ongoing","Medtronic MiniMed Inc.","Northridge","CA","US","Voluntary: Firm Initiated","Telephone","New Jersey and Worldwide: Belgium, France, Netherland, and Sweden","Z-2173-2014","Class II","Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D","n/a",".","764 units","Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.",6/16/2014,"06/16/2014",8/20/2014,"08/20/2014"
"Devices",68634,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","UT, WI, NY","Z-2180-2014","Class II","Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.","Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only: 10010 10046 10586 No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S. ",".","56","Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data. ",6/17/2014,"06/17/2014",8/20/2014,"08/20/2014"
"Food",68635,"Ongoing","Baroody Imports Inc.","Clifton","NJ","US","Voluntary: Firm Initiated","Telephone","NY","F-2305-2014","Class III","Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar.","None",".","178 Jars","Beirut Lift Turnip Pickles contains undeclared FD & C Red #40 and unallowable dye 45170 Rhodamine B - Basic Violet 10. ",4/28/2014,"04/28/2014",8/13/2014,"08/13/2014"
"Biologics",68636,"Ongoing","Stryker Medical Division of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: Nationwide including Puerto Rico. Product was also shipped to the following countries: Algeria, Argentina, Bangladesh, Belgium, Brazil, Canada, France, Greece, Hong Kong, Indonesia, Italy, Japan, Malaysia, Netherlands, Pakistan, Peru, Phillipines, Saudi Arabia, Singapore, Sweden, Turkey, United Arab Emirates, United Kingdom & Venezuela.","B-0880-14","Class II","Medi-Temp Blood/Fluid Warming Cassette, Stryker Medical, 3800 E. Centre Avenue, Portage, MI 49002 ","Model # D25310CE; Lot #'s: M0112, M0113, M0114, M0212, M0213, M0214, M0214, M0314, M0412, M0413, M0414, M0512, M0514, M0514, M0612, M0614, M0712, M0713, M0713, M0714, M0714, M0812, M0814, M0814, M0914, M1012, M1014, M1112, M1113, M1114, M1213, M1213, M1214, M1313, M1313, M1412, M1413, M1413, M1512, M1513, M1513, M1611, M1612, M1613, M1711, M1712, M1713, M1713, M1812, M1813, M1813, M1911, M1912, M2011, M2012, M2111, M2113, M2211, M2213, M2213, M2311, M2312, M2313, M2313, M2412, M2413, M2413, M2612, M2713, M2811, M2812, M2911, M2912, M2913, M2913, M3011, M3012, M3013, M3013, M3111, M3112, M3113, M3113, M3211, M3312, M3313, M3313, M3412, M3511, M3612, M3613, M3712, M3713, M3811, M3911, M4011, M4012, M4112 & M4211 Model # D25315CE; Lot # s: M0112, M0213, M0413, M0414, M0414, M0512, M0612, M0713, M1014, M1114, M1511, M1611, M1813, M1912, M1913, M2212, M2411, M2413, M2513, M2611, M2613, M2913, M3111, M3113, M3211, M3213, M3413, M3511, M3513, M3513, M3611, M3612, M3713, M3812, M3813, M3813, M4011, M4012, M4111 & M4212 Model # D25340CE; Lot # s: M0312, M1112, M1511, M1712, M1811, M2311, M2312, M2411, M2513, M2712, M2712, M3011, M3213, M3311, M3611 & M3711. Model # D25310NL; Lot # s: M0312, M0412, M0414, M0414, M0713, M0812, M0913, M0913, M1012, M1314, M1511, M1811, M1812, M2011, M2013, M2211, M2212, M2411, M2412, M2413, M2512, M2513, M2513, M2711, M2811, M3011, M3012, M3111, M3311, M3413, M3512, M3711, M3812, M3812, M4011 & M401 ",".","4 Units","Blood/Fluid Warmer Cassettes, associated with complaints in regards to malformed threads on the female luer fitting of specific models, were distributed. ",7/15/2014,"07/15/2014",8/13/2014,"08/13/2014"
"Drugs",68637,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico","D-1415-2014","Class II","Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81. ","30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.",,"26,530 30-Count Bottles; 14,597 90-Count Bottles","Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.",6/12/2014,"06/12/2014",7/9/2014,"07/09/2014"
"Drugs",68638,"Ongoing","Doctor's Best, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-1549-2014","Class II","Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673"," Lot # 3121005; Exp 02/17 ",,"7,379 bottles","Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.",6/24/2014,"06/24/2014",8/27/2014,"08/27/2014"
"Drugs",68639,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.","D-1485-2014","Class III","Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30","Lot # V130822; Exp 01/15",,"22,461 bottles","Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. ",6/19/2014,"06/19/2014",8/6/2014,"08/06/2014"
"Devices",68640,"Terminated","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated",,"Distributed in the states of AR, TN MO, KS, TX, MS, and AL.","Z-1945-2014","Class II","Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.","Lot Numbers: GD894535, GD894550",,"20,940 units","the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.",7/8/2013,"07/08/2013",7/9/2014,"07/09/2014"
"Food",68641,"Ongoing","Silva International, Inc.","Momence","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: WI","F-2520-2014","Class I","Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box.","Item No.: 90S; Lot No.: 05091490S-28",,"166 cases (4,648 lb.)","Silva International Inc. is a lot of recalling Minced Green Onion, ''Irradiated'' due to reported Salmonella contamination.",5/30/2014,"05/30/2014",10/1/2014,"10/01/2014"
"Drugs",68642,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide","D-1539-2014","Class III","Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.","Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014. ",,"9225 Bottles","Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.",6/20/2014,"06/20/2014",8/27/2014,"08/27/2014"
"Devices",68643,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, IL, OK, OR and WI.","Z-2037-2014","Class II","GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.","GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606 GEMINI TF Big Bore: 882476 9019,9227,9232,9233 ",,"33","When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly. ",6/18/2014,"06/18/2014",7/16/2014,"07/16/2014"
"Devices",68644,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.","Z-1982-2014","Class II","BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT). Medical Device for imaging.","BrightView XCT: product code 882482 BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454 All Codes:, , 6000305,6000306,6000307,6000308,6000309,6000310,6000311,6000312,6000313,6000314,",,"407","Flat Panel Display (FPD) failed to remain securely locked in the deployed position.",6/23/2014,"06/23/2014",7/9/2014,"07/09/2014"
"Drugs",68645,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1557-2014","Class III","Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.","Lot 3040063 Exp. 07/14",".","2,658 Bottles ","Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.",6/19/2014,"06/19/2014",9/3/2014,"09/03/2014"
"Devices",68646,"Ongoing","Karl Storz Endoscopy","El Segundo","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada.","Z-2039-2014","Class II","Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.","Serial Numbers: 20110322-01 HLS-20110706-01 HLS-20110315-03 MLS-20101208-01 MLS-20101101-01 MLS-20130418-22 MLS-20130715-03 MLS-20130514-06 MLS-20130514-13 MLS-20130514-14 MLS-20130514-09 MLS-20130514-18 MLS-20130514-19 MLS-20130514-16 MLS-20130514-11 MLS-20130514-08 MLS-20130514-15 MLS-20130514-17 HLS-20130523-02 HLS-20130523-04 MLS-20130514-07 HLS-20130523-03 MLS-20130715-04 MLS-20130514-12 MLS-20130514-10 MLS-20110609-01 MLS-20110603-02 MLS-20110603-01 MLS-20110527-02 MLS-20110531-01 MLS-20110531-02 MLS-20110601-01 MLS-20110601-03 MLS-20140411-01 MLS-20130418-18 MLS-20130418-13 HLS16-20130128-04 HLS16-20130128-03 HLS16-20130128-01 HLS16-20130128-02 MLS-20140424-02 MLS-20130514-02 MLS-20130418-21 MLS-20120924-03 LLS-20111003-03 MLS-20111011-03 MLS-20110920-03 MLS-20120117-14 MLS-20120523-03 MLS-20120905-02 LLS-20121112-04 MLS-20130322-01 MLS-20120713-05 MLS-20110713-04 MLS-20110629-01 MLS16-20131028-01 MLS-20120208-01 HLS24-20130823-01 LLS-20120103-03 MLS-20111005-08 HLS-20120118-03 HLS-20120112-01 MLS-20120910-05 MLS-20121010-01 MLS-20120910-03 MLS-20120910-01 MLS-20120830-01 MLS-20120920-03 MLS-20120920-05 MLS-20120920-06 MLS-20120920-07 MLS-20120808-01 MLS-20121010-02 MLS-20121008-02 MLS16-20130708-06 MLS-20120207-04 LLS-20130109-01 MLS-20120213-02 MLS-20120213-03 MLS-20120215-01 MLS-20120215-03 MLS-20120306-02 MLS-20120329-01 HLS-20120207-01 MLS-20120301-01 MLS-20120319-01 MLS-20120313-01 MLS-20120104-03 LLS-20120430-02 MLS-20120511-02 MLS-20120523-02 MLS-20120618-01 MLS-20120301-02 LLS-20120615-01 LLS8-20121024-01 MLS-20120703-07 MLS16-20130927-01 MLS-20121231-01 MLS-20130418-01 MLS-20130405-01 MLS-20130405-10 MLS-20130405-08 20110314-02 HLS24-20130923-01 MLS16-20130923-03 LLS8-20140523-01 HLS24-20130923-02 HLS24-20130826-01 MLS16-20130823-01 LLS8-20130726-04 HLS24-20130809-01 LLS-20120103-12 LLS-20111207-03 LLS-20120103-04 LLS-20111227-02 MLS-20121231-07 MLS-20130418-09 LLS-20120427-03 20110211-01 MLS-20130418-08 MLS-20130418-15 LLS-20110315-01 LLS-20110309-01 HLS24-20130923-03 HLS32-20131206-01 LLS-20",,"968 units","KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.",6/25/2014,"06/25/2014",7/16/2014,"07/16/2014"
"Devices",68647,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-2143-2014","Class III","Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.","Lot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501 ",".","1633 boxes","Carestream manufacturing identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees. ",7/2/2014,"07/02/2014",8/13/2014,"08/13/2014"
"Devices",68647,"Ongoing","Carestream Health Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-2142-2014","Class III","INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.","Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1 ",".","1633 boxes","Carestream manufacturing identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees. ",7/2/2014,"07/02/2014",8/13/2014,"08/13/2014"
"Devices",68648,"Ongoing","Biosound Esaote, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada","Z-2167-2014","Class II","Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging","Part #: 9600165000 PROBE, PA230E Serial #'s: 07011, 10005, 10007, 10010, 10011, 10012, 10013, 10015, 10017, 10021, 10042, 10068, 10070, 10079, 10085, 10086, 10087, 10088, 10089, 10092, 10101, 10102, 10117, 10139, 10149, 10154, 10155, 10169, 10170, 10176, 10177, 10179, 10183, 10184, 10194, 10203, 10205, 10217, 10238, 10246, 10247, 10284, 10285, 10286, 10294, 10300, 10301, 10303, 10305, 10306, 10313, 10314, 10318, 10482, 10533, 10534, 10539, 10548, 10559, 10560, 106, 10729, 10820, 10905, 10906, 10907, 10908, 10909, 10984, 1100, 11011, 11032, 11108, 11124, 11126, 11138, 11168, 11171, 11179, 11184, 11188, 11198, 11199, 11206, 11215, 11226, 11326, 11327, 11332, 11353, 11374, 1142, 1152, 1154, 1161, 1163, 1170, 11794, 11809, 11987, 12003, 12006, 12018, 12028, 12059, 12060, 12062, 12063, 12064, 12065, 12073, 12126, 12127, 12133, 12137, 12138, 12141, 12143, 12144, 12150, 12151, 12153, 12158, 12161, 12174, 12178, 12180, 12183, 12184, 12186, 12192, 12193, 1220, 12200, 12202, 12203, 12205, 12216, 12217, 12312, 12321, 12327, 12332, 12335, 1235, 12353, 12355, 12356, 12384, 12627, 12632, 12812, 12912, 1300, 13019, 13025, 13046, 13051, 13073, 13074, 13075, 13082, 13129, 13146, 13168, 13179, 13180, 13186, 13255, 13258, 13260, 13265, 13268, 13271, 13274, 13275, 13277, 13288, 13289, 13290, 13292, 13323, 13325, 13326, 13437, 13524, 13540, 13567, 13588, 13590, 13593, 13629, 139, 14083, 14085, 14088, 14203, 14204, 14317, 14318, 14319, 14328, 14329, 14331, 14333, 14347, 14541, 14545, 14547, 14548, 14784, 148, 14827, 14875, 14894, 14895, 14921, 14926, 14927, 14929, 14949, 14950, 14951, 14952, 14953, 14954, 14955, 14956, 14970, 14977, 14978, 15242, 15243, 15244, 15247, 15289, 15291, 15293, 15307, 15308, 15310, 15311, 15315, 1543, 15631, 15632, 15646, 15648, 15649, 15650, 15654, 15656, 15711, 15712, 15714, 15716, 15949, 1595, 15951, 15954, 15955, 15957, 15958, 15959, 1596, 15960, 15961, 15962, 1600, 16004, 16005, 16008, 16009, 16010, 16011, 16013, 16015, 16019, 16022, 16023, 1603, 164, 16410, 16474, 16475, 16477, 16478, 16556, 16712, ",".","1,301 units","Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.",6/26/2014,"06/26/2014",8/20/2014,"08/20/2014"
"Biologics",68649,"Ongoing","Citra Labs LLC.","Braintree","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Foreign: UK, Venezuela","B-0991-14","Class III","Citra Labs ACD-A, Anticoagulant Citrate Dextrose Solution, Solution A, USP, 50 mL. Intended for use as an anticoagulant in the extracorporeal blood processing. PN 60S3","Batch Code/Exp Date: F23 2015/05; G22 2015/06; H15 2014/07; H16 2014/07; J14 2014/08; J15 2014/08; K110 2014/09; K17 2014/09; L13 2014/10; L17 2014/10 ",,"18,672 vials","ACD-A (Anticoagulant Citrate Dextrose Solution, Solution A, USP 50mL) contaminated with silicone particles, was distributed. ",6/24/2014,"06/24/2014",10/15/2014,"10/15/2014"
"Devices",68650,"Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, US Virgin Islands, Venezuela and Vietnam.","Z-2562-2014","Class II","Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. ","Model #'s: P3700B, P3700C, P3700D and P3700E",,"13,000 units","The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. ",6/26/2014,"06/26/2014",9/10/2014,"09/10/2014"
"Devices",68651,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,","Z-2212-2014","Class II","Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581 ","Catalog Number: DNPDG, Lot Number: NB0311 and NB0611",,"37","The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.",6/23/2014,"06/23/2014",8/27/2014,"08/27/2014"
"Drugs",68652,"Ongoing","Mckesson Packaging Services","Concord","NC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1483-2014","Class III","Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC ","Lot 0093943",,"1,511,250 tablets","Failed Dissolution Specification; at the 12 month time interval.",6/19/2014,"06/19/2014",8/6/2014,"08/06/2014"
"Devices",68653,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.","Z-2289-2014","Class II","PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. ","Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861",,"190 units","The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.",7/1/2014,"07/01/2014",8/27/2014,"08/27/2014"
"Devices",68653,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.","Z-2288-2014","Class II","PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. ","Item Number 00-5907-015-00, Lot Numbers: 56518863 & 56518862 ",,"190 units","The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.",7/1/2014,"07/01/2014",8/27/2014,"08/27/2014"
"Devices",68654,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.","Z-2215-2014","Class II","Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement. ","Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot 62400669; Part 00402101248, Lot 62400670; Part 00402101249, Lot 62467222; Part 00402101251, Lot 62470576; Part 00402101252, Lot 62435851; Part 00402101254, Lot 62424470; Part 00402101257, Lot 62524114; & Part 00402101260, Lot 62524115.",,"68","Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lots.",7/1/2014,"07/01/2014",8/27/2014,"08/27/2014"
"Devices",68655,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.","Z-2582-2014","Class II","Natural-Knee System Pateella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.","Part Number 6290-00-690. Lots Manufactured by Zimmer: 1327524, 1339783, 1344879, 1346702, 1361955, 1368604, 1382204, 1386058, 1388164, 1429297, 1437553, 1441291, 1441897, 1451867, 1465171, 1470848, 1470849, 1472371, 1516851, 1530342, 1538118, 1547978, 1555574, 1560246, 1565076, 1583036, 1593277, 1594775, 1595926, 1598696, 1601040, 1606098, 1606511, 170454, 171324, 173342-09, 173342-10, 173342-2, 173342-3, 173342-9, 601863, 60319687, 60339959, 60415511, 60457440, 60539669, 60621386, 60732865, 60929928, 60946367, 60951770, 60961665, 60970630, 60994794, 61028392, 61080335, 61099775, 61171949, 61171950, 61208215, 61247557, 61444751, 61580595, 61732750, 61905939, 61924234, 61999723, 62156016, 62190266, 62220910, 62281030, 62298031, 62400882, 62597910, 640601, 669401, 691488, 741824, 783833, 784261, 789465, 789470, 791158, 796231, 796408, 802258, 803823, 810082, 825931-1, 825931-2, 831825-2, 863224-1, & 869009. Lots Manufactured by Centerpulse: 93302, 95066, 95067, 95068, 95069, 97240, 97538, 97539, 99928, 1142822, 1147427, 1148798, 1151284, 1151286, 1151287, 1151288, 1153331, 1155442, 1155443, 1156670, 1156671, 1156672, 1157975, 1163692, 1163693, 1163694, 1163695, 1179240, 1179241, 1179242, 1179243, 1179244, 1190722, 1190723, 1190724, 1190725, 1190726, 1204516, 1204517, 1204518, 1204519, 1204537, 1204538, 1204539, 1204540, 1204541, 1204542, 1226013, 1238476, 1238477, 1238478, 1238479, 1238480, 1268798, 1268799, 1276896, 1276897, 1276898, 1276899, 1276900, 1307948, 1307949, 1312646, 1321254, 1324202, 1327524, 1332586, 1339783, 1340512, 1344879, 1346702, 1351210, 1361955, 1368604, 1373550, 1382204, 1386058, 1388164, 1429297, 1437553, 1441291, 1441897, 1451867, 1465171, 1470848, 1470849, 1472371, 1516851, 1530342, 1534065, 1538118, 1547978, 1555574, 1560246, 1565076, 1583036, 1583719, 1583720, 1593277, 1594775, 1595926, 1598696, 1601040, 1606098, & 1606511. ",,"8638 devices in total","Zimmer received a trend of complaints indicating corrosion of product.",7/10/2014,"07/10/2014",9/10/2014,"09/10/2014"
"Devices",68655,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.","Z-2585-2014","Class II","Natural-Knee System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter","Part Number 6290-00-704. Lots Manufactured by Zimmer: 1137602, 1324205, 1331331, 1346218, 1351208, 1368598, 1373552, 1376006, 1382199, 1386059, 1422626, 1426895, 1438006, 1441899, 1475757, 1475758, 1478938, 1493445, 1517176, 1525953, 1525954, 1549263, 1551990, 1554289, 1556787, 1560245, 1596097, 1601264, 1601980, 1606097, 1606956, 170675, 172228, 173342-3, 173342-8, 173342-9, 593336, 597424, 60259011, 60293370, 60305590, 60380932, 60398259, 60607433, 60671091, 60704501, 60744843, 60924671, 60931675, 60946362, 60949827, 60956490, 60961653, 60973615, 60983070, 60987243, 61010771, 61092652, 61099690, 611105, 61132248, 61240154, 61240155, 61513545, 61750140, 62028651, 62130964, 62238170, 62477497, 625041, 689492, 747883, 783836, 784561, 789471, 791165, 796410, 802259, 803825, 825355-1, 825355-2, 831825-1, 863226-1, 863226-2,& 9907272. Lots Manufactured by Centerpulse: 9827, 10406, 95319, 95659, 95660, 95661, 96666, 97909, 97910, 97911, 97918, 97919, 97920, 97921, 97922, 1137602, 1141806, 1142826, 1142827, 1146540, 1147430, 1148802, 1155438, 1155439, 1164234, 1164235, 1164236, 1164237, 1180626, 1180627, 1180628, 1180629, 1180630, 1190942, 1190943, 1190944, 1200830, 1200831, 1200832, 1200833, 1200834, 1200835, 1200836, 1200837, 1200838, 1200839, 1200840, 1232870, 1232871, 1232872, 1232873, 1232874, 1265021, 1265022, 1265023, 1265024, 1265025, 1265026, 1299412, 1299413, 1307097, 1307745, 1307746, 1313080, 1321261, 1324205, 1331331, 1331516, 1340515, 1346218, 1351208, 1353797, 1361953, 1368598, 1373552, 1376006, 1382199, 1386059, 1388166, 1422626, 1426895, 1438006, 1441899, 1475757, 1475758, 1478938, 1493445, 1517176, 1525953, 1525954, 1549263, 1551990, 1554289, 1556787, 1560245, 1583307, 1583622, 1583623, 1594529, 1596097, 1601264, 1601980, 1606097, 1606956, & 1346218-B. ",,"8638 devices in total","Zimmer received a trend of complaints indicating corrosion of product.",7/10/2014,"07/10/2014",9/10/2014,"09/10/2014"
"Devices",68655,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.","Z-2584-2014","Class II","Natural-Knee System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.","Part Number: 6290-00-703. Lots Manufactured by Zimmer: 1324204, 1346689, 1361954, 1371127, 1374460, 1382191, 1386076, 1388163, 1421648, 1440890, 1441119, 1476227, 1476229, 1493832, 1493841, 1516853, 1530324, 1549264, 1549388, 1554288, 1554290, 1560754, 1563440, 1598691, 1598692, 1598693, 1598695, 1601605, 1606099, 1606510, 170675, 172016, 173342-09, 173342-10 , 173342-3 , 173342-5, 173342-9 , 601804, 60278820, 60310873, 60426582, 60541727, 60621363, 60641020, 60728521, 60763272, 60933532, 60936986, 60946365, 60947926, 60954309, 60961655, 60964904, 60970610, 60978734, 60998043, 61004755, 61019426, 61025143, 61037534, 61092670, 61092673, 61092674, 61099693, 61188779, 61208208, 61244656, 61444749, 61588176, 61626531, 61815323, 618303, 61910780, 62007198, 62159771, 62238171, 62298008, 62495684, 672559, 691440, 739625, 751350, 784259, 784516, 786652, 791148, 795930, 802251, 803806, 825358-2, 831816-1, 863218-1, 865553, 866726, & 869004. Lots Manufactured by Centerpulse: 9878, 11486, 95318, 95657, 97415, 98273, 98697, 98698, 98699, 98700, 1142825, 1146539, 1147429, 1155440, 1155441, 1163886, 1163887, 1163888, 1163889, 1180631, 1180632, 1180633, 1180634, 1180635, 1190945, 1190946, 1190947, 1190948, 1190949, 1190950, 1204513, 1204514, 1204515, 1204529, 1204530, 1204531, 1204532, 1204533, 1204534, 1204535, 1204536, 1216592, 1238464, 1238465, 1238466, 1238467, 1238468, 1267379, 1267380, 1267381, 1267383, 1267384, 1267385, 1299603, 1299604, 1306224, 1306225, 1307950, 1307951, 1312647, 1324204, 1331517, 1332138, 1339782, 1340514, 1346689, 1353798, 1361954, 1371127, 1373553, 1374460, 1382191, 1386076, 1388163, 1421648, 1439178, 1440890, 1441119, 1476227, 1476228, 1476229, 1493832, 1493833, 1493841, 1498789, 1503345, 1516853, 1530324, 1533357, 1549264, 1549388, 1554288, 1554290, 1560754, 1563440, 1583518, 1583721, 1583722, 1593708, 1595927, 1598691, 1598692, 1598693, 1598695, 1601605, 1606099, 1606510, & 95658-A. ",,"8638 devices in total","Zimmer received a trend of complaints indicating corrosion of product.",7/10/2014,"07/10/2014",9/10/2014,"09/10/2014"
"Devices",68655,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.","Z-2583-2014","Class II","Natural-Knee System Patella Bushings Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.","Part Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203, 1339203, 1346701, 1363348, 1373979, 1382208, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1598694, 1601263, 1601606, 1606096, 1606957, 170454, 172361, 173342-10, 173342-3, 173342-8, 173342-9, 596146, 597424, 60278535, 60305599, 60319668, 60426581, 60557544, 60712149, 60767845, 60931683, 60946366, 60947929, 60968638, 60970621, 60986924, 60986941, 61025150, 61037537, 61080336, 61080337, 61088939, 61099737, 61099765, 61105152, 61149082, 61240132, 61444750, 61588175, 61799358, 62007189, 62043610, 62123986, 62156012, 62192074, 62216444, 62253081, 62298037, 62304814, 62353344, 625039, 62575710, 640562, 731461, 752886, 783833, 784261, 784530, 789465, 789470, 791153, 791158, 796231, 802256, 803819, 810082, 825360-1, 825360-2, 833061-1, 863221-1, & 869007. Lots Manufactured by Centerpulse: 10249, 95077, 95316, 95317, 95655, 95656, 96228, 97923, 97923, 97924, 97925, 97926, 97927, 97928, 1141805, 1142824, 1146537, 1146538, 1146673, 1154080, 1155982, 1160641, 1164199, 1164200, 1164232, 1164233, 1179234, 1179235, 1179236, 1179237, 1179238, 1190951, 1190952, 1190953, 1190954, 1190955, 1202697, 1202698, 1202699, 1202700, 1202701, 1202702, 1202703, 1202704, 1202705, 1202706, 1204532, 1238469, 1238470, 1238471, 1238472, 1238473, 1238474, 1238475, 1267914, 1268394, 1268395, 1268396, 1268397, 1299414, 1299415, 1299416, 1306226, 1306227, 1308485, 1308486, 1313079, 1324203, 1332585, 1332695, 1339203, 1340513, 1346701, 1351209, 1353798, 1363348, 1371128, 1373979, 1382208, 1382209, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1583624, 1583727, 1594531, 1594583, 1595925, 1598694, 1601263, 1601606, 1606096, 1606957, 1299414-A, 1299419-A, & 95315-A. ",,"8638 devices in total","Zimmer received a trend of complaints indicating corrosion of product.",7/10/2014,"07/10/2014",9/10/2014,"09/10/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2222-2014","Class II","Double Offset Rasp Handle, Right Hand Nonsterile ","Item Number 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2216-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757821 Lot Number 97005188, 97005789 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2225-2014","Class II","VER2 D8L OFFSET RASP HANDLE, RT Nonsterile ","Item Number 82016761302 Lot Number 97009564, 97009565, 97009570 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2218-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2219-2014","Class II","VI DBL OFFST W/ LRG STPL, LT Nonsterile ","Item Number 82016757841 Lot Number 97009219, 97009254 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2223-2014","Class II","Vl DBL OFFST WI LRG STPL, RT Nonsterile ","Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2220-2014","Class II","Double Offset Rasp Handle, Right Hand Nonsterile ","Item Number 82016757922 Lot Number 97005189, 97005833 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2230-2014","Class II","23.5 Deg Rasp Handle Assy- LEFT Nonsterile ","Item Number 82-0167-636-00 Lot Number 97009530, 97009782 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2231-2014","Class II","23.5 Deg Rasp Handle Assy- RIGHT Nonsterile ","Item Number 82-0167-636-20 Lot Number 97009531, 97009781 ",".",,"The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2228-2014","Class II","VER2 HANDLE, PIN REWORK, LT Nonsterile ","Item Number 82-0167-612-31, Lot Number 97009753, 97010150 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2221-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757931 Lot Number 97009560 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2229-2014","Class II","VER2 HANDLE, PIN REWORK, RT Nonsterile ","Item Number 82-0167-613-32 Lot Number 97010151 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2227-2014","Class II","Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) ","Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2217-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757830 Lot Number 97009559 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2226-2014","Class II","Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) ","Item Number 00780803521 Lot Number 56474891, 56474892, 56474893, 56474894 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2224-2014","Class II","VER2 DBL OFFSET RASP HANDLE, LT Nonsterile ","Item Number 82016761201 Lot Number 97009494, 97009561, 97009569 ",".","412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/20/2014,"08/20/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2218-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2229-2014","Class II","VER2 HANDLE, PIN REWORK, RT Nonsterile ","Item Number 82-0167-613-32 Lot Number 97010151 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2217-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757830 Lot Number 97009559 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2224-2014","Class II","VER2 DBL OFFSET RASP HANDLE, LT Nonsterile ","Item Number 82016761201 Lot Number 97009494, 97009561, 97009569 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2219-2014","Class II","VI DBL OFFST W/ LRG STPL, LT Nonsterile ","Item Number 82016757841 Lot Number 97009219, 97009254 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2220-2014","Class II","Double Offset Rasp Handle, Right Hand Nonsterile ","Item Number 82016757922 Lot Number 97005189, 97005833 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2216-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757821 Lot Number 97005188, 97005789 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2231-2014","Class II","23.5 Deg Rasp Handle Assy- RIGHT Nonsterile ","Item Number 82-0167-636-20 Lot Number 97009531, 97009781 ",,,"The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2227-2014","Class II","Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) ","Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2223-2014","Class II","Vl DBL OFFST WI LRG STPL, RT Nonsterile ","Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2230-2014","Class II","23.5 Deg Rasp Handle Assy- LEFT Nonsterile ","Item Number 82-0167-636-00 Lot Number 97009530, 97009782 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2226-2014","Class II","Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) ","Item Number 00780803521 Lot Number 56474891, 56474892, 56474893, 56474894 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2225-2014","Class II","VER2 D8L OFFSET RASP HANDLE, RT Nonsterile ","Item Number 82016761302 Lot Number 97009564, 97009565, 97009570 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2228-2014","Class II","VER2 HANDLE, PIN REWORK, LT Nonsterile ","Item Number 82-0167-612-31, Lot Number 97009753, 97010150 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2222-2014","Class II","Double Offset Rasp Handle, Right Hand Nonsterile ","Item Number 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68656,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.","Z-2221-2014","Class II","Double Offset Rasp Handle, Left Hand Nonsterile ","Item Number 82016757931 Lot Number 97009560 ",,"412 units","The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Devices",68657,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.","Z-2131-2014","Class II","Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.","Part Number 00-2358-014-04; lot 62276042",,"28 units","A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.",6/10/2014,"06/10/2014",8/6/2014,"08/06/2014"
"Devices",68658,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong","Z-2027-2014","Class II","The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders. ","1) Software Version 5.5, List Number: 16037-04-13; 2) Software Version 5.8.1, List Number: 16037-04-31; 3) Software Version 5.8.2, List Number: 16037-04-33",,"13 units","Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of ''nanog/kg/min'' and ''milliUnits/min'' are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of ''nanog/kg/min'' or ''milliUnits/min'' on an unmatched medication will produce an incorrect program on the Plum A+/Plum A+3 infuser. The incorrect rate that will appear on the infuser will be a higher or lower value than what was intended from the original Auto Program. The incorrect program displayed on the Plum A+ device cannot start on its own; father a clinician must verify the program before starting the infusion. This issue can only occur with Plum A+/Plum A+3 devices using the Auto Programming feature.",6/6/2014,"06/06/2014",7/16/2014,"07/16/2014"
"Devices",68659,"Ongoing","ITC-Nexus Dx","Edison","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.","Z-2088-2014","Class II","Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.","Lot Number A4JCA001",,"US- 315 cuvettes; OUS - 2835 cuvettes","Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code.",6/20/2014,"06/20/2014",7/30/2014,"07/30/2014"
"Drugs",68660,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1443-2014","Class III","VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70","Lot H45241, exp. 11/16",".","1200 tablets","Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. ",7/8/2014,"07/08/2014",7/23/2014,"07/23/2014"
"Biologics",68661,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX; Austria","B-0884-14","Class II","Red Blood Cells Leukocytes Reduced","W0352111169400",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/9/2014,"06/09/2014",10/1/2014,"10/01/2014"
"Biologics",68661,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX; Austria","B-0885-14","Class II","Cryoprecipitated AHF","W0352111169400",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/9/2014,"06/09/2014",10/1/2014,"10/01/2014"
"Biologics",68661,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX; Austria","B-0886-14","Class III","Blood and Blood Products for Reprocessing","W0352111169400",,"1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",6/9/2014,"06/09/2014",10/1/2014,"10/01/2014"
"Biologics",68662,"Terminated","BloodCenter of Wisconsin, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","Telephone","WI","B-0883-14","Class II","Red Blood Cells Leukocytes Reduced","W036314015109; W036314285712; W036314015097; W036314285668; W036314304448; W036314015190",".","6 units","Blood products, collected using equipment that had not been validated, were distributed. ",5/13/2014,"05/13/2014",8/20/2014,"08/20/2014"
"Biologics",68663,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","TN","B-0867-14","Class II","Plasma Frozen within 24 hours (FP24)","W071213063523",".","1 unit","Blood product, possibly contaminated with air, was distributed.",5/19/2014,"05/19/2014",8/20/2014,"08/20/2014"
"Devices",68665,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.","Z-2149-2014","Class II","SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.","Lot# 38479172 and 39181172",".","1,191 kits","Complaints of failed calibration. ",6/23/2014,"06/23/2014",8/13/2014,"08/13/2014"
"Devices",68665,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.","Z-2150-2014","Class II","SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.","Lot# 38059172 and 39463172",".","961 kits","Complaints of failed calibration. ",6/23/2014,"06/23/2014",8/13/2014,"08/13/2014"
"Devices",68667,"Ongoing","Alphatec Spine, Inc.","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.","Z-2092-2014","Class II","Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).","Lot No. 7117902",,"14 units total (12 units in US)","Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. ",6/26/2014,"06/26/2014",7/30/2014,"07/30/2014"
"Food",68668,"Ongoing","Land O' Lakes, Inc","Arden Hills","MN","US","Voluntary: Firm Initiated","Telephone","FL, GA, IL, IN, MD, MO, PA, TX, VA.","F-2221-2014","Class II","Item: 48135 Land O'Lakes, Premium Deli Cheese, American, 5 lbs (2.27 KG) ","Lot#: 31510765 ",,"9,070 lbs","Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. ",6/18/2014,"06/18/2014",7/30/2014,"07/30/2014"
"Food",68668,"Ongoing","Land O' Lakes, Inc","Arden Hills","MN","US","Voluntary: Firm Initiated","Telephone","FL, GA, IL, IN, MD, MO, PA, TX, VA.","F-2220-2014","Class II","Item: 48770 Land O'Lakes, Pasteurized Process Cheese Product, Yellow, NET WT 5 LBS (2.27 KG). ","Lot#: 31508147 and 31510762",,"32,910 lbs","Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. ",6/18/2014,"06/18/2014",7/30/2014,"07/30/2014"
"Food",68668,"Ongoing","Land O' Lakes, Inc","Arden Hills","MN","US","Voluntary: Firm Initiated","Telephone","FL, GA, IL, IN, MD, MO, PA, TX, VA.","F-2218-2014","Class II","Item: 4815 Land O'Lakes, Extra Melt American White, Pasteurized Process American Cheese, Net WT 5 lbs (2.26 KG) ","Lot#: 31507365",,"32,880 lbs","Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. ",6/18/2014,"06/18/2014",7/30/2014,"07/30/2014"
"Food",68668,"Ongoing","Land O' Lakes, Inc","Arden Hills","MN","US","Voluntary: Firm Initiated","Telephone","FL, GA, IL, IN, MD, MO, PA, TX, VA.","F-2219-2014","Class II","Item: 48775 Land O'Lakes, Golden Velvet Pasteurized Process Cheese Spread - Yellow, NET WT 5 LBS (2.26 KG) ","Lot#: 31508146 & 31507367 ",,"6,570 lbs","Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. ",6/18/2014,"06/18/2014",7/30/2014,"07/30/2014"
"Drugs",68669,"Ongoing","Pharmacy Creations","Randolph","NJ","US","Voluntary: Firm Initiated","Letter","NY, NJ, and Puerto Rico","D-1546-2014","Class I","Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.","Lot: 06062014@8, Do Not Use Beyond 12/03/2014",,"70 vials","Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.",6/25/2014,"06/25/2014",8/27/2014,"08/27/2014"
"Devices",68670,"Ongoing","PerkinElmer Health Sciences, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK","Z-2166-2014","Class II","PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. ","Product Code: 5002-0500; Software Versions, 1.4 and 1.6",".","13 devices","Potential for demographic information and test result to be mismatch. ",6/27/2014,"06/27/2014",8/13/2014,"08/13/2014"
"Drugs",68671,"Ongoing","Poly Pharmaceuticals, Inc","Owens Cross Roads","AL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1431-2014","Class III","POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.","Lot #: 04413, Expiry: 02/15 ",".","208 Bottles","Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording ''Rx Only''.",6/26/2014,"06/26/2014",7/23/2014,"07/23/2014"
"Drugs",68671,"Ongoing","Poly Pharmaceuticals, Inc","Owens Cross Roads","AL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1432-2014","Class III","LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.","Lot #: 03613, Expiry: 02/15 ",".","102 Bottles","Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording ''Rx Only''.",6/26/2014,"06/26/2014",7/23/2014,"07/23/2014"
"Food",68673,"Ongoing","Modern Macaroni Co Ltd","Honolulu","HI","US","Voluntary: Firm Initiated","Combination ","HI and one location in San Francisco","F-2090-2014","Class III","Hula Brand Products; Hana Ebi Green, artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages. Serving size 2 pinches (1 g) Manufactured by Modern Macaroni Co., Honolulu, HI Serving size is ''2'' pinches","Red - 1 lb UPC 73366-22044; Red - 0.6 oz. UPD 73366-22042; Green - i lb. - UPC 73366-22045; Green - 0.6 oz. UPC 73366-22043. No other code numbers",,"unknown","FDA sample 466576 found 208.46 ppm of Sulfites in Hana Ebi dried shrimp product.",6/20/2014,"06/20/2014",7/16/2014,"07/16/2014"
"Food",68673,"Ongoing","Modern Macaroni Co Ltd","Honolulu","HI","US","Voluntary: Firm Initiated","Combination ","HI and one location in San Francisco","F-2089-2014","Class III","Hula Brand Products; Hana Ebi Red; artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages. Servins size 2 pinches (1 g) Manufactured by Modern Macaroni Co., Honolulu, HI Serving size is ''2'' pinches","Red - 1 lb UPC 73366-22044; Red - 0.6 oz. UPD 73366-22042; Green - i lb. - UPC 73366-22045; Green - 0.6 oz. UPC 73366-22043. No other code numbers",,"unknown","FDA sample 466576 found 208.46 ppm of Sulfites in Hana Ebi dried shrimp product.",6/20/2014,"06/20/2014",7/16/2014,"07/16/2014"
"Devices",68674,"Ongoing","Laser Peripherals LLC","Plymouth","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution to IL, IN, and MD","Z-2073-2014","Class II","LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology","E14128 & E14129",".","25","Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'. ",6/20/2014,"06/20/2014",7/23/2014,"07/23/2014"
"Food",68675,"Ongoing","Garber Ice Cream Company Inc","Winchester","VA","US","Voluntary: Firm Initiated","E-Mail","MD, PA, VA, WV","F-2311-2014","Class II","Frederick Farms 4oz chocolate ice cream cups, net wt. 67grams, 24 per box, 231 boxes per pallet, expiration 6-10-15","Product Code: FFC4, Lot# 18422, Exp. Date : 06/10/2015, Bin - 421BF",".","Produced 905 cases of 24 cups on 6-10-14. 368 boxes were sent out to customers. 537 boxes never left the production facility.","The firm used the wrong lid on end of production run on Frederick Farms 4oz regular Chocolate Ice Cream. The wrong lid used was Frederick Farm NSA (No Sugar Added) Chocolate Ice Cream.",6/18/2014,"06/18/2014",8/20/2014,"08/20/2014"
"Food",68676,"Ongoing","Nestle","Glendale","CA","US","Voluntary: Firm Initiated","Press Release","distributed in District of Columbia, Delaware, Florida, Maryland, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Virginia and West Virginia.","F-2191-2014","Class I","Hagen-Dazs Chocolate Chocolate Chip Ice Cream, 14 oz, UPC of 74570-08400","BATCH CODE: 4133580418D/ Best By 13 May 2015 Batch Code date Breakdown:YDDDPPPPLLO Y-Year (2014) JJJ-Julian date (133) PPPP-Plant code (5804) Line (14) O- D-Shift ",".","1260 units","Nestle is recalling the Hagen-Dazs Chocolate Chocolate Chip Ice Cream because it mislabeled and the ingredient statement does not identify peanuts. The affected products are labeled as Hagen-Dazs Chocolate Chocolate Chip Ice Cream, and lid labeled as Hagen-Dazs Chocolate Peanut Butter. These mismatched packages contain Chocolate Peanut Butter ice cream, and the ingredient statement on the carton applies to Chocolate Chocolate Chip Ice Cream and does not identify peanuts. ",6/27/2014,"06/27/2014",7/23/2014,"07/23/2014"
"Food",68677,"Ongoing","Richard's Rub & Seasonings, LLC","Renton","WA","US","Voluntary: Firm Initiated","Press Release","Direct consignees in state of Washington.","F-2234-2014","Class II","Richards Too Good Hot Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. ","Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014.",,"unknown","Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. ",6/27/2014,"06/27/2014",8/6/2014,"08/06/2014"
"Food",68677,"Ongoing","Richard's Rub & Seasonings, LLC","Renton","WA","US","Voluntary: Firm Initiated","Press Release","Direct consignees in state of Washington.","F-2233-2014","Class II","Richards Too Good BBQ Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. ","Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014.",,"unknown","Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. ",6/27/2014,"06/27/2014",8/6/2014,"08/06/2014"
"Food",68677,"Ongoing","Richard's Rub & Seasonings, LLC","Renton","WA","US","Voluntary: Firm Initiated","Press Release","Direct consignees in state of Washington.","F-2235-2014","Class II","Richards Too Good Teriyaki Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. ","Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014.",,"unknown","Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. ",6/27/2014,"06/27/2014",8/6/2014,"08/06/2014"
"Devices",68678,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.","Z-2026-2014","Class II","The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures. ","All Model Numbers",,"3689","STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked. ",6/27/2014,"06/27/2014",7/16/2014,"07/16/2014"
"Devices",68679,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution in TX only.","Z-2182-2014","Class II","Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. ","The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components) ",".","4 units","Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery.",6/27/2014,"06/27/2014",8/20/2014,"08/20/2014"
"Food",68680,"Ongoing","Grace Foods (USA) Inc","Hollywood","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, IL, MD, and FL","F-2421-2014","Class III","Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I. ","MFG: 2013 MAR16 EXP: 2015 MAR 16; MFG: 2013 MAR 19 EXP: 2015 MAR19; MFG: 2013 MAR 25 EXP: 2015 MAR 25; MFG: 2013 MAR 27 EXP: 2015 MAR 27; MFG: 2013 APR 08 EXP: 2015 APR 08; MFG: 2013 APR 22 EXP: 2015 APR 22; MFG: 2013 APR 24 EXP: 2015 APR 24; MFG: 2013 MAY 04 EXP: 2015 MAY 04; MFG: 2013 MAY 08 EXP: 2015 MAY 08; MFG: 2013 MAY 17 EXP: 2015 MAY 17; MFG: 2013 MAY 22 EXP: 2015 MAY 22; MFG: 2013 JUN 06 EXP: JUN 06; MFG: 2013 JUN 22 EXP 2015 JUN 22; MFG: 2013 JUN 29 EXP: 2015 JUN 29; MFG: 2013 JUL 04 EXP: 2015 JUL 04; MFG: 2013 JUL 27 EXP: 2015 JUL 27; MFG: 2013 JUL 30 EXP: 2015 JUL 30; MFG: 2013 AUG 05 EXP: 2015 AUG 05; MFG: 2013 AUG 22 EXP: 2015 AUG 22; MFG: 2013 SEP 12 EXP: 2015 SEP 12.",".","35,900 cases / 24 cans","Label misprint on the front panel. Incorrectly declaring ''No Gums, Thickeners or Stabilizers Added''",11/14/2013,"11/14/2013",9/17/2014,"09/17/2014"
"Devices",68681,"Ongoing","Dynarex Corporation","Orangeburg","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Canada, and Mexico.","Z-2117-2014","Class II","CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.","Lot Numbers 28619 & 28621",,"Domestic: 208 cases; Foreign: 42 cases","''THIS SIDE UP'' is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.",7/2/2014,"07/02/2014",8/6/2014,"08/06/2014"
"Food",68682,"Ongoing","EBRO North America dba New World Pasta","Harrisburg","PA","US","Voluntary: Firm Initiated","Letter","CA CT FL MA MN MO NJ NY PA PR TX VT","F-2306-2014","Class II","Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes","all production codes and Best By dates",".","90,011 cases 12 units per case","The firm initiated this recall as a precaution out of concern that the product contains an undeclared allergen soy. Even though the product may contain a very small amount of soy, it has been further processed so there is no detectable level of soy protein. ",6/2/2014,"06/02/2014",8/20/2014,"08/20/2014"
"Drugs",68683,"Ongoing","Fougera Pharmaceuticals Inc.","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1441-2014","Class III","Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.","Lot: 849R, Exp 04/2015 ",".","3,594 Bottles","Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.",7/3/2014,"07/03/2014",7/23/2014,"07/23/2014"
"Drugs",68683,"Ongoing","Fougera Pharmaceuticals Inc.","Melville","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1440-2014","Class III","Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.","Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015. ",".","111,388 Bottles","Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.",7/3/2014,"07/03/2014",7/23/2014,"07/23/2014"
"Drugs",68685,"Ongoing","Trigen Laboratories, Inc.","Tampa","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1544-2014","Class III","Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.","Lot #: 505024006, 505024007, Exp 03/15; 505024008; 505024009, Exp 06/15; 505024010, Exp 08/15; 505024011, Exp 09/15; and 505024012, Exp 10/15",,"142,732 bottles ","Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.",4/17/2014,"04/17/2014",8/27/2014,"08/27/2014"
"Devices",68686,"Ongoing","PerkinElmer Health Sciences, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.","Z-2153-2014","Class II","Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. "," Serial Numbers: 20810001 through 20810148 ",".","144 units","Risk of incorrect results from samples prepared with Panthera-Puncher 9 ",7/1/2014,"07/01/2014",8/13/2014,"08/13/2014"
"Biologics",68687,"Ongoing","Celera Corporation","Alameda","CA","US","Voluntary: Firm Initiated","Letter","US, Taiwan, Singapore, and Hong Kong.","B-0993-14","Class III","ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0. Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual","ViroSeq HIV-1 Genotyping System v2.0 (reagent kit), Abbott Product List Number 4J9491, Celera Part Number 5002979; ViroSeq HIV-1 Genotyping Software v3.0 and Algorithm Advisor, Abbott Product List Number 4J9427, Celera Part Number 5003671- Software Revision v3.0, Build v3.0.0.32; ViroSeq HIV-1 Genotyping Software v3.0 Software Manual, Abbott Product List Number 4J9428, Celera Part Number 5003698; ViroSeq HIV-1 Genotyping System v2.0 (3130) Operator's Manual, Abbott Product List Number 4J9457, Celera Part Number 5002960.",,"1 unit","ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed. ",6/18/2014,"06/18/2014",10/1/2014,"10/01/2014"
"Biologics",68688,"Terminated","American Red Cross Blood Services","Saint Louis","MO","US","Voluntary: Firm Initiated","Telephone","Arkansas","B-0844-14","Class III","Cryoprecipitated AHF, Pooled","W20111490211; W201114902109; ",,"2 units","Blood products, in which pooled cryo did not meet acceptable product specifications were distributed.",5/23/2014,"05/23/2014",8/6/2014,"08/06/2014"
"Biologics",68689,"Terminated","Carter BloodCare, Inc.","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0843-14","Class III","Blood and Blood Products for Reprocessing","W035212077434N; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Biologics",68689,"Terminated","Carter BloodCare, Inc.","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0841-14","Class II","Red Blood Cells Leukocytes Reduced","W035212077434N; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Biologics",68689,"Terminated","Carter BloodCare, Inc.","Tyler","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0842-14","Class II","Cryoprecipitated AHF","W035212077434N; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Biologics",68690,"Terminated","Community Blood Center Of Gtr KC","Kansas City","MO","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0845-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W045014904537; ",,"1 unit","Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed.",4/22/2014,"04/22/2014",8/6/2014,"08/06/2014"
"Biologics",68691,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0839-14","Class II","Platelets","W035213029024M; W0352133025163; W035214030021C; ",,"3 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/10/2014,"06/10/2014",8/27/2014,"08/27/2014"
"Biologics",68691,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0837-14","Class II","Fresh Frozen Plasma","W035214005157X; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/10/2014,"06/10/2014",8/27/2014,"08/27/2014"
"Biologics",68691,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0838-14","Class II","Red Blood Cells Leukocytes Reduced","W035213029024M; W035214005157X; W0352133025163; W035214030021C; ",,"4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/10/2014,"06/10/2014",8/27/2014,"08/27/2014"
"Biologics",68691,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","Texas; Austria","B-0840-14","Class III","Blood and Blood Products for Reprocessing","W035213029024M; W0352133025163; W035214030021C; ",,"3 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",6/10/2014,"06/10/2014",8/27/2014,"08/27/2014"
"Biologics",68692,"Terminated","Grifols PlasmaCare, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","E-Mail","Spain","B-0832-14","Class II","Source Plasma","2820787937; 2820790203; 2820789153; ",".","3 units","Blood products, collected from a donor who was permanently deferred, were distributed.",6/5/2014,"06/05/2014",8/20/2014,"08/20/2014"
"Biologics",68693,"Terminated","Grifols PlasmaCare, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","E-Mail","Spain; California","B-0833-14","Class II","Source Plasma","2820739383; 2820705265; 2820705662; 2820707752; 2820708537; 2820712270; 2820713449; 2820714505; 2820715261; 2820716334; 2820717114; 2820718185; 2820718950; 2820720009; 2820720689; 2820721594; 2820722173; 2820723334; 2820724090; 2820725169; 2820725872; 2820727210; 2820727922; 2820728980; 2820729963; 2820730662; 2820731591; 2820732542; 2820733564; 2820734296; 2820736021; 2820736364; 2820739859; 2820788476; 2820789122; 2820737586; 2820742706; 2820742149; 2820752514; 2820752921; 2820754088; 2820754545; 2820765145; 2820770851; 2820771756; 2820772613; 2820773533; 2820774141; 2820775704; 2820776038; 2820776994; 2820777459; 2820778557; 2820778888; 2820779813; 2820780113; 2820781044; 2820781674; 2820783411; 2820784573; 2820785140; 2820786054; 2820786487; 2820787603; ",".","64 units","Blood products, collected from a donor who was permanently deferred, were distributed.",6/5/2014,"06/05/2014",8/20/2014,"08/20/2014"
"Biologics",68694,"Terminated","Grifols PlasmaCare, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","E-Mail","Spain; California","B-0859-14","Class III","Source Plasma","2820721948; 2820722336; 2820723770; 2820724285; 2820725965; 2820726577; 2820727839; 2820728883; 2820730483; 2820730836; 2820780433; 2820780969; 2820781929; 2820782356; 2820783397; 2820789414; ",,"16","Blood products, collected from a donor who disclosed history that warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed. ",6/5/2014,"06/05/2014",8/27/2014,"08/27/2014"
"Biologics",68695,"Terminated","New York Blood Center, Inc.","Long Island City","NY","US","Voluntary: Firm Initiated","FAX","New York","B-0888-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W047014011451; ",,"1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. ",6/11/2014,"06/11/2014",8/27/2014,"08/27/2014"
"Devices",68696,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Visit","US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.","Z-2036-2014","Class III","Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients. ","Serial Number Range: 3632511020 - 3613214010",,"37","STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable. ",6/30/2014,"06/30/2014",7/16/2014,"07/16/2014"
"Devices",68697,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","Z-2130-2014","Class II","RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.","Product Code: 004660000, (Size Miller 0), Lot numbers: 1306602, 1308602 & 1310602; Product Code: 004660001, (Size Miller 1), Lot numbers: 1306612, 1308612 & 1310612; Product Code: 004660002, (Size Miller 2), Lot numbers: 1306622, 1308622, 1309622 & 1310622; Product Code: 004660003, (Size Miller 3), Lot numbers: 1306632 & 1310632; Product Code: 004660004, (Size Miller 4), Lot numbers: 1306642, 1308642 & 1309642; Product Code: 004660010, (Size Miller 00), Lot numbers: 1306592, 1308592, 1309592, 1312592 & 1401592; Product Code: 004661002, (Size Mac 2), Lot numbers: 1306522, 1308522 & 1310522; Product Code: 004661003, (Size Mac 3), Lot numbers: 1306532, 1308532 & 1310532 and Product Code: 004661004, (Size Mac 4), Lot numbers: 306542, 1308542 & 1309542. ",,"6,246 units","There is a possibility the handle of the laryngoscope may heat up and melt the end cap.",6/30/2014,"06/30/2014",8/6/2014,"08/06/2014"
"Food",68698,"Ongoing","Metagenics, Inc.","Aliso Viejo","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide in US and worldwide: South Africa, Netherlands,","F-2198-2014","Class II","UltraBalance Protein Powder, Net Wt. 14.8 oz (420g)","Lot # 0712072, 0213041, 0813013, 0913002, 0214064 ",,"6158 units","Metagenics is recalling UltraBalance Protein powder because it may contain undeclared soy.",7/3/2014,"07/03/2014",7/30/2014,"07/30/2014"
"Food",68699,"Ongoing","Flowers Foods","Thomasville","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, GA, LA and TN.","F-2206-2014","Class I","BBQ Pull-A-Part Bread (Brands: Sunbeam (UPC 0 77633 05303 1), Bunny (UPC 0 71025 01500 3), Flowers [Foodservice] (UPC 0 72250 01866 1) and Ingles (UPC 0 86854 01543 8), 16oz clear flexible plastic bags, Distributed by Flowers Bakeries, LLC, Thomasville, GA 31757.","Sell by date codes: JUL 3 180 172",,"2820/16oz units","Undeclared allergen: Milk; Products made from margarine did not declare milk as part of the ingredient.",6/23/2014,"06/23/2014",7/30/2014,"07/30/2014"
"Devices",68700,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France","Z-2147-2014","Class II","Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems. ","Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339. ",".","21","A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as ''failed'' without any other indication of failure. There are no reported injuries from the devices.",6/19/2014,"06/19/2014",8/13/2014,"08/13/2014"
"Devices",68701,"Ongoing","Salter Labs","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.","Z-2093-2014","Class II","Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.","Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614",,"584 units","The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.",6/25/2014,"06/25/2014",7/30/2014,"07/30/2014"
"Food",68702,"Ongoing","Oriya Organics","Katy","TX","US","Voluntary: Firm Initiated","Telephone","Product was sold in retail stores in Texas and Louisiana and directly to consumers in Texas, New York, Louisiana, Florida, and Virginia via Internet sales.","F-2490-2014","Class I","Oriya organics Superfood Protein Medley Sprouted Chia Seeds Spirulina Sprouted Brown Rice Protein Hemp Protein Chlorella in NET WT. 21.2 OZ. (600 g) white poly bottles USDA ORGANIC ","UPC 85370100401, Lot A14314, Exp. 05/23/2015",,,"Product may be contaminated with Salmonella.",7/1/2014,"07/01/2014",10/1/2014,"10/01/2014"
"Devices",68703,"Ongoing","Heartsine Technologies, Limited","Belfast",,"GB","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.","Z-2115-2014","Class II","Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P) Automate External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.","Pad-Pak 01 & Pad-Pak 02 Adult Lot Numbers: A1785 to A1805 Pediatric Lot Numbers: P433 to P445.",,"3245","HeartSine Technologies, Ltd. initiated a voluntary recall of its Pad-Pak and Pedi-Pak user-replaceable sub-assemblies for the HeartSine family of automated external defibrillators because a small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. ",6/12/2014,"06/12/2014",7/30/2014,"07/30/2014"
"Devices",68704,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2569-2014","Class II","Artis zee and Artis zeego systems. x-ray, angiographic system","running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers . ",,"206","There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily. ",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Devices",68706,"Ongoing","Ra Medical Systems Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.","Z-2123-2014","Class II","PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma","Serial Numbers: 40 41 99 112 114 119 124 234 237 250 251 271 272 274 276 283 299 302 306 314 315 316 319 321 323 324 325 326 329 333 337 350 351 352 356 357 358 359 360 382 383 394 396 397 398 400 402 404 405 407 409 411 414 417 418 419 420 421 423 424 428 430 431 441 450 455 457 459 460 462 463 464 465 467 471 475 476 480 482 483 484 486 488 490 491 494 495 496 497 500 505 507 509 512 516 518 519 525 526 527 528 529 531 532 533 534 535 537 538 539 541 543 546 550 552 553 554 555 556 557 559 560 561 562 563 565 566 567 570 571 572 573 574 576 579 580 582 583 585 586 588 589 591 592 593 594 595 597 598 599 600 601 602 603 604 605 606 609 610 614 615 617 622 623 624 628 629 631 632 633 635 636 637 638 639 644 645 646 647 648 649 654 655 656 657 659 661 662 663 664 665 667 668 669 672 673 674 678 682 683 684 685 686 687 688 689 690 692 694 695 697 698 699 700 702 703 705 706 707 708 709 712 713 714 715 716 717 718 719 720 721 722 901 902 903 904 905 908 909 911 912 914 915 916 917 918 921 922 923 925 926 927 928 929 930 931 932 933 935 936 938 939 940 941 942 943 944 948 949 950 951 952 954 955 956 957 958 959 960 961 962 963 964 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1014 1015 1016 1017 1018 1021 1022 1023 1024 1025 1027 1028 1029 1030 1031 1032 1034 1035 1036 1037 1039 1040 1041 305 307 327 331 386 415 425 437 443 444 445 446 447 448 540 577 578 618 619 620 621 353 454 312 322 328 330 335 346 348 349 370 381 385 387 410 510 511 515 524 558 575 608 ",,"435 units","RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.",6/30/2014,"06/30/2014",8/6/2014,"08/06/2014"
"Veterinary",68707,"Ongoing","PGG/HSC Feed Co. LLC","Hermiston","OR","US","Voluntary: Firm Initiated","Telephone","Product was sold to two retail customers, located in Idaho and Oregon.","V-149-2014","Class II","KOXY KRUMBLES MEDICATED calf pellet/crumble feed; 50 lb bag; Active Drug Ingredient Amprolium 1.25%; Manufactured By: CHS Inc. Sioux Falls, SD 57107","Manufacturer's Lot Code: M927140 Product Code: 2730",,"84 fifty pound bags","PGG/HSC Feed Co., LLC is recalling Koxy Krumbles, an amprolium medicated calf pellet/crumble, due to 70% of declared amprolium.",6/10/2014,"06/10/2014",7/30/2014,"07/30/2014"
"Devices",68708,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA and WA","Z-2168-2014","Class III","Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.","Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E",".","280 sets of trays","Nanosphere has received report of an increased rate of ''No Call - INT CTL 2'' results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.",10/16/2013,"10/16/2013",8/20/2014,"08/20/2014"
"Devices",68709,"Terminated","Biogenex Laboratories, Inc.","Fremont","CA","US","Voluntary: Firm Initiated","Other","Brazil and Ecuador. No US distribution","Z-2113-2014","Class II","Insite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.","Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.",,"4 kits","Product was distributed without 510(k) approval.",7/1/2014,"07/01/2014",7/30/2014,"07/30/2014"
"Devices",68710,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.","Z-2559-2014","Class III","Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.","(Catalog No. 20-005-019) Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1 Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1 ",".","78 kits ","Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.",3/18/2014,"03/18/2014",9/3/2014,"09/03/2014"
"Biologics",68711,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Telephone","Missouri","B-0901-14","Class III","Red Blood Cells Leukocytes Reduced","W333414009307; ",,"1","Blood product, which was also tested as part of a clinical trial, but was not handled according to protocol, was distributed. ",5/12/2014,"05/12/2014",8/27/2014,"08/27/2014"
"Biologics",68712,"Terminated","Mississippi Valley Reg Bld Ctr","Davenport","IA","US","Voluntary: Firm Initiated","Letter","New York","B-0899-14","Class II","Red Blood Cells Leukocytes Reduced","W333613092147; ",,"1","Blood product, collected from a donor who emigrated from a malarial endemic country, was distributed.",6/5/2014,"06/05/2014",8/27/2014,"08/27/2014"
"Biologics",68713,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Texas","B-0894-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W0415130095307; W041513013459G; W041513013459G; W0415130131841; W0415130131841; W0415130178544; W041513021982F; W0415130095307; W041513021982F; ",,"9","Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.",5/6/2014,"05/06/2014",8/27/2014,"08/27/2014"
"Biologics",68714,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Maryland","B-0890-14","Class III","Red Blood Cells","W050911076204",".","1","Blood products, collected from donors whose health history screening was not adequately performed, were distributed.",4/15/2014,"04/15/2014",9/3/2014,"09/03/2014"
"Biologics",68714,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Maryland","B-0891-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W050911081096; ",".","1","Blood products, collected from donors whose health history screening was not adequately performed, were distributed.",4/15/2014,"04/15/2014",9/3/2014,"09/03/2014"
"Biologics",68714,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania; Maryland","B-0889-14","Class II","Red Blood Cells"," W050911079673; ",".","1","Blood products, collected from donors whose health history screening was not adequately performed, were distributed.",4/15/2014,"04/15/2014",9/3/2014,"09/03/2014"
"Biologics",68715,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0900-14","Class II","Platelets Pheresis Leukocytes Reduced","W050914015360; W050914015360; ",,"2","Blood products,that did not undergo quality control testing for pH or platelet count, were distributed.",4/22/2014,"04/22/2014",8/27/2014,"08/27/2014"
"Biologics",68716,"Terminated","Bio-Rad Medical Diagnostics GmbH","Dreieich",,"DE","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0824-14","Class III","Reagent Red Blood Cells","842201100",,"Biotestcell - I8 Reagent Blood Cells, PN 816020100 - 37 kits; Biotestcell I11 Reagent Blood Cells, PN 816021100 - 214 kits ","Misbranded reagent red blood cells were distributed. ",6/18/2014,"06/18/2014",7/30/2014,"07/30/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2273-2014","Class II","Mega Jex, Capsules","12/11/12 > 12/12/12 4/30/13 > 5/1/13 12/13/13 > 12/17/13 ",,"51,120 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2256-2014","Class II","Calcium Formula, 250 cc HDPE Bottles","EXP08.2016 ",,"501 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2264-2014","Class II","Garcinia Cambogia, 225cc HDPE Bottle","EXP04.2017 ",,"829 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2243-2014","Class II","Samurai-X, Blister Packs","No lot numbers",,"21,394 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2286-2014","Class II","Albert, Capsules","3/6/12 > 3/8/12 6/1/12 > 6/4/12 8/3/12 > 8/3/12 9/6/12 > 9/6/12 9/21/12 > 9/28/12 10/16/12 > 10/16/12 11/8/12 > 11/8/12 11/29/12 > 11/29/12 ",,"81,600 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2246-2014","Class II","Oyavon, Blister Packs","No lot numbers",,"3,404 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2261-2014","Class II","Rinozan, 250cc HDPE Bottles","EXP09.2016 ",,"501 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2279-2014","Class II","Longetivity Plus, Bottles","724EXP08.2015 ",,"338 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2269-2014","Class II","Actra-SX, Vinyl Bags","11/1/13 ",,"188 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2245-2014","Class II","Gold, Blister Packs","No lot numbers",,"5,039 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2242-2014","Class II","Tiger-X, Blister Packs","No lot numbers",,"11,218 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2250-2014","Class II","Platinum A, Blister Packs","No lot numbers",,"6,250 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2270-2014","Class II","Maxium, Capsules; Prolong, Capsules ","11/1/13 > 11/15/13 ",,"62,280 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2251-2014","Class II","Platinum B, Blister Packs","No lot numbers",,"5,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2282-2014","Class II","Circulation and Energy Formula, Bottles","EXPFEB2015 ",,"336 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2249-2014","Class II","Affirm XL, Blister Packs","No lot numbers",,"4,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2253-2014","Class II","Single Mojo, small vinyl Packs","LOT08162013 EXPDEC2016 ",,"45,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2278-2014","Class II","Detoxification Plus, Bottles","724EXP08.2015 ",,"338 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2259-2014","Class II","Bitter Melon, 225cc HDPE Bottle","EXP10.2016 ",,"380 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2244-2014","Class II","Samurai Gold, Blister Packs","No lot numbers",,"3,500 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2277-2014","Class II","Kidney&Chi Plus, Bottles","724EXP08.2015 EXP12.2015 ",,"674 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2255-2014","Class II","Ginseng Power, Blister Packs","No Lot numbers",,"3,025 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2263-2014","Class II","Saw Palmetto, Glass Bottle","EXP11.2016 ",,"501 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2274-2014","Class II","Chitosan, Blister Pack","7/9/12 > 7/11/12 ",,"2,010 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2254-2014","Class II","Double Mojo, small vinyl Packs","LOT08172013 EXPDEC2016 ",,"40,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2268-2014","Class II","Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B. Capsules for C","LOTKZ1350, EXP11/2016 LOT KZ1351, EXP11/2016 LOTKZ1352, EXP11/2016 ",,"168,874 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2284-2014","Class II","Vital Balance Formula, Bottles","EXP12.2015 ",,"336 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2283-2014","Class II","Tendon & Muscle Plus, Bottles","509EXP05.2015 ",,"330 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2285-2014","Class II","Via-Max Gold, Blister packs ","No Lot numbers ",,"4,640 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2252-2014","Class II","Ninja Mojo, small vinyl Packs","LOT08152013 EXPDEC2016 ",,"50,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2280-2014","Class II","Stomach & Spleen Plus, Bottles","819EXP08.2015 ",,"338 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2260-2014","Class II","Chanca Piedra, 225cc HDPE Bottles","EXP10.2016 ",,"378 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2281-2014","Class II","Bone & Joint Plus, Bottles","819EXP08.2015 ",,"336 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2271-2014","Class II","Serrapeptase, 100cc HDPE Bottles","LOTKZ1320 EXPFEB2016 ",,"801 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2275-2014","Class II","Garcinia Cambogia Extract, Capsules","10/26/12 > 10/29/12 ",,"21,600 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2276-2014","Class II","Nano Papa","8/22/13 > 8/26/13 8/29/13 > 9/6/13 10/8/13 > 10/10/13 ",,"60,840 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2287-2014","Class II","CKLS, Capsules","No Lot numbers",,"1,000,500 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2266-2014","Class II","DMSA, 100cc HDPE bottle","LOTKZ8010 EXP10.2016 ",,"414 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2272-2014","Class II","Garcinia Series, Capsules","4/9/14 > 4/12/14 ",,"30,600 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2248-2014","Class II","Actimeta, Blister Packs","No lot numbers",,"5,104 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2247-2014","Class II","Adam, Blister Packs","No lot numbers",,"9,500 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2258-2014","Class II","Shark Formula, 250 cc HDPE Bottles","EXP10.2016 EXP11.2016 EXP12.2016 ",,"1,503 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2267-2014","Class II","Noni Supplement, Capsules","9/23/13 > 9/30/13 ",,"200,100 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2262-2014","Class II","Una De Gato, 225cc HDPE Bottle","EXP12.2016 ",,"502 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2265-2014","Class II","BTI Lean Formula, 400cc HDPE Bottle","LT7345 EX10.16 ",,"1,000 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Food",68717,"Ongoing","GM Manufacturing Inc.","Gardena","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2257-2014","Class II","Green Coffee Bean","EXP08.2016 EXP10.2016 ",,"1,110 units","GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.",7/3/2014,"07/03/2014",8/6/2014,"08/06/2014"
"Devices",68718,"Terminated","Zoll Circulation, Inc.","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Distributed in Japan.","Z-2090-2014","Class III","Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.","LifeBand Single Pack: product code 8700-03, lot 41515; Nickel-Metal hyride battery: product code 8700-0702-03: serial numbers: 03690,03695,03696,03700,03701,03702,03706,03707,03708,03709,03710, 03711,03715,03717,03718,03720,03721,03726,03727,03728,03730,03732, 03733,03734,03736,03738,03742,03743,03745,03749,03750,03758,03768, 03770,03772,03773,03778,03779,03781,03782,03783,03786,03788,03797, 03799,03805,03806,03809,03863,03866,03867,03869,03871,03874,03875, 03880,03881,03882,03883,03888,03889,03890,03893,03894,03895,03896, 03899,03901,03906,03910,03916,03926,03943,04064,04067,04100,04119, 04133,04193,04223,04233,04301,04303,04304,04337,04364,04397,04399, 04400,04405,04406,04408,04409,04410,04411,04415,04417,04418,04419, 04420,04421,04422,04423,04433,04442,04468,04470,04478,04482,04483, 04510,04511,04514,04585,04586,04587,04588,04589,04591,04593,04594, 04595,04596,04598,04599,04600,04603,04607,04608,04610,04611,04612, 04617,04619,04635,04641,04662,04674,04675,04676,04678,04679,04682, 04704,04705,04712,04718,04744,04762,04763,04773,04774,04777,04780, 04782,04785,04786,04789,04795,04828,04838.",,"161 Nickel Metal batteries, 40 LifeBand","Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.",7/16/2013,"07/16/2013",7/30/2014,"07/30/2014"
"Devices",68719,"Ongoing","Intelerad Medical Systems","Montreal",,"CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.","Z-2267-2014","Class II","IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources. ","software versions 3-8-1 to 4-9-1",,"230","In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.",7/3/2014,"07/03/2014",8/27/2014,"08/27/2014"
"Food",68720,"Ongoing","PUREFRUIT CHILE S.A","Curico",,"CL","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.","F-2230-2014","Class II","fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***'' UPC Code: 7804636770367","26 FEB 2015 through 30 APR 2015 ",,"Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).","Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.",7/1/2014,"07/01/2014",8/6/2014,"08/06/2014"
"Food",68720,"Ongoing","PUREFRUIT CHILE S.A","Curico",,"CL","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.","F-2229-2014","Class II","Market Pantry Apple Cinnamon; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***market pantry Apple Cinnamon Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***'' UPC Code: 0-85239-20508-2","BEST BY 22 FEB 2015 through BEST BY 30 MAY 2015 ",,"Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).","Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.",7/1/2014,"07/01/2014",8/6/2014,"08/06/2014"
"Food",68720,"Ongoing","PUREFRUIT CHILE S.A","Curico",,"CL","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.","F-2231-2014","Class II","fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***fruty U APPLE CINNAMON applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***'' UPC Code: 7804636770374","23 FEB 2015 through 26 APR 2015 ",,"Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).","Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.",7/1/2014,"07/01/2014",8/6/2014,"08/06/2014"
"Food",68720,"Ongoing","PUREFRUIT CHILE S.A","Curico",,"CL","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.","F-2232-2014","Class II","HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, ''***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***'' UPC Code: 075450082029","Best By: NOV 12 2014",,"Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).","Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.",7/1/2014,"07/01/2014",8/6/2014,"08/06/2014"
"Food",68720,"Ongoing","PUREFRUIT CHILE S.A","Curico",,"CL","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was manufactured and shipped from Chile and stored in Purefruit Chile warehouses located in Marlyland and California. Product was further distributed to retail stores nationwide.","F-2228-2014","Class II","Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, ''***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***'' UPC Code: 0-85239-20507-5","BEST BY 19 FEB 2015 through BEST BY 28 MAY 2015",,"Market Pantry (app+app cin) : 63,958 cases (48 pouches/case); Fruty U: 51,105 cases (40 pouches/case); Mother's Choice: 3132 cases (16 pouches/case).","Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.",7/1/2014,"07/01/2014",8/6/2014,"08/06/2014"
"Devices",68721,"Ongoing","Peters Surgical","Bobigny",,"FR","Voluntary: Firm Initiated","Letter","*** US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); *** FOREIGN: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NORTH KOREA, PAKISTAN, PERU, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, VENEZUELA, VIETNAM, YEMEN","Z-2675-2014","Class II","The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).","1) Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018 , GTIN on box label: 3661522016527 ; 2) Item reference: 73P20B , Batch number: 987180 , Expiration date: 07/2018 , GTIN on box label: 3661522016527 ; 3) Item reference: 73P20B , Batch number: 997390 , Expiration date: 08/2018 , GTIN on box label: 3661522016527 ; 4) Item reference: 73P30AA , Batch number: 932870 , Expiration date: 02/2018 , GTIN on box label: 3661522016701 ; 5) Item reference: 73P30AG , Batch number: 931880 , Expiration date: 12/2017 , GTIN on box label: 3661522029510 ; 6) Item reference: 73P30AG , Batch number: 932880 , Expiration date: 01/2018 , GTIN on box label: 3661522029510 ; 7) Item reference: 73P30AG , Batch number: 952490 , Expiration date: 03/2018 , GTIN on box label: 3661522029510 ; 8) Item reference: 73P30AG , Batch number: 954720 , Expiration date: 04/2018 , GTIN on box label: 3661522029510 ; 9) Item reference: 73P30AG , Batch number: 961280 , Expiration date: 06/2018 , GTIN on box label: 3661522029510 ; 10) Item reference: 73P30AG , Batch number: 967610 , Expiration date: 07/2018 , GTIN on box label: 3661522029510 ; 11) Item reference: 73P30AG , Batch number: 967620 , Expiration date: 10/2018 , GTIN on box label: 3661522029510 ; 12) Item reference: 73P30AG , Batch number: E04258 , Expiration date: 12/2018 , GTIN on box label: 3661522029510 ; 13) Item reference: 73P30AI , Batch number: 2415 , Expiration date: 10/2018 , GTIN on box label: 3661522016923 ; 14) Item reference: 73P30AI , Batch number: 911280 , Expiration date: 11/2017 , GTIN on box label: 3661522016923 ; 15) Item reference: 73P30AI , Batch number: 953070 , Expiration date: 03/2018 , GTIN on box label: 3661522016923 ; 16) Item reference: 73P30AI , Batch number: 997980 , Expiration date: 09/2018 , GTIN on box label: 3661522016923 ; 17) Item reference: 73P30AM , Batch number: 5006 , Expiration date: 01/2019 , GTIN on box label: 3661522024348 ; 18) Item reference: 73P30AM , Batch number: 913570 , Expiration date: 12/2017 , GTIN on box label: 366152202",,"4,976 units","A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.",6/25/2014,"06/25/2014",10/1/2014,"10/01/2014"
"Devices",68721,"Ongoing","Peters Surgical","Bobigny",,"FR","Voluntary: Firm Initiated","Letter","Worldwide Distribution- US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); and countries: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NORTH KOREA, PAKISTAN, PERU, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, VENEZUELA, VIETNAM, YEMEN","Z-2676-2014","Class II","The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).","1) Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018 , GTIN on box label: 3661522016527 ; 2) Item reference: 73P20B , Batch number: 987180 , Expiration date: 07/2018 , GTIN on box label: 3661522016527 ; 3) Item reference: 73P20B , Batch number: 997390 , Expiration date: 08/2018 , GTIN on box label: 3661522016527 ; 4) Item reference: 73P30AA , Batch number: 932870 , Expiration date: 02/2018 , GTIN on box label: 3661522016701 ; 5) Item reference: 73P30AG , Batch number: 931880 , Expiration date: 12/2017 , GTIN on box label: 3661522029510 ; 6) Item reference: 73P30AG , Batch number: 932880 , Expiration date: 01/2018 , GTIN on box label: 3661522029510 ; 7) Item reference: 73P30AG , Batch number: 952490 , Expiration date: 03/2018 , GTIN on box label: 3661522029510 ; 8) Item reference: 73P30AG , Batch number: 954720 , Expiration date: 04/2018 , GTIN on box label: 3661522029510 ; 9) Item reference: 73P30AG , Batch number: 961280 , Expiration date: 06/2018 , GTIN on box label: 3661522029510 ; 10) Item reference: 73P30AG , Batch number: 967610 , Expiration date: 07/2018 , GTIN on box label: 3661522029510 ; 11) Item reference: 73P30AG , Batch number: 967620 , Expiration date: 10/2018 , GTIN on box label: 3661522029510 ; 12) Item reference: 73P30AG , Batch number: E04258 , Expiration date: 12/2018 , GTIN on box label: 3661522029510 ; 13) Item reference: 73P30AI , Batch number: 2415 , Expiration date: 10/2018 , GTIN on box label: 3661522016923 ; 14) Item reference: 73P30AI , Batch number: 911280 , Expiration date: 11/2017 , GTIN on box label: 3661522016923 ; 15) Item reference: 73P30AI , Batch number: 953070 , Expiration date: 03/2018 , GTIN on box label: 3661522016923 ; 16) Item reference: 73P30AI , Batch number: 997980 , Expiration date: 09/2018 , GTIN on box label: 3661522016923 ; 17) Item reference: 73P30AM , Batch number: 5006 , Expiration date: 01/2019 , GTIN on box label: 3661522024348 ; 18) Item reference: 73P30AM , Batch number: 913570 , Expiration date: 12/2017 , GTIN on box label: 366152202",,"22,190 units","A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.",6/25/2014,"06/25/2014",10/1/2014,"10/01/2014"
"Drugs",68722,"Ongoing","Novel Laboratories, Inc.","Somerset","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1484-2014","Class III","Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.","Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.",".","25,776 containers","Failed Impurity/Degradation Specification; 12-month stability time point",6/20/2014,"06/20/2014",9/3/2014,"09/03/2014"
"Devices",68723,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.","Z-0182-2015","Class II","Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.","Allura Xper Software version R8.2.0 ",".","2 units","Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.",7/8/2014,"07/08/2014",11/19/2014,"11/19/2014"
"Devices",68723,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.","Z-0181-2015","Class II","Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.","Allura Xper Software version: R8.2.0",".","22 systems","Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.",7/8/2014,"07/08/2014",11/19/2014,"11/19/2014"
"Food",68724,"Ongoing","mom Brands","Lakeville","MN","US","Voluntary: Firm Initiated","Letter","To foodservice distributors in CA, GA, ID, NC, PA","F-2227-2014","Class III","Malt-O-Meal Frosted Flakes, item number 00955, UPC 42400-00955. Net Wt. 2.00oz (56g)","Lot Code on Bowl: FEB1215M2P",,"595 cases (48 units / case)","Malt-O-Meal Sugar Frosted Flakes Bowls for foodservice may contain Honey and Oat Blenders and are therefore mislabeled.",6/20/2014,"06/20/2014",8/6/2014,"08/06/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2727-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc. Catalog Code: 90-9525; Lot Number: 030214; 2) Instrumed Item No.: 250-08930; Symmetry Surgical Inc. Catalog Code: 90-9522; Lot Number: 070511; 3) Instrumed Item No.: 250-08990; Symmetry Surgical Inc. Catalog Code: 90-9526; Lot Number: 031511; 4) Instrumed Item No.: 250-09010; Symmetry Surgical Inc. Catalog Code: 90-9523; Lot Number: 080112",".","895 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2730-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112",".","2 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2728-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411; 2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411 ",".","71 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2724-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111; 2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111; 5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212; 6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110; 7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410; 8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312; 9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312; 10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211; 11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410; 12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213; 13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310; 14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410; 15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210; 16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110; 17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312; 18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111; 19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310; 20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number:",".","3,093 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2729-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512; 2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211; 3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113; 4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412; 5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413",".","15 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2722-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412; ",".","2 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2726-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413",".","122 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2723-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411, 100110, 110210; 2) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 030111; 3) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111; 4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code: 35-8020; Lot Number: 020411, 070111, 100412, 110412; 5) Instrumed Item No.: 250-08770; Boss Instruments Catalog Code: 35-8020L; Lot Number: 020112, 110211, 120310; 6) Instrumed Item No.: 250-08800; Boss Instruments Catalog Code: 35-8025; Lot Number: 060110, 100112; 7) Instrumed Item No.: 250-08820; Boss Instruments Catalog Code: 35-8026 ; Lot Number: 032811; 8) Instrumed Item No.: 250-08860; Boss Instruments Catalog Code: 35-8030; Lot Number: 050413, 070412, 110510, 090110; 9) Instrumed Item No.: 250-08880; Boss Instruments Catalog Code: 35-8030L; Lot Number: 090110; 10) Instrumed Item No.: 250-08890; Boss Instruments Catalog Code: 35-8035; Lot Number: 100213; 11) Instrumed Item No.: 250-08930; Boss Instruments Catalog Code: 35-8040; Lot Number: 010211, 020213, 020811, 021711, 040212, 040311, 080212, 100310, 110113, 120413; 12) Instrumed Item No.: 250-08960; Boss Instruments Catalog Code: 35-8040L; Lot Number: 030413, 040412, 040513, 120113; 13) Instrumed Item No.: 250-08990; Boss Instruments Catalog Code: 35-8042; Lot Number: 050312; 14) Instrumed Item No.: 250-09000; Boss Instruments Catalog Code: 35-8042L; Lot Number: 100406; 15) Instrumed Item No.: 250-09010; Boss Instruments Catalog Code: 35-8045; Lot Number: 010311, 020311, 090312, 100212, 120112, 120213",".","156 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.","Z-2725-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745",".","83 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Devices",68725,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide in the states of: (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY)","Z-2721-2014","Class II","Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.","1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411; 4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310; 5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211",".","65 instruments","Additional caution statements have been added to the Instruction For Use for monopolar electrodes. The additional caution statements are as follows: 1) "To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes." and 2) "For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years."",5/30/2014,"05/30/2014",10/7/2014,"10/07/2014"
"Food",68726,"Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NY, NJ","F-2239-2014","Class I","Whole Foods Mesclun Goat Cheese Salad Mini Net Wt 4 0z plastic shell","Sell By 7/11/14",,"592 units","Product labels switched and undeclared allergens not declared in ingredient statement. Caesar salad contains undeclared tree nuts and Goat Cheese salad undeclared fish ",7/8/2014,"07/08/2014",8/6/2014,"08/06/2014"
"Food",68726,"Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NY, NJ","F-2238-2014","Class II","Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell","Sell By 7/11/14",,"592 units","Product labels switched and undeclared allergens not declared in ingredient statement. Caesar salad contains undeclared tree nuts and Goat Cheese salad undeclared fish ",7/8/2014,"07/08/2014",8/6/2014,"08/06/2014"
"Devices",68727,"Ongoing","Carestream Health, Inc.","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.","Z-2177-2014","Class II","Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.","The device can be tracked according to service code. The service code for the DR 7500 system is 8087. ",".","589 systems","An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened. ",7/9/2014,"07/09/2014",8/20/2014,"08/20/2014"
"Drugs",68728,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Singapore, and Hong Kong","D-1591-2014","Class I","0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.","Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14",,"a) 217,536 bags; b) 161,760 bags","Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Drugs",68728,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Singapore, and Hong Kong","D-1592-2014","Class I","0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.","Lot #: P308650, Exp 10/14",,"390,560 bags","Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Drugs",68728,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, Singapore, and Hong Kong","D-1593-2014","Class I","Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.","Lot #: P309476, Exp 10/14",,"171,672 bags","Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Drugs",68729,"Ongoing","X-Gen Pharmaceuticals Inc.","Horseheads","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1444-2014","Class III","Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.","Lot: PLNB1412, Exp 12/15",,"8,356 vials","Labeling: Label Error On Declared Strength: The side label description incorrectly states ''Each mL contains 500 mcg Clonidine Hydrochloride'' instead of stating ''Each mL contains 100 mcg Clonidine Hydrochloride''.",7/17/2014,"07/17/2014",7/30/2014,"07/30/2014"
"Devices",68730,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Telephone","US and Foreign","Z-2542-2014","Class II","BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.","A) REF #362753, 8 mL,16 x 125 mm, Lot #'s 4063409, 4063413 and 4063414 with expiry 03/15, Lot #'s 4090214, 4090215 and 4090216 with expiry 04/15; B) REF #362760, 4 mL, 13 x 100 mm, Lot #4063412 with expiry 03/15; C) REF #362761, 8 mL, 16 x 125 mm, Lot #'s 4063410, 4063411, 4063415, 4063416, 4063417, 4063418 and 4063419 with expiry 03/15; Lot #'s 4090230, 4090232, 4090234 and 4090237 with expiry 04/15. Outside US D) REF #362780, 8 mL, 16 x 125 mm, Lot #'s 4063420 and 4063455 with expiry 03/15; Lot #'s 4090241 and 4090242 with expiry 04/15. E) REF #362781, 4 mL, 13 x 100 mm, Lot # 4063421 with expiry 03/15 F) REF #362782, 8 mL, 16 x 125 mm, Lot #'s 4063422 and 4063423 with expiry 03/15; Lot #'s 4090244 and 4090246 with expiry 04/15",".","296,160 tubes","BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. ",7/3/2014,"07/03/2014",9/3/2014,"09/03/2014"
"Devices",68731,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines","Z-2107-2014","Class II","Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.","Catalog Number: 780-96, Lot numbers: 02L1300073 & 02A140133.",,"11,679 units","The temperature probe does not properly connect to the temperature port.",7/9/2014,"07/09/2014",7/30/2014,"07/30/2014"
"Devices",68731,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines","Z-2108-2014","Class II","Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.","Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320.",,"11,679 units","The temperature probe does not properly connect to the temperature port.",7/9/2014,"07/09/2014",7/30/2014,"07/30/2014"
"Biologics",68732,"Terminated","American National Red Cross (The)","Oakland","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0908-14","Class II","Platelets Pheresis Leukocytes Reduced","W208414804652; W208414804652; ",".","2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.",5/19/2014,"05/19/2014",9/17/2014,"09/17/2014"
"Biologics",68733,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0907-14","Class II","Red Blood Cells Leukocytes Reduced","W116314703772; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",6/16/2014,"06/16/2014",9/17/2014,"09/17/2014"
"Biologics",68734,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0917-14","Class II","Red Blood Cells Leukocytes Reduced","W035513663991; W035513662394; W035513636101; W035513621356; W035512628300; ",".","5","Blood products, collected from donors who emigrated from a malarial endemic area, were distributed.",5/21/2014,"05/21/2014",9/17/2014,"09/17/2014"
"Devices",68735,"Ongoing","Ansar Group, Inc. Dba Ansar Medical Technologies, Inc","Philadelphia","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2268-2014","Class II","blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.","ANX 3.0 unit numbers: 193 through 1203.",,"351","Ansar Group, Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system because of complaints that it occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.",7/1/2014,"07/01/2014",8/27/2014,"08/27/2014"
"Food",68736,"Terminated","Ledgendairy Cheeseworks, LLC DBA Sequatchie Cove Creamery","Sequatchie","TN","US","Voluntary: Firm Initiated","Telephone","TN","F-2226-2014","Class II","SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN 37374","Lot # 93",,"2 wheels 4 lbs each","Sample of cheese taken by FDA was found to contain generic E Coli.",7/7/2014,"07/07/2014",8/6/2014,"08/06/2014"
"Devices",68737,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.","Z-2134-2014","Class II","Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.","Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2. Software Versions: 2.0.0, 2.0.1, and 2.0.2",,"154 systems","The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to be displayed. For non-square pixels, the pixel width x is different to the pixel height y. Due to a software error in PDM 2.0, the x and y values are swapped, leading to the result that each individual pixel appears rotated by 90 degrees. This results in a distorted display of the image data. The magnitude of distortion may vary, depending on the Pixel Aspect Ratio, the ratio of width and height of a pixel. Accordingly, for some cases the data distortion will be clearly visible on the Brainlab planning or navigation system, e.g. during the review of the data or when performing the initial patient registration. However, if a non-obvious distortion would occur and not be detected during review of the data, the deviation of the information displayed in the planning or navigation software could mislead the user regarding clinical decisions. 2) It has been determined that non-square pixel data is not suitable for dose calculation with the current Brainlab iPlan RT systems. The actual delivered treatment dose might be different from the dose shown in the treatment plan.",6/27/2014,"06/27/2014",8/6/2014,"08/06/2014"
"Devices",68738,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of WI and MI.","Z-2265-2014","Class II","Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set","Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623. ",,"4","A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.",6/30/2014,"06/30/2014",8/27/2014,"08/27/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2538-2014","Class I","H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit","Lot Numbers: 2474641, 2470638, 2453454, 2448650, 2438611, 2433436, 2428205, 2412133, 2400804, 2347041, 2343292, 2326893, 2298737, 2271338, 2260550, 2211923, 2188448, 2175049, 2135974, 2099500, 2068120, 2042404, 11872, 11861 ",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2541-2014","Class I","H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit","Lot Numbers: 2602399, 2588625, 2580799, 2576366, 2523679, 2513119, 2492246, 2481855, 2474647, 2465829, 2457754, 2443379, 2438616, 2433451, 2428215, 2412146, 2394061, 2380352, 2376566, 2365454, 2361579, 2357822, 2347642, 2343312, 2343311, 2329584, 2322827, 2309473, 2298755, 2298754, 2286596, 2271359, 2250054, 2244752, 2244751, 2228364, 2211930, 2208196, 2191931, 2188460, 2179231, 2175057, 2154535, 2152054, 2146301, 2142179, 2135984, 2128636, 2120121, 2116100, 2109019, 2090224, 2077180, 2068123, 2063991, 2063990, 11889, 11870, 11859, 11697, 11695, 11694, 11657, 11654, 11406",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2537-2014","Class I","H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit","Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179, 2191911, 2188447, 2179221, 2175047, 2154527, 2152029, 2142174, 2128628, 2119944, 2109010, 2099495, 2090213, 2068117, 2063968, 2063967, 2042403, 12049, 12047, 12044, 11669, 11403",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2540-2014","Class I","H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit","Lot Numbers: 2597332, 2585074, 2580798, 2576365, 2564404, 2564403, 2563088, 2549367, 2519413, 2500170, 2488207, 2474646, 2465828, 2453473, 2443378, 2438615, 2433450, 2412145, 2380351, 2376498, 2365494, 2365493, 2361580, 2357823, 2353347, 2343313, 2329583, 2326899, 2322825, 2298752, 2286594, 2278069, 2271358, 2263553, 2260562, 2260561, 2250053, 2250052, 2250050, 2250049, 2244749, 2228363, 2219213, 2211929, 2208194, 2191930, 2179229, 2175056, 2154534, 2142178, 2135983, 2128635, 2124241, 2120119, 2116099, 2090223, 2077179, 2063989, 2063988, 12040, 12033, 11877, 11876, 11874, 11873, 11679, 11655, 11407, 11405 ",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2536-2014","Class I","4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit","Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050 ",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68739,"Ongoing","Smiths Medical ASD, Inc.","Keene","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.","Z-2539-2014","Class I","H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit","Lot Numbers: 2481849, 2474643, 2470640, 2470639, 2465819, 2462292, 2462291, 2457748, 2453455, 2448671, 2443372, 2438612, 2428206, 2420088, 2412135, 2394046, 2394045, 2394044, 2385648, 2380341, 2376618, 2376489, 2365439, 2361588, 2343298, 2329576, 2326894, 2322814, 2317088, 2309465, 2309464, 2298739, 2298738, 2286586, 2278062, 2271339, 2188449, 2179222, 2164289, 2146292, 2142175, 2137959, 2128629, 2119945, 2109011, 2099501, 2090215, 2068121, 2063971, 2063970, 2042408, 12046, 11871, 11862, 11858, 11696, 11693, 11656, 11653 ",".","135,518 (110,246 nationwide)","The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Devices",68741,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.","Z-2146-2014","Class II","ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. ","ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR); 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR); 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR); 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED; 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC; 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4; 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4; 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 13) 49973B ET DATA PREP / REVIEW SYSTEM; 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY; 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED; 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT",".","15 systems","When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green ''OK'' icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.",6/24/2014,"06/24/2014",8/13/2014,"08/13/2014"
"Devices",68742,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Algeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mexico.","Z-2072-2014","Class II","Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L","Catog No. 110-4B, Lot No.: 305000222640, 305000223280, 305000223866, 305000223867, 305000224353, 305000225045, 305000225632, 305000225633, 305000226127, 305000226836, 305000226844, 305000227128, 305000228521, 305000228522, 305000228971, 305000229328, 305000229329, 305000229825, 305000229826, 305000230302, 305000230303, 305000230780, 305000230781, 305000231461, 305000231462, 305000232098, 305000232099, 305000232604, 305000232605, 305000233240, 305000233241, 305000233242, 305000233243, 305000233607, 305000233608, 305000234304, 305000235022, 305000236104, 305000236105, 305000236653, 305000236655, 305000237232, 305000238263, 305000238818, 305000238819, 305000242236, 305000243881, 305000243883, 305000243889, 305000244481, 305000244934, 305000245408, 305000245835, 305000246460, 305000247007, 305000247717, 305000248479, 305000249072, 305000249743, 305000250456, 305000251055, 305000251453, 305000252058, 305000252646, 305000254589, 305000255038, 305000257280, 305000257281, 305000258048, 305000258379, 305000258921, 305000258922, 305000259431, 305000259432, 305000259960, 305000259966, 305000260514, 305000261326, 305000261737, 305000262327, 305000262328, 305000262977, 305000263504, 305000263505, 305000264073, 305000264074, 305000264624, 305000265527, 305000265530, 305000266134, 305000266135, 305000266784, 305000267193, 305000267194, 305000267421, 305000268293, 305000268294, 305000268915, 305000269220, 305000269221, 305000270081, 305000271715, 305000271716, 305000272273, 305000272274, 305000272852, 305000273463, 305000273466, 305000274200, 305000274201, 305000274817, 305000275390, 305000275892, 305000276522, 305000277102, 30500R201407, 30500R201421, 30500R202108, 30500X226540, 30500X227059, 30500X227564, 30500X229560, 30500X230565, 30500X231786, 30500X234183, 30500X237761, 30500X238273, 30500X239497, 30500X241368, 30500X246951, 30500X248284, 30500X256614, 30500X259557, 30500X260159, 30500X272367, 30500X274204, 30500Y237087, 3050RX227127, 3050RX241516, 3050RX242793, 3050RX244513, 3050RX253785, 3050RX256709, 3050RX261325, 30",".","28,752 units","Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment. ",7/9/2014,"07/09/2014",7/23/2014,"07/23/2014"
"Biologics",68743,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Nevada; Utah","B-0910-14","Class II","Red Blood Cells","W1165131217591; ",".","1","Blood products, possibly air contaminated but not labeled with a 24-hour expiration date, were distributed. ",3/20/2014,"03/20/2014",9/17/2014,"09/17/2014"
"Biologics",68743,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Nevada; Utah","B-0911-14","Class II","Red Blood Cells Leukocytes Reduced","W1165131217583; W116513504795C; ",".","2","Blood products, possibly air contaminated but not labeled with a 24-hour expiration date, were distributed. ",3/20/2014,"03/20/2014",9/17/2014,"09/17/2014"
"Devices",68744,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MI, GA, OH, IL, MO, and IN.","Z-2124-2014","Class II","DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.","Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363",,"128 units","The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.",6/4/2014,"06/04/2014",8/6/2014,"08/06/2014"
"Devices",68744,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MI, GA, OH, IL, MO, and IN.","Z-2125-2014","Class II","DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala","Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541",,"230 units","The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.",6/4/2014,"06/04/2014",8/6/2014,"08/06/2014"
"Devices",68745,"Ongoing","Market-Tiers Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2145-2014","Class III","Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.","Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048, 6283800-049, 6283800-050, 6929500-002, 6929500-003, 6929500-004, 6929500-005, 6929500-006, 6929500-007, 6929500-008, 6929500-010, 7010201-002, 7010201-003, 7010201-005, 7010201-006, 7010201-007, 7010201-008, 7010201-015, 7010201-010, 7010201-013, 7010201-014, 7010201-016, 7010201-019, 7010201-018, 7010201-020, 7010201-021, 7010201-022, 7010201-023, 7010201-024, 7686200-010, 7010201-025, 7686200-002, 7686200-003, 7686200-006, 7686200-004, 7686200-007, 7686200-008, 7686200-024, 7686200-009, 7686200-017, 7686200-011, 7686200-012, 7686200-013, 7686200-014, 7686200-015, 7686200-016, 7686200-018, 7686200-019, 7686200-020, 7686200-023, 7686200-025, 8037400-001, 8037400-002, 8037400-006, 8037400-004, 8037400-012, 8037400-005, 8037400-007, 8037400-011, 8037400-018, 8037400-008, 8037400-010, 8037400-013, 8037400-014, 8037400-017, 8037400-003, and 8374200-008",".","100 units","Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. ",7/16/2014,"07/16/2014",8/13/2014,"08/13/2014"
"Devices",68745,"Ongoing","Market-Tiers Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2145-2014","Class II","Instructions for Use for the blue endo moresolution Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.","Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048, 6283800-049, 6283800-050, 6929500-002, 6929500-003, 6929500-004, 6929500-005, 6929500-006, 6929500-007, 6929500-008, 6929500-010, 7010201-002, 7010201-003, 7010201-005, 7010201-006, 7010201-007, 7010201-008, 7010201-015, 7010201-010, 7010201-013, 7010201-014, 7010201-016, 7010201-019, 7010201-018, 7010201-020, 7010201-021, 7010201-022, 7010201-023, 7010201-024, 7686200-010, 7010201-025, 7686200-002, 7686200-003, 7686200-006, 7686200-004, 7686200-007, 7686200-008, 7686200-024, 7686200-009, 7686200-017, 7686200-011, 7686200-012, 7686200-013, 7686200-014, 7686200-015, 7686200-016, 7686200-018, 7686200-019, 7686200-020, 7686200-023, 7686200-025, 8037400-001, 8037400-002, 8037400-006, 8037400-004, 8037400-012, 8037400-005, 8037400-007, 8037400-011, 8037400-018, 8037400-008, 8037400-010, 8037400-013, 8037400-014, 8037400-017, 8037400-003, and 8374200-008",".","100 units","Some of the information in the Instructions for Use was omitted.",7/16/2014,"07/16/2014",12/2/2014,"12/02/2014"
"Devices",68746,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.","Z-2154-2014","Class III","RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.","Product Code: 76730, Lot number: 307505.",".","720 ","Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.",7/10/2014,"07/10/2014",8/13/2014,"08/13/2014"
"Devices",68747,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY","Z-2232-2014","Class II","VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.","Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11/2013; 1001789540, Exp. date 10/29/2013; 1001932680, Exp. date 12/12/2013",".","2160 units","Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.",4/17/2013,"04/17/2013",8/20/2014,"08/20/2014"
"Food",68748,"Ongoing","Blue Venture Inc.","East Windsor","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-2307-2014","Class II","Ocean Garden Wild Co-treated Steak IVP 10LB 10 oz. UPC 076550080922 ","Lot number 33241",".","300 cases","NYSDAM analysis has revealed the presence of histamines above the allowable level in Yellowfin Tuna Steaks.",7/10/2014,"07/10/2014",8/20/2014,"08/20/2014"
"Devices",68749,"Ongoing","BioMerieux SA","Marcy L'Etoile",,"FR","Voluntary: Firm Initiated","Letter","FL, LA, MI, MS, NV, OH, OK, TN, TX","Z-2152-2014","Class II","VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.","Lot 1001904130",".","1902","Product is not approved or authorized for distribution in the US.",10/14/2013,"10/14/2013",8/13/2014,"08/13/2014"
"Drugs",68751,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1433-201","Class II","Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.","Lot #: 39474DK, Expiry: 03/01/2016.",".","47,400 vials","Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.",6/27/2014,"06/27/2014",7/23/2014,"07/23/2014"
"Devices",68752,"Ongoing"," AGFA Healthcare Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada","Z-2175-2014","Class II","DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.","Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105",".","17 units","Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.",7/2/2014,"07/02/2014",8/20/2014,"08/20/2014"
"Devices",68753,"Ongoing","Pentax Medical Company","Montvale","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.","Z-2290-2014","Class II","PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve","Model No. OF-B130 OF-B194 ",,"98 units US; 1108 units OUS","The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.",7/17/2014,"07/17/2014",8/27/2014,"08/27/2014"
"Devices",68754,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.","Z-2570-2014","Class II","CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.","Lot 153914",".","1,400 units","Unsealed pouches. ",7/3/2014,"07/03/2014",9/17/2014,"09/17/2014"
"Food",68755,"Ongoing","Jody's Inc.","Virginia Beach","VA","US","Voluntary: Firm Initiated","Letter","CA, KY, LA, MN, MS, NC, NJ, NY, OH, OK, PA, TX, VA","F-2331-2014","Class III","Jody's, Breast Cancer Awareness Kettle Corn; Net Wt 3oz in clear cellophane bag.","3/15/14, 6/12/14",,"144 bags","Undeclared color Red #3 .",6/13/2014,"06/13/2014",8/27/2014,"08/27/2014"
"Food",68755,"Ongoing","Jody's Inc.","Virginia Beach","VA","US","Voluntary: Firm Initiated","Letter","CA, KY, LA, MN, MS, NC, NJ, NY, OH, OK, PA, TX, VA","F-2330-2014","Class III","Jody's, Freedom Funfetti; Net Wt 7.5 oz (213 g) in clear cellophane bag.","8/13/14, 10/9/14, 11/1/14, 11/12/14, and 11/22/14. ",,"636 bags","Undeclared colors Blue #1, Blue #2 and Red #40.",6/13/2014,"06/13/2014",8/27/2014,"08/27/2014"
"Food",68755,"Ongoing","Jody's Inc.","Virginia Beach","VA","US","Voluntary: Firm Initiated","Letter","CA, KY, LA, MN, MS, NC, NJ, NY, OH, OK, PA, TX, VA","F-2329-2014","Class II","Jody's, Funfetti, Net Wt 7.5 oz (213 g) and 4 oz in clear cellophane bag.","7.5 oz bags: 9/24/14, 9/28/14, 10/1/14, 10/9/14, 10/14/14, 10/18/14, 10/24/14, 11/1/14, 11/10/14, 11/22/14, 11/30/14, 12/7/14. 4 oz bags: 9/7/14.",,"4587 bags","Undeclared colors Blue #1, Red #3 and Yellow #5.",6/13/2014,"06/13/2014",8/27/2014,"08/27/2014"
"Devices",68756,"Ongoing","Philips Ultrasound, Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, IA, KY, MD, NJ, NY, PA, UT, WA and WI.","Z-2109-2014","Class II","QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.","795041 All serial numbers.",,"84","Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams.",7/9/2014,"07/09/2014",7/30/2014,"07/30/2014"
"Devices",68756,"Ongoing","Philips Ultrasound, Inc.","Bothell","WA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, IA, KY, MD, NJ, NY, PA, UT, WA and WI.","Z-2110-2014","Class II","QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.","795041 All serial numbers.",,"84","Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams.",7/9/2014,"07/09/2014",7/30/2014,"07/30/2014"
"Devices",68757,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.","Z-2119-2014","Class II","Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.","Product Code: 004434400, Lot number: 02A1402138",,"120 units","Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.",7/9/2014,"07/09/2014",8/6/2014,"08/06/2014"
"Devices",68758,"Ongoing","Hitachi Medical Systems America Inc","Twinsburg","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.","Z-2564-2014","Class II","Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. ","Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information. ",,"39 systems","The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.",8/18/2014,"08/18/2014",9/10/2014,"09/10/2014"
"Biologics",68759,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0929-14","Class III","Red Blood Cells Leukocytes Reduced","W3985140023394; W398514001687H",,"2 units","Blood products, collected from a donor for whom there was no record of an arm inspection, were distributed.",5/24/2014,"05/24/2014",10/1/2014,"10/01/2014"
"Biologics",68759,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0930-14","Class III","Platelets Pooled Leukocytes Reduced","W398614000504B",,"1 unit","Blood products, collected from a donor for whom there was no record of an arm inspection, were distributed.",5/24/2014,"05/24/2014",10/1/2014,"10/01/2014"
"Biologics",68760,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0933-14","Class II","Fresh Frozen Plasma","W398514003462J",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/27/2014,"05/27/2014",10/1/2014,"10/01/2014"
"Biologics",68760,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0931-14","Class II","Red Blood Cells Leukocytes Reduced","W398514003462J",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/27/2014,"05/27/2014",10/1/2014,"10/01/2014"
"Biologics",68760,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","NC","B-0932-14","Class II","Platelets Pheresis Leukocytes Reduced","W398514001266M; W3985140531318",,"2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",5/27/2014,"05/27/2014",10/1/2014,"10/01/2014"
"Food",68762,"Ongoing","Tate's Wholesale, Llc. ","East Moriches","NY","US","Voluntary: Firm Initiated","E-Mail","GIANT Carlisle Stores","F-2288-2014","Class II","Simply Enjoy Chocolate Chip Walnut Cookies, 7oz.","Use by date Nov 5 2014, UPC # 688267135132, lot#140509AR. This product was on SO#27571. DPI ref-32722125 ",".","60pcs","Recent tests show that the ''Simply Enjoy Chocolate Chip Walnut Cookies'', Use by date Nov 5 2014, contain undeclared Macademia Nuts which could run the risk of serious or life-threatening allergic reaction if consumed by an individual with an allergy or severe sensitivity.",7/11/2014,"07/11/2014",8/13/2014,"08/13/2014"
"Devices",68763,"Ongoing","Medical Positioning Inc","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.","Z-2211-2014","Class II","Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.","Serial number--803976",,"1 bed","Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Devices",68763,"Ongoing","Medical Positioning Inc","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.","Z-2208-2014","Class II","Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.","Serial number--802971, 803106, 803356, 803588, 803616, 803854, 802781, 802783, 802780, 802784, 802421, 802861, 802939, 802949, 802924, 803867, 803926, 802809 and 804118.",,"20 beds","Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Devices",68763,"Ongoing","Medical Positioning Inc","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.","Z-2210-2014","Class II","Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.","Serial number--802722, 802368, 803147, 804007, 804132, 803195, 802286, 802303, 802782, 803112, 803200, 803274, 803455, 803468, 803883, 803961 and 803960.",,"17 beds","Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Devices",68763,"Ongoing","Medical Positioning Inc","Kansas City","MO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.","Z-2209-2014","Class II","Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.","Serial number--803942",,"2 beds","Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Cosmetics",68765,"Ongoing","White & Blue Lion, Inc","City Of Industry","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in US","F-2309-2014","Class II","Ink Cups, Item No. W00099, W00100. Size: Medium, Small.","None",".","169 units","White & Blue Lion is recalling all tattoo inks, tattoo needles, and tattoo kits because of microbial contamination.",7/10/2014,"07/10/2014",8/20/2014,"08/20/2014"
"Cosmetics",68765,"Ongoing","White & Blue Lion, Inc","City Of Industry","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in US","F-2308-2014","Class II","Tattoo Ink (all colors), 5ml bottle, Batch No. 8; Tattoo Ink (10 colors), 10ml, Item No. W00231; Tattoo Ink (20 colors), 10ml, Item No. W00232; Tattoo Ink (8 colors), 10ml, Item No. W00233.","Lot OR20036",".","1,702 units","White & Blue Lion is recalling all tattoo inks, tattoo needles, and tattoo kits because of microbial contamination.",7/10/2014,"07/10/2014",8/20/2014,"08/20/2014"
"Cosmetics",68765,"Ongoing","White & Blue Lion, Inc","City Of Industry","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in US","F-2310-2014","Class II","Tattoo Kits, Item No. W00223, W00243, W00248, W00252, W00280; Sizes: T20, T17, K1A, K1E.","P1-P403",".","8,970 units","White & Blue Lion is recalling all tattoo inks, tattoo needles, and tattoo kits because of microbial contamination.",7/10/2014,"07/10/2014",8/20/2014,"08/20/2014"
"Devices",68766,"Ongoing","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.","Z-2132-2014","Class II","MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.","Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.",,"29 units (26 already re-labeled)","Laser aperture label was not affixed to device prior to shipment in the US.",6/9/2014,"06/09/2014",8/6/2014,"08/06/2014"
"Devices",68768,"Ongoing","Gyrus Medical, Inc","Osseo","MN","US","Voluntary: Firm Initiated","Letter","Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, ,MN, MS, NH, HY, OH,OR, PA, TN TX, UT, VA, WA, WI,and WV. and the country of CANADA.","Z-2269-2014","Class II","Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands. ","catalog No.: 000878-4, not lot controlled.",,"507 units","Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.",7/8/2014,"07/08/2014",8/27/2014,"08/27/2014"
"Devices",68769,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2111-2014","Class II","Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications. ","model number: 10496279",,"141","Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel Lens, Edge enhancement and Histograms. This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel depth less than or equal to 12 bit are correct. ",6/30/2014,"06/30/2014",7/30/2014,"07/30/2014"
"Biologics",68771,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","RI","B-0928-14","Class III","Platelets Pooled Leukocytes Reduced","W051714804850",".","1 unit","Blood product, collected from an ineligible donor, was distributed. ",6/30/2014,"06/30/2014",9/3/2014,"09/03/2014"
"Biologics",68772,"Terminated","Blood Bank Of Delmarva, Inc","Newark","DE","US","Voluntary: Firm Initiated","Telephone","DE","B-0927-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W036914853460; W036914208922; W036914853601; W036914853332",,"4 units","Blood products, labeled with incorrect expiration dates, were distributed.",5/13/2014,"05/13/2014",10/1/2014,"10/01/2014"
"Food",68773,"Ongoing","Manufacturing Solutions International","Portage","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: CA, CO, TX, PA, NC, FL, and TN.","F-2327-2014","Class II","Cool Tropics Rips Slush, Blue Raspberry Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE'' ","Batch 228 and 229 Best By 5-16-2015M1 and 5-19-2015M1",".","259 cases of 5-16-15M1 and 84 cases of 5-19-15M1","Manufacturing Solutions International is recalling Cool Tropics Rips Slush, Blue Raspberry Flavored drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts. The product was released prior to receiving the test results.",6/25/2014,"06/25/2014",8/20/2014,"08/20/2014"
"Food",68773,"Ongoing","Manufacturing Solutions International","Portage","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: CA, CO, TX, PA, NC, FL, and TN.","F-2328-2014","Class II","Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL),Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE","Batch 221: Best By 5-12-15M1 and Batch 184: Best By 4-15-15M1 and 4-15-15M2",".","80 cases","Manufacturing Solutions International is recalling Cool Tropics Rips Slush Cherry Limeade drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts. The product was released prior to receiving the test results.",6/25/2014,"06/25/2014",8/20/2014,"08/20/2014"
"Food",68773,"Ongoing","Manufacturing Solutions International","Portage","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: CA, CO, TX, PA, NC, FL, and TN.","F-2326-2014","Class II","Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE'' UPC Code 9 76017 00310 1","Batch 226 and 227, Manufactured 5/15/2014 and 5/16/2014. Best by dates 5-15-15M1 and 5-16-15M1.",".","502 cases of 5-15-15M1 and 5-16-15M1","Manufacturing Solutions International is recalling Cool Tropics Rips Slush, Sour Apple Flavored drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts. The product was released prior to receiving the test results.",6/25/2014,"06/25/2014",8/20/2014,"08/20/2014"
"Devices",68774,"Ongoing","Advandx Inc","Woburn","MA","US","Voluntary: Firm Initiated","E-Mail","Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.","Z-2138-2014","Class II","AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)","Lot Number: 04914 Exp. Date: 2015-06",".","10 kits","Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC",7/4/2014,"07/04/2014",8/13/2014,"08/13/2014"
"Drugs",68776,"Ongoing","Jubilant Cadista Pharmaceuticals Inc.","Salisbury","MD","US","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1500-2014","Class II","Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90","Lot #14P0292, Exp 04/2016",,"9,358 bottles","Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.",7/11/2014,"07/11/2014",8/6/2014,"08/06/2014"
"Devices",68777,"Ongoing","Richard Wolf Medical Instruments Corp.","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.","Z-0037-2015","Class II","The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.","Product Code: 4986.09; Lot: 51000232",,"73 cartons (1,460 clips)","Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.",7/9/2014,"07/09/2014",10/15/2014,"10/15/2014"
"Cosmetics",68778,"Ongoing","Vogue International","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, AZ, ,CA, CT, GA, ID, IL, KS, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, OR, PA, RI, TX, VA, WA, WI and Hawaii","F-2411-2014","Class II","OGX 50% More Free Thick and full Biotin and Collagen Conditioner 19.5 fl.oz/577ml and 13 fl oz/385 ml e Dist by Vogue International, Clearwater, FL (Purple Bottle) ","19.5 fl oz:UPC: 022796918499; Batch #'s: F1422800 and F1422801. 13 fl oz: UPC: 022796916716 ; Batch #'s: F1420702, F1420703, F1420704. F1420705 and F1420707.",,"228,966 bottles","Due to the presence of Burkholderia cepacia. ",5/30/2014,"05/30/2014",9/10/2014,"09/10/2014"
"Drugs",68779,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1590-2014","Class I","Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01","Lot #142544, Exp 02/2016 ",,"59,200 tablets","Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.",7/1/2014,"07/01/2014",9/24/2014,"09/24/2014"
"Drugs",68779,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1589-2014","Class I","Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01","Lot #142588, Exp 01/2016",,"137,300 tablets","Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544",7/1/2014,"07/01/2014",9/24/2014,"09/24/2014"
"Devices",68780,"Ongoing","Owens & Minor Distribution, Inc.","Mechanicsville","VA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.","Z-0416-2015","Class II","MediChoice Dual-Release Folding Walker with 5'' wheel","Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236; ",".","1214 cases; 4 units/case","Product wheels may be too loose, too tight, or fall off.",6/25/2014,"06/25/2014",11/26/2014,"11/26/2014"
"Devices",68781,"Ongoing","Innovasis, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.","Z-2067-2014","Class II","Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.","E2S47525 Lot 1301 and E2S47535 Lot 1301",".","32","Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.",7/7/2014,"07/07/2014",7/23/2014,"07/23/2014"
"Biologics",68782,"Ongoing","Olerup SSP AB","Stockholm",,"SE","Voluntary: Firm Initiated","Letter","CA and FL","B-0836-14","Class III"," AbSorber XM-ONE Transplantation Cross Match, ABX100-03 ","Lot 14E03002",,"l Lot","AbSorber XM-ONE Transplantation Cross Match (ABX100-03), containing a certain lot of BD Vacutainer Cell Preparation Tubes (CPT) which has the potential for poor separation resulting in a reduced number of recovered mononuclear cells, was distributed. ",7/7/2014,"07/07/2014",9/24/2014,"09/24/2014"
"Drugs",68783,"Ongoing","Mylan Pharmaceuticals Inc.","Morgantown","WV","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0009-2015","Class II","Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.","Lot 3023805 Exp. 11/15",,"15,966 bottles","Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol",7/3/2014,"07/03/2014",10/15/2014,"10/15/2014"
"Biologics",68784,"Ongoing","Terumo BCT, Inc.","Lakewood","CO","US","Voluntary: Firm Initiated","E-Mail","Product was distributed nationwide; foreign (globally); and Government/VA consignees.","B-0994-14","Class III","Terumo BCT Lake wood, CO 80215, Catalog No 61000 Spectra Optima Apheresis System, Country of Origin: US. ","Catalog number 61000 (all serial numbers)",,"2241","Spectra Optia Apheresis Systems Return Line Air Detector (RLAD) Sensors, associated with component failure which may disrupt or end an ongoing apheresis procedure, were distributed. ",8/4/2014,"08/04/2014",10/1/2014,"10/01/2014"
"Devices",68785,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2292-2014","Class II","Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. ","model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers",".","192","It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. This malfunction can only occur in automatic exposure mode. Moreover using this mode the malfunction will statistically only occur approximately once every 7000 images. ",7/7/2014,"07/07/2014",9/17/2014,"09/17/2014"
"Drugs",68786,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1511-2014","Class II","Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.","Lot #: a) AGL0058B, AGL0059B, AGL0060B, AGL0061B, Exp 06/14; AGL0062B, AGL0063B, AGL0064B, Exp 07/14; AGL0083B, AGL0084B, AGL0085B, AGL0086B, AGL0087B, AGL0088B, AGL0089B, AGL0090B, Exp 08/14; AGL0120B, AGL0121B, AGL0122B, AGL0123B, Exp 11/14; AGM0001B, AGM0002B, AGM0003B, AGM0004B, Exp 12/14; AGM0021B, AGM0022B, AGM0023B, AGM0024B, Exp 01/15; AGM0031B, AGM0032B, AGM0033B, AGM0034B, Exp 02/15; AGM0053B, AGM0054B, AGM0055B, AGM0056B, Exp 03/15; AGM0075B, AGM0076B, AGM0077B, AGM0078B, Exp 04/15; AGM0091B, AGM0092B, AGM0093B, AGM0094B, Exp 05/15; AGM0118B, AGM0119B, AGM0120B, AGM0121B, Exp 07/15; AGM0138B, AGM0144B, AGM0145B, AGM0146B, Exp 08/15; AGM0164B, AGM0165B, AGM0166B, Exp 09/15; b) AGL0065A, AGL0066A, AGL0067A, AGL0068A, AGL0069A, AGL0070A, AGL0071A, AGL0072A, AGL0073A, AGL0074A, AGL0075A, AGL0076A, Exp 07/14; AGL0077A, AGL0078A, AGL0079A, AGL0080A, AGL0081A, AGL0082A, AGL0091A, Exp 08/14; AGL0106A, AGL0107A, AGL0108A, AGL0109A, AGL0110A, AGL0111A, Exp 09/14; AGL0113A, AGL0114A, AGL0115A, AGL0116A, AGL0117A, AGL0118A, AGL0119A, Exp 10/14; AGL0124A, AGL0125A, AGL0126A, AGL0127A, AGL0128A, AGL0129A, AGL0130A, AGL0131A, AGL0132A, AGL0133A, AGL0134A, Exp 11/14; AGM0005A, AGM0006A, AGM0007A, AGM0008A, AGM0009A, AGM0010A, AGM0011A, AGM0012A, AGM0013A, AGM0014A, AGM0015A, AGM0016A, Exp 12/14; AGM0017A, AGM0018A, AGM0019A, AGM0020A, AGM0025A, AGM0026A, AGM0027A, AGM0028A, AGM0029A, AGM0030A, Exp 01/15; AGM0035A, AGM0036A, AGM0037A, AGM0038A, AGM0039A, AGM0040A, AGM0041A, AGM0042A, AGM0043A, AGM0044A, AGM0045A, AGM0046A, AGM0047A, AGM0048A, Exp 02/15; AGM0049A, AGM0050A, AGM0051A, AGM0052A, AGM0057A, AGM0058A, AGM0059A, AGM0060A, AGM0061A, AGM0062A, AGM0063A, AGM0064A, AGM0065A, AGM0066A, Exp 03/15; AGM0079A, AGM0080A, AGM0081A, AGM0082A, AGM0083A, AGM0084A, Exp 04/15; AGM0087A, AGM0088A, AGM0089A, AGM0090A, AGM0095A, AGM0096A, AGM0097A, AGM0098A, AGM0099A, Exp 05/15; AGM0100A, AGM0101A, AGM0102A, AGM0103A, AGM0104A, AGM0105A, AGM0106A, AGM0107A, AGM0108A, AGM0109A, AGM0110A, AGM0111A, AGM0112A, AGM0113A, AGM0114A",".","a) 43,585 bottles; b) 296,968 bottles ","CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.",6/26/2014,"06/26/2014",8/13/2014,"08/13/2014"
"Drugs",68786,"Ongoing","Caraco Pharmaceutical Laboratories, Ltd.","Detroit","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1510-2014","Class II","Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.","Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15",".","a) 70,152 bottles; b) 43,525 bottles ","CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.",6/26/2014,"06/26/2014",8/13/2014,"08/13/2014"
"Drugs",68787,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","Rockford","IL","US","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, and Guam.","D-1435-2014","Class III","Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.","Lot #: 3045659, 3048256, Exp 07/14",".","1,184 cartons","Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.",7/3/2014,"07/03/2014",7/23/2014,"07/23/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2198-2014","Class II","Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2194-2014","Class II","Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2199-2014","Class II","Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2193-2014","Class II","Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box","Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2205-2014","Class II","Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2207-2014","Class II","X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541","Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017 ",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2197-2014","Class II","Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2206-2014","Class II","PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch ","Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2200-2014","Class II","Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2201-2014","Class II","Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2195-2014","Class II","Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2202-2014","Class II","Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2203-2014","Class II","Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2204-2014","Class II","Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2196-2014","Class II","Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.",".","401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2206-2014","Class II","PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch ","Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2196-2014","Class II","Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2198-2014","Class II","Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2195-2014","Class II","Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2201-2014","Class II","Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2193-2014","Class II","Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box","Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2202-2014","Class II","Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2199-2014","Class II","Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2207-2014","Class II","X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541","Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017 ",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2197-2014","Class II","Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2204-2014","Class II","Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2205-2014","Class II","Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2194-2014","Class II","Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2203-2014","Class II","Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68788,"Ongoing","Gambro Renal Products, Incorporated","Lakewood","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2200-2014","Class II","Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box","Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015",,"401,451","Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.",7/18/2014,"07/18/2014",8/27/2014,"08/27/2014"
"Devices",68789,"Ongoing","Baxter Healthcare Corporation","Westlake Village","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of United Kingdom, Germany, Sweden, Spain, Israel and Denmark.","Z-2126-2014","Class II","FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.","Lot Number SPSGT14-02B0027a SPSGT14-04D0005 SPSGT14-04D0023 SPSGT13-10J0016 SPSGT13-11K0041 SPSGT13-12L0008 SPSGT14-01A0009 SPSGT14-02B0026 SPSGT14-04D0015 SPSGT14-04D0026 SPSGT13-10J0017 SPSGT13-11K0039 SPSGT13-11K0042 SPSGT13-12L0015 SPSGT14-01A0028 SPSGT14-02B0028 SPSGT14-02B0033 SPSGT14-04D0014 SPSGT14-04D0027 SPSGT14-05E0005 SPSGT13-10J0018 SPSGT13-11K0040 SPSGT13-12L0007 SPSGT13-12L0012 SPSGT14-01A0027 Part No. 5151-01200-010 5151-01200-010 5151-01200-010 5151-01200-011 5151-01200-011 5151-01200-011 5151-01200-011 5151-01250-010 5151-01250-010 5151-01250-010 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 ",,"1,315 units","Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.",7/11/2014,"07/11/2014",8/6/2014,"08/06/2014"
"Devices",68790,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-2140-2014","Class II","VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).","Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers, for VITROS 4600 systems the J Numbers start with 4600XXXX)",".","Domestic: 81, Foreign: 238","Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.",7/7/2014,"07/07/2014",8/13/2014,"08/13/2014"
"Devices",68790,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-2139-2014","Class II","VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).","Serial Numbers J36000101 - J36000806 (J Numbers are analogous to Serial Numbers and for VITROS 3600 systems the J Numbers start with 3600XXXX)",".","Domestic: 142, Foreign: 536","Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.",7/7/2014,"07/07/2014",8/13/2014,"08/13/2014"
"Devices",68790,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-2141-2014","Class II","VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).","Serial Numbers J56000110 - J56001954 (J Numbers are analogous to Serial Numbers, for VITROS 5600 systems the J Numbers start with 5600XXXX)",".","Domestic: 838, Foreign: 949","Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.",7/7/2014,"07/07/2014",8/13/2014,"08/13/2014"
"Devices",68792,"Ongoing","Smith & Nephew, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL","Z-2258-2014","Class II","TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, LEFT, REF 71676575, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, RIGHT, REF 71676576, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, LEFT, REF 71676577, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, RIGHT, REF 71676578, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, LEFT, REF 71676579, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, RIGHT, REF 71676580, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, LEFT, REF 71676581, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, RIGHT, REF 71676582, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, LEFT, REF 71676583, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, RIGHT, REF 71676584, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 44 CM NAIL, 130o, LEFT, REF 71676585, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, LEFT, REF 71676597, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, RIGHT, REF 71676598, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 38 CM NAIL, 125o, RIGHT, REF 71676602, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 40 CM NAIL, 125o, LEFT, REF 71676603, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 42 CM NAIL, 125o, RIGHT, REF 71676606, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 44 CM NAIL, 125o, RIGHT, REF 71676608, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 32 CM NAIL, 130o, RIGHT, REF 71676618, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 130o, RIGHT, REF 71676620, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM)","TRIGEN INTERTAN 10MM X 18 CM NAIL, 125o, REF 71675201, Lot Numbers: 14CM05726, 14DM08712, 14CM12004, 14DM08713, 14CM12005, 14DM08714, 14CM12006, 14DM08715, 14CM12008, 14DM09828, 14CM12009, 14DM09829, 14CM15434, 14DM09830, 14CM15435, 14DM11951, 14CM15438, 14DM11952, 14CM15488, 14DM16264, 14CM15490, 14DM19617, 71675201 14CM17964, 14CM17965, 14CM17966, 14CM17966, 14DM01455, 14DM01456, 14DM04231, 14DM04232, 14DM04233, 14DM04234, 14DM04235, 14DM05411, 14DM05412, 71675201 14DM05413, 14DM05414, 14DM08711 TRIGEN INTERTAN 11.5MM X 18 CM NAIL, 125o, REF 71675202, Lot Numbers: 14CM15413, 14CM15415, 14CM15416, 14CM15417, 14CM15418, 14DM06190, 14DM06191, 14DM06192, 14DM06193, 14DM09835, 14DM09837 TRIGEN INTERTAN 13MM X 18 CM NAIL, 125o, REF 71675203, Lot Numbers: 14CM15443, 14CM01161, 14CM03675, 14CM05731, 14CM05732 TRIGEN INTERTAN 10MM X 20 CM NAIL, 125o, REF 71675204, Lot Numbers: 14CM15480 TRIGEN INTERTAN 11.5MM X 20 CM NAIL, 125o, REF 71675205, Lot Numbers: 14CM16786 TRIGEN INTERTAN 13MM X 20 CM NAIL, 125o, REF 71675206, Lot Numbers: 14CM03676, 14CM15471, 14CM16787 TRIGEN INTERTAN 10MM X 18 CM NAIL, 130o, REF 71675207, Lot Numbers: 14DM06197, 14DM08716, 14DM13210, 14DM13212 TRIGEN INTERTAN 11.5MM X 18 CM NAIL, 130o, REF 71675208, Lot Numbers: 14DM01460, 14DM01461, 14DM01462, 14DM01463, 14DM01464 TRIGEN INTERTAN 13MM X 18 CM NAIL, 130o, REF 71675209, Lot Numbers: 14CM15467, 14CM16788, 14CM16789, 14DM11044 TRIGEN INTERTAN 10MM X 20 CM NAIL, 130o, REF 71675210, Lot Numbers: 14CM15466, 14CM18995, 14CM18996, 14CM18997, 14CM18998, 14DM00764, 14DM00765, 14DM00766, 14DM00767 TRIGEN INTERTAN 11.5MM X 20 CM NAIL, 130o, REF 71675211, Lot Numbers: 14CM15464, 14CM18999, 14CM19000, 14CM21712, 14CM19001, 14CM21720, 14DM00769, 14DM00770 TRIGEN INTERTAN 13MM X 20 CM NAIL, 130o, REF 71675212, Lot Numbers: 14CM15463, 14CM16790 TRIGEN INTERTAN 10MM X 26 CM NAIL, 125o, LEFT, REF 71675213, Lot Numbers: 14DM14689 TRIGEN INTERTAN 10MM X 32 CM NAIL, 125o, LEFT, REF 71675219, Lot Numbers: 14DM17741 TRIGEN INTERTAN 10MM X 34 CM NAIL, 125o, LEFT,",,"601 units","There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.",7/2/2014,"07/02/2014",8/27/2014,"08/27/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1506-2014","Class II","Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90","30 count - Lot #0002096 Exp - 12/31/2016; 90 count - Lot #0002058 Exp -12/31/2016 ",,,"Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1505-2014","Class II","Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 ","Lot NVWG Exp - 11/30/2016",,"68 bottles","Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1501-2014","Class II","Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30","Lot #213655B Exp - 12/31/2014",,"5 bottles","Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1507-2014","Class II","Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30","Lot #0002073 Exp - 12/31/2016",,"86 bottles","Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1503-2014","Class II","Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30 ","Lot #0002106 Exp - 11/30/2016 ",,"108 bottles","Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1502-2014","Class II","Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 ","30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016 ",,"262 bottles","Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1508-2014","Class II","Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90 ","30 count/Lot #0002073 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016",,,"Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Drugs",68793,"Ongoing","Daiichi Sankyo Pharma Development","Edison","NJ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-1504-2014","Class II","Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30 ","Lot #211836 Exp - 11/30/2016",,,"Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping",7/12/2014,"07/12/2014",8/6/2014,"08/06/2014"
"Devices",68794,"Ongoing","Novocol, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.","Z-2128-2014","Class II","Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.","Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.",,"60","Septodont is recalling Self-Etch bond because the material was incorrectly packaged.",7/16/2014,"07/16/2014",8/6/2014,"08/06/2014"
"Devices",68794,"Ongoing","Novocol, Inc.","Louisville","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.","Z-2129-2014","Class II","Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.","Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.",,"24","Septodont is recalling Self-Etch bond because the material was incorrectly packaged.",7/16/2014,"07/16/2014",8/6/2014,"08/06/2014"
"Devices",68795,"Completed","Perouse Medical","Irigny",,"FR","Voluntary: Firm Initiated","E-Mail","US.","Z-2089-2014","Class II","Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. ","Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448. ",,"2,496 units","Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.",5/10/2012,"05/10/2012",7/30/2014,"07/30/2014"
"Biologics",68796,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Telephone","Texas","B-0866-14","Class III","Fresh Frozen Plasma","W036514012312; ",".","1 (one)","Blood product, collected from a donor who had unsuitable test results, was distributed.",4/24/2014,"04/24/2014",9/3/2014,"09/03/2014"
"Biologics",68797,"Terminated","LifeShare Blood Centers","Alexandria","LA","US","Voluntary: Firm Initiated","Letter","Louisiana","B-0861-14","Class II","Red Blood Cells Leukocytes Reduced","W036513143356; ",".","1 unit","Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed.",5/21/2014,"05/21/2014",9/3/2014,"09/03/2014"
"Devices",68798,"Terminated"," AGFA Healthcare Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Other","US in the state of WV","Z-2176-2014","Class III","Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.","Serial Number A5410000042",".","1","Unit was mislabeled with a factory label showing 32 KW output power.",5/13/2014,"05/13/2014",8/20/2014,"08/20/2014"
"Devices",68799,"Ongoing","Mckesson Medical Immaging","Richmond","BC","CA","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.","Z-2121-2014","Class II","Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. ","HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0",,"659 units","The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.",5/5/2014,"05/05/2014",8/6/2014,"08/06/2014"
"Drugs",68800,"Ongoing","Ben Venue Laboratories Inc","Bedford","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1543-2014","Class II","CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01","Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14",,"7172 vials","Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.",7/31/2014,"07/31/2014",8/27/2014,"08/27/2014"
"Devices",68801,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.","Z-2543-2014","Class II","Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.","Item Number 42509900400, Lot Number: 62313324, 62415340, 62561031, 62668655, 62313326, 62430425, 62580270, 62695918, 62341561, 62442314, 62590506, 62702686, 62358628, 62473246, 62594059, 62715932, 62368700, 62507846, 62611157, 62728374, 62376588, 62522771, 62624943, 62742362, 62396348, 62530133, 62637095, 62749057, 62401156, 62534170, 62641120, 62757397, 62407514, 62538842, 62662172, 62766074, 62410673, 62542958, & 62668654. ",".","2,248 units","Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. ",7/30/2014,"07/30/2014",9/3/2014,"09/03/2014"
"Devices",68802,"Ongoing","Nellcor Puritan Bennett Inc. (dba Covidien LP)","Boulder","CO","US","Voluntary: Firm Initiated","Letter","US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.","Z-2234-2014","Class II","Vital Sync'' VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. ","Model # 10007101; Lot # 14A0041IN",,"3","Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.",7/17/2014,"07/17/2014",8/27/2014,"08/27/2014"
"Devices",68803,"Ongoing","Beevers Manufacturing & Supply, Inc.","McMinnville","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.","Z-2181-2014","Class II","Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.","Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.",".","240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).","Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.",7/11/2014,"07/11/2014",8/20/2014,"08/20/2014"
"Food",68804,"Ongoing","Coastal KOP LLC dba King of Pops","Charleston","SC","US","Voluntary: Firm Initiated","Visit","SC","F-2240-2014","Class II","King of Pops Key Lime Pie, frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405","UPC codes: 59959 00305 and 59959 00304",,"100 3.2-oz units total for both flavors","Undeclared Allergens: Soy, Wheat ",7/14/2014,"07/14/2014",8/6/2014,"08/06/2014"
"Food",68804,"Ongoing","Coastal KOP LLC dba King of Pops","Charleston","SC","US","Voluntary: Firm Initiated","Visit","SC","F-2241-2014","Class II","King of Pops Banana Puddin', frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405","UPC codes: 59959 00305 and 59959 00304",,"100 3.2-oz units total for both flavors","Undeclared Allergens: Soy, Wheat ",7/14/2014,"07/14/2014",8/6/2014,"08/06/2014"
"Devices",68805,"Ongoing","Primus Medical LLC","Boardman","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.","Z-2596-2014","Class II","Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced Mattress, Prime Care Transcend Advanced Perimeter Mattress, Prime Plus Bariatric Mattress and Prime Plus Bariatric Perimeter Mattress, individual units packaged seperately. Model Numbers: TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. Intended to protect inner foam layers of mattress from any fluids that may be on the mattress.","Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.",".","1,557 units","The firm found that the top cover of the mattresses were delaminating.",8/11/2014,"08/11/2014",9/17/2014,"09/17/2014"
"Devices",68806,"Completed","Cardiovascular Systems, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.","Z-2155-2014","Class I","CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.","100573, 100575, 100674, 100676, 100678, 100680. ",,"48","CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.",5/23/2014,"05/23/2014",8/27/2014,"08/27/2014"
"Devices",68807,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.","Z-2156-2014","Class II","Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. ","Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255 06C0503 07G0752 08L1004 1018200094 1106700024 1202400234 1231200324 1320000094 01H0006 04G0256 06C0504 07G0753 08L1005 1018200104 1106800014 1202400244 1232000014 1320000104 01H0007 04G0257 06C0505 07G0754 08L1006 1018900014 1106800024 1203200214 1232000024 1320600014 01H0008 04G0258 06C0506 07G0755 09A1007 1018900024 1106800034 1203200224 1232000034 1320600024 01H0009 04G0263 06C0507 07G0756 09A1008 1018900034 1106800044 1203200234 1232000044 1320600034 01H0010 04G0264 06C0508 07G0757 09A1009 1018900044 1106800054 1203200244 1232000064 1320600044 01I0011 04H0259 06D0509 07G0758 09A1010 1018900054 1106800064 1203200254 1232000074 1320600054 01I0012 04H0260 06D0510 07G0759 09A1011 1018900064 1106800074 1203200274 1232000084 1320600064 01I0013 04H0261 06D0511 07G0760 09A1012 1018900074 1106800084 1203700954 1232600034 1321200214 01I0014 04H0265 06D0512 07G0761 09A1013 1018900084 1106800094 1203700964 1233400044 1321200224 01I0015 04H0266 06D0513 07H0762 09A1014 1018900094 1106800104 1203700974 1233400054 1321200234 01J0016 04H0267 06D0514 07H0763 09A1015 1018900104 1108100014 1203900024 1233400064 1321200244 01J0017 04H0268 06D0515 07H0764 09A1016 1019700014 1108100024 1204000044 1233900114 1321200254 01J0018 04H0269 06D0516 07H0765 09A1017 1019700024 1108100034 1204000054 1233900124 1321200264 01J0019 04H0270 06D0517 07H0766 09A1018 1019700034 1108100044 1204800264 1234000014 1321200274 01J0020 04I0262 06D0518 07H0767 09A1020 1019700044 1108100054 1205100514 1234000024 1321200284 01J0021 04I0271 06D0519 07H0768 09A1021 1019700054 1108100064 120510052",".","2,460 units","The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.",6/24/2014,"06/24/2014",8/13/2014,"08/13/2014"
"Food",68808,"Ongoing","Nutrition Express Corporation","Torrance","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-2318-2014","Class II","Lindberg B-Complex, 100mg, 60 capsules (UPC 092865239602), 240 capsules (UPC 092865239244),","Lot no. 4032606, 3110707",".","605 units","Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the amount of folic acid in the products was found to be higher than the label claim.",7/8/2014,"07/08/2014",8/20/2014,"08/20/2014"
"Food",68808,"Ongoing","Nutrition Express Corporation","Torrance","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-2317-2014","Class II","Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 654186946227).","Lot no. 4010707, 4030710.",".","1384 units","Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the amount of folic acid in the products was found to be higher than the label claim.",7/8/2014,"07/08/2014",8/20/2014,"08/20/2014"
"Food",68808,"Ongoing","Nutrition Express Corporation","Torrance","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-2316-2014","Class II","Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186946609). ","Lot no. 3112016, 4042313.",".","1468 units","Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the amount of folic acid in the products was found to be higher than the label claim.",7/8/2014,"07/08/2014",8/20/2014,"08/20/2014"
"Food",68808,"Ongoing","Nutrition Express Corporation","Torrance","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA","F-2315-2014","Class II","Lindberg B-Complex, 50mg, 60 capsules (UPC 092865236601), 120 capsules (UPC 092865236120), 240 capsules (UPC 092865236243). ","Lot no. 3092328, 4032606.",".","667 units","Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the amount of folic acid in the products was found to be higher than the label claim.",7/8/2014,"07/08/2014",8/20/2014,"08/20/2014"
"Food",68809,"Ongoing","Florida Bottling, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, FL, GA, IA, IN, MO, NH, NY, PA, TX, and WA","F-2488-2014","Class II","Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL Lakewood Miami, FL 33127 ","Code 226F, Best by 08OCT2015",,"5,642 cases // 16 bottles // 32 Fl Oz","Found to have levels of inorganic arsenic that exceeds FDA levels of concern limits.",7/14/2014,"07/14/2014",10/1/2014,"10/01/2014"
"Food",68810,"Ongoing","Miceli Dairy Products Co","Cleveland","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: IL, MN, OH, and WI.","F-2322-2014","Class II","Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packaged in 15 ounce plastic tubs. ","Sargento Fat Free Ricotta Natural Cheese item # SARGFF15B with EXP 14SEP14 and Dutch Farms Fat Free Ricotta Cheese item # DFFREE15B with EXP 4OCT14",".","169 cases SARS15B and 13 cases DFFREE15B","These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Food",68810,"Ongoing","Miceli Dairy Products Co","Cleveland","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: IL, MN, OH, and WI.","F-2324-2014","Class II","Sargento Whole Milk Ricotta Natural Cheese packaged in 15 ounce plastic tubs.","Sargento Light Ricotta Natural Cheese item # SARG15B with EXP 13SEP14",".","805 cases","These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Food",68810,"Ongoing","Miceli Dairy Products Co","Cleveland","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: IL, MN, OH, and WI.","F-2323-2014","Class II","Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs.","Sargento Light Ricotta Natural Cheese item # SARGLF15B with EXP 14SEP14",".","341 Cases","These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Food",68810,"Ongoing","Miceli Dairy Products Co","Cleveland","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: IL, MN, OH, and WI.","F-2325-2014","Class II","Farimont Foods Ricotta Cheese packaged in 30 pound bags.","Farimont Foods Ricotta Cheese item # 2013WM with EXP 16914.",".","90 cases.","These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Food",68810,"Ongoing","Miceli Dairy Products Co","Cleveland","OH","US","Voluntary: Firm Initiated","E-Mail","Product was distributed to the following states: IL, MN, OH, and WI.","F-2321-2014","Class II","Part Skim Ricotta cheese: SYSCO Imperial Ricotta Cheese packaged in 5 pound tubs and Sargento Part-Skim Ricotta Natural Cheese and Miceli's Part-Skim Ricotta Cheese packaged in 15 ounce tubs.","SYSCO Imperial Ricotta Cheese item # SYSCO5A with EXP 27AUG14, Sargento Part-Skim Ricotta Natural Cheese item # SARGS15B with EXP 14SEP14 and Miceli's Part-Skim Ricotta Cheese item # CS15B with EXP 14SEP14",".","357 cases of SYSCO5A, 36 cases of CS15B, and 169 cases of SARS15B","These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.",6/19/2014,"06/19/2014",8/20/2014,"08/20/2014"
"Food",68811,"Ongoing","Mars Food US","Rancho Dominguez","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2312-2014","Class II","Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334","Code: Best Before Date 06/15 MADE IN CANADA with either 422GBBFP1[L or R] or 423AABFP1[L or R]",".","1964 cases of 12 units","Some pouches were filled with a different product that contains barley, a non-wheat source of gluten, which is not declared on the product packaging.",7/16/2014,"07/16/2014",8/20/2014,"08/20/2014"
"Drugs",68812,"Ongoing","Bracco Diagnostic Inc","Monroe Township","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1536-2014","Class III","E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.","Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15 ",".","216,792 bottles","Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.",7/2/2014,"07/02/2014",8/20/2014,"08/20/2014"
"Drugs",68813,"Ongoing","Wockhardt Usa Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1513-2014","Class III","buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.","Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14",".","840 bottles","Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.",7/14/2014,"07/14/2014",8/13/2014,"08/13/2014"
"Devices",68814,"Terminated","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Visit","Distribution to Florida and South Carolina","Z-2171-2014","Class II","EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).","Model number 410298-05 and 410298-06",".","2","Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic cleaners in the pH range of 8.0-11.0 had not been validated for compatibility or efficacy with the Stapler Instrument when the changes were made. ",6/2/2014,"06/02/2014",8/20/2014,"08/20/2014"
"Drugs",68815,"Ongoing","Novartis Pharmaceuticals Corp.","Suffern","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1516-2014","Class III","Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.","Lot # PKTS, Exp 01/17",".","50 bottles","Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.",7/30/2014,"07/30/2014",8/13/2014,"08/13/2014"
"Food",68816,"Ongoing","Milk Specialties Co ","Eden Prairie","MN","US","Voluntary: Firm Initiated","Telephone","NY","F-2303-2014","Class II","MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479","Lot 403720 and 403721",".","9,149 bottles","Milk Specialties Global is recalling 2 lots of MuscleTech Amino Build Fruit Punch due to potential cross contamination with egg protein.",7/3/2014,"07/03/2014",8/13/2014,"08/13/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2298-2014","Class II","Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP ","Item Numbers: 42517000410 Lot Numbers: 62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346 ",,"70,986 distribution events","Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.",6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2300-2014","Class II","Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM ","Item Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, 42527600919 Lot Numbers: 62345370 62402721 62423922 62424796 62494665 62563912 62590524 62696878 62717331 62347233 62399612 62428432 62505575 62563917 62592279 62692687 62352330 62416376 62432157 62490790 62563913 62590525 62696881 62357329 62374803 62412999 62432797 62490792 62563911 62654931 62717334 62357328 62372411 62407772 62432794 62463961 62525489 62563914 62575756 62702758 62724743 62358632 62373739 62405896 62432154 62463962 62563916 62656074 62710626 62432790 62462267 62572574 62443455 62456923 62568289 62357865 62410790 62423921 62424804 62500930 62573363 62695299 62347240 62399870 62430403 62504858 62572571 62692683 62732165 62357866 62406970 62432150 62479624 62573364 62695293 62351310 62410788 62435708 62507548 62569955 62698727 62358633 62373740 62410789 62432796 62465722 62517280 62581856 62695873 62363685 62364505 62407568 62432152 62463963 62505999 62572570 62695889 62710608 62432792 62499171 62704629 62445747 62497257 ",,"70,986 distribution events","Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.",6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2299-2014","Class II","Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP ","Item Numbers: 42517200410 42517200510 42517200610 42517200710 Lot Numbers: 62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418 ",,"70,986 distribution events",,6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2301-2014","Class II","Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP ","Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733 ",,"70,986 distribution events",,6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2296-2014","Class II","Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP ","Item Numbers: 42517400410 42517400510 42517400610 42517400710 42517400810 42517400910 42517401010 Lot Numbers: 62043556 62110045 62121489 62125589 62147235 62168383 62177247 62165546 62311021 62314722 62386421 62442838 62525491 62558585 62605208 62627292 62683432 62696865 62717343 62022344 62041351 62073566 62104372 62117744 62121488 62149175 62187324 62187325 62247351 62311022 62314723 62364961 62391117 62436468 62474903 62538403 62564311 62611089 62669905 62690895 62720225 62020946 62028233 62073570 62110047 62130976 62187327 62187329 62189325 62290822 62305407 62314724 62386424 62420258 62469459 62531662 62565041 62551356 62584447 62612266 62687089 62690049 62690909 62702763 62724739 62022345 62024978 62104374 62124040 62134006 62200223 62200224 62233921 62294595 62314725 62385328 62436479 62511942 62544381 62565042 62597795 62669933 62696869 62710618 62043559 62104415 62121530 62203396 62203397 62314728 62314730 62356529 62390841 62442847 62511926 62565057 62551396 62595859 62654933 62656069 62720226 62034569 62055683 62113088 62130978 62149714 62165547 62168384 62177253 62184260 62256285 62256284 62397161 62420223 62511956 62565108 62551402 62601570 62696376 62043561 62055684 62116593 62152728 62145793 62166196 62166195 62168385 62184261 62239294 62319851 62320878 62356546 62390865 62474905 62538415 62565044 62581863 62622558 62632819 62740693 62398035 62440437 62515479 62515499 62563803 62581853 62675491 ",,"70,986 distribution events","Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.",6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68817,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.","Z-2297-2014","Class II","Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM ","Item Numbers: 42517000303 42517000313 42517000505 42517000515 42517000707 42517000717 42517000909 42517000919 42527000303 42527000313 42527000505 42527000515 42527000707 42527000717 42527000909 42527000919 Lot Numbers: 62022340 62024973 62062232 62104367 62187314 62187315 62190367 62190370 62265725 62301862 62314675 62385126 62385132 62355857 62403987 62414017 62420244 62456269 62506026 62506044 62531664 62558106 62564325 62596552 62600208 62614790 62683419 62691385 62698730 62716777 62024974 62032099 62075271 62144791 62171682 62171684 62184223 62187317 62239237 62256256 62248153 62386757 62391108 62414001 62391109 62414002 62456271 62474902 62544384 62565107 62565106 62601564 62612269 62627270 62678888 62684675 62695301 62710627 62745014 62019862 62091183 62177238 62177239 62177240 62268818 62282708 62305406 62314683 62351287 62356123 62385455 62401419 62405946 62419059 62429198 62456279 62504887 62531665 62559945 62565049 62595861 62621822 62627202 62663169 62690886 62696853 62698724 62716769 62710616 62030854 62050136 62125572 62154284 62165540 62168382 62177242 62190375 62247344 62247345 62256257 62364951 62391110 62413998 62391111 62427064 62413999 62469454 62525495 62538399 62565110 62565111 62565109 62595858 62630285 62632817 62680122 62680123 62691389 62696886 62710624 62717356 62022342 62024977 62087042 62091198 62165542 62189343 62187321 62233919 62239239 62256279 62247347 62386756 62391114 62391115 62403989 62419057 62429191 62461234 62525494 62544359 62564327 62587605 62601573 62601574 62668825 62696851 62717321 62744886 62747704 62030862 62029578 62125573 62165544 62189323 62189322 62189324 62201539 62239240 62256280 62247349 62372408 62386777 62391226 62403995 62420263 62456272 62506051 62544380 62565113 62565114 62595867 62663132 62668575 62691387 62689234 62717344 62338672 62338673 62338674 623386",,"70,986 distribution events","Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.",6/10/2013,"06/10/2013",8/27/2014,"08/27/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2549-2014","Class II","Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0MMX120MMLG CANN BONE SCREW 7.0X125LG CANN BONE SCREW 7.0MMX125MMLG CANN BONE SCREW 7.0X130LG CANN BONE SCREW 7.0MMX130MMLG RECON SCR LGE 5.5MMDX105MM RECON SCR LGE 5.5MMDX110MM RECON SCR LGE 5.5MMDX115MM RECON SCR LGE 5.5MMDX120MM RECON SCR LGE 5.5MMDX125MM RECON SCR LGE 5.5MMDX130MM ITST ANTI-ROT SCR 6.5MMDX105MM ITST ANTI-ROT SCR 6.5MMDX110MM PERI. SCR 3.5MM X105MML PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 140MM L PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 100MM L 3.5MM CORT SCR X 105MM SELFTAP 3.5MM CORT SCR X 110MM SELFTAP 5.5MM X 100MM CANN LKNG SCREW Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115 CANC SCREW FA Z NAIL 6.0 X 120 CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115CANC SCREW FA Z NAIL 6.0 X 120CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA 3.5X105 CORT SCR 3.5 X 105 CORT SCR SELF TAP 3.5X110","Item Numbers 00114610099, 00114610500, 00114610532, 00114610599, 00114611000, 00114611032, 00114611099, 00114611500, 00114611532, 00114611599, 00114612000, 00114612032, 00114612099, 00114612500, 00114612599, 00114613000, 00114613099, 00225210555, 00225211055, 00225211555, 00225212055, 00225212555, 00225213055, 00225710565, 00225711065, 47234712005, 47234712400, 47234712440, 47234712500, 47234712600, 47234810535, 47234811035, 47235910055, 47248310560, 47248311060, 47248311560, 47248312060, 47248312560, 47248313060, 47248313560, 47248314060, 47248410560, 47248411060, 47248411560, 47248412060, 47248412560, 47248413060, 47248413560, 47248414060, 47348310560, 47348311060, 47348311560, 47348312060, 47348312560, 47348313060, 47348313560, 47348314060, 47348410560, 47348411060, 47348411560, 47348412060, 47348412560, 47348413060, 47348413560, 47348414060, 47483510500, 47483510501, 47483511000, 47483511001, 47483511500, 47483511501, 47483512000, 47483512001, 47483512500, 47483513000, 47483513500, 47483514000, 47483514500, 47483515000, 47484510501, 47484511001, 47484512001, 47486510500, 47486510501, 47486510502, 47486511000, 47486511001, 47486511002, 47486511502, 47486512002 EXPIRATION DATE PRIOR TO 2024-07 ",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2548-2014","Class II","Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA ","Item Numbers : 00781804300, 00781805300, 00781804700, 00781805000, 00781804200, 00781805400, 00781804800, 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500 Lot Numbers: 37210958, 37210967, 37211180, 37211183, 37211311, 37211316, 37211320, 37211379, 37211482, 62561484, 37211643, 37211645, 37211646, 37211647, 37211653, 37211655, 37211657, 37211658, 37211661, 37211801, 37211804, 37211805, 37211806, 37211811, 37211812, 37211815, 37211817, 37211820, 37212062, 37212063, 37212065, 37212074, 37212079, 62573574, 62573576, 62576002, 62576008, 62593298, 62593302, 37212608, 37211644",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2551-2014","Class II","Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PR","Item Numbers:00400500038, 00400500040, 00400500041, 00400500042, 00400500043, 00400500044, 00400500045, 00400500046, 00400500047, 00400500048, 00400500049, 00400500050, 00400500051, 00400500052, 00400500053, 00400500054, 00400500055, 00400500057, 00400500060, 00400500063, 00400600038, 00400600040, 00400600041, 00400600042, 00400600043, 00400600044, 00400600045, 00400600046, 00400600047, 00400600048, 00400600049, 00400600050, 00400600051, 00401000038, 00401000040, 00401000041, 00401000042, 00401000043, 00401000044, 00401000045, 00401000046, 00401000047, 00401000048, 00401000049, 00401000050, 00401000051, 00401000052, 00401000053, 00401000054, 00401000055,, 00401000057, 00401000060, 00401000063, 00402200038, 00402200040, 00402200041, 00402200042, 00402200043, 00402200044, 00402200045, 00402200046, 00402200047, 00402200048, 00402200049, 00402200050, 00402200051, 00402200052, 00402200053, 00402200054, 00402200055, 00402200057, 00402200060, 00402200063, 00402300038, 00402300041, 00402300043, 00402300044, 00402300046, 00402300048, 00402300049, 00402300051, 30400500038, 30400500040, 30400500041, 30400500042, 30400500043, 30400500044, 30400500045, 30400500046, 30400500047, 30400500048, 30400500049, 30400500050, 30400500051, 30400500052, 30400500053, 30400500054, 30400500055, 30400500057, 30400500060, 30400500063, 30402200038, 30402200040, 30402200041, 30402200042, 30402200043, 30402200044, 30402200045, 30402200046, 30402200047, 30402200048, 30402200049, 30402200050, 30402200051, 30402200052, 30402200053, 30402200054, 30402200055, 30402200057, 30402200060, 30402200063 EXPIRATION DATE PRIOR TO 2024-07 ",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2546-2014","Class II","Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM ","Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2550-2014","Class II","Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135DX10H TUBE&SCP PLT 135DX12H TUBE&SCP PLT 135DX14H TUBE&SCP PLT 140DX8H TUBE&SCP PLT 140DX10H TUBE&SCP PLT 140DX12H TUBE&SCP PLT 140DX14H TUBE&SCP PLT 145DX8H TUBE&SCP PLT 145DX10H TUBE&SCP PLT 145DX12H TUBE&SCP PLT 145DX14H TUBE&SCP PLT 150DX6H TUBE&SCP PLT 150DX8H TUBE&SCP PLT 150DX10H TUBE&SCP PLT 150DX12H TUBE&SCP PLT 150DX14H VERSA-FX II SC TUBE PLT 90DX6H VERSA-FX II SC TUBE PLT 90DX8H VERSA-FXII SC TUBE PLT 90DX10H VERSA-FXII SC TUBE PLT 90DX12H VERSA-FXII SC TUBE PLT 90DX14H VERSA-FXII SC TUBE PLT 95DX6H VERSA-FXII SC TUBE PLT 95DX8H VERSA-FXII SC TUBE PLT 95DX10H VERSA-FXII SC TUBE PLT 95DX12H VERSA-FXII SC TUBE PLT 95DX14H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95D X 14HOLE VERSA-FX II STD TUBE 130DX8H VERSA-FX II STD TUBE 130DX10H VERSA-FX II STD TUBE 130DX12H VERSA-FX II STD TUBE 130DX14H VERSA-FX II STD TUBE 135DX8H VERSA-FX II STD TUBE 135DX10H VERSA-FX II STD TUBE 135DX12H VERSA-FX II STD TUBE 135DX14H VERSA-FX II STD TUBE 140DX8H VERSA-FX II STD TUBE 140DX10H VERSA-FX II STD TUBE 140DX12H VERSA-FX II STD TUBE 140DX14H VERSA-FX II STD TUBE 145DX8H VERSA-FX II STD TUBE 145DX10H VERSA-FX II STD TUBE 145DX12H VERSA-FX II STD TUBE 145DX14H VERSA-FX II STD TUBE 150DX8H VERSA-FX II STD TUBE 150DX10H VERSA-FX II STD TUBE 150DX12H VERSA-FX II STD TUBE 150DX14H VERSA-FX II KEYLESS TB 130DX8H VERSA-FX II KEYLESS TB 135DX8H VERSA-FX II KEYLESS TB 140DX8H VERSA-FX II KEYLESS TB 145DX8H VERSA-FX II KEYLESS TB 150DX8H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95","Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514 EXPIRATION DATE PRIOR TO 2024-07 ",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2552-2014","Class II","Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1 ","Item Numbers:00598801020, 00598801022, 00598801024, 00598801520, 00598801522, 00598801524, 00598801620, 00598801622, 00598801624, 00598801913, 31810604200, 32598801212, 32598801213, 32598801214, 32598801215, 32598801216, 32598801217, 32598801218, 32598801220, 32598801222, 621519095, 621519115, 621519135, 621519155, 621519175, 621520105, 621520125, 621520145, 621520165, 621520185, 621525105, 621525125, 621525145, 621525165, 681515125, 681515145, 681515165, 681515185, 681515205, 681517125, 681517145, 681517165, 681517185, 681517205, 681517225, 681519105, 681519115, 681519125, 681519135, 681519145, 681519165, 681519185 EXPIRATION DATE PRIOR TO 2024-07 ",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68818,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution.","Z-2547-2014","Class II","Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM ","Item Numbers 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01",".","972,125 units","Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.",7/22/2014,"07/22/2014",9/3/2014,"09/03/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2248-2014","Class II","6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4865-045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-02",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2246-2014","Class II","6.5 mm Cancellous Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4865-020, 025, 030-00",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2247-2014","Class II","6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-01",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2249-2014","Class II","6.5 mm Cancellous Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-00",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2245-2014","Class II","Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 00-1146-040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-32",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2244-2014","Class II","Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 00-1146-030,035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, -99",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2251-2014","Class II","4.0 mm Cancellous Screw, Partially Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4840-010, 012, 014, 016, 018, 020, 022, 024, 026, 028, 030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-01",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Devices",68819,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE","Z-2250-2014","Class II","4.5 mm Malleolar Screw Sterile zimmer, WARSAW, IN 46580, U.S.A.","Item Number 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08",,"47,682 units total","Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.",7/22/2014,"07/22/2014",8/27/2014,"08/27/2014"
"Food",68820,"Completed","Whole Food Market","Cambridge","MA","US","Voluntary: Firm Initiated","E-Mail","MA","F-2418-2014","Class I","Whole Foods Market Chocolate Chewies Cookies in clamshell packaging, sold by the lb. Item # 6126"," Use By date of: 7/18/14.",".","16 units","Product contains undeclared walnuts",7/18/2014,"07/18/2014",9/17/2014,"09/17/2014"
"Devices",68821,"Ongoing","Ab Sciex","Framingham","MA","US","Voluntary: Firm Initiated","Letter","FL, NC, OK, PA, TX","Z-2609-2014","Class II","AB SCIEX API 3200MD'' LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.","Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401",".","6 units","Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis",7/15/2014,"07/15/2014",9/17/2014,"09/17/2014"
"Biologics",68822,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0862-14","Class II","Blood and Blood Products for Reprocessing","4324143; 1778709; ",".","2 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ",6/27/2014,"06/27/2014",9/3/2014,"09/03/2014"
"Biologics",68823,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0864-14","Class II","Platelets Irradiated","W0352130159273; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Biologics",68823,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0863-14","Class II","Red Blood Cells Leukocytes Reduced","W0352130159273; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Biologics",68823,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0865-14","Class III","Blood and Blood Products for Reprocessing","W0352130159273; ",".","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/7/2014,"07/07/2014",9/3/2014,"09/03/2014"
"Biologics",68824,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0877-14","Class III","Red Blood Cells Leukocytes Reduced","W041014084117W; ",".","1 unit","Blood product, in which an antibody identified was labeled and distributed without antibody documented on final label, was distributed.",6/10/2014,"06/10/2014",9/3/2014,"09/03/2014"
"Biologics",68825,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Utah","B-0878-14","Class III","Red Blood Cells Leukocytes Reduced","W116514736867Z; ",".","1 unit","Blood product, collected from a donor that was missing or incorrectly identified on deferral list who should have been deferred due to history, was distributed.",5/20/2014,"05/20/2014",9/3/2014,"09/03/2014"
"Biologics",68826,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","AZ","B-0925-14","Class III","Platelets Pheresis Leukocytes Reduced Irradiated","W042214015569N ",,"1 unit","Blood product, labeled with an incorrect expiration date, was distributed.",5/19/2014,"05/19/2014",10/1/2014,"10/01/2014"
"Biologics",68827,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","GA","B-0924-14","Class II","Platelets Pheresis Leukocytes Reduced","W043214048230",,"1 unit","Blood products, which did not meet the acceptable product specifications for release, were distributed.",7/10/2014,"07/10/2014",10/1/2014,"10/01/2014"
"Biologics",68828,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0923-14","Class II","Red Blood Cells Leukocytes Reduced","1388248",,"1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",6/30/2014,"06/30/2014",10/1/2014,"10/01/2014"
"Biologics",68829,"Terminated","Arc Blood Services, New England Region","Dedham","MA","US","Voluntary: Firm Initiated","Telephone","MA","B-0922-14","Class III","Red Blood Cells Leukocytes Reduced","W203414010276",,"1 unit","Blood product, which was labeled with an incorrect expiration date, was distributed.",5/30/2014,"05/30/2014",10/1/2014,"10/01/2014"
"Biologics",68830,"Terminated","Northern Illinois Blood Bank dba Rock River Valley BC","Rockford","IL","US","Voluntary: Firm Initiated","Letter","Illinois","B-0879-14","Class II","Red Blood Cells Leukocytes Reduced","W044413308634; ",".","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. ",5/23/2014,"05/23/2014",9/3/2014,"09/03/2014"
"Devices",68831,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Telephone","Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT","Z-2236-2014","Class II","Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. ","VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14",".","1045 extraction trays (840 affected by recall)","Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.",7/9/2014,"07/09/2014",8/20/2014,"08/20/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0620-2015","Class I","Sweet 2 Eat Plums; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's 3 1/2 lb Clamshell (Black Diamond)Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; 2 lb. bag. Labels: 4040 CA Black Plum; 4042 CA Red Plum; 4440 Tree Ripe Plum; 94040 Org Black Plum; 94042 Org Red Plum. Varieties include: Black Plum: Angeleno, Black Amber, black Diamond 11, Black Kat, Slack Splendor, Catalina, Earli Queen, Flavor Rich, Friar, Howard Sun, Owen T,, SP-25 Black Giant, Su Plum 11/37, SU Plum 34/36, SU Plum 41/42. SU Plum, 43. Red Plum: Betty Ann, Fall Fiesta, Fortune, Fruit Punch, Hiromi Red,Joanna Red, John W., Red Yummy, Royal Diamond, September Yummy, Simka, Yummy Beauty Green Plum: October Sun Wawona Packing Cutler, CA.","Item 4040 - 3099501; 00895009002311; Item 4042 - 3099536; 00895009002218; Item 4440 - 3189881; 00895009002366; Item 94040 - 3098816; 00895009002335 Item 94042 - 3098824; 00895009002342; Sam's Club Consumer Box 4 lb UPC 0 33383 32016 8; BJ's Clamshell 4-4.5 lb. UPC 0 33383 45468 9; 2 lb Bag Plum UPC 033383 32010 6. ",".","2.2 millions boxes total all fruit (20 lbs per box) estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0621-2015","Class I"," Pluot: Product of USA: Brand names: Sweet 2 Eat, Sweet 2 Eat Organic Orchard Perfect, Trader Joes, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configuration: BJ's 4 lb. Clamshell; Labels: 3278 Plumcot; 3609 Red Plumcot 3610 Green Plumcot 3611 Black Plumcot. Varieties include Dapple Dandy, Dapple Supreme. Flavor Fall, Flavor Grenade, Flavor Heart, Flavorosa, Sugar Jewell, Sweet Treat, Crimson Glo. Wawona Packing Cutler, CA.","Item 3278 - 3099552; 00895009002519; Item 3609 - 3099561; 00895009002526; Item 3610 - 3099579; 00895009002533; Item 3611 - 3099587; 00895009002540. Item 94040 - 3098816; 00895009002335 Item 94042 - 3098824; 00895009002342; BJ's Clamshell 4-4.5 lb. UPC 0 46142 001290 1.",".","2.2 millions boxes all fruits total all fruit (20 lbs per box) estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0617-2015","Class I","Sweet 2 Eat White Peaches; California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: 4-4.5 lb. box BJ's 4 lb Clamshell Costco 5 lb box. Sam's Club consumer box - 4 lbs (Summer Flame) Sticker information - Sweet 2 Eat: 94041 Org TR WF Peach 4401 - White Peach Varieties include: Autumn Snow, ice Princess, Ivory Dutchess, Ivory Queen, Late White Delight, September Snow, Sierra Snow, Snow Angel, Snow Blaze, Snow Gem, Snow Giant, Snow King, Snow Lady, Snow Princess, Summer Sweet, White Delight. Wawona Packing Cutler, CA.","Item 4401 - 3099608; 00895009002250; Item 94401 -3098841; 00895009002243; 4-4.5 lb box UPC 033383 32372 5: BJ's 4-4.5 clamshell UPC 0 33383 32216 2; Sam's club 4 lb carton UPC 8 49315 00028 8; Costco Consumer Box 5 lbs UPC 8 4931589407 8; ",".","2.2 millions boxestotal all fruits (20 lbs per box;) estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0618-2015","Class I","Sweet 2 Eat Yellow Nectarines California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's Club 4 lb Nectarine Pouch (summer Flare); Sam's Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; Costco Consumer Box - 5 lbs. Organic 8/2 Clamshell - 2 lbs. Organic 2 1/2 lb. consumer box; Trader Joe's 4 lb consumer - 4-4.5 lbs. Labels: 94378 - Org TR YF NEC; 4378 TR NEC; 4036 CA Nectarine Varieties Include:August Bright, August Fire, August Red, Diamond Bright. Diamond Ray, Fire Sweet, Grand Bright, Honey Fire, honey May, Honey Royale, Kay Glo, Late Red Jim, Mango, Prince Jim, Red Bright, Red Glenn, Red Jim, Red Roy, ,Rose Bright, Royal Glo, September Bright NS 21 Super Star, Spring Bright, Spring Fire, Spring Flare 20, Spring Flare 22, Spring Flare 23, Summer Bright, Summer Fire , Summer Flare 27, Summer Flare 28, summer flare 30, Summer Flare 31, Summer Flare 35, Zee Fire Wawona Packing Cutler, CA.","Item 94378 - 3098808; 00895009002137; Item 4378 -3099499; 00895009002113 Item 4036 - 3099528 00898009002120; 4-4.5 lb box UPC 033383 32372 5: Sam's Club 4 lb Nectarine Pouch UPC 0 3338373419 4; Sam's Club Consumer Box 4 lb UPC 0 33383 32315 2; BJ's Clamshell 4-4.5 lb. UPC 0 33383 32315 2 Costco Consumer Box 5 lbs UPC 8 49315 32320 2; Organic 8/2 Clamshell UPC 8 49315 00037 0; Organic 2.5 lb. consumer box UPD 8 49315 00037 0: Trader Joe's 4 - 4.5 lb consumer box UPC 0093530. ",".","2.2 millions boxes total all fruit (20 lbs per box); estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0619-2015","Class I","Sweet 2 Eat White Nectarines, California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; 4-4.5 lb box; Costco Consumer Box - 5 lbs.; . Labels: 3035 White Nectarine 93035 Organic TR WF NEC; Varieties include Arctic Pride, Arctic Snow, August Pearl, Candy Pearl Diamond Pearl,Fire Pearl, Giant Pearl,Grand Pearl, Kay Pearl, Majestic Pearl, Summer Pearl, Polar Light, Regal Pearl, Ruby Pearl Snow Flare 21, Snow Pearl, Spring Pearl. Wawona Packing Cutler, CA.","Item 94378 - 3098808; 00895009002137; Item 4378 -3099499; 00895009002113 4-4.5 lb box UPC 033383 32373 2; Sam's Club Consumer Box 4 lb UPC 0 33383 32361 9; BJ's Clamshell 4-4.5 lb. UPC 0 33383 32315 2 Costco Consumer Box 5 lbs UPC 8 49315 47932 9. ",".","2.2 millions boxes total all fruit (20 lbs per box) estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Food",68833,"Ongoing","Wawona Packing Company","Cutler","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including Canada, Taiwan, Singapore, Indonesia, Malaysia, Columbia, Costa Rica, Guatemala, Honduras, Australia, India, Mexico, Philippines, Brazil, Hong Kong, Ecuador and Manila","F-0616-2015","Class I","Sweet 2 Eat Yellow Peaches; California Tree Fruit; Product of USA; Packed in the following configurations: 2.5 lb. box, 4-4.5 lb. box 4-4.5 lb box for Trader Joe's 8/2 Clamshell - net weight 2 lbs. Costco Consumer Box, 5 lbs Sam's Club consumer box - 4 lbs (Summer Flame) BJ's 4 lb clamshell 2 lb bag. Sticker information - Sweet 2 Eat: 94044 Org TR YF Peach 4044 TR Peach; 4038 CA Peach Varieties include: August Flame, August Lady, , Autumn Flame, Bright Princess, Brittney Lane, Candy Flame, Crimson Lady, Crimson Princess, Earli Rich, Elegant Lady, Grand Finale, Henry 2,3 & 4, July Flame, June Flame, June Flavor, June Time, Kaweah, King Midas 17, Last Tango., May Princess, O'Henry, , Princess Time, Rich Lady,, Sierra Rich, Spring Flame 18, 20, 20.5, 21, 22, SU Peach 13, 15, 17, Sugartime, Summer Flame 26, 29. 24, , Summer Zee, Sweet Dream, Sweet Henry, Tra Zee, Vista, Zee Lady, Zee Pride. Wawona Packing Cutler, CA.","Item 94044 - 3098795; 00895009002236; Item 4044 - 3099510; 00895009002212; Item 4038 - 3099544; 00895009002229; 2 lb. bag UPC: 0 33383 32200 1; Organic 2.5 lb box UPC 8 491300036 3; 4-4.5 lb box UPC 033383 32370 1: BJ's 4-4.5 clamshell UPC 0 33383 32211 7; Sam's club 4 lb carton UPC 8 49315 00028 8; Organic 8/2 Clamshell - 2 lb.s UPC 0 33383 73169 0; Costco Consumer Box 5 lbs UPC 8 49315 45518 7; Trader Joe's 4 lb consumer box UPC 00934015",".","2.2 millions boxes (20 lbs per box) estimated since 6-2014","Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.",7/18/2014,"07/18/2014",12/17/2014,"12/17/2014"
"Devices",68834,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.","Z-2557-2014","Class II","Cordis EMPIRA RX PTCA Dilatation Catheter ","70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.",".","250,000 units.","The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.",6/23/2014,"06/23/2014",9/3/2014,"09/03/2014"
"Devices",68834,"Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.","Z-2556-2014","Class II","Cordis EMPIRA NC RX PTCA Dilatation Catheter "," 63 Catalog numbers: 75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, 75R25400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, and 75R25400N.",".","250,000 units","The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.",6/23/2014,"06/23/2014",9/3/2014,"09/03/2014"
"Food",68836,"Ongoing","Farmers Market","Belleville","IL","US","Voluntary: Firm Initiated","Press Release","US: IL","F-2313-2014","Class I","Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand.","All Pack Dates from March 2014 through May 2014",".","32 containers","Belleville Farmer's Market of Belleville, IL is recalling its packages of Shelled Walnuts because they have the potential to be contaminated with Listeria monocytogenes.",5/23/2014,"05/23/2014",8/20/2014,"08/20/2014"
"Devices",68837,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.","Z-2191-2014","Class II","Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. ","Lot Numbers: CLPCNB, CMBCPT, CMCC2W, CMDB6L, CMDDJV, CMI. ",8/28/2014,"08/28/2014",11/19/2014,"11/19/2014"
"Devices",68840,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-2214-2014","Class II","VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY","Lots 0168 and 0169 ",".","5906 total: 240 (US); 5666 (OUS)","Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.",7/15/2014,"07/15/2014",8/20/2014,"08/20/2014"
"Drugs",68841,"Ongoing","Unique Pharmaceutical, Ltd","Temple","TX","US",,"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0011-2015","Class I","N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133","Lot #: 86513, Exp 07/23/2014",,"3,529 Vials","Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.",7/18/2014,"07/18/2014",10/15/2014,"10/15/2014"
"Drugs",68841,"Ongoing","Unique Pharmaceutical, Ltd","Temple","TX","US",,"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0012-2015","Class II","All sterile products within expiry","All Lots ",,"325,225 units (syringes, vials, bags)","Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile. ",7/18/2014,"07/18/2014",10/15/2014,"10/15/2014"
"Devices",68843,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2615-2014","Class II","***Baxter***Non-DEHP***BURETROL Solution Set 105'' (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***","2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043 ",".","11184","Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.",7/14/2014,"07/14/2014",9/17/2014,"09/17/2014"
"Devices",68843,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2614-2014","Class II","***Baxter***BURETROL Solution Set***105'' (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. ****Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***","2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette, lots: DR13E08015 DR13E08023 DR13E09013 DR13I26027 DR13I27017 DR13I27025 DR13I28015 DR13I28023 DR13J16027 DR13J17025 DR13J28022 DR13J29020 DR13K01019 DR13K20027 DR13K21025 DR13L19019 DR13L19027 DR14A11017 DR14A14011 DR14A24010 DR14A24036 DR14A31049 DR14B07054 DR14B22012 DR14B28050 DR14C01030 DR14C06013 DR14C06039 ",".","107232","Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.",7/14/2014,"07/14/2014",9/17/2014,"09/17/2014"
"Devices",68843,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2613-2014","Class II","***Baxter***Buretrol Solution Set***105'' (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***","2C7564- Buretrol Solution Set with 150mL INTERLINK Burette, lots: DR13E06019 DR13E07017 DR13E07025 DR13I14023 DR13I16010 DR13I16028 DR13I23016 DR13I23024 DR13J03033 DR13J04015 DR13J04023 DR13J08024 DR13J09014 DR13J09022 DR13J24021 DR13J24039 DR13K07024 DR13K08022 DR13K12024 DR13K13022 DR13K18021 DR13K19029 DR13K25026 DR13K26024 DR13L02023 DR13L03039 DR13L10018 DR13L11016 DR13L18011 DR13L18029 DR13L19035 DR14A09052 DR14A10035 DR14A23012 DR14A23020 DR14A29027 DR14A30017 DR14B06049 DR14B07013 DR14B07047 DR14B11023 DR14B13037 DR14B13045 DR14B14019 DR14B20016 DR14B20032 DR14B21014 DR14B26013 DR14B26039 DR14C05015 DR14C05031 ",".","234196","Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.",7/14/2014,"07/14/2014",9/17/2014,"09/17/2014"
"Devices",68844,"Ongoing"," AGFA Healthcare Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada","Z-2178-2014","Class III","Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.","Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063 ",".","2617","Some sheets of the medical screen film are fogged.",7/16/2014,"07/16/2014",8/20/2014,"08/20/2014"
"Devices",68845,"Ongoing","Brainlab AG","Feldkirchen",,"DE","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.","Z-2213-2014","Class II","Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.","Model/Catalog Number: 19061-03",,"17 systems","Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called "table-zero-position" is sent from the CT scanner to the Brainlab navigation software in a special format. Due to a change in the corresponding Siemens data output, the information from the CT scanner cannot be correctly processed in the navigation software, when using: 1) Automatic Registration of iCT Data, in combination with 2) Siemens SOMATOM Definition AS CT scanner with Software Somaris SOM 7 (or higher), and 3) Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only). As a result, in the navigation software the CT image data set appears shifted in the scanner movement direction (patient head-feet direction). The scale of the shift can differ in each scan, varying from sub-millimeters to meters.",5/21/2014,"05/21/2014",8/27/2014,"08/27/2014"
"Devices",68846,"Ongoing","Ion Beam Applications S.A.","Louvain La Neuve",,"BE","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.","Z-0020-2015","Class II","Proteus 235 Proton Therapy System for cancer treatment.","PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.",".","8","While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.",3/27/2014,"03/27/2014",11/5/2014,"11/05/2014"
"Drugs",68847,"Ongoing","Bio-pharm, Inc.","Levittown","PA","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-0028-2015","Class II","Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,","Lot 3L20, Exp. 11/15 ",,"35,739 bottles","Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint. ",7/16/2014,"07/16/2014",10/29/2014,"10/29/2014"
"Devices",68848,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution and Internationally to Canada.","Z-2238-2014","Class II","Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.","lot RD41041, exp. 10/13/2014",,"3200","Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal investigation has confirmed bacterial contamination in ChemistryWash lot RD41041. A positive bias will be observed on CTNI, LTNI, TSH, PBNP and LPBN and a negative bias will be seen on FT4 when this lot is first placed on the instrument without recalibration of methods. Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results.",7/15/2014,"07/15/2014",8/27/2014,"08/27/2014"
"Biologics",68849,"Terminated","LifeSouth Community Blood Centers Inc","Madison","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0921-14","Class II","Platelets Pheresis Leukocytes Reduced","W115114109743B",,"1 unit","Blood product, with a low platelet count, was distributed.",6/16/2014,"06/16/2014",10/1/2014,"10/01/2014"
"Biologics",68850,"Terminated","Houchin Community Blood bank","Bakersfield","CA","US","Voluntary: Firm Initiated","FAX","California","B-0946-14","Class III","Red Blood Cells Leukocytes Reduced","W224314502250; ",".","1","Blood product, collected from a donor with a reported post donation illness, was distributed.",6/26/2014,"06/26/2014",9/3/2014,"09/03/2014"
"Biologics",68851,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Telephone","PA","B-0920-14","Class III","Red Blood Cells","W087614561470",,"1 unit","Blood product, labeled with an incorrect expiration date, was distributed.",6/5/2014,"06/05/2014",10/1/2014,"10/01/2014"
"Biologics",68852,"Terminated","Central Texas Regional Blood & Tissue Center","Austin","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0945-14","Class III","Platelets Leukocytes Reduced","W221614607085(Part A); W221614607085(Part B); ",".","2 units","Blood products, in which labels applied to blood units or products were incorrect or missing information, were distributed.",6/6/2014,"06/06/2014",9/17/2014,"09/17/2014"
"Biologics",68853,"Terminated","Childrens Hospital Colorado Transfusion Medical Services","Aurora","CO","US","Voluntary: Firm Initiated","E-Mail","Colorado","B-0934-14","Class III","Blood and Blood Products for Reprocessing","W140514441312; ",,"1 unit","Blood product, in which the donor screening/donor record was incomplete or incorrect, was distributed.",7/8/2014,"07/08/2014",9/10/2014,"09/10/2014"
"Devices",68854,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Nationwide and internationally, including Canada and Mexico","Z-2553-2014","Class II","Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.","All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338",".","2757",,7/16/2014,"07/16/2014",9/3/2014,"09/03/2014"
"Biologics",68855,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0881-14","Class II","Blood and Blood Products for Reprocessing","W036513019029; ",,"1","Blood product, collected from a donor considered to be at risk for variant Creutzfeldt- Jakob Disease (vCJD), was distributed.",6/5/2014,"06/05/2014",8/27/2014,"08/27/2014"
"Biologics",68856,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-0902-14","Class II","Platelets Pheresis Leukocytes Reduced","W036514080032; W036514080032; W036514037192; W036514037192; ",,"4 units","Blood products, collected using automated equipment that lacked validation, were distributed.",6/27/2014,"06/27/2014",9/10/2014,"09/10/2014"
"Biologics",68857,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0903-14","Class III","Platelets Pheresis","W200314805338; ",,"One unit","Platelets with incorrect or missing information, were distributed.",5/9/2014,"05/09/2014",9/10/2014,"09/10/2014"
"Biologics",68858,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Telephone","Utah","B-0904-14","Class III","Red Blood Cells","W116514325191P; ",,"1 unit","Blood product, prepared without the appropriate amount of additive (ADSOL), was distributed. ",2/25/2014,"02/25/2014",9/10/2014,"09/10/2014"
"Food",68859,"Ongoing","Ciranda, Inc.","Hudson","WI","US","Voluntary: Firm Initiated","E-Mail","CA, FL, GA, and IA","F-2334-2014","Class I","Ciranda Organic Carob Powder Light, Product Code 20030. Net Wt. 55.11 lbs / 25 kg. Ingredients: Organic Carob Powder. Manufactured in Italy.","Lot 395-13",,"359 bags ( 19,784.49 lbs)","Ciranda is recalling one lot of Organic Carob Powder Light after learning that a customer received a positive test for Salmonella.",7/21/2014,"07/21/2014",8/27/2014,"08/27/2014"
"Drugs",68860,"Ongoing","Sandoz Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1445-2014","Class III","Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.","Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16",,"781,000 extended release tablets","Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.",7/11/2014,"07/11/2014",7/30/2014,"07/30/2014"
"Food",68861,"Ongoing","Japanese Specialty Food Distributors Ltd, Co.","Brookfield","CT","US","Voluntary: Firm Initiated","Letter","Product was distributed directly to CT, NY, NJ, TX, and GA","F-2443-2014","Class II","JSF Ground Tuna - IQF - Origin: Indonesia - 2/11LB, frozen","All lots",,"961 cases","Product associated with scombroid illness.",7/21/2014,"07/21/2014",9/24/2014,"09/24/2014"
"Devices",68862,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.","Z-2144-2014","Class II","Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8. dental implant component.","Lot No. 62552804",".","291 units","Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state ''03.7 x 8mm'' instead of ''04.7 x 8 mm.''",7/17/2014,"07/17/2014",8/13/2014,"08/13/2014"
"Devices",68863,"Completed","X Spine Systems Inc","Miamisburg","OH","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of FL and MO.","Z-2136-2014","Class II","Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.","Part numbers X079-0096 and X079-0097 with Lot #12320",".","A total of 5-pieces of each part number distributed","Revision B of the tissue shields of the device was 7 mm longer than the previous design.",7/11/2014,"07/11/2014",8/13/2014,"08/13/2014"
"Food",68864,"Ongoing","Readington Farms Inc.","Whitehouse","NJ","US","Voluntary: Firm Initiated","Letter","CT, MA, MD, NJ, NY, PA,& RI","F-2319-2014","Class II","Shoprite Spring Water Net 1 GAL (120 Fl Oz.) 3.78L Distributed by Wakefern Food Corp Elizabeth, NJ Made in USA UPC 041190007196","Code Date: 060514 Exp 060515 Code Date: 060714 Exp 060715",".","53,008 gallons (total units)","Spring Water was found to be positive for E. Coli bacteria.",6/13/2014,"06/13/2014",9/3/2014,"09/03/2014"
"Food",68864,"Ongoing","Readington Farms Inc.","Whitehouse","NJ","US","Voluntary: Firm Initiated","Letter","CT, MA, MD, NJ, NY, PA,& RI","F-2320-2014","Class II","PriceRite Spring Water Net 1 GAL (3.78 L) Distributed by P.R.R.C. Inc. 5000 Riverside Drive Keasby, NJ 00832 UPC 041190755189","0849 060514 EXP 06/05/15 and 0839 060714 EXP 06/07/15",".","53,008 gallons (total units)","Spring Water was found to be positive for E. Coli bacteria.",6/13/2014,"06/13/2014",9/3/2014,"09/03/2014"
"Biologics",68865,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0986-14","Class III","Pedi-Pak Quad 75mL with In-Line Filter Transfer Pak Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16 ","CAT #402504F Lot # 997024327; 997024637; 997025300",,"2016 units; 3 lots","Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. ",7/17/2014,"07/17/2014",10/1/2014,"10/01/2014"
"Biologics",68865,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0988-14","Class III","Pedi-Pak Quad 75 mL Transfer Pack - Needless 'Y'' site Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16 ","CAT #402524 Lot# 998024328",,"216 units; 1 lot","Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. ",7/17/2014,"07/17/2014",10/1/2014,"10/01/2014"
"Biologics",68865,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0989-14","Class III","Pedi-Pak Single 75 mL Transfer Bag -Single Rx Only 75 mL Genesis BPS, LLC 65 Commerce Way, Hackensack, NJ 07601 Tel: 201-708-1400 Fax: 201-708-1104 Genesis BPS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16","CAT #402501 Lot # 967024879; 967024325; 967024585",,"2976 units; 3 lots","Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. ",7/17/2014,"07/17/2014",10/1/2014,"10/01/2014"
"Biologics",68865,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","B-0987-14","Class III","Pedi-Pak Quad 75mL Transfer Pack w/o filter Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260 Nyon 2 Switzerland +41.22.363.18.16 ","CAT #402504 Lot # 968023365; 968024880; 968024326; 968024586",,"10,880 units; 4 lots","Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. ",7/17/2014,"07/17/2014",10/1/2014,"10/01/2014"
"Biologics",68866,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Other","Illinois; Florida","B-0912-14","Class II","Red Blood Cells","W039714865009N; ",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Biologics",68866,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","Aurora","IL","US","Voluntary: Firm Initiated","Other","Illinois; Florida","B-0913-14","Class II","Red Blood Cells Frozen Leukocytes Reduced","W0397148945288; ",,"1 unit","Blood products, collected from an ineligible donor, were distributed. ",7/10/2014,"07/10/2014",8/27/2014,"08/27/2014"
"Biologics",68867,"Terminated","Blood Systems, Inc. DBA United Blood Services","Lafayette","LA","US","Voluntary: Firm Initiated","FAX","Mississippi","B-0905-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W2876140014486; ",,"1 unit","Blood product, labeled with an incorrect expiration date, was distributed.",6/17/2014,"06/17/2014",9/10/2014,"09/10/2014"
"Biologics",68868,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0906-14","Class II","Red Blood Cells Leukocytes Reduced","W036808157431; ",,"1 unit","Blood product, in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed.",5/28/2014,"05/28/2014",9/10/2014,"09/10/2014"
"Biologics",68869,"Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","FAX","New Jersey","B-0882-14","Class II","Platelets Pheresis Leukocytes Reduced","W044114555810; ",,"1","Blood product for which some quality control procedures were not performed, was distributed.",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Devices",68870,"Ongoing","Biolase Technology Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE.","Z-2263-2014","Class II","WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.","Serial No. 72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110940 72110983 72130260 72130263 72140014 72140033 72140034 72140036 72140037 72140038 72140041 72140042 72140045 72140046 72140047 72140048 72140052 72140054 72140057 72140058 72140059 72140060 72140061 72140063 72140064 72140066 72140068 72140070 72140072 72140078 72140110 72140111 72140083 72140114 72140165 72140176 72140126 72140129 72140129 72140130 72140136 72140139 72140140 72140141 72140144 72140145 72140152 72140153 72120052 72140039 72140077 72140079 72140090 72140127 72140131 72140133 72140148 72140177 72140051 72140053 72140055 72140056 72140073 72140074 72140075 72140085 72140076 72140154 72120057 72130195 72130540 72130631 72140132 72140112 72140067 72140128 72140071 72140087 72140089 72140086 72140084 72140088 72140123 72140106 72140107 72140146 72140108 72140137 72140122 72140134 72140124 72140115 72140116 72140117 72140118 72140119 72140120 72140121 72140091 72140092 72140095 72140096 72140097 72140098 72140099 72140125 ",,"117 units","Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF.",6/12/2014,"06/12/2014",8/27/2014,"08/27/2014"
"Devices",68871,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.","Z-2643-2014","Class II","ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591-5097 USA --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. ","Lots 3HD044 (exp. 11/01/2015), and 3LD068 (exp. 01/01/2016)",,"Domestic: 1122 kits; Foreign: 236 kits","ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.",8/6/2014,"08/06/2014",9/24/2014,"09/24/2014"
"Food",68872,"Ongoing","American Spoon Foods, Inc.","Petoskey","MI","US","Voluntary: Firm Initiated","Letter","AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI AND WV.","F-2343-2014","Class II","American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Total package size (e.g. 12 packages per case): 12 jars per case ","Catalog #: MARM-CH, Lots:408400040001 - 408400040431, Best flavor date: 03/2016 and Lots: 408400050001 - 408400050459, Best flavor date: 03/2016 ",,"682 jars","Product may have mold in jar.",7/21/2014,"07/21/2014",8/27/2014,"08/27/2014"
"Devices",68874,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2668-2014","Class II","Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion","Cat #405-560BD Lot # 3650-23508; 3650-24116; 3650-24332; 3650-24399; 3650-24487; 3650-24519; 3650-23478; 3650-23971 Cat # 405-60MJ Lot #3630-23509; 3630-23972; 3630-24181; 3630-24333; 3630-24397; 3630-24488; 3630-24152",,"7272 units","Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.",7/17/2014,"07/17/2014",9/24/2014,"09/24/2014"
"Devices",68874,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2667-2014","Class II","Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion","Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521",,"7560 units","Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.",7/17/2014,"07/17/2014",9/24/2014,"09/24/2014"
"Devices",68874,"Ongoing","Genesis BPS, LLC.","Hackensack","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2669-2014","Class II","Pedi-Pak Pedi-Syringe Filter 35 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.","Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301",,"4608 units","Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.",7/17/2014,"07/17/2014",9/24/2014,"09/24/2014"
"Food",68875,"Ongoing","River Canyon Retreat","Grass Valley","CA","US","Voluntary: Firm Initiated","Press Release","US and Canada: CA, OR, HI, WA, FL, WI, IN, AZ, NC, IL, MD, KY, NV, CO, VA, NY, MN, NJ.","F-1987-2014","Class I","Organic Carob Powder; Certified Organic, Product of Italy. Store in Cool, Dark place. Packaged in 16 oz., 5 lb., 20 lb and 55 lb. containers. 16 oz.. - 6 per case; 5 lb. - 6 per case; 20 lb. - 2 per case; 55 lb. - 1 per case. Earth Circle Organics; Grass Valley, CA","Product SKU Lots #;s UPC code CRBP 16 oz.; 3642, 3404, 3221, 3267 894932002283; CRBP 5 lb; 3405, 3262 894932002733; CRBP 20 lb. 3487, 3387, 3292 813313011485; CRBP 55 lb. 201901, 196201, 194801, 188901, 0786 894932002740. All lots expire 6/15/2015.",,"10,051 lbs.","Firm was notified by supplier of recall or Organic Carob Powder that they repacked has been recalled due to Salmonella contamination.",7/22/2014,"07/22/2014",9/10/2014,"09/10/2014"
"Drugs",68876,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1537-2014","Class III","Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23 "," Lot H43272, H43265 Exp. 09/14",".","93,800 vials","Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0",7/30/2014,"07/30/2014",8/20/2014,"08/20/2014"
"Devices",68877,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.","Z-2617-2014","Class II","CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor ","Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109 SGV14150039HA M1199109 SGV14150041HA M1199109 SGV14150042HA M1199109 SGV14150043HA M1199109 SGV14150044HA M1199109 SGV14150045HA M1199109 SGV14150051HA M1199109 SGV14150060HA M1199109 SGV14150064HA M1199109 SGV14150068HA M1199109 SGV14150071HA M1199109 SGV14150074HA M1199109 SGV14150075HA M1199109 SGV14150079HA M1199109 SGV14150170HA M1199109 SGV14150179HA M1199109 SGV14150180HA M1199109 SGV14150182HA M1199109 SGV14150194HA M1199109 SGV14150195HA M1199109 SGV14150197HA M1199109 SGV14150203HA M1199109 SGV14150204HA M1199109 SGV14150207HA M1199109 SGV14150208HA M1199109 SGV14159469HA M1199109 SGV14159471HA M1199109 SGV14159472HA M1199109 SGV14159484HA M1199109 SGV14159488HA M1199109 SGV14159489HA M1199109 SGV14159490HA M1199109 SGV14159494HA M1199109 SGV14159498HA M1199109 SGV14159499HA M1199109 SGV14159501HA M1199109 SGV14159502HA M1199109 SGV14159504HA M1199109 SGV14159505HA M1199109 SGV14159506HA M1199109 SGV14159507HA M1199109 SGV14159685HA M1199109 SGV14159688HA M1199109 SGV14159689HA M1199109 SGV14159692HA M1199109 SGV14159694HA M1199109 SGV14159695HA M1199109 SGV14159698HA M1199109 SGV14159703HA M1199109 SGV14159707HA M1199109 SGV14159709HA M1199109 SGV14159713HA M1199109 SGV14159716HA M1199109 SGV14159717HA M1199109 SGV14159718HA M1199109 SGV14159722HA M1199109 SGV14159728HA M1199109 SGV14159966HA M1199109 SGV14159971HA M1199109 SGV14159976HA M1199109 SGV14159978HA M1199109 SGV14159979HA M1199109 SGV14159990HA M1199109 SGV14159995HA M1199109 SGV14159999HA M1199109 SGV14160322HA M1199109 SGV14160324HA M1199109 SGV14160325HA M1199109 SGV14160511HA M1199109 SGV14160512HA M1199109 SGV14160513HA M1199109 SGV14160514HA M1199109 SGV14160515HA M1199109 SGV14160519HA M1199109 SGV14160520HA M1199109 SGV14160522HA M1199109 SGV14160524HA M1199109 SGV14160525HA M1199109 SGV14160526HA ",".","748 (307 units US, 441 units OUS)","GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.",8/8/2014,"08/08/2014",9/17/2014,"09/17/2014"
"Devices",68877,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.","Z-2617-2014","Class II","CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor ","SGV14159700HA M1184207 SGV14159981HA M1184207 SGV14159986HA M1184207 SGV14160535HA M1184207 SGV14160549HA M1184207 SGV14182004HA M1184207 SGV14182014HA M1184207 SGV14182016HA M1184207 SGV14182018HA M1184207 SGV14182019HA M1184207 SGV14182020HA M1184207 SGV14182021HA M1184207 SGV14182023HA M1184207 SGV14182024HA M1184207 SGV14182026HA M1184207 SGV14182027HA M1184207 SGV14182031HA M1184207 SGV14192718HA M1184207 SGV14192721HA M1184207 SGV14192726HA M1184207 SGV14159407HA M1226039 SGV14160339HA M1226039 SGV14170903HA 2070605-001 SGV14181895HA M1226039 SGV14181904HA M1226039 SGV14181905HA M1226039 SGV14150049HA 2065630-001 SGV14150066HA 2065630-001 SGV14150199HA 2065630-001 SGV14160221HA 2070608-001 SGV14160222HA 2070608-001 SGV14160225HA 2070608-001 SGV14160226HA 2070608-001 SGV14160227HA 2070608-001 SGV14160230HA 2070608-001 SGV14160232HA 2070608-001 SGV14160233HA 2070608-001 SGV14160234HA 2070608-001 SGV14160235HA 2070608-001 SGV14160237HA 2070608-001 SGV14160241HA 2070608-001 SGV14160244HA 2070608-001 SGV14160247HA 2070608-001 SGV14160248HA 2070608-001 SGV14160254HA 2070608-001 SGV14160255HA 2070608-001 SGV14160258HA 2070608-001 SGV14160260HA 2070608-001 SGV14160326HA 2065630-001 SGV14160334HA M1226042 SGV14160336HA M1226042 SGV14160345HA M1226042 SGV14160346HA M1226042 SGV14170898HA 2070608-001 SGV14170912HA 2070608-001 SGV14170916HA 2070608-001 SGV14170917HA 2070608-001 SGV14170918HA 2070608-001 SGV14170919HA 2070608-001 SGV14170921HA 2070608-001 SGV14170922HA 2070608-001 SGV14170923HA 2070608-001 SGV14170930HA 2070608-001 SGV14170932HA 2070608-001 SGV14171146HA 2070608-001 SGV14171147HA 2070608-001 SGV14171149HA 2070608-001 SGV14171151HA 2070608-001 SGV14171152HA 2070608-001 SGV14171154HA 2070608-001 SGV14171158HA 2070608-001 SGV14171159HA 2070608-001 SGV14171161HA 2070608-001 SGV14192263HA 2070608-001 SGV14224462HA 2065630-001 SGV14150072HA 2073871-001 SGV14159977HA SGV14160328HA SGV14160516HA SGV14170925HA SGV14192615HA 206",".","748 (307 units US, 441 units OUS)","GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.",8/8/2014,"08/08/2014",9/17/2014,"09/17/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2578-2014","Class II","PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.","Part Numbers: 42517000303, 42517000313, 42517000505, 42517000515, 42517000707, 42517000717, 42517000909, 42517000919, 42527000303, 42527000313, 42527000505, 42527000515, 42527000707, 42527000717, 42527000909, and 42527000919. Lot numbers:62022340, 62024973, 62062232, 62104367, 62187314, 62187315, 62190367, 62190370, 62265725, 62301862, 62314675, 62355857, 62385126, 62385132, 62403987, 62414017, 62420244, 62456269, 62506026, 62506044, 62531664, 62558106, 62564325, 62596552, 62600208, 62614790, 62683419, 62691385, 62698730, 62716777, 62751902, 62752809, 62765288, 62774042, 62024974, 62032099, 62075271, 62144791, 62171682, 62171684, 62184223, 62187317, 62239237, 62248153, 62256256, 62386757, 62391108, 62391109, 62414001, 62414002, 62456271, 62474902, 62544384, 62565106, 62565107, 62601564, 62612269, 62627270, 62678888, 62684675, 62695301, 62710627, 62745014, 62745021, 62019862, 62091183, 62177238, 62177239, 62177240, 62268818, 62282708, 62305406, 62314683, 62351287, 62356123, 62385455, 62401419, 62405946, 62419059, 62429198, 62456279, 62504887, 62531665, 62559945, 62565049, 62595861, 62621822, 62627202, 62663169, 62690886, 62696853, 62698724, 62710616, 62716769, 62752807, 62778335, 62030854, 62050136, 62125572, 62154284, 62165540, 62168382, 62177242, 62190375, 62247344, 62247345, 62256257, 62364951, 62391110, 62391111, 62413998, 62413999, 62427064, 62469454, 62525495, 62538399, 62565109, 62565110, 62565111, 62595858, 62630285, 62632817, 62680122, 62680123, 62691389, 62696886, 62710624, 62717356, 62737725, 62741936, 62022342, 62024977, 62087042, 62091198, 62165542, 62187321, 62189343, 62233919, 62239239, 62247347, 62256279, 62386756, 62391114, 62391115, 62403989, 62419057, 62429191, 62461234, 62525494, 62544359, 62564327, 62587605, 62601573, 62601574, 62668825, 62696851, 62717321, 62744886, 62747704, 62756025, 62029578, 62030862, 62125573, 62165544, 62189322, 62189323, 62189324, 62201539, 62239240, 62247349, 62256280, 62372408, 62386777, 62391226, 62403995, 62420263, 62456272, 62506051, 62544380, 62565113, 6256511",,"77,737 total units","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2580-2014","Class II","PERSONA'' The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.","Part Numbers: 42517200410, 42517200510, 42517200610, 42517200710, 42527200410, 42527200510, 42527200610, and 42527200710. Lot numbers:62034570, 62117742, 62156315, 62187322, 62247350, 62314721, 62372409, 62381836, 62397160, 62429190, 62474906, 62551390, 62565048, 62595853, 62614781, 62700416, 62702297, 62724349, 62043548, 62055681, 62104368, 62117743, 62144794, 62165545, 62177246, 62256282, 62351288, 62356244, 62391228, 62427419, 62456268, 62506003, 62551338, 62564355, 62597762, 62614786, 62702292, 62705808, 62717332, 62055682, 62068376, 62068378, 62144795, 62152727, 62187323, 62256283, 62351289, 62356275, 62386419, 62445931, 62456266, 62558584, 62575757, 62611087, 62638672, 62698749, 62736074, 62736075, 62330130, 62563854, 62567418, 62622596, 62070845, 62102088, 62130979, 62149717, 62200303, 62240485, 62256293, 62351304, 62356605, 62391239, 62420238, 62469444, 62551099, 62581081, 62597792, 62627223, 62696849, 62715617, 62059519, 62072593, 62103263, 62110051, 62196614, 62198205, 62248171, 62351307, 62385105, 62401423, 62468266, 62558588, 62595866, 62690052, 62715613, 62072225, 62103266, 62144798, 62156319, 62209049, 62229728, 62282887, 62315140, 62356622, 62386430, 62401427, 62427062, 62428459, 62505998, 62565073, 62581864, 62627283, 62690948, 62696884, 62717330, 62398030, 62428342, 62444343, 62510048, 62515508, 62516058, and 62600154.",,"77,737 total units","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2577-2014","Class II","PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.","Part Numbers: 42517000410, 42517000510, 42517000610, 42517000710, 42527000410, 42527000510, 42527000610, and 42527000710. Lot numbers: 62024975, 62043546, 62144792, 62152725, 62165538, 62187318, 62337961, 62372407, 62386776, 62397159, 62405917, 62456263, 62499170, 62551386, 62565051, 62568272, 62572572, 62663168, 62691384, 62707494, 62717346, 62020920, 62144793, 62156313, 62165539, 62184228, 62353932, 62356176, 62385100, 62420242, 62468277, 62538412, 62564340, 62611088, 62612263, 62690056, 62702295, 62717337, 62736078, 62024976, 62054776, 62147232, 62177243, 62187319, 62187320, 62359057, 62364955, 62391222, 62414006, 62461233, 62558583, 62564345, 62608889, 62638657, 62646286, 62702749, 62724348, 62394279, 62443397, 62487490, 62492802, 62506001, 62563915, 62568271, 62704633, 62055686, 62144796, 62161537, 62162597, 62256286, 62351297, 62356578, 62385099, 62404282, 62424802, 62455897, 62538392, 62565037, 62595855, 62611083, 62663162, 62680121, 62686205, 62695286, 62724347, 62724744, 62019863, 62156317, 62165548, 62168386, 62184268, 62256288, 62344258, 62356586, 62391232, 62391233, 62455892, 62504877, 62551337, 62564335, 62597816, 62638685, 62646284, 62695878, 62036673, 62138318, 62149715, 62189326, 62189327, 62356593, 62377738, 62391236, 62420225, 62461232, 62564360, 62564361, 62595865, 62611086, 62680120, 62690951, 62710615, 62761109, 62394280, 62428338, 62444959, 62500931, and 62568278.",,"77,737 total units","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2579-2014","Class II","PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.","Part Numbers: 42517400410, 42517400510, 42517400610, 42517400710, 42517400810, 42517400910, 42517401010, 42517401110, 42527400410, 42527400510, 42527400610, 42527400710, 42527400810, 42527400910, 42527401010, and 42527401110. Lot numbers:62043556, 62110045, 62121489, 62125589, 62147235, 62165546, 62168383, 62177247, 62311021, 62314722, 62386421, 62442838, 62525491, 62558585, 62605208, 62627292, 62683432, 62696865, 62717343, 62022344, 62041351, 62073566, 62104372, 62117744, 62121488, 62149175, 62187324, 62187325, 62247351, 62311022, 62314723, 62364961, 62391117, 62436468, 62474903, 62538403, 62564311, 62611089, 62669905, 62690895, 62720225, 62742767, 62747707, 62020946, 62028233, 62073570, 62110047, 62130976, 62187327, 62187329, 62189325, 62290822, 62305407, 62314724, 62386424, 62420258, 62469459, 62531662, 62551356, 62565041, 62584447, 62612266, 62687089, 62690049, 62690909, 62702763, 62724739, 62022345, 62024978, 62104374, 62124040, 62134006, 62200223, 62200224, 62233921, 62294595, 62314725, 62385328, 62436479, 62511942, 62544381, 62565042, 62597795, 62669933, 62696869, 62710618, 62736059, 62768447, 62043559, 62104415, 62121530, 62203396, 62203397, 62314728, 62314730, 62356529, 62390841, 62442847, 62511926, 62551396, 62565057, 62595859, 62654933, 62656069, 62720226, 62034569, 62055683, 62113088, 62130978, 62149714, 62165547, 62168384, 62177253, 62184260, 62256284, 62256285, 62397161, 62420223, 62511956, 62551402, 62565108, 62601570, 62696376, 62742762, 62756031, 62043561, 62055684, 62116593, 62145793, 62152728, 62166195, 62166196, 62168385, 62184261, 62239294, 62319851, 62320878, 62356546, 62390865, 62474905, 62538415, 62565044, 62581863, 62622558, 62632819, 62740693, 62398035, 62440437, 62515479, 62515499, 62563803, 62581853, 62675491, 62059520, 62079725, 62113046, 62144799, 62188423, 62188424, 62188425, 62290837, 62386431, 62436425, 62544361, 62564334, 62601567, 62669897, 62703452, 62742764, 62745001, 62059521, 62064136, 62079726, 62087046, 62104427, 62147239, 62189345, 62189346, 62189347, 62290841, 623513",,"77,737 total units","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2576-2014","Class II","PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J. ","Part Numbers: 42517600410, 42517600510, 42517600610, 42517600710, 42517600810, 42517600910, 42517601010, 42517601110, 42527600410, 42527600510, 42527600610, 42527600710, 42527600810, 42527600910, 42527601010, and 42527601110. Lot numbers: 62342526, 62423918, 62423919, 62423920, 62427414, 62482212, 62563745, 62612225, 62656072, 62740698, 62342527, 62405895, 62430401, 62504179, 62511925, 62563784, 62638665, 62695870, 62343066, 62406967, 62432146, 62515486, 62564324, 62691390, 62717335, 62351291, 62374838, 62415307, 62430397, 62518138, 62622527, 62696875, 62357867, 62374796, 62427836, 62441229, 62511924, 62563908, 62565948, 62590523, 62695295, 62361315, 62376662, 62420192, 62434748, 62518137, 62540059, 62563778, 62627131, 62698733, 62363684, 62367078, 62423914, 62430398, 62494662, 62565936, 62658602, 62695876, 62445930, 62340579, 62344051, 62423923, 62423924, 62423925, 62423926, 62482213, 62563747, 62610937, 62710619, 62342528, 62405897, 62434390, 62515483, 62563726, 62612227, 62695297, 62349892, 62422726, 62434393, 62515488, 62563788, 62631075, 62698741, 62355455, 62374809, 62421505, 62434752, 62522772, 62602612, 62695290, 62717336, 62368460, 62374671, 62415303, 62435709, 62435710, 62435711, 62505567, 62563909, 62565944, 62691386, 62360467, 62374806, 62422729, 62434754, 62504020, 62630275, 62691388, 62698735, 62368463, 62374824, 62423915, 62435712, 62435713, 62499165, 62563927, 62565963, 62446275, and 62502226.",,"77,737 units total","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Devices",68878,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.","Z-2575-2014","Class II","PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and ","Part Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, and 42527600919. Lot numbers: 62345370, 62402721, 62423922, 62424796, 62494665, 62563912, 62590524, 62696878, 62717331, 62347233, 62399612, 62428432, 62505575, 62563917, 62592279, 62692687, 62352330, 62416376, 62432157, 62490790, 62563913, 62590525, 62696881, 62357329, 62374803, 62412999, 62432797, 62490792, 62563911, 62654931, 62717334, 62357328, 62372411, 62407772, 62432794, 62463961, 62525489, 62563914, 62575756, 62702758, 62724743, 62358632, 62373739, 62405896, 62432154, 62463962, 62563916, 62656074, 62710626, 62432790, 62462267, 62572574, 62443455, 62456923, 62568289, 62357865, 62410790, 62423921, 62424804, 62500930, 62573363, 62695299, 62347240, 62399870, 62430403, 62504858, 62572571, 62692683, 62732165, 62357866, 62406970, 62432150, 62479624, 62573364, 62695293, 62351310, 62410788, 62435708, 62507548, 62569955, 62698727, 62358633, 62373740, 62410789, 62432796, 62465722, 62517280, 62581856, 62695873, 62363685, 62364505, 62407568, 62432152, 62463963, 62505999, 62572570, 62695889, 62710608, 62432792, 62499171, 62704629, 62445747, and 62497257. ",,"77,737 units total ","Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.",8/7/2014,"08/07/2014",9/10/2014,"09/10/2014"
"Drugs",68879,"Ongoing","Boehringer Ingelheim Roxane Inc","Columbus","OH","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1486-2014","Class III","OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.","Lot #: 360241A, Expiry: 05/2015.",,"2,149 Bottles","Failed Stability Specifications: Out of specification result for preservative sodium benzoate.",7/28/2014,"07/28/2014",8/6/2014,"08/06/2014"
"Food",68880,"Ongoing","BrandStorm Inc","Van Nuys","CA","US","Voluntary: Firm Initiated","Letter","North Dakota","F-2332-2014","Class I","Organic Carob Powder, Net Wt. 55lbs (25kg), Product Code: CAROB-100","Lot Code: AN-395-13",,"2640 lbs","BrandStorm is recalling Organic Carob Powder because it may be contaminated with Salmonella.",7/21/2014,"07/21/2014",8/27/2014,"08/27/2014"
"Biologics",68881,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","Visit","CO","B-0919-14","Class II","Red Blood Cells Leukocytes Reduced","W290614054949",,"1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",7/7/2014,"07/07/2014",10/1/2014,"10/01/2014"
"Biologics",68882,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0950-14","Class III","Red Blood Cells Leukocytes Reduced","W04101407700600; ",".","1 unit","Misbranded Red Blood Cell was distributed. ",6/1/2014,"06/01/2014",9/3/2014,"09/03/2014"
"Biologics",68883,"Terminated","Cangene Plasma Resources, Inc.","Altamonte Springs","FL","US","Voluntary: Firm Initiated","FAX","California","B-0949-14","Class III","Source Plasma","9140152016; 9140156096; 9140180695; ",".","3 units","Source Plasma, collected from an ineligible donor, was distributed.",6/2/2014,"06/02/2014",9/3/2014,"09/03/2014"
"Biologics",68884,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0948-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W038114057623; W038114053700; W038114022752; W038114024500; ",".","4 units","Misbranded Red Blood Cells were distributed. ",6/17/2014,"06/17/2014",9/3/2014,"09/03/2014"
"Biologics",68885,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Letter","Connecticut","B-0947-14","Class II","Platelets Pooled Leukocytes Reduced","W051714803732; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. ",6/16/2014,"06/16/2014",9/3/2014,"09/03/2014"
"Biologics",68887,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0871-14","Class II","Fresh Frozen Plasma","W290614052314; W290614051423; W290614051402; W290614051405; W290614051407; W290614051408; W290614051426; W290614051214; W290614050926; W290614050895; W290614050820; W290613048777; W290613048784; W290613048780; W290613048785; W290613048827; W290613047881; W290613047883; W290613047887; W290613047895; W290613047896; W290614051640; W290613048356; W290613048015; W290613048032; W290613048563; W290613048564; W290613048201; W290613048234; W290613048259; W290613048273; W290613047897; W290614050746; W290613048010; W290613047864; W290613047571; W290613049006; W290613049003; W290613048886; W290613048585; W290613048599; W290613048632; W290613048663; W290613048460; W290613048546; W290613048548; W290613048549; W290613048550; W290613048555; W290613048556; W290613048559; W290614051680; W290613048391; W290614050688; W290614050631; W290614050630; W290614050629; W290614050607; W290614050591; W290614050579; W290614050565; ",".","61 units","Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed",5/8/2014,"05/08/2014",8/13/2014,"08/13/2014"
"Biologics",68887,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0872-14","Class II","Red Blood Cells Leukocytes Reduced","W290613049083; W290613049031; W290613048853; W290614052529; W290614052569; W290614052868; W290614052874; W290614052881; W290614051857; W290614051663; W290614051358; W290614051360; W290614050797; W290614050785; W290613048505; W290613048086; W290613048088; W290613047668; W290613047671; W290613048852; W290614050579; W290613048854; ",".","22 units","Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed",5/8/2014,"05/08/2014",8/13/2014,"08/13/2014"
"Biologics",68887,"Terminated","Penrose-St Francis Health Services Blood Bank","Colorado Springs","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0870-14","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W290613048934; ",".","1 unit","Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed. ",5/8/2014,"05/08/2014",8/13/2014,"08/13/2014"
"Devices",68888,"Ongoing","Medtronic MiniMed Inc.","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.","Z-2179-2014","Class II","Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.","CSS7100 and CSS7100K",".","86 units","Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.",7/21/2014,"07/21/2014",8/20/2014,"08/20/2014"
"Devices",68890,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","Bridgend",,"GB","Voluntary: Firm Initiated",,"Worldwide Distribution - USA (nationwide) and Internationally to France and Japan","Z-2183-2014","Class II","VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma. ","Lot 1320, Product code: 6800035 and 6800040",".","475","Customers may receive positively biased results when using VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values. ",7/16/2014,"07/16/2014",8/20/2014,"08/20/2014"
"Drugs",68891,"Ongoing","SST Corporation","Clifton","NJ","US","Voluntary: Firm Initiated","Telephone","CA","D-1517-2014","Class II","Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5 ","Lot: 168.862, Expiry: 6/2017 ",".","1 Drum","CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.",7/17/2014,"07/17/2014",8/13/2014,"08/13/2014"
"Devices",68892,"Ongoing","BD Biosciences, Systems & Reagents","San Jose","CA","US","Voluntary: Firm Initiated","Letter","IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium","Z-2233-2014","Class III","BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry. ","Catalog number 340916; Lot number BM084L",".","85","The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02",7/18/2014,"07/18/2014",8/20/2014,"08/20/2014"
"Food",68893,"Ongoing","Allegro Fine Foods Inc","Paris","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, LA, TN, TX, IL, GA, OH, IN, NC, VA, MO, FL","F-2304-2014","Class III","Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7","Best By 6/17/17, Lot 14168",".","20,160 units","Elevated yeast level with likelihood of premature spoilage.",7/21/2014,"07/21/2014",8/13/2014,"08/13/2014"
"Food",68893,"Ongoing","Allegro Fine Foods Inc","Paris","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, LA, TN, TX, IL, GA, OH, IN, NC, VA, MO, FL","F-2304-2014","Class III","Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7","Best By 6/17/17, Lot 14168",".","20,160 units","Elevated yeast level with likelihood of premature spoilage.",7/21/2014,"07/21/2014",8/20/2014,"08/20/2014"
"Food",68894,"Ongoing","D.A. Stein Culinary Group, LLC dba Brett Anthony Foods","Northbrook","IL","US","Voluntary: Firm Initiated","Telephone","US: IN","F-2344-2014","Class II","Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated.","Batch Numbers and Expiration Dates: 1) Batch 14196, Expires 7/26/14; 2) Batch 14198, Expires 7/28/14; 3) Batch 14200, Expires 7/30/14; 4) Batch 14203, Expires 8/2/14",,"144 jars","Brett Anthony Foods is recalling Sesame Ginger Dressing because the allergen almonds (a tree nut) is not listed in the ''Contains'' allergen warning statement although almonds are listed in the list of ingredients.",7/23/2014,"07/23/2014",8/27/2014,"08/27/2014"
"Food",68895,"Ongoing","Great American Marketing Company","Houston","TX","US","Voluntary: Firm Initiated","Press Release","The product was distributed to one company in Schertz, TX.","F-0029-2015","Class I","Turkey & Swiss Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.","sell by date of 07/26/14",".","264 units (sandwiches)","The product has the potential to be contaminated with Listeria monocytogenes.",7/24/2014,"07/24/2014",10/22/2014,"10/22/2014"
"Food",68895,"Ongoing","Great American Marketing Company","Houston","TX","US","Voluntary: Firm Initiated","Press Release","The product was distributed to one company in Schertz, TX.","F-0028-2015","Class I","Ham & Cheddar Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.","sell by date of 07/26/14",".","288 units (sandwiches)","The product has the potential to be contaminated with Listeria monocytogenes.",7/24/2014,"07/24/2014",10/22/2014,"10/22/2014"
"Drugs",68896,"Ongoing","Fagron, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide and Australia","D-1498-2014","Class II","Fagron, Pentravan Plus Base 2.5 Kg, RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Preserved and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8,","Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17 ",,"99 jars","Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. ",7/24/2014,"07/24/2014",8/6/2014,"08/06/2014"
"Drugs",68896,"Ongoing","Fagron, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide and Australia","D-1496-2014","Class II","Fagron, Phytobase Cream, 500 g, RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.","Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15 ",,"430 jars","Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. ",7/24/2014,"07/24/2014",8/6/2014,"08/06/2014"
"Drugs",68896,"Ongoing","Fagron, Inc","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide and Australia","D-1497-2014","Class II","Fagron, Pentravan Base 2.5 Kg, RX only, For prescription compouning, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.","Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17 ",,"97 jars","Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. ",7/24/2014,"07/24/2014",8/6/2014,"08/06/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0674-2015","Class II","Whole Foods Market Peach Glazed Pork Loin, UPC/PLU 20249000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0637-2015","Class II","Whole Foods Market Cake Large Layer 1/4 Sheet Chantilly, UPC/PLU 21677200000; Whole Foods Market Cake Individual Chantilly, UPC/PLU 21677400000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0691-2015","Class II","Whole Foods Market Peach Goat Medallion, UPC/PLU 29535400000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0676-2015","Class II","Whole Foods Market Peaches, UPC/PLU 21085000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0690-2015","Class II","Whole Foods Market Tea Hive-Peach Julep Sparkler, UPC/PLU 30865","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0692-2015","Class II","Whole Foods Market Tart Galette Peach, UPC/PLU 24070900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0626-2015","Class II","Whole Foods Market Dip Peach Salsa, UPC/PLU 029648300000 Whole Foods Market Scale-Salsa Peach, UPC/PLU 96483 Whole Foods Market Peach Salsa MIN, UPC/PLU 96483 Whole Foods Market Peach Salsa XS, UPC/PLU 90614 Whole Foods Market Peach Salsa, UPC/PLU 25023900000 Whole Foods Market Dip Salsa Peach-LG, UPC/PLU 29648300000 Whole Foods Market Salsa Peach, UPC/PLU 29648300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".",,"The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0660-2015","Class II","Whole Foods Market Smoothie-Peach Pizazz 24 oz., UPC/PLU 50279; Whole Foods Market Smoothie-Peach Pizazz 16 oz., UPC/PLU 50278; Whole Foods Market Smoothie-Peach Pizazz 32 oz., UPC/PLU 50280","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0669-2015","Class II","Whole Foods Market Grilled Shrimp and Nectarine Salad, UPC/PLU 20254100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0633-2015","Class II","Whole Foods Market Mango Peach Salsa MIN, UPC/PLU 50195 Whole Foods Market Mango Peach Salsa XS, UPC/PLU 58122","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0656-2015","Class II","Whole Foods Market Upside Down Cake-Peach Blueberry, UPC/PLU 25715800000, Whole Foods Market Cake Small Upside Down Peach Blue, UPC/PLU 24632500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0671-2015","Class II","Whole Foods Market Heirloom Tomato and Nectarine Salad, UPC/PLU 20253800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0687-2015","Class II","Whole Foods Market Chipotle Peach Turkey, UPC/PLU 29966100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0700-2015","Class II","Whole Foods Market Fresh Peachy Keen Juice 16 oz., UPC/PLU 29683800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0663-2015","Class II","Whole Foods Market Bleu Peach Pizza, UPC/PLU 20547600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0638-2015","Class II","Whole Foods Market Sweet Petites 2 For $3, UPC/PLU 21687700000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0658-2015","Class II","Whole Foods Market Smoothie-Immunity Boost 16 oz., UPC/PLU 50172; Whole Foods Market Smoothie-Immunity Boost 24 oz., UPC/PLU 50173; Whole Foods Market Smoothie-Immunity Boost 32 oz., UPC/PLU 50174","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0697-2015","Class II","Whole Foods Market Salsa Peach and Cucumber, UPC/PLU 29648300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0651-2015","Class II","Whole Foods Market WFM Dess Bar-Peach Crumble, UPC/PLU 20666800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0641-2015","Class II","Whole Foods Market Tart Large Galette Seasonal Fruit, UPC/PLU 24987600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0694-2015","Class II","Whole Foods Market Peachy Keen Cold Pressed 16 oz, UPC/PLU 29682700000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0698-2015","Class II","Whole Foods Market Peachy Palmer, UPC/PLU 15766","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0628-2015","Class II","Whole Foods Market Grilled Peaches with Burrata & Balsamic, UPC/PLU 22206300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0668-2015","Class II","Whole Foods Market Grilled Salmon with Peach Rosemary Jam, UPC/PLU 20255600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0672-2015","Class II","Whole Foods Market Heirloom Tomato Peach and Mozzarella Salad, UPC/PLU 20253800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0648-2015","Class II","Whole Foods Market Cake-Peaches Cream 9'', UPC/PLU 20179200000; Whole Foods Market Cake-Peaches Cream 6'', UPC/PLU 20931300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0670-2015","Class II","Whole Foods Market Grilled Spiced Peach and Kale Salad, UPC/PLU 20213300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0696-2015","Class II","Whole Foods Market Lime Infused Peaches and Raspberries, UPC/PLU 29178200000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0689-2015","Class II","Whole Foods Market Tea Hive-Orchard Peach Freeze, UPC/PLU 30868","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0685-2015","Class II","Whole Foods Market Peach Basil Stuffed Blackened Salmon, UPC/PLU 29512800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0686-2015","Class II","Whole Foods Market Peach Basil Stuffed Salmon, UPC/PLU 25179600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0680-2015","Class II","Whole Foods Market Caramelized Peach with Ricotta, UPC/PLU 20256300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0653-2015","Class II","Whole Foods Market WF Bakery Parfait-Seasonal Fruit, UPC/PLU 20690500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0659-2015","Class II","Whole Foods Market Smoothie-Apple Pie 16 oz (HSH), UPC/PLU 25113; Whole Foods Market Smoothie-Apple Pie 24 oz (HSH), UPC/PLU 2007","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0677-2015","Class II","Whole Foods Market Peaches with Toasted Almonds and Basil (HSH), UPC/PLU 20250100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0654-2015","Class II","Whole Foods Market Ramekin Peach, UPC/PLU 20129300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0640-2015","Class II","Whole Foods Market Pie Large Peach, UPC/PLU 21759600000; Whole Foods Market Pie Small 6'' Peach, UPC/PLU 24032900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0630-2015","Class II","Whole Foods Market Grilled Peaches, UPC/PLU 22703900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0644-2015","Class II","Whole Foods Market Peach Nectarine Lemonade, UPC/PLU 25104900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0667-2015","Class II","Whole Foods Market Grilled Salmon with Peach Ginger Jam, UPC/PLU 20217400000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0678-2015","Class II","Whole Foods Market Peaches, Feta with toasted almonds and Basil, UPC/PLU 20253800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0657-2015","Class II","Whole Foods Market HSH Parfait-Blueberry, UPC/PLU 20659600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0635-2015","Class II","Whole Foods Market Cake Large Chantilly Peach, UPC/PLU 21617800000; Whole Foods Market Cake Small Chantilly Peach, UPC/PLU 21617900000; Whole Foods Market Cake Slice Chantilly Peach, UPC/PLU 21623200000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0634-2015","Class II","Whole Foods Market Cake Slice Chantilly Seasonal, UPC/PLU 21615600000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 24420800000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 28825800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0652-2015","Class II","Whole Foods Market WF Bakery Parfait-Peach, UPC/PLU 20683800000; Whole Foods Market Peach Parfait, UPC/PLU 20690500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0684-2015","Class II","Whole Foods Market Peach Basil Glazed Smoked Salmon, UPC/PLU 29074000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0699-2015","Class II","Whole Foods Market 4'' fresh fruit tart decorated with plums, UPC/PLU 0201189005002; Whole Foods Market 6'' fresh fruit tart decorated with plums, UPC/PLU 0201898022000; Whole Foods Market 9'' fresh fruit tart decorated with plums, UPC/PLU 0201897029000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0627-2015","Class II","Whole Foods Market FM Grill Tray Peach, UPC/PLU 025994200000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".",,"The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0646-2015","Class II","Whole Foods Market Seasonal Fruit Tart 4'', UPC/PLU 20900400000; Whole Foods Market Seasonal Fruit Tart 6'', UPC/PLU 20900600000 Whole Foods Market Seasonal Fruit Tart 9'', UPC/PLU 20900700000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0662-2015","Class II","Whole Foods Market BBQ Peach Tempeh, UPC/PLU 20254000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0647-2015","Class II","Whole Foods Market Peaches n Cream Cake 6'', UPC/PLU 20733500000; Whole Foods Market Peaches n Cream Cake 8'', UPC/PLU 20733600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0661-2015","Class II","Whole Foods Market Balsamic Chicken Breast & Peaches, UPC/PLU 20254100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0666-2015","Class II","Whole Foods Market Grilled Peaches and Cream, UPC/PLU 20253700000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0629-2015","Class II","Whole Foods Market HSH Kale Barley Peach Salad, UPC/PLU 22442300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0639-2015","Class II","Whole Foods Market Tart Peach 6'', UPC/PLU 21704100000; Whole Foods Market WF Bakery Tart-Peach 4'', UPC/PLU 20791000000; Whole Foods Market WF Bakery Tart-Peach 9'', UPC/PLU 20791100000; Whole Foods Market WF Bakery Tart-Peach Mini, UPC/PLU 20791200000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0681-2015","Class II","Whole Foods Market CC HSH Pear Crisp Slaw, UPC/PLU 25730500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0673-2015","Class II","Whole Foods Market Peach Fruit Crisp, UPC/PLU 21222100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0682-2015","Class II","Whole Foods Market FM Sangria Mix LG, UPC/PLU 29690300000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0683-2015","Class II","Whole Foods Market Salmon Fillet with Peach Salsa, UPC/PLU 29913800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0632-2015","Class II","Whole Foods Market Scale-Yogurt Cup Peaches and Cream, UPC/PLU 96595","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0649-2015","Class II","Whole Foods Market Pie-Peaches and Cream 8in, UPC/PLU 20139000000;Whole Foods Market Pie-Peaches and Cream 4in, UPC/PLU 20628800000; Whole Foods Market WFM Pie-Peaches and Cream Mini, UPC/PLU 20656900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0693-2015","Class II","Whole Foods Market Parfait, UPC/PLU 20642800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0655-2015","Class II","Whole Foods Market Cobbler Peach, UPC/PLU 20136000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0642-2015","Class II","Whole Foods Market Tart Large Square Fruit, UPC/PLU 28893200000; Whole Foods Market Tart Fruit Large, UPC/PLU 20189700000; Whole Foods Market Tart Fruit Large Square, UPC/PLU 20611000000; Whole Foods Market Tart Fruit Medium, UPC/PLU 26255; Whole Foods Market Tart Fruit Medium, UPC/PLU 20189800000; Whole Foods Market Tart Fruit Small, UPC/PLU 20189600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0636-2015","Class II","Whole Foods Market Tart Large Fresh Fruit, UPC/PLU 21633000000; Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 21633100000, Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 24985200000; Whole Foods Market Tart Fresh Fruit Large, UPC/PLU 14450","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0650-2015","Class II","Whole Foods Market WFM Dess Bar Cobbler-Peach, UPC/PLU 20643100000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0643-2015","Class II","Whole Foods Market Summer Splash, UPC/PLU 25102000000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0688-2015","Class II","Whole Foods Market MRH Peach Butter, UPC/PLU 20034900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0675-2015","Class II","Whole Foods Market Peach Stuffed Pork Loin, UPC/PLU 20216400000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0631-2015","Class II","Whole Foods Market HSH Peach Chutney, UPC/PLU 22935500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0664-2015","Class II","Whole Foods Market Crispy BBQ Peach Tempeh, UPC/PLU 20253800000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0645-2015","Class II","Whole Foods Market Heirloom Tomato & Peach Salad, UPC/PLU 28353400000/83534; UPC/PLU 20264900000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0679-2015","Class II","Whole Foods Market Caramelized Peach, UPC/PLU 20256200000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0695-2015","Class II","Whole Foods Market Fruit Kabobs for Grilling, UPC/PLU 29656500000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Food",68897,"Ongoing","Whole Foods Market","Austin","TX","US","Voluntary: Firm Initiated","Press Release","All states where Whole Foods Market stores are located except Florida, Washington, and Oregon.","F-0665-2015","Class II","Whole Foods Market Cumin Lime Grilled Peach and Mozzarella Towers, UPC/PLU 20211600000","Sold between June 1 and July 21, 2014 at Whole Foods Stores",".","Unknown","The product has the potential to be contaminated with Listeria monocytogenes.",7/23/2014,"07/23/2014",12/17/2014,"12/17/2014"
"Devices",68898,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.","Z-2256-2014","Class II","Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component ","UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,",,"13","Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",7/11/2014,"07/11/2014",8/27/2014,"08/27/2014"
"Devices",68898,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.","Z-2257-2014","Class II","Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed ","CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666",,"1","Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",7/11/2014,"07/11/2014",8/27/2014,"08/27/2014"
"Devices",68898,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.","Z-2255-2014","Class II","PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component ","PS Tibial Insert Size 3 8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3 9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3 12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5 9mm,Part 163-1509,Lot A135827,",,"11","Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",7/11/2014,"07/11/2014",8/27/2014,"08/27/2014"
"Devices",68898,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.","Z-2253-2014","Class II","Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum ","Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,",,"188","Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",7/11/2014,"07/11/2014",8/27/2014,"08/27/2014"
"Devices",68898,"Ongoing","Ortho Development Corporation","Draper","UT","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.","Z-2254-2014","Class II","Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component","Patella 38mm Part 164-0038, Lot A135844",,"14","Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",7/11/2014,"07/11/2014",8/27/2014,"08/27/2014"
"Food",68899,"Ongoing","Dancing Star LLC","Greenfield","MA","US","Voluntary: Firm Initiated","Telephone","The recalled items are distributed nationwide and sold to retail stores, some of them in bulk for the sales of smaller quantities to their customers.","F-0100-2015","Class I","Date Flax with Turmeric Chunks of Energy (10# UPC 7-69270-20004-5); also Date Flax Turmeric Chunks of Energy and Rave Bites Date Flax with Turmeric (7 oz UPC 7-69270-70006-4). ","Production Lots: 10-lb (0794-1, 0794-2, 0794-3, 0954, 1004, 1084, 1124, 1134-1, 1134-2, 1134-3, 1134-4, 1134-5, 1624-3, 1784-1, 1914, 1974); Production Lot: 7 oz 1004; Rave Bites Date Flax with Turmeric (7oz Sell By Dates 4/10/15 and 4/25/15)",,,"Product may be contaminated with Salmonella. ",7/22/2014,"07/22/2014",11/12/2014,"11/12/2014"
"Food",68899,"Ongoing","Dancing Star LLC","Greenfield","MA","US","Voluntary: Firm Initiated","Telephone","The recalled items are distributed nationwide and sold to retail stores, some of them in bulk for the sales of smaller quantities to their customers.","F-0099-2015","Class I","Carob Supergreens Chunks of Energy (10# UPC 7-69270-10009-7); also, Carob Supergreens Chunks of Energy and Rave BItes Brand Carob Supergreens (7 oz UPC 7-69270-70008-8).","Production lots 10 lb: (0844-1, 0844-2, 0844-3, 0954-1, 0954-2, 0954-3, 0954-4, 0994-1, 0994-2, 1014, 1094-1, 1094-2, 1094-3, 1154-1, 1154-2, 1154-3, 1154-4, 1574, 1634-1,1634-2, 1634-3, 1644, 1684, 1744-1, 1744-2, 1744-3, 1824-1, 1824-2, 1924-1, 1924-2, 1994). Production Lot, 7 oz: 1014.; Rave Bites Carob Supergreens, 7 oz. Sell By Date 6/06/15. ",,,"Product may be contaminated with Salmonella. ",7/22/2014,"07/22/2014",11/12/2014,"11/12/2014"
"Food",68899,"Ongoing","Dancing Star LLC","Greenfield","MA","US","Voluntary: Firm Initiated","Telephone","The recalled items are distributed nationwide and sold to retail stores, some of them in bulk for the sales of smaller quantities to their customers.","F-0101-2015","Class I","Bulk organic Carob powder (10# UPC 7-69270-80001-6) ","Julian dates (0154, 0914, 0974, 0994, 1044, 1054, 1114, 1154, 1194, 1534, 1684, 1704, 1824, 1894)",,,"Product may be contaminated with Salmonella. ",7/22/2014,"07/22/2014",11/12/2014,"11/12/2014"
"Drugs",68900,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1509-2014","Class II","Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10","Lot EJ9591",,"1,332 bottles","Presence of Foreign Substance; tablets may contain stainless steel metal particulates",7/25/2014,"07/25/2014",8/6/2014,"08/06/2014"
"Drugs",68901,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Press Release","Nationwide","D-0020-2015","Class I","Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05","Lot Number: 25-550-DD, Exp: 1JAN2015",".","109,110 Vials","Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.",7/29/2014,"07/29/2014",10/22/2014,"10/22/2014"
"Food",68902,"Ongoing","GoMacro, Inc.","Viola","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide. OUS to Include: Canada, United Kingdom","F-2406-2014","Class II","gomacro MACROBAR brand sunflower butter + chocolate Net Wt. 2.3 oz (65 g)","18MAR15 Lot 1646",,"20,063 bars total","GoMacro is recalling MARCO BARS brand almond butter + carob (lots 1634 and 1645), and sunflower butter + chocolate (lot 1646) because they have the potential to be contaminated with Salmonella.",7/24/2014,"07/24/2014",9/10/2014,"09/10/2014"
"Food",68902,"Ongoing","GoMacro, Inc.","Viola","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide. OUS to Include: Canada, United Kingdom","F-2405-2014","Class I","gomacro MACROBAR brand almond butter + carob. Net Wt. 2 oz (57 g)","10MAR15, Lot 1634, and 18MAR15, Lot 1645",,"20,063 bars total","GoMacro is recalling MARCO BARS brand almond butter + carob (lots 1634 and 1645), and sunflower butter + chocolate (lot 1646) because they have the potential to be contaminated with Salmonella.",7/24/2014,"07/24/2014",9/10/2014,"09/10/2014"
"Food",68903,"Ongoing","Arise & Shine Herbal Products, Inc.","Medford","OR","US","Voluntary: Firm Initiated","E-Mail","Product is distributed worldwide.","F-2514-2014","Class II","The product is labeled in part ''***Arise & Shine Hydrated Bentonite Dietary Supplement Extra Thick Formula 32 FL OZ ***% Daily Value Iron 0***Distributed by: Arise & Shine Herbal Products 562 Parsons Drive Medford, Oregon 97501***'' Product is packaged in a foil pouch with a plastic screw-on lid. UPC 701088032067","2011 LOT/EXP DATE: 3461106 -12/2014, 3431106 -12/2014, 3411106 -12/2014, 3201106 - 11/2014, 3191106 - 11/2014, 3141106 - 11/2014, 2991106 - 11/2014, 2711106 - 10/2014, 2571106 - 09/2014, 2561106 - 09/2014, 2351106 - 09/2014, 2221106 - 08/2014, 2091106 - 07/2014, 1941106 - 07/2014, 1801106 - 06/2014. 2012 LOT/EXP DATE: 3541206 - 01/2016, 3421206 - 12/2015, 3141206 - 11/2015, 3131206 - 11/2015, 3001206 - 11/2015, 2851206 - 10/2015, 2771206 - 10/2015, 2761206 - 10/2015, 2511206 - 09/2015, 2161206 - 08/2015, 2151206 - 08/2015, 2071206 - 08/2015, 2021206 - 07/2015, 1801206 - 07/2015, 1651206 - 06/2015, 1641206 - 06/2015, 1511206 - 06/2015, 1451206 - 06/2015, 1251206 - 05/2015, 1161206 - 05/2015, 1181206 - 04/2015, 1111206 - 04/2015, 1011206 - 04/2015, 0871206 - 04/2015, 0741206 - 03/2015, 0671206 - 03/2015, 0601206 - 03/2015, 0121206 - 01/2015, 0111206 - 01/2015, 0041206 - 01/2015. 2013 LOT/EXP DATE: 3511306 -12/2016, 3471306 - 12/2016, 3461306 - 12/2016, 3391306 - 12/2016, 3381306 - 12/2016, 3111306 - 11/2016, 3041306 - 11/2016, 2911306 - 10/2016, 2901306 - 10/2016, 2831306 - 10/2016, 2771306 - 10/2016, 2621306 - 09/2016, 2611306 - 09/2016, 2331306 - 08/2016, 2321306 - 08/2016, 2201306 - 08/2016, 2191306 - 08/2016, 1991306 - 07/2016, 1981306 - 07/2016, 1651306 - 06/2016, 1641306 - 06/2016, 1361306 - 06/2016, 1351306 - 06/2016, 1281306 - 05/2016, 1271306 - 05/2016, 1231306 - 05/2016, 1221306 - 05/2016, 0931306 - 04/2016, 0921306 - 04/2016, 0731306 - 03/2016, 0721306 - 03/2016, 0651306 - 03/2016, 0531306 - 03/2016, 0391306 - 02/2016, 0311306 - 02/2016, 0171306 - 01/2016, 0151306 - 01/2016, 0091306 - 01/2016. 2014 LOT/EXP DATE: 1551406 - 06/2017,1501406 - 06/2017,1291406 - 05/2017,1271406 - 05/2017,1121406 - 04/2017,1071406 - 04/2017,0711406 - 03/2017,0781406 - 03/2017,0771406 - 03/2017,0571406 - 03/2017,0561406 - 03/2017,0431406 - 02/2017,0421406 - 02/2017,0221406 - 01/2017,0211406 - 01/2017. Code breakdown: Lot # 0091306: 009 (Julian date) 13 (year of 2013) 06 (Product identifier) ",,"Approximately 24,794 / 32 oz pouches.","Arise & Shine Herbal Products, Inc. is voluntarily recalling Hydrated Bentonite 32 oz liquid pouch due to mis-labeling. The product is labeled as containing 0% Daily Value of iron and actually contains 106% Daily Value of iron.",7/23/2014,"07/23/2014",10/1/2014,"10/01/2014"
"Food",68904,"Ongoing","The TJX Companies, Inc.","Framingham","MA","US","Voluntary: Firm Initiated","E-Mail","Alabama, Connecticut, Maryland, Massachusetts, Rhode Island, South Carolina, District of Columbia, Mississippi, Tennessee, Florida, New Hampshire, Texas, Georgia, New York, Virginia, Illinois, Louisiana, North Carolina, Puerto Rico","F-2333-2014","Class I","Product is in a 160 gram, light green tin container, labeled in part: ''ecoato Sweet Paprika Powder Product of Spain''","Lot# 8147",,"approx. 150 units","Salmonella",7/24/2014,"07/24/2014",8/27/2014,"08/27/2014"
"Food",68905,"Ongoing","Turkana Food Inc.","Kenilworth","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-2489-2014","Class III","Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, UPC 86925940080","None",,"18 cases (12 per case)","Tunas Turkish Delight Rose Flavored contains Ponceau 4R which is an unapproved color in the US. ",7/15/2014,"07/15/2014",10/1/2014,"10/01/2014"
"Food",68906,"Ongoing","Carmel Food Group, Inc.","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","GA, NH, CT, IA, PA, WA, IN, TX OH, AZ, FL, MD","F-2339-2014","Class II","Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA ","Sell by APR 09 2015; Product code 55557.",,"2,160 cases (6 x 8 oz. packages)","Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package.",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Food",68906,"Ongoing","Carmel Food Group, Inc.","Hayward","CA","US","Voluntary: Firm Initiated","Press Release","GA, NH, CT, IA, PA, WA, IN, TX OH, AZ, FL, MD","F-2339-2014","Class II","Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA ","Sell by APR 09 2015; Product code 55557.",".","2,160 cases (6 x 8 oz. packages)","Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68907,"Ongoing","Sunfood Superfoods","El Cajon","CA","US","Voluntary: Firm Initiated","E-Mail","AK, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA ,WI","F-2415-2014","Class I","Organic Carob Powder, 1 lb., 20 lb., and 55 lb. bags Expiry date: 6/5/2015, UPC Code 803813-04429-8","Lot Numbers- 140616;140516;140416;140321;140609;140509;140623",,"1773 lbs","Sunfood Corporation is recalling Organic Carob Powder because it may be contaminated with Salmonella",7/27/2014,"07/27/2014",9/10/2014,"09/10/2014"
"Devices",68908,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.","Z-2626-2014","Class II","Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.","Catalog #48758500, Lot #'s 107400, 10G906 and 110214; ",".","64 units","Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. ",7/7/2014,"07/07/2014",9/17/2014,"09/17/2014"
"Devices",68908,"Ongoing","Stryker Spine","Allendale","NJ","US","Voluntary: Firm Initiated",,"Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.","Z-2627-2014","Class II","Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.","Catalog #IS3021ARI, Lot #'s 20774, 20798, 20805 and 21990",".","57 units","Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. ",7/7/2014,"07/07/2014",9/17/2014,"09/17/2014"
"Devices",68909,"Ongoing","MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK","HIROSHIMA",,"JP","Voluntary: Firm Initiated","E-Mail","Distributed in the states of NY, FL, and TX.","Z-2653-2014","Class II","VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.","Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919",,"3 units in use in the US","Software Anomaly: Due to certain software bug, if a user changes the calendar setting from ''workday'' to ''holiday'' or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become ''treated (completed)'' status on the exact day when such change is made, to ''untreated'' status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as ''untreated'' treatment.",7/5/2014,"07/05/2014",9/24/2014,"09/24/2014"
"Drugs",68910,"Ongoing","Fresenius Kabi USA, LLC","Melrose Park","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1545-2014","Class II","PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01","Lot 6007698, Exp. 03/16",,"56,060 vials","CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.",8/13/2014,"08/13/2014",8/27/2014,"08/27/2014"
"Food",68911,"Terminated","Starway Inc.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, MA and MI","F-0002-2015","Class I","PEONY MARK brand ROASTED AND SALTED PUMPKIN SEED, NET WT. 12 oz. (340 gm), Barcode 6 932692 225765, PRODUCT OF CHINA --- PACKED FOR: STARWAY INC 137 GRATTAN STREET, BROOKLYN, NEW YORK 11237 --- NUTRITION FACTS: Serving Size 1 oz., Servings per container 12","Barcode 6 932692 225765 and no other coding",,"29 cases (24 x 12 oz. packages per case)","The product contained undeclared sulfites (873.3 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.",7/21/2014,"07/21/2014",10/15/2014,"10/15/2014"
"Devices",68912,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, NE, NH, NJ, NY, OH, OR, PA, PR, SC, TN, TX, VA, VT, WA, WI, and WV.","Z-2563-2014","Class II","Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.","Part Numbers: 04420306001 Serial #'s: 2706, 2724, 2743, 2744, 2745, 2749, 2750, 2751, 2752, 2754, 2755, 2764, 2770, 2771, 2772, 2773, 2774, 2775, 2776, 2780, 2781, 2782, 2783, 2784, 2785, 2789, 2790, 2791, 2792, 2793, 2794, 2795, 2796, 2797, 2798, 2799, 2808, 2814, 2815, 2816, 2818, 2819, 2823, 2824, 2825, 2826, 2828, 2829, 2830, 2831, 2847, 2848, 2849, 2857, 2858, 2859, 2860, 2861, 2862, 2863, 2864, 2865, 2904, 2905, 2906, 2908, 2909, 2914, 2915, 2916, 2917, 2920, 2921, 2928, 2931, 2932, 2933, 2934, 2935, 2936, 2937, 2938, 2939, 2940, 2941, 2943, 2983, 2984, 2985, 2986, 2987, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 2998, 3006, 3007, 3008, 3009, 3016, 3020, 3021, 3023, 3024, 3025, 3026, 3027, 3048, 3049, 3050, 3051, 3053, 3057, 3058, 3059, 3060, 3061, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3077, 3079, 3082, 3083, 3084, 3085, 3086, 3087, 3089, 3090, 3104, 3105, 3106, and 3107. ",,"148 Units","It has been internally found that if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured in cobas IT 1000 as the Generic Patient ID (999999 by default) it can assign previously stored generic patient test results to the newly created patient ID. This issue has not been reported by any customers; however the outcome of the issue is that test results would be assigned to the wrong Patient ID.",7/31/2014,"07/31/2014",9/10/2014,"09/10/2014"
"Food",68913,"Ongoing","CaCoCo, Inc.","Grass Valley","CA","US","Voluntary: Firm Initiated","Press Release","CA only and internet sales.","F-2337-2014","Class I","CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet, Medicinal, Energizing Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Beans, Cacao Butter, Maca, Carob, coconut Crystal Sugar, Mesquite, Wildcrafted Shilajit, Vanilla Bean, Turmeric, Cardamon, Orange Peel, Himalayan Salt, Whole Leaf Stevia. Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA UPC 091131352076","Lot # GW99, Exp 10/19/2014; GW100, Exp 11/28/2014; GW101, Exp 6/18/2015.",,"1603.5 lbs.","Firm used organic powder that is now under recall by supplier for potential contamination with Salmonella.",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Food",68913,"Ongoing","CaCoCo, Inc.","Grass Valley","CA","US","Voluntary: Firm Initiated","Press Release","CA only and internet sales.","F-2338-2014","Class I","CaCoCo Superfood Drinking Chocolate; Original - Flavor Melody: Sweet, Playful, Perfectly Spiced Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Butter, Maca, Coconut Crystal Sugar,Carob, Cacao Bean, Cacao Powder, Lucuma, Himalayan Salt, Vanilla Bean, Cinnamon, Nutmeg, Cayenne. Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA UPC 09113152113","Lot # OG99, Exp 10/19/2014; OG100, Exp 11/28/2014; OG101, Exp 6/18/2015.",,"1603.50 lbs.","Firm used organic powder that is now under recall by supplier for potential contamination with Salmonella.",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Devices",68914,"Ongoing","Cook Inc.","Bloomington","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internationally to: Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.","Z-2243-2014","Class I","CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.","Model Number(s): VRS-6.0-9.0 Lot numbers: 3583416, 3583418, 3583422, 3583424, 3583426, 3583428, 3583430, 3583432, 3583434, 3583436, 3583440, 3583442, 3583452, 3583456, 3583458, 3583462, 3583464, 3583466, 3583468, 3583470, 3583472, 3583474, 3583476, 3583478, 3583480, 3583482, 3583484, 3583486, 3583488, 3583490, 3583492, 3583494, 3583496, 3583498, 3583500, 3583502, 3583504, 4293921, 4293923, 4293925, 4293927, 4319573, 4319575, 4319577, 4319579, 4319581, 4319583, 4319585, 4319587, 4319589, 4319591, 4572365, 3583418X, 3583430X, 3583442X, 3583442XX, 3583464XXX, 3583480XX, and 3583486X. ",".","696 devices total distribution (671 nationwide)","This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. ",7/17/2014,"07/17/2014",9/3/2014,"09/03/2014"
"Devices",68915,"Ongoing","Biomet 3i, LLC","Palm Beach Gardens","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to NH and TX.","Z-2594-2014","Class II","BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration. ","Model Number IEHA458, Lot number: 1167545. ",".","6 units","Identifiers on the label are correct but the label has the incorrect color coding.",6/25/2014,"06/25/2014",9/17/2014,"09/17/2014"
"Drugs",68917,"Terminated","Unit Dose Solutions Inc","Morrisville","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA","D-0017-2015","Class II","Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808","Lot 204751 Exp. 04/15",".","1,177 packets","Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium ",6/2/2014,"06/02/2014",10/22/2014,"10/22/2014"
"Biologics",68918,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0951-14","Class II","Source Plasma","3770200847; 3770200549; 3770199963; 3770199790; ",".","4 units","Source Plasma, collected from an ineligible donor, was distributed. ",5/21/2014,"05/21/2014",9/3/2014,"09/03/2014"
"Biologics",68919,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0897-14","Class II","Platelets Pooled Leukocytes Reduced","W270111536940; ",".","1","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jacob Disease (CJD), were distributed.",6/21/2014,"06/21/2014",9/17/2014,"09/17/2014"
"Biologics",68919,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0895-14","Class II","Fresh Frozen Plasma","W270111538857; ",".","1","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jacob Disease (CJD), were distributed.",6/21/2014,"06/21/2014",9/17/2014,"09/17/2014"
"Biologics",68919,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0896-14","Class II","Red Blood Cells Leukocytes Reduced","W270111538857; ",".","1","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jacob Disease (CJD), were distributed",6/21/2014,"06/21/2014",9/17/2014,"09/17/2014"
"Biologics",68920,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0898-14","Class II","Source Plasma","3770200579; 3770200319; ",".","2 units","Blood product, for which donor eligibility was not complete, was distributed.",5/21/2014,"05/21/2014",9/3/2014,"09/03/2014"
"Biologics",68921,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","Arizona","B-0918-14","Class II","Plasma Frozen within 24 hours (FP24)","W036214120951; ",".","1","Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed. ",5/20/2014,"05/20/2014",9/17/2014,"09/17/2014"
"Biologics",68922,"Terminated","Walter L. Shepeard Community Blood Center, Inc.","Augusta","GA","US","Voluntary: Firm Initiated","E-Mail","Indiana; Georgia","B-0914-14","Class II","Red Blood Cells Leukocytes Reduced","W038513350781; W038513343287; ",".","2","Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",7/8/2014,"07/08/2014",9/3/2014,"09/03/2014"
"Biologics",68922,"Terminated","Walter L. Shepeard Community Blood Center, Inc.","Augusta","GA","US","Voluntary: Firm Initiated","E-Mail","Indiana; Georgia","B-0915-14","Class II","Plasma Frozen","W038513350781; W038513343287; ",".","2"," Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. ",7/8/2014,"07/08/2014",9/3/2014,"09/03/2014"
"Biologics",68923,"Terminated","American Red Cross Blood Services Heart of America Region","Peoria","IL","US","Voluntary: Firm Initiated","Letter","Illinois","B-0916-14","Class II","Platelets Pheresis Leukocytes Reduced","W2040148044161; W2040148044162; ",".","2","Platelet products, collected on an instrument which failed leukoreduction quality control procedures, were distributed.",6/2/2014,"06/02/2014",9/17/2014,"09/17/2014"
"Biologics",68924,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0937-14","Class II","Source Plasma","3770199794; 3770199121; ",,"2 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.",5/21/2014,"05/21/2014",9/10/2014,"09/10/2014"
"Biologics",68925,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","E-Mail","California","B-0938-14","Class II","Source Plasma","3770199150; ",".","1 unit","Blood product, collected from a donor who did not have a complete physical examination, was distributed.",5/21/2014,"05/21/2014",9/17/2014,"09/17/2014"
"Biologics",68927,"Terminated","Kentucky Blood Center Inc","Lexington","KY","US","Voluntary: Firm Initiated","Telephone","Kentucky","B-0940-14","Class III","Platelets Pheresis Leukocytes Reduced","W038214041538; W038214041538; W038214041538; ",,"Three units","Blood products, in which CMV testing was performed with an expired reagent, were distributed.",6/2/2014,"06/02/2014",9/10/2014,"09/10/2014"
"Biologics",68927,"Terminated","Kentucky Blood Center Inc","Lexington","KY","US","Voluntary: Firm Initiated","Telephone","Kentucky","B-0941-14","Class III","Red Blood Cells Leukocytes Reduced","W038214040416; W038214040418; W038214033686; W038214033688; W038214040389; W038214040391; ",," Six units","Blood products, in which CMV testing was performed with an expired reagent, were distributed.",6/2/2014,"06/02/2014",9/10/2014,"09/10/2014"
"Biologics",68927,"Terminated","Kentucky Blood Center Inc","Lexington","KY","US","Voluntary: Firm Initiated","Telephone","Kentucky","B-0939-14","Class III","Platelets Leukocytes Reduced Irradiated","W038214040413; ",,"One unit","Blood products, in which CMV testing was performed with an expired reagent, were distributed",6/2/2014,"06/02/2014",9/10/2014,"09/10/2014"
"Biologics",68928,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan;","B-0936-14","Class III","Red Blood Cells Leukocytes Reduced","W120614600847; ",,"One unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, was distributed.",6/25/2014,"06/25/2014",9/10/2014,"09/10/2014"
"Biologics",68929,"Terminated","Saving Sight","Kansas City","MO","US","Voluntary: Firm Initiated","E-Mail","Missouri; China","B-0876-14","Class III","Cornea","PH121898OS; CH121898OD; ",".","2 corneas","Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. ",7/21/2014,"07/21/2014",8/13/2014,"08/13/2014"
"Biologics",68930,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0942-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W118813524645(Part A); W118813524645(Part B); ",,"Two units","Blood products, which did not meet acceptable product specifications, were distributed.",5/28/2014,"05/28/2014",9/10/2014,"09/10/2014"
"Devices",68931,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","California, Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, & Canada","Z-2242-2014","Class II","Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA","Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950",,"66","The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.",7/1/2014,"07/01/2014",8/27/2014,"08/27/2014"
"Devices",68932,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Finland , France , Germany , Hong Kong , Hungary , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Vietnam","Z-2712-2014","Class II","The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and t","1) Symbia T; Product Code: 10275007; Serial Numbers: 1055 , 1056 , 1057 , 1058 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1105 , 1106 , 1107 , 1108 , 1109 , 1110 , 1111 , 1112 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1124 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1134 , 1135 , 1136 , 1137 , 1138 , 1139 , 1140 , 1141 , 1142 , 1143 , 1144 , 1145 , 1146 , 1147 , 1148 , 1149 , 1150 , 1151 , 1152 , 1153 , 1154 , 1155 , 1156 , 1157 , 1158 , 1159 , 1160 , 1161 , 1162 , 1163 , 1164 , 1165 , 1166 , 1167 , 1168 , 1169 , 1170 , 1171 , 1172 , 1173 , 1175 , 1176 , 1177 , 1178 , 1179 , 1180 , 1181 , 1182 , 1183 , 1184 , 1185 , 1186 , 1187 , 1188 , 1189 , 1190 , 1191 , 1192 , 1193 , 1194 , 1195 , 1196 , 1197 , 1198 , 1199 , 1200 , 1201 , 1202 , 1203 , 1204 , 1205 , 1206 , 1207 , 1208 , 1209 , 1210 , 1211 , 1212 , 1213 , 1214 , 1215 , 1216 , 1217 , 1218 , 1219 , 1220 , 1221 , 1222 , 1223 , 1224 , 1225 , 1226 , 1227 , 1228 , 1229 , 1230 , 1231 , 1232 , 1233 , 1234 , 1235 , 1236 , 1238 , 1239 , 1240 , 1241 , 1242 , 1243 , 1244 , 1245 , 1246 , 1247 , 1248 , 1249 , 1250 , 1251 , 1252 , 1253 , 1254 , 1255 , 1256 , 1257 , 1258 , 1259 , 1260 , 1261 , 1262 , 1263 , 1264 , 1265 , 1266 , 1267 , 1268 , 1269 , 1270 , 1271 , 1272 , 1273 , 1275 , 1276 , 1277 , 1278 , 1279 , 1280 , 1281 , 1282 , 1283 , 1284 , 1285 , 1286 , 1287 , 1288 , 1289 , 1290 , 1291 , 1292 , 1293 , 1294 , 1295 , 1296 , 1297 , 1298 , 1299 , 1300 , 1301 , 1302 , 1303 , 1304 , 1305 , 1306 , 1307 , 1308 , 1309 , 1310 , 1311 , 1312 , 1313 , 1314 , 1315 , 1317 , 1318 , 1319 , 1320 , 1321 , 1322 , 1323 , 1324 , 1325 , 1326 , 1327 , 1328 , 1329 , 1330 , 1331 , 1332 , 1333 , 1334 , 1335 , 1336 , 1337 , 1338 , 1339 , 1340 , 1341 , 1342 , 1343 , 1344 , 1345",".","1039 systems","Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient.",7/28/2014,"07/28/2014",10/7/2014,"10/07/2014"
"Devices",68932,"Ongoing","Siemens Medical Solutions USA, Inc.","Hoffman Estates","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Finland , France , Germany , Hong Kong , Hungary , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Vietnam","Z-2713-2014","Class II","The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.","1) Symbia Intevo Excel; Product Code: 10764801; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 ; 2) Symbia Intevo 2; Product Code: 10764802; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 ; 3) Symbia Intevo 6; Product Code: 10764803; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 ; 4) Symbia Intevo 16; Product Code: 10764804; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015",".","44 systems","Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient.",7/28/2014,"07/28/2014",10/7/2014,"10/07/2014"
"Food",68933,"Ongoing","SW Wisconsin Dairy Goat Products Coop","Mount Sterling","WI","US","Voluntary: Firm Initiated","E-Mail","GA and WI","F-2484-2014","Class I","Raw Milk Mild Cheddar Cheese, in 8 oz, (UPC 79004-10002) and 5 lb. (no UPC) size packages. ","Lot # 103-114",,"763.45 lbs.","Mt. Sterling Coop Creamery is recalling one lot of Raw Goat Milk Cheddar Style Cheese in 5 lb and 8 oz sizes because it may be contaminated with Shiga toxin producing Escherichia coli (STEC) O111:H8 bacteria.",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Devices",68934,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.","Z-2545-2014","Class II","Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.","00-5926-014-01; Lot 62455332",".","15 units","Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.",7/30/2014,"07/30/2014",9/3/2014,"09/03/2014"
"Devices",68935,"Ongoing","Medtronic Neuromodulation","Minneapolis","MN","US","Voluntary: Firm Initiated","Visit","Distributed in the states of: MA, NC, OH, and TX.","Z-2259-2014","Class II","Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain. ","Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.",,"6","Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.",7/14/2014,"07/14/2014",8/27/2014,"08/27/2014"
"Food",68936,"Ongoing","Natural Grocers by Vitamin Cottage","Denver","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-2336-2014","Class I","Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600","''Packed On'' dates: 125-14, 133-14, 147-14, 155-14",,"3172 bags","Natural Grocers by Vitamin Cottage is recalling Chunks of Energy Carob Greens and Chunks of Energy Date Flax/Tumeric due to the potential presence of Salmonella.",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Food",68936,"Ongoing","Natural Grocers by Vitamin Cottage","Denver","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/military/govt/VA consignees.","F-2335-2014","Class I","Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600","''Packed On'' dates: 155-14, 167-14, 175-14",,"1748 bags","Natural Grocers by Vitamin Cottage is recalling Chunks of Energy Carob Greens and Chunks of Energy Date Flax/Tumeric due to the potential presence of Salmonella.",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Food",68937,"Ongoing","Honey Heaven Wholesale, Inc.","Eugene","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to processors and retail outlets in Oregon, Washington, and California.","F-2402-2014","Class I","Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part ''OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401 Certified Organic by Oregon Dept. of Agriculture***'', with the lot number applied with a stick-on label. The twenty pound supplier case is labeled in part, ''***Sunfood SUPERFOODS RAW ORGANIC CAROB POWDER***NET WT. 9 kg (19.8lb)***Distributed by Sunfood 1830 Gillespie Way, Suite 101 El Cajon, CA 92020 USA***''. UPC code 803813-04429 8.","5lb bags coded with lot #: 14142, 14156, 14177, and 14189. 20lb case coded lot # 140509 and 140609; Exp Date 6/5/2015 or 11/2015.",".","1/20 lbs. bag and 14/5 lbs. bags","Hummingbird Wholesale was notified by their Organic Carob Powder supplier of the voluntary recall of this product due to potential Salmonella contamination. ",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68938,"Ongoing","BoKU International","Ventura","CA","US","Voluntary: Firm Initiated","E-Mail","Online sales direct to customers","F-2517-2014","Class I","Boku Super Food 3.0, Product Sizes: 10 oz.","Lot No. FM06070714A ",,"289 lbs ","Boku is recalling Super Food because it may be contaminated with Salmonella.",7/30/2014,"07/30/2014",10/1/2014,"10/01/2014"
"Food",68938,"Ongoing","BoKU International","Ventura","CA","US","Voluntary: Firm Initiated","E-Mail","Online sales direct to customers","F-2516-2014","Class I","Boku Super Food 2.0, Product Sizes: 28.2 oz","Lot No. FM01070214A, FM01072114A",,"218 lbs ","Boku is recalling Super Food because it may be contaminated with Salmonella.",7/30/2014,"07/30/2014",10/1/2014,"10/01/2014"
"Food",68938,"Ongoing","BoKU International","Ventura","CA","US","Voluntary: Firm Initiated","E-Mail","Online sales direct to customers","F-2515-2014","Class I","Boku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk. ","Lot No. FM05071014A, FM05070714A, FM05062314B, FM05062314A, FM05062014A, FM05070314A.",,"1329 lbs. ","Boku is recalling Super Protein because it may be contaminated with Salmonella.",7/30/2014,"07/30/2014",10/1/2014,"10/01/2014"
"Devices",68939,"Ongoing","Galt Medical Corporation","Garland","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.","Z-2588-2014","Class II","GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. ","Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.",,"11,155 units in total","The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.",7/25/2014,"07/25/2014",9/10/2014,"09/10/2014"
"Devices",68939,"Ongoing","Galt Medical Corporation","Garland","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.","Z-2589-2014","Class II","GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. ","Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22",,"11,155 units in total","The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.",7/25/2014,"07/25/2014",9/10/2014,"09/10/2014"
"Biologics",68940,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0943-14","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W20031401378800; W20031401381900; W20031403832200; W20031404091100; W20411401107700; W20031403581500; W20031402579900; ",,"Seven units","Blood products, labeled with an incorrect expiration date, were distributed.",3/11/2014,"03/11/2014",9/10/2014,"09/10/2014"
"Drugs",68941,"Ongoing","Wockhardt Usa Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1541-2014","Class II","Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA ","Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15 ",,"11,661 HDPE bottles","Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.",7/24/2014,"07/24/2014",8/27/2014,"08/27/2014"
"Food",68942,"Ongoing","Nestle USA, Inc.","Springville","UT","US","Voluntary: Firm Initiated","Press Release","Nationwide to WA, CA, MT, LA, TX. No foreign/VA/govt/military","F-2450-2014","Class I","Lean Cuisine Culinary Collection Chicken with Peanut Sauce. Packaged in 9 oz (255g) Plastic Tray in Fiberboard Carton 12 cartons per case by Nestle USA, INC, Solon, OH 44139 USA.","UPC code 13800 10154, production code of 4165595911U and has a best before date of JULY 2015",,"450 cases shipped with 12 cartons in each case.","Nestl Prepared Foods Company Announces Allergy Alert and Voluntary Recall of LEAN CUISINE Culinary Collection Chicken with Peanut Sauce Recall Due to Package Mislabeling ",8/21/2014,"08/21/2014",9/24/2014,"09/24/2014"
"Food",68943,"Ongoing","Great American Appetizers, Inc.","Nampa","ID","US","Voluntary: Firm Initiated","Telephone","Product was distributed to a DC in Greenville SC. It was further distributed to retail stores under the authority of Topco. owner of the product.","F-2522-2014","Class II","Product is packaged in a cardboard box and labeled in part, ''SOUTHERN HOME Mozzarella Sticks***CONTAINS: WHEY, MILK, EGG, SOY***DISTRIBUTED BY SOUTHERN HOME P.O.BOX 99 MAULDIN, SC 29662***'' 6/case 30oz UPC 607880027150","Lot Codes: 14083602, 14083702, 14083602, 13356402, 14083602 and 14157402. BEST IF USED BY 9 2015; BEST IF USED BY 12 2015.",,"2696 cases; 6 per case.","Incorrect declaration of allergens. The ingredient label properly lists the wheat allergen but the ''Contains'' statement does not. ",7/29/2014,"07/29/2014",10/1/2014,"10/01/2014"
"Biologics",68945,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0944-14","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W036214140275; W0362141402550",,"Two units","Blood products, which were out of controlled storage for 30 minutes during irradiation, were distributed.",6/18/2014,"06/18/2014",9/10/2014,"09/10/2014"
"Drugs",68946,"Ongoing","Mckesson Packaging Services","Concord","NC","US","Voluntary: Firm Initiated","Letter","CO & OH","D-1515-2014","Class II","Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10","Lot 102492, exp 01/2016",".","1240 boxes/124,000 tablets","Presence of Foreign Substance; tablets may contain stainless steel metal particulates ",7/30/2014,"07/30/2014",8/13/2014,"08/13/2014"
"Devices",68948,"Ongoing","TomoTherapy Incorporated","Madison","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL, GA, HI, IL IN, IA, KS,KY, LA, MD, MA, MI, MO, MT, NE, NV, NJ, NM, NY, NC,ND, OH,OK, OR, PA, SC, SD, TX, UT, VA, WV, and WI, and the countries of AUSTRALIA, BELGIUM CANDA, CHINA, EL SALVADOR, ENGLAND, FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NETHERLANDS, PHILIPPINE, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.","Z-2239-2014","Class II","TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). . ","Serial # 110403 110366 110319 110352 110034 110083 110140 110336 110126 110009 110129 110014 110332 110333 110212 110287 110130 110417 110133 110450 110416 110365 110389 110340 110341 110372 110279 110370 110345 110167 110292 110061 110142 110334 110306 110342 110143 110351 110374 110208 110356 110430 110315 110447 110431 110444 110124 110263 110123 110151 110294 110435 110111 110422 110353 110364 110384 110261 110297 110157 110300 110267 110428 110405 110299 110246 110429 110071 110200 110171 110305 110330 110407 110359 110361 110136 110371 110211 110304 110075 110063 110437 110183 110199 110184 110337 110049 110172 110076 110036 110426 110107 110113 110326 110093 110400 110393 110085 110229 110412 110425 110052 110182 110391 110178 110159 110291 110302 110350 110265 110288 110237 110150 110289 110301 110449 110293 110278 110442 110436 110148 110068 110233 110376 110236 110153 110181 110439 110411 110241 110295 110064 110303 110249 110058 110114 110296 110414 110110 110240 110313 110079 110191 110156 110128 110069 110362 110310 110207 110423 110443 110433 110382 110421 110375 110460 110335 110404 110307 110324 110325 110432 110321 110245 110440 110194 110317 110418 110051 110177 110108 110206 110120 110257 110329 110179 110311 110125 110115 110040 110074 110406 110283 110165 110195 110225 110161 110210 110160 110204 110175 110006 110098 110144 110187 110217 110262 110214 110067 110047 110222 110097 110119 110048 110149 110221 110198 110193 110239 110203 110318 110215 110258 110244 110256 110312 110023 110378 110132 110201 110016 110322 110343 110145 110282 110190 110039 110026 110250 110056 110216 110066 110320 110401 110035 110209 110091 110281 110346 110380 110379 110284 110099 110094 110273 110105 110054 110168 110186 110185 110122 110272 110331 110234 1100",,"322","Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions. ",7/17/2014,"07/17/2014",8/27/2014,"08/27/2014"
"Food",68949,"Ongoing","Vibrant Health","Canaan","CT","US","Voluntary: Firm Initiated","Letter","Nationwide OUS: UK, Iceland, South Africa","F-2436-2014","Class I","Green Vibrance, 240 Vegicaps/bottle Product Code: GVC","Lot Number:1401078",,"5,355","A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria.",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Food",68949,"Ongoing","Vibrant Health","Canaan","CT","US","Voluntary: Firm Initiated","Letter","Nationwide OUS: UK, Iceland, South Africa","F-2435-2014","Class I","Green Vibrance 15 single serve pkts, 181.5g, 6.4oz. Product Code: GVSD","Lot Number: 1401076",,"8,726","A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria.",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Food",68949,"Ongoing","Vibrant Health","Canaan","CT","US","Voluntary: Firm Initiated","Letter","Nationwide OUS: UK, Iceland, South Africa","F-2434-2014","Class I","Green Vibrance- A Comprehensive Restorative Advanced Daily Superfood (Dietary Supplement) packaged as follows: A. 15-day, 181.5g, 6.4 oz. powder- Product Code GV15; B. 30-day, 363g, 12.8 oz. powder; Product Code GV 30; C.60-day, 726g, 25.61 oz. family size powder, -Product Code GV60; D. Bulk Supply Kilo Canister, 1 kg (35.27 oz.) powder,-Product Code GVKG","Lot Numbers: A. 1401084 B. 1401083, 1401092, 1401094 C. 1401081, 1401082, 1401085, 1401086, 1401087, 1401088,1401089 D. 1401079, 1401080, 1401081 ",,"44,257 units","A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria.",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Food",68949,"Ongoing","Vibrant Health","Canaan","CT","US","Voluntary: Firm Initiated","Letter","Nationwide OUS: UK, Iceland, South Africa","F-2437-2014","Class I","Rainbow Vibrance Hi ORAC Superfood, 177g, 6.24 oz. Product Code: RV","Lot Number:1311139",,"5,164","A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria.",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Drugs",68950,"Ongoing","HLI dba Humphreyline Inc","Florence","KY","US","Voluntary: Firm Initiated","Letter","Kentucky, Maryland, and Virginia.","D-1518-2014","Class II","Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing. ","Lot #: MB140417; Expiry: 04/2017. ",".","975 bottles","Microbial Contamination of Non-Sterile Product",8/6/2014,"08/06/2014",8/13/2014,"08/13/2014"
"Devices",68951,"Ongoing","Civco Medical Instruments Inc","Kalona","IA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.","Z-2558-2014","Class II","CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.","Lot numbers: M431760, M431710, M426580, M430200, M423010",".","52 kits","A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.",8/1/2014,"08/01/2014",9/3/2014,"09/03/2014"
"Devices",68952,"Ongoing","Vascutek, Ltd.","Inchinnan",,"GB","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.","Z-2266-2014","Class II","Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company","731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL ",,"63,162","The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).",7/15/2014,"07/15/2014",8/27/2014,"08/27/2014"
"Devices",68953,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. and Internationally to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Congo, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, and Yemen.","Z-2237-2014","Class II","IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.","ISP DX/HX/EX; 881001 870081 85254 870044 870065 950104 85045 95027 82202 85319 87187 85170 85244 85218 95030 92003 85166 85172 87162 85330 85337 85164 95038 950129 870037 87193 82117 80905 85042 920005 80864 95057 950094 85104 85359 950084 85180 950071 850001 87201 87014 85588 85607 85623 85619 80974 85578 80752 85628 85627 85637 85601 80898 85599 85594 85629 85585 85636 85668 85584 85617 85581 81135 85645 85634 85625 85600 85640 85630 85639 85616 85642 85582 85673 85618 85670 85676 85598 85422 85577 85580 85631 85678 85589 85644 85648 85653 85621 85626 85638 85620 85596 85597 85614 85641 85615 85595 85675 85647 85649 85650 85651 85652 85654 85622 85587 85427 80973 85426 80939 85624 85635 82247 85583 85613 85590 95058 87204 870067 87030 87029 870031 870099 870085 82238 87151 95066 82146 85307 85327 870030 870086 87158 85308 85309 870078 85168 85069 82094 950149 82018 82008 87166 82109 85394 85249 35023 82240 85108 85317 36001 85311 870032 82141 82098 82237 81076 870052 81119 82118 79932 87017 87161 82099 85331 82145 81089 85025 85252 82093 87165 85165 81034 82035 85080 822020 87167 85031 35030 35009 80911 80965 870034 82086 82085 82082 81160 87170 87180 87003 95068 81063 82236 82006 360006 870053 81173 87182 87197 85026 870040 95071 82120 95029 82089 82124 87205 87192 95032 95005 87001 870082 950130 95037 87179 870050 870104 870106 870105 870043 360005 870076 82140 80991 85383 95010 81111 95021 85266 95036 82241 87194 870110 870012 870041 850015 87174 87191 87163 87150 870098 87189 87202 870109 87159 87200 870079 95075 870100 950153 95034 81171 870072 87178 81186 45007 95039 81188 950022 950116 85213 95007 87013 81117 95008 870049 950131 870092 950114 81008 870035 870026 87177 87172 87184 450009 950045 870074 950160 95069 870080 950096 87190 85314 85303 85256 85298 870038 870062 82148 95067 870108 310007 87198 95033 95065 870070 85235 870033 82135 142301 870028 82127 87171 870047 82201 87195 82134 82136 870102 870097 870042 950135 95025 85313 87185 310006 80071 87208 85239 95070 85312 35003 85258 82125 81190 8",".","1099 Units","The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (EF) may be different. Problem 2: When processing using one of the following NM clinical applications: AutoQUANT, Emory Cardiac Toolbox, Corridor4DM, or NeuroQ, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. Problem 3: While using the NM Viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. Problem 4: While displaying PET images within CT Viewer, the SUV results displayed may be calculated with an SUV method different from the one specified in system preferences. This issue affects the CT Viewer and Multi-Modality Tumor Tracking applications. The expected behavior in such a case is that the application displays a warning that SUV cannot be calculated due to missing information, and the images are displayed with the original acquisition units (BQ/ML). Instead, in affected systems, if the patient height has not been entered and the selected SUV calculation method requires height data (i.e., SUV-BSA), the system may display an SUV calculated using a different method (SUV-BW) without providing any warning that required data had not been entered or informing the user of the change.",7/27/2014,"07/27/2014",8/20/2014,"08/20/2014"
"Devices",68954,"Ongoing","Integra York PA, Inc","York","PA","US","Voluntary: Firm Initiated","Letter","US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746","Z-2624-2014","Class II","Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid. ","Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622",".","84","Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",68955,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.","Z-2689-2014","Class II","CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.","All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485-4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790-4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10849-4S2 ; 14) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 10865-4H2 ; 15) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10868-4S2 ; 16) CIRCUIT RESP DISP INF HTD 30/CS , Product Code 1175-4H2 ; 17) CIRCUIT RESP INFANT DUAL DISP 30/CS , Product Code 1208-4H1 ; 18) CIRCUIT RESP INFANT DISP 30/CS , Product Code 1553-4H1 ; 19) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 1815-409 ; 20) CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS , Product Code 1998-4H1 ; 21) INFANT RESP CIRC HTD 4 FT. , Product Code 2119-4S2G ; 22) INFANT RESP CIRC HTD 4 FT. , Product Code 2120-4S2G ; 23) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 4319-4H2 ; 24) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4326-4H2 ; 25) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4652-501 ; 26) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4677-4H2 ; 27) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4875-4H2 ; 28) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5665-4H2 ; 29) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 5682-409 ; 30) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5732-4H1 ; 31) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5868-4H2 ; 32) CIRCUIT RESP I",,"Approximately 318,280 devices","The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.",7/31/2014,"07/31/2014",10/1/2014,"10/01/2014"
"Devices",68956,"Ongoing","Invivo Corporation","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.","Z-2270-2014","Class II","Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.","Product: 865471 Number 453564251511 Serial Numbers: US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200257, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, U",,"573 devices.","The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.",6/30/2014,"06/30/2014",8/27/2014,"08/27/2014"
"Food",68958,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC (Further shipment by the NC distributors is: TN, VA, NC, SC, and GA).","F-2060-2014","Class I","Lacteos Santa Martha Quesito Casero Fresh Curd Net Weight 12oz Distributed by Oasis Brands Inc., Miami FL 33192 ","UPC 635349 000420 / Exp. Date 092714",,"375 units","A State sample came positive for Listeria monocytogenes",7/31/2014,"07/31/2014",9/10/2014,"09/10/2014"
"Devices",68959,"Ongoing","Illumina Inc","San Diego","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.","Z-2611-2014","Class II","Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.","M70113 M70144 M70131 M70138 M70143 M70119 M70134 M70156 M70103 M70123 M70159 M70153 M70136 M70102 M70137 M70130 M00533L M70139 M70132 M70160 M70106 M70135 M70107 M70104 M70108 M70157 M70105 M70165 M70116 M70172 M70166 M70114 M70158 M70109 M70115",".","35","A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended",7/28/2014,"07/28/2014",9/17/2014,"09/17/2014"
"Devices",68960,"Ongoing","TomoTherapy Incorporated","Madison","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.","Z-2240-2014","Class II","TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.","Serial # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 110065 110077 110078 110081 110082 110084 110088 110090 110095 110096 110100 110102 110106 110109 110117 110121 110131 110137 110146 110147 110155 110158 110162 110163 110164 110169 110170 110174 110180 110189 110196 110197 110202 110205 110226 110227 110228 110231 110232 110248 110254 110259 110260 110264 110266 110268 110270 110275 110285 110286 110290 110298 110308 110314 110327 110328 110338 110347 110348 110349 110352 110355 110360 110363 110367 110368 110369 110373 110377 110381 110383 110385 110386 110387 110388 110392 110394 110395 110396 110397 110402 110408 110409 110410 110411 110413 110415 110419 110420 110424 110427 110434 110438 110441 110445 110446 110448 110451 110452 110453 110454 110455 110456 110457 110458 110459 110460 110461 110462 110463 110464 110465 110466 110467 110468 110469 110470 110471 110472 110473 110474 110475 110476 110477 110478 110479 110480 110481 110482 110483 110484 110485 110486 110487 110488 110489 110490 110491 110492 110493 110494 110495 110496 110497 110498 110499 110500 110501 110502 110503 110505 110507 110508 110504 110509 ",,"168 (75 US; 93 OUS) ","Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions. ",7/16/2014,"07/16/2014",8/27/2014,"08/27/2014"
"Devices",68961,"Ongoing","Curbell Medical, Inc.","Orchard Park","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide, Canada, Ireland, Italy","Z-2554-2014","Class II","CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm. ","Lot 0414",".","Domestic: 112 units; Foreign: 211 units ","The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function. ",8/5/2014,"08/05/2014",9/3/2014,"09/03/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2528-2014","Class II","Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g)","Lot A2437 8 BB 08/09/18 ",".","6183","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2532-2014","Class II","Goya Small Red Beans Habichuelas Coloradas Pequenas 15.5 OZ (439g)","Lot A2420 BB 09/06/18",".",,"Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2525-2014","Class II","Pink Beans sold under two brand names Goya and Jibarito (see labels description below) Goya Pink Beans Habichuelas Rosadas 15.5 oz. (439g) El Jibarito Habichuelas Rosadas 15.5 oz. (439g) ","Lots A2406 8 BB 07/12/18; A2406 8 BB 08/07/18; A2406 8 BB 08/09/18; A 2406 8 BB 08/14/18, A2406 8 BB 08/14/18(6 pack); A2406 8 BB 09/05/18; A2406 8 BB 09/16/18; A2406 8 BB 09/10/18; and A 2031 8 BB 08/14/18 (rosadas pink}-jibarito)",".","71945","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2531-2014","Class II","Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g)","Lot A2062 8 BB 08/15/18 ",".","9756","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2526-2014","Class II"," Goya Chick Peas Garbanzos 15.5 oz. (439g)","Lot A2422 8 BB 07/11/18 ",".","14317","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2530-2014","Class II","Goya Black Bean Soup Prepared with Olive Oil, Bell Pepper & Onion 15 oz. (425g)","Lot A 2067 8 BB 08/13/18 ",".","6397","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2527-2014","Class II","Goya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g) ","Lots: A2402 8 BB 08/08/18; A 2402 8 BB 09/05/18 and A2402 8 BB 04/02/19",".","28036","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2523-2014","Class II"," Goya Black Beans Frijoles Negros 15.5 oz (439g) ","Lots A2466 8 BB 06/21/18 and Lot A2466 8 BB 08/06/18 ",".","19009","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2524-2014","Class II","Goya Whole Green Peas Chicharos 15.5 oz (439g)","Lot A2461 8 BB 07/09/18 ",".","5138","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Food",68962,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Bayamon","PR","US","Voluntary: Firm Initiated","Letter","Domestic to Puerto Rico and USA (NY,MA,NJ,TX,IL,FL,GA,CA,VA) and Internationally (Aruba, Curacao,Virgen Gorda, Angilla, Antilles, Saint Barts, Dominica, St.Vincent, Barbados, Saint Marteen, Saint Thomas, Monserrat, Grenada, Antigua, Tortolo, Nevis, St. Kitts, Nevis, St. Jonhs, and St. Croix)","F-2529-2014","Class II","Goya Pink Beans In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g) ","Lot A2055 8 BB 08/12/18 and A2055 8 BB 8/11/18 ",".","10693","Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product. ",7/30/2014,"07/30/2014",10/7/2014,"10/07/2014"
"Drugs",68963,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1542-2014","Class II","ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.","Lot #: P306225, Exp 08/14",,"6,204 bags","Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).",8/4/2014,"08/04/2014",8/27/2014,"08/27/2014"
"Food",68964,"Ongoing","Super Organic Foods, Inc","Tuckahoe","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2409-2014","Class I","Sunburst SUPERFOODS ORGANIC RAW CAROB POWDER in ONE POUND and 5 POUNDS bags --- Firm on label: SunburstSuperfoods.com Clifton, NJ (old label) and SunburstSuperfoods.com Tuckahoe, NY (new label) ","Uncoded",,"180 lbs.","The repacked product has the potential to be contaminated with Salmonella (from raw material). ",7/29/2014,"07/29/2014",9/10/2014,"09/10/2014"
"Devices",68965,"Completed","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2561-2014","Class II","Siemens EasyLink'' Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 Product Usage: The EasyLink Data Management System is a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions. It provides: autoverification, integrated QC capabilities, and remote services to help keep systems running optimally and audit trail capabilities. ","EasyLink'' Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219",,"1347","Under certain conditions, the Siemens EasyLink Data Management System may not perform as intended, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.",8/13/2013,"08/13/2013",9/10/2014,"09/10/2014"
"Devices",68966,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.","Z-2291-2014","Class II","GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages. ","Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 00000099012HL7 419PERRYDR 00000099013HL5 252962ED1 00000099016HL8 419435DR 00000099440HL0 417347DPORT1 00000099441HL8 708684RAD3 00000099443HL4 708684RAD2 00000099444HL2 732840ER1 00000099445HL9 504349R8 00000099447HL5 608775XR6561 00000099448HL3 408259RMCED1 00000099846HL8 239424XR656 00000099848HL4 HSSE3D656 00000099850HL0 732840ER2 00000099851HL8 7737021555 00000100228HL6 802775RAD5 00000100230HL2 440816D656 00000100231HL0 910WAROBINSON2 00000100366HL4 334793SXR656 00000100368HL0 608775XR6563 00000100369HL8 509838RM1 00000100653HL5 303GVA656RM3 00000100654HL3 225658DR1 00000100655HL0 718240UCD 00000100658HL4 802775RAD1 00000100659HL2 610902XR656 00000101139HL4 843847TR3 00000101140HL2 765747XR656 00000101251HL7 724357ED1 00000101252HL5 281METHP656 00000101253HL3 206598UWEAST 00000101255HL8 919731XR656 00000101256HL6 518943D656 00000101257HL4 630208DR4 00000101258HL2 314768SMRM5 00000101259HL0 303GVA656RM1 00000101260HL8 949517RM3 00000101261HL6 239HPCXR1 00000101881HL1 708226XR656B 00000101882HL9 313745ER656 00000101883HL7 504349R4 00000102301HL9 804764ER2 00000102304HL3 225658DR2 00000102305HL0 509946XR656A 00000102306HL8 303GVA656RM2 00000102307HL6 248305D656RM2 00000102575HL8 770385DR1 00000102576HL6 830RHHRAD1 00000102851HL3 757736PWR1 00000102852HL1 914MSK656 00000102853HL9 504349POB1 00000103439HL6 303DHXR656 00000103441HL2 910417XR656 00000103669HL8 312996D656 00000103671HL4 801714RM2DR 00000103672HL2 504842IMR2 00000103959HL3 304429DIS656 00000103961HL9 701234XR656 00000104239HL9 979SJRHCRAD 00000104241HL5 517841XR656 00000104242HL3 808QMCER 00000104243HL1 713792XR3656 00000104709HL1 850505NH656 00000104711HL7 816234COPC2 00000104712HL5 XR249643 00000104713HL3 770382CER 00000104714HL1 406731MXR1 00000105160HL6 713792XR3656 00000105161HL4 419291DR2 00000105162HL2 414649XR656 00000105163HL0 314633SW 00000105165HL5 720UCHAOP2 00000105503HL7 MHXRAY1 00000105506HL0 713792XR4656 00000105507HL8 717791D6",,"334 (162 US, 172 OUS).","GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad'' detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported. ",7/25/2014,"07/25/2014",8/27/2014,"08/27/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1578-2014","Class II","PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3","Lot # 2F004, Exp. 06/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1580-2014","Class II","PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3","Lot # 2ZP7113, Exp. 08/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1582-2014","Class II","PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3","Lot # 2ZP3908, Exp. 05/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1575-2014","Class II","PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5","Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15 ",,"13,429 bottles","Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1579-2014","Class II","PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3","Lot # 2E001; Exp. 05/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1581-2014","Class II","PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3","Lot # 2ZP5499, Exp. 02/15 ",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1577-2014","Class II","Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3","Lot # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1576-2014","Class II","Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3","Lot # 2A002, Exp. 01/15 Lot # 2A003, Exp. 01/15 Lot # 2C004, Exp. 03/15 Lot # 2C005, Exp. 03/15 Lot # 2E008, Exp. 05/15 Lot # 2F009, Exp. 06/15 Lot # 2F010, Exp. 06/15 Lot # 2H011, Exp. 08/15 Lot # 2H012, Exp. 08/15 Lot # 2H013, Exp. 0815",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Drugs",68967,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1574-2014","Class II","Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 ","Lot # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15",,,"Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.",3/24/2014,"03/24/2014",9/10/2014,"09/10/2014"
"Food",68968,"Ongoing","Puratos Chocolate USA","Kenosha","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, PA and Canada","F-2412-2014","Class I","Puratos Chocolante, Dark Organic 1M Chip, Item Number 0065064002SH11, Net Weight: 25 lbs.","Lot: 310212736, Best Before: 08/20/15",,"22,000 lbs.","Puratos initiated a recall due to an allergic reaction to milk protein, reported by a consumer. ",7/24/2014,"07/24/2014",9/10/2014,"09/10/2014"
"Drugs",68969,"Ongoing","Cubist Pharmaceuticals, Inc.","Lexington","MA","US","Voluntary: Firm Initiated","Press Release","Nationwide Foreign: Israel, Taiwan","D-0001-2015","Class I","CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. ","Lot #: 081753F, 081803F, 081853F, Exp 08/2014; 090103F, 090153F, 090303F, 090353F, 090403F, 090453F, 090503F, Exp 09/2014; 100503F, 100553F, 100603F, 100653F, 100703F, 100753F, 100803F, 100853F, 100903F, Exp 10/2014; 101303F, 110303F, 110353F, 110403F, 110453F, 110503F, 110603F, 110653F, 110703F, Exp 11/2014; 120303F, 120353F, 120403F, 120453F, 120503F, 120553F, 120653F, 120703F, Exp 12/2014; 140453F, Exp 02/2015; 140603F, 140653F, 140703F, 150203F, 150253F, 150303F, 150353F, 150403F, 150453F, Exp 03/2015; 160853F, 160903F, 160953F, 161003F, 161053F, 161103F, Exp 05/2015; 181003F, 181053F, 181103F, 181153F, 181603F, 181653F, 181703F, Exp 06/2015; 201503F, 201553F, 201603F, Exp 08/2015; 201753F, 210453F, Exp 09/2015; 210503F, 210553F, 210603F, 210653F, 220353F, 220403F, 220453F, Exp 10/2015; 220503F, 220553F, 220603F, 230303F, 230353F, 230403F, 230453F, 230503F, 230553F, Exp 11/2015; 240053F, 240153F, 240203F, 240253F, 240303F, Exp 12/2015; 260603F, 260653F, 260703F, Exp 02/2016; 271303F, 271353F, 271403F, 271453F, 271503F, 271553F, Exp 03/2016; 280203F, 280253F, 280303F, 280403F, Exp 04/2016; 290203F, 290303F, 290353F, Exp 06/2016. ",".","4,966,575 Vials","Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. ",8/1/2014,"08/01/2014",10/7/2014,"10/07/2014"
"Devices",68970,"Completed","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution in countries of: Germany and Slovernia.","Z-2565-2014","Class II","Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033","Lot #0413 Expiration Date: 2015-01-26",,"30 cases (300 electordes)","Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators",3/12/2013,"03/12/2013",9/10/2014,"09/10/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2161-2014","Class II","Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2866991",".","200 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2159-2014","Class II","Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2841944, 2841945, 2859326, 2865873, 2869445",".","1,560","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2158-2014","Class II","Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2873662",".","40 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2162-2014","Class II","Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2841690, 2841691, 2859331",".","900 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2160-2014","Class II","Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2848741, 2859329, 2862831, 2869453",".","60 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2163-2014","Class II","Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2866974",".","100 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2157-2014","Class II","Transpac IV Trifurcated Monitoring Kit w/84'' Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2886730",".","20 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2164-2014","Class II","Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal","Lot No. 2817530, 2852405, 2869455, 2883663",".","640 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Devices",68971,"Completed","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA including Oregon and Internationally to Australia.","Z-2165-2014","Class II","Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.","Lot No. 2837897",".","50 units","ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ",7/18/2014,"07/18/2014",8/13/2014,"08/13/2014"
"Food",68972,"Ongoing","Seoul Shik Poom, Inc.","Englewood","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-2416-2014","Class I","Choripdong Chocolate Almond Richmond Ice Bar 4 bars/432 mL Seoul Trading USA Inc., Englewood NJ 07631 code # IC1006 and upc code: 761898632925","3/20/2015",,"360 packages","Seoul Trading USA Inc. is recalling Choripdong Chocolate Almond Richmond Ice Bar due to undeclared eggs.",7/8/2014,"07/08/2014",9/10/2014,"09/10/2014"
"Devices",68973,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA including AL and MD.","Z-2294-2014","Class II","Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.","Lot No. 2705219",,"300 units","ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.",8/5/2014,"08/05/2014",8/27/2014,"08/27/2014"
"Devices",68973,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA including AL and MD.","Z-2295-2014","Class II","Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.","Lot No. 2705203",,"400 units","ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.",8/5/2014,"08/05/2014",8/27/2014,"08/27/2014"
"Devices",68973,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - USA including AL and MD.","Z-2293-2014","Class II","CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.","Lot No. 2704633, 2705206",,"300 units","ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.",8/5/2014,"08/05/2014",8/27/2014,"08/27/2014"
"Devices",68974,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","Bridgend",,"GB","Voluntary: Firm Initiated","Letter","NY, NJ, CT, MA, PA, VA, MD, FL and GA","Z-2671-2014","Class II","VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).","Lot 9090 (exp. December 15, 2014)",,"463 sales units","VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).",8/6/2014,"08/06/2014",10/1/2014,"10/01/2014"
"Food",68975,"Terminated","Homestead Pole Bean Cooperative, Inc.","Homestead","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA and GA","F-2408-2014","Class I","Avocados Simmons in white cardboard flats with black lettering ''FLORIDA AVOCADO US COMB'' 10 count ","#10 handwritten in black ink on carton Lot # 053*45615",,"226 flats / 10 avocados ","FDA sample found the product contaminated with traces of Salmonella.",7/24/2014,"07/24/2014",9/10/2014,"09/10/2014"
"Food",68976,"Ongoing","Ortho Molecular Products Inc","Stevens Point","WI","US","Voluntary: Firm Initiated","Letter","nationwide OUS to China","F-2413-2014","Class I","Ortho Molecular Products LifeCORE, Rich Dark Chocolate, Dietary Supplement Net Wt. 732.2 Grams (25.8Oz), Product #927001, UPC 15033-00927","Lot numbers beginning with the following numbers: 73286, 73288, 73455, 73482, 73569, 73620, 73840, 73859, 73987, 74038, 74419, 74562, 74773, 74920, 75309, 75339, 75568, 75749, 75919. Expiration dates: Feb-13 thru Apr-15 Lot number and expiration date can be located at the neck of the bottle just above the label. ",,"19,288 units total","Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk.",8/1/2014,"08/01/2014",9/10/2014,"09/10/2014"
"Food",68976,"Ongoing","Ortho Molecular Products Inc","Stevens Point","WI","US","Voluntary: Firm Initiated","Letter","nationwide OUS to China","F-2414-2014","Class I","Ortho Molecular Products LifeCORE Complete, Rich Dark Chocolate, Dietary Supplement, Sold in the following size containers: 1. Net Wt. 32.6 Grams (1.2Oz), Product #929032, UPC 15033-01929; 2. Net Wt. 911.4 Grams (32.1oz), Product #929001, UPC 15033-00929.","Lot numbers beginning with the following numbers: 73286, 73288, 73455, 73482, 73569, 73620, 73840, 73859, 73987, 74038, 74419, 74562, 74773, 74920, 75309, 75339, 75568, 75749, 75919. Expiration dates: Feb-13 thru Apr-15 Lot number and expiration date can be located at the neck of the bottle just above the label. ",,"19,288 units total","Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk.",8/1/2014,"08/01/2014",9/10/2014,"09/10/2014"
"Food",68978,"Ongoing","Marjon Specialty Foods, Inc.","Plant City","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & FL","F-2427-2014","Class II","Marjon Kale Sprouts, Keep Refrigerated. NET WT. 6/3 oz. packaged in cups; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.","Used by 7/06/14.",".","856 cases (all products)","Firm environmental samples found Listeria in the sprout production area.",6/24/2014,"06/24/2014",9/17/2014,"09/17/2014"
"Food",68978,"Ongoing","Marjon Specialty Foods, Inc.","Plant City","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & FL","F-2425-2014","Class II","Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.","Used by 7/06/14.",".","856 cases (all products)","Firm environmental samples found Listeria in the sprout production area.",6/24/2014,"06/24/2014",9/17/2014,"09/17/2014"
"Food",68978,"Ongoing","Marjon Specialty Foods, Inc.","Plant City","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & FL","F-2426-2014","Class II","Marjon Bean Sprouts, Keep Fresh Zip Lock: Keep Refrigerated. NET WT. 8/8 oz. plastic bag; 5 lb bag and 2/5 Bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC codes: 10077554000012; 0200077554000466; 010077554000463 Used by 06/28/14.","Used by 6/28/14.",".","856 cases (all products)","Firm environmental samples found Listeria in the sprout production area.",6/24/2014,"06/24/2014",9/17/2014,"09/17/2014"
"Food",68978,"Ongoing","Marjon Specialty Foods, Inc.","Plant City","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & FL","F-2428-2014","Class II","Marjon Spicy Sprouts, NET WT. 6/6 oz. packaged in bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 010077554000197. Used by 7/06/14.","Used by 7/06/14.",".","856 cases (all products)","Firm environmental samples found Listeria in the sprout production area.",6/24/2014,"06/24/2014",9/17/2014,"09/17/2014"
"Devices",68979,"Ongoing","Philips Healthcare Informatics, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.","Z-2252-2014","Class II","Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. ","IntelliSpace 4.4",,"109 units","A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.",7/24/2014,"07/24/2014",8/27/2014,"08/27/2014"
"Devices",68980,"Ongoing","Angiodynamics, Inc.","Queensbury","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.","Z-2261-2014","Class II","Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804","Lot 4731641 (exp. date 31-Mar-17)",,"Domestic: 81 units; Foreign: 13 units","AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).",8/6/2014,"08/06/2014",8/27/2014,"08/27/2014"
"Devices",68980,"Ongoing","Angiodynamics, Inc.","Queensbury","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.","Z-2262-2014","Class II","Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804","Lot 4762513 (exp. date 31-May-17)",,"Domestic: 36 units","AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).",8/6/2014,"08/06/2014",8/27/2014,"08/27/2014"
"Devices",68980,"Ongoing","Angiodynamics, Inc.","Queensbury","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.","Z-2260-2014","Class II","Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804","Lot 4731639 (exp. date 31-Mar-17)",,"Domestic: 70 units; Foreign: 27 units","AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).",8/6/2014,"08/06/2014",8/27/2014,"08/27/2014"
"Food",68981,"Ongoing","Regeneca, Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Product is sold through multi-level marketing.","F-2403-2014","Class II","RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement ","11414RE5516, EX0616R15814, 823230415, EX0616R15813",".","154,748 packets","RegeneSlim was found to contain DMAA by FDA analysis.",8/4/2014,"08/04/2014",9/3/2014,"09/03/2014"
"Devices",68982,"Ongoing","Radiometer America Inc","Westlake","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.","Z-2597-2014","Class II","RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.","Verions 2.4X, 2.5X and 2.6X",".","N/A",,7/28/2014,"07/28/2014",9/17/2014,"09/17/2014"
"Devices",68983,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.","Z-2535-2014","Class II","Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426"," Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020",,"11 units","Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy. ",8/7/2014,"08/07/2014",8/27/2014,"08/27/2014"
"Devices",68984,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Pakistan Portugal, Romania, Russia, Saudi Arabia, Singapore, Solvenia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom","Z-2574-2014","Class II","Focal Sim Product Usage: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be able to perform CT simulations and forward their information to the RTP System for dose calculation. ","Software versions 4.70.00 & 4.80.00",,"554 units","When DICOM's exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.",8/18/2014,"08/18/2014",9/10/2014,"09/10/2014"
"Devices",68985,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Other","Worldwide distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, Puerto Rico; and countries of: Algeria, Angola, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sir Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ukraine.","Z-2581-2014","Class II","Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.","Versions 3.20.00 and higher",,"928 units","When DICOM's exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.",8/18/2014,"08/18/2014",9/10/2014,"09/10/2014"
"Devices",68986,"Completed","Thermedx LLC","Solon","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.","Z-2555-2014","Class II"," The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.","Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005 ",".","21","A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.",2/10/2014,"02/10/2014",9/3/2014,"09/03/2014"
"Devices",68987,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0066-2015","Class II","Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.","Product Numbers: ASK-04001-VCUH, ASK-04510-MM3, ASK-05001-TSC, ASK-05052-QV, ASK-05052-SFL, ASK-05502-UWMC, ASK-05541-MS2, ASK-09804-SPH, ASK-09810-PCMH1, ASK-09903-ECL, ASK-09903-PCMH1, ASK-11142-MGH3, ASK-12703-MGH2, ASK-12703-SPH, ASK-15703-MH, ASK-15854-FAM, ASK-17702-PJHH1, ASK-21142-HF2, ASK-21242-PCMH1, ASK-21242-SFM1, ASK-21242-UVA3, ASK-29803-HF3, ASK-29803-MM, ASK-29803-MS, ASK-29903-UK, ASK-29903-UK, ASK-34041-PTG, ASK-34052-PTG, ASK-35052-PTG, ASK-42703-AMC, ASK-42703-OHU1, ASK-42703-PCCH1, ASK-42703-PCSJ, ASK-42703-PPMC, ASK-42703-PSBM, ASK-42703-PSCH, ASK-42703-PSFM, ASK-42703-PTRH, ASK-42703-SJMT, ASK-42703-UHC, ASK-42802-ECL1, ASK-42802-PMCG, ASK-42802-PUCS, ASK-42854-CMC2, ASK-45703-MM2, ASK-45703-NYU1, ASK-45703-PCCH1, ASK-45703-PCHS1, ASK-45703-PCSJ, ASK-45703-PDCH, ASK-45703-PGBM1, ASK-45703-PHCH, ASK-45703-PHF, ASK-45703-PHF1, ASK-45703-PHPA2, ASK-45703-PIA, ASK-45703-PLGH1, ASK-45703-PMHG, ASK-45703-PSA, ASK-45703-PTMC, ASK-45703-PUAB, ASK-45703-PUC, ASK-45703-PUHC, ASK-45703-PUR, ASK-45703-PVCU, ASK-45703-UHC, ASK-45703-UKM, ASK-45802-PCMH1, ASK-45854-NG, ASK-45854-PCHS1, ASK-45854-PECL, CDC-02041-MK1A, CDC-05041-HPK1A, CDC-05052-HPK1A, CDC-21242-X1A, CDC-24703-X1A, CDC-25123-X1A, CDC-25402-X1A, CDC-25502-X1A, CDC-25553-X1A, CDC-26553-X1A, CDC-29803-X1A, CDC-29903-X1A CDC-34052-HPK1A, CDC-35041-VPS, CDC-35052-HPK1A, CDC-35052-VPS, CDC-35063-VPS, CDC-35563-VPS, CDC-42703-XP1A, CDC-42802-XP1A, CDC-42802-XP1A, CDC-44041-HPK1A, CDC-44052-HPK1A, CDC-45041-HPK1A, CDC-45041-VPS, CDC-45541-HPK1A, CDC-45541-VPS, CDC-45552-HPK1A, CDC-45703-XP1A, CDC-45703-XPB1A, CDC-45802-XP1A, CDC-45854-XP1A, CDC-46702-XP1A, with lot numbers: 23F13H1030, 23F13H0046,RF3053077, 23F13J0406, 23F13H0230, 23F13J0435, 23F13J0440, 23F13H1031, 23F13J0181, 23F13G0409, 23F13H0060, 23F13H0231, RF3053088, 23F13H0232, 23F13H0062, 23F13H0233, RF3053092, RF3053096, 23F13J0072, 23F13H0520, 23F13H1032, 23F13H0064, 23F13J0446, 23F13H0804, 23F13J0187, 23F13H0069, 23F13J0193, 23F13H1033, 23F13G0724, 23F13H0898, RF3053035, 23F13",".","71255","Arrow International Inc. is recalling Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe because the component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.",8/6/2014,"08/06/2014",10/22/2014,"10/22/2014"
"Drugs",68988,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0007-2015","Class II","ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01","MP2292 Exp. 01/16",,"5400 bottles","Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.",8/5/2014,"08/05/2014",10/15/2014,"10/15/2014"
"Devices",68989,"Ongoing","Centurion Medical Products Corporation","Williamston","MI","US","Voluntary: Firm Initiated","Letter","The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.","Z-2670-2014","Class II","0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. ","0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650; Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180; Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250; Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880; Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950; Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780; Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150; Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380; Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980; Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880, 2013111180; Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750; Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480; Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080; Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280; Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780; Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180; Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880; Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080; Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080; Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180; Kit Code/Description: DT17300/NEONATAL CAP CHANGE ",,"21388","Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.",7/25/2014,"07/25/2014",10/1/2014,"10/01/2014"
"Food",68990,"Ongoing","Live Superfoods","Bend","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to AR; AZ; CA; CO; DC; FL; IL; IN; MA; MD; MO; NC; NH; NV; NY; OH; OK; OR; RI; TN; TX; UT; VA; WA. Israel, Norway.","F-2410-2014","Class I","Brown carob powder packed in a plastic heat sealed 16oz. bag, labeled in part ''Live Superfoods Carob Powder***NET WT 16 OZ***Live Superfoods Bend, Oregon''. UPC code 797734313543 The product also sold in 10 lbs. bags.","20140097 sell by 3/1/2016; 20140098 sell by 3/1/2016 (this is for 10 lbs. bag); 20140164 sell by 6/1/2016. ",,"125 lbs of carob powder was distributed.","Live Superfoods was notified of a recall of organic carob powder by their supplier, Earth Circle Organics, on July 23, 2014. Live Superfoods re-packed organic carob powder for further distribution and is also voluntarily recalling this product due to potential Salmonella contamination.",7/23/2014,"07/23/2014",9/10/2014,"09/10/2014"
"Devices",68991,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.","Z-2618-2014","Class II","The BD MAX'' MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.","All Lots with the expiration date January 21, 2014 or later",".","585,048 tests","The performance of the assay no longer conforms to the following statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAXTM MRSA Assay. Based on our investigation of incorrect results observed when testing the College of American Pathologists (CAP) surveys MRS5-A 2014 and MRS5-B 2014 using the BD-MAX MRSA Assay, it was confirmed that one of the samples for each of these surveys yielded false positive results. This investigation currently continues to determine the root cause and identify appropriate corrective measures. ",7/23/2014,"07/23/2014",9/17/2014,"09/17/2014"
"Devices",68993,"Ongoing","Medical Components, Inc dba MedComp","Harleysville","PA","US","Voluntary: Firm Initiated","Letter","USA Nationwide Distribution","Z-2592-2014","Class II","Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. ","TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.",,"110","The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.",8/4/2014,"08/04/2014",9/10/2014,"09/10/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2381-2014","Class I","Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,coconut, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC 011386711909; No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2379-2014","Class I","Tiny Isle Chocolate Truffles: Gluten-Free, Raw, Vegan, Flavor varieties: Kauai Coconut, Mac Nut, Sea Salt, Mint Crunch, Spicy Lava. 1-oz Tiny Isle 4504 Kukui St, 20A Kapaa, HI 96746","No lot codes or expiry dates ",".","ALL","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2386-2014","Class I","Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2389-2014","Class I","Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2378-2014","Class I","Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","4 pack box UPC 011386711558 No lot codes or expiry dates All individual truffles have the same UPC number so I made them one product..",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2390-2014","Class I","Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2382-2014","Class I","Tiny Isle Mac Nut Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC 011386071188; No lot codes or expiry dates ",".","ALL","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2387-2014","Class I","Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2380-2014","Class I","Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC 011386071157No lot codes or expiry dates ",".","ALL","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2384-2014","Class I","Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC 011386071164; No lot codes or expiry dates ",".","ALL","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2383-2014","Class I","Tiny Isle Mint Crunch Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder cacao nibs, mint, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC 011386071164; No lot codes or expiry dates ",".","ALL","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2388-2014","Class I","Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2391-2014","Class I","Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746","UPC for Fudge Pack: 11386071195 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Food",68994,"Ongoing","Florimont, Inc.","Kapaa","HI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","HI only","F-2385-2014","Class I","Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746","UPC for single truffles: 11386711886 No lot codes or expiry dates ",".","All","Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.",7/25/2014,"07/25/2014",9/3/2014,"09/03/2014"
"Devices",68997,"Ongoing","EMG Technology Co., Ltd.","Taichung",,"TW","Voluntary: Firm Initiated","Letter","Distributed in the state of IL.","Z-2642-2014","Class II","Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.","''Product Model No: SUAOI ''SeriaJ No: SUI4B01391-SU14B02117. SU14C00556-SU14C01280 ",,"1452","EMG Technology Co., Ltd. Is voluntarily recalling Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister) with serial number ranges: SU14B01391-SU14B02117 and SU14C00556-SU14C01280 which contain suction canister lids that may have occluded ports.",8/3/2014,"08/03/2014",9/24/2014,"09/24/2014"
"Veterinary",68998,"Ongoing","Pegasus Laboratories, Inc.","Pensacola","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL, GA, KY, MO, NY, PA, TX, and VA","V-167-2014","Class II","ReBalance Antiprotozoal Oral Suspension (Sulfadiazine and Pyrimethamine For Oral Use in Horses Only ","Lot # 131110",".","2,988 bottles ","Low assay result for the Pyrimethamine at the 6-month stability time point.",7/10/2014,"07/10/2014",10/7/2014,"10/07/2014"
"Biologics",68999,"Terminated","Talecris Plasma Resources, Inc.","Research Triangle Park","NC","US","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0893-14","Class II","Source Plasma","3940135686; 3940135217; 3940134813; 3940133734; 3940133338; 3940132544; 3940132206; ",,"Seven units","Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.",6/17/2014,"06/17/2014",9/24/2014,"09/24/2014"
"Biologics",69000,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA, CA","B-0978-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated Washed","W068514003939",,"1 unit","Blood products, possibly contaminated with air, were distributed.",5/9/2014,"05/09/2014",10/1/2014,"10/01/2014"
"Biologics",69000,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA, CA","B-0979-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated","W068514004236; W068514004236; W068514004249; W068514004249; W068514003939",,"5 units","Blood products, possibly contaminated with air, were distributed.",5/9/2014,"05/09/2014",10/1/2014,"10/01/2014"
"Biologics",69000,"Terminated","Inland Northwest Blood Center","Spokane","WA","US","Voluntary: Firm Initiated","Telephone","WA, CA","B-0980-14","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W068514004778; W068514004778; W068514004650; W068514004659; W068514004600; W068514004600; W068514004602; W068514004602; W068514004609; W068514004609; W068514004370; W068514004122; W068514004101; W068514004101; W068514004102; W068514004102; W068514004370; W068514004163; W068514004163; W068514004119; W068514004119; W068514004122; W068514003891; W068514003891; W068514003805; W068514003805; ",,"26 units","Blood products, possibly contaminated with air, were distributed.",5/9/2014,"05/09/2014",10/1/2014,"10/01/2014"
"Biologics",69001,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","Telephone","IN","B-0977-14","Class II","Red Blood Cells Leukocytes Reduced","W20381409929600",,"1 unit","Blood product, possibly contaminated with air, was distributed.",6/9/2014,"06/09/2014",10/1/2014,"10/01/2014"
"Biologics",69003,"Terminated","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Illinois","B-0909-14","Class II","Ligament","126370107; ",,"1 allograft","Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. ",6/5/2014,"06/05/2014",8/27/2014,"08/27/2014"
"Biologics",69004,"Terminated","Carter BloodCare, Inc.","Tyler","TX","US","Voluntary: Firm Initiated","FAX","TX","B-0976-14","Class III","Red Blood Cells Leukocytes Reduced","W0352141452119; W035214146310O; W035214124176Q; W035214124196I; W035214233270O; W035214096925E; W035214060814Z",,"7 units","Blood products, shipped using coolers that had not been validated and possibly reached unacceptable temperatures, were distributed.",6/20/2014,"06/20/2014",10/1/2014,"10/01/2014"
"Biologics",69005,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH, Switzerland","B-0974-14","Class II","Red Blood Cells Leukocytes Reduced","W037711205638",,"1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed.",4/4/2014,"04/04/2014",10/1/2014,"10/01/2014"
"Biologics",69005,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","OH, Switzerland","B-0975-14","Class II","Blood and Blood Products for Reprocessing","W037711205638 ",,"1 unit","Blood products, collected from a donor with a history of Hepatitis A, were distributed.",4/4/2014,"04/04/2014",10/1/2014,"10/01/2014"
"Biologics",69006,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","MS","B-0973-14","Class II","Red Blood Cells Leukocytes Reduced","W069109116335",,"1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",7/14/2014,"07/14/2014",9/24/2014,"09/24/2014"
"Biologics",69007,"Terminated","DCI Biologicals, LLC","Bryan","TX","US","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0984-14","Class III","Source Plasma","BY0444467",,"1 unit","Blood product, in which donor testing was not performed or incomplete, was distributed. ",4/29/2014,"04/29/2014",9/24/2014,"09/24/2014"
"Biologics",69008,"Terminated","DCI Biologicals Wilmington, Inc.","Wilmington","NC","US","Voluntary: Firm Initiated","FAX","TN","B-0972-14","Class III","Source Plasma","WN0389104",,"1 unit","Blood product, collected from a donor with no documentation of an arm inspection or general appearance, was distributed.",6/27/2014,"06/27/2014",9/24/2014,"09/24/2014"
"Biologics",69009,"Terminated","DCI Biologicals Orlando LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","PA","B-0985-14","Class II","Source Plasma","JV0122563; JV0122875; JV0123645; JV0123925; JV0124728; JV0125150; JV0126722; JV0127025; JV0127788; JV0128178; JV0128948; JV0129346; JV0130015; JV0130382; JV0131205; JV0131560; JV0132415; JV0132765; JV0133787; JV0134377; JV0134974; JV0136689; JV0137281; JV0139215; JV0139589; JV0141293; JV0141745; JV0142416; JV0142821; JV0167217; JV0143791; JV0144309; JV0145020; JV0146031; JV0146344; JV0146980; JV0147407; JV0148164; JV0148546; JV0150534; JV0150966; JV0151670; JV0152222; JV0152777; JV0153679; JV0154019; JV0155316; JV0155692; JV0157060; JV0157676; JV0158086; JV0158991; JV0159334; JV0160046; JV0160366; JV0161149; JV0161434; JV0162056; JV0162421; JV0163081; JV0163882; JV0164157; JV0165059; JV0165295; JV0166028; JV0167586; JV0169162; JV0169471; JV0170445; JV0170807; JV0149281; JV0156573; JV0166366; ",,"73 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",5/16/2014,"05/16/2014",9/24/2014,"09/24/2014"
"Biologics",69010,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","FAX","IA","B-0971-14","Class II","Platelets Pheresis Leukocytes Reduced","W051514058460",,"1 unit","Platelets, with insufficient plasma volume to support the platelet yield, were distributed.",5/25/2014,"05/25/2014",9/24/2014,"09/24/2014"
"Drugs",69011,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1610-2014","Class I","Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05. ","Lot #: C940700, C940841, Exp 05/16",".","50,530 bags","Presence of Particulate Matter: particulate matter was found during the manufacturing process.",8/7/2014,"08/07/2014",10/7/2014,"10/07/2014"
"Biologics",69012,"Ongoing","Terumo BCT, Inc.","Lakewood","CO","US","Voluntary: Firm Initiated","Letter","Nationwide and worldwide. No VA/govt/military.","B-0995-14","Class III","TerumoBCT, Lakewood, CO 80215 USA. Catalog No: 6100 Spectra Optia Apheresis System","Catalog Number: 61000; Serial Number 1P00000",,"393","Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback, were distributed. ",8/27/2014,"08/27/2014",10/1/2014,"10/01/2014"
"Drugs",69013,"Ongoing","Akorn, Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1571-2014","Class III","Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42","Lot: 12RIF4A, Expiration Date: 9/30/2014",,"5,539 vials","Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point",8/5/2014,"08/05/2014",10/1/2014,"10/01/2014"
"Drugs",69014,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0039-2015","Class II","CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC","Codes: L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, L007J13A ",,"170113 units","Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. ",8/6/2014,"08/06/2014",10/29/2014,"10/29/2014"
"Drugs",69014,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0038-2015","Class II","CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC","Codes: L084A13A, L095F13A, L027H13A, L102K13A",,"101208 units","Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. ",8/6/2014,"08/06/2014",10/29/2014,"10/29/2014"
"Drugs",69014,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0037-2015","Class II","CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC ","Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A",,"181908 units","Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint. ",8/6/2014,"08/06/2014",10/29/2014,"10/29/2014"
"Biologics",69015,"Terminated","Our Lady Of The Lake Hospital Inc","Baton Rouge","LA","US","Voluntary: Firm Initiated","FAX","LA","B-0981-14","Class II","Red Blood Cells Leukocytes Reduced","W165713021650Q",,"1 unit","Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.",7/17/2014,"07/17/2014",9/24/2014,"09/24/2014"
"Biologics",69016,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0892-14","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W043214051674; ",".","1","Plateletpheresis product, lacking product quality control, was distributed.",7/18/2014,"07/18/2014",10/7/2014,"10/07/2014"
"Biologics",69017,"Terminated","Walter L. Shepeard Community Blood Center, Inc.","Augusta","GA","US","Voluntary: Firm Initiated","FAX","Georgia","B-0926-14","Class II","Red Blood Cells Leukocytes Reduced","W038514701995; ",".","One unit","Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, was distributed.",7/28/2014,"07/28/2014",9/17/2014,"09/17/2014"
"Biologics",69018,"Terminated","Micro Typing Systems, Inc.","Pompano Beach","FL","US","Voluntary: Firm Initiated","Letter","Canada; Multiple U.S. States","B-0813-14","Class III","Blood Grouping Reagent Combination Kit","10011303759; 10241303753; 10241303764; 12021303755; 12021303761; 12021303766; 01201403756; 02121403751; ",,"8 Lots","MTS A/B/D Monoclonal and Reverse Grouping Cards, with the potential for false positive reactions with some lots, were distributed. ",7/7/2014,"07/07/2014",9/24/2014,"09/24/2014"
"Biologics",69019,"Terminated","Walter L. Shepeard Community Blood Center, Inc.","Augusta","GA","US","Voluntary: Firm Initiated","FAX","Indiana; Georgia","B-0953-14","Class II","Red Blood Cells Leukocytes Reduced","W038513100983; ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",6/16/2014,"06/16/2014",9/17/2014,"09/17/2014"
"Biologics",69019,"Terminated","Walter L. Shepeard Community Blood Center, Inc.","Augusta","GA","US","Voluntary: Firm Initiated","FAX","Indiana; Georgia","B-0954-14","Class II","Plasma Frozen","W038513100983; ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.",6/16/2014,"06/16/2014",9/17/2014,"09/17/2014"
"Devices",69020,"Ongoing","CareFusion 203, Inc.","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI.","Z-2593-2014","Class I","CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.","SERIAL # ENVE CUSTOMER UNITS: 26562 44554 44559 45317 45322 45324 45328 45330 45333 45334 45336 45339 45341 45343 45736 45737 45740 45741 45742 45744 45745 45750 45751 45752 45907 45908 46040 46041 46043 46044 46050 46051 46632 46636 46641 46642 46643 46644 46645 46646 47069 47071 47073 47075 47076 47077 47078 47079 47080 47081 47082 47210 47211 47213 47214 47215 47216 47217 47219 47221 47223 47225 47226 47227 47229 47230 47231 47232 47233 47234 47236 47237 47238 47239 47538 47539 47541 47542 47543 47544 47545 47546 47547 47548 47549 47550 47551 47552 47553 47554 47555 47556 47557 47558 47559 47560 47561 47562 47563 47564 47565 47566 47567 48759 48760 48761 48762 48763 48764 48765 48766 48767 48768 48769 48770 48771 48772 48773 48774 48775 48776 48777 48778 48779 48780 48781 48782 48783 48784 48785 48786 48787 48788 48868 48869 48870 48871 48872 48873 48874 48875 48876 48877 48878 48879 48881 48883 48884 48885 48886 48887 48888 48889 48890 48891 48892 48893 48894 48895 48896 48897 50390 50391 50392 50393 50394 50395 50397 50398 50401 50405 50409 50411 50412 50415 50416 50417 50418 50419 50648 50650 50651 50652 50654 50656 50657 50658 50659 50660 50662 50663 50664 50665 50666 50667 50668 50669 50671 50672 50673 50674 51569 51570 51572 51573 51574 51575 51576 51578 51579 51580 51582 51583 51584 51585 51586 51587 51588 51589 51590 51591 51592 51593 51594 51595 51596 51597 51598 52222 52223 52224 52225 52226 52227 52228 52229 52230 52231 52372 52373 52376 52377 52378 52380 52381 52594 52595 52596 52597 52598 52599 52600 52601 52602 52603 52604 52605 52606 52608 61822 61823 61825 64594 64595 64596 64597 64598 64599 64600 64601 65295 65296 65297 65298 65299 65301 65302 65303 65454 65455 65456 65457 65458 65459 65460 65461 65462 65463 65464 65465 65466 65467 65468 65469 65470 65471 65472 65473 66398 66399 66400 66401 66402 66403 66404 66405 66406 66407 66408 66409 67353 67354 67355 67356 67357 67358 67359 67360 67361 67362 67363 67364 67365 67366 67367 67368 67369 67370 68903 68904 68905 68906 68907 68908 68909 68910",,"1729","CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and preventing charge to the ventilator battery.",8/8/2014,"08/08/2014",10/1/2014,"10/01/2014"
"Devices",69021,"Ongoing","Ellex iScience, Inc. ","Menlo Park","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.","Z-2590-2014","Class II","iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.","Lot number 1404-03; Expiration: March 31, 2016",,"148 devices","One lot may not have been properly sealed, resulting in a non-sterile device.",8/6/2014,"08/06/2014",9/10/2014,"09/10/2014"
"Devices",69022,"Ongoing","Mentor Texas, LP.","Irving","TX","US","Voluntary: Firm Initiated","Letter","U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.","Z-2591-2014","Class II","EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted. Mentor Sterile Saline Mammary Volume Sizer (Sizer) is a silicone elastomer device designed for temporary intraoperative placement in the surgically prepared mammary pocket. The Sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implant of a mammary prosthesis. The Sizer is inflated to its optimal volume with saline after it is placed within the pocket, and then deflated prior to its removal. ","Part Number (PN) 351-3380SZ Lot Number 6830722",,"34 units","The device labeling is stamped with 330cc and the device is actually 380cc device.",7/2/2014,"07/02/2014",9/10/2014,"09/10/2014"
"Food",69023,"Ongoing","Glaser Organic Farms","Miami","FL","US","Voluntary: Firm Initiated","Telephone","PA, NY, NJ, GA, IL, NC, and FL Bahamas","F-0045-2015","Class I","All Raw Vegan Carob Coconut Raspberry Raw Fruit Pie, Net WT. 8.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. ","Lot #0207151474",,"244","Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. ",7/24/2014,"07/24/2014",10/29/2014,"10/29/2014"
"Food",69023,"Ongoing","Glaser Organic Farms","Miami","FL","US","Voluntary: Firm Initiated","Telephone","PA, NY, NJ, GA, IL, NC, and FL Bahamas","F-0042-2015","Class I","All Raw Vegan, Raw Carob Powder, Net Wt. 8 oz. and 5 lb bag, - Keep Cool & Dry. Glaser Organic Farms, Miami, FL. (305) 238-7747. UPC Code: 83291005567","Lot #0507081456",,"148 ","Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. ",7/24/2014,"07/24/2014",10/29/2014,"10/29/2014"
"Food",69023,"Ongoing","Glaser Organic Farms","Miami","FL","US","Voluntary: Firm Initiated","Telephone","PA, NY, NJ, GA, IL, NC, and FL Bahamas","F-0044-2015","Class I","All Raw Vegan Carob Pudding Pie, Net WT. 4.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. ","Lot #0207151478",,"153","Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. ",7/24/2014,"07/24/2014",10/29/2014,"10/29/2014"
"Food",69023,"Ongoing","Glaser Organic Farms","Miami","FL","US","Voluntary: Firm Initiated","Telephone","PA, NY, NJ, GA, IL, NC, and FL Bahamas","F-0043-2015","Class I","All Raw Vegan Certified Organic Carob Fudgy Brownie, Net WT. 5.5 oz. (156 g) - Keep Cool & Dry. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. UPC Code: 832910002061.","Lot #0207211406",,"1,442 ","Glaser Organic Farms has been notified by its supplier Earth Circle Organics, of a recall of Organic Carob Powder due to possible health risks related to Salmonella contamination. ",7/24/2014,"07/24/2014",10/29/2014,"10/29/2014"
"Devices",69024,"Ongoing","ELITech Clinical Systems SAS","SEES",,"FR","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0006-2015","Class III","ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.","Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015; ",".","878 kits","Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.",8/11/2014,"08/11/2014",10/7/2014,"10/07/2014"
"Devices",69025,"Ongoing","St. Jude Medical, Inc.","Plano","TX","US","Voluntary: Firm Initiated","Letter","Distributed in the states of Texas and Illinois.","Z-2718-2014","Class II","Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. ","Material 100077113, Batch 4558337",".","2 units","The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.",7/29/2014,"07/29/2014",10/7/2014,"10/07/2014"
"Devices",69025,"Ongoing","St. Jude Medical, Inc.","Plano","TX","US","Voluntary: Firm Initiated","Letter","Distributed in the states of Texas and Illinois.","Z-2719-2014","Class II","Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. ","Material 100077108, Batch 4519182",".","4 units","The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.",7/29/2014,"07/29/2014",10/7/2014,"10/07/2014"
"Biologics",69026,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","New Hampshire","B-0935-14","Class III","Red Blood Cells Leukocytes Reduced","W051714624122; ",".","1 unit","Blood product, manufactured without additive solution, was distributed.",7/10/2014,"07/10/2014",9/17/2014,"09/17/2014"
"Biologics",69027,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","Telephone","Arizona","B-0952-14","Class II","Plasma Frozen within 24 hours (FP24)","W041013191843F; ",,"1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",6/23/2014,"06/23/2014",9/24/2014,"09/24/2014"
"Biologics",69028,"Terminated","Southern California Permanente Medical Group","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0955-14","Class II","Red Blood Cells (Apheresis) Leukoreduced","W072114001043; ",,"One unit","Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed.",6/25/2014,"06/25/2014",9/24/2014,"09/24/2014"
"Biologics",69029,"Terminated","Southern California Permanente Medical Group","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0956-14","Class II","Red Blood Cells Leukocytes Reduced","W072114003240; ",,"One unit","Blood product, labeled ''leukoreduced'', but which had not undergone leukoreduction, was distributed.",6/17/2014,"06/17/2014",9/24/2014,"09/24/2014"
"Biologics",69030,"Terminated","Central Pennsylvania Blood Bank","Hummelstown","PA","US","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0957-14","Class II","Red Blood Cells Leukocytes Reduced","W270114200164; W270114512390; ",".","2","Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed",7/18/2014,"07/18/2014",9/17/2014,"09/17/2014"
"Cosmetics",69031,"Ongoing","Dd Traders Inc","Leawood","KS","US","Voluntary: Firm Initiated","E-Mail","Distribution was made to AL, AK, AR, AZ, CA, CO, DE, IA, IL, IN, FL, GA, KS, KY, MA, MD, ME, MI, MO, MN, NC, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Foreign distribution was made to Canada and Australia.","F-2533-2014","Class II","Glow OLOGY Renew body butter packaged in 226 g (8 oz.) jars. Made in the USA. Distributed by DD Traders Inc. dba DEMDACO, Leawood, Kansas 66209. glowologyskincare.com","Batch # 2025 (Lot 4112 and Lot 4113)",".","Lot 4112 - 2,340/8-oz jars and Lot 4113 - 264/8-oz jars ","The product is contaminated with Pseudomonas luteola.",7/24/2014,"07/24/2014",10/7/2014,"10/07/2014"
"Devices",69032,"Ongoing","Biofire Defense","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and country of: Guam.","Z-2644-2014","Class III","JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis. ","Model Number(s): JRPD-SFW-0001 ",," 43 Units w/ laptops","BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.",8/13/2014,"08/13/2014",9/24/2014,"09/24/2014"
"Devices",69033,"Completed","PIONEER SURGICAL TECHNOLOGY, INC.","Marquette","MI","US","Voluntary: Firm Initiated","Telephone","Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.","Z-2573-2014","Class II","STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY ","Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.",,"11 sets","Some set screw thread profiles were found not to be within specifications.",9/10/2012,"09/10/2012",9/10/2014,"09/10/2014"
"Devices",69034,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.","Z-2685-2014","Class II","The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may no","Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14",,"220 units","Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.",10/10/2013,"10/10/2013",10/1/2014,"10/01/2014"
"Devices",69034,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.","Z-2681-2014","Class II","The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain.","Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14",,"400 units","Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.",10/10/2013,"10/10/2013",10/1/2014,"10/01/2014"
"Devices",69034,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.","Z-2683-2014","Class II","The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp. In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.","Product Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14",,"4,440 units","Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.",10/10/2013,"10/10/2013",10/1/2014,"10/01/2014"
"Devices",69034,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.","Z-2684-2014","Class II","The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ fac","Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14 ",,"780 units","Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.",10/10/2013,"10/10/2013",10/1/2014,"10/01/2014"
"Devices",69034,"Ongoing","Nanosphere, Inc.","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.","Z-2682-2014","Class II","The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.","Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14",,"80 units","Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.",10/10/2013,"10/10/2013",10/1/2014,"10/01/2014"
"Devices",69035,"Ongoing","Pdg Product Design Group Inc","Vancouver","BC","CA","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution- US Distribution including the states of : AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA., and Internationally to Canada and Hong Kong.","Z-2695-2014","Class II","No packaging. Device is a wheel chair. Fuze T50, Fuze T20 and Fuze T50 Jr ","Fuze T50, Fuze T20 and Fuze T50 Jr 52752 52794 52750 52667 52679 52692 52729 52745 52779 52826 52865 52878 52823 52912 52804 52666 52680 52702 52731 52746 52780 52827 52866 52879 52749 52913 52753 52669 52682 52703 52732 52747 52781 52828 52867 52880 52696 52796 52734 52670 52681 52695 52735 52768 52782 52856 52868 52881 52748 52705 52701 52671 52683 52707 52736 52770 52802 52857 52869 52882 52825 52699 52698 52672 52684 52708 52737 52771 52803 52858 52870 52883 52829 52706 52834 52668 52685 52710 52738 52772 52805 52859 52871 52884 52916 52751 52821 52673 52687 52709 52739 52773 52806 52860 52872 52885 52767 52799 53192 52674 52690 52711 52740 52774 52807 52861 52873 52886 52795 52914 52663 52676 52688 52726 52741 52775 52808 52862 52874 52887 52919 52824 52664 52677 52691 52728 52742 52776 52809 52863 52876 52888 52831 52918 52665 52675 52693 52727 52743 52777 52810 52864 52877 52889 52754 52917 52733 52678 52694 52730 52744 52778 52811 ",,"153","The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.",6/12/2012,"06/12/2012",10/1/2014,"10/01/2014"
"Devices",69036,"Completed","PIONEER SURGICAL TECHNOLOGY, INC.","Marquette","MI","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including TX, CA, IL, and FL.","Z-2616-2014","Class II","Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.","Lot number: 148062, 148440",".","9","The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.",6/14/2013,"06/14/2013",9/17/2014,"09/17/2014"
"Devices",69038,"Ongoing","JK Products & Services, Inc","Jonesboro","AR","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2635-2014","Class II","SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.","PN 8000809705; Serial numbers 248-1298",,"1948 units","The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).",7/25/2014,"07/25/2014",9/24/2014,"09/24/2014"
"Devices",69039,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.","Z-2737-2014","Class II","Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2, Sterilized using irradiation, single use.","Lot Numbers: 62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435 ",".","16,380 units","The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.",9/9/2014,"09/09/2014",10/7/2014,"10/07/2014"
"Biologics",69040,"Terminated","Central California Blood Center","Fresno","CA","US","Voluntary: Firm Initiated","FAX","California","B-0958-14","Class II","Red Blood Cells Leukocytes Reduced","W115914040200; ",".","One unit","Blood product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed.",7/25/2014,"07/25/2014",9/17/2014,"09/17/2014"
"Biologics",69041,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","Colorado and New Jersey","B-0997-14","Class II","Red Blood Cells Leukocytes Reduced","W036212456713; W036212430018; W036211169353; W036211165203 ",,"4 units","Blood products, collected from donors who lived in a malarial endemic area, were distributed. ",7/2/2014,"07/02/2014",10/15/2014,"10/15/2014"
"Biologics",69042,"Terminated","DCI Biologicals Orlando LLC","Orlando","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0970-14","Class II","Source Plasma","OL0399363; ",".","1 unit","Source plasma product, for which donor eligibility was not complete, was distributed.",7/4/2014,"07/04/2014",10/7/2014,"10/07/2014"
"Devices",69043,"Ongoing","Life Force of Tampa, LLC","Tampa","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.","Z-2625-2014","Class II","Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality. ","ALL Life Force Chambers",".","10"," The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigational device exemptions and has not notify FDA of its intent to introduce the chamber into commercial distribution as a medical device.",6/27/2014,"06/27/2014",9/17/2014,"09/17/2014"
"Devices",69045,"Completed","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.","Z-2664-2014","Class II","The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.","91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157",,"6","During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software update to Beta 3 to correct this issue. ",9/1/2011,"09/01/2011",9/24/2014,"09/24/2014"
"Devices",69047,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution.","Z-2673-2014","Class II","BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 3065553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.","REF #306533 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017",,"3,088,320 units","BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306533).",7/22/2014,"07/22/2014",10/1/2014,"10/01/2014"
"Drugs",69048,"Ongoing","Perrigo Holland Inc","Holland","MI","US","Voluntary: Firm Initiated","Telephone","U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.","D-1558-2014","Class III","Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.","Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15; Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15; Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15; Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15. 20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15. ",".","366,936 Tubes","Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.",8/19/2014,"08/19/2014",9/3/2014,"09/03/2014"
"Devices",69049,"Ongoing","Volcano Corporation","Rancho Cordova","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.","Z-2636-2014","Class II","Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. ","Part number 91003: All Lots",,"8251 total devices (3777 US)","Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.",8/13/2014,"08/13/2014",9/24/2014,"09/24/2014"
"Devices",69050,"Completed","OrthoPediatrics Corp","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution.","Z-2560-2014","Class II","ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone. ","Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770 ",,"56 units ","Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.",7/25/2014,"07/25/2014",9/10/2014,"09/10/2014"
"Devices",69051,"Completed","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.","Z-2666-2014","Class II","The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.","System Code #, 728243, 728244, Serial #: 7022, 7118, 7151, 7298, 7343, 7360, 7361, 7362, 7363, 7364, 7365, 7366, 7367, 7368, 7369, 7370, 7371, 7372, 7373, 7374, 7375, 7376, 7377, 7378, 7379, 7380, 7381, 7382, 7383, 7384, 7385, 7386, 7387, 7388, 7389, 7390, 7391, 7392, 7393, 7394, 7395, 7396, 7397, 7398, 7399, 7400, 7401, 7402, 7403, 7404, 7405, 7406, 7407, 7408, 7409, 7410, 7411, 7412, 7413, 7414, 7415, 7416, 7417, 7418, 7419, 7420, 7421, 7422, 7423, 7424, 7425, 7426, 7427, 7428, 7429, 7430, 7431, 7432, 7433, 7434, 7435, 7436, 7437, 7438, 7439, 7440, 7441, 7442, 7443, 7444, 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7452, 7453, 7454, 7455, 7456, 7457, 7458, 7459, 7461, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7486, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7510, 7511, 7512, 7513, 7514, 7515, 7516, 7517, 7518, 7519, 7520, 7521, 7522, 7523, 7524, 7525, 7526, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7534, 7535, 7536, 7537, 7538, 7539, 7540, 7541, 7542, 7543, 7544, 7545, 7546, 7547, 7548, 7549, 7550, 7551, 7552, 7553, 7554, 7555, 7556, 7557, 7558, 7559, 7560, 7561, 7562, 7563, 7564, 7565, 7566, 7567, 7568, 7569, 7570, 7571, 7572, 7573, 7574, 7575, 7576, 7577, 7578, 7578, 7579, 7580, 7581, 7582, 7583, 7584, 7585, 7586, 7587, 7588, 7589, 7590, 7591, 7592, 7593, 7594, 7595, 7596, 7597, 7598, 7599, 7600, 7601, 7602, 7603, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7611, 7612, 7613, 7614, 7615 ",,"257","Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.",8/31/2012,"08/31/2012",9/24/2014,"09/24/2014"
"Devices",69052,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.","Z-0061-2015","Class II","Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.","Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157 ",,"21 units","The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. ",8/27/2014,"08/27/2014",10/15/2014,"10/15/2014"
"Devices",69053,"Ongoing","Baro-Therapies, Inc","Miramar Beach","FL","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of FL, GA, MS, TN and CO.","Z-2734-2014","Class II","The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather. ","All Lots, Series and Codes",".","10","The firm is distributing the Rejuvenator device without an approved 510(k).",8/8/2014,"08/08/2014",10/7/2014,"10/07/2014"
"Devices",69054,"Ongoing","B. Braun Medical, Inc.","Allentown","PA","US","Voluntary: Firm Initiated","Letter","Distributed in the state of Missouri.","Z-2655-2014","Class II","B.Braun ''Accuflo 100ML/H 100ML'' Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.","Lot Number: 4A1125F111",,"8,640 units","B. Braun Medical Inc. (USA) became aware that one (1) lot of the CT-1000-100 ''Accufix 100ML/H 100ML'' product was recalled by their German manufacturing site due to customer complaints that product was distributed to U.S. customers which contains incorrect product labeling. Specifically, the primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are CT-1000-100.",8/6/2014,"08/06/2014",9/24/2014,"09/24/2014"
"Drugs",69056,"Ongoing","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas and Georgia","D-1555-2014","Class II","fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04 ","Lot 7257-0 Exp. 08/14",,,"Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ",6/27/2014,"06/27/2014",8/27/2014,"08/27/2014"
"Drugs",69056,"Ongoing","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas and Georgia","D-1551-2014","Class II","fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90"," Lot 7088-0 Exp. 07/14",,"50 syringes ","Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ",6/27/2014,"06/27/2014",8/27/2014,"08/27/2014"
"Drugs",69056,"Ongoing","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas and Georgia","D-1554-2014","Class II","fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33 "," Lots 7083-0, 7202-0, 7222-0 Exp. 08/14",,"220 syringes","Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ",6/27/2014,"06/27/2014",8/27/2014,"08/27/2014"
"Drugs",69056,"Ongoing","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas and Georgia","D-1552-2014","Class II","fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04 ","Lots 7230-0, 7269-0 Exp. 08/14",,"48 bags","Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ",6/27/2014,"06/27/2014",8/27/2014,"08/27/2014"
"Drugs",69056,"Ongoing","Healix Infusion Therapy, Inc.","Sugar Land","TX","US","Voluntary: Firm Initiated","Letter","Texas and Georgia","D-1553-2014","Class II","fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02 ","Lot 7250-0 Exp. 08/14",,"12 bags","Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. ",6/27/2014,"06/27/2014",8/27/2014,"08/27/2014"
"Devices",69057,"Ongoing","GF Health Products, Inc./d.b.a.Basic American Metal Products","Fond Du Lac","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA,MI, MN, MS, MO,MT, NE, NH, NJ, NM, NY,M NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, LT, VA, WA, WV, and WI and PUERTO RICO and the country of CANADA.","Z-2656-2014","Class II","Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).","Model # Serial # APS98674 1161998674140123 APS98674 1169000522 APS98674 1161998674130104 APS98674 1161998674130105 APS98674 1169000642 APS98674 1169000643 APS98674 1161998674130049 APS98674 1161998674130002 APS98674 1161998674130003 APS98674 1161998674130004 APS98674 1161998674130005 APS98674 1161998674130006 APS98674 1161998674130007 APS98674 1161998674130008 APS98674 1161998674130009 APS98674 1161998674130010 APS98674 1161998674130011 APS98674 1161998674130012 APS98674 1161998674130013 APS98674 1161998674130014 APS98674 1161998674130015 APS98674 1161998674130016 APS98674 1161998674130017 APS98674 1161998674130018 APS98674 1161998674130019 APS98674 1161998674130020 APS98674 1161998674130021 APS98674 1161998674130022 APS98674 1161998674130023 APS98674 1161998674130024 APS98674 1161998674130025 APS98674 1161998674130026 APS98674 1161998674130027 APS98674 1161998674130028 APS98674 1161998674130029 APS98674 1161998674130030 APS98674 1161998674130031 APS98674 1161998674130032 APS98674 1161998674130033 APS98674 1161998674130034 APS98674 1161998674130035 APS98674 1161998674130036 APS98674 1161998674130037 APS98674 1161998674130038 APS98674 1161998674130039 APS98674 1161998674130040 APS98674 1161998674130041 APS98674 1161998674130042 APS98674 1161998674130043 APS98674 1161998674130044 APS98674 1161998674130046 APS98674 1161998674130047 APS98674 1161998674130048 APS98674 1161998674130103 APS98674 2626903676 APS98674 1161998674130001 APS98674 1169000889 APS98674 1169000890 APS98674 1169000891 APS98674 1169000892 APS98674 1169000893 APS98674 1169000894 APS98674 1169000895 APS98674 1169000896 APS98674 1169000897 APS98674 1169000898 APS98674 1169000899 APS98674 1169000900 APS98674 1169000901 APS98674 1169000902 APS98674 1169000903 APS98674 1169000826 APS98674 1169000905 APS98674 1161998674130106 APS98674 1161998674130107 APS98674 1161998674130108 APS98674 1161998674130109 APS98674 1161998674130110 APS98674 1161998674130111 APS98674 1161998674130112 APS98674 1161998674130113 APS98674 1161998674130114 APS98674 1161998674130"," ZZ98674 2626903761 ZZ98674 2626903762 ZZ98674 2626903764 ZZ98674 2626903765 ZZ98674 2626903841 ZZ98674 2626903842 ZZ98674 2626903843 ZZ98674 2626903844 ZZ98674 2626903845 ZZ98674 2626903846 ZZ98674 2626903982 ZZ98674 2626903983 ZZ98674 2626903984 ZZ98674 2626903985 ZZ98674 2626903986 ZZ98674 2626903987 ZZ98674 2626903988 ZZ98674 2626903989 ZZ98674 2626903990 ZZ98674 2626903991 ZZ98674 2626903992 ZZ98674 2626903993 ZZ98674 2626903994 ZZ98674 2626903995 ZZ98674 2626903996 ZZ98674 2626903997 ZZ98674 2626903998 ZZ98674 2626903999 ZZ98674 2626904000 ZZ98674 2626904001 ZZ98674 2626904002 ZZ98674 2626904003 ZZ98674 2626904004 ZZ98674 2626904005 ZZ98674 2626904006 ZZ98674 2626904007 ZZ98674 2626904008 ZZ98674 2626904009 ZZ98674 2626904010 ZZ98674 2626904011 ZZ98674 2626904012 ZZ98674 2626904013 ZZ98674 2626904014 ZZ98674 2626904015 ZZ98674 2626904016 ZZ98674 2626904017 ZZ98674 2626904018 ZZ98674 2626904019 ZZ98674 2626904020 ZZ98674 2626904021 ZZ98674 2626904022 ZZ98674 2626904023 ZZ98674 2626904024 ZZ98674 2626904025 ZZ98674 2626904026 ZZ98674 2626904027 ZZ98674 2626904028 ZZ98674 2626904029 ZZ98674 2626904030 ZZ98674 2626904031 ZZ98674 2626904032 ZZ98674 2626904033 ZZ98674 2626904034 ZZ98674 2626904035 ZZ98674 2626904036 ZZ98674 2626904037 ZZ98674 2626904038 ZZ98674 2626904039 ZZ98674 2626904040 ZZ98674 2626904041 ZZ98674 2626904042 ZZ98674 2626904043 ZZ98674 2626904044 ZZ98674 2626904045 ZZ98674 2626904046 ZZ98674 2626904047 ZZ98674 2626904048 ZZ98674 2626904049 ZZ98674 2626904050 ZZ98674 2626904051 ZZ98674 2626904052 ZZ98674 2626904053 ZZ98674 2626904054 ZZ98674 2626904055 ZZ98674 262698674130060 ZZ98674 262698674130151 ZZ98674 262698674130152 ZZ98674 262698674130148 ZZ98674 262698674130149 ZZ98674 2626904059 ZZ98674 262698674140724 ZZ98674 262698674140770 ZZ98674 2626903615 ZZ98674 2626903070 ZZ98674 262698674130577 ZZ98674 262698674140657 ZZ98674 262698674140658 ZZ98674 262698674140659 ZZ98674 262698674140742 ZZ98674 262698674140743 ZZ98674 262698674140744 ZZ98674 262698674130565 ZZ98674 262698674130566 ZZ98674","1941","GF Health Products, Inc / Basic American Medical Products is conducting a recall on various models of Zenith Slide W-I-D-E Long Term Care Beds. The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended. ",7/21/2014,"07/21/2014",9/24/2014,"09/24/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2602-2014","Class II","CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1490004, 1490005, 1490199, 1490200, 1490201, 1490202, 1518483, 1519493, 1519494, 1519495, 1522021, 1522898, 1522899, 1522900, 1523735, 1523736, 1526519, 1526520, 1526521, 1538760, 1538761, 1539402, 1540715, 1540716, 1540717, 1542703, 1542704, 1542776, 1543491, 1543891",".","1127 units"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2599-2014","Class II","CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic ","Lot Number: 1543488",".","0"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2603-2014","Class II","CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1490367, 1490368, 1512152, 1521232, 1523734, 1523746, 1537160, 1537161, 1539401, 1541613, 1541614, 1542652, 1542774, 1542775",".","400 units","Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2600-2014","Class II","CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Number: 1509955",".","9 units"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2608-2014","Class II","CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1513144, 1518479, 1534798, 1538331, 1543489",".","50 units"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2601-2014","Class II","CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, 1543149",".","497 units"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2605-2014","Class II","CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1512153, 1518480, 1532497, 1538075, 1538076, 1538332",".","66 units"," Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2607-2014","Class II","CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1517327, 1538333, 1543490",".","18 units","Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69058,"Ongoing","Wright Medical Technology, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.","Z-2604-2014","Class II","CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic","Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714",".","178 units","Plates manufactured from an incorrect raw material.",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2498-2014","Class II","Roots, Spinach Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 860971000047, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2496-2014","Class II","Roots, Hot Chipotle Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000054, and 723175787612, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2493-2014","Class II","Roots, Roasted Garlic Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000016, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2499-2014","Class II","Roots, Lima Bean Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2495-2014","Class II","Roots, Roasted Red Bell Pepper Hummus, Net Wt. 8oz (227 g), and 16oz. (454 g), Gluten-Free Vegan, UPC: 860971000023, and 723175787605, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2494-2014","Class II","Roots, Thai Coconut Curry Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000092, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2492-2014","Class II","Roots, Original Hummus, Net Wt. 8oz (227 g), and 16oz (454 g), Gluten-Free Vegan, UPC: 860971000009, and 723175787629, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,"4063 cases (6x8oz & 16oz units per case)","Although ingredient statement lists ''Tamari,'' Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2497-2014","Class II","Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000030, and 723175787636, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Food",69059,"Ongoing","Roots Organic Gourmet","Asheville","NC","US","Voluntary: Firm Initiated","E-Mail","CA, GA, NC, NH, NJ and NY.","F-2500-2014","Class II","Roots, Oil Free Original Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs. ","Products are labeled with a 'Best By' date of 08/25/14 or prior. ie. ''BEST BY: 08/25/14'' ",,,"Although ingredient statement lists ''Tamari'', Label lacks statement, ''Contains Soy.''",8/15/2014,"08/15/2014",10/1/2014,"10/01/2014"
"Biologics",69060,"Terminated","Avera McKennan Hospital & University Health Center","Sioux Falls","SD","US","Voluntary: Firm Initiated","FAX","South Dakota; Kentucky","B-0827-14","Class II","Red Blood Cells Leukocytes Reduced","W116113006606; ",".","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed.",7/8/2014,"07/08/2014",10/7/2014,"10/07/2014"
"Biologics",69060,"Terminated","Avera McKennan Hospital & University Health Center","Sioux Falls","SD","US","Voluntary: Firm Initiated","FAX","South Dakota; Kentucky","B-0828-14","Class III","Plasma","W116113006606; ",".","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt- Jacob Disease (vCJD), were distributed.",7/8/2014,"07/08/2014",10/7/2014,"10/07/2014"
"Biologics",69061,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida; Switzerland","B-0962-14","Class II","Red Blood Cells Leukocytes Reduced","W118814572017; ",".","1","Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed",7/9/2014,"07/09/2014",11/5/2014,"11/05/2014"
"Biologics",69061,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida; Switzerland","B-0963-14","Class II","Blood and Blood Products for Reprocessing","W118814572017; ",".","1","Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed",7/9/2014,"07/09/2014",11/5/2014,"11/05/2014"
"Devices",69062,"Ongoing","Becton Dickinson & Co.","Sparks","MD","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV., and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.","Z-2628-2014","Class II","BD BBLTM Vancomycin Screen Agar Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.","Product number - 4080291 4042217 4048040 4052349 4058242 4073274 4127728 ",,"28540","BD has confirmed reports that the referenced lots of Vancomycin Screen Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Vancomycin Screen Agar that is allowing susceptible enterococci to grow gives the appearance of a falsely resistant culture. With the majority of laboratories performing appropriate QC testing, it is likely that QC will identify the problem and the results would not be used for patient reports. However, on the chance that a laboratory is not performing QC, falsely resistant enterococci would still go on to have further AST workup and the error would be identified. There could be a delay in the identification of false-resistance. ",7/28/2014,"07/28/2014",9/24/2014,"09/24/2014"
"Devices",69063,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland","Z-2720-2014","Class II","Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista System.","lot 3GM081, exp. 07-01-2014",".","9769 Total (6000 US)","Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.",8/18/2014,"08/18/2014",10/7/2014,"10/07/2014"
"Devices",69064,"Ongoing","Gendex Corp","Hatfield","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.","Z-0009-2015","Class II","eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray","Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details. ",".","651","Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm. ",8/12/2014,"08/12/2014",10/7/2014,"10/07/2014"
"Devices",69065,"Ongoing","Stryker Howmedica Osteonics Corp.","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.","Z-0065-2015","Class II","Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion. ","Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019",".","484 units ","Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.",7/24/2014,"07/24/2014",10/22/2014,"10/22/2014"
"Devices",69066,"Ongoing","Catheter Connections, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","US Distribution to states of: CT, GA, MD, and PA. .","Z-2595-2014","Class II","DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo'' disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.","Lot 1406509",".","23,800 units","Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.",8/5/2014,"08/05/2014",9/17/2014,"09/17/2014"
"Devices",69067,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.","Z-2649-2014","Class II","AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. ","model # 10094200, see distribution list for individual device serial numbers",,"33","It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically disable the affected button(s) with the start-up of the system. Pressing button on the control panel may lead to unintended system movement. The remote control panel is not affected by any malfunction of the tableside control panel and can reliably be used at any time. In case of a malfunction of the tableside control panel, users are recommended to switch to solely using the remote control panel(s). ",8/12/2014,"08/12/2014",9/24/2014,"09/24/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0564-2015","Class I","MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408.","Best By Dates Range: 06JAN15 thru 20MAY15; 20-May-15; ",".","8881 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0556-2015","Class I","Arrowhead Mills Organic Crunchy Peanut Butter No Salt Added, 16 oz., UPC 74333470328.","Best By Dates Range: 31DEC14 thru 14MAY15",".","4412 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0550-2015","Class I","MaraNatha Roasted Creamy Almond Butter, 16 oz., UPC 51651060325; MaraNatha Roasted Creamy Almond Butter, 26 oz., UPC 51651092897; Whole Foods 365 Creamy Almond Butter, 16 oz., UPC 99482406578. ","Best By Dates Range: 24DEC14 thru 17JUN15; 04DEC14 thru 21APR15; 23DEC14 thru 24DEC14; ",".","101,922 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0553-2015","Class I","MaraNatha No Stir Raw Maple Creamy Almond Butter, 12 oz., UPC 51651093866.","Best By Dates Range: 30MAY15 thru 31MAY15 ",".","7530 cases ","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0560-2015","Class I","MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415.","Best By Dates Range: 13MAR15 thru 28JUN15 ",".","1703 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0545-2015","Class I","MaraNatha No Stir Crunchy Almond Butter low in sodium, 340 grams, UPC 51651093460. ","Best By Dates Range: 16DEC14 thru 14MAY15 ",".","4768 cases ","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0557-2015","Class I","MaraNatha Organic Roasted Crunchy Peanut Butter, 16 oz., UPC 51651092203.","Best By Dates Range: 06APR15 thru 07APR15",".","512 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0549-2015","Class I","MaraNatha Roasted Almond Butter, 340 grams, UPC 51651093057.","Best By Dates Range: 11DEC14 thru 02JUN15 ",".","9185 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0546-2015","Class I","MaraNatha Raw Creamy Almond Butter, 16 oz., UPC 51651092180 Trader Joe's Raw Creamy Almond Butter Unsalted, 16 oz., UPC 00569958. ","Best By Dates Range: 05APR15 thru 02JUL15; 27DEC14 thru 18JUL15; ",".","85,714 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0544-2015","Class I","MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699.","Best By Dates Range: 17DEC14 thru 20JUL15 and 17DEC14 thru 18JUL15 ",".","155,333 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0559-2015","Class I","MaraNatha Organic No Stir Roasted Crunchy Peanut Butter, 16 oz, UPC 51651092364. ","Best By Dates Range: 05JAN15 thru 28JUN15; ",".","31092 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0542-2015","Class I","MaraNatha Organic Raw Crunchy Almond Butter, 16 oz., UPC 51651092128. ","Best By Dates Range: 22DEC14 thru 01JUL15 ",".","7398 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0551-2015","Class I","MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960. ","Best By Dates Range: 23DEC14 thru 04JUN15; 23DEC14 ",".","2882 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0563-2015","Class I","MaraNatha Organic No Stir Creamy Peanut Butter, 16 oz, UPC 51651092357.","Best By Dates Range: 04JAN15 thru 27JUN15; ",".","53577 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0558-2015","Class I","MaraNatha Organic Roasted Crunchy Peanut Butter Hint of Sea Salt, 16 oz., UPC 51651092333; MaraNatha Organic Crunchy Peanut Butter Hint of Sea Salt, 26 oz., UPC 51651092920; MaraNatha Organic Crunchy Peanut Butter, 500 gram, UPC 51651093316","Best By Dates Range: 31DEC14 thru 15MAY15; 02JAN15 thru 15MAY15; 02JAN15 thru 25JUN15; ",".","14,568 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0540-2015","Class I","MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561.","Best By Dates Range: 26DEC14 thru 06JUN15 and 24DEC14 thru 26DEC14 ",".","7897 cases total","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0548-2015","Class I","MaraNatha Organic Raw Creamy Almond Butter, 8 oz., UPC 51651092630; MaraNatha Organic Raw Creamy Almond Butter, 16 oz., UPC 51651092173. ","Best By Dates Range: 13APR15 thru 30JUN15; 14APR15 thru 01JUL15;",".","15342 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0547-2015","Class I","MaraNatha Raw Almond Butter, 340 grams, UPC 51651093064. ","Best By Dates Range: 07MAY15 thru 05JUN15; ",".","8927 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0555-2015","Class I","MaraNatha Roasted Creamy Almond Butter No Sodium, 737 grams, UPC 51651092869 ","Best By Dates Range: 08DEC14 thru 03JUL15 ",".","51150 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0543-2015","Class I","Trader Joe's Raw Crunchy Almond Butter Unsalted, 16 oz., UPC 919890. ","Best By Dates Range: 28DEC14 thru 18JUN15 ",".","69,759 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0554-2015","Class I","Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746 ","Best By Dates Range: 11DEC14 thru 03JUL15",".","13,685 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0552-2015","Class I","MaraNatha No Stir Creamy Almond Butter, 12 oz., UPC 51651093682; MaraNatha No Stir Creamy Almond Butter, 340 grams, UPC 51651093453; Kroger No Stir Creamy Almond Butter, 12 oz., UPC 11110791214; ","Best By Dates Range: 16DEC14 thru 11MAY15 11DEC14 thru 05JUL15; 14DEC14 thru 14JUL15; 12DEC14 thru 21JUL15; ",".","293,038 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0541-2015","Class I","MaraNatha Organic Roasted Crunchy Almond Butter, 16 oz., UPC 51651092036.","Best By Dates Range: 4JUNE15",".","181 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0561-2015","Class I","MaraNatha Organic Roasted Creamy Peanut Butter, 16 oz., UPC 51651092197; Arrowhead Mills Organic Creamy Peanut Butter, 16 oz., UPC 74333470526. ","Best By Dates Range: 7-Apr-15; 31DEC14 thru 14MAY15. ",".","7805 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Food",69068,"Ongoing","nSpired Natural Foods, Division of the Hain Celestial Group","Ashland","OR","US","Voluntary: Firm Initiated","Press Release","Products were distributed through out the United States, Canada, Dominican Republic, Hong Kong, Jordan, Mexico, and United Arab Emirates. The products also were available for purchase on the internet: Harristeeter.com; Quidsi (1-800 diapers.com); Walmart.com; Kehe Foods (eyelevelsolutions.com); and Target.com. Products were also donated at Oregon Food Bank in Oregon and was further distributed to regional food bank facility in Washington.","F-0562-2015","Class I","MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 16 oz., UPC 51651092326; MaraNatha Organic Creamy Peanut Butter with Hint of Sea Salt, 26 oz., UPC 51651092913; MaraNatha Organic Creamy Peanut Butter, 500 grams, UPC 51651093309.","Best By Dates Range: 03JAN15 thru 25JUN15; 03JAN15 thru 24JUN15;",".","29073 cases","Products have the potential to be contaminated with Salmonella. ",8/19/2014,"08/19/2014",12/2/2014,"12/02/2014"
"Devices",69070,"Ongoing","Diagnostica Stago, Inc.","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: USA (nationwide) and the country of Canada.","Z-2650-2014","Class III","Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.","510(k) #K111822, Lot #112366, Part # REF 00311US",,"514 kits","Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.",7/18/2014,"07/18/2014",9/24/2014,"09/24/2014"
"Biologics",69071,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0960-14","Class III","Red Blood Cells Leukocytes Reduced","W038113151385; ",".","1","Blood products, collected from a donor who previously tested reactive for anti-HCV, were distributed. ",7/8/2014,"07/08/2014",11/5/2014,"11/05/2014"
"Biologics",69071,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0961-14","Class III","Plasma Frozen within 24 hours (FP24)","W038113151385; ",".","1","Blood products, collected from a donor who previously tested reactive for anti-HCV, were distributed. ",7/8/2014,"07/08/2014",11/5/2014,"11/05/2014"
"Devices",69072,"Ongoing","Datascope Corporation","Fairfield","NJ","US","Voluntary: Firm Initiated","Letter","US Distribution to TX.","Z-2568-2014","Class III","LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group ","Part Number - 0684-00-0480-01U",,"one unit","During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.",8/11/2014,"08/11/2014",9/10/2014,"09/10/2014"
"Devices",69074,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.","Z-2662-2014","Class II","ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. ","All Serial Numbers",,"10,515 (Domestic: 2771; Foreign: 7744) in total","The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.",8/13/2014,"08/13/2014",9/24/2014,"09/24/2014"
"Devices",69074,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.","Z-2663-2014","Class II","ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. ","All Serial Numbers",,"10,515 (Domestic: 2771; Foreign: 7744) in total","The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.",8/13/2014,"08/13/2014",9/24/2014,"09/24/2014"
"Drugs",69075,"Ongoing","Taro Pharmaceuticals U.S.A., Inc.","Hawthorne","NY","US","Voluntary: Firm Initiated","Letter","United States including: OH, HI, NH, MS, IL, TX, CA.","D-1584-2014","Class III","Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.","Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016. ",,"1396 Bottles","Failed Content Uniformity Specifications.",8/25/2014,"08/25/2014",9/24/2014,"09/24/2014"
"Drugs",69076,"Ongoing","ChiroNutraceutical LLC","Chesterfield","MO","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1569-2014","Class III","CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.","Lot #: 072010-22, Exp: 12/2013; Lot #: 072010-23, Exp: 01/2014; Lot #: 072010-25, Exp: 03/2014; Lot #: 072010-26, Exp: 04/2014; Lot #: 072010-27, Exp: 05/2014; Lot #: 072010-29, Exp: 07/2014; Lot #: 072010-30, Exp: 08/2014; Lot #: 072010-31, Exp: 09/2014; Lot #: 072010-33, Exp: 11/2014; Lot #: 072010-34, Exp: 01/2015; Lot #: 072010-36, Exp: 02/2015; Lot #: 072010-39, Exp: 05/2015; Lot #: 072010-43, Exp: 06/2015; and Lot #: 072010-48, Exp: 10/2015. ",".","12,948 Bottles","Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.",8/20/2014,"08/20/2014",9/17/2014,"09/17/2014"
"Biologics",69077,"Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","Letter","Texas; Louisiana","B-0959-14","Class II","Red Blood Cells Leukocytes Reduced","W036514080418; W036514036459; W036513145471; ",".","3","Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.",8/13/2014,"08/13/2014",11/5/2014,"11/05/2014"
"Food",69078,"Terminated","Dairy Farmers of America","Kansas City","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, IL, MO, and MI.","F-2486-2014","Class III","Cream (Bulk; approximately 40,000 pounds per tanker load) ","The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717",,"94,020 lbs","Two loads of raw milk shipped from Beaver Creek Farm located in Coopersville, MI tested positive for Supra Sulfa III (Sulfamethazine). One load was co-mingled with other loads of raw milk at the DFA facility in Adrian, MI and processed into cream and condensed skim milk. The second load went directly from the producers farm to Continental Dairy Facilities, LLC in Coopersville, Michigan and was further processed. ",8/21/2014,"08/21/2014",10/1/2014,"10/01/2014"
"Food",69078,"Terminated","Dairy Farmers of America","Kansas City","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, IL, MO, and MI.","F-2487-2014","Class III","Raw Milk (Bulk; approximately 40,000 pounds per tanker load) ","The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717",,"51,500 lbs","Two loads of raw milk shipped from Beaver Creek Farm located in Coopersville, MI tested positive for Supra Sulfa III (Sulfamethazine). One load was co-mingled with other loads of raw milk at the DFA facility in Adrian, MI and processed into cream and condensed skim milk. The second load went directly from the producers farm to Continental Dairy Facilities, LLC in Coopersville, Michigan and was further processed. ",8/21/2014,"08/21/2014",10/1/2014,"10/01/2014"
"Food",69078,"Terminated","Dairy Farmers of America","Kansas City","MO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, IL, MO, and MI.","F-2485-2014","Class III","Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load) ","The Dannon Company: Batch No.'s 1002810163 1002810445 1002810700 1002810745 1002810885 1002811154 1002811681 1002811849 1002811932 Dean Foods: Batch No. 1002812313 Unilever: Batch No. 1002810249 Continental Dairy Facilities, LLC: Load No. 990000000000055717",,"438,680 lbs","Two loads of raw milk shipped from Beaver Creek Farm located in Coopersville, MI tested positive for Supra Sulfa III (Sulfamethazine). One load was co-mingled with other loads of raw milk at the DFA facility in Adrian, MI and processed into cream and condensed skim milk. The second load went directly from the producers farm to Continental Dairy Facilities, LLC in Coopersville, Michigan and was further processed. ",8/21/2014,"08/21/2014",10/1/2014,"10/01/2014"
"Food",69079,"Ongoing","Garden-Fresh Foods, Inc.","Milwaukee","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, IN, MI, and WI","F-2518-2014","Class I","Garden Fresh Egg Salad, Code #2022, Net Wt. 5 lbs. (2.268 Kg) UPC 11596-52022","Use By 09121401",,"425 lbs. (85 - 5 lb. containers)","Garden Fresh Foods, Inc. is recalling Garden Fresh Egg Salad because it has the potential to be contaminated with Listeria monocytogenes.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Food",69080,"Ongoing","Swanson Health Products, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Letter","US: AL AK, AZ, AR, C,A CO, CT, DC, FL, HI ID, IL IN, IA, KS, KYT,LA, MD, MA, MI, MN, NS, NO, NT,NV, NJ, NM, NY, NC, ND, OH,OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WV, WI, WY. OUS: AUSTRALIA, SWEDEN, CANADA, MEXICO, KOREA, CHILE.","F-2438-2014","Class I","Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115.","Lot 206401 Best By date of 6/15.",,"544 containers","Swanson Certified Organic Carob Powder, item number SWF115 is being recalled due to a potential risk of Salmonella contamination from a raw ingredient used in this product.",7/28/2014,"07/28/2014",9/24/2014,"09/24/2014"
"Devices",69083,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.","Z-2640-2014","Class II","Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.","Lot codes: JCA0086 through JCA0106.",,"116,633 units","Not approved labeling claims (antimicrobial and autolytic debridement) ",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Devices",69083,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.","Z-2639-2014","Class II","Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.","Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180.",,"21,108 units","Not approved labeling claims (antimicrobial and autolytic debridement) ",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Devices",69083,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.","Z-2638-2014","Class II","Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.","Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05",,"382,620 units","Not approved labeling claims (antimicrobial and autolytic debridement) ",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Devices",69083,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.","Z-2641-2014","Class II","Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.","Lot codes: 2WD07.",,"1,740 units","Not approved labeling claims (antimicrobial and autolytic debridement) ",7/11/2014,"07/11/2014",9/24/2014,"09/24/2014"
"Devices",69084,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.","Z-2716-2014","Class II","ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. ","All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 ",".","Domestic: 2771 units; Foreign: 7744 units","The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports.",8/19/2014,"08/19/2014",10/7/2014,"10/07/2014"
"Devices",69084,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.","Z-2715-2014","Class II","ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. ","All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 ",".","Domestic: 2771 units; Foreign: 7744 units","The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports.",8/19/2014,"08/19/2014",10/7/2014,"10/07/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0034-2015","Class II","PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.","Batch/Lot No. 4753216 (exp.30-Apr-15)",,"51 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0028-2015","Class II","BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.","Batch/Lot No. 4748676 (exp. 31-Jan-16)",,"125 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0036-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. ","Batch/Lot No. 4753765 (exp. 31-May-15)",,"3 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0026-2015","Class II","BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. ","Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16)",,"300 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0031-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 ","Batch/Lot No. 4748898 (exp. 31-May-15)",,"45 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0030-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 ","Batch/Lot No. 4763165 (exp. 31-May-15)",,"3 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0035-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.","Batch/Lot No. 4753215 (exp. 30-Apr-15)",,"54 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0025-2015","Class II","BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.","Batch/Lot No. 4767162 (exp. date 30-JUN-15)",,"20 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0027-2015","Class II","BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.","Batch/Lot No. 4752351 (exp. 31-Jan-16)",,"65 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0032-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.","Batch/Lot No. 4754060 (exp. 31-May-15)",,"84 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0033-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.","Batch/Lot No. 4754052 (exp. 30-Apr-15)",,"60 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69085,"Ongoing","Navilyst Medical, Inc","Glens Falls","NY","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0029-2015","Class II","PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. ","Batch/Lot No. 4756773 (exp. 31-May-15)",,"15 units/pouches","NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.",8/25/2014,"08/25/2014",10/15/2014,"10/15/2014"
"Devices",69086,"Ongoing","Dawning Technologies, Inc","Fort Myers","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.","Z-2637-2014","Class II","ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.","Version #s: 1.0.0 Date Released 6/17/2004, 1.0.1 Date Released 8/18/2004, 1.1.1 Date Released 9/9/2004, 1.2.0 Date Released 10/11/2004, 1.3.0 Date Released 11/1/2004, 1.3.1 Date Released 1/20/2005, 1.3.2 Date Released 2/18/2005, 1.4.0 Date Released 3/30/2005, 1.4.1 Date Released 8/31/2005, 1.4.2 Date Released 9/12/2005, 1.4.2 Date Released 10/5/2005, 1.4.3 Date Released 2/8/2006, 1.4.4 Date Released 2/20/2006, 1.4.5 Date Released 3/3/2006, 1.4.5 Date Released 3/23/2006, 1.4.5 Date Released 5/17/2006, 1.5.0 Date Released 6/26/2007, 1.5.1 Date Released 9/17/2007, 1.5.1 Date Released 12/13/2007, 1.5.1 Date Released 11/7/2008, 1.5.2 Date Released 4/13/2009, 1.5.3 Date Released 1/12/2011.",,"84","Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.",8/15/2014,"08/15/2014",9/24/2014,"09/24/2014"
"Devices",69087,"Ongoing","St Jude Medical Cardiac Rhythm Management Division","Sylmar","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and courntries including: EU, Mideast, Canada, Australia/New Zealand, Latin America, and Asia-Pacific and Japan.","Z-2572-2014","Class II","Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.","Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989 1004990 1004991 1004992 1004993 1004994 1004995 1004996 1004997 1004998 1004999 1005000 1005001 1005002 1005003 1005004 1005005 1005006 1005007 1005008 1005009 1005010 1005011 1005139 1005140 1005141 1005142 1005143 1005144 1005145 1005146 1005147 1005148 1005149 1005150 1005151 1005152 1005153 1005154 1005155 1005156 1005157 1005158 1005159 1005160 1005161 1005162 1005163 1005164 1005165 1005166 1005167 1005168 1005169 1005170 1005171 1005172 1005173 1005174 1005175 1005176 1005177 1005178 1005179 1005180 1005181 1005182 1005183 1005184 1005185 1005186 1005187 1005188 1005311 1005312 1005313 1005314 1005315 1005316 1005317 1005318 1005319 1005320 1005321 1005322 1005323 1005324 1005325 1005326 1005327 1005328 1005329 1005330 1005331 1005332 1005333 1005334 1005335 1005336 1005337 1005338 1005339 1005340 1005341 1005342 1005343 1005344 1005345 1005346 1005347 1005348 1005349 1005350 1005351 1005352 1005353 1005354 1005355 1005356 1005357 1005358 1005359 1005360 1005734 1005735 1005736 1005737 1005739 1005740 1005741 1005742 1005743 1005744 1005745 1005746 1005747 1005748 1005749 1005750 1005751 1005752 1005753 1005754 1005755 1005756 1005757 1005758 1005759 1005761 1005762 1005763 1005764 1005766 1005767 1005768 1005769 1005770 1005771 1005772 1005773 1005774 1005775 1005776 1005777 1005778 1005779 1005780 1005781 1005782 1005783 1005784 1005785 1005786 1005787 1005788 1005790 1005791 1005792 1005793 1006090 1006091 1006092 1006093 1006094 1006095 1006096 1006097 1006098 1006099 1006100 1006101 1006102 1006103 1006104 1006105 1006106 1006107 1006108 1006109 1006110 1006111 1006112 1006113 1006114 1006115 1006116 1006117 1006118 1006119 1006120 1006121 1006122 1006123 1006124 1006125 1006126 1006127 1006128 1006129 1006130 1006131 1006132 1006133 1006134 1006135 1006136 10061"," 1023272 1023273 1023274 1023275 1023276 1023277 1023278 1023279 1023280 1023281 1023282 1023283 1023284 1023285 1023286 1023287 1023288 1023289 1023290 1023291 1023292 1023293 1023294 1023295 1023296 1023297 1023298 1023299 1023300 1023301 1023302 1023303 1023304 1023305 1023306 1023307 1023308 1023309 1023310 1023311 1023312 1023313 1023314 1023315 1023316 1023317 1023318 1023319 1023320 1023321 1023322 1023323 1023324 1023325 1023326 1023327 1023328 1023329 1023330 1023331 1023332 1023333 1023334 1023335 1023336 1023337 1023338 1023339 1023340 1023341 1023342 1023343 1023344 1023345 1023346 1023347 1023348 1023349 1023350 1023351 1023352 1023353 1023354 1023355 1023356 1023357 1023358 1023359 1023360 1023361 1023362 1023363 1023364 1023365 1023366 1023367 1023368 1023369 1023370 1023371 1023372 1023373 1023374 1023375 1023376 1023377 1023378 1023379 1023380 1023381 1023382 1023383 1023384 1023385 1023386 1023387 1023388 1023389 1023390 1023391 1023392 1023393 1023394 1023395 1023396 1023397 1023398 1023399 1023400 1023401 1023402 1023403 1023404 1023405 1023406 1023407 1023408 1023409 1023410 1023411 1023412 1023413 1023414 1023415 1023416 1023417 1023418 1023419 1023420 1023421 1023422 1023423 1023424 1023425 1023426 1023427 1023428 1023429 1023430 1023431 1023432 1023433 1023434 1023435 1023436 1023437 1023438 1023439 1023440 1023441 1023442 1023443 1023444 1023445 1023446 1023447 1023448 1023449 1023450 1023451 1023452 1023453 1023454 1023455 1023456 1023457 1023458 1023459 1023460 1023461 1023462 1023463 1023464 1023465 1023466 1023467 1023468 1023469 1023470 1023471 1023472 1023473 1023474 1023475 1023476 1023477 1023478 1023479 1023480 1023481 1023482 1023483 1023484 1023485 1023486 1023487 1023488 1023489 1023490 1023491 1023492 1023493 1023494 1023495 1023496 1023497 1023498 1023499 1023500 1023501 1023502 1023503 1023504 1023505 1023506 1023507 1023508 1023509 1023510 1023511 1023512 1023513 1023514 1023515 1023516 1023517 1023518 1023519 1023520 1023521 1023522 1023523 1023524 1023525 1023526 1023","62,133 units (21,283 units in US)","St. Jude is recalling the Ellipse family of Implantable Cardioverter Defibrillator (ICD) devices because of an anomaly that may result in delayed delivery of high voltage therapy or prevent delivery of part or all of a programmed high voltage therapy shock. The anomaly occurs as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices, which may result in an extended charge time. The anomaly most commonly presents as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert indicating a ''Capacitor Charge Time Limit reached'' message. This may occur during a capacitor maintenance or charging for high voltage therapy.",8/19/2014,"08/19/2014",9/10/2014,"09/10/2014"
"Devices",69088,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.","Z-2620-2014","Class I","STAT 2 Flow Controller; 80'' (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. ","Lot # 2768417",,"1250 units","ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Devices",69088,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.","Z-2619-2014","Class I","STAT 2 Flow Controller; 80'' (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. ","Lot # 2768416",,"3750 units","ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Devices",69088,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.","Z-2621-2014","Class I","83'' (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. ","Lot # 2801951",,"100 units","ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Devices",69088,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.","Z-2622-2014","Class I","98'' (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. ","Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL",,"1150 units","ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Devices",69089,"Ongoing","Medtronic Cardiovascular Surgery-the Heart Valve Division","Santa Ana","CA","US","Voluntary: Firm Initiated","Letter","Distributed in the states of MD and TX.","Z-2623-2014","Class II","Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.","Serial Numbers: B146341, B146350",".","2 units","Medtronic has decided to discontinue production and distribution of this low-volume product.",8/15/2014,"08/15/2014",9/17/2014,"09/17/2014"
"Devices",69092,"Ongoing","Nemschoff Chairs, Inc.","Sheboygan","WI","US","Voluntary: Firm Initiated","Visit","Distributed USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL ,IN, KS, KY, MA, MD, MI, MN, MO, MN, MT, NC, ND,NE, BH, NJ NM, NV, NY, OH, OK, OR, PA, PE, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and the country of CANADA.","Z-0011-2015","Class II","Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.","Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. ",,"1868","Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of potential elevated temperatures in the seat and back lumbar areas of the chair.",1/18/2011,"01/18/2011",10/15/2014,"10/15/2014"
"Devices",69094,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and in the country of: Singapore.","Z-0007-2015","Class II","VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. ","Lot Number 2613-0150-4913, exp. 15-Nov-2014",".","Domestic: 339 sales units; Foreign: 10 sales units","Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.",8/20/2014,"08/20/2014",10/7/2014,"10/07/2014"
"Biologics",69096,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","New Mexico","B-0019-15","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W041214031815F; W041214031815F; ",".","2 units","Blood products, leukoreduced using a Fenwal filter greater than 72 hours of draw, were distributed.",6/25/2014,"06/25/2014",10/22/2014,"10/22/2014"
"Biologics",69097,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0020-15","Class II","Red Blood Cells Leukocytes Reduced","W045214015928; ",".","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",7/28/2014,"07/28/2014",10/22/2014,"10/22/2014"
"Biologics",69098,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona; Switzerland","B-0022-15","Class II","Cryoprecipitated AHF","W041014066694Z; ",".","1 unit","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",6/26/2014,"06/26/2014",10/22/2014,"10/22/2014"
"Biologics",69098,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona; Switzerland","B-0023-15","Class III","Blood and Blood Products for Reprocessing","W041014066694Z; ",".","1 unit","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",6/26/2014,"06/26/2014",10/22/2014,"10/22/2014"
"Biologics",69098,"Terminated","United Blood Services","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona; Switzerland","B-0021-15","Class II","Red Blood Cells Leukocytes Reduced","W041014066694Z; ",".","1 unit","Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.",6/26/2014,"06/26/2014",10/22/2014,"10/22/2014"
"Biologics",69099,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","New Mexico","B-0025-15","Class III","Red Blood Cells Leukocytes Reduced","W041214030925J; W041214024351V; ",".","2 units","Red Blood Cells, lacking antibody identification labeling, were distributed.",6/19/2014,"06/19/2014",10/22/2014,"10/22/2014"
"Biologics",69099,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","New Mexico","B-0024-15","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W0412140309645; W0412140309645; ",".","2 units","Red Blood Cells, lacking antibody identification labeling, were distributed.",6/19/2014,"06/19/2014",10/22/2014,"10/22/2014"
"Devices",69101,"Ongoing","Maquet Cardiovascular, LLC","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, FINLAND, FRANCE, GREECE, HONG KONG, INDICA, INDONESIA, ISRAEL, ITALY, JAPAN, MEXICO, MALAYSIA, NETHERLANDS, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND VIETNAM.","Z-0132-2015","Class II","Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.","class I 510 K exempt Acrobat V Vacuum Off-Pump System OM-9100S 25081832 25083629 25084722 25086515 25087723 25089063 25089942 25090685 25091907 25092783 25092968 25093960 25095207 25096649 25097068 25097679 25097895 25098213 Acrobat SUV Vacuum Off-Pump System OM-9000S 25083904 25084006 25084498 25084648 25084928 25085094 25085850 25086057 25086330 25086468 25086786 25086869 25087249 25087330 25087412 25087793 25088394 25088704 25089154 25089224 25089724 25090578 25090748 25090943 25091171 25092128 25092272 25092690 25092813 25093167 25093281 25094024 25094065 25094473 25094712 25094860 25095107 25095600 25095769 25096128 25096305 25096404 25096913 25097097 25097336 25097417 25097747 25097801 25098540 25098968 Axius Xpose 3 Access Device XP-3000 25063171 25063264 25064005 25064805 25065216 25066072 25066261 25067242 25067493 25067915 25068869 25070671 25071619 25072468 25073684 25075060 25077055 25077999 25078510 25078808 25080773 25081495 25082997 25084179 25086061 25087498 25088896 25090502 25090832 25091779 25092248 25092884 25093619 25094030 25095768 25096118 25096687 25097508 25098402 25098904 XPOSE 4 Access Device XP-4000 25063351 25063594 25064160 25064428 25064917 25065315 25065547 25067036 25067396 25068245 25068555 25069189 25069589 25069971 25070492 25070808 25071242 25072056 25072852 25073562 25074441 25075249 25075644 25076681 25077208 25077638 25078154 25079334 25079975 25080256 25080465 25081324 25081566 25081959 25083287 25083699 25084533 25085038 25085516 25085696 25086333 25086530 25087192 25088336 25088517 25089557 25089623 25090324 25090692 25091410 25091811 25092398 25092567 25093083 25093570 25094620 25094845 25095211 25095862 25097087 25097274 ",".","16,532 units (19,270 units international)","An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.",8/13/2014,"08/13/2014",11/5/2014,"11/05/2014"
"Devices",69102,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.","Z-2678-2014","Class II","No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. ","Model 728243 Software version 2.2.1 and 2.2.2",,"61","When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. ",1/9/2007,"01/09/2007",10/1/2014,"10/01/2014"
"Veterinary",69103,"Ongoing","Mars Petcare US","Mattoon","IL","US","Voluntary: Firm Initiated",,"US: AR, IN, LA, MI, MS, OH, TN","V-152-2014","Class II","PEDIGREE Adult Complete Nutrition Dry Dog Food sold under the Pedigree brand in 15 and 55 lbs. bags.","1) 15 lbs. bags; UPC: 23100 10944; 2) 55 lbs. bags; UPC: 23100 10731",,"1) 15 lbs. bags: 72 bags; 2) 55 lbs. bags: 1,685 bags","Mars Petcare US is recalling specific 15 and 55 pound bags of PEDIGREE Adult Complete Nutrition Dry Dog Food because they may contain metal fragments.",8/21/2014,"08/21/2014",9/24/2014,"09/24/2014"
"Devices",69104,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.","Z-0038-2015","Class II","RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.","J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125. ",,"875 units","Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.",9/3/2014,"09/03/2014",10/15/2014,"10/15/2014"
"Devices",69105,"Ongoing","Horiba Instruments, Inc dba Horiba Medical","Irvine","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-2692-2014","Class II","ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).","All Lots",,"359 units","Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.",8/11/2014,"08/11/2014",10/1/2014,"10/01/2014"
"Food",69106,"Ongoing","Specialty Commodities, Inc.","Fargo","ND","US","Voluntary: Firm Initiated","Telephone","CO & NJ No product was distributed OUS.","F-2444-2014","Class I","Thien Minh Cashew Kernels, Net Wt. 50 lb. Product of Vietnam","Lot Number: 105327-1-01",,"95 - 50 lb. cartons","The Cashew Pieces have the potential to be contaminated with Salmonella.",8/15/2014,"08/15/2014",9/24/2014,"09/24/2014"
"Devices",69107,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.","Z-2687-2014","Class II","UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls. ","Sample probe cables, Lot number 2014. Serial No. 600785 601704 900359 900950 601257 600968 900613 604013 603950 604006 603963 603972 604002 604008 603995 604004 603939 603940 603932 603934 603978 603998 604009 603948 603945 603977 603956 603933 604007 603929 604019 604017 604012 603935 603941 603997 603996 604000 603976 604014 601897 604005 603955 603944 603942 601801 603962 603928 603992 603993 603982 603991 603971 603970 603983 603980 603964 603986 603985 603984 603967 603981 603969 603994 603943 603957 603953 604001 604016 603973 900939 603951 600525 900231 601251 603936 601831 603545 6303547 602589 900913 603859 603860 900368 900935 603078 900782 601493 606694 603693 602113 602595 900933 603917 600571 601220 601265 603013 600794 600306 601718 602771 602782 601925 600758 600857 603007 601658 603717 602020 601894 600891 600882 600980 602036 603539 603706 603975 900940 603999 601510 601381 900947 601624 603946 603949 603947 603952 603016 602996 603974 601509 601513 601928 900834 600931 600693 600511 600341 900264 601969 601109 600113 601791 600959 603931 603966 600680 601305 601872 603503 603125 603915 603988 601255 604003 603965 603989 900851 900826 601984 602278 900765 602356 900581 600343 900948 602313 900057 600912 602360 601828 601745 900722 601764 601210 602533 900566 900539 603879 900928 900927 900949 900212 900065 601724 601827 900796 900951 900946 603694 900941 900930 900929 600233 603938 603954 900936 600657 604015 601567 603147 900944 900938 603765 900632 603968 604010 900937 900636 603752 900531 900429 603930 603937 900932 601967 604011 603979 603987 900931 900710 900934 601622 602561 900426 603961 603959 603958 603960 900592 603473 900943 900952 900945 603865 ",,"236 units total (70 units in US)","Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but will not cause erroneous results.",8/21/2014,"08/21/2014",10/1/2014,"10/01/2014"
"Biologics",69108,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0026-15","Class II","Platelets Pheresis Leukocytes Reduced Irradiated","W142814015881H; ",".","1 unit","Blood products, which did not meet acceptable product specifications, were distributed.",7/14/2014,"07/14/2014",10/22/2014,"10/22/2014"
"Biologics",69108,"Terminated","Blood Systems, Inc","San Luis Obispo","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0027-15","Class II","Platelets Pheresis Leukocytes Reduced","W142814015881H; ",".","1 unit","Blood products, which did not meet acceptable product specifications, were distributed.",7/14/2014,"07/14/2014",10/22/2014,"10/22/2014"
"Devices",69109,"Ongoing","Ethicon Endo-Surgery Inc","Blue Ash","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.","Z-2610-2014","Class II","PROXIMATE Skin Stapler. Product is in a sterile barrier system. The barrier is a flexible blister packaging made from Amcor C-film. Lid made with Tyvek coating with Perfecseal heat seal coating. Skin stapler is a sterile instrument for use in a single patient, which is designated to apply rectangular stainless stell staples for routine wound closure. ","PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87 PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch L4EG2T L4EH20 L4EH85 L4EK50 L4EN58 L4EN94 L4EP2F L4EP6G L4ER1L L4EU0J L4EV07 Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch L90W40 L90X3C L90Y0U L90Y4V L90Z7C L9108Z L91151 L91223 L91970 L91A7N L91C5C L91E2Z L91E6P L91G46 L91J4L L91K3A L91M4U L91T81 ",".","42,798",,8/12/2014,"08/12/2014",9/17/2014,"09/17/2014"
"Food",69110,"Ongoing","The Dannon Company, Inc - Discovery & Innovation Center","White Plains","NY","US","Voluntary: Firm Initiated","Letter","In the US: FL, IL, WI, NC, OH, GA, MI, VA, SC. No foreign firms.","F-2449-2014","Class III","Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups. ","UPC 3663202602 Exp code Oct 04 2014",,"1829 cases","The recalled product includes an ingredient (condensed skim milk) that the supplier Dairy Farmers of America has advised may have been produced from raw milk that has tested positive for the presence of sulfamethazine antibiotic. ",8/25/2014,"08/25/2014",9/24/2014,"09/24/2014"
"Veterinary",69111,"Ongoing","ICU Medical, Inc.","San Clemente","CA","US","Voluntary: Firm Initiated","Letter","AZ","V-165-2014","Class II","STAT 2 Flow Controller; 26'' (66 cm) Appx 2.8 mL, 15 Drop Admin Set w/2 Clave, STAT 2 Flow Controller, Inj Site, MicroClave, Item No. AH7007.","Lot # 2758229 and 2785379",,"925 units","ICU is recalling the ConMed Stat2 flow controller because it may deliver a significantly higher flow rate than marked on the controller.",8/19/2014,"08/19/2014",10/1/2014,"10/01/2014"
"Devices",69112,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .","Z-2651-2014","Class II","Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.","Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.",,"46,050 units total (40,078 units in US)","Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.",8/25/2014,"08/25/2014",9/24/2014,"09/24/2014"
"Devices",69113,"Ongoing","Motion Concepts","Concord",,"CA","Voluntary: Firm Initiated","Letter","US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.","Z-2657-2014","Class II","TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.","All units manufactured between June 2011 and May 2014: Serial Numbers 28583, 28597, 28604, 28607, 28629, 30138, 30334, 028380, U001050, U001083, U001544, U002020, U002326, U002386, U002403, U002411, U002489, U002502, U002505, U002509, U002510, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006132, U006234, U006235, U006260, U006295, U006296, U006353, U006378, U007126, U007138, U007163, U007239, U007245, U007279, U007288, U007407, U008556, U008631, U008698, U008840, U008896, U009548, U009569, U009579, U009707, U009718.",,"US: 60 units","Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).",8/28/2014,"08/28/2014",9/24/2014,"09/24/2014"
"Biologics",69115,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","California","B-0002-15","Class III","Bone","0087050120; 0087050122; 0087050124; 0087050125; 0087050126; 0087050127; 0087050128; 0087050129; 0087050131; 0087050132; 0087050133; 0087050134; 0087050135; 0087050136; 0087050137; 0087050138; 0087050140; 0087050141; 0087050142; 0087050144; 0087050145; 0087050146; 0087050147; 0087050148; 0087050149; 0087050150; 0087050151; 0087050152; 0087050153; 0087050154; 0087050155; 0087050156; 0087050157; 0087050158; 0087050161; 0087050162; 0087050163; 0087050164; 0087050166; 0087050167; ",,"40 allografts","HCTP allografts, mislabeled with an extended expiration date, were distributed. ",5/23/2014,"05/23/2014",10/15/2014,"10/15/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2700-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"1005 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2704-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"360 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2706-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"207 units","Water may leak into the center gas lumen of the Patient Circuit",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2702-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"387 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2703-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"22042 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2699-2014","Class II","Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"22828 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2705-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"865 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69116,"Ongoing","Vapotherm, Inc.","Exeter","NH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.","Z-2701-2014","Class II","Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow'' is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.","Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).",,"635 units","Disposable Patient Circuit that allows water to leak into the center gas lumen",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69117,"Ongoing","Advanced Photonic Systems, LLC","Cocoa Beach","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland","Z-2645-2014","Class II","Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required. ","Models BR-144, BRS-144 and BRC-144",,"235 Total","Marketing without marketing clearance or approval.",5/6/2014,"05/06/2014",9/24/2014,"09/24/2014"
"Devices",69117,"Ongoing","Advanced Photonic Systems, LLC","Cocoa Beach","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland","Z-2647-2014","Class II","Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes. ","Models ULT-1, TDR-1, and TDR-2",,"235 Total","Marketing without marketing clearance or approval.",5/6/2014,"05/06/2014",9/24/2014,"09/24/2014"
"Devices",69117,"Ongoing","Advanced Photonic Systems, LLC","Cocoa Beach","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland","Z-2646-2014","Class II","Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes. ","Model 150",,"235 Total","Marketing without marketing clearance or approval.",5/6/2014,"05/06/2014",9/24/2014,"09/24/2014"
"Food",69118,"Ongoing","Mccall Farms Inc","Effingham","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DC, GA, MD, NC, NJ, SC, PA, TN and VA.","F-0703-2015","Class III","Margaret Holmes, Turnip Greens, 14.5 oz, Distributed by McCall Farms, Effingham, SC","Can Code: F13EX",".",,"Swollen Cans; Firm received complaints of illnesses due to consumption of recalled products. ",8/22/2014,"08/22/2014",12/17/2014,"12/17/2014"
"Food",69118,"Ongoing","Mccall Farms Inc","Effingham","SC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DC, GA, MD, NC, NJ, SC, PA, TN and VA.","F-0702-2015","Class III","Margaret Holmes Mixed Greens 14.5 oz, Distributed by McCall Farms, Effingham, SC","Can Code: F13EX",".","1,843 cases (12/14.5oz can per case)","Swollen Cans; Firm received complaints of illnesses due to consumption of recalled products. ",8/22/2014,"08/22/2014",12/17/2014,"12/17/2014"
"Devices",69119,"Ongoing","Concentric Medical Inc","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of PA, CA, TX, NM, and OH.","Z-2598-2014","Class II","Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.","Model Number 90109; Lot number 35695",".","9 devices","Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.",6/25/2014,"06/25/2014",9/17/2014,"09/17/2014"
"Food",69120,"Ongoing","La Orocovena Biscuit","Orocovis","PR","US","Voluntary: Firm Initiated","Telephone","Distributed wholesale to retailers only within Puerto Rico.","F-2519-2014","Class I","La Orocovena, Pound Cake Queso, NET WT. 2 OZ. (56.7 grams)","08112014 to 101214 (numbers correspond to manufacturing and distribution date)",,"810 units","Undeclared allergens: milk, wheat, soy, yellow 5&6 and red 40.",8/25/2014,"08/25/2014",10/1/2014,"10/01/2014"
"Devices",69122,"Ongoing","Baxter Healthcare Corp.","Round Lake","IL","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution -- USA and Canada.","Z-2738-2014","Class II","SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. ","Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.",".","USA: 56 units, Canada: 2 units","One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.",9/3/2014,"09/03/2014",10/7/2014,"10/07/2014"
"Food",69124,"Ongoing","Michael Foods, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution. No product was distributed to foreign, military, or government facilities.","F-0023-2015","Class III","Shell Eggs packaged under the following labels: (1) Abbotsford Farms Cage Free Pasteurized Shell Eggs, Grade A Large Brown Eggs, packaged as 15 dozen per 1 case. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 7. (2) AbbotsFord Farms Cage Free 1 Dozen Large Eggs Pasteurized for Safety. The product was packaged as 1 case of 15 1-dozen eggs per carton. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 6. (3) Pepetti's Pasteurized Shell Eggs made with Grade A Large White Eggs, packaged as 15 dozen per 1 case. Distributed by: Michael Foods, Inc., Minnetonka, MN 55305. UPC Code 1 07 46025 86990 7. (4) Glenview Farms Pasteurized Shell Eggs made with Grade A Large White Eggs, packaged as 15 dozen per 1 case. Distributed by U.S. Foodservice Inc., Rosemount, IL 60018. UPC Code 5 07 58108 62234 5. (5) Crystal Farms One Dozen Large Eggs, Pasteurized Eggs. The product was packaged as 1 case of 15 1-dozen eggs per carton. Distributed by Crystal Farms, Lake Mills, WI 53551-0753. UPC Code 1 00 75925 00032 6. (6) GFS Large Pasteurized Eggs, packaged as 15 dozen per 1 case. Distributed by Gordon Food Service, Grand Rapids, MI 49548. UPC Code 0 00 93901 26545 6.","(1) AbbotsFord Farms, Product No.: 14616-64000, Lot Nos.: 4143W, 4150W, 4157W, and 4171W. (2) AbbotsFord Farms, Product No.: 14616-64010, Lot No.: 4136W. (3) Papettis, Product No.: 46025-86990, Lot Nos.: 4131W-4144W, 41417W-4150W, 4153W-4157W, 4160W-4164W, 4168W-4172W, 4174W-4176W. (4) Glenview Farms, Product No.: 58108-62234, Lot Nos.: 4131W, 4139W, 4147W, 4153W, 4160W, 4167W, and 4174W. (5) Crystal Farms, Product No.: 75925-00032, Lot Nos.: 4135W, 4142W, 4149W, 4156W, 4163W, 4170W, and 4177W. (6) GFS, Product No.: 93901-26545, Lot Nos.: 4132W, 4140W, 4148W, 4154W, 4161W, 4168W, and 4175W.",".","40,966 cases","Shell eggs contaminated with Pseudomonas fluorescens.",7/8/2014,"07/08/2014",10/22/2014,"10/22/2014"
"Devices",69125,"Ongoing","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","E-Mail","US Distribution to TX.","Z-2586-2014","Class II","ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.","Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C. ",,"8 units","The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of RES 67243 Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.",7/2/2014,"07/02/2014",9/10/2014,"09/10/2014"
"Devices",69126,"Ongoing","Varian Medical Systems, Inc.","Palo Alto","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, Russia, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine and United Kingdom.","Z-2654-2014","Class II","4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.","Model number H51; Serial numbers: H51B429 H514517 H511720 H514463 H511002 H513925 H514115 H510855 H515068 H514544 H512492 H515879 H515060 H513064 H514438 H514022 H512957 H514553 H515102 H515991 H515511 H51B421 H515106 H514189 H513551 H513009 H515033 H51B568 H515804 H51B611 H515004 H513477 H513133 H513562 H510966 H515691 H513894 H515363 H513801 H51B362 H518326 H518191 H514863 H513889 H514050 H515619 H515282 H515413 H51B240 H515815 H51B204 H512299 H513438 H51B233 H510451 H512146 H512507 H515601 H513692 H51B136 H51B479 H515247 H513069 H514278 H515588 H51B948 H514126 H512828 H513786 H515095 H513002 H515583 H51B100 H513891 H513591 H515657 H512829 H515800 H513300 H513249 H515249 H515819 H514365 H513127 H515064 H515849 H514464 H515998 H512287 H511424 H515561 H515454 H51B328 H51A050 H515727 H514433 H514282 H514186 H510889 H518106 H515031 H513826 H515251 H51B656 H512357 H514479 H512513 H51B585 H518138 H515947 H513772 H515336 H515759 H510340 H515231 H511399 H514336 H513353 H515446 H514609 H51B220 H515574 H514488 H513195 H515387 H514435 H512378 H514552 H51B154 H51B250 H513373 H512445 H512781 H510794 H510732 H512506 H513510 H512930 H51B331 H515393 H514101 H513054 H514382 H514160 H515323 H51B435 H51B781 H518526 H514599 H515259 H512464 H513152 H514102 H51B173 H515678 H513606 H51B098 H513354 H513081 H512613 H510408 H510004 H514313 H515681 H515521 H513307 H511012 H512785 H513517 H511275 H515115 H51B120 H513051 H51B725 H515317 H511551 H513545 H514192 H512134 H51B666 H513321 H512240 H511852 H514468 H510126 H512241 H513254 H511276 H514359 H511965 H512666 H515288 H51B733 H511703 H515718 H511607 H51B131 H511593 H512929 H514093 H51B769 H512938 H511675 H511840 H515943 H51B470 H513825 H51B083 H51A018 H514637 H51B537 H511748 H511865 H511983 H514662 H511691 H51B175 H515394 H515034 H515789 H513202 H515051 H513471 H515221 H515138 H514010 H51B034 H514600 H511964 H515346 H513554 H51B132 H515689 H511313 H515461 H51B153 H514649 H515874 H512433 H511878 H511330 H513117 H515182 H513769 H51B413 H51B868 H515966 H515298 H513700 H513298 H515262 H51",,"512 affected devices","Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.",8/18/2014,"08/18/2014",9/24/2014,"09/24/2014"
"Food",69128,"Terminated","Dole Fresh Vegetables Inc","Monterey","CA","US","Voluntary: Firm Initiated","Telephone","One distribution center in AZ and retail stores in AZ, NM and NV.","F-2441-2014","Class I","Dole Baby Spinach: Thoroughly Washed, Preservative Free, All natural Net W.t6 oz. bag; SKU 323 Perishable, keep refrigerated. UPC 071430009642; Dole Fresh Vegetables Monterey, CA 93940","Bag Code Expiration Date B2311020 9/4/2014 B23110211 9/4/2014 B2311022 9/4/2014 B2311023 9/4/2014 B2311024 9/4/2014 B2311025 9/4/2014. ",,"150 cartons (6 x 6 oz bags per carton)","Green Walnuts from a tree dropped into spinach as it was being tractored away from the harvested field. Walnuts were discovered on the Dole spinach processing line",8/27/2014,"08/27/2014",9/24/2014,"09/24/2014"
"Food",69128,"Terminated","Dole Fresh Vegetables Inc","Monterey","CA","US","Voluntary: Firm Initiated","Telephone","One distribution center in AZ and retail stores in AZ, NM and NV.","F-2440-2014","Class I","Dole Spinach: Thoroughly Washed, Preservative Free Net Wt. 8 oz. bag; Perishable, keep refrigerated. UPC 071430009765 SKU 320 Dole Fresh Vegetables Monterey, CA 93940","Bag Code Expiration Date B2311020 9/4/2014 B23110211 9/4/2014 B2311022 9/4/2014 B2311023 9/4/2014 B2311024 9/4/2014 B2311025 9/4/2014 ",,"70 cartons, (12 x 8 oz bags per carton)","Green Walnuts from a tree dropped into spinach as it was being tractored away from the harvested field. Walnuts were discovered on the Dole spinach processing line",8/27/2014,"08/27/2014",9/24/2014,"09/24/2014"
"Devices",69129,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lebanon, Lithuania, Luxemburg, Malaysia, Mexico, Netherland, New Zealand Norway, Pakistan, Portugal, Peru, Qatar, Russia, Saudi Arabia, Singapore Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand United Arab Emirates, United Kingdom, Uruguay, Zambia.","Z-2665-2014","Class II","Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.","Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474",,"858","Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink'' Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.",8/19/2014,"08/19/2014",9/24/2014,"09/24/2014"
"Drugs",69130,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1606-2014","Class II","Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.","Lot P318220, EXP 05/31/15",,"148632 bags","Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside. ",9/8/2014,"09/08/2014",10/1/2014,"10/01/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2476-2014","Class II","Strawberry Rose Petal- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2469-2014","Class II","Pumpkin 5 spice- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2468-2014","Class II","Pineapple Yogurt- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2457-2014","Class II","Cranberry Royale- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2474-2014","Class II","Spiced Pecan Praline- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2455-2014","Class II","Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2456-2014","Class II","Cocoa Zin- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2454-2014","Class II","Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2452-2014","Class II","Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2478-2014","Class II","Sweet Basil with Honey- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2472-2014","Class II","Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2470-2014","Class II","Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2467-2014","Class II","Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2481-2014","Class II","Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2458-2014","Class II","Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2482-2014","Class II","Winter Squash with Pecan Pralines- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2473-2014","Class II","Savannah Buttermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2459-2014","Class II","Creme Fraiche- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2463-2014","Class II","Forest Berry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2460-2014","Class II","Cucumber Granita- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2462-2014","Class II","Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2453-2014","Class II","Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2479-2014","Class II","Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2464-2014","Class II","Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2477-2014","Class II","Strawberry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2466-2014","Class II","Lapsang Souchong with Armagnac Prumes- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2461-2014","Class II","Dark Cocoa Peppermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2475-2014","Class II","Star Anise with Candied Fennel- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2471-2014","Class II","Belgian Milk Chocolate- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2465-2014","Class II","Heirloom Melon Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2480-2014","Class II","Sweet Corn with Blackberry- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"Unknown for this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Food",69131,"Ongoing","Jenis Splendid Ice Creams LLC","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Distributed to all 50 states. No foreign countries.","F-2451-2014","Class II","Apple Cider Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. ","No codes: product distributed/purchased 1/1/2006-6/27/2008",,"unknown of this product","Frozen desserts do not include ingredients on the labeling. ",7/7/2008,"07/07/2008",9/24/2014,"09/24/2014"
"Devices",69132,"Ongoing","Apollo Endosurgery Inc","West Lake Hills","TX","US","Voluntary: Firm Initiated","Telephone","Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.","Z-2732-2014","Class II","LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.","Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653",".","10","Product was distributed past its expiration date.",8/15/2014,"08/15/2014",10/7/2014,"10/07/2014"
"Drugs",69133,"Ongoing","Micro Labs Usa, Inc S","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","CT, FL, MD, MS, NY","D-0046-2015","Class II","GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540","GLBG001 Exp.12/14, GLBG008 Exp. 06/15 ",".","11,328 bottles ","Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing. ",10/9/2014,"10/09/2014",11/5/2014,"11/05/2014"
"Food",69134,"Ongoing","Michael Foods, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution. No product was distributed to foreign or U.S. government military and/or civilian units.","F-0060-2015","Class II","Papetti's Table Ready Refrigerated pre-cooked scrambled eggs with butter flavor. Keep refrigerated 33 - 40 degrees F. Packaged in 12- 1.85 pound bags with Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85877. UPC Code: 1 07 46025 85877 2.","Lot Nos. with exp. date: Lots 4156L-4184L with exp. dates 8/28-9/25/2014; Lots 4188L-4234L with exp. dates 9/29-11/14/2014; Lot 4237L with exp. date 11/17/2014; and Lot 4238L with exp. date 11/18/2014 ",,,"Product may be contaminated with spoilage microorganism.",8/29/2014,"08/29/2014",10/29/2014,"10/29/2014"
"Food",69134,"Ongoing","Michael Foods, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Telephone","Nationwide distribution. No product was distributed to foreign or U.S. government military and/or civilian units.","F-0061-2015","Class II","Papetti's Table Ready Refrigerated pre-cooked scrambled eggs. Keep refrigerated 33 - 40 degrees F. Packaged in two different size configurations: (1) 12- 1.85 pound bags, Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85878. UPC Code: 1 07 46025 85878 9, and (2) 8- 3.25 lb bags, Net Wt. 26 lbs (11.79 kg). Product code: 46025-85858. UPC Code: 1 07 46025 85858 1.","Lot Numbers with Exp. dates for the following packaging configurations: Product code: 46025-85858, packaged as 8 / 3.25 lb. bags per case: 4169L, exp. date 9/10/2014; 4204L, exp. date 10/15/2014; and 4226L, exp. date 11/6/2014. Product code: 46025-85878, packaged as 12 / 1.85 lb. bags per case: 4169L, exp. date 9/10/2014; 4190L, exp. date 10/1/2014; 4204L, exp. date 10/15/2014; and 4226L, exp. date 11/6/2014.",,"Product 46025-85858: 519 cases and Product 46025-85878: 1965 cases","Product may be contaminated with spoilage microorganism.",8/29/2014,"08/29/2014",10/29/2014,"10/29/2014"
"Drugs",69135,"Ongoing","Solace International Inc","Reno","NV","US","Voluntary: Firm Initiated","Press Release","Amazon US and Amazon UK","D-1585-2014","Class II","Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA","All lots",,"1606 containers ","Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.",8/28/2014,"08/28/2014",9/24/2014,"09/24/2014"
"Drugs",69135,"Ongoing","Solace International Inc","Reno","NV","US","Voluntary: Firm Initiated","Press Release","Amazon US and Amazon UK","D-1586-2014","Class II","Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA","All lots",,"1249 containers and kits","Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.",8/28/2014,"08/28/2014",9/24/2014,"09/24/2014"
"Devices",69136,"Ongoing","Bard Peripheral Vascular Inc","Tempe","AZ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and internationally to: Australia, Canada, and European, Latin American and Asian Pacific countries.","Z-2648-2014","Class II","Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.","LW0037 REVH0625 LW0037 REVJ0285 LW0037 REVK0279 LW0037 REWD1346 LW0037 REWE1663 LW0037 REWH0210 LW0037 REWJ1662 LW0037 REWL1233 LW0037 REXC0151 LW0037 REXC1597 LW0037 REXJ0487 LW0037 REXK2010 LW0037 REYB1500 LW0037 REYC1644 LW0037 REYE2175 LW0037 REYG0975 LW0057 REVH1110 LW0057 REXF0126 LW0057 REVJ0284 LW0057 REXF2249 LW0057 REVJ1392 LW0057 REXG2346 LW0057 REVK0821 LW0057 REXH0014 LW0057 REWA0386 LW0057 REXH1180 LW0057 REWB0291 LW0057 REXJ0280 LW0057 REWB1686 LW0057 REXJ0560 LW0057 REWC0831 LW0057 REXJ2036 LW0057 REWD1328 LW0057 REXK0397 LW0057 REWE1476 LW0057 REXK0676 LW0057 REWF1566 LW0057 REXL0506 LW0057 REWG1788 LW0057 REYA0345 LW0057 REWG1807 LW0057 REYA1244 LW0057 REWJ1663 LW0057 REYA2521 LW0057 REWJ1664 LW0057 REYB1364 LW0057 REWK1459 LW0057 REYC0520 LW0057 REWL1432 LW0057 REYD1314 LW0057 REXB0180 LW0057 REYE2170 LW0057 REXC0152 LW0057 REYF0719 LW0057 REXC1592 LW0057 REYF1846 LW0077 REVJ0287 LW0077 REWI1706 LW0077 REXH1476 LW0077 REVJ1391 LW0077 REWJ1174 LW0077 REXH1519 LW0077 REVK0280 LW0077 REWJ1679 LW0077 REXI1623 LW0077 REVL0641 LW0077 REWK1425 LW0077 REXI1846 LW0077 REWA1600 LW0077 REWL0885 LW0077 REXJ2030 LW0077 REWB0099 LW0077 REWL1436 LW0077 REXK0937 LW0077 REWB1751 LW0077 REXA1813 LW0077 REYA0199 LW0077 REWC0848 LW0077 REXC0751 LW0077 REYA0346 LW0077 REWC1485 LW0077 REXC1113 LW0077 REYA2522 LW0077 REWD1230 LW0077 REXD1361 LW0077 REYB1366 LW0077 REWD1426 LW0077 REXD1362 LW0077 REYC0486 LW0077 REWE1052 LW0077 REXE1361 LW0077 REYC0648 LW0077 REWE1479 LW0077 REXF0129 LW0077 REYC2209 LW0077 REWF0904 LW0077 REXG0098 LW0077 REYD1387 LW0077 REWG1776 LW0077 REXG0602 LW0077 REYE2137 LW0077 REWH0282 LW0077 REXG1586 LW0077 REYF1017 LW0077 REWI0065 LW0077 REXG2360 LW0077 REYG1057 LW0107 REVH1111 LW0107 REWI1586 LW0107 REXJ0484 LW0107 REVJ0282 LW0107 REWI1746 LW0107 REXJ1985 LW0107 REVK0267 LW0107 REWJ1560 LW0107 REXJ2326 LW0107 REVK0284 LW0107 REWK0101 LW0107 REXK1320 LW0107 REVK0817 LW0107 REWK1426 LW0107 REXK2000 LW0107 REVL0570 LW0107 REWL1438 LW01",,"177,760 units","Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.",8/26/2014,"08/26/2014",9/24/2014,"09/24/2014"
"Devices",69137,"Ongoing","Smith & Nephew, Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- US (nationwide) including states: MA, MN, NY and Puerto Rico; and countries: Canada, Mexico, Dubai, Australia, Chile, Columbia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.","Z-2688-2014","Class II","RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.","Model #'s 66800059, all lots since product launched 01/16/2009",,"2,142 units","Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.",8/13/2014,"08/13/2014",10/1/2014,"10/01/2014"
"Devices",69138,"Ongoing","Siemens Medical Solutions USA, Inc.","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Bolivia, Brazil, Canada, China, Columbia, France, Germany, Great Britain, India, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand,and United Arab Emirates.","Z-2571-2014","Class II","V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications","Model numbers 8264577 and 8263703; Serial numbers: US: 33707625 32807460 34507747 42208166 S34707777 32907477 33007494 33307538 33507577 33507584 33707612 34107671 34707781 40908018 41508085 41608100 41908126 41908129 S34607757 S34907818 33907638 33907642 34807802 33007497 34207690 34307704 34607760 40607983 41808117 41908127 35107862 35107863 40107882 40407947 S34307696 33707631 34207694 33007487 41508082 41608089 34707771 41708101 33207509 33207519 33207522 33707622 34907824 35107872 40107896 42008137 33207520 41708109 S34607755 33307537 33607596 33707619 34607768 41808119 33707630 42008136 40407946 34207680 34607762 40808002 41008037 41708108 S33207505 33507578 41108046 41308062 42008132 34307703 34707778 40307937 40407951 40808007 41908128 40207906 32907474 33307539 34607758 35107875 40908017 41308054 41508088 41508080 41508087 33507576 33607590 33707621 40407958 40607982 41008032 41808118 42208161 42208163 41408065 33207513 33407545 33507575 33707615 33707624 34207693 34707785 35107867 35107868 40307938 40707986 S33007483 S33707609 40307940 42208165 41108044 42108156 42108157 41508076 42008133 34307712 34007659 32807451 32807459 34207678 34307702 34707787 34907832 40607979 40607980 41808120 41908125 32807454 33707614 41008033 34407716 34707776 S33007481 S34307698 S34407722 33507569 34607764 34907840 40707991 40407944 33907651 33907633 34807811 34907838 34207695 41108041 S34307700 33407553 35007855 40407949 40307924 40307927 S33307527 32907479 33007498 33507582 33907635 34007662 34707782 34907831 40407955 41608096 40707988 ROW: 35007853 40807999 34307711 40607974 40207909 34607767 40307933 33407548 40107885 34507743 33907648 42108150 40207910 33607599 32907471 35107859 40707992 41608093 40507963 34807806 40107887 41008038 33907636 34807807 41008034 34807810 S34007656 S34607750 33707607 33507572 34807805 4210815",,"321 units","Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.",8/13/2014,"08/13/2014",9/10/2014,"09/10/2014"
"Devices",69139,"Ongoing","Lumenis, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA.","Z-2733-2014","Class II","Array LaserLink, Manufactured by Lumenis, The Array'' LaserLink'' is a laser system accessory intended for use in the treatment of ocular pathology. '' For the Posterior Segment, the Array'' LaserLink'' is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: '' Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy '' Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy '' Choroidal Neovascularization '' Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) '' Macular Edema associated with Branch Retinal Vein Occlusion '' Retinal Tears and Detachments And Anterior Segments as follows: '' Iridotomy in Closed Angle Glaucoma '' Trabeculoplasty in Open Angle Glaucoma ","All assembled units since product release, Part Number: GA-0006700.",".","16","Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.",8/15/2014,"08/15/2014",10/7/2014,"10/07/2014"
"Devices",69140,"Ongoing","Justright Surgical, LLC","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of Colorado, California and New York.","Z-2691-2014","Class II","Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.","Lot: 75FD0417",,"3 cases containing 36 units","JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.",8/27/2014,"08/27/2014",10/1/2014,"10/01/2014"
"Devices",69140,"Ongoing","Justright Surgical, LLC","Boulder","CO","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of Colorado, California and New York.","Z-2690-2014","Class II","Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.","Lot: 75DD0406",,"3 cases containing 18 units","JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.",8/27/2014,"08/27/2014",10/1/2014,"10/01/2014"
"Drugs",69141,"Ongoing","Sage Products Inc","Cary","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1573-2014","Class II","Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013"," Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15",,"8-ct. 7,066 cases; 24-ct. 2,664 cases","Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.",8/27/2014,"08/27/2014",9/10/2014,"09/10/2014"
"Food",69142,"Ongoing","Kraft Foods Group","Northfield","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, AR, CA, CA, FL, GA, IL, IN, KS, MI, NC, NJ, OH, OK, TN, TX, VA)","F-0022-2015","Class III","Individually 2/3 oz. slices of American cheese product individually wrapped in transparent plastic an packaged in 12 oz. and 16 oz.. packages, and 4 lb. cartons under the Kraft brand name. Cases of 12 oz. packages include 48 packages per case. Cases of 16 oz. packages include either 12 or 36 packages per case. Cases of 4 lb. cartons include 8 cartons per case.","1) 12 oz. packages of singles; UPC (Retail Package): 021000604647; Code Dates: 20 FEB 2015, 21 FEB 2015; UPC Code (Case): 210006046400; 2) 16 oz. packages of singles; UPC (Retail Package): 021000615261; Code Date: 20 FEB 2015; UPC Code (Case): 210006145000; 3) 16 oz. packages of singles; UPC (Retail Package): 021000615261; Code Date: 20 FEB 2015; UPC Code (Case): 210006152600; 4) 4 lb. cartons of singles; UPC (Retail Package): 021000633609; Code Date: 20 FEB 2015; UPC Code (Case): 210006255900",".","7,691 cases","Kraft Foods Group is voluntarily recalling 7,691 cases of select varieties of regular Kraft American Singles Pasteurized Prepared Cheese Product. A supplier did not store an ingredient used in this product in accordance with Kraft's temperature standards.",8/29/2014,"08/29/2014",10/22/2014,"10/22/2014"
"Food",69143,"Ongoing","4 C Foods, Corp.","Brooklyn","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IA, IL, MI, MN, ND, NE, SD, and WI","F-2491-2014","Class I","4C GRATED CHEESE HOMESTYLE 100% NATURAL PARMESAN, NET WT. 6 OZ. (170g) glass jars, UPC Number:0-41387-32790-8. Manufactured by 4C FOOD CORP., BROOKLYN, NY 11208. Product of USA. ","Unit Code: BEST BY JUL 21 2016 4CF22:37:05 to BEST BY JUL 21 2016 4CF24:00:00 BEST BY JUL 22 2016 4CF00:00:01 to BEST BY JUL 22 2016 4CF06:00:00 Case Code: Best By: JUL 21 2016 4CF 22:37 to Best By: JUL 21 2016 4CF 24:00 Best By: JUL 22 2016 4CF 00:00 to Best By: JUL 22 2016 4CF 06:00 ",,"3,696 total units (308 cartons x 12 jars per carton)","4C Foods Corp. has recalled 4C HomeStyle Parmesan Grated Cheese due to Salmonella contamination.",8/29/2014,"08/29/2014",10/1/2014,"10/01/2014"
"Drugs",69144,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1583-2014","Class II","0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03","Lot #C926642, Product Code: 2B1323N",".","157,080 containers","Lack of Assurance of Sterility; complaints of mold in the overpouch",7/30/2014,"07/30/2014",9/17/2014,"09/17/2014"
"Devices",69145,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.","Z-2659-2014","Class II","ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.","Lot Number: 2314",,"12 each","Sterility of device is not assured ",8/26/2014,"08/26/2014",9/24/2014,"09/24/2014"
"Devices",69145,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.","Z-2658-2014","Class II","ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.","Lot Number: 2314",,"198 cases ","Sterility of device is not assured ",8/26/2014,"08/26/2014",9/24/2014,"09/24/2014"
"Devices",69145,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.","Z-2660-2014","Class II","ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. ","Lot Number: 2314",,"100 cases =600 units","Sterility of device is not assured ",8/26/2014,"08/26/2014",9/24/2014,"09/24/2014"
"Devices",69146,"Ongoing","Smith & Nephew, Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.","Z-0039-2015","Class II","RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). ","Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067",,"19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))","RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.",7/18/2014,"07/18/2014",10/15/2014,"10/15/2014"
"Devices",69146,"Ongoing","Smith & Nephew, Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.","Z-0040-2015","Class II","RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). ","Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124",,"77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))","RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.",7/18/2014,"07/18/2014",10/15/2014,"10/15/2014"
"Devices",69146,"Ongoing","Smith & Nephew, Inc.","Saint Petersburg","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.","Z-0041-2015","Class II","RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). ","Item 66800912 Lot # M400071",,"45,466","RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.",7/18/2014,"07/18/2014",10/15/2014,"10/15/2014"
"Devices",69148,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-2680-2014","Class II","The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. ","Model numbers: 10281013, 10281163. ",,"62","Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated. ",8/27/2014,"08/27/2014",10/1/2014,"10/01/2014"
"Devices",69149,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.","Z-0024-2015","Class II","Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.","lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01.",,"6562","Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been detected. Due to the drift, Siemens is revising the expiration date of this product.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2511-2014","Class II","Supreme Choice brand Colossal, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2508-2014","Class II","Supreme Choice brand Backfin, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2504-2014","Class II","Supreme brand Special Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2503-2014","Class II","Supreme brand Colossal Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,"unknown","Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2510-2014","Class II","Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2507-2014","Class II","Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2505-2014","Class II","Sebastian Supreme brand Super Lump Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,"unknown","Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2506-2014","Class II","Supreme Choice brand Claw , 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2512-2014","Class II","Blue Star Claw Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69150,"Ongoing","Supreme Distributors, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV only","F-2509-2014","Class II","Supreme Choice brand Super Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181","ALL",,,"Potential hazard of Clostridium botulinum toxin formation as a result of temperature abuse during storage. ",8/30/2014,"08/30/2014",10/1/2014,"10/01/2014"
"Food",69151,"Ongoing","TJs Place","Kirkland","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington State","F-2539-2014","Class I","Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz. A green sticker is placed on the lid of the package which contains the lot code. Product is refrigerated","0825, 0826, 0827, and 0828. Code represents month (08) and day (25) of expiration",".","20-40 units","Tj's Place is recalling Basil Pesto Pasta packed in 8 oz. plastic tubs because it has the potential to be contaminated with Listeria monocytogenes.",8/25/2014,"08/25/2014",10/7/2014,"10/07/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0149-2015","Class II","Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07142014@39, Exp 9/30/2014; 07262014@1, Exp 10/24/2014",".","75 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0062-2015","Class II","Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03082014@2, Exp 9/4/2014; 04142014@8, Exp 10/11/2014; 05242014@2, Exp 11/20/2014; 06202014@20, Exp 12/17/2014; 08192014@33, Exp 2/15/2015",".","600 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0151-2015","Class II","Tri-mix, 30 mg/2 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06272014@52, Exp 9/25/2014; 07112014@40, Exp 9/30/2014; 07252014@32, Exp 10/23/2014; 08192014@24, Exp 11/17/2014",".","260 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0068-2015","Class II","Chlorhexidine gluconate 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06062014@27, Exp 9/4/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0059-2015","Class II","Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06062014@26, Exp 9/4/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0057-2015","Class II","Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 05022014@19, Exp 10/29/2014; 05022014@28, Exp 10/29/2014; 06122014@17, Exp 12/9/2014; 07302014@22, Exp 1/26/2015",".","800 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0159-2015","Class II","Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07202014@8, Exp 10/18/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0137-2015","Class II","Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@63, Exp 9/6/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0071-2015","Class II","Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08062014@24, Exp 11/4/2014",".","190 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0104-2015","Class II","Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07242014@28, Exp 10/22/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0117-2015","Class II","Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06062014@44, Exp 9/4/2014; 07302014@14, Exp 10/28/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0122-2015","Class II","Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@28, Exp 11/9/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0126-2015","Class II","Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07302014@29, Exp 10/28/2014; 08192014@31, Exp 11/17/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0085-2015","Class II","Hyaluronidase base vehicle (PF) solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08192014@45, Exp 9/18/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0074-2015","Class II","Cyclosporine suspending vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07032014@30, Exp 12/30/2014",".","180 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0089-2015","Class II","Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08152014@34, Exp 9/14/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0115-2015","Class II","PGE 4, 300 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08062014@40, Exp 11/4/2014",".","60 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0147-2015","Class II","Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08132014@35, Exp 11/11/2014",".","5 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0123-2015","Class II","Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@24, Exp 11/9/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0167-2015","Class II","Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07142014@48, Exp 9/30/2014",".","60 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0138-2015","Class II","Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08012014@34, Exp 10/30/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0106-2015","Class II","Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08182014@47, Exp 9/15/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0111-2015","Class II","PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07182014@24, Exp 10/16/2014; 08072014@24, Exp 11/5/2014",".","160 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0131-2015","Class II","Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@41, Exp 9/10/2014",".","27 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0067-2015","Class II","Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06062014@28, Exp 9/4/2014; 08012014@16, Exp 10/30/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0165-2015","Class II","Tri-mix T108, 30 mg/1.5 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07142014@43, Exp 9/30/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0168-2015","Class II","Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06102014@40, Exp 9/8/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0139-2015","Class II","Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08202014@4, Exp 11/18/2014",".","35 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0069-2015","Class II","Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03182014@24, Exp 9/14/2014; 04012014@31, Exp 9/28/2014; 06032014@30, Exp 11/30/2014; 07292014@28, Exp 1/25/2015",".","500 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0136-2015","Class II","Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08062014@32, Exp 9/5/2014; 08072014@62, Exp 9/6/2014",".","270 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0081-2015","Class II","Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08142014@45, Exp 11/12/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0153-2015","Class II","Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06252014@32, Exp 9/23/2014; 08072014@57, Exp 11/5/2014",".","115 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0063-2015","Class II","Benzalkonium chloride water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 04292014@19, Exp 10/26/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0144-2015","Class II","Triamcinolone acetonide suspending vehicle (PF) vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06172014@27, Exp 9/15/2014",".","200 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0154-2015","Class II","Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07202014@5, Exp 9/15/2014; 07152014@1, Exp 9/30/2014",".","110 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0091-2015","Class II","Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08182014@45, Exp 9/17/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0158-2015","Class II","Tri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06042014@20, Exp 9/15/2014",".","60 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0169-2015","Class II","Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06102014@39, Exp 9/8/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0076-2015","Class II","Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. ","Lot Number: 04032014@13, Exp 9/30/2014; 06042014@5, Exp 12/1/2014",".","110 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0133-2015","Class II","Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08182014@30, Exp 9/17/2014",".","10.5 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0083-2015","Class II","Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08142014@27, Exp 9/13/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0150-2015","Class II","Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number: 08182014@23, Exp 11/16/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0132-2015","Class II","Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 05142014@16, Exp 11/10/2014; 07142014@47, Exp 1/10/2015; 07152014@18, Exp 1/11/2015; 08062014@16, Exp 2/2/2015",".","1,300 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0142-2015","Class II","Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08012014@7, Exp 9/30/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0079-2015","Class II","Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06162014@34, Exp 9/14/2014; 08142014@39, Exp 11/12/2014",".","510 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0055-2015","Class II","Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07022014@43, Exp 9/30/2014; 08052014@1, Exp 11/3/2014",".","450 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0058-2015","Class II","Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07162014@33, Exp 10/14/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0120-2015","Class II","Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03222014@1, Exp 9/18/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0143-2015","Class II","Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06192014@16, Exp 9/15/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0099-2015","Class II","Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 05082014@15, Exp 11/4/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0114-2015","Class II","PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@40, Exp 11/5/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0160-2015","Class II","Tri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03142014@14, Exp 9/10/2014; 08062014@49, Exp 1/20/2015",".","150 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0086-2015","Class II","Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 05232014@32, Exp 11/19/2014; 08192014@48, Exp 2/15/2015",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0128-2015","Class II","Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08042014@36, Exp 11/2/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0109-2015","Class II","Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03102014@23, Exp 9/6/2014; 05282014@16, Exp 11/24/2014; 08132014@18, Exp 2/9/2015",".","3 bottles","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0072-2015","Class II","Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08082014@9, Exp 11/6/2014",".","180 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0161-2015","Class II","Tri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06262014@17, Exp 9/24/2014; 07182014@38, Exp 10/16/2014; 07302014@24, Exp 10/28/2014; 08192014@14, Exp 11/17/2014",".","480 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0095-2015","Class II","Lidocaine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. ","Lot Number: 07202014@3, Exp 10/18/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0066-2015","Class II","Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06062014@21, Exp 9/4/2014; 06062014@25, Exp 9/4/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0078-2015","Class II","Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08192014@50, Exp 11/17/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0102-2015","Class II","Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 04092014@14, Exp 10/6/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0108-2015","Class II","Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07312014@27, Exp 10/29/2014",".","30 gm","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0084-2015","Class II","Histamine 2.75 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08062014@27, Exp 9/5/2014; 08152014@30, Exp 9/14/2014",".","130 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0125-2015","Class II","Quad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06052014@24, Exp 9/12/2014",".","60 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0064-2015","Class II","Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable vial,Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. ","Lot Number: 08112014@31, Exp 9/10/2014",".","15 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0166-2015","Class II","Tri-mix T25, 4.413 mg/0.145 mg/1.475 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08122014@23, Exp 11/10/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0060-2015","Class II","Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08192014@36, Exp 11/17/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0121-2015","Class II","Pilocarpine (PF) 0.25% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07202014@11, Exp 10/18/2014",".","5 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0090-2015","Class II","Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08182014@41, Exp 11/16/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0118-2015","Class II","Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 04032014@14, Exp 9/30/2014; 07152014@36, Exp 1/11/2015; 07242014@21, Exp 1/20/2015",".","135.9261 gm","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0077-2015","Class II","Dexamethasone sodium phosphate 24 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08122014@14, Exp 2/8/2015",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0124-2015","Class II","Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 05082014@23, Exp 11/4/2014",".","55 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0092-2015","Class II","Hydroxocobalamin 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07232014@25, Exp 10/21/2014",".","25 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0148-2015","Class II","Tri-mix, 30 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08132014@36, Exp 11/11/2014",".","5 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0129-2015","Class II","Quad mix, 30 mg/1 mg/20 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06052014@16, Exp 9/15/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0119-2015","Class II","Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07182014@40, Exp 9/16/2014; 07252014@43, Exp 9/23/2014",".","350 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0073-2015","Class II","Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. ","Lot Number: 07152014@14, Exp 10/13/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0075-2015","Class II","Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06262014@39, Exp 9/24/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0157-2015","Class II","Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08122014@40, Exp 9/30/2014; 08122014@42, Exp 11/10/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0152-2015","Class II","Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07302014@33, Exp 10/28/2014",".","5 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0116-2015","Class II","PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@35, Exp 11/5/2014; 08182014@18, Exp 11/16/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0080-2015","Class II","Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07292014@37, Exp 10/27/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0146-2015","Class II","Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07152014@2, Exp 10/13/2014; 08062014@55, Exp 12/22/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0061-2015","Class II","Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07152014@39, Exp 10/13/2014",".","1 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0145-2015","Class II","Trimethoprim/sulfadiazine excipient stock solution injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06252014@23, Exp 12/22/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0112-2015","Class II","PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06232014@47, Exp 9/21/2014",".","200 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0127-2015","Class II","Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06052014@13, Exp 9/15/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0155-2015","Class II","Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number 06102014@38, Exp 9/8/2014; 06122014@9, Exp 9/10/2014; 07152014@59, Exp 9/30/2014; 07302014@23, Exp 10/28/2014",".","360 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0088-2015","Class II","Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@55, Exp 9/10/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0097-2015","Class II","Lidocaine 2% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08132014@29, Exp 11/11/2014",".","60 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0130-2015","Class II","Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number: 07182014@46, Exp 10/16/2014; 08192014@40, Exp 11/17/2014",".","25 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0140-2015","Class II","Testosterone cypionate 200 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06112014@14, Exp 9/9/2014; 07312014@17, Exp 10/29/2014; 08202014@1, Exp 11/18/2014",".","2,500 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0134-2015","Class II","Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@50, Exp 9/10/2014",".","6.3 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0171-2015","Class II","Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08202014@31, Exp 9/19/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0105-2015","Class II","Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08112014@51, Exp 9/10/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0135-2015","Class II","Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL..","Lot Number: 08062014@31, Exp 9/5/2014; 08112014@47, Exp 9/10/2014",".","72 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0156-2015","Class II","Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06252014@33, Exp 9/23/2014",".","200 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0163-2015","Class II","Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06102014@44, Exp 9/8/2014; 06262014@8, Exp 9/24/2014; 07182014@30, Exp 10/16/2014; 07302014@16, Exp 10/28/2014; 08062014@29, Exp 11/4/2014; 08132014@37, Exp 11/11/2014",".","1,150 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0082-2015","Class II","Glycerin 72% (w/v) sodium chloride injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@59, Exp 11/5/2014",".","260 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0056-2015","Class II","Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07092014@21, Exp 10/7/2014; 08082014@40, Exp 11/6/2014",".","30 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0065-2015","Class II","Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@61, Exp 9/6/2014 ",".","110 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0141-2015","Class II","Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07152014@50, Exp 10/13/2014; 07152014@54, Exp 10/13/2014; 07152014@55, Exp 10/13/2014; 07152014@56, Exp 10/13/2014; 07152014@48, Exp 10/13/2014; 07152014@49, Exp 10/13/2014; 08062014@53, Exp 11/4/2014",".","7 kits","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0070-2015","Class II","Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03222014@5, Exp 9/18/2014; 04042014@9, Exp 10/1/2014; 05162014@15, Exp 11/12/2014; 07242014@18, Exp 1/20/2015 ",".","22.89055 gm","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0110-2015","Class II","Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03312014@29, Exp 9/27/2014; 06262014@20, Exp 12/23/2014",".","900 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0107-2015","Class II","''NB2014'' 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07152014@52, Exp 9/30/2014; 07202014@7, Exp 10/18/2014",".","85 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0087-2015","Class II","Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 04252014@26, Exp 10/22/2014; 07092014@17, Exp 1/5/2015",".","90 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0170-2015","Class II","Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08012014@17, Exp 10/30/2014; 08142014@47, Exp 11/12/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0162-2015","Class II","Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08192014@18, Exp 11/17/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0054-2015","Class II","Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08072014@64, Exp 9/6/2014",".","1440 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0164-2015","Class II","Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06232014@48, Exp 9/21/2014; 06262014@9, Exp 9/24/2014; 08192014@29, Exp 11/17/2014",".","420 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0103-2015","Class II","Morphine sulfate (PF) 20 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07302014@31, Exp 10/28/2014",".","40 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0094-2015","Class II","Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08192014@51, Exp 11/17/2014",".","10 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0096-2015","Class II","Lidocaine (PF) 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 08152014@33, Exp 9/14/2014",".","20 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0098-2015","Class II","Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03212014@22, Exp 9/17/2014; 05222014@19, Exp 11/18/2014",".","175 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0113-2015","Class II","PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07182014@28, Exp 9/15/2014",".","160 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0100-2015","Class II","Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 06072014@1, Exp 12/4/2014",".","100 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0093-2015","Class II","Hydroxocobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 07232014@15, Exp 10/21/2014",".","32 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Drugs",69152,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0101-2015","Class II","Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.","Lot Number: 03262014@24, Exp 9/22/2014",".","50 mL","Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",8/27/2014,"08/27/2014",11/5/2014,"11/05/2014"
"Biologics",69153,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0847-14","Class II","Platelets Pheresis Leukocytes Reduced","W0352141765603 (2 units)",,"2 units","Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.",7/14/2014,"07/14/2014",9/24/2014,"09/24/2014"
"Biologics",69154,"Terminated","St Mary's Hospital and Medical Center, Inc.","Grand Junction","CO","US","Voluntary: Firm Initiated","E-Mail","Colorado","B-0028-15","Class III","Blood and Blood Products for Reprocessing","W056311042421; ",".","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.",8/22/2014,"08/22/2014",10/22/2014,"10/22/2014"
"Biologics",69155,"Terminated","University Of Miami Miller School of Medicine Tissue Bank","Miami","FL","US","Voluntary: Firm Initiated","Telephone","California","B-0001-15","Class III","Bone","0086540140; 0086540141; 0086540142; 0086540143; 0086540144; 0086540145; 0086540146; 0086540147; 0086540148; 0086540150; 0086540151; 0086540152; 0086540149; ",,"13 allografts","HCTP allografts, mislabeled with an extended expiration date, were distributed. ",5/23/2014,"05/23/2014",10/15/2014,"10/15/2014"
"Biologics",69156,"Terminated","American National Red Cross (The)","Madison","WI","US","Voluntary: Firm Initiated","Letter","WI","B-0983-14","Class II","Platelets Pheresis Leukocytes Reduced","W203214808832",,"1 unit","Platelet, with an unacceptable pH, was distributed. ",7/10/2014,"07/10/2014",9/24/2014,"09/24/2014"
"Drugs",69157,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1572-2014","Class II","OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21","T062A14A, Exp 12/15",,"23,544 bottles","Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.",8/27/2014,"08/27/2014",9/10/2014,"09/10/2014"
"Devices",69158,"Ongoing","Fresenius Medical Care Holdings, Inc.","Waltham","MA","US","Voluntary: Firm Initiated","Letter","Distributed in Texas.","Z-2686-2014","Class II","Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.","Lot Number: 14BMLB012",,"72 cases","Product was held at temperature above the labeled recommended storage temperature",6/23/2014,"06/23/2014",10/1/2014,"10/01/2014"
"Drugs",69159,"Ongoing","Alvogen, Inc","Pine Brook","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1607-2014","Class II","Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.","NDC #47781-0230-01; Lot # 453289; Exp 08/31/15",,"8,964 (100 Count) bottles","Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.",8/28/2014,"08/28/2014",10/1/2014,"10/01/2014"
"Devices",69160,"Ongoing","Cooper Vision Caribbean Corp.","Juana Diaz","PR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.","Z-0134-2015","Class III","ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.","10029500013022 10029550001022 10036550020022 10055500013022 10099500007022 10106500024022 10125500021022 10169500001022 10195550000022 10423500014022 10423550004022 10424500021022 10426500012022 10427500014022 10427500015022 10427500016022 10427500017022 10427500018022 10428500020022 10428500021022 10428500022022 10428500023022 10428500024022 10428500025022 10429500006022 10429550000022 10430500016022 10430500017022 10430500018022 10430500019022 10430500020022 10019550013017 10089500019017 10089500020017 10159500008017 10229550003017 10001500011008 10001500012008 10003550007008 10003550008008 10007500018008 10007500019008 10007550010008 10008500014008 10008500015008 10010550020008 10011500013008 10011550013008 10016550012008 10024500018008 10024550004008 10037500023008 10037550008008 10043500019008 10043500020008 10044550009008 10044550010008 10045500015008 10045500016008 10046500024008 10046550006008 10052500021008 10052550006008 10052550007008 10053550012008 10053550013008 10073500023008 10073500024008 10073500025008 10077500031008 10077500032008 10077500033008 10078500032008 10078500033008 10080550002008 10086500022008 10086500023008 10094500017008 10094500018008 10107500027008 10107500028008 10107550003008 10113500023008 10113500024008 10114500029008 10115500026008 10115500027008 10115550002008 10116500029008 10116500030008 10116550002008 10122500020008 10123500030008 10148550001008 10156500016008 10156550004008 10183550000008 10183550001008 10184500006008 10185500007008 10192500005008 10193500014008 10211550004008 10213500017008 10217500016008 10218500014008 10226500023008 10234500010008 10234500011008 10247500020008 10247500021008 10253500009008 10254500014008 10255500020008 10255500021008 10256500010008 10262500014008 10263550000008 10009550018007 10014500016007 10014500017007 10020500020007 10020500021007 10054550013007 10084500019007 10084500020007 10090500023007 10124500028007",".","13639 lenses/246 product lots","Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.",9/17/2014,"09/17/2014",11/5/2014,"11/05/2014"
"Veterinary",69161,"Ongoing","Vetix Inc.","Lexington","KY","US","Voluntary: Firm Initiated","E-Mail","US distribution: FL, CO, PA, OH, TX, CA, MI, KY, NC, MA, MN, TX, ID, OK, NY, LA, SC and PR.","V-004-2015","Class II","Pheniramine Maleate 0.3% per 14.78 mL bottle.Oval 15-mL eye drop container labeled and placed inside of brand name box. ","Lot # 112612 Exp. Date 11/15",,"3,336","The products includes an active ingredient that has been linked to accidental ingestion that has caused serious harm to children.",9/8/2014,"09/08/2014",10/15/2014,"10/15/2014"
"Veterinary",69161,"Ongoing","Vetix Inc.","Lexington","KY","US","Voluntary: Firm Initiated","E-Mail","US distribution: FL, CO, PA, OH, TX, CA, MI, KY, NC, MA, MN, TX, ID, OK, NY, LA, SC and PR.","V-003-2015","Class II","Naphazoline HCI - 0.025% per 14.78 mL bottle.Oval 15-mL eye drop container labeled and placed inside of brand name box. ","Lot # 083012 Exp. Date 8/14",,"3,093","The products includes an active ingredient that has been linked to accidental ingestion that has caused serious harm to children.",9/8/2014,"09/08/2014",10/15/2014,"10/15/2014"
"Veterinary",69162,"Ongoing","Carefusion 2200 Inc","Vernon Hills","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT) + Puerto Rico; *** FOREIGN: Canada, China, Kuwait, Mexico, Saudi Arabia, Switzerland","V-005-2015","Class II","ermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 35) 6274-H12, AirLife Isothermal Infant Respiratory Breathing Circuit, 7 ft., Heated, X1 Per Bag, 20 Per Case, CareFusion; 36) 6301-H12, AirLife Isothermal Infant Respiratory Breathing Circuit, 7 ft., Heated, X1 Per Bag, 20 Per Case, CareFusion; 37) 6313-501, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 38) 6459-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 39) 6485-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 40) 6588-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 41) WYE KIT INFANT 30/CS, Product Code 6603-504 ; 42) 6862-504, AirLife, Isothermal Breathing Circuit 2.1 m (7'), Infant Inspiratory Line Heated, CareFusion; 43) 6921-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 44) 6942-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 45) 7100-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 46) 7147-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 47) 7156-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 48) 7184-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 49) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7206-4S2 ; 50) 7213- 4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 51) 7354-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Ca","All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485- 4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790- 4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10849-4S2 ; 14) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 10865-4H2 ; 15) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10868-4S2 ; 16) CIRCUIT RESP DISP INF HTD 30/CS , Product Code 1175-4H2 ; 17) CIRCUIT RESP INFANT DUAL DISP 30/CS , Product Code 1208-4H1 ; 18) CIRCUIT RESP INFANT DISP 30/CS , Product Code 1553-4H1 ; 19) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 1815-409 ; 20) CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS , Product Code 1998-4H1 ; 21) INFANT RESP CIRC HTD 4 FT. , Product Code 2119-4S2G ; 22) INFANT RESP CIRC HTD 4 FT. , Product Code 2120-4S2G ; 23) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 4319-4H2 ; 24) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4326- 4H2 ; 25) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4652-501 ; 26) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4677-4H2 ; 27) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4875-4H2 ; 28) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5665-4H2 ; 29) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 5682-409 ; 30) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5732-4H1 ; 31) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5868-4H2 ; 32) CIRCUIT RES",,"Approximately 318,280 devices","The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.",7/31/2014,"07/31/2014",10/15/2014,"10/15/2014"
"Drugs",69163,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated",,"Nationwide","D-1604-2014","Class II","Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32 ","Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015",,"373,180 Carpuject units ","Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.",9/9/2014,"09/09/2014",10/1/2014,"10/01/2014"
"Veterinary",69164,"Ongoing","Bimeda MTC Animal Health Inc.","Cambridge",,"CA","Voluntary: Firm Initiated","Letter","US: IA, MN","V-166-2014","Class II","Ivermax (Ivermectin) 1% sterile solution is provided in a 500 mL plastic bottle suitable for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine.","Item Number: 1IVE038, Lot Number: 2E055",".","1,022 bottles","This recall has been initiated due to incorrect information printed on the bottle carton. Specifically the carton indicates that the manufacturing date was May 2014 where as the correct information (as indicated on the bottle) is that the expiry date is May 2014. There is a chance that customers may use the product after the expiration date based on the carton label. The bottle inside the carton is correctly labeled as ''EXP MAY 2014''.",8/14/2014,"08/14/2014",10/7/2014,"10/07/2014"
"Food",69167,"Ongoing","Phoenix Produce & Noodle Company, LLC.","Phoenix","AZ","US","Voluntary: Firm Initiated","Letter","Arizona","F-2502-2014","Class II","Chinese Style Noodles, 10lbs./bx","No lot codes, no expiration dates",,"1190 lbs.","Phoenix Produce is recalling Chinese Style Noodles because it contains undeclared FD&C Yellow No. 5, Yellow No. 6, and Red No. 40.",8/29/2014,"08/29/2014",10/1/2014,"10/01/2014"
"Food",69168,"Ongoing","Tullia's","Spokane","WA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Spokane area of Washington.","F-0024-2015","Class II","Tullia's Italian Meatless Pasta Sauce, packaged in a 16 oz. (436g) and 32 oz. (872g) glass jars with one-piece metal closures. The 32 oz. (872g) glass jar has the UPC 7 48863 64322 3. The 16 oz (436g) glass jar has the UPC 7 48863 64321 6.","Code 530140 ",".","312 jars (16 oz. each) and 172 jars (32 oz. each)","Italian Meatless Pasta Sauce is recalled because review of the production records revealed that one batch of sauce produced had a pH high enough to allow the growth of Clostridium botulinum, a bacterium which can cause life-threatening illness or death. ",9/2/2014,"09/02/2014",10/22/2014,"10/22/2014"
"Biologics",69169,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","Letter","Virginia","B-0059-15","Class III","Red Blood Cells","K57004; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/15/2014,"08/15/2014",11/19/2014,"11/19/2014"
"Drugs",69170,"Ongoing","Apotex Corp.","Weston","FL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1570-2014","Class III","Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9","Lot # KK6086, exp 03/2015, UPC 360505375998.",,"1,494 bottles","Failed Impurity/Degradation Specification; high out of specification for CAD II degradant",8/21/2014,"08/21/2014",9/24/2014,"09/24/2014"
"Veterinary",69171,"Ongoing","Virbac AH, Inc","Fort Worth","TX","US","Voluntary: Firm Initiated","Telephone","Alabama, Arizona, California, Colorado, Connecticut, Delaware, Illinois, Indiana, Iowa, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Minnesota, Mississippi, Missouri, New Jersey, New Mexico, New York, North Dakota, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin; Quebec, Canada; Ontario, Canada","V-006-2015","Class II","Suprelorin F (DESLORELIN ACETATE) 4.7 mg Implant. NOT APPROVED BY FDA - Legally marketed as an FDA Indexed Product under MIF 900-013. FOR USE IN FERRETS ONLY. Extra-label use is prohibited. This product is not to be used in animals intended for use as food for humans or other animals.","Lot Numbers SCV281B21 and SCV281B51",,"120 Units","The recalled product was subject to severe temperature excursions during product transit from Australia to the United States.",9/2/2014,"09/02/2014",10/15/2014,"10/15/2014"
"Food",69172,"Ongoing","JP Trading and Global Imports LLC","Newark","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NJ and NY","F-2521-2014","Class II","Tradiciones' Andinas Purple Corn Drink Chicha Morada, Net Wt: 33,81 Fl. oz. (1 Lt.), Distributed by: JP Trading and Global Imports LLc, Newark, NJ 07102 (973) 242-3143, Toll free (888) 606 PERU, NDC 854219002795","a) ML:N.CH Lot 08-14 with expiry date 04/05/2015 and b) ML:N.CH lot 09-14 with expiry date 05/05/2015",,"85 Cases","Tradiciones' Andinas Purple Corn Drink Chicha Morada contains undeclared FD & C Blue #1, Yellow #5 and contains unallowable dye: 16185- Amaranth (E123) - delisted FD & C Red 2.",8/11/2014,"08/11/2014",10/1/2014,"10/01/2014"
"Devices",69173,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI.","Z-0064-2015","Class III","Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.","Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692",".","492 devicees","The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.",9/12/2014,"09/12/2014",10/22/2014,"10/22/2014"
"Veterinary",69174,"Ongoing","Boehringer Ingelheim Vetmedica Inc","Saint Joseph","MO","US","Voluntary: Firm Initiated","Letter","The product was distributed to veterinarians, veterinary hospitals, and distributors nationwide, including Puerto Rico. No foreign distribution reported.","V-001-2015","Class II","Metacam (meloxicam) Oral Suspension 0.5 mg/mL packaged in 15 ml plastic bottles, RX, NADA 141-213, UPC 012313601416, Manufactured for Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO.","Lot: AH001AN, Expiry: 31 Mar 2015; and Lot: AH006JG, Expiry 31 Oct 2015",,"Lot AH001AN - 48,477 bottles; and Lot AH006JG - 47,584 bottles","The product strength printed on the bottle label is different from the product strength listed on the display carton (outer packaging). ",9/18/2014,"09/18/2014",10/15/2014,"10/15/2014"
"Veterinary",69174,"Ongoing","Boehringer Ingelheim Vetmedica Inc","Saint Joseph","MO","US","Voluntary: Firm Initiated","Letter","The product was distributed to veterinarians, veterinary hospitals, and distributors nationwide, including Puerto Rico. No foreign distribution reported.","V-002-2015","Class II","Metacam (meloxicam) Oral Suspension 1.5 mg/mL packaged in 10 ml plastic bottles, RX, NADA 141-213, UPC 012313601515, Manufactured for Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO.","Lot: 5402LHT, Expiry: 30 Nov 2014; Lot: AH001AR, Expiry: 30 Jun 2015; and Lot: AH001G4, Expiry 31 Jul 2015",,"Lot 5402LHT - 62,159 bottles; and Lot AH001AR - 65, 955 bottles; Lot AH001G4 - 66,915 bottles","The product strength printed on the bottle is different from the product strength listed on the display carton (outer packaging). ",9/18/2014,"09/18/2014",10/15/2014,"10/15/2014"
"Biologics",69176,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX, Switzerland","B-0051-15","Class III","Blood and Blood Products for Reprocessing","W035214063159H",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/25/2014,"08/25/2014",11/5/2014,"11/05/2014"
"Biologics",69176,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX, Switzerland","B-0049-15","Class II","Red Blood Cells Leukocytes Reduced","W035214063159H",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/25/2014,"08/25/2014",11/5/2014,"11/05/2014"
"Biologics",69176,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Letter","TX, Switzerland","B-0050-15","Class II","Platelets","W035214063159H",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/25/2014,"08/25/2014",11/5/2014,"11/05/2014"
"Drugs",69177,"Ongoing","Apotex Corp.","Weston","FL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1609-2014","Class III","Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03","Lot # KM4951; Exp. 04/15",,"5,397 bottles","Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.",4/18/2014,"04/18/2014",10/1/2014,"10/01/2014"
"Devices",69178,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada.","Z-2674-2014","Class II","DePuy Synthes TI Vectra Plates: TI Vectra-One'' Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra'' Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra'' Plate 4 Level / 64 mm part 04.613.364 lot 8143905 ","TI Vectra-One'' Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra'' Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra'' Plate 4 Level / 64 mm part 04.613.364 lot 8143905 ",,"16","DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the inability to lock the screw onto the plates.",9/2/2014,"09/02/2014",10/1/2014,"10/01/2014"
"Devices",69179,"Ongoing","Invivo Corporation","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.","Z-0069-2015","Class II","Philips Expression MR200 MRI Patient Monitoring System ","Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.",".","24 units.","Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.",9/5/2014,"09/05/2014",10/22/2014,"10/22/2014"
"Food",69180,"Ongoing"," Plum, Inc.","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, Chins, Indonesia, Singapore, Malaysia, hong Kong, Mexico and Bermuda.","F-0056-2015","Class II","Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC DRIED KALE, ORGANIC APPLE FLAVOR, ORGANIC CINNAMON. Plum Inc., Emeryville, CA 94608 ","Item number 1559; Seling unit UPC 846675000330; Case UPC: 84665001559; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15.",,"99,623 cases - all varieties","Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.",9/5/2014,"09/05/2014",10/29/2014,"10/29/2014"
"Food",69180,"Ongoing"," Plum, Inc.","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, Chins, Indonesia, Singapore, Malaysia, hong Kong, Mexico and Bermuda.","F-0058-2015","Class II","Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC BEET JUICE CONCENTRATE Plum Inc., Emeryville, CA 94608 ","Item number 1535; Seling unit UPC 846675000323; Case UPC: 84665001535; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15..",,"99,623 cases - all varieties.","Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.",9/5/2014,"09/05/2014",10/29/2014,"10/29/2014"
"Food",69180,"Ongoing"," Plum, Inc.","Emeryville","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and to Korea, Chins, Indonesia, Singapore, Malaysia, hong Kong, Mexico and Bermuda.","F-0057-2015","Class II","Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Purples: Acai, Blackberry and Purple Carrot; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC BLACKBERRY PUREE, ORGANIC APPLE PUREE, ORGANIC ACAI PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC PURPLE CARROT JUICE CONCENTRATE, NATURAL FLAVOR. Plum Inc., Emeryville, CA 94608 ","Item number 1542; Seling unit UPC 846675000347; Case UPC: 84665001542; All codes and sell by dates of BB 05 AUG 14 to 12Aug 15..",,"99, 623 cases - all varieties.","Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.",9/5/2014,"09/05/2014",10/29/2014,"10/29/2014"
"Devices",69181,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico, and the country of Canada.","Z-0085-2015","Class I","Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.","Product code 2B8013 Lot Number: UR13K14095 ",,"20448","Particulate matter found inside the fluid path.",9/16/2014,"09/16/2014",11/12/2014,"11/12/2014"
"Devices",69181,"Ongoing","Baxter Healthcare Corp","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico, and the country of Canada.","Z-0084-2015","Class I","Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.","Product code: 2B8011 Lot Number: UR13D15112 ",,"94,224","Particulate matter found inside the fluid path.",9/16/2014,"09/16/2014",11/12/2014,"11/12/2014"
"Devices",69182,"Ongoing","Teleflex Medical","Research Triangle Park","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.","Z-2661-2014","Class II","Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.","Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. ",,"193,363 units","Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.",9/4/2014,"09/04/2014",9/24/2014,"09/24/2014"
"Food",69183,"Ongoing","Wholesome Harvest Baking, Inc.","Des Plaines","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","***US: Nationwide(AZ, FL, OH, MI, NY); ***FOREIGN: Canada","F-0007-2015","Class II","Frozen jalapeno bagels sold under the Maple Leaf Bakery brand in three different sizes: 3 oz. (64 bagels/case), 4 oz. (78 bagels/case), and 4.5 oz. (72 bagels/case)","Product Code (SKU): 39677 03041 3; Best Before Dates: *** 3oz. bagels- Best Before 2015 APR 12 *** 4oz. bagels Best Before 2014 AUG 07, 2014 AUG 08, 2014 AUG 14, 2015 JAN 1, 2015 JAN 2, 2015 JAN 8, 2015 JAN 9, 2015 JAN 15, 2015 JAN 22, 2015 JAN 23 *** 4.5oz. bagels Best Before 2014 OCT 31, 2014 NOV 03, 2014 DEC 08, 2015 FEB 28, 2015 MAR 05 ***",,"342 cases of 3oz. bagels (Publix), 1,791 cases of 4oz. bagels (Tim Horton's), and 6,925 cases of 4.5oz. bagels (Generic)","Wholesome Harvest Baking, Inc. (''WHB''), formerly Maple Leaf Bakery, Inc., of Chicago is initiating a voluntary recall of frozen in-store bakery Jalapeno Bagel based on reports of foreign material (glass pieces and stones) in product.",9/5/2014,"09/05/2014",10/15/2014,"10/15/2014"
"Food",69185,"Ongoing","Mars Chocolate North America","Hackettstown","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-0019-2015","Class I","Twix Unwrapped Bites 7.0 oz. distributed by Mars chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 040000484325 contained in a Metallized-golden stand up pouch (SUP) package 5 pouches per carton, 2 cartons per case","Lot # 421BA4GA60 ",,"1356 cases (13560 Stand Up Pouches)","Mars Chocolate North is recalling Twix Brand Unwrapped Bites 7 oz. pouch due to undeclared peanuts and eggs.",9/5/2014,"09/05/2014",10/15/2014,"10/15/2014"
"Biologics",69187,"Terminated","DCI Biologicals LLC","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0047-15","Class III","Source Plasma","AB1406502",".","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.",6/26/2014,"06/26/2014",11/5/2014,"11/05/2014"
"Biologics",69188,"Terminated","Portland Biologicals, LLC","Lewiston","ME","US","Voluntary: Firm Initiated","FAX","CA","B-0048-15","Class II","Source Plasma","PL0508234; PL0508680; PL0509221",".","3 units","Blood products, collected from a donor who subsequently reported a tattoo, were distributed.",7/14/2014,"07/14/2014",11/5/2014,"11/05/2014"
"Biologics",69189,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","RI","B-0982-14","Class II","Red Blood Cells Leukocytes Reduced","W051714625890",,"1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",8/7/2014,"08/07/2014",9/24/2014,"09/24/2014"
"Food",69190,"Ongoing","R.M. Palmer Company","West Reading","PA","US","Voluntary: Firm Initiated","Telephone","AL, FL, HI, IA, LA, OR, PA, TX","F-0027-2015","Class II","soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ Creepy Peepers Lot/Code Date: 066113 UPC 00041269503734 MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT BUTTER AND ALMONDS Inside plastic bag: Foil wrapped balls with appearance of an eyeball. On back of candy, labeled: ''peanut butter'' ","Lot/Code: 066113",,"142 cases/24 - 9 oz. packages per case","Product contains undeclared peanut butter. Peanut butter coated chocolate balls packed in bags labeled as Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs",8/29/2014,"08/29/2014",10/29/2014,"10/29/2014"
"Devices",69192,"Ongoing","Invivo Corporation","Orlando","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.","Z-0001-2015","Class II","Philips Expression MR200 MRI Patient Monitoring System Model 866120","Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013",".","10 units","During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.",9/8/2014,"09/08/2014",10/7/2014,"10/07/2014"
"Food",69193,"Ongoing","Calavo Growers, Inc. (Corporate)","SANTA PAULA","CA","US","Voluntary: Firm Initiated","Letter","US: WA, IL, and WI","F-2442-2014","Class I","Avocados, PLU#4770, size 32, 32 pcs/case. Packed in boxes with green, yellow, and red print with a black and white label. ","Lot No. 03053161",,"338 cases","Calavo Growers is recalling Avocados because they may be contaminated with Salmonella.",9/5/2014,"09/05/2014",9/24/2014,"09/24/2014"
"Devices",69194,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, OH, NJ, NY, TX, LA, OR, SD, WA, including Puerto Rico, and the countries of Belgium, Canada, Chile, China, Colombia, Korea, Mexico, Peru, Venezuela and Zaire.","Z-2714-2014","Class I","Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.","Product Code: 313905, Lot #02F1300085; Product Code: 353900, Lot #02D1300584; Product Code: 353901, Lot #0241300618; Product Code: 353911, Lot #02G1300296, 02G1300861, 02F1300729; Product Code: 313901, Lot #02G1300088; Product Code: 353811, Lot #02E1300090; 02E1301383 & 02E1301867; Product Code: 353911, Lot #02F1300102 & 02F1300177; Product Code: 353900, Lot #02F1302029; Product Code: 353801, Lot #02E1300623, 02FF1300098, 02H1300172, 02H1300454, 02H1301128, 02F300180, 02E1301891, 02J1300876, 02H1301838, 02J1302412 & 02B1400324; Product Code: 353901, Lot #02E1301378; Product Code: 353900, Lot #02E1301892, 02F1300100 and Product Code: 353901, Lot #02F1302047, 02F1300101 & 2G1300879. ",".","27,176 units","The pediatric breathing circuits can crack prior to and during use.",9/8/2014,"09/08/2014",10/7/2014,"10/07/2014"
"Biologics",69195,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0046-15","Class II","Red Blood Cells","1526605",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/26/2014,"08/26/2014",11/5/2014,"11/05/2014"
"Biologics",69196,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0056-15","Class II","Platelets","1490041; 1628442",".","2 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",7/10/2014,"07/10/2014",11/19/2014,"11/19/2014"
"Biologics",69196,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0058-15","Class II","Fresh Frozen Plasma","1628442; 2083949 ",".","2 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",7/10/2014,"07/10/2014",11/19/2014,"11/19/2014"
"Biologics",69196,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0057-15","Class II","Red Blood Cells","1490041; 1628422; 2083949",".","3 units","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",7/10/2014,"07/10/2014",11/19/2014,"11/19/2014"
"Biologics",69196,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","FL","B-0055-15","Class II","Cryoprecipitated AHF","1490041",".","1 unit","Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.",7/10/2014,"07/10/2014",11/19/2014,"11/19/2014"
"Devices",69197,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0022-2015","Class II","Philips Healthcare Integris Allura 15 -12 ","Model Number: Integris Allura 15-12 Serial Number: 16741023",,"one system","Philips had discovered through a field service testing where a device failed to comply with a Federal standard.",8/8/2014,"08/08/2014",10/15/2014,"10/15/2014"
"Food",69198,"Ongoing","Publix Super Markets, Inc.","Lakeland","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, GA, and SC","F-0005-2015","Class II","Publix brand Jalapeno Bagels, sold in self service bins and counter sales.","Item # 76669, Lot # 002-76669-00000; serve service bins Item # 964707, Lot # 000-00000-00000; over the counter",,"20,520 each","May contain pieces of glass and small stones.",9/5/2014,"09/05/2014",10/15/2014,"10/15/2014"
"Food",69199,"Ongoing","Ikko International Trading LLC","Elizabeth","NJ","US","Voluntary: Firm Initiated","Letter","US: Illinois","F-0004-2015","Class II","Wheat Cake (Maruto ''C'' Cake), 6.3 ounces (180g), individually packaged in gold foil pouches and sold under the Maruto Brand. Sold at retail locations in display cases containing 8 bars per display case.","Lot Code: 55-H422",,"10 cases (160 pieces)","This voluntary recall has been initiated because Maruto 'C' Cakes (Wheat Cakes) omitted soy lecithin as an ingredient and an accompanying allergen warning.",8/5/2014,"08/05/2014",10/15/2014,"10/15/2014"
"Devices",69204,"Ongoing","Vygon Corporation","Lansdale","PA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA and Internationally to CA.","Z-0113-2015","Class II","Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.","Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.",,"42250","Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.",8/28/2014,"08/28/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0032-2015","Class II","Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.","Batch Numbers: 305206",,"36 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0034-2015","Class II","Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.","Batch Numbers: 202504, 310455",,"4320 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A. ",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0031-2015","Class II","MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.","Batch Numbers: 305150, 312236, 311231",,"1320 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0035-2015","Class II","Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.","Batch Numbers: 311478, 305207",,"2,304 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements. ",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0029-2015","Class II","alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana.","Batch Numbers: 201158, 307056, 311457",,"690 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0030-2015","Class II","alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.","Batch Numbers: 304159, 211463, 308345",,"900 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. ",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Drugs",69206,"Ongoing","New Gpc Inc.","East Bank Demerara",,"GY","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York","D0033-2015","Class II","WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.","Batch Numbers: 308289",,"360 units","Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.. ",8/7/2014,"08/07/2014",10/29/2014,"10/29/2014"
"Devices",69207,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.","Z-0060-2015","Class II","GE Healthcare Carescape Patient Data Module","Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR SA307080497GA SA307080498GR SA307080499GA SA307080502GR SA307080504GR SA307080508GR SA307080509GA SA307080510GR SA307080513GA SA307080520GR SA307080521GA SA307080522GR SA307080524GA SA307080525GR SA307080526GR SA307080533GR SA307105145GA SA307110544GA SA307110548GR SA307110556GA SA307110559GR SA307110560GR SA307110572GR SA307110575GR SA307110579GR SA307120587GR SA307140598GA SA307140599GR SA307140606GA SA307140607GA SA307140610GA SA307140611GA SA307140614GA SA307140615GA SA307140618GR SA307140619GA SA307140621GA SA307140623GA SA307140627GA SA307140628GA SA307140631GA SA307140637GA SA307140640GR SA307140642GA SA307150645GA SA307150651GA SA307150655GA SA307150656GA SA307150671GR SA307150675GA SA307150681GR SA307180694GR SA307180695GA SA307180696GR SA307180697GR SA307180698GA SA307180699GR SA307180701GA SA307180702GR SA307180704GR SA307180705GR SA307180706GR SA307180707GA SA307180708GA SA307190717GR SA307190722GA SA307190727GA SA307190729GR SA307190730GR SA307190731GR SA307190732GR SA307190733GA SA307190734GR SA307190736GR SA307190737GR SA307190738GR SA307190739GR SA307190741GR SA307190742GR SA307190743GR SA307190744GR SA307190745GR SA307190749GR SA307190750GR SA307190751GA SA307190752GA SA307190753GA SA307190754GA SA307190755GR SA307190756GR SA307190757GR SA307190759GA SA307190760GA SA307190761GA SA307190762GA SA307190764GR SA307190768GR SA307190769GR SA307190770GR SA3071907"," SA307504109GA SA307504110GA SA307504111GA SA307504112GA SA307504114GA SA307504117GA SA307504118GA SA307504119GA SA307504120GA SA307504122GA SA307504123GA SA307504125GA SA307504126GA SA307504127GA SA307504128GA SA307504129GA SA307504130GA SA307504132GA SA307504133GA SA307504134GA SA307504135GA SA307504136GA SA307504137GA SA307504138GA SA307504139GA SA307504140GA SA307504141GA SA307504142GA SA307504143GA SA307504144GA SA307504145GA SA307504147GA SA307504148GA SA307504149GA SA307504150GA SA307504151GA SA307504152GA SA307504153GA SA307504154GA SA307504155GA SA307504156GA SA307504157GA SA307504159GA SA307504160GA SA307504161GA SA307504162GA SA307504163GA SA307504164GA SA307504165GA SA307504166GA SA307504168GA SA307504170GA SA307504171GA SA307504172GA SA307504173GA SA307504174GA SA307504175GA SA307504176GR SA307504177GA SA307504178GA SA307504179GA SA307504180GA SA307504181GA SA307504182GA SA307504183GA SA307504184GA SA307504185GA SA307504186GA SA307504190GA SA307504193GA SA307504196GA SA307504197GA SA307504198GA SA307504199GA SA307504200GA SA307504201GA SA307504203GA SA307504206GA SA307504207GA SA307504208GA SA307504209GA SA307504213GA SA307504215GA SA307504216GA SA307504217GA SA307504218GA SA307504219GA SA307504220GA SA307504221GA SA307504223GA SA307504233GR SA307514308GA SA307514321GA SA307514325GA SA307514328GA SA307514330GA SA307514331GA SA307514332GA SA307514333GR SA307514336GA SA307514337GA SA307514340GA SA307514342GA SA307514352GA SA307514355GR SA307514356GR SA307514357GR SA307514358GA SA307514359GR SA307514360GA SA307514363GR SA307514364GR SA307514365GR SA307514366GR SA307514367GR SA307514368GR SA307514370GR SA307514371GA SA307514372GR SA307514373GR SA307514376GA SA307514377GA SA307514378GA SA307514379GA SA307514380GR SA307514381GA SA307514382GA SA307514383GR SA307514384GR SA307514385GR SA307514386GA SA307514387GR SA307514388GR SA307514389GR SA307514391GR SA307514410GA SA307514414GA SA307514415GA SA307514418GA SA307514423GA SA307514424GA SA307514434GR SA308044513GR SA308044517GR SA308044520GR SA308044521GR ","68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)","GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly.",9/19/2014,"09/19/2014",10/15/2014,"10/15/2014"
"Biologics",69208,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","IN","B-0052-15","Class II","Red Blood Cells Leukocytes Reduced","W040714131737",".","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.",8/22/2014,"08/22/2014",11/5/2014,"11/05/2014"
"Biologics",69209,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","NY, GA","B-0054-15","Class III","Blood and Blood Products for Reprocessing","W043210035868",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/20/2014,"08/20/2014",11/5/2014,"11/05/2014"
"Biologics",69209,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","NY, GA","B-0053-15","Class II","Red Blood Cells Leukocytes Reduced","W043210035868 ",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/20/2014,"08/20/2014",11/5/2014,"11/05/2014"
"Biologics",69210,"Terminated","Biomat USA, Inc","McAllen","TX","US","Voluntary: Firm Initiated","E-Mail","Spain; California","B-0062-15","Class II","Source Plasma","0350632946; 0350644300; 0350645314; 0350646230; 0350647321; 0350648230; 0350649235; 0350650853; 0350651962; 0350653025; 0350653985; 0350655122; 0350656116; 0350657175; 0350658080; 0350662599; 0350663442; 0350664621; 0350666007; 0350666839; 0350668164; 0350668940; 0350670225; 0350633685; 0350634717; 0350635503; 0350636595; 0350637419; 0350638492; 0350639322; 0350640401; 0350641396; 0350642339; 0350643386; 0350674554; 0350675403; 0350679907; 0350671021; 0350672439; 0350673212; 0350680205; 0350681590; 0350682450; 0350683335; 0350684133; 0350685060; 0350685784; 0350686948; 0350687658; 0350688972; 0350689717; 0350691029; 0350691857; 0350693233; 0350694581; 0350695353; 0350696543; 0350700418; 0350701149; 0350702140; 0350702909; 0350704013; 0350704671; 0350705860; 0350706912; 0350707884; 0350708942; 0350710590; 0350710912; 0350712370; 0350713834; 0350714563; 0350715692; 0350717674; 0350718474; 0350719659; 0350720497; 0350721627; 0350722318; 0350723660; 0350724483; 0350725763; 0350726579; ",,"83 units","Blood products, collected from a donor who was previously deferred by another donor center, were distributed.",7/14/2014,"07/14/2014",10/29/2014,"10/29/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0964-14","Class II","Cryoprecipitated AHF","W050910047496 W050910045366 W050910055975 W050910052566 W050910055973 W050910040784 W050910048003 W050910054073 W050910054082 W050910062762 W050910062770 W050910042074 W050910042065 W050910055764 W050910043591 W050910043590 W050910042007 W050910042025 W050910055982 W050910061069 ",,"20 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0968-14","Class II","Red blood cells leukocytes reduced","W050910084327 W050910089911 W050910086212 W050910088385 W050910086299 W050910086222 W050910084311 W050911000031 W050911000962 W050910088095 W050910088612 W050910086226 W050911002351 W050910084319 W050910084345 W050910091016 W050910086223 W050911000981 W050910089912 W050910086216 W050911000971 W050910084309 W050910084321 W050910084331 W050910086214 W050910090902 W050911000831 W050911000848 W050911000958 W050911000967 W050911004547 W050911000846 W050911002352 W050911000969 W050911004549 W050911000960 W050911002357 W050911000844 W050911004776 W050911000965 ",,"40 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0966-14","Class II","Red Blood Cells","W050910091018 W050911000033 W050911000239 W050911000037 W050910088077 W050910088078 W050910086210 W050911000043 W050911002359 W050910086213 W050910086224 W050910090596 W050911000038 W050910086345 W050910088085 W050910090600 W050910084341 W050910084357 W050910086339 W050910086340 W050910088087 W050910089916 W050911000819 W050911000821 W050910086227 W050910084314 W050910084317 W050910086354 W050910090594 W050910090905 W050910090922 W050911000034 W050910088090 W050910089909 W050910089920 W050910084641 W050911004548 W050910086349 W050910088079 W050911002355 W050911004537 W050910090908 W050910090597 W050911000826 W050910088093 W050910088091 W050910088382 W050910088611 W050911000828 W050911000983 W050910088601 W050910086207 W050910088099 W050910086208 W050910086337 W050910088088 W050911000242 W050910091006 W050910089914 W050910084636 W050911000039 W050911000249 W050911000990 W050911004994 W050911004992 W050911004993 W050911000246 W050911002350 W050910088609 W050910090912 W050911004538 W050911000253 W050910088080 W050911004792 W050911000985 ",,"75 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0965-14","Class II","Plasma cryoprecipitate reduced","W050910055975 W050910048003 W050910052566 W050910054073 W050910054082 W050910055764 W050910055973 W050910061069 W050910047496 W050910062770 W050910062762 ",,"11 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0967-14","Class II","Fresh frozen plasma","W050910055793 W050910056206 W050910077070 W050910077072 W050910077090 W050910077091 W050910078541 W050910082479 W050910082517 W050910082527 W050910082530 W050910082535 W050910082536 W050910084357 W050910052277 W050910078501 W050910078524 W050910055767 W050910056205 W050910061015 W050910052160 W050910052162 W050910063287 W050910077309 W050910070323 W050910070341 W050910055768 W050910055783 W050910047478 W050910043599 W050910042100 W050910046943 W050910064629 W050910070525 W050910070528 W050910081033 W050910052255 W050910054076 W050910082800 W050910052581 W050910068698 W050910071446 W050910055918 W050910055921 W050910055936 W050910059364 W050910059366 W050910061024 W050910063294 W050910068779 W050910070348 W050910070355 W050910071434 W050910071440 W050910077096 W050910081004 W050911000034 W050910046907 W050910046970 W050910058994 W050910046909 W050910055763 W050910055923 W050910063290 W050910063293 W050910070531 W050910084436 W050910088085 W050910058895 W050910063147 W050910077078 W050910067789 W050910081008 W050910086214 W050910052576 W050910052575 W050910082797 W050910067771 W050910058888 W050910071428 W050910084431 W050910090908 W050910042071 W050910050599 W050910051493 W050910067769 W050910067773 W050910067788 W050910070779 W050910071942 W050910084341 W050910084345 W050910084433 W050910086339 W050910050585 W050910058877 W050910086223 W050910051428 W050910051437 W050910081035 W050910047495 W050910055758 W050910086210 W050910086220 W050910070439 W050910055933 W050910059311 W050910055932 W050910045355 W050910077084 W050910078503 W050910046921 W050910046953 W050910040778 W050910084321 W050910071409 W050910081029 W050910082515 W050910082532 W050910086226 W050910086354 W050910084443 W050911000253 W050911004982 W050911004992 W050911000828 W050910062765 W050910070778 W050910046784 W050910068772 W050910071947 W050911004538 W050910078021 W050911004548 W050910084439 W050910090600 W05091",,"142 units","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Biologics",69212,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","FAX","Nationwide","B-0969-14","Class II","Red blood cells leukocytes reduced irradiated","W050911000042 ",,"1 unit","Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. ",2/23/2010,"02/23/2010",9/24/2014,"09/24/2014"
"Devices",69213,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide and the countries of: Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.","Z-2731-2014","Class II","ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.","PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081.",".","75 devices","Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.",9/11/2014,"09/11/2014",10/7/2014,"10/07/2014"
"Biologics",69215,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0063-15","Class III","Red Blood Cells Leukocytes Reduced","W036814207426; ",,"1 unit","Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.",7/21/2014,"07/21/2014",10/29/2014,"10/29/2014"
"Biologics",69216,"Terminated","Biotest Pharmaceuticals Corp.","Dickson City","PA","US","Voluntary: Firm Initiated","E-Mail","Pennsylvania; New Jersey","B-0064-15","Class II","Source Plasma","0091157340; 0091156797; 0091157792; 0091155084; 0091153966; 0091153711; 0091152803; 0091152605; ",,"8 units","Blood products, collected from a donor who was previously deferred, were distributed.",8/5/2014,"08/05/2014",10/29/2014,"10/29/2014"
"Biologics",69217,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0031-15","Class III","Blood and Blood Products for Reprocessing","W069113127822; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/30/2013,"07/30/2013",11/5/2014,"11/05/2014"
"Biologics",69217,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0030-15","Class II","Red Blood Cells Leukocytes Reduced","W069113127822; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",7/30/2013,"07/30/2013",11/5/2014,"11/05/2014"
"Biologics",69218,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","Colorado","B-0032-15","Class II","Platelets Pheresis Leukocytes Reduced","W036214188969; W036214188969; W036214188969; ",".","3","Blood products, incorrectly labeled as negative for the cytomegalovirus (CMV), were distributed.",7/30/2014,"07/30/2014",11/5/2014,"11/05/2014"
"Biologics",69219,"Terminated","Community Blood Center of Carolinas","Charlotte","NC","US","Voluntary: Firm Initiated","FAX","North Carolina","B-0039-15","Class II","Platelets Pheresis Leukocytes Reduced","W398514055567V; ",".","1","Blood product, with platelet count below the specified minimum requirement, was distributed.",6/30/2014,"06/30/2014",11/5/2014,"11/05/2014"
"Biologics",69220,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Tennessee","B-0065-15","Class II","Red Blood Cells Leukocytes Reduced","W071214032790; W071214032803; W071214031297; W071214032735; W071214031008; W071214031689; W071214031038; W071214031636; ",,"8 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",7/11/2014,"07/11/2014",11/12/2014,"11/12/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0011-2015","Class II","Hostess Frosted Bagged Donettes- FROZEN ONLY, 11.25 oz.","UPC: 8 88109 15002 0 Best By Dates (2014): AUG 29, 30, 31 SEPT 01, 05, 06, 08, 09, 10, 18, 19, 20, 21, 24, 25, 26, 27 OCT 01, 02, 03 Julian Date- Lot Codes: 181, 182, 183, 184, 188, 189, 191, 192, 193, 196, 197, 198, 199, 202, 203, 204, 205, 209, 210, 211",,"4,102","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0012-2015","Class II","Hostess Powdered Bagged Donettes- FROZEN ONLY, 10.5 oz.","UPC: 8 88109 15004 4 Best By Dates (2014): SEPT 24 OCT 02, 03, 04 Julian Date- Lot Codes: 202, 210, 211, 212",,"8,664","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0008-2015","Class II","Hostess Frosted Bagged Donettes, 11.25 oz","UPC: 8 88109 15002 0 Best By Dates (2014): AUG 29, 30, 31 SEPT 01, 05, 06, 08, 09, 10, 18, 19, 20, 21, 24, 25, 26, 27 OCT 01, 02, 03 Julian Date- Lot Codes: 181, 182, 183, 184, 188, 189, 191, 192, 193, 196, 197, 198, 199, 202, 203, 204, 205, 209, 210, 211",,"122,705","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0010-2015","Class II","Hostess Powdered Single-Serve Donettes, 3 oz., 6 ct.","UPC: 8 88109 05004 7 Best By Dates (2014): AUG 29, 30, 31 SEPT 05, 06, 07, 08, 09, 17, 18, 19, 20, 21, 24, 25 OCT 01, 02, 03, 10 Julian Date- Lot Codes: 181, 182, 183, 188, 189, 190, 191, 192, 195, 196, 197, 198, 199, 202, 203, 209, 210, 211, 219",,"48,974","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0009-2015","Class II","Hostess Powdered Bagged Donettes, 10.5 oz.","UPC: 8 88109 15004 4 Best By Dates (2014): SEPT 24 OCT 02, 03, 04 Julian Date- Lot Codes: 202, 210, 211, 212",,"17,330","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Food",69221,"Ongoing","Hostess Brands LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","The products were distributed nationwide to MO, KY, IL, UT, LA, WA, IN, AL, NE, WY, WI, AZ, TX, OH, NV, AZ, TX, ME, AL, MS, VA, CA, AR, OK, FL, GA, SC, MS, MI, NY, PA, IA, MD, CO, OR, CT, NC, KS, WY, NE, MS, NM, MO, ID, SD, NJ, NH, and WV. International: Canada","F-0013-2015","Class II","Hostess Powdered Single-Serve Donettes- FROZEN ONLY, 3 oz., 6 ct.","UPC: 8 88109 05004 7 Best By Dates (2014): AUG 29, 30, 31 SEPT 05, 06, 07, 08, 09, 17, 18, 19, 20, 21, 24, 25 OCT 01, 02, 03, 10 Julian Date- Lot Codes: 181, 182, 183, 188, 189, 190, 191, 192, 195, 196, 197, 198, 199, 202, 203, 209, 210, 211, 219",,"3,247","Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content.",8/28/2014,"08/28/2014",10/15/2014,"10/15/2014"
"Devices",69223,"Ongoing","Spacelabs Healthcare Inc","Snoqualmie","WA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, and Puerto Rico and to the following countries: Argentine, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, Guam, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.","Z-2707-2014","Class II","Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed","The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed. THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US: 040-1548-00, 1367-000033, 1369-001517, 1369-003051, 1369-003077, 1369-004247, 1369-005914, 1369-006877, 1369-007165, 1369-008519, 1369-010292, 1369-011637, 1369-017520, 1369-061217, 1370-000013, 1370-000014, 1370-000025, 1370-000095, 1370-000285, 1370-000449, 1370-000471, 1370-000579, 1370-000658, 1370-001700, 1370-002494, 1370-002510, 1370-003785, 1370-004176, 1370-004184, 1370-004275, 1370-004292, 1387-000465, 1387-000535, 1387-000543, 1387-001071, 1387-001677, 1387-006200, 1387-010824, 1387-010830, 1387-011914, 1387-014142, 1387-014159, 1387-014184, 1387-014186, 1387-014187, 1387-014188, 1387-014596, 1387-015721, 1387-015722, 1387-015723, 1387-016045, 1387-018424, 1387-018947, 1387-019766, 1387-019768, 1387-019769, 1387-019771, 1387-019772, 1387-100036, 1387-101646, 1387-104672, 1387-105801, 1387-105811, 1387-105812, 1387-105882, 1393-000442, 1393-000579, 1393-000580, 1393-000581, 1393-000582, and 387-002421. THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US: 1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 13",,"82 units distributed in US and 140 units distributed outside US","The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).",8/26/2014,"08/26/2014",10/1/2014,"10/01/2014"
"Devices",69224,"Ongoing","Parker Laboratories, Inc.","Fairfield","NJ","US","Voluntary: Firm Initiated","Telephone","Worldwide Distribution: US (Nationwide) and country of: Canada.","Z-0145-2015","Class II","Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75''W x 9.5''L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.","Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10",".","367 boxes","Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.",8/6/2014,"08/06/2014",11/5/2014,"11/05/2014"
"Food",69225,"Ongoing","Expo Fresh L.L.C","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","Nationwide in US: NJ, MA, CA, AZ, OR, WA,","F-0006-2015","Class I","Roma Tomatoes, 25lbs. case","Lot Code: 23914 214",,"10,072 boxes","Expo Fresh is recalling Roma Tomatoes because they have a potential to be contaminated with Salmonella.",9/11/2014,"09/11/2014",10/15/2014,"10/15/2014"
"Devices",69226,"Ongoing","Gyrus Medical, Inc","Osseo","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.","Z-0100-2015","Class II","GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.","All product manufactured before July 28, 2014.",,"5520 US, 40 OUS","Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.",8/27/2014,"08/27/2014",10/29/2014,"10/29/2014"
"Food",69227,"Ongoing","Blue Diamond Growers ","Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Product was shipped to the following States: WA, CA, NY, WI, TX, CO, PA, IN, MD and IL.","F-2501-2014","Class II","Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free Net wt. 4.25 oz. Box. (120.5g) Cracker Snacks UPC: 41570 10938 Best Before Dates: AUG 06 15 and AUG 07 15 Manufactured for: Blue Diamond Growers 1802 C St. Sacramento, CA 95811","UPC: 41570 10938 Best Before Dates: AUG 06 15 and AUG 07 15 ",,"1843 cases (12 units per case)","Gluten Protein detected up to 50 ppm in product with gluten free statement. ",9/8/2014,"09/08/2014",10/1/2014,"10/01/2014"
"Biologics",69230,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0015-15","Class III","Cryoprecipitated AHF","Unit ID Numbers: W280314200420; W280314602973; W280314602981; W280314602986; W280314602987; ",".","5 units","Plasma products, not prepared in accordance with specifications, were distributed. ",7/25/2014,"07/25/2014",11/5/2014,"11/05/2014"
"Biologics",69231,"Terminated","CSL Plasma, Inc.","Salt Lake City","UT","US","Voluntary: Firm Initiated","Other","Switzerland","B-0040-15","Class II","Source Plasma","62704598990; 62704670613; 62704671560; 62704741485; 62704692222; 62704613109; 62704434071; 62704445774; 62704442012; 62704588548; 62704501764; 62704585970; 62704466049; 62704488897; 62704409968; 62704417474; 62704540501; 62704353280; 62704397602; 62704366961; 62704377601; 62704246441; 62704239532; 62704235970; 62704191014; 62704266143; 62704281052; 62704131345; 62704123521; 62704077924; 62704077393; 62704176949; 62704160541; 62704090934; 62703957946; 62703969939; 62703988689; 62704008734; 62704047979; 62704054010; 62704050094; 62703918031; 62703907199; 62703835471; 62703831753; 62703863990; 62703884839; 62703714100; 62703702193; 62703768310; 62703750750; 62703785451; 62703793910; 62704664002; 62704607382; 62703817011; 62703649804; 62703593134; 62703593206; 62703553538; 62703577724; 62703635437; 62703632842; 62703520170; 62703517027; 62703536164; 62703464121; 62703499033; 62703474629; 62703437908; 62703456308; 62703168656; 62703162342; ",".","73","Blood products, collected from a donor who had not had an annual physical performed, were distributed.",3/27/2014,"03/27/2014",11/5/2014,"11/05/2014"
"Drugs",69233,"Ongoing","Qualitest Pharmaceuticals","Huntsville","AL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1605-2014","Class III","MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811","100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015",,"159,913 tablets","Subpotent; 6 month stability time point",9/11/2014,"09/11/2014",10/1/2014,"10/01/2014"
"Devices",69234,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-0077-2015","Class II","VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.","Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)",".","USA: 97; Foreign: 232","Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).",9/8/2014,"09/08/2014",10/22/2014,"10/22/2014"
"Devices",69234,"Ongoing","Ortho-Clinical Diagnostics","Rochester","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.","Z-0078-2015","Class II","VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.","Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers)",".","USA: 843; Foreign: 945","Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).",9/8/2014,"09/08/2014",10/22/2014,"10/22/2014"
"Devices",69235,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.","Z-2711-2014","Class II","The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories","Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300035,300037,300039,300043,300047,300050,300051, 300052,300054,300055,300057,300060,300061,300062,300063,300072,300074, 300082,300086,300087,300089,300094,300095,300100,300101,300102,300106, 300108,300110,300112,300113,300129,300135,300136,300140,300143 Ingenuity Core: 728321 310001,310002,310009,310055,310059,310064,310069,310070,310087,333015 Ingenuity Core128: 728323 300137,320003,320005,320006,320018,320024,320029,320030,320033,320037, 320078,320092,320099,320103,320114,336011,336012,336013,336016,336018 ",".","79"," Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. ",9/11/2014,"09/11/2014",10/7/2014,"10/07/2014"
"Devices",69236,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-0119-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG-AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034; 2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134; 3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088; 4) Model Number: AG-AS3000-SC; Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091; 5) Model Number: AG-AS3000-SE; Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097; 6) Model Number: AG-AS3000-UK; Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044; 7) Model Number: AG-AS3000-US; Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030; 8) Model Number: AG-PX1000-IN; Lot Numbers: 9133140704002; 9) Model Number: ; Lot Numbers: ; 10) Model Number: AG-PX1000-NE; Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040; 11) Model Number: AG-PX1000-SC; Lot Numbers: 9132140519072 , 9132140526107; 12) Model Number: AG-PX1000-SE; Lot Numbers: 9131140623154; 13) Model Number: AG-PX1000-UK; Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024; 14) Model Number: AG-PX1000-US; Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087; 15) Model Number: AG-PX1000-US-Promo; Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071",,"1,223 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/29/2014,"10/29/2014"
"Devices",69236,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-0118-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers: 1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 ; 2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100, 8000140624100; 3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125; 4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093; 5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153; 6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132; 7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091 , 9939140630138; 8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025; 9) Model Number: AG-AP6000(DG)-GE; Lot Numbers: 9997140611024; 10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059; 11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056 , 9915140722089; 12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021 , 9966140624102; 13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072; 14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097; 15) Model Number: AG-AP6",,"2,421 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/29/2014,"10/29/2014"
"Devices",69236,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-0121-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046",,"323 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/29/2014,"10/29/2014"
"Devices",69236,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-0120-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079",,"36 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/29/2014,"10/29/2014"
"Drugs",69237,"Ongoing","Actavis Laboratories, FL, Inc.","Davie","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1617-2014","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. ","Lot #: 660513A, Exp. 10/31/2014",".","6,041 bottles","Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.",4/24/2014,"04/24/2014",10/7/2014,"10/07/2014"
"Drugs",69237,"Ongoing","Actavis Laboratories, FL, Inc.","Davie","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-1616-2014","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. ","Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015",".","36,538 bottles","Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.",4/24/2014,"04/24/2014",10/7/2014,"10/07/2014"
"Biologics",69238,"Ongoing","Life Technologies Corporation","Brown Deer","WI","US","Voluntary: Firm Initiated","Letter","Nationwide and Worldwide","B-0035-15","Class III","Invitrogen by Life Technologies, DPB1 SSP UniTray, DPB1 SSP UniTray with Taq, AllSet Gold DPB1 High Res SSP. ","Catalog # (SKU) Product Name Lot/Serial Number 210101 (AMBISOLV TUBE FORMAT 40 TESTS): 134487 451606D (DPB1 SSP UNITRAY 12 TESTS): 0081190373, 0081220578, 0081289713, 0091415057, 0091464121, 0091568516 451616D (DPB1 SSP UNITRAY W/TAQ 12 TEST): 0081154360, 0081190373, 0081220578, 0081289713, 0091415057, 0091464121 54070D (ALLSET GOLD DPB1 HIGH RES SSP): 0081204422, 0081256851, 0091377591, 0091450550, 0091544263 ",,"1358 kits","HLA typing assay, associated with false negative results, were distributed. ",8/14/2014,"08/14/2014",11/12/2014,"11/12/2014"
"Food",69240,"Ongoing","McCain Foods USA","Lisle","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was to foodservice customers in AZ, CA, CO, GA, IA, IL, LA, MN, MO MT, ND, NE, NM, PA, TN, TX, WA, and WI. Product was distributed in Canada.","F-0063-2015","Class II","Frozen beer battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Intros Appetizers & Snacks Beer Battered Thin Cut Onion Rings, Marketed by Independent Marketing Alliance, Houston, Texas 77079, Product no.: 5791088, and UPC code: 8 22468 13390 0; and (2) Freddy's Onion Rings, Net Wt. 40 oz (2.5 lb), Packed for Freddy's Frozen Custard & Steakburgers, Wichita, KS 67206, Product no. 100000640, UPC 0 72714 00081 2. ","(1) Product no. 5791088, Lot no. 1000843147; and (2) Product no. 100000640, Lot no. 1000843148",,"Lot 1000843147: 709 cases; and Lot 1000843148: 709 cases","Product may be contaminated with glass.",9/10/2014,"09/10/2014",10/29/2014,"10/29/2014"
"Food",69240,"Ongoing","McCain Foods USA","Lisle","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was to foodservice customers in AZ, CA, CO, GA, IA, IL, LA, MN, MO MT, ND, NE, NM, PA, TN, TX, WA, and WI. Product was distributed in Canada.","F-0062-2015","Class II","Frozen battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Imperial Sysco 3/8'' Battered Onion Rings, Distributed by Sysco Corporation, Houston, Texas 77077-2099, Product no.: 41010044, and UPC code: 074865 84822 0; and (2) KickStarts Batter Dipt Onion Rings, Net Wt. 40 oz (2.5 lb), Distributed by Food Services of America, Inc., Seattle, WA 98106, Product no. 10210070, UPC 0 41493 49025 0; and (3) McCain Onion Rings, Net Wt. 3.18 kg, packaged as 8 x 397g boxes, Product of U.S.A., Prepared for: McCain Foods (Canada) A Division of McCain Foods Limited, Florenceville-Bristol, New Brunswick, Canada E7L 1B2, Product No. 1000001362, UPC 0 55773 00089 4. ","(1) Product no. 41010044, Lot no. 1000843118; and (2) Product no. 10210070, Lot no. 1000843114; and (3) Product no. 1000001362, Lot no. V40728 ",,"(1) Lot no. 1000843118 - 748 cases, and (2) Lot no. 1000843114 - 264 cases, and (3) Lot no. V40728 - 2109 cases ","Product may be contaminated with glass.",9/10/2014,"09/10/2014",10/29/2014,"10/29/2014"
"Devices",69242,"Ongoing","Estill Medical Technologies, Inc","Dallas","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Serbia.","Z-0101-2015","Class II","Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.","06-2011; 07-2011; 08-2011; 09-2011; 03-2012; 04-2012; 05-2012; 06-2012; 07-2012; 08-2012; 01-2013; 03-2013; 08-2013; 09-2013; 10-2013; 11-2013; 12-2013; 01-2014; 02-2014; 04-2014; 07-2012; 02-2014",,"6,886","Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in the instructions for use are incorrect. The corrected voltage range is 12-30V. The product is marketed for vehicle systems operating at 12 V and 28V.",7/25/2014,"07/25/2014",10/29/2014,"10/29/2014"
"Drugs",69243,"Ongoing","Gyma Laboratories Of Amer,Inc","Westbury","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0023-2015","Class II","Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01","Lot Numbers: 166247, 166248, Exp 10/2016",".","55.8 Kg","cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. ",7/9/2014,"07/09/2014",10/22/2014,"10/22/2014"
"Drugs",69243,"Ongoing","Gyma Laboratories Of Amer,Inc","Westbury","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0021-2015","Class II","Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084","Lot Number: 161600, Exp 03/2016",".","10 Kg","cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. ",7/9/2014,"07/09/2014",10/22/2014,"10/22/2014"
"Drugs",69243,"Ongoing","Gyma Laboratories Of Amer,Inc","Westbury","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0024-2015","Class II","Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002","Lot Numbers: 167219, 163367, 167220, 167221, Exp 03/2017",".","97 Kg","cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. ",7/9/2014,"07/09/2014",10/22/2014,"10/22/2014"
"Drugs",69243,"Ongoing","Gyma Laboratories Of Amer,Inc","Westbury","NY","US","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0022-2015","Class II","Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004","Lot Number: 154919, Exp 11/2014",".","1 Kg","cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. ",7/9/2014,"07/09/2014",10/22/2014,"10/22/2014"
"Biologics",69244,"Completed","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Missouri; California; Oklahoma","B-0017-15","Class II","Bone","122323503; 122323505; 122323506; 125952102; 125952103; 125952104; 125952105; 125952106; 125952107; 125952108; 125952109; 125952110; 125952111; 125952112; 125952113; 125952114; 125952115; ",".","17 allografts","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",6/26/2014,"06/26/2014",11/5/2014,"11/05/2014"
"Biologics",69244,"Completed","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","Missouri; California; Oklahoma","B-0016-15","Class II","Tendon","125700111",".","1 allograft","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",6/26/2014,"06/26/2014",11/5/2014,"11/05/2014"
"Biologics",69245,"Completed","Merck Sharpe & Dohme Corp","West Point","PA","US","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0996-14","Class II","Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Recombinant Vaccine","J007354; ",,"1 Lot; (743,360 vials)","GARDASIL, one lot with the potential for small glass particles to be present in the vial, was distributed. ",12/19/2013,"12/19/2013",10/1/2014,"10/01/2014"
"Drugs",69246,"Ongoing","Astellas Pharma US Inc","Northbrook","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0008-2015","Class II","Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01","Lot 66482CW, Exp 04/16",,"9,236 bottles ","Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.",9/15/2014,"09/15/2014",10/15/2014,"10/15/2014"
"Drugs",69247,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-1588-2014","Class II","Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02 ","LOT 37-268-DK; Exp: 1JAN2016",,"75,000 vials","Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. ",9/4/2014,"09/04/2014",9/24/2014,"09/24/2014"
"Drugs",69248,"Ongoing","American Family Pharmacy, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","E-Mail","VA, WA, and CA.","D-0040-2015","Class II","Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320","Lot#12084; Exp. 05/16",,"4,207,200 tablets","Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69249,"Ongoing","Biomedix, Inc.","Bloomington","IN","US","Voluntary: Firm Initiated","E-Mail","US Distribution including the states of OH, NC, and TX","Z-0023-2015","Class II","Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE ","Model/Product Number: B30-102 Lot #416130 Exp. 12/2016",,"2,928","Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.",8/14/2014,"08/14/2014",10/15/2014,"10/15/2014"
"Drugs",69250,"Ongoing","VistaPharm, Inc.","Largo","FL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide, including Puerto Rico","D-0010-2015","Class II","METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.","Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.",,"322,650 Cups","Defective Container: Product leaks when inverted.",8/13/2014,"08/13/2014",10/15/2014,"10/15/2014"
"Devices",69251,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Other","US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX","Z-0201-2015","Class II","Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536","Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.",".","43 (LCX02) and 17 (LCX02R)","Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.",8/18/2014,"08/18/2014",11/19/2014,"11/19/2014"
"Food",69252,"Terminated","Taylor Farms Pacific Inc. (MacArthur Facility)","Tracy","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Arizona, Nevada, Washington","F-0020-2015","Class I","CST Roma Tomatoes Whole Roma 1/25# Origin: USA Keep Refrigerated UPC: 40000356942 Taylor Farms, Pacific, Tracy, CA 95376","Packed on: 9/5/2014 Packed on: 9/6/2014",".","45 / 25 Lb. Boxes","Firm was notified by supplier that specific lots of ''expo fresh'' Roma tomatoes may be contaminated with Salmonella.",9/12/2014,"09/12/2014",10/22/2014,"10/22/2014"
"Food",69252,"Terminated","Taylor Farms Pacific Inc. (MacArthur Facility)","Tracy","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Arizona, Nevada, Washington","F-0021-2015","Class I","Signature Cafe SWY Sicilian Vegetable Salad 2CT Kit Pack Size: 2-6.75 lb bags S3197 Perishable Keep Refrigerated Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566-0009 1-877-232-4271 Product is distributed to be assembled and sold at deli counters where customers request purchase amount. Roma tomatoes are shipped with the salad kit and diced at retail locations to be mixed with salad.","Use By: 9/20 and 9/21/2014",".","130 Cases","Firm was notified by supplier that specific lots of ''expo fresh'' Roma tomatoes may be contaminated with Salmonella.",9/12/2014,"09/12/2014",10/22/2014,"10/22/2014"
"Biologics",69254,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio","B-0034-15","Class II","Red Blood Cells Leukocytes Reduced","W037714031050; ",,"1","Blood product, collected from a donor who lived in a malarial endemic area, was distributed.",7/3/2014,"07/03/2014",10/29/2014,"10/29/2014"
"Biologics",69255,"Terminated","American National Red Cross, Greater Ozark-Arkansas Region","Little Rock","AR","US","Voluntary: Firm Initiated","Letter","Arkansas","B-0036-15","Class II","Platelets Pheresis Leukocytes Reduced","W205514802424; ",,"1","Plateletpheresis product, which failed a monthly product QC test, was distributed.",4/2/2014,"04/02/2014",10/29/2014,"10/29/2014"
"Devices",69256,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in Utah only.","Z-0114-2015","Class II","ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit ","Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969 ",,"300","Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, G",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0045-2015","Class I","Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660","Al lot codes",".","31,590 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0044-2015","Class I","Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC","Al lot codes",".","9,850 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0047-2015","Class I","MediChoice Multifunction Electrode Part Number: MC171 OH","Al lot codes",".","330 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0048-2015","Class I","Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A","Al lot codes",".","151,210 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0046-2015","Class I","Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006","Al lot codes",".","133,930 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69257,"Ongoing","Covidien LLC","Mansfield","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.","Z-0043-2015","Class I","Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R","All lots",".","317,550 pairs","Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69258,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.","Z-0004-2015","Class II","Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: ''Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; ''X-ray examinations of the urogenital area ''Ultrasound examinations ''Endourological interventions ''Percutaneous interventions ''Laparoscopy ''Application of fistula ''Simple procedures ''Extracorporeal shock wave lithotripsy ''Uroflow/urodynamics ''Pediatric radiological and therapeutic applications ","Siemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015 ",".","2","Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. ",9/2/2014,"09/02/2014",10/7/2014,"10/07/2014"
"Devices",69258,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.","Z-0005-2015","Class II","Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.","Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017 ",".","5","Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. ",9/2/2014,"09/02/2014",10/7/2014,"10/07/2014"
"Devices",69258,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.","Z-0003-2015","Class II","Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. ","Siemens AXIOM Luminos dRF Max system material #s: 10762471 with serial number: 5037.",".","1","Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. ",9/2/2014,"09/02/2014",10/7/2014,"10/07/2014"
"Devices",69258,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.","Z-0002-2015","Class II","Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. ","Siemens Ysio Max material #s: 10762470, serial numbers: 24033 24028 24024 24034 24015 24026 24014 24016 24025 24037 ",".","10","Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis. ",9/2/2014,"09/02/2014",10/7/2014,"10/07/2014"
"Devices",69260,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","Mahwah","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.","Z-0107-2015","Class II","Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature. ","V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.",,"2,247 units","Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.",7/31/2014,"07/31/2014",10/29/2014,"10/29/2014"
"Devices",69262,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa","Z-0089-2015","Class II","Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated","All lots with expiration on or before August 2017 (2017-08)",,"66,120 units","tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69262,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa","Z-0091-2015","Class II","Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated","All lots with expiration on or before August 2017 (2017-08)",,"1145 units","tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69262,"Ongoing","Codman & Shurtleff, Inc.","Raynham","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa","Z-0090-2015","Class II","Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated","All lots with expiration on or before August 2017 (2017-08)",,"93,558 units","tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Food",69263,"Ongoing","Gel Spice Co, Inc.","Bayonne","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH and then Nationwide","F-0025-2015","Class I","Fresh Finds ground black pepper Net Wt. 3.53 oz (100g) Distributed by: Big Lots Stores, Inc. P.O. Box 28523 Columbus, OH 43228-0523 Packed in the USA UPC 411010982901 packaged in plastic jars; 12 jars per case","Best By Dates of 6/30/17, 7/01/17, 7/02/17, 7/22/17, and 7/23/17 ",".","16,443 cases (containing 3.53 oz plastic jars)","Fresh Finds Black Pepper may contain Salmonella.",9/15/2014,"09/15/2014",10/22/2014,"10/22/2014"
"Food",69264,"Ongoing","Dominguez Foods of Washington, Inc.","Zillah","WA","US","Voluntary: Firm Initiated","Telephone","Distributed in Oregon and Washington","F-0026-2015","Class I","Su Cocina brand Pan Molido (Plain Bread Crumbs). Product is packaged in 8 oz. bags. The UPC is 6 79790 05912 5. The Label is read in parts: ''***SU COCINA***Plain Bread Crumbs***INGREDIENTS: Bread Crumbs*** DOMINGUEZ FOODS OF WASHINGTON*** P.O. Box 506, Zillah, Washington 98953***509-829-6089***''.","None",".","12 cases (12/8 oz. Packages per case)","Product is recalled due to undeclared wheat, milk, and soy. ",9/16/2014,"09/16/2014",10/22/2014,"10/22/2014"
"Devices",69265,"Ongoing","IMRIS Inc","Hopkins","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.","Z-0144-2015","Class II","IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.","10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.",".","14","One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Biologics",69266,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio; Kentucky","B-0068-15","Class III","Red Blood Cells (Apheresis) Leukocytes Reduced","W037714001547; W037714001547; W037713024767; W037713024767;",,"4 units","Blood products, collected from a donor who was at risk for leishmaniasis, were distributed.",5/20/2014,"05/20/2014",11/12/2014,"11/12/2014"
"Biologics",69266,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio; Kentucky","B-0066-15","Class III","Red Blood Cells Leukocytes Reduced","W037713060158; ",,"1 unit","Blood products, collected from a donor who was at risk for leishmaniasis, were distributed.",5/20/2014,"05/20/2014",11/12/2014,"11/12/2014"
"Biologics",69266,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Ohio; Kentucky","B-0067-15","Class III","Platelets Pooled Leukocytes Reduced","W037713506167; ",,"1 unit","Blood products, collected from a donor who was at risk for leishmaniasis, were distributed.",5/20/2014,"05/20/2014",11/12/2014,"11/12/2014"
"Food",69267,"Ongoing","Boskovich Farms, Inc","Oxnard","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2535-2014","Class I","2-5 lb. clear plastic overwrapped black poly trays of 3/8'' diced Roma Tomato per cardboard carton. Cardboard carton labeled: 2-5 LB. DICED TOMATOES 3/8 PACKED BY BOSKOVICH FARMS OXNARD CA, 93030 PRODUCT OF MEXICO.","L091-EI03712, L091-EI09362.",".","12 units","Boskovich Farms is recalling Roma Tomatoes because they may be contaminated with Salmonella.",9/12/2014,"09/12/2014",10/7/2014,"10/07/2014"
"Food",69267,"Ongoing","Boskovich Farms, Inc","Oxnard","CA","US","Voluntary: Firm Initiated","Letter","CA","F-2534-2014","Class I","2/24 ounce clear plastic bags of 3/8 inch diced Roma tomatoes. These bags are in a cardboard carton. The bags and carton have a yellow label that reads in part: Boskovich Farms, Inc Costco Deli Dept. 63 ***QUINOA SALAD KIT Item # 624843 CONTENTS: (2) QUINIA MIX *** (2) Diced Roma *** NET WT: 23.96 LBS.","L091-EI03718, L091-EI08269, L-091-EI05092, L091-10510510.",".","899 units","Boskovich Farms is recalling Roma Tomatoes because they may be contaminated with Salmonella.",9/12/2014,"09/12/2014",10/7/2014,"10/07/2014"
"Drugs",69268,"Ongoing","Micro Labs Usa, Inc S","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","NY","D-0246-2015","Class III","Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90","Lot #: STBG005, Exp 2/2015",".","1,008 bottles","Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.",8/19/2014,"08/19/2014",11/19/2014,"11/19/2014"
"Food",69269,"Terminated","Mothers' Milk Bank of Montana","Missoula ","MT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","354oz bottle of unpasteurized milk was transfered to Mother's Milk of San Jose, CA. 12 - 4oz bottles was delivered to Community Medical Center, Missoula, Montana.","F-0016-2015","Class III","Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo","MMBMT-050114-71-1 through MMBMT-050114-71-12. 050114 represents the date the milk was pasteurized; 71 refers to the batch number; 1 refers to the bottle number. A total of 46 bottles were pasteurized for batch 71.",,"12 - 4oz bottles","Donor answered NO to question #32 ''In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?'' It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery.",5/13/2014,"05/13/2014",10/15/2014,"10/15/2014"
"Food",69269,"Terminated","Mothers' Milk Bank of Montana","Missoula ","MT","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","354oz bottle of unpasteurized milk was transfered to Mother's Milk of San Jose, CA. 12 - 4oz bottles was delivered to Community Medical Center, Missoula, Montana.","F-0017-2015","Class III","Frozen Unpasteurized Human Milk in glass bottle. No labeling provided","No lot coding",,"354 fl oz","Donor answered NO to question #32 ''In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?'' It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery.",5/13/2014,"05/13/2014",10/15/2014,"10/15/2014"
"Devices",69270,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.","Z-0063-2015","Class II","EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.","Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323 SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 USG435 USG183 SH2079 USG035 USG144 USG647 SH1590 USG641 SH0087 USG580 SH0389 USG106 SH1642 USG351 SH0280 SH1963 SH0566 USG551 USG566 USG636 SH2076 USG122 USG163 SH0084 USG706 USG563 SH0252 SH1494 SH1249 SH1588 SH1495 USG103 USG484 SH0329 SH1980 USG060 USG421 USG364 SH0148 USG398 SH0412 SH0881 SH1687 SH2154 SH1998 SH1802 SH1863 SH1939 SH2100 SH2128 SH0572 SH0208 SH1159 SH1592 SH0273 SH2143 SH1297 SH1852 SH2014 SH1941 SH2009 SH2015 SH2013 SH2027 SH2116 SH2056 SH2012 SH2161 SH2193 SH2209 SH0467 SH0238 USG605 SH1962 SH1757 SH1874 SH1938 SH1607 SH1854 SH2096 SH2070 SH2082 SH2095 USG560 USG279 SH1608 USG726 SH1114 SH1614 SH2054 USG116 USG277 USG345 SH2179 SH2207 SH0328 SH1901 SH1940 SH0733 SH0658 SH0062 SH0357 SH1691 SH0893 USG129 SH1565 SH2121 USG418 SH1806 USG127 USG159 USG438 SH1118 SH0030 SH0332 SH0586 SH0819 SH0435 USG445 SH0108 USG156 SH0436 SH0883 SH0950 SH1096 SH1336 SH1369 SH0306 SH0640 SH0481 SH0453 SH1282 SH1177 SH0341 SH0850 SH1192 SH1293 SH0214 SH0319 SH0078 SH0741 SH0949 SH1391 SH1372 SH1322 SH1362 SH1401 SH1353 SH0098 SH0592 SH1027 SH0181 USG098 USG639 SH0212 SH1375 SH1359 SH1213 SH1337 SH0582 SH1332 SH0802 SH1396 SH0475 SH1394 SH1338 SH0438 SH1367 SH1409 SH1348 SH0829 SH1395 SH1376 USG542 SH0118 SH1389 SH1142 SH1402 SH0379 SH1399 SH1294 SH0830 SH1287 SH1398 SH1335 SH0394 SH1392 SH0483 SH1383 SH1347 SH1325 SH0321 USG623 SH0115 SH0770 SH1412 SH1343 USG334 SH0599 SH1410 SH0847 SH0962 SH1466 SH0168 SH0415 SH0159 SH1413 SH0041 SH1446 SH0418 SH1427 SH0318 SH0921 SH0723 SH1451 SH1022 SH0613 USG114 SH0314 SH1504 SH0476 SH0142 SH1432 SH0729 SH0722 USG221 USG515 SH0837 SH1438 SH0299 SH0609 SH0966 SH1109 SH0169 USG533 USG558 SH0417 SH1512 SH1426 SH1276 SH1448 SH1323 SH1",".","1,483 devices","Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.",9/17/2014,"09/17/2014",10/22/2014,"10/22/2014"
"Devices",69271,"Ongoing","DePuy Orthopaedics, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.","Z-0199-2015","Class II","ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag","Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ",".","3,082","Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.",10/15/2014,"10/15/2014",11/19/2014,"11/19/2014"
"Biologics",69272,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0037-15","Class III","Red Blood Cells Leukocytes Reduced","W044214163535; ",,"1 unit","Blood product, not prepared in accordance with standard operating procedure, was distributed.",8/6/2014,"08/06/2014",10/29/2014,"10/29/2014"
"Biologics",69273,"Terminated","San Diego Blood Bank","San Diego","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0044-15","Class III","Red Blood Cells Leukocytes Reduced","W044214148970; ",,"1 unit","Blood product, not prepared in accordance with standard operating procedure, was distributed.",7/23/2014,"07/23/2014",10/29/2014,"10/29/2014"
"Biologics",69274,"Terminated","Michigan Blood","Grand Rapids","MI","US","Voluntary: Firm Initiated","FAX","Michigan","B-0061-15","Class II","Red Blood Cells Leukocytes Reduced","W120614089852; ",,"1 unit","Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.",7/30/2014,"07/30/2014",10/29/2014,"10/29/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0013-2015","Class I","Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: 534801 Lot Number: 296986",,"285 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0018-2015","Class I","Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: C4320-450B Lot Number: 300403",,"235 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0015-2015","Class I","Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: 59601 Lot Number: 300233",,"383 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0012-2015","Class I","Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: 426-796 Lot Number: 298987",,"175 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0017-2015","Class I","Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: 53151 Lot Number: 300143",,"264 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0016-2015","Class I","Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: 51401 Lot Number: 300649",,"199 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69276,"Ongoing","Richard-Allan Scientific Company","Kalamazoo","MI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.","Z-0014-2015","Class I","Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.","Product Code: LC-0060 Lot Number: 300445",,"80 cases","The affected lots could have NBF concentrations that are lower or higher than the desired specifications. ",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Drugs",69277,"Ongoing","Noven Pharmaceuticals, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-1608-2014","Class II","Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.","Lot # 71165; Exp. 12/14 ",,"160,800 patches","Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. ",7/15/2014,"07/15/2014",10/1/2014,"10/01/2014"
"Food",69278,"Ongoing","NatureBox, Inc.","San Carlos","CA","US","Voluntary: Firm Initiated","E-Mail","Internet sales only.","F-0015-2015","Class II","naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for cherry berry granola labeled in part as: Ingredients: Whole grain oats, brown sugar, dried cranberries (cranberries, sugar, sunflower oil) almonds, coconut, pecans, dried cherries (cherries, sugar, sunflower oil), maltodextrin [dietary fiber], natural flavor, salt, cinnamon, mixed tocopherols (vitamin E, soybean oil). Contains: Tree nuts (almonds, coconut, pecans). Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy. Distributed by NatureBox San Carlos, CA 94070","CORRECT berry macaroon granola UPC: 8 52523 00590 7 INCORRECT: Cherry berry granola UPC: 8 52523 00575 4 Lot Number: 3BC14204 Expiration Date: 3/10/15",,"1,262 pouches","Firm discovered a pouch that had an incorrect back label. The front of the pouch was correctly labeled Cranberry Macaroon Granola but the back of the pouch was incorrectly labeled with the label for Cherry Berry Granola.",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69279,"Ongoing","Coloplast Manufacturing US, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","US Distribution to MO and RI.","Z-0138-2015","Class III","Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging. ","4201931",".","6","Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.",9/8/2014,"09/08/2014",11/5/2014,"11/05/2014"
"Devices",69280,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.","Z-0021-2015","Class II","Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. ","Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290",,"4","Investigation determined that units supplied were missing the 4x21 degree helix angle.",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Devices",69282,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.","Z-0214-2015","Class III","ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.","Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014",".","4645 (12 pk)","Stability of the ADVIA Centaur Cleaning Solution is not assured",9/12/2014,"09/12/2014",11/26/2014,"11/26/2014"
"Devices",69283,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0074-2015","Class II","EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. ","EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.",".","1,034 Devices","Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Veterinary",69284,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*** US: Nationwide (CA, GA, IL, MS, NC, TX); *** FOREIGN: Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam","V-162-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG -AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034; 2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134; 3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088; 4) Model Number: AG-AS3000-SC; Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091; 5) Model Number: AG-AS3000-SE; Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097; 6) Model Number: AG-AS3000-UK; Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044; 7) Model Number: AG-AS3000-US; Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030; 8) Model Number: AGPX1000- IN; Lot Numbers: 9133140704002; 9) Model Number: ; Lot Numbers: ; 10) Model Number: AG-PX1000-NE; Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040; 11) Model Number: AG-PX1000-SC; Lot Numbers: 9132140519072 , 9132140526107; 12) Model Number: AG-PX1000-SE; Lot Numbers: 9131140623154; 13) Model Number: AG-PX1000-UK; Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024; 14) Model Number: AGPX1000- US; Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087; 15) Model Number: AG-PX1000-US-Promo; Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071",".","1,223 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/22/2014,"10/22/2014"
"Veterinary",69284,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*** US: Nationwide (CA, GA, IL, MS, NC, TX); *** FOREIGN: Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam","V-161-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers: 1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 ; 2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100, 8000140624100; 3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125; 4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093; 5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153; 6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132; 7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091 , 9939140630138; 8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025; 9) Model Number: AGAP6000( DG)-GE; Lot Numbers: 9997140611024; 10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059; 11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056 , 9915140722089; 12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021 , 9966140624102; 13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072; 14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097; 15) Model Number: AG-AP6000-IN; Lot Numbers: 9913140520026 , 9913140526077 , 9913140526102 , 9",".","2,421 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/22/2014,"10/22/2014"
"Veterinary",69284,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*** US: Nationwide (CA, GA, IL, MS, NC, TX); *** FOREIGN: Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam","V-163-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079",".","36 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/22/2014,"10/22/2014"
"Veterinary",69284,"Ongoing","Aerogen Ltd.","Galway",,"IE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*** US: Nationwide (CA, GA, IL, MS, NC, TX); *** FOREIGN: Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam","V-164-2015","Class II","The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.","FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG -UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046",".","323 power adapters","Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.",9/2/2014,"09/02/2014",10/22/2014,"10/22/2014"
"Drugs",69285,"Ongoing","AbbVie Inc","North Chicago","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide","D-1611-2014","Class II","CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.","Lot #: 1020156; Expiry: 3/31/2016",".","18,021 Bottles","Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.",9/15/2014,"09/15/2014",10/7/2014,"10/07/2014"
"Biologics",69287,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","FAX","California","B-0038-15","Class III","Red Blood Cells Leukocytes Reduced","W036214233130; ",,"1 unit","Blood product, for which donor suitability was not fully determined, was distributed. ",8/8/2014,"08/08/2014",10/29/2014,"10/29/2014"
"Biologics",69288,"Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Letter","Rhode Island","B-0045-15","Class III","Platelets Pheresis Leukocytes Reduced","W051714111922; ",,"1 unit","Plateletpheresis product, labeled with an incorrect volume, was distributed.",8/26/2014,"08/26/2014",10/29/2014,"10/29/2014"
"Devices",69289,"Ongoing","Abbott Ireland Diagnostics Division","Co. Longford",,"IE","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.","Z-0474-2015","Class II","ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.","Product List Numbers, Lot Numbers, and Expiration Dates: 1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15; 2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15",".","7,415 kits","17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.",9/11/2014,"09/11/2014",12/2/2014,"12/02/2014"
"Devices",69290,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.","Z-0076-2015","Class II","Multi-Lumen Central Venous Catheterization Kit","Catolog No - AK-12703 lot number RF3039028 ",".","65","Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69291,"Ongoing","Boston Scientific CRM Corp","Saint Paul","MN","US","Voluntary: Firm Initiated","Visit","Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.","Z-0088-2015","Class II","Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias ","Model E102 - Serial Numbers: 240307, 240308, 240310, 240312, 240313, 240318, 240319, 240320, 240321, 240324, 240325, 240326, 240327, 240329, 240330, 240332, 240336, 240338, 240340, 240342, 240344, 240345, 240346, 240348, 240349, 240350, 240351, 240354, 240355, 240356, 240358, 240359, 240360, 240363, 240365, 240366, 240367, 240368, 240369, 240371, 240372, 240373, 240374, 240375, 240376, 240378, 240380, 240383, 240384, 240386, 240389, 240391, 240393, 240397, 240398, 240399, 240401, 240403, 240404, 240405, 240406, 240407, 240408, 240410, 240414, 240415, 240416, 240418, 240421, 240422, 240423, 240424, 240426, 240432, 240433, 240434, 240438, 240439, 240441, 240443, 240444, 240448, 240450, 240451, 240452, 240454, 240455, 240456, 240457, 240459, 240460, 240461, 240462, 240466, 240468, 240471, 240472, 240473, 240474, 240475, 240478, 240479, 240480, 240484, 240485, 240488, 240489, 240490, 240491, 240492, 240493, 240496, 240497, 240500, 240501, 240503, 240505, 240508, 240510, 240511, 240512, 240517, 240519, 240521, 240523, 240524, 240525, 240527, 240529, 240530, 240531, 240533, 240535, 240536, 240537, 240540, 240542, 240544, 240547, 240548, 240549, 240550, 240551, 240552, 240555, 240556, 240557, 240558, 240559, 240561, 240562, 240563, 240566, 240573, 240575, 240576, 240579, 240582, 240583, 240584, 240586, 240587, 240589, 240590, 240591, 240592, 240593, 240594, 240596, 240597, 240598, 240599, 240600, 240602, 240605, 240606, 240607, 240608, 240609, 240610, 240611, 240612, 240615, 240616, 240618, 240619, 240622, 240623, 240624, 240627, 240628, 240630, 240633, 240635, 240636, 240637, 240639, 240640, 240641, 240642, 240644, 240645, 240646, 240647, 240648, 240649, 240650, 240652, 240653, 240655, 240656, 240657, 240658, 240659, 240660, 240663, 240664, 240665, 240666, 240668, 240669, 240672, 240674, 240678, 240679, 240680, 240681, 240687, 240688, 240690, 240692, 240699, 240701, 240703, 240705, 240707, 240708, 240709, 240712, 240713, 240715, 240717, 240718, 240719, 240720, 240722, 240723, 240725, 240726, 240727, 240728, 240729, "," 254063, 254065, 254066, 254068, 254069, 254070, 254071, 254072, 254075, 254076, 254077, 254078, 254079, 254080, 254081, 254082, 254083, 254084, 254087, 254093, 254095, 254097, 254098, 254100, 254102, 254103, 254105, 254108, 254110, 254111, 254112, 254116, 254118, 254120, 254121, 254122, 254125, 254127, 254128, 254129, 254130, 254132, 254133, 254134, 254136, 254137, 254138, 254139, 254141, 254143, 254144, 254145, 254147, 254150, 254151, 254152, 254154, 254155, 254157, 254158, 254160, 254161, 254164, 254165, 254167, 254169, 254170, 254173, 254174, 254175, 254176, 254177, 254179, 254180, 254182, 254184, 254185, 254187, 254188, 254189, 254191, 254192, 254193, 254194, 254195, 254197, 254198, 254199, 254200, 254201, 254202, 254204, 254205, 254206, 254207, 254208, 254209, 254211, 254212, 254214, 254215, 254216, 254217, 254218, 254219, 254221, 254222, 254223, 254224, 254228, 254229, 254230, 254232, 254233, 254234, 254235, 254237, 254238, 254239, 254240, 254241, 254242, 254243, 254244, 254246, 254247, 254250, 254251, 254254, 254255, 254256, 254258, 254262, 254264, 254265, 254267, 254268, 254269, 254272, 254273, 254274, 254276, 254278, 254280, 254281, 254284, 254285, 254286, 254288, 254289, 254291, 254294, 254295, 254300, 254302, 254303, 254305, 254307, 254308, 254309, 254310, 254311, 254312, 254313, 254315, 254316, 254317, 254321, 254323, 254324, 254326, 254328, 254330, 254332, 254333, 254336, 254338, 254339, 254340, 254341, 254343, 254344, 254345, 254346, 254347, 254348, 254350, 254351, 254352, 254353, 254354, 254355, 254357, 254358, 254359, 254361, 254362, 254364, 254365, 254368, 254369, 254371, 254372, 254373, 254374, 254375, 254377, 254378, 254379, 254382, 254385, 254386, 254387, 254388, 254391, 254392, 254393, 254394, 254396, 254398, 254399, 254400, 254402, 254403, 254404, 254405, 254406, 254407, 254408, 254409, 254410, 254412, 254414, 254415, 254416, 254417, 254418, 254419, 254420, 254422, 254424, 254425, 254426, 254427, 254428, 254429, 254432, 254434, 254436, 254437, 254438, 254439, 254440, 254442, 254444, 2544","31,144 devices total","Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low voltage (LV) capacitor.",9/17/2014,"09/17/2014",10/29/2014,"10/29/2014"
"Devices",69292,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.","Z-0102-2015","Class II","Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.","Lot Number: 100064 Exp.Date:February 10, 2015",,"5434 (200 tests)","Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69292,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.","Z-0103-2015","Class II","ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.","Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015",,"5434 ","Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.",9/15/2014,"09/15/2014",10/29/2014,"10/29/2014"
"Devices",69293,"Ongoing","Animas Corporation","West Chester","PA","US","Voluntary: Firm Initiated","Letter","International Distribution in Israel only.","Z-0136-2015","Class II","Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. ","Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,IL 11220408 PMPW/OKIT,VIBE,PGL,mg,IL 11220508 PMPW/OKIT,VIBE,LGN,mg,IL 11251008 REV KIT,VIBE,BLU,mg,IL 11251108 REV KIT,VIBE,BLK,mg,IL 11251208 REV KIT,VIBE,SIL,mg,IL 11251408 REV KIT,VIBE,PGL,mg,IL 11251508 REV KIT,VIBE,LGN,mg,IL 11451008 REV KIT,VIBEPL,BLU,mg,IL 11451108 REV KIT,VIBEPL,BLK,mg,IL 11451208 REV KIT,VIBEPL,SIL,mg,IL 11451408 REV KIT,VIBEPL,PGL,mg, IL 11451508 REV KIT,VIBEPL,LGN,mg,IL 11420008 PMPW/OKIT,VIBEPL,BLU,mg,IL 11420108 PMPW/OKIT,VIBEPL,BLK,mg,IL 11420208 PMPW/OKIT,VIBEPL,SIL,mg,IL 11420408 PMPW/OKIT,VIBEPL,PGL,mg,IL 11420508 PMPW/OKIT,VIBEPL,LGN,mg,IL",".","1028","Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.",6/10/2014,"06/10/2014",11/5/2014,"11/05/2014"
"Devices",69295,"Ongoing","Merge Healthcare, Inc.","Hartland","WI","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen.","Z-0068-2015","Class II","eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. ","versions 4.0 and 4.0.1",".","2,630","There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.",8/28/2014,"08/28/2014",10/22/2014,"10/22/2014"
"Devices",69296,"Ongoing","Animas Corporation","West Chester","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the countries of France, Italy, Sweden, and UK.","Z-0137-2015","Class II","Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.","Part Numbers 101200-57 100512-57 100510-02 100510-03 100510-04 100510-53 100510-56 100510-57 100510-63 100510-67 100511-02 100511-03 100511-04 100511-53 100511-56 100511-57 100511-63 100512-02 100512-02 100512-03 100512-04 100512-53 100512-56 100512-57 100512-63 100514-02 100514-03 100514-04 100514-53 100514-56 100514-57 100514-63 100515-02 100515-03 100515-04 100515-53 100515-56 100515-57 100515-63 101200-02 101002-03 101002-53 101002-56 101002-57 101002-63 101201-02 101201-03 101201-53 101210-56 101201-57 101201-63 101202-02 101202-03 101202-04 101202-53 101202-57 101202-63 101204-03 101204-04 101204-53 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63 ",".","1938","Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.",10/25/2012,"10/25/2012",11/5/2014,"11/05/2014"
"Food",69297,"Ongoing","Original Soup Man","Staten Island","NY","US","Voluntary: Firm Initiated","Press Release","retail stores nationwide","F-0504-2015","Class II","THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers per carton. Distributed exclusively by: SoupMan Inc. Staten Island, NY 10314","Lot numbers: 0314435801, 0411435801, 0523435801, 0709435803, 0822435801, 0709435802 and 0821435801",".","Total of 3,083 cases (1859 cases/12/17 oz and 1244 cases/6/17 oz)","The Original Soup Man has recalled Lobster Bisque due to the presense of Undeclared Shrimp, Tilapia and Perch.",9/24/2014,"09/24/2014",11/26/2014,"11/26/2014"
"Drugs",69298,"Ongoing","Forest Pharmaceuticals Inc","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico.","D-0036-2015","Class II","Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07","Lot A369286, exp. date 31 Jan 2016",,"94,584 cartons","Failed Dissolution Specification; at the 6-month stability time point",9/26/2014,"09/26/2014",10/29/2014,"10/29/2014"
"Devices",69301,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.","Z-0094-2015","Class II","Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer","Part Number: 00-8757-068-02; Lot Number: 62207029",,"19","The affected products are missing polar boss threads.",10/1/2014,"10/01/2014",10/29/2014,"10/29/2014"
"Drugs",69302,"Ongoing","Janssen Ortho L.L.C.","Gurabo","PR","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0006-2015","Class II","Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 ","Lot 13JG2616 Exp. 07/16",,"13500 bottles","Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.",9/17/2014,"09/17/2014",10/15/2014,"10/15/2014"
"Drugs",69303,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Canada","D-0004-2015","Class II","DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.","Lot# P303172; Exp. 12/14",".","11,808 bags","Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.",9/29/2014,"09/29/2014",10/7/2014,"10/07/2014"
"Devices",69304,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, DC, DE, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA and WI., and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom and Viet Nam.","Z-0203-2015","Class II","BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.","Brightview XCT",".","344 units worldwide, with approximately 114 units in the United States.","It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.",10/23/2013,"10/23/2013",12/17/2014,"12/17/2014"
"Food",69305,"Ongoing","Mars Chocolate North America","Hackettstown","NJ","US","Voluntary: Firm Initiated","Press Release","NC, TX, MN, IL, FL, KY, MS, AZ, GA, AI, CA NJ, PA, WA NY, CO, MO, MI, NH, CT, TN, MD, SC, OH, ME, VA, RI, WI, WV, IA, LA, OK, MA, NE, OK, AR, VT, ID and IN","F-0014-2015","Class II","Mars Chocolate North America Milk Chocolate M & M's Net Wt. 3.40 oz packed in a brown, 3 inch x 6.5 inch cardboard box 12 Theater boxes per case Distributed by Mars Snackfoods US LLC., Hackettstown, NJ 07840-1503 UPC 40000294764 ","417DH4JP09; 417EM4JP10; 417FM4JP09; 418AG4JP10; 418BG4JP10; 418CG4JP10; 418DM4JP09; 418EG4JP10; 419AM4JP09; 417EG4JP09; 417FG4JP09; 417FM4JP10; 418AM4JP09; 418BM4JP10 ;418CM4JP10; 418DM4JP10; 418EM4JP09; 419AM4JP10; 417EG4JP10; 417FG4JP10; 418AG4JP09; 418AM4JP10; 418CG4JP09; 418DG4JP10; 418EG4JP09; 418EM4JP10; and 419BM4JP10 ",,"65,496 cases ","Mars Chocolate North America is recalling M & Ms due to undeclared peanuts.",9/19/2014,"09/19/2014",10/15/2014,"10/15/2014"
"Biologics",69306,"Terminated","Blood Systems, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Other","Switzerland","B-0092-15","Class II","Blood and Blood Products for Reprocessing","W042513078984A",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",7/29/2014,"07/29/2014",11/19/2014,"11/19/2014"
"Biologics",69307,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0041-15","Class II","Cryoprecipitated AHF, Pooled","W036814807525; ",,"1 unit","Blood product, that did not meet homologous criteria, was distributed.",7/8/2014,"07/08/2014",10/29/2014,"10/29/2014"
"Biologics",69308,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0060-15","Class III","Red Blood Cells Leukocytes Reduced","W036813271047; ",,"1 unit","Blood product, that did not meet allogeneic criteria, was distributed.",4/1/2014,"04/01/2014",10/29/2014,"10/29/2014"
"Food",69310,"Ongoing","Venus Wafers Inc.","Hingham","MA","US","Voluntary: Firm Initiated","Letter","Canada","F-0040-2015","Class II","President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0","Lot : 2015JA21 ",,"784 cases (10/cs)=7840 units","Product contains undeclared sesame seeds",9/19/2014,"09/19/2014",10/29/2014,"10/29/2014"
"Cosmetics",69311,"Ongoing","Keystone Laboratories Inc","Memphis","TN","US","Voluntary: Firm Initiated","Telephone","GA, CT, OR, CA, FL, IL, MD, TN, NJ, NC, Nassau, Bahamas","F-0080-2015","Class III","LONG AID Curl Activator Gel, NET WT. 16.4 OZ. (464.9g), KEYSTONE LABORATORIES, 1103 KANSAS STREET, MEMPHIS, TN 38106, UPC 070596003655","MAER , MAES, MAEX, MAFO, MAFA, MAJG, MADB, MAHX, MAGX ",".","39,498 units","Product has a cloudy appearance",12/13/2013,"12/13/2013",11/5/2014,"11/05/2014"
"Food",69312,"Ongoing","United Natural Trading","Edison","NJ","US","Voluntary: Firm Initiated","Letter","CT, GA, FL, PA, NH, NC & NY","F-0092-2015","Class II","1) Nature's Place Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by DZA Brands LLC 2110 Executive Drive Salisbury, NC 28147; UPC 725439951920 2) Nature's Promise Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by Foodhold USA LLC Landover, MD 20785; 1-877-846-9949; UPC 688267066092 3) Woodstock Organic Campfire Trail Mix; Net. Wt. 10 oz. (283 g); Distributed by Woodstock 313 Iron Horse Way Providence, RI 02908 USA; UPC 042563009366","1) Nature's Place Organic Campfire Trail Mix - Lot #14203 2) Nature's Promise Organic Campfire Trail Mix - Lot #14199 3) Woodstock Organic Campfire Trail Mix - Lot #14207",".","820 cases ","The various trail mixes may contain undeclared cashew kernels.",9/19/2014,"09/19/2014",11/5/2014,"11/05/2014"
"Devices",69313,"Ongoing","Respironics California Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.","Z-0008-2015","Class I","Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.","Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884 VS0002844 VS0002846 VS0002847 VS0002851 VS0002856 VS0002891 VS0002815 VS0002816 VS0002924 VS0002927 VS0002929 VS0002932 VS0002933 VS0002934 VS0002936 VS0002938 VS0002939 VS0002943 VS0002942 VS0002947 VS0002946 VS0002960 VS0002994 VS0002998 VS0002708 VS0002817 VS0002940 VS0002958 VS0002959 VS0002963 VS0003023 VS0003029 VS0003074 VS0003079 VS0003080 VS0003092 VS0003093 VS0003141 VS0003095 VS0003114 VS0003176 VS0003260 VS0003139 VS0003172 VS0003259 VS0003286 VS0003303 VS0003343 VS0003357 VS0003361 VS0003430 VS0003440 VS0003444 VS0003446 VS0003448 VS0003451 VS0003494 VS0003500 VS0003503 VS0003504 VS0003505 VS0003506 VS0003507 VS0003509 VS0003511 VS0003513 VS0003514 VS0003518 VS0003545 VS0003546 VS0003554 VS0003549 VS0003557 VS0003607 VS0003601 VS0003704 VS0003684 VS0003690 VS0003694 VS0003698 VS0003701 VS0003702 VS0003705 VS0003707 VS0003709 VS0003713 VS0003657 VS0003733 VS0003600 VS0003757 VS0003743 VS0003744 VS0003750 VS0003751 VS0003755 VS0003756 VS0003818 VS0003819 VS0003820 VS0003822 VS0003823 VS0003825 VS0003826 VS0003828 VS0003829 VS0003830 VS0003831 VS0003876 VS0003886 VS0003890 VS0003891 VS0003892 VS0003922 VS0003907 VS0003921 VS0003923 VS0003924 VS0003925 VS0003896 VS0003913 VS0003939 VS0003940 VS0003942 VS0003897 VS0003906 VS0003944 VS0003945 VS0003960 VS0003971 VS0003975 VS0003973 VS0004010 VS0004016 VS0004017 VS0003791 VS0003792 VS0003993 VS0004004 VS0004023 VS0004024 VS0004056 VS0004062 VS0004068 VS0004069 VS0004072 VS0004077 VS0004079 VS0004087 VS0004095 VS0004060 VS0004065 VS0004083 VS0004097 VS0004098 VS0004099",,"2,206 units total (665 units in US)","A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.",9/17/2014,"09/17/2014",10/29/2014,"10/29/2014"
"Drugs",69314,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0044-2015","Class II","Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.","Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015",,"145,600 vials","Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.",10/1/2014,"10/01/2014",10/29/2014,"10/29/2014"
"Biologics",69316,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, CA","B-0096-15","Class II","Platelets Pooled Leukocytes Reduced","W20221492617700",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Biologics",69316,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, CA","B-0097-15","Class II","Red Blood Cells Leukocytes Reduced","W20221413210800",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Biologics",69316,"Terminated","American National Red Cross, Penn Jersey Region","Philadelphia","PA","US","Voluntary: Firm Initiated","FAX","PA, CA","B-0095-15","Class III","Blood and Blood Products for Reprocessing","W20221413210800",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Biologics",69317,"Terminated","Kaiser Foundation Hospital","Woodland Hills","CA","US","Voluntary: Firm Initiated","Telephone","CA","B-0093-15","Class II","Red Blood Cells Leukocytes Reduced","W072014002986",".","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.",8/11/2014,"08/11/2014",11/19/2014,"11/19/2014"
"Devices",69319,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY","Z-0098-2015","Class II","DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital","Lot 364817213",,"5112 units","These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. ",8/22/2014,"08/22/2014",10/29/2014,"10/29/2014"
"Devices",69319,"Ongoing","DeRoyal Industries Inc","Powell","TN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY","Z-0097-2015","Class II","Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital","1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622 ",,"13,900 units","These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. ",8/22/2014,"08/22/2014",10/29/2014,"10/29/2014"
"Devices",69320,"Ongoing","Nellcor Puritan Bennett Inc. (dba Covidien LP)","Boulder","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, WI; and, the countries of Canada, Mexico, Saudi Arabia, South Africa, and United Arab Emirates.","Z-0112-2015","Class I","Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.","Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482, 35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502, 35B1400507, 35B1400577, 35B1400207, 35B1400211, 35B1400216, 35B1400222, 35B1400225, 35B1400231, 35B1400267, 35B1400312, 35B1400323, 35B1400340, 35B1400383, 35B1400128, 35B1400363, 35B1400459, 35B1400589, 35B1400616, 35B1400637, 35B1400483, 35B1400311, 35B1400447, 35B1400648, 35B1400651, 35B1400654, 35B1400662, 35B1400686, 35B1400692, 35B1400175, 35B1400294, 35B1400436, 35B1400485, 35B1400586, 35B1400644, 35B1400687, 35B1400689, 35B1400694, 35B1400700, 35B1400661, 35B1400676, 35B1400693, 35B1400732, 35B1400734, 35B1400736, 35B1400737, 35B1400742, 35B1400280, 35B1400360, 35B1400471, 35B1400609, 35B1400674, 35B1400688, 35B1400755, 35B1400480, 35B1400675, 35B1400706, 35B1400771, 35B1400667, 35B1400704, 35B1400705, 35B1400727, 35B1400743, 35B1400279, 35B1400285, 35B1400262, 35B1400265, 35B1400259, 35B1400494, 35B1400403, 35B1400779, 35B1400783, 35B1400509, 35B1400724, 35B1400763, 35B1400767, 35B1400566, 35B1400768, 35B1400772, 35B1400791, 35B1400793, 35B1400817, 35B1400525, 35B1400796, 35B1400801, 35B1400809, 35B1400821, 35B1400828, 35B1400333, 35B1400366, 35B1400392, 35B1400440, 35B1400463, 35B1400478, 35B1400308, 35B1400347, 35B1400367, 35B1400396, 35B1400078, 35B1400099, 35B1400130, 35B1400155, 35B1400157, 35B1400158, 35B1400174, 35B1400176, 35B1400178, 35B1400180, 35B1400281, 35B1400315, 35B1400631, 35B1400635, 35B1400625, 35B1400653, 35B1400843, 35B1400847, 35B1400233, 35B1400271, 3",".","324 units","A software issue may lead to ventilator inoperative situations.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69321,"Ongoing","Siemens Healthcare Diagnostics","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and internationally to Canada.","Z-0122-2015","Class II","IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.","Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014) ",,"US: 772 units, Canada: 43 units","Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.",9/19/2014,"09/19/2014",10/29/2014,"10/29/2014"
"Devices",69322,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.","Z-0010-2015","Class II","GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. ","Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0 210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64 00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9 423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500 00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9 904202RF 00000149495MO4 208557RM1 00000149496MO2 515226RF 00000149498MO8 847535RF1 00000149499MO6 704210RX5 00000149500MO1 515226RF2 00000149501MO9 970244AMPRF2 00000149502MO7 215750PRECIS1 00000149503MO5 504447P500 00000149505MO0 602344RM7 00000149506MO8 609584RM1 00000149507MO6 603433PRF3 00000149508MO4 828766R2 00000149509MO2 210297SEBRF3 00000149510MO0 651232RF4 00000149511MO8 502868RF1 00000149512MO6 314525SARM2 00000149513MO4 515247RF1 00000150005M00 308398RF 00000152264MO8 708783RM1 00000152265MO5 319283M500D 00000152266MO3 608873RF 00000152267MO1 210297BMCRF11 00000152269MO7 540776RF1 00000152270MO5 409727MJRF1 00000152276MO2 601936RF1 00000152277MO0 409985PRF3 00000152278MO8 617636RMD 00000152279MO6 760FCI2500D 00000152280MO4 973971RF8 00000152281MO2 651480RF1 00000152282MO0 832355SLT3 00000152283MO8 903232LRP500 00000152285MO3 978521MVRF4 00000152286MO1 760830500D 00000152290MO3 304379RF 00000152292M09 260920RF 00000152295MO2 850325RF4 00000152295MO7 850325RF3 00000152296MO0 314577GC31 00000152298M06 320693PREC 00000152302MO6 972698P500D3 00000152307M05 781744RF3 00000152311MO7 972566P500D1 00000152312MO5 720225RM3 00000152313MO3 720225RM1 00000152316MO6 215750PRECIS2 00000152317MO4 270389RF 00000152318MO2 956632MCRF1 00000152321MO6 847570RF10 00000152322MO4 816348BRF1 00000152323MO2 913498MR2 00000152324MO0 662536RF1 00000152325MO7 847872RF1 00000152327MO3 812450RF12 00000152328M01 304792PRE1 00000152329MO9 913541HPR3 00000152330MO7 636916BRM4 00000152331M05 650723RF2 00000152",".","204 (199 US, 5 OUS).","GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.",9/5/2014,"09/05/2014",10/7/2014,"10/07/2014"
"Devices",69323,"Ongoing","Roche Diagnostics Operations, Inc.","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.","Z-0146-2015","Class II","ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. ","Model/Catalog/Part Number: Accu-Chek Combo Kit mg US/English version, 05458544001 Accu-Chek Combo Kit mg US/Spanish version, 055004686001 Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001 Accu-Chek Spirit Combo Demo Pump- US, 0539175000",".","8116","The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.",9/25/2014,"09/25/2014",11/5/2014,"11/05/2014"
"Devices",69324,"Ongoing","Nellcor Puritan Bennett Inc. (dba Covidien LP)","Boulder","CO","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.","Z-0180-2015","Class I","Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.","Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482, 35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502, 35B1400507, 35B1400577, 35B1400207, 35B1400211, 35B1400216, 35B1400222, 35B1400225, 35B1400231, 35B1400267, 35B1400312, 35B1400323, 35B1400340, 35B1400383, 35B1400128, 35B1400363, 35B1400459, 35B1400589, 35B1400616, 35B1400637, 35B1400483, 35B1400311, 35B1400447, 35B1400648, 35B1400651, 35B1400654, 35B1400662, 35B1400686, 35B1400692, 35B1400175, 35B1400294, 35B1400436, 35B1400485, 35B1400586, 35B1400644, 35B1400687, 35B1400689, 35B1400694, 35B1400700, 35B1400661, 35B1400676, 35B1400693, 35B1400732, 35B1400734, 35B1400736, 35B1400737, 35B1400742, 35B1400280, 35B1400360, 35B1400471, 35B1400609, 35B1400674, 35B1400688, 35B1400755, 35B1400480, 35B1400675, 35B1400706, 35B1400771, 35B1400667, 35B1400704, 35B1400705, 35B1400727, 35B1400743, 35B1400279, 35B1400285, 35B1400262, 35B1400265, 35B1400259, 35B1400494, 35B1400403, 35B1400779, 35B1400783, 35B1400509, 35B1400724, 35B1400763, 35B1400767, 35B1400566, 35B1400768, 35B1400772, 35B1400791, 35B1400793, 35B1400817, 35B1400525, 35B1400796, 35B1400801, 35B1400809, 35B1400821, 35B1400828, 35B1400333, 35B1400366, 35B1400392, 35B1400440, 35B1400463, 35B1400478, 35B1400308, 35B1400347, 35B1400367, 35B1400396, 35B1400078, 35B1400099, 35B1400130, 35B1400155, 35B1400157, 35B1400158, 35B1400174, 35B1400176, 35B1400178, 35B1400180, 35B1400281, 35B1400315, 35B1400631, 35B1400635, 35B1400625, 35B1400653, 35B1400843, 35B1400847, 35B1400233, 35B1400271, 3",".","324 units","Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.",10/1/2014,"10/01/2014",12/17/2014,"12/17/2014"
"Cosmetics",69325,"Ongoing","Rockline Industries, Inc","Sheboygan","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MI, MN,MS,MO, NH, NY,NC, OH,OK,OR, PA,TN, TX, UT,VT, VA, WA,WI.","F-0089-2015","Class III","Wipes under the following labels: Pure'n Gentle Wipes, Softly Scented, 120 wipes 5.9 x 6.8 in(15.0 x 17.3 cm). UPC 0 71287 86297 1. Soffs, Baby Wipes, 120 wipes 5.9 x 6.8 in(15.0 x 17.3 cm). UPC 0 7128783626 2. Kroger, Scented Baby Wipes, 120 wipes 5.9 x 6.8 in(15.0 x 17.3 cm). UPC 0 4126037109 7. Publix, Hand & Face Wipes, 120 wipes 5.9 x 6.8 in(15.0 x 17.3 cm). UPC 041415-25167 Western Family, CozyCare, Scented, 120 wipes 5.9 x 6.8 in(15.0 x 17.3 cm). UPC 01540013076 9. The primary packaging is a round HDPE plastic canister with a reclosable polypropylene dispensing lid. ","14125 12100, 14126 12100, 14139 12100 - 14143 12100, 14194 12100, 14195 12100, 14209 12100 - 14213 12100. ",".","51,678 cases (310,068 canisters)","Rockline Industries is recalling Pure'n Gentle Wipes, Softly Scented, 120 count (additionally sold under private labels), due to the presence of mold contamination.. ",8/28/2014,"08/28/2014",11/5/2014,"11/05/2014"
"Devices",69326,"Ongoing","Trivascular, Inc","Santa Rosa","CA","US","Voluntary: Firm Initiated","Letter","International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.","Z-0125-2015","Class I","Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs). ","The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging ''May-17'' through ''Jun-17''",,"0 Devices","TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.",9/20/2014,"09/20/2014",11/12/2014,"11/12/2014"
"Biologics",69328,"Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","AL, GA","B-0094-15","Class II","Platelets Pheresis Leukocytes Reduced","W115114198912X- part 1; W115114198912X-part 2",".","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.",8/26/2014,"08/26/2014",12/10/2014,"12/10/2014"
"Biologics",69329,"Terminated","LifeShare Community Blood Services","Elyria","OH","US","Voluntary: Firm Initiated","Telephone","Ohio","B-0073-15","Class III","Red Blood Cells Deglycerolized Leukocytes Reduced","W043813005867; ",,"1 unit","Blood product, labeled with incorrect expiration date, was distributed.",8/11/2014,"08/11/2014",10/29/2014,"10/29/2014"
"Biologics",69330,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Tennessee","B-0070-15","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W071214033970 (double collection) ",".","2 units","Blood products, collected from donors with unsuitable health histories, were distributed.",7/28/2014,"07/28/2014",11/19/2014,"11/19/2014"
"Biologics",69330,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Tennessee","B-0069-15","Class II","Red Blood Cells Leukocytes Reduced","W071214035769; ",".","1 unit","Blood products, collected from donors with unsuitable health histories, were distributed.",7/28/2014,"07/28/2014",11/19/2014,"11/19/2014"
"Devices",69333,"Ongoing","Ameditech Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Distributed in AL.","Z-0072-2015","Class II","ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. ","Lot No. 140874",".","80 kits","Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.",9/23/2014,"09/23/2014",10/22/2014,"10/22/2014"
"Devices",69333,"Ongoing","Ameditech Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Distributed in AL.","Z-0071-2015","Class II","ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. ","Lot No. 141012",".","400 kits","Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.",9/23/2014,"09/23/2014",10/22/2014,"10/22/2014"
"Devices",69333,"Ongoing","Ameditech Inc","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Distributed in AL.","Z-0073-2015","Class II","ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine. ","Lot No. 141001",".","320 kits","Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.",9/23/2014,"09/23/2014",10/22/2014,"10/22/2014"
"Devices",69334,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and country of: Canada.","Z-0127-2015","Class II","Dimension Vista HbA1c ","catalog #K3105A, material #10470481, All in-date lots",".","20043","In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% to + 6.5% (Note: The percent bias range is a percentage of the HbA1c result. It is NOT % HbA1c units).",8/14/2014,"08/14/2014",11/5/2014,"11/05/2014"
"Food",69335,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide","F-0500-2015","Class II","1) Chiclets Peppermint Gum, 6-10 piece packages (60 pieces), Retail UPC 0 12546 10105 9; 2)Chiclets Peppermint Gum, 20 - 12 piece packages (240 pieces), Retail UPC 0 12546 02501 0, Case UPC 1001254 3)Chiclets Peppermint Gum, (12 pieces), Retail UPC 0 12546 10128 8; 4)Chiclets Peppermint Gum, 7-6 PAK packages (420 pieces), Retail UPC 0 12546 02601 7, Case UPC 000125461010","1)Best When Used By 12 Oct 2015 - 6 Nov 2015; 2)Best When Used By 31 Aug 2014 - 8 Nov 2015; 3)Best When Used By 31 Aug 2014 - 8 Nov 2015; 4)Best When Used By 12 Oct 2015 - 6 Nov 2015",".","approx. 1,993,432 units","Mondelez Global LLC is conducting a voluntary recall of Chiclets Chewing Gum due to undeclared soy lecithin on the label.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Food",69335,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide","F-0501-2015","Class II","1) Chiclets Fruit Flavor Gum, 12 piece, Retail UPC 0 12546 10628 3; 2) Chiclets Fruit Flavor Gum, 20 - 12 piece packages (240 pieces), Retail UPC 0 12546 02503 4, Case UPC 10012","Best When Used By 30 Aug 2014 - 6 Nov 2015",".","1,614,000 units","Mondelez Global LLC is conducting a voluntary recall of Chiclets Chewing Gum due to undeclared soy lecithin on the label.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Food",69335,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide","F-0503-2015","Class II","Chiclets Gum, 200 - 2 piece packs (400 pieces), Retail UPC 0 12546 02509 6, Case UPC 10012546108499","Best When Used By 2 Sep 2014 - 28 Dec 2015,",".","3,863,888 total units","Mondelez Global LLC is conducting a voluntary recall of Chiclets Chewing Gum due to undeclared soy lecithin on the label.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Food",69335,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide","F-0502-2015","Class II","Chiclets Gum, 200 - 2 piece packs (400 pieces), Retail UPC 0 12546 02509 6, Case UPC 10012546108499","Best When Used By 2 Sep 2014 - 28 Dec 2015,",".",,"Mondelez Global LLC is conducting a voluntary recall of Chiclets Chewing Gum due to undeclared soy lecithin on the label.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Food",69335,"Ongoing","Mondelez Global Llc","East Hanover","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide","F-0499-2015","Class II","Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 6-10 piece packages (60 pieces), 6 PAK, Retail UPC 0 12546 10102 8; 2)Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 7-6 PAK packages (420 pieces), Retail UPC 0 12546 0","Best When Used By 4 Oct 2015 - 11 Oct 2015",".","53,452 units","Mondelez Global LLC is conducting a voluntary recall of Chiclets Chewing Gum due to undeclared soy lecithin on the label.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Devices",69337,"Ongoing","STERILMED, INC.","Maple Grove","MN","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of WA and CA.","Z-0059-2015","Class II","Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. ","Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577",,"22","Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is connected with the CARTO®3 System, Error 6103 for expiration is displayed on the CARTO®3 System and the catheter cannot be used.",9/24/2014,"09/24/2014",10/15/2014,"10/15/2014"
"Devices",69340,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.","Z-0075-2015","Class II","Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components. ","Catalog Number: 414837 Lot Number: 555011",".","6","An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.",9/24/2014,"09/24/2014",10/22/2014,"10/22/2014"
"Biologics",69341,"Terminated","BloodSource, Inc.","Mather","CA","US","Voluntary: Firm Initiated","Telephone","California","B-0042-15","Class II","Platelets Pheresis Leukocytes Reduced","W035814074688 (Portions 1 & 2)",,"2 units","Plateletpheresis products, collected in a manner that may have compromised sterility of the units, were distributed. ",8/19/2014,"08/19/2014",10/29/2014,"10/29/2014"
"Biologics",69342,"Terminated","Medic Inc","Knoxville","TN","US","Voluntary: Firm Initiated","Letter","TN","B-0091-15","Class III","Red Blood Cells Leukocytes Reduced Washed","W071214031867; W071214032934; W071214035409; W071214036141",".","4 units","Blood products, which did not meet the acceptable product specifications, were distributed.",8/12/2014,"08/12/2014",12/10/2014,"12/10/2014"
"Biologics",69343,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0043-15","Class II","Red Blood Cells Leukocytes Reduced","W036809310644; W036809310644; ",,"2 units","Misbranded Red Blood Cells were distributed. ",7/28/2014,"07/28/2014",10/29/2014,"10/29/2014"
"Food",69344,"Ongoing","Formulations For Life","Hauppauge","NY","US","Voluntary: Firm Initiated","Letter","NY, PA","F-0526-2015","Class II","FORMULATIONS FOR LIFE Resevera Action High Potency Longevity Complex DIETARY SUPPLEMENT, 60 VEGETARIAN CAPSULES. Distributed by: Formulations for LIfe Hauppauge, New York 11788 USA.","Lot # 405130",".","24 bottles","Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. ",9/24/2014,"09/24/2014",11/26/2014,"11/26/2014"
"Food",69344,"Ongoing","Formulations For Life","Hauppauge","NY","US","Voluntary: Firm Initiated","Letter","NY, PA","F-0527-2015","Class II","FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSULES. Distributed by: Formulations for Life Hauppauge, New York 11788 USA.","Lot # 404120",".","64 bottles Total (40 bottles/60 ct, 24 bottles/120 ct","Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding.",9/24/2014,"09/24/2014",11/26/2014,"11/26/2014"
"Food",69344,"Ongoing","Formulations For Life","Hauppauge","NY","US","Voluntary: Firm Initiated","Letter","NY, PA","F-0525-2015","Class II","Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Venetia, Pennsylvania 15367 USA.","Lot # 405130",".","220 bottles","Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding.",9/24/2014,"09/24/2014",11/26/2014,"11/26/2014"
"Devices",69345,"Ongoing","Eyemart Express Ltd","Farmers Branch","TX","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.","Z-0167-2015","Class II","Prescription eyeglass safety lenses. Vision correction","No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28",,"76 pairs of eyeglasses","Prescription eyeglass safety lenses did not meet specifications.",9/12/2014,"09/12/2014",11/12/2014,"11/12/2014"
"Drugs",69346,"Ongoing","Mckesson","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.","D-0005-2015","Class II","Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.","Lot #140502, Exp 10/31/2015",,"10 vials","Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.",9/12/2014,"09/12/2014",10/15/2014,"10/15/2014"
"Devices",69347,"Ongoing","Bausch & Lomb Inc- Greenville Solutions Plant","Greenville","SC","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA, and WI.","Z-0126-2015","Class II","Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.","Lot number: GBD14070 (twin packs), SKU: 630308",".","18,792 bottles (9,396 twin packs)","Product lot did not meet the specification for its disinfectants at the time of manufacture.",9/25/2014,"09/25/2014",11/5/2014,"11/05/2014"
"Devices",69348,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.","Z-0104-2015","Class II","Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.","software revisions J.21.03, J.21.19",,"7587 units","Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped",10/3/2014,"10/03/2014",10/29/2014,"10/29/2014"
"Devices",69348,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.","Z-0105-2015","Class II","Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: '' Monitoring the physiological parameters of pregnant women '' Non-invasive monitoring of fetal heart rates and movements. ","software revision J.30.58: ",,"118 units","Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped",10/3/2014,"10/03/2014",10/29/2014,"10/29/2014"
"Biologics",69349,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0100-15","Class II","Platelets Pheresis Leukocytes Reduced","W115114206559W",".","1 unit","Blood product, associated with a unit of platelets with an unacceptable pH, was distributed",9/4/2014,"09/04/2014",12/10/2014,"12/10/2014"
"Biologics",69350,"Terminated","Blood Systems, Inc","Albuquerque","NM","US","Voluntary: Firm Initiated","FAX","TX, NM","B-0101-15","Class II","Red Blood Cells Leukocytes Reduced","W041214037636; W041214022068W ",".","2 units","Blood products, which was not quarantined subsequent to receiving information regarding a post donation illness, were distributed.",8/1/2014,"08/01/2014",12/10/2014,"12/10/2014"
"Biologics",69351,"Terminated","Blood Systems, Inc","Fargo","ND","US","Voluntary: Firm Initiated","Telephone","North Dakota","B-0072-15","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced","W042514051221X (double collection)",".","2 units","Blood products, for which donor screening testing may not have been performed according to manufacturer's specifications, were distributed.",8/22/2014,"08/22/2014",11/19/2014,"11/19/2014"
"Biologics",69352,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","E-Mail","Austria; Virginia","B-0111-15","Class III","Red Blood Cells Leukocytes Reduced","W087613832378; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Biologics",69352,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","E-Mail","Austria; Virginia","B-0110-15","Class III","Blood and Blood Products for Reprocessing","W087613832378; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Biologics",69352,"Terminated","Virginia Blood Services","Richmond","VA","US","Voluntary: Firm Initiated","E-Mail","Austria; Virginia","B-0112-15","Class III","Cryoprecipitated AHF, Pooled","W088613900922; ",".","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",8/12/2014,"08/12/2014",11/19/2014,"11/19/2014"
"Devices",69354,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan","Z-0123-2015","Class II","The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.","Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.",,"618 units","Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.",10/7/2014,"10/07/2014",10/29/2014,"10/29/2014"
"Food",69355,"Ongoing","Whole Herb Company","Sonoma","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Nevada, and Canada.","F-0077-2015","Class I","Nettle Leaf powder Gross Wt: 55.5 Lbs. Net Wt: 55.0 Lbs. This material is being sold for further processing, and for Manufacturing use only. Distributed by Whole Herb Company","UPC: 010020559358 Item No: NET17000 Lot No: 319349HT",,"660 Lbs.","The product was tested and found to be positive for Salmonella.",9/24/2014,"09/24/2014",10/29/2014,"10/29/2014"
"Devices",69357,"Ongoing","Primus Medical LLC","Boardman","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, GA, IL, IN, KS, KY, MA, MN,MS, NC, NM, NV, NY, OH, PA, TN, TX, and VA, and the country of Canada.","Z-0067-2015","Class II","AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.","PCB900 manufactured between 09/13/2010 and 05/22/2012",".","1726","Firm received several complaints that the head deck actuator bracket had separated from the bed frame.",9/15/2014,"09/15/2014",10/22/2014,"10/22/2014"
"Food",69358,"Terminated","Whole Food Market","Cambridge","MA","US","Voluntary: Firm Initiated","Letter","MA","F-0590-2015","Class I","Whole Foods Market Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base","Sell By September 19-30, 2014",".","14 units","Product contains undeclared pecans",9/26/2014,"09/26/2014",12/2/2014,"12/02/2014"
"Drugs",69359,"Ongoing","Valeant Pharmaceuticals International","Bridgewater","NJ","US",,"Letter","Nationwide and Puerto Rico","D-0026-2015","Class III","Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15","Lot number 13052B, Exp. 03/2015, NDC16781-382-15",".","1663 tubes","Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point",10/2/2014,"10/02/2014",10/22/2014,"10/22/2014"
"Drugs",69359,"Ongoing","Valeant Pharmaceuticals International","Bridgewater","NJ","US",,"Letter","Nationwide and Puerto Rico","D-0025-2015","Class III","Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15","Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15",".","34,218 tubes","Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point",10/2/2014,"10/02/2014",10/22/2014,"10/22/2014"
"Devices",69360,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.","Z-0058-2015","Class II","Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.","Catalog Number: 110010851 Lot Number: 139800, 139810, 139820",,"164 units","An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.",9/26/2014,"09/26/2014",10/15/2014,"10/15/2014"
"Devices",69360,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.","Z-0057-2015","Class II","Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.","Catalog Number: 110010850 Lot Number: 231120, 253210",,"12 units","An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.",9/26/2014,"09/26/2014",10/15/2014,"10/15/2014"
"Devices",69360,"Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.","Z-0056-2015","Class II","Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.","Catalog Number: 110010849 Lot Number: 169620, 253190",,"15 units","An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.",9/26/2014,"09/26/2014",10/15/2014,"10/15/2014"
"Veterinary",69361,"Ongoing","Virbac AH, Inc","Fort Worth","TX","US","Voluntary: Firm Initiated","Letter","Product was distributed to: CA, FL, IA, IN, MI, MO, MS, OK, PA, SD, TN, TX, WI, and Puerto Rico.","V-168-2015","Class III","Clindamycin hydrochloride oral liquid, 25 mg per mL, in 20-ml. plastic bottles, RX, ANDA #200-291, packaged under the following labels: (1) Virbac Animal Health Clinsol Liquid, NDC 051311-500-25, Mfd. by Virbac AH, Inc., Fort Worth, TX; and (2) VEDCO ClindaCure, NDC 050989-495-09, Mfd. for VEDCO, Inc., St. Joseph, MO.","(1) Lot numbers for Clindacure: 130158, 130528, 130840, 130748, 131107, 131353, 131404, 140117, 140229, and 140531; and (2) Lot numbers for Clinsol: 130278, 131107, and 140276.",,"253,020 bottles","Failing stability specifications at the 18 month time point.",9/30/2014,"09/30/2014",11/12/2014,"11/12/2014"
"Biologics",69362,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0102-15","Class II","Platelets Pheresis Leukocytes Reduced","W115114183952I-part 1; W115114183952I-part 2 ",".","2 units","Blood products, associated with a unit of platelets with an unacceptable pH, were distributed.",8/25/2014,"08/25/2014",12/10/2014,"12/10/2014"
"Biologics",69363,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0074-15","Class II","Red Blood Cells","W038111397516; ",".","1 unit","Blood products, collected from a donor who disclosed history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.",7/23/2014,"07/23/2014",11/19/2014,"11/19/2014"
"Biologics",69363,"Terminated","OneBlood, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0075-15","Class II","Blood and Blood Products for Reprocessing","W038111397516; ",".","1 unit","Blood products, collected from a donor who disclosed history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.",7/23/2014,"07/23/2014",11/19/2014,"11/19/2014"
"Biologics",69364,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Alabama; Tennessee","B-0106-15","Class II","Red Blood Cells, Leukocytes Reduced ","W201914035032",".","1 unit","Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. ",4/9/2014,"04/09/2014",11/5/2014,"11/05/2014"
"Biologics",69364,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Alabama; Tennessee","B-0105-15","Class II","Plasma Frozen within 24 hours (FP24)","W201914021707; W201914021719; W201914021722; W201914005852; W201914028571; W201914037029; W201914021999; W201914021346; W201914021332; W201914005771; W201914028504; W201914028506; W201914028510; ",".","13 units","Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. ",4/9/2014,"04/09/2014",11/5/2014,"11/05/2014"
"Biologics",69364,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Alabama; Tennessee","B-0104-15","Class II","Red Blood Cells Leukocytes Reduced","W201914028514; W201914021701; W201914021706; W201914021709; W201914021713; W201914021719; W201914021726; W201914021732; W201914005843; W201914005847; W201914005852; W201914028550; W201914028567; W201914028571; W201914028577; W201914028592; W201914028598; W201914006447; W201914022000; W201914035002; W201914035003; W201914037086; W201914037092; W201914006483; W201914006489; W201914006493; W201914006494; W201914021309; W201914021311; W201914021313; W201914021315; W201914021318; W201914021320; W201914021324; W201914021327; W201914021328; W201914021332; W201914021335; W201914021337; W201914021339; W201914021340; W201914021342; W201914021347; W201914021351; W201914021360; W201914021362; W201914021367; W201914021373; W201914021377; W201914021378; W201914021382; W201914021384; W201914021387; W201914021391; W201914021392; W201914021394; W201914021395; W201914021396; W201914021401; W201914021403; W201914021407; W201914021409; W201914021638; W201914021642; W201914021645; W201914021648; W201914021651; W201914021654; W201914005759; W201914005762; W201914005771; W201914005774; W201914005775; W201914021483; W201914021487; W201914021491; W201914021492; W201914021497; W201914021498; W201914021500; W201914028504; W201914028506; W201914021490; W201914028507; W201914028510; W201914028513; ",".","86 units","Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. ",4/9/2014,"04/09/2014",11/5/2014,"11/05/2014"
"Biologics",69364,"Terminated","American Red Cross Blood Services Tennessee Valley Region","Nashville","TN","US","Voluntary: Firm Initiated","Telephone","Kentucky; Alabama; Tennessee","B-0103-15","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W201914005768; ",".","1 unit","Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. ",4/9/2014,"04/09/2014",11/5/2014,"11/05/2014"
"Devices",69366,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.","Z-0423-2015","Class II","Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. ","Item 00-5953-056-00; all lots",".","1165 units","To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Devices",69366,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.","Z-0424-2015","Class II","Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. ","Item 00-5953-056-06; all lots",".","4961 units","To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Devices",69367,"Ongoing","Roscoe Medical Inc","Strongsville","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.","Z-0204-2015","Class II","Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)","30194, Roscoe Transport Rollator, Blue 30192, Roscoe Transport Rollator, Burgundy MH140401502-MH140401890 MH140500217-MH140500466 MH140406602-MH140406891 MH140407092-MH140407291 ",".","831 units","The caster may separate completely from the device frame causing injury to user.",10/1/2014,"10/01/2014",11/19/2014,"11/19/2014"
"Devices",69368,"Ongoing","KCI USA, Inc.","San Antonio","TX","US","Voluntary: Firm Initiated","Letter","The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.","Z-0070-2015","Class II","V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only. ","Lot Number 50775911",".","1090 pouches (109 boxes)","A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.",9/18/2014,"09/18/2014",10/22/2014,"10/22/2014"
"Devices",69369,"Ongoing","Tecan US, Inc.","Morrisville","NC","US","Voluntary: Firm Initiated","Telephone","US Distribution to IL.","Z-0149-2015","Class II","Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.","Part Number: 10641100, SN: 1407006311.",".","2 units","Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.",9/26/2014,"09/26/2014",11/5/2014,"11/05/2014"
"Drugs",69370,"Ongoing","Sun Pharma Global Inc.","Dubai",,"AE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-0236-2015","Class II","Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India","Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015",,"68194","Failed Dissolution Specification; 12 month stability timepoint",9/26/2014,"09/26/2014",11/12/2014,"11/12/2014"
"Devices",69371,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: NY, VA, and MA.","Z-0086-2015","Class II","Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.","material #10140000, with serial numbers: 5018 3849 5042 ",,"3","The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already inserted, it could lead to an unintentional patient injury.",9/18/2014,"09/18/2014",10/29/2014,"10/29/2014"
"Devices",69372,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay","Z-0148-2015","Class II","siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.","lot FA5154, exp. 2015-06-03",".","1733","Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.",9/24/2014,"09/24/2014",11/5/2014,"11/05/2014"
"Devices",69373,"Ongoing","C P Medical, Inc.","Portland","OR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA","Z-0140-2015","Class II","Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.","Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06. ",".","74 boxes /12 sutures per box; plus an additional 13 sutures","CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.",9/22/2014,"09/22/2014",11/5/2014,"11/05/2014"
"Veterinary",69374,"Ongoing","Jakks Pacific Inc","Malibu","CA","US","Voluntary: Firm Initiated","Letter","AZ","V-166-2015","Class III","Kong Jumbo Aussie Sticks Beef 1 Chew, UPC 0 39897 75559 5","Item No. 75559",".","17,569 units","JAKKS Pacific is recalling Kong Brand Rawhide products because they may be contaminated with mold.",9/19/2014,"09/19/2014",10/22/2014,"10/22/2014"
"Veterinary",69374,"Ongoing","Jakks Pacific Inc","Malibu","CA","US","Voluntary: Firm Initiated","Letter","AZ","V-167-2015","Class III","Kong Jumbo Aussie Sticks Lamb 1 Chew, UPC 0 39897 75560 1","Item No. 75560 ",".","8,336 units","JAKKS Pacific is recalling Kong Brand Rawhide products because they may be contaminated with mold.",9/19/2014,"09/19/2014",10/22/2014,"10/22/2014"
"Biologics",69375,"Terminated","Atlanta Blood Services","Atlanta","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0085-15","Class II","Platelets Pheresis Leukocytes Reduced","W311214001571; ",,"1 unit","Plateletpheresis product, for which leukoreduction specifications were not met, was distributed.",8/6/2014,"08/06/2014",10/29/2014,"10/29/2014"
"Biologics",69376,"Terminated","Atlanta Blood Services","Atlanta","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0080-15","Class II","Platelets Pheresis Leukocytes Reduced","W311214001607; ",,"1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed",8/11/2014,"08/11/2014",11/12/2014,"11/12/2014"
"Devices",69377,"Ongoing","Mckesson Information Solutions LLC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.","Z-0042-2015","Class II","McKesson Cardiology'' Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.","McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.",,"272 devices","Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.",8/27/2014,"08/27/2014",10/15/2014,"10/15/2014"
"Devices",69379,"Ongoing","Straumann USA, LLC","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: FL and MA.","Z-0117-2015","Class II","Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.","Lot number: GY030 Exp. 2019-04",,"6 units","Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)",9/19/2014,"09/19/2014",10/29/2014,"10/29/2014"
"Devices",69380,"Ongoing","Mckesson Information Solutions LLC","Alpharetta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.","Z-0093-2015","Class II","McKesson Cardiology Hemo. McKesson Cardiology'' Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.","McKesson Cardiology TM Hemo versions: 11.0HF5, 11.1, 11.1SP5, 11.1SP6, 11.1SP6HF1, 11.1SP6HF3, 12SP1, 12.1, 12.1HF1, 12.1HF2, 12.2, 12.2HF1, 12.2HF2, 12.2HF3, 12.2HF4.",,"625 devices","McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 HF4 and earlier versions of the McKesson Cardiology Hemo user guides.",6/25/2014,"06/25/2014",10/29/2014,"10/29/2014"
"Food",69381,"Ongoing","Ikea North America Srvcs Inc","Conshohocken","PA","US","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN,NC, NJ, NY, OH, OR, PA, TX, UT, WA","F-0087-2015","Class II","Elk shaped pasta Ekologiska PASTA-ALGAR Pasta elks, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FOR: IKEA FOOD SERVICES","all date/product codes UPC 001.124.32.xxx",".","15,635 retail units","Pasta-Algar and Pasta-Algar Fullkorn are recalled due to undeclared soy.",9/30/2014,"09/30/2014",11/5/2014,"11/05/2014"
"Food",69381,"Ongoing","Ikea North America Srvcs Inc","Conshohocken","PA","US","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN,NC, NJ, NY, OH, OR, PA, TX, UT, WA","F-0088-2015","Class II","Elk shaped pasta Ekologiska PASTA-ALGAR FULLKORN Pasta elks wholemeal, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FOR: IKEA FOOD SERVICES","All date/product codes UPC 201.396.14.xxx",".","22,025 retail units","Pasta-Algar and Pasta-Algar Fullkorn are recalled due to undeclared soy.",9/30/2014,"09/30/2014",11/5/2014,"11/05/2014"
"Devices",69382,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.","Z-0173-2015","Class II","Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife'' Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.","Part Number 7222-120-000; All lot numbers from 13072 to 14121",,"3,138 in total","The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.",10/8/2014,"10/08/2014",11/12/2014,"11/12/2014"
"Devices",69382,"Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.","Z-0172-2015","Class II","Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife'' Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.","Part Number 7126-120-000; All lot numbers from 13027 to 14093",,"3,138 in total","The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.",10/8/2014,"10/08/2014",11/12/2014,"11/12/2014"
"Food",69383,"Ongoing","Anova Food, Llc","Tampa","FL","US","Voluntary: Firm Initiated","Letter","FL, IL, GA, SC, MN, and NC Canada","F-0030-2015","Class I","Wild Caught Seared Ahi Tuna Seasoned with Cracked Black Pepper and Garlic, manufactured by Lagniappe Louisiana Foods, Inc.-Instructions say to keep frozen.","UPC: 53849 09183",".","6,475 cases","Possible contamination with Listeria monocytogenes.",9/26/2014,"09/26/2014",10/22/2014,"10/22/2014"
"Biologics",69385,"Terminated","South Dakota Lions Eye Bank, Inc","Sioux Falls","SD","US","Voluntary: Firm Initiated","Letter","North Carolina","B-0113-15","Class II","Cornea","SD13315OD; ",,"1 cornea","Human Cornea, recovered from a donor whose donor eligibility determination failed to assure the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.",8/14/2014,"08/14/2014",11/12/2014,"11/12/2014"
"Devices",69386,"Ongoing","Dharma Research, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirats.","Z-0476-2015","Class II","Dharma Cavity Varnish 15mL","All Lots - Item # 14-00016",".","916","During an FDA inspection it was found that the products are marketed without a cleared 510k.",9/29/2014,"09/29/2014",12/2/2014,"12/02/2014"
"Devices",69386,"Ongoing","Dharma Research, Inc.","Miami","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirats.","Z-0475-2015","Class II","Dharma Cavity Varnish with Fluoride","All Lots - Item #14-00015",".","2,842","During an FDA inspection, it was found that the products are being marketed without a cleared 510k.",9/29/2014,"09/29/2014",12/2/2014,"12/02/2014"
"Drugs",69387,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-0015-2015","Class II","TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.","Lot #: MN9828, Expiry: Oct 2015.",".","14,568 Bottles","Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.",9/15/2014,"09/15/2014",10/22/2014,"10/22/2014"
"Drugs",69389,"Ongoing","Bracco Diagnostic Inc","Monroe Township","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0014-2015","Class III","E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01","Lot # F12C01; Exp. 02/15",,"58,050 packets","Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.",9/18/2014,"09/18/2014",10/15/2014,"10/15/2014"
"Food",69390,"Ongoing","Multiple Organics, Inc.","Hercules","CA","US","Voluntary: Firm Initiated","E-Mail","U.S. Distribution. No Foreign.","F-0059-2015","Class II","Outer Carton labeled in part as: Multiple Organics Certified 100% Organic Mango Fillets Net Weight 20 Lbs. (9.07 kgs) In 5 X 4 Lb. bags Product of Mexico Certified Organic by QAI www.multipleorganics.com USDA Organic Inner plastic bag labeled in part as: Organic Mango Filets Net Weight 5Lbs (2.26 kgs) Product of Mexico Certified Organic by QAI www.multipleorganics.com 209 Linus Pauling Dr., Hercules, CA 94547","Organic lot #s 12030614, 12180614, 12100614, 12230614 Dates of production are 6/3/2014, 6/18/2014, 6/10/2014 and 6/23/2014 Item Code 2-MA-20-24073 No UPC codes",,"687 / 20 Lb. cartons","Firm was notified that the product may contain fragments of metal that if ingested, may be injurious to human health. Firm has not been able to independently verify the reports, but believes it prudent to take this action.",9/30/2014,"09/30/2014",10/29/2014,"10/29/2014"
"Food",69391,"Ongoing","Family Food Distributors, Inc.","Kearny","NJ","US","Voluntary: Firm Initiated","Letter","CT, IL, MD, NJ, NY, & PA","F-0465-2015","Class II","Mama Tere Arepa de Blanca de Maiz White Corn Patty 14.1 oz/400g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011676","None.",,,"Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled.",8/26/2014,"08/26/2014",11/12/2014,"11/12/2014"
"Food",69391,"Ongoing","Family Food Distributors, Inc.","Kearny","NJ","US","Voluntary: Firm Initiated","Letter","CT, IL, MD, NJ, NY, & PA","F-0466-2015","Class II","Mama Tere Arepa de Moto Hominy Patty 14.1 oz / 400 g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011652","None.",,,"Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled.",8/26/2014,"08/26/2014",11/12/2014,"11/12/2014"
"Food",69391,"Ongoing","Family Food Distributors, Inc.","Kearny","NJ","US","Voluntary: Firm Initiated","Letter","CT, IL, MD, NJ, NY, & PA","F-0464-2015","Class II","Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032 ","None.",,,"Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled.",8/26/2014,"08/26/2014",11/12/2014,"11/12/2014"
"Devices",69392,"Ongoing","Zimmer Dental Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.","Z-0153-2015","Class II","Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.","Lot No. 61792330",".","1,044 units","Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69392,"Ongoing","Zimmer Dental Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.","Z-0154-2015","Class II","Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth ","Lot No. 62659204, 62658448",".","1,044 units","Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69394,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.","Z-0500-2015","Class II","Amerigel Saturated Gauze Dressing Wound management","Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180",".","21,108","Formulation deviation",9/26/2014,"09/26/2014",12/10/2014,"12/10/2014"
"Devices",69394,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.","Z-0498-2015","Class II","Amerigel Post-op Surgical Kits Wound management","Model # A2002, Lot #s: JCA0086, JCA0087, JCA0088, JCA0089, JCA0090, JCA0091, JCA0092, JCA0093, JCA0094, JCA0095, JCA0096, JCA0097, JCA0098, JCA0099, JCA0100, JCA0101, JCA0102, JCA0103, JCA0104, JCA0105, JCA0106",".","79,677","Formulation deviation",9/26/2014,"09/26/2014",12/10/2014,"12/10/2014"
"Devices",69394,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.","Z-0497-2015","Class II","Amerigel Hydrogel Wound Dressing Wound management","Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05",".","340,896","Formulation deviation",9/26/2014,"09/26/2014",12/10/2014,"12/10/2014"
"Devices",69394,"Ongoing","Amerx Health Care Corp.","Clearwater","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.","Z-0499-2015","Class II","Amerigel Daily Dressing Packets Wound management","Model # A2003, Lot #s: 2WD07",".","1740","Formulation deviation",9/26/2014,"09/26/2014",12/10/2014,"12/10/2014"
"Devices",69395,"Ongoing","Sam Medical Products","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Worldwide Distribution: US (nationwide) in states of Ohio, Oregon, New Mexico, North Carolina, Texas and to the following countries: Australia, Canada, Hong Kong, Iceland, Japan, Lebanon, Singapore, Thailand, and United Kingdom.","Z-0133-2015","Class II","SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture. ","SJT 112 Lot number (represented as date codes): 6/5/14; SJT 102 Lot numbers (represented as date codes): 3/29/2013, 5/15/2013, 6/11/2013, 7/16/2013, 8/27/2013, 9/3/2013, 9/10/2013, 11/4/2013, 12/9/2013, 12/11/2013, 1/10/2014, 1/30/2014, 2/25/2014, 3/4/2014, 3/5/2014, 3/19/2014, 3/21/2014, 3/24/2014, 3/31/2014, 4/1/2014, 4/2/2014, 4/4/2014, 4/7/2014, 4/9/2014, 4/11/2014, 4/22/2014, 4/28/2014, 4/29/2014, 5/5/2014, and 6/12/2014. ",".","total 3633 units (3342 units in US and 291 units Outside US)","SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.",8/14/2014,"08/14/2014",11/5/2014,"11/05/2014"
"Food",69396,"Ongoing","Tropical Valley Foods, Inc.","Plattsburgh","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Iowa, California, Colorado, Florida, Maryland, Massachusetts, New York, Ohio, Texas, Vermont, Virginia, Canada and Japan","F-0046-2015","Class II","next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901","Lot 460013; Best by: 2016.03.31 (on back label)",,"615 cases (12 - 3 oz. bags per case) ","Next by Nature brand Dark Chocolate Cherries Lot 460013 may contain undeclared peanuts (from bulk product).",9/26/2014,"09/26/2014",10/29/2014,"10/29/2014"
"Devices",69397,"Ongoing","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.","Z-0198-2015","Class II"," Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only. ","Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790",".","138 units","Cleaning process validation failure.",10/9/2014,"10/09/2014",11/19/2014,"11/19/2014"
"Food",69398,"Ongoing","Markpol Distributors Inc.","Schiller Park","IL","US","Voluntary: Firm Initiated","Letter","***US: Nationwide (IL, NJ, NY, CT)","F-0041-2015","Class I","Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of the packaging. Sold to retail locations with 16 packages per case.","Lot Number: 149/MA/8 and 149/JP/3 Expiration Date: 05/29/2015 UPC Code: 5 906747 171742",,"235 cases (16-31.oz packages/case)","This voluntary recall has been initiated because the Kupiec Rice Cakes with Dark Chocolate may contain undeclared milk.",10/1/2014,"10/01/2014",10/29/2014,"10/29/2014"
"Devices",69400,"Ongoing","Joerns Healthcare","Arlington","TX","US","Voluntary: Firm Initiated","Letter","US Nationwide Distirbution and Canada","Z-0151-2015","Class II","Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. ","901172875, 901173369-901173393, 901173395, 901173417, 901173422-901173423, 901173443-901173447, 901173558-901173560, 901173762-901173776, 901173854-901173857, 901173860-901173861, 901173914, 901174007-901174013, 901174014-901174015, 901174027-901174029, 901174031, 901174033-901174058, 901174162, 901174251-901174302, 901174319-901174320, 901174323, 901174331, 901174342-901174385, 901174389, 901174412-901174426, 901174429-901174430, 901174491-901174521, 901174531-901174541, 901174710-901174716, 901174845, 901174850-901174892, 901174895-901174896, 901174898-901174899, 901174980-901175087, 901175089-901175095, 901175098-901175117, 901175120, 901175123-901175130, 901175185-901175196, 901175202-901175217, 901175225-901175229, 901175246-901175249, 901175341-901175347, 901175359-901175378, 901175380-901175381, 901175383-901175385, 901175387-901175388, 901175392-901175501, 901175513-901175514, 901175533-901175543, 901175549-901175550, 901175553-901175555, 901175571-901175646, 901175688-901175717, 901175719-901175740, 901175745-901175768, 901175792-901175827, 901175988-901175998, 901176002-901176006, 901176008-901176014, 901176033-901176056, 901176059-901176060, 901176065-901176185, 901176187-901176188, 901176190-901176205, 901176223-901176226, 901176230, 901176243-901176254, 901176265-901176281, 901176292-901176311, 901176314-901176316, 901176318-901176323, 901176326-901176331, 901176333-901176340, 901176343, 901176352-901176362, 901176365-901176366, 901176370-901176371, 901176374-901176379, 901176383-901176387, 901176397-901176401, 901176419-901176420, 901176431-901176440, 901176451-901176463, 901176493, 901176495-901176505, 901176513-901176585, 901176644-901176772, 901176317, 901780437-901780453, 901780458-901780460, 901780462-901780574, 901780596-901780722, 901780726-901780735, 901780738-901780744, 901780746-901780756, 901780874-901780910, 901781000-901781435, 901781556-901781570, 901781577-901781610, 901781616-901781625, 901781634-901781684, 901781688-901781726, 901781732-901781733, 901781751-901781766, 901781780-9",".","3135","The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal.",9/24/2014,"09/24/2014",11/5/2014,"11/05/2014"
"Biologics",69401,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0081-15","Class II","Red Blood Cells Leukocytes Reduced","W035214063997F; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2014,"08/27/2014",11/12/2014,"11/12/2014"
"Biologics",69401,"Terminated","Carter BloodCare","Bedford","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0082-15","Class III","Fresh Frozen Plasma","W035214063997F; ",,"1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/27/2014,"08/27/2014",11/12/2014,"11/12/2014"
"Biologics",69402,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","E-Mail","Arkansas; California","B-0117-15","Class III","Blood and Blood Products for Reprocessing","003GY55671; 003GR09579; W200314023944; ",".","3 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/13/2014,"08/13/2014",11/19/2014,"11/19/2014"
"Biologics",69402,"Terminated","The American National Red Cross - Southern Region","Douglasville","GA","US","Voluntary: Firm Initiated","E-Mail","Arkansas; California","B-0116-15","Class II","Cryoprecipitated AHF","W200314023944; ",".","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.",8/13/2014,"08/13/2014",11/19/2014,"11/19/2014"
"Biologics",69403,"Terminated","Atlanta Blood Services","Atlanta","GA","US","Voluntary: Firm Initiated","Telephone","Georgia","B-0086-15","Class III","Platelets Pheresis Leukocytes Reduced","W311214001033; W311214001038; W311214001031; W311214001031; W311214001034; W311214001035; W311214001035; W311214001033; ",".","8 units","Blood products, in which Viral Testing/Testing performed, interpreted, or documented incorrectly, were distributed.",6/2/2014,"06/02/2014",11/19/2014,"11/19/2014"
"Devices",69404,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY and TX.","Z-0051-2015","Class II","StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457","Material/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258",,"33 units","Product is not cleared for use with lasers other than the Auriga XL system",9/30/2014,"09/30/2014",10/15/2014,"10/15/2014"
"Devices",69404,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY and TX.","Z-0049-2015","Class II","StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453","Material/Part Number: 6453 Batch Code: 2011-00238",,"5 units","Product is not cleared for use with lasers other than the Auriga XL system",9/30/2014,"09/30/2014",10/15/2014,"10/15/2014"
"Devices",69404,"Ongoing","Boston Scientific Corporation","Marlborough","MA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY and TX.","Z-0050-2015","Class II","StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455","Material/Part Number: 6455 Batch Code: 2012-00268, 2013-00443",,"7 units","Product is not cleared for use with lasers other than the Auriga XL system",9/30/2014,"09/30/2014",10/15/2014,"10/15/2014"
"Drugs",69405,"Ongoing","Avella of Deer Valley, Inc.","Phoenix","AZ","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-0016-2014","Class II","HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.","Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15 ",".","197 vials","Crystallization: Formation of crystals observed in product.",10/1/2014,"10/01/2014",10/22/2014,"10/22/2014"
"Devices",69406,"Ongoing","Merge Healthcare, Inc.","Hartland","WI","US","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.","Z-0143-2015","Class II","Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV. ","Merge Hemo 9.x with Nellcor SpO2",".","52","It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.",9/29/2014,"09/29/2014",11/5/2014,"11/05/2014"
"Food",69407,"Ongoing","Heather's Choice","Anchorage ","AK","US","Voluntary: Firm Initiated","E-Mail","sold interstate via internet sale from the website: http://www.heatherschoice.com","F-0098-2015","Class II","Rancheros, sold under brand Heather's Choice. The product is labeled in parts: ''***Rancheros***HEATHER'S CHOICE***meals for adventuring***ingredients: bison + yams + tomatoes + onions + tomatillos + garlic + jalapenos + green bell peppers***directions: cover food with hot water + let sit for 15 minutes***''.","Expiration date: September 2015",".","12 units","Heather's Choice Rancheros is being recalled because the firm operated without a permit and lack a HACCP plan.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Food",69407,"Ongoing","Heather's Choice","Anchorage ","AK","US","Voluntary: Firm Initiated","E-Mail","sold interstate via internet sale from the website: http://www.heatherschoice.com","F-0097-2015","Class II","Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: ''***Salmon Chowder***HEATHER'S CHOICE***meals for adventuring***ingredients: salmon + peas + carrots + potatoes+ coconut milk powder***directions: cover food with hot water + let sit for 15 minutes***''.","Expiration date: September 2015",".","13 units","Heather's Choice Salmon Chowder is being recalled because the firm operated without a permit and lack a HACCP plan. This product also contains undeclared coconut.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69408,"Ongoing","Smiths Medical ASD, Inc.","Saint Paul","MN","US","Voluntary: Firm Initiated","Visit","US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.","Z-0166-2015","Class II","CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher). ","Lot Number 2752712",,"24","Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.",9/29/2014,"09/29/2014",11/12/2014,"11/12/2014"
"Devices",69409,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.","Z-0052-2015","Class II","ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. ","Lot Numbers: 1614, 1814, 1914",,"237 cases (6/case)","Product sterility is not assured",9/16/2014,"09/16/2014",10/15/2014,"10/15/2014"
"Devices",69409,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.","Z-0053-2015","Class II","ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. ","Lot Numbers: 1614, 1814",,"18 singles","Product sterility is not assured",9/16/2014,"09/16/2014",10/15/2014,"10/15/2014"
"Devices",69409,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.","Z-0055-2015","Class II","ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. ","Lot Numbers: 1614, 1914, 2114",,"41 singles","Product sterility is not assured",9/16/2014,"09/16/2014",10/15/2014,"10/15/2014"
"Devices",69409,"Ongoing","Bio-Detek, Inc.","Pawtucket","RI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.","Z-0054-2015","Class II","ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. ","Lot Numbers: 1614, 1914, 2114",,"193 cases (6/case)","Product sterility is not assured",9/16/2014,"09/16/2014",10/15/2014,"10/15/2014"
"Food",69410,"Ongoing","Oro Candy Distributors","Orocovis","PR","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed by the firm to retailers","F-0496-2015","Class II","***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g)","All lots packed on 09/26/2014",".","11 carton cases / 30 units each","Undeclared color additives (FD&C yellow 5 & 6 and FD&C Red 40)",9/29/2014,"09/29/2014",11/19/2014,"11/19/2014"
"Drugs",69411,"Ongoing","Gilead Sciences, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","United States, Puerto Rico, Fiji.","D-0045-2015","Class II","Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.","FG Lot Number: HDNTD1 and HDNTD exp 30-Jun-15, KCMGD and KCMGD1 exp 31-Oct-15, KYGHA, KYGKA and KYGKK exp 30-Apr-16, MZVBA and MZTZA exp 31-Oct-16",".","6,290 bottles","Defective Container; leaking around the cap",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69412,"Ongoing","Coloplast Manufacturing US, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.","Z-0155-2015","Class II","Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.","Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.",".","217,540","Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.",9/29/2014,"09/29/2014",11/5/2014,"11/05/2014"
"Drugs",69413,"Ongoing","Taro Pharmaceuticals U.S.A., Inc.","Hawthorne","NY","US","Voluntary: Firm Initiated","Letter","IL, OH, LA","D-0049-2015","Class III","Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.","Lot 137393, exp. 10/2016",".","1,966 bottles ","Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval. ",10/21/2014,"10/21/2014",11/5/2014,"11/05/2014"
"Drugs",69414,"Ongoing","Gilead Sciences, Inc.","Foster City","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0013-2015","Class III","Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1 ","TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017",,"10,317 bottles","Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.",9/30/2014,"09/30/2014",10/15/2014,"10/15/2014"
"Biologics",69415,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","Virginia","B-0087-15","Class II","Red Blood Cells Leukocytes Reduced","W089813351081; ",,"1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.",3/27/2014,"03/27/2014",11/12/2014,"11/12/2014"
"Biologics",69416,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0083-15","Class II","Red Blood Cells","2137026; ",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/10/2014,"09/10/2014",11/12/2014,"11/12/2014"
"Biologics",69416,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0084-15","Class II","Cryoprecipitated AHF","2137026; ",,"1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.",9/10/2014,"09/10/2014",11/12/2014,"11/12/2014"
"Devices",69417,"Ongoing","Cook Medical Incorporated","Bloomington","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.","Z-0124-2015","Class II","Spirotome'' Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.","Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10; SS-10-15; SS-14-06; SS-14-10; SS-14-15. Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E. ",".","1239 units","MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products. Use of the affected products could create risk for non-sterile use or accidental puncture.",9/26/2014,"09/26/2014",11/5/2014,"11/05/2014"
"Devices",69418,"Ongoing","Signal Medical Corporation","Marysville","MI","US","Voluntary: Firm Initiated","Telephone","US Distribution in MO only.","Z-0109-2015","Class II","Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement. ","Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085 Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099 Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105 Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106",,"12 devices","Incorrect dimension on four liners was detected",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Devices",69420,"Ongoing","Signal Medical Corporation","Marysville","MI","US","Voluntary: Firm Initiated",,"Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.","Z-0111-2015","Class II","Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75). ","Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R",,"41","Packaging of a device was compromised",9/30/2014,"09/30/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0054-2015","Class III","FLYING BISCUIT, Oatmeal Pancake Batter #70002, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921","090314",,"484 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0050-2015","Class III","Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612","082814",,"1833 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0052-2015","Class III","Logan's Roadhouse Meatloaf Mix #25018, Keep Frozen, Net Weight: 40 Lbs. (20 - 2 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921","091914",,"380 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0055-2015","Class III","Ovation Brands Bead Pudding Base #67008, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921","091714",,"147 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0053-2015","Class III","PERKINS Meatloaf Mix #31607, Keep Frozen, Net Weight: 20.125 Lbs. (7 - 2.875 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921","091214",,"240 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69421,"Ongoing","Processed Foods, Inc.- Custom Foods","Knoxville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH GA, OK, NC, IN, TN, TX, SC, PA, KS","F-0051-2015","Class III","Golden Corral MEATLOAF MIX #18029, KEEP FROZEN, NET WEIGHT: 20 lbs (4 - 5 lb Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612","082814",,"561 units","Products contain eggs which were recalled due to susceptibility to premature spoilage.",9/23/2014,"09/23/2014",10/29/2014,"10/29/2014"
"Food",69423,"Ongoing","General Mills, Inc.","New Albany","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: OH, NY, ME, MA, CT, NJ, MD, PA, and IA International: None","F-0086-2015","Class II","Pillsbury refrigerated Biscuit Flaky Layers retail 4pk package. ","Pillsbury Biscuit Flaky Layers 4pk package Code Date: 19DEC2014NA",".","720 cases, 6 - 4pk / case ","Undeclared Milk ingredient on retail package. In error, individually wrapped packages of Pillsbury Biscuits Buttermilk were placed into Pillsbury Biscuit Flaky layers overwrap to make the 4pk. The individual packages of the product are labeled correctly however the overwrap is not the correct product.",9/26/2014,"09/26/2014",11/5/2014,"11/05/2014"
"Food",69423,"Ongoing","General Mills, Inc.","New Albany","IN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: OH, NY, ME, MA, CT, NJ, MD, PA, and IA International: None","F-0085-2015","Class II","Cases of refrigerated Pillsbury Biscuits Buttermilk 4pk. (6 - 4pk / case) ","Pillsbury Biscuits Buttermilk 4pk case Code Date: 19DEC2014NA ",".","720 cases, 6 - 4pk / case ","Undeclared Milk ingredient on retail package. In error, individually wrapped packages of Pillsbury Biscuits Buttermilk were placed into Pillsbury Biscuit Flaky layers overwrap to make the 4pk. The individual packages of the product are labeled correctly however the overwrap is not the correct product.",9/26/2014,"09/26/2014",11/5/2014,"11/05/2014"
"Devices",69424,"Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.","Z-0165-2015","Class II","UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.","89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946 222947 222948 222949 222950 222951 222952 222953 222955 222956 223077 223078 223079 223080 223081 223082 223083 223084 223085 223086 223199 223200 223201 223202 223203 223204 223205 223206 223207 223208 223209 223210 223401 223403 223404 223405 223406 223407 223408 223409 223410 223411 223730 223731 223732 223733 223734 223735 223736 223737 223738 223739 223804 224187 224188 224189 224190 224191 224192 224193 224194 224195 224196 224197 224198 224199 224200 224201 224202 224203 224204 224205 224206 224207 224208 224209 224210 224393 224394 224395 224396 224397 224398 224399 224400 224402 224625 224626 224627 224628 224629 224630 224631 224632 224633 224634 224635 224636 224637 224638 224639 224640 224641 224642 224643 224644 224645 224646 224647 224648 224815 224816 224819 224825 224997 224998 224999 225000 225001 225002 225003 225004 225005 225006 225007 225124 225125 225126 225127 225128 225129 225130 225131 225132 225133 225134 225135 225297 225298 225299 225301 225302 225303 225304 225305 225306 225307 225418 225419 225420 225421 225422 225423 225424 225425 225426 225427 225428 225429 225530 225531 225532 225533 225534 225535 225536 225537 225538 225539 225540 225554 225555 225556 225557 225558 225559 225560 225561 225563 225564 225565 225566 225567 225568 225569 225570 225571 225572 225573 225574 225575 225576 225577 226491 226492 226493 226494 226495 226496 226497 226498 226499 226500 226501 226502 226504 226511 226512 226513 226514 226515 226516 226517 226518 226519 226520 226521 226522 226523 226524 226525 226526 226527 226528 226529 226530 226531 226532 226533 226534 226535 226536 226537 226538 226539 226540 226541 226542 226543 226544 226545 226546 226547 226548 226549 226550 227582 227590 227594 227811 227820 227821 227822 227823 227824 227825 227826 227827 227828 2",,"828","Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Devices",69425,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OR, PA, RI, SC, TX, TN, UT, VA, WA and WV, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Mexico, Morocco, Netherland, Norway, Poland, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.","Z-0152-2015","Class II","Laksell Gamma Knife Perfexion","Serial No. 6052, 6144, 6088, 6122, 6158, 6005, 6028, 6097, 6153, 6064, 6081, 6103, 6120, 6143, 6145, 6213, 6215, 6076, 6070, 6136, 6002, 6090, 6131, 6063, 6160, 6077, 6018, 6031, 6040, 6105, 6121, 6013, 6026, 6038, 6050, 6089, 6042, 6055, 6058, 6071, 6080, 6087, 6091, 6096, 9098, 6106, 6108, 6109, 6116, 6118, 6125, 6132, 6133, 6142, 6148, 6149, 6161, 6162, 6175, 6181, 6183, 6198, 6205, 6206, 6163, 6169, 6033, 6041, 6046, 6068, 6113, 6019, 6067, 6110, 6104, 6043, 6044, 6062, 6085, 6086, 6101, 6111, 6123, 6126, 6157, 6177, 6178, 6024, 6069, 6094, 6007, 6075, 6182, 6065, 6159, 6199, 6003, 6017, 6027, 6039, 6112, 6146, 6194, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6053, 6054, 6056, 6057, 6060, 6061, 6066, 6072, 6073, 6074, 6078, 6079, 6082, 6083, 6084, 6092, 6093, 6095, 6099, 6100, 6102, 6107, 6114, 6115, 6117, 6119, 6124, 6127, 6128, 6129, 6130, 6134, 6135, 6139, 6141, 6150, 6151, 6165, 6167, 6171, 6172, 6173, 6176, 6179, 6180, 6184, 6185, 6191, 6192, 6200, 6203, 6207, 6211",".","181","Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Devices",69426,"Ongoing","Trumpf Medical Systems, Inc.","Charleston","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.","Z-0141-2015","Class II","TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.","TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.",".","184 units","Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.",10/9/2014,"10/09/2014",11/5/2014,"11/05/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0037-2015","Class II","Bumble Bee Jalapeno Albacore Tuna with Jalapeno & Olive Oil, Net Wt. 2.5oz, UPC 5763800428","All ''Best By'' dates ",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0031-2015","Class II","Bumble Bee Premium Albacore Tuna in Water, Net Wt. 2.5oz, UPC 8660024011, 8660024031, 5763800424. Bumble Bee Premium Albacore Tuna In Water, Net Wt. 5oz, UPC 8660024016; UPC 8660024051, 5763800425. ","UPC: 8660024011, 8660024016, 8660024031, 8660024051: ''Best By'' dates: March 2017 to September 2017. UPC: 5763800424, 5763800425: All ''Best By'' dates",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0038-2015","Class II","Bumble Bee Chipotle Albacore Tuna with Chipotle & Olive Oil, Net Wt. 2.5oz, UPC 5763800429.","All ''Best By'' dates ",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0033-2015","Class II","Bumble Bee Prime Fillet Albacore Tuna with Sundried Tomatoes and Olive Oil, Net Wt. 2.5oz, UPC 8660024013","Best By dates: March 2017 to September 2017",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0032-2015","Class II","Bumble Bee Prime Fillet Albacore Tuna with Jalapenos and Olive Oil, Net Wt. 2.5 oz, UPC 8660024012","Best By dates: March 2017 to September 2017",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0036-2015","Class II","Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 2.5oz, UPC 5763800426. Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 5oz, UPC 5763800427.","All ''Best By'' dates",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0035-2015","Class II","Bumble Bee Prime Fillet Omega-3 Albacore Tuna with Omega 3 Tuna Oil, Net Wt. 2.5oz, UPC 8660024191","Best By dates: March 2017 to September 2017",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0039-2015","Class II","Bumble Bee Sun Dried Tomato with Sun Dried Tomatoes & Olive Oil, Net Wt. 2.5oz, UPC 5763800430.","All ''Best By'' dates ",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Food",69427,"Ongoing","Bumble Bee Foods LLC","San Diego","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0034-2015","Class II","Bumble Bee Prime Fillet Albacore Tuna with Chipotle and Olive Oil, Net Wt. 2.5oz, UPC 8660024014","Best By dates: March 2017 to September 2017",".","188,185 cases total","Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.",10/6/2014,"10/06/2014",10/22/2014,"10/22/2014"
"Biologics",69428,"Terminated","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","Letter","North Carolina; Alabama; Colorado; Michigan; Georgia","B-0071-15","Class I","Bone","123437108; 123437112; 123437120; 123437121; 123437122; 123437123; 123437124; 123437125; 123437127; 123437128; ",".","10 bone allografts ","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.",9/8/2014,"09/08/2014",12/2/2014,"12/02/2014"
"Biologics",69429,"Terminated","CSL Plasma, Inc.","Brownsville","TX","US","Voluntary: Firm Initiated","Other","Switzerland","B-0088-15","Class III","Source Plasma","11400430805; 11400324797; 11400292270; 11400341255; 11400312500; 11400347024; ",".","6 units","Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.",7/3/2014,"07/03/2014",12/2/2014,"12/02/2014"
"Devices",69430,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Unit.Arab Emir., Vatican, Yemen, AR, AU, BD, BR, CA , CH, CL, CN, CO, DO, EC, EG, GT, HK, ID, IE, IL, IN, JP, KR, LY, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VN, ZA","Z-0164-2015","Class II","Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)","26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39",,"Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)","Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.",9/26/2014,"09/26/2014",11/12/2014,"11/12/2014"
"Cosmetics",69431,"Ongoing","Nutek Disposables, Inc.","Mc Elhattan","PA","US","Voluntary: Firm Initiated","Telephone","nationwide and internationally to Mexico, Canada, and China.","F-0575-2015","Class II","All lots of non-medicated, scented, unscented, and sensitive varieties of baby wipes, packaged in 14 count to 1000 count sizes of plastic flow wrap soft packs, refill, trial, and plastic tubs, labeled as: Kidgets Baby Wipes, Distributed by Family Dollar, Charlotte, NC 28201; Walgreen's Well Beginnings Baby Wipes, Distributed by Walgreens, Deerfield, IL.; Member's Mark Baby Wipes, Distributed by Walmart de Mexico, Ciudad De Mexico, Mexico; Simply Right Baby Care Wipes, Distributed by Sam's Club, Bentonville, AR; Cuties Premium Baby Wipes Distributed by First Quality, Great Neck, NY, Manufactured by First Quality Products, Inc., McElhattan, PA; Tender Touch Baby Wipes, Manufactured by First Quality Products, Inc., McElhattan, PA ; Well Beginnings Wipes, Distributed by Walgreens, Deerfield, IL; Femtex Premium Feminine Wipes, Distributed by Family Dollar, Charlotte, NC 28201; Fred's Kids Baby Wipes, Distributed by Fred's Inc. Memphis, TN; and Sunny Smiles Baby Wipes, Distributed by Walgreens, Deerfield, IL. Also sold as trial packs inside DIAPERS.COM DIAPER SZ 5 CLUB 1/156; IAPERS.COM DIAPER SZ 3 CLUB 1/200;DIAPERS.COM DIAPER SZ 4 CLUB 1/176; WELL BEGINNINGS DIAPER SZ 3 JR CLUB 1/96;WELL BEGINNINGS DIAPER SZ 4 JR CLUB 1/82;WELL BEGINNINGS DIAPER SZ 5 JR CLUB 1/70; SIMPLY RIGHT DIAPER SZ 5 CLUB 1/196; SMPLY RIGHT DIAPER SZ 3 CLUB 1/252; SMPLY RIGHT DIAPER SZ 4 CLUB 1/225; KIDGET DIAPER SZ5 JR CLUB 1/62; KIDGET DIAPER SZ 3 JR CLUB 1/86; KIDGET DIAPER SZ4 JR CLUB 1/74; KIDGET DIAPER SZ 6 JR CLUB 1/54; FRED DIAPER SZ 3 JR CLUB 1/86; and DIAPER SZ 5 JR CLUB 1/62. ","All lots, beginning with 00114 increasing by one number sequentially until 29414, with UPC codes: 0032251025778, 0032251026508, 0032251026515, 0032251026522, 0032251026539, 0032251026546, 0032251026553, 0032251063381, 0032251089411, 0032251089428, 0032251089466, 0032251094491, 0078742023038, 0078742057415, 0084579123643, 0084579126637, 0084579126644, 0084579126651, 0084579126668, 0084579126750, 0090891125234, 0090891125289, 0090891125296, 0090891125302, 0090891125319, 0090891128129, 0090891128136, 0311917147246, 0311917152080, 0311917152097, 0311917152103, 0311917152110, 0311917152127, 0311917152134, 0681131077699. ",".","4024878","All lots of Disposable baby wipes manufactured by Nutek Disposables, Inc., were recalled due to complaints of discoloration and/or odor and irritation, later determined to be the result of bacterial contamination confirmed as B. cepacia. ",10/3/2014,"10/03/2014",12/2/2014,"12/02/2014"
"Devices",69432,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.","Z-0092-2015","Class II","DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715","Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.",,"11","Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy. ",10/2/2014,"10/02/2014",10/29/2014,"10/29/2014"
"Devices",69433,"Ongoing","Medartis, Inc.","Kennett Square","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.","Z-0150-2015","Class II","APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. ","Part no. A-2791.05, lot no. 14125026",".","44","A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.",10/1/2014,"10/01/2014",11/5/2014,"11/05/2014"
"Devices",69434,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Newark","DE","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and internationally to: Canada.","Z-0420-2015","Class II"," Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus. ","Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020 ",".","53, 046","Siemens Healthcare Diagnostics is conducting a field recall for certain lots of the Dimension Vista® HbA1c Flex® reagent cartridge and lots of Dimension® HB1C Flex® reagent cartridge due to confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.",9/30/2014,"09/30/2014",12/2/2014,"12/02/2014"
"Food",69435,"Ongoing","H. A. R. Maspeth Corp.","Maspeth","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, MA, MD and VA","F-0084-2015","Class I","JINGA brand PANFRIED ANCHOVY(S), NET WT. 2 oz. and 4 oz., KEEP REFRIGERATED -- JINGA 44-28 55TH AVE., MASPETH, NY 11378 --- The product is packaged in clear, hard plastic containers. ","BEST BY 9/28/2014 stamped on the top",".","2 oz: 49 units, 4 oz.: 34 units","The product was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the Virginia Department of Agriculture and Consumer Services. ",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Devices",69436,"Ongoing","Ad-Tech Medical Instrument Corporation","Racine","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.","Z-0106-2015","Class II","Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. ","Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.",,"13 kits (26 electrodes, 26 applicator wands, 26 leadwires)."," The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .",10/8/2014,"10/08/2014",10/29/2014,"10/29/2014"
"Devices",69437,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.","Z-0175-2015","Class II","Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. ","Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 509566, 509579, 509570 508887, 509489, 509542, 509538, 509541, 509645, 509647, 509652, 509649, 509648, 509642, 509644 509341, 509346 508885, 508891, 509781, 509782, 509770 509026, 509020, 509025, 509027, 509028, 509021 509651, 509784 509194, 509190 509713, 509710 509175 509560, 509557, 509556, 509558 509553, 509554 509219, 509237, 509236, 509233, 509231, 509234, 509238, 509212, 509240, 509230, 509208, 509216, 509232, 509214 509535 509072, 508994, 508981, 508990 509531, 509417, 509398, 509759 509089 509050, 508991 508884, 508888, 508870, 509075, 509074, 509076, 509069, 509147, 509145, 509155 509442, 509443 509622 509107 508937, 509697, 509698 509821, 509810 509512, 509169, 509174, 509170, 509695 509610, 509620, 509613 509355, 509471, 509468, 509699, 509700, 509702, 509703 509517, 509520, 509664, 509665, 509666 509637 508954, 508996, 509203, 509210, 509205, 509209 509401, 509202, 509780, 509779 509423 ,509426, 509806, 509804, 509812, 509807, 509805 509561 508940 509564 509141 509142 509156 509507 509598 509023 509045 509090 509342 509217 509098 509104 509359 509415 509586 509539 509005 509002 509487 509345 508872 5",,"1,519 units total (403 units total)","Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Devices",69437,"Ongoing","Beckman Coulter Inc.","Brea","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.","Z-0176-2015","Class II","UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. ","Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 509566, 509579, 509570 508887, 509489, 509542, 509538, 509541, 509645, 509647, 509652, 509649, 509648, 509642, 509644 509341, 509346 508885, 508891, 509781, 509782, 509770 509026, 509020, 509025, 509027, 509028, 509021 509651, 509784 509194, 509190 509713, 509710 509175 509560, 509557, 509556, 509558 509553, 509554 509219, 509237, 509236, 509233, 509231, 509234, 509238, 509212, 509240, 509230, 509208, 509216, 509232, 509214 509535 509072, 508994, 508981, 508990 509531, 509417, 509398, 509759 509089 509050, 508991 508884, 508888, 508870, 509075, 509074, 509076, 509069, 509147, 509145, 509155 509442, 509443 509622 509107 508937, 509697, 509698 509821, 509810 509512, 509169, 509174, 509170, 509695 509610, 509620, 509613 509355, 509471, 509468, 509699, 509700, 509702, 509703 509517, 509520, 509664, 509665, 509666 509637 508954, 508996, 509203, 509210, 509205, 509209 509401, 509202, 509780, 509779 509423 ,509426, 509806, 509804, 509812, 509807, 509805 509561 508940 509564 509141 509142 509156 509507 509598 509023 509045 509090 509342 509217 509098 509104 509359 509415 509586 509539 509005 509002 509487 509345 508872 5",,"1,519 units total (403 units total)","Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Biologics",69438,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Letter","Indiana","B-0089-15","Class II","Red Blood Cells Leukocytes Reduced","W037713087821; ",".","1 unit","Blood product, collected from a donor who disclosed travel history that warranted deferral, was distributed.",9/4/2014,"09/04/2014",11/19/2014,"11/19/2014"
"Biologics",69439,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0185-15","Class II","Plasma Frozen within 24 hours (FP24)","W045214012038",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",9/3/2014,"09/03/2014",12/2/2014,"12/02/2014"
"Biologics",69439,"Terminated","South Bend Medical Foundation, Inc.","South Bend","IN","US","Voluntary: Firm Initiated","Letter","Indiana","B-0184-15","Class II","Red Blood Cells Leukocytes Reduced","W045214012038",".","1 unit","Blood products, collected from an ineligible donor, were distributed. ",9/3/2014,"09/03/2014",12/2/2014,"12/02/2014"
"Biologics",69440,"Terminated","Hoxworth Blood Center","Cincinnati","OH","US","Voluntary: Firm Initiated","Telephone","Indiana; Kentucky","B-0090-15","Class III","Platelets Pheresis Leukocytes Reduced","W037714051684 (double collection)",".","2 units","Blood products, that were not quarantined after receiving information concerning post-donation illness, were distributed.",7/23/2014,"07/23/2014",11/19/2014,"11/19/2014"
"Devices",69441,"Ongoing","Invacare Corporation","Elyria","OH","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.","Z-0577-2015","Class II","Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.","The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099. The serial number range is as follows for the finished device: 14GF053772-14HF032124 (Sequential serial numbers) ",".","5,963","It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.",9/23/2014,"09/23/2014",12/17/2014,"12/17/2014"
"Veterinary",69442,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)","V-172-2015","Class II","Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number and Expiration Date: 1) Lot 08012014@34, Expires 10/30/2014",,"20 mL","Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",9/2/2014,"09/02/2014",11/12/2014,"11/12/2014"
"Veterinary",69442,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)","V-171-2015","Class II","Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number and Expiration Date: 1) Lot 05082014@23, Expires 11/4/2014",,"55 mL","Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",9/2/2014,"09/02/2014",11/12/2014,"11/12/2014"
"Veterinary",69442,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)","V-170-2015","Class II","Phenylephrine 1% injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number and Expiration Date: 1) Lot 07182014@40, Expires 9/16/2014; 2) Lot 07252014@43, Expires 9/23/2014",,"350 mL","Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",9/2/2014,"09/02/2014",11/12/2014,"11/12/2014"
"Veterinary",69442,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)","V-173-2015","Class II","''Tri-mix'' 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number and Expiration Date: 1) Lot 07302014@33, Expires 10/28/2014",,"5 mL","Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",9/2/2014,"09/02/2014",11/12/2014,"11/12/2014"
"Veterinary",69442,"Ongoing","Martin Avenue Pharmacy, Inc.","Naperville","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: Nationwide (AL, FL, IL, MI, MO, OH, OK, OR, TX, WI)","V-169-2015","Class II","Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.","Lot Number and Expiration Date: 1) Lot 03312014@29, Expires 9/27/2014; 2) Lot 06262014@20, Expires 12/23/2014",,"900 mL","Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.",9/2/2014,"09/02/2014",11/12/2014,"11/12/2014"
"Food",69443,"Ongoing","Lotte International America Corp (LA Branch)","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in the US: California, Nevada, Arizona, New Mexico, Washington, Texas, Oklahoma, Illinois, New Jersey, Maryland, Georgia. Worldwide to Canada retail stores.","F-0076-2015","Class I","Lotte European Waffle, Net Wt. 40g, 160g UPC 8801062518111, 8801062518135","UPC 8 801062 518111 14.07.04 14.07.05 14.07.15 14.07.14 14.07.15 14.07.16 14.07.17 14.07.18 14.08.06 14.08.07 14.08.08 14.08.09 14.08.11 14.08.12 14.08.13 14.08.15 14.08.16 14.08.29 14.09.01 14.09.02 14.09.03 14.09.04 14.09.06 14.09.14 14.09.22 14.09.23 14.09.24 14.09.25 14.09.26 14.10.06 14.10.07 14.10.08 14.10.09 14.10.10 14.10.15 14.10.27 14.10.28 14.10.29 14.10.30 14.10.31 14.11.30 14.12.01 14.12.02 14.12.03 14.12.04 14.12.05 14.12.06 14.12.07 14.12.15 14.12.16 14.12.17 14.12.18 14.12.19 14.12.20 15.01.01 15.01.02 15.01.03 15.01.12 15.01.13 15.01.14 15.01.15 15.01.26 15.01.27 15.01.28 15.01.31 15.02.09 15.02.10 15.02.11 15.02.12 15.02.25 15.02.26 15.02.27 15.02.28 15.03.02 15.03.03 15.03.11 15.03.12 15.03.13 15.03.14 15.03.23 15.03.24 15.03.25 15.03.26 15.03.27 15.03.31 15.04.06 15.04.07 15.04.08 15.04.09 15.04.10 15.04.11 15.04.20 15.04.27 15.04.28 15.04.29 15.04.30 15.05.01 15.05.11 15.05.12 15.05.13 15.05.14 15.05.15 15.05.16 15.05.18 15.05.19 15.05.20 15.06.01 15.06.02 15.06.03 15.06.04 15.06.05 15.06.06 15.06.15 15.06.16 15.06.30 15.07.06 15.07.07 15.07.08 15.07.22 15.07.23 15.07.24 15.07.25 15.07.31 15.08.10 15.08.11 15.08.12 15.08.13 15.08.14 15.08.20 15.08.31 15.09.01 15.09.02 15.09.03 15.09.04 15.09.05 15.09.06 15.09.14 15.09.15 15.09.16 15.09.17 15.09.18 15.09.19 UPC 8801062 518135 14.06.30 14.07.01 14.07.02 14.07.03 14.07.07 14.07.08 14.07.09 14.07.10 14.07.11 14.07.12 14.07.18 14.07.19 14.07.20 14.07.21 14.07.22 14.07.23 14.07.24 14.07.25 14.07.26 14.07.28 14.07.29 14.07.31 14.08.01 14.08.04 14.08.05 14.08.06 14.08.10 14.08.18 14.08.19 14.08.20 14.08.21 14.08.22 14.08.25 14.08.26 14.08.27 14.08.31 14.09.08 14.09.09 14.09.10 14.09.13 14.09.14 14.09.29 14.09.30 14.10.01 14.10.02 14.10.03 14.10.04 14.10.11 14.10.13 14.10.14 14.10.15 14.10.16 14.10.17 14.10.18 14.10.20 14.10.21 14.10.22 14.10.23 1",,"9,172 units","Lotte International is recalling the Lotte Waffles because it contains undeclared eggs.",10/8/2014,"10/08/2014",10/29/2014,"10/29/2014"
"Drugs",69445,"Ongoing","Valeant Pharmaceuticals North America LLC ","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0053-2015","Class III","APLENZIN (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 ","Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16 ",".","55,650 HDPE bottles","Labeling: Incorrect or Missing Package Insert",6/5/2014,"06/05/2014",11/5/2014,"11/05/2014"
"Drugs",69445,"Ongoing","Valeant Pharmaceuticals North America LLC ","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0051-2015","Class III","APLENZIN (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07. ","Lot # 13E019P; Exp 03/17 ",".","20,499 HDPE bottles","Labeling: Incorrect or Missing Package Insert",6/5/2014,"06/05/2014",11/5/2014,"11/05/2014"
"Drugs",69445,"Ongoing","Valeant Pharmaceuticals North America LLC ","Bridgewater","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0052-2015","Class III","APLENZIN (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 ","Lot #: a) 13E020P; Exp. 03/17 Lot #: b) 13E029P, 13E028P, 13K032P; Exp. 03/17 ",".","23,057 HDPE bottles","Labeling: Incorrect or Missing Package Insert",6/5/2014,"06/05/2014",11/5/2014,"11/05/2014"
"Devices",69446,"Ongoing","CooperSurgical, Inc. D.B.A. Lone Star Medical Products","Stafford","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.","Z-0147-2015","Class II","Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.","Lots 149460 and 149911",".","90 units","CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.",9/13/2013,"09/13/2013",11/5/2014,"11/05/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0392-2015","Class I","Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513377 140513456 140613840 140714396 ",".","340","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0250-2015","Class I","Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112954 111112965 111123297 111123444 112010204 112020511 112030694 112051651 112052014 112083064 112093637 112104287 112114538 112124884 113025834 113026068 113036743 113047031 113057506 113067936 113067964 140111127 140312184 140513161 140613781 140814822 1130688891 ",".","20960","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0330-2015","Class I","Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513126 140513397 140613659 140714234 140814768 140915245 ",".","460","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0353-2015","Class I","Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312137 140513134 140613729 ",".","129","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0311-2015","Class I","Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513347 140613822 140714391 ",".","625","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0244-2015","Class I","Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160 ",".","50950","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0290-2015","Class I","Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513084 140613592 140714177 ",".","48","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0402-2015","Class I","Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513145 140513340 140613848 140814683 140915202 ",".","236","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0269-2015","Class I","Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412449 140513057 140613558 140714144 140814613 140815030 ",".","380","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0241-2015","Class I","Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112975 112020298 112030800 112062308 131010025 131210852 140211529 140513036 140714141 ",".","12300","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0319-2015","Class I","Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513465",".","96","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0313-2015","Class I","Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513111 140513393 140613803 140814739 ",".","60","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0285-2015","Class I","Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513080 140513459 140613814 140714432 140814944 ",".","335","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0332-2015","Class I","Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513478 140714235 140714541 140814982 ",".","880","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0335-2015","Class I","Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412651 140612902 140714241 140915248 ",".","280","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0308-2015","Class I","Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513108 140613625 140714199 140814673 140915236 ",".","180","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0359-2015","Class I","Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140814785 ",".","50","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0323-2015","Class I","Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513120 140613644 140714218 140814755 ",".","57","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0336-2015","Class I","General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312128 140412652 140613722 140714242 140814776 ",".","308","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0248-2015","Class I","Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 112051996 112114535 113025779 113078335 113099443 140111073 140412695 140613606 140714299 ",".","9700","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0301-2015","Class I","Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312077 140412454 140613617 140714189 140814665 140915233 ",".","156","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0256-2015","Class I","Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111113039 111123389 112010093 112020412 112030646 112041203 112051652 112051882 112062451 112062568 112093753 112114887 113036455 113047208 113057433 113057863 113078277 113088761 113099393 113109754 131110201 131210683 131210763 140111120 140312090 140512615 140513043 140613601 140613631 1121114534 ",".","66200","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0400-2015","Class I","Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513381 140613779 ",".","36","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0355-2015","Class I","Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312139 140412663 140513136 140613731 ",".","96","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0237-2015","Class I","Suture Removal Kit Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022 ",".","185000","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0325-2015","Class I","Laparoscopy Chole Pack, Catalog number 900-2004. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613472",".","36","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0378-2015","Class I","Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513247 140613834 140714393 140814875 ",".","1680","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0326-2015","Class I","Angiography Pack, Catalog number 900-2038. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140111450 140513123 140613860 140714392 ",".","212","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0274-2015","Class I","Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513063 140513390 140613948 140714429 140814966 140915118 ",".","256","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0331-2015","Class I","Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513127 140613830 140714540 140814769 ",".","270","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0369-2015","Class I","Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714520",".","18","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0251-2015","Class I","Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112986 111123441 112010278 112041183 112051733 112062333 112093745 112104134 113026216 113047151 113068038 113078678 131110157 140111110 140312050 140513069 140814630 1130154790 ",".","27024","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0347-2015","Class I","Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412657 140513132 140613727 140714252 140814780 ",".","222","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0316-2015","Class I","Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513115 140613633 140714207 ",".","28","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0340-2015","Class I","Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513219 140714247 ",".","400","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0365-2015","Class I","Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513141 140613737 140714268 140814793 ",".","128","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0341-2015","Class I","Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513400",".","200","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0246-2015","Class I","Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111103265 111113126 112010183 112020505 112030804 112041056 112051993 112072804 112093631 112104361 112104533 112124897 113026196 113036804 113057491 113067873 113078333 113088873 113099438 113109852 131110265 131210654 140111126 140211540 140312173 140312384 140513370 140714295 140814813 140814957 140915481 ",".","86912","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0295-2015","Class I","Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513091 140613610 140714183 140814654 ",".","70","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0284-2015","Class I","Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513344 140613813 140714389 140814943 ",".","1020","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0259-2015","Class I","Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 112104267 ",".","170","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0262-2015","Class I","Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 113036400",".","1120","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0239-2015","Class I","Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111123439 111123477 112030810 112041388 112051661 112072578 140211712 140513053 ",".","8000","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0408-2015","Class I","Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513470 140714316 ",".","105","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0364-2015","Class I","Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714267 140814792 ",".","300","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0324-2015","Class I","Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140814757 140915244 ",".","36","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0315-2015","Class I","Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513114 140513454 140613824 140714334 ",".","582","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0328-2015","Class I","Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513124 140613657 140714232 140814767 ",".","144","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0263-2015","Class I","Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 113036395",".","2240","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0407-2015","Class I","Curation Kit, Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714315 140814826 140915194 ",".","100","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0382-2015","Class I","Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140111229 140613760 140714287 ",".","75","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0298-2015","Class I","Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412871 140613717 140614025 140714326 140814867 140814991 ",".","48","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0272-2015","Class I","Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513062 140513474 140613801 140613808 140714385 ",".","480","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0339-2015","Class I","Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140512912 140613725 ",".","92","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0342-2015","Class I","Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714248",".","200","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0249-2015","Class I","Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111123296 112030746 112124854 112124886 113036382 113088890 131110313 140412880 140613780 140915163 ",".","9200","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0277-2015","Class I","Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613812",".","1500","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0270-2015","Class I","OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513060 140714150 140814622 ",".","224","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0370-2015","Class I","Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613790 140714518 ",".","20","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0396-2015","Class I","O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513351 140613843 140814682 140814880 ",".","420","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0397-2015","Class I","Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513352 140613844 140714398 140814879 ",".","490","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0242-2015","Class I","Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942 ",".","78600","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0288-2015","Class I","Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613718 140714321 140814870 140815034 ",".","108","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0294-2015","Class I","ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513090 140613609 140714182 140814653 ",".","140","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0281-2015","Class I","Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513169 140613799 140714322 140814871 ",".","71","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0275-2015","Class I","Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513064 140513451 140613809 140714386 140814882 140915230 ",".","740","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0354-2015","Class I","Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513135 140613730 140714256 ",".","168","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0412-2015","Class I","Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714319 140814829 140915189 ",".","120","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0255-2015","Class I","Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 112010064 112062429 112072429 113015552 113078579 140211537 140613802 140714188 140814663 ",".","3540","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0280-2015","Class I","Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513072 140513334 140614028 140714508 140915120 ",".","105","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0387-2015","Class I","Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513372 140915211 ",".","70","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0406-2015","Class I","Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412917 140513342 140614032 140915195 ",".","60","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0345-2015","Class I","Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513220 140714250 ",".","204","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0271-2015","Class I","Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412451 140513061 140613568 140714151 140814623 ",".","180","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0299-2015","Class I","Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513346 140613816 140714533 ",".","284","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0374-2015","Class I","Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513356 140613743 140714277 140814798 ",".","240","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0268-2015","Class I","Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513056 140513343 140613807 140814832 140814874 ",".","840","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0356-2015","Class I","Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513137 140814869 ",".","106","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0338-2015","Class I","Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412654",".","6","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0292-2015","Class I","Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513089 140613856 140614076 140814651 140814971 ",".","315","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0413-2015","Class I","Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513385 140513485 140613851 140814554 140814964 140915188 ",".","372","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0415-2015","Class I","C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513471 140613852 140814555 ",".","122","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0372-2015","Class I","Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613791 140714521 ",".","20","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0302-2015","Class I","Retina Pack, Catalog number 900-1611. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","(4 lots) Lot numbers 140513000 140613621 140714194 140814670 ",".","84","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0276-2015","Class I","Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513066 140513253 140613811 140714388 140915251 ",".","9770","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0264-2015","Class I","Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 113036396",".","2670","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0261-2015","Class I","Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 113036399",".","2520","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0377-2015","Class I","Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513246 140613833 140714545 140814876 ",".","654","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0360-2015","Class I","Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140512992 140613733 140714260 140814786 ",".","160","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0350-2015","Class I","OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714253 140814783 ",".","80","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0346-2015","Class I","Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513131 140613726 140714251 140814779 ",".","400","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0266-2015","Class I","O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513051 140613549 140714119 140814605 140815024 ",".","176","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0334-2015","Class I","Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513128 140613720 140714240 140814775 140915247 ",".","114","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0399-2015","Class I","Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312026 140412702 140513380 140513481 140714306 140814551 140814961 ",".","660","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0309-2015","Class I","OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513109 140613626 140714200 140814737 ",".","120","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0391-2015","Class I","Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513221 140613773 140714302 140814680 ",".","210","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0303-2015","Class I","Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513392 140513453 140613818 140814735 140814878 ",".","270","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0398-2015","Class I","Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412700 140412908 140613778 140714305 140814550 140915204 ",".","400","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0306-2015","Class I","Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513104 140513464 140613820 ",".","126","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0286-2015","Class I","Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513082 140613588 140614074 140714502 140814970 ",".","207","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0351-2015","Class I","Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513355 140613728 140714254 140814784 ",".","144","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0257-2015","Class I","Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111103390 112041455 112062288 112093634 113046894 113088762 140111121 140111176 140814743 ",".","10090","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0414-2015","Class I","Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513386 140613787 140714320 140814830 140915187 ",".","230","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0254-2015","Class I","Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 11123442 111112934 112041187 112051647 112051758 112062415 112072773 112083390 113026043 113026103 113026229 113057384 113068146 113078701 113109725 140613855 140814650 ",".","23300","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0243-2015","Class I","Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111113095 111123232 112010156 112020472 112030761 112041313 112062452 112072959 112082969 112083427 112104362 112114536 112124889 113026115 113036350 113036799 113047312 113068166 113109823 131110258 131210686 140312144 140412667 140513046 140613603 140714263 140814789 140915159 ",".","134160","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0296-2015","Class I","Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412830 140513345 140613815 140714436 ",".","892","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0240-2015","Class I","Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112932 111123285 112010264 112030760 112041053 112051645 112062307 112083045 112093740 112104126 112114893 113025998 113046869 113078228 113078662 113099263 131110063 131210669 140111107 140211528 140412569 140412798 140613556 140714140 140815029 ",".","66250","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0289-2015","Class I","Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513083 140814646 ",".","40","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0333-2015","Class I","Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412835 140512993 140613955 140714236 140814770 ",".","105","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0273-2015","Class I","Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513473 140714152 140714428 ",".","162","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0349-2015","Class I","Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140814782",".","64","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0404-2015","Class I","Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513147 140513483 140613782 140714311 140814685 ",".","264","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0343-2015","Class I","Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513401 140714249 ",".","240","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0282-2015","Class I","Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140211633 140513335 140513452 140614072 140714431 ",".","180","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0321-2015","Class I","Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513455",".","35","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0361-2015","Class I","Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312143 140412666 140513139 140613734 140714262 140814788 ",".","126","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0405-2015","Class I","Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513484 140613783 140714312 140814686 ",".","195","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0390-2015","Class I","Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513375 140613772 140714301 140814679 140915208 ",".","160","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0409-2015","Class I","C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513148 140513469 140613849 140714552 140814963 ",".","600","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0352-2015","Class I","Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412660 140513133 140513402 140613957 140714513 140915132 ",".","75","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0386-2015","Class I","Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513249 140613839 140814809 ",".","126","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0300-2015","Class I","Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412914 140613614 140714185 ",".","1050","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0265-2015","Class I","Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513048 140613547 140714116 ",".","1152","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0318-2015","Class I","Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613638 140814751 ",".","36","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0314-2015","Class I","Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513112 140613823 140714531 140814706 ",".","2520","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0291-2015","Class I","Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412872 1405133354 140513354 140613716 140613945 140814327 140914990 ",".","48","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0363-2015","Class I","Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513140 140613736 140714266 140814791 ",".","288","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0393-2015","Class I","O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513154 140613796 140915134 ",".","550","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0385-2015","Class I","Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613763 140714289 ",".","48","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0320-2015","Class I","Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412891 140613640 140714213 ",".","45","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0375-2015","Class I","Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513333 140914937 ",".","63","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0327-2015","Class I","Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Catalog number 900-210 (4 lots) Lot numbers 140513348 140613829 140714402 140814873 ",".","1068","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0388-2015","Class I","Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312022 140412694 140613769 140714298 140714332 140814677 140814940 ",".","354","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0260-2015","Class I","Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 113036397 ",".","2640","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0287-2015","Class I","Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613591 140714175 140814645 ",".","56","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0380-2015","Class I","Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513363 140613756 140613835 140714394 ",".","440","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0371-2015","Class I","Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613789 140714519 ",".","36","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0337-2015","Class I","Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613805",".","8","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0348-2015","Class I","Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412658 140513479 140613831 140714542 140814781 ",".","944","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0304-2015","Class I","Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513102 140513461 140714196 140814534 140814736 140814972 ",".","352","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0384-2015","Class I","Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513480 140613838 140814548 140814955 ",".","240","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0411-2015","Class I","Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513384 140613786 140714318 140814828 140915190 ",".","120","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0362-2015","Class I","Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412669 140412796 140613735 140714265 ",".","852","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0305-2015","Class I","Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513103 140513462 140613819 140814603 ",".","246","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0297-2015","Class I","D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513092 140513391 140613611 140614079 140714437 ",".","176","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0317-2015","Class I","Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613947 ",".","12","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0310-2015","Class I","Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513110 140613628 140814738 ",".","76","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0283-2015","Class I","Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412594 140513078 140513477 140714172 140814642 140814732 ",".","150","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0358-2015","Class I","Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714517 ",".","6","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0312-2015","Class I","Urology Pack, Catalog number 900-1738. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140211651 140312085 140714201 140915241 ",".","40","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0357-2015","Class I","Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140814938 ",".","20","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0389-2015","Class I","Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513373 140613770 140614115 140714333 140814678 140915190 ",".","192","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0368-2015","Class I","Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613794 140714522 140915137 ",".","60","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0394-2015","Class I","Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513350 140613841 140714395 140814959 140815096 ",".","6300","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0395-2015","Class I","Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513250 140613842 140714397 140814960 ",".","475","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0383-2015","Class I","Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513248 140613761 140613837 ",".","250","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0245-2015","Class I","Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111103264 112010182 112020504 112030803 112041055 112051992 112062557 112062558 112072803 112093630 112104254 112104360 112114532 112114896 112125100 113026195 113036464 113036803 113057608 113057848 113068173 113088872 113089076 113109851 131210264 131210653 140111125 140211539 140312172 140312383 140513369 140714294 140714515 140814956 140915480 ",".","89284","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0366-2015","Class I","ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140714524",".","6","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0238-2015","Class I","Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025 ",".","76800","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0376-2015","Class I","Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513144 140513338 140613746 140613832 140814544 ",".","242","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0252-2015","Class I","Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111112987 112010275 112030830 112041392 112051737 112062338 112072827 112093746 113015492 113026217 113047317 113068142 113109711 140111111 140312056 140513037 140714161 140915150 ",".","28020","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0267-2015","Class I","Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513052 140513243 140613806 140714400 ",".","1152","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0258-2015","Class I","Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 111123478 112041407 113047224 113109998 ",".","4000","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0367-2015","Class I","Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140312147 140613795 140714523 ",".","51","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0329-2015","Class I","Femoral Pack Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140412645 140513125 140613658 140714233 140714335 ",".","92","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0247-2015","Class I","Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 112020506 112030882 112062454 112093946 112114888 113047160 113068174 113109854 131210826 140211849 140412693 140613605 140915161 ",".","13680","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0401-2015","Class I","General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513251 140613847 140714399 140814962 ",".","680","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0410-2015","Class I","Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513353 140613850 140714553 140814881 140815097 ",".","1140","Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0381-2015","Class I","Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140211670 140311939 140613759 140714547 ",".","344","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0379-2015","Class I","Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513349 140714284 140814546 ",".","260","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0322-2015","Class I","Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513119 140613951 140714510 ",".","160","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0278-2015","Class I","Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140211777 140513068 140513475 140714157 140814629 ",".","132","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0307-2015","Class I","Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513106 140513245 140613821 140714336 140814672 140814948 ",".","160","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0344-2015","Class I","Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613956 140714512 ",".","400","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0403-2015","Class I","Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513146 140513482 140714310 140814684 ",".","288","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0373-2015","Class I","Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513143 140714276 ",".","96","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","Distributed to Puerto Rico, Florida, and New York.","Z-0253-2015","Class I","Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers: 113046906 140412564 140513040 140814664 ",".","4710","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0293-2015","Class I","D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140613857 140814652 140915231 ",".","108","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69448,"Ongoing","Customed, Inc","Fajardo","PR","US","Voluntary: Firm Initiated","Letter","US Distribution to states of Florida and New York including Puerto Rico.","Z-0279-2015","Class I","Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.","Lot numbers 140513071 140513476 140714159 140814602 140915119 ",".","156","Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.",10/8/2014,"10/08/2014",12/10/2014,"12/10/2014"
"Devices",69449,"Completed","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.","Z-0129-2015","Class II","ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack) ","Lot numbers: 82069A22 Exp Date: 01/19/2013 82946A22 84494A22 85340A22 85804B22 87430B22 90884B22 95232A23 Exp. Date: 10/16/2013 95589A23 96012A23 ",".","2440 kits","Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system",10/9/2012,"10/09/2012",11/5/2014,"11/05/2014"
"Devices",69449,"Completed","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.","Z-0128-2015","Class II","ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack) ","Lot numbers: 82052A22 Exp Date 01/19/2013 82335A22 82909A22 85268A22 86701B22 88921B22 89956B22 90925B22 91336B22 95231A23 Exp. Date: 01/16/2013 95553A23",".","8263 kits","Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system",10/9/2012,"10/09/2012",11/5/2014,"11/05/2014"
"Devices",69449,"Completed","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.","Z-0130-2015","Class II","ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack) ","Lot numbers: 83496A22 88716A22 95040822 95889A22 Exp. 01/19/2013",".","234 kits","Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system",10/9/2012,"10/09/2012",11/5/2014,"11/05/2014"
"Food",69451,"Completed","Real Foods of Seattle, LLC","Kent","WA","US","Voluntary: Firm Initiated","Telephone","QFC stores in Washington State","F-0096-2015","Class I","Mexican Cheddar Dip 10oz non-flex plastic, distributed by Taylor Farms Salinas, CA 93902. The label will show UPC 0 3022300960 9 or UPC 0 30223 00952 8","Sell by 10/10/14, 10/11/14 and 10/12/14 ",".","96 units","Real Foods of Seattle is recalling Mexican Cheddar Dip due to the absence of egg in the ingredient statement.",10/8/2014,"10/08/2014",11/5/2014,"11/05/2014"
"Devices",69452,"Ongoing","Merit Medical Systems, Inc.","South Jordan","UT","US","Voluntary: Firm Initiated","Letter","Nationwide and to India. No govt/military/VA consignees.","Z-0162-2015","Class II","Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.","Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/3112014",,"56 units","Merit Medical Systems, Inc. is voluntarily recalling the Merit Maestro Microcatheter due to a discrepancy between the labeling and the actual configuration of the device in the packaging. These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.",9/26/2014,"09/26/2014",11/12/2014,"11/12/2014"
"Food",69453,"Ongoing","Buddy's Kitchen, Inc.","Burnsville","MN","US","Voluntary: Firm Initiated","Telephone","IL","F-0457-2015","Class II","Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337","Production Dates: 07/18/14 and 08/14/14",,"242 ","An ingredient, Tid-bit Potato, tested positive for Listeria monocytogenes. The Tid-Bit Potatoes is an ingredient in Fiesta Breakfast Scramble",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Devices",69454,"Ongoing","Straumann USA, LLC","Andover","MA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0174-2015","Class II","Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used ","Lot number: GY256",,"111 units","Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)",9/24/2014,"09/24/2014",11/12/2014,"11/12/2014"
"Biologics",69457,"Terminated","DCI Biologicals, LLC","Jonesboro","AR","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0124-15","Class II","Source Plasma","JB0394597; JB0395135; JB0394278",".","3 units","Blood product, collected from a donor who had been incarcerated, was distributed. ",7/7/2014,"07/07/2014",12/10/2014,"12/10/2014"
"Biologics",69459,"Terminated","DCI Biologicals LLC","Farmington","NM","US","Voluntary: Firm Initiated","FAX","California","B-0120-15","Class II","Source Plasma","FD0851469; ",".","1 unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.",7/5/2014,"07/05/2014",12/2/2014,"12/02/2014"
"Biologics",69460,"Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","VA","B-0123-15","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W089814000891",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",9/16/2014,"09/16/2014",12/10/2014,"12/10/2014"
"Devices",69461,"Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.","Z-0229-2015","Class III","ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)","Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.",".","100 test - 4,600 kits; 500 test - 1,878 kits","Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.",10/6/2014,"10/06/2014",11/26/2014,"11/26/2014"
"Devices",69462,"Ongoing","C.R. Bard, Inc.","Covington","GA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.","Z-0163-2015","Class II","Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.","Product code: 042316, Lot number: BMXJM031",,"86 units","The product is non-sterile.",10/7/2014,"10/07/2014",11/12/2014,"11/12/2014"
"Devices",69463,"Ongoing","Cynosure, Inc.","Westford","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.","Z-0169-2015","Class II","Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System","All Serial numbers",,"322 units","If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock",10/9/2014,"10/09/2014",11/12/2014,"11/12/2014"
"Devices",69464,"Ongoing","Davol, Inc., Subs. C. R. Bard, Inc.","Warwick","RI","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.","Z-0191-2015","Class II","Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.","Lot# HUYD0176 ",".","78 units","The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.",10/8/2014,"10/08/2014",11/19/2014,"11/19/2014"
"Devices",69467,"Ongoing","Mortara Instrument, Inc","Milwaukee","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) in the states of: AZ, AR, CA, DC, FL, ID, IL IN, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NJ, NY, NC, OK PA, SC, TN, TX, VA, and WI; and internationally to: AUSTRALIA, BANGLADESH, CANADA, CHILE, CROATIA, EGYPT, GERMANY, ITALY, JORDAN, LEBANON, MALAYSIA, MOROCCO, OMAN, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, THAILAND, THE NETHERLANDS, UNITED KINGDOM.","Z-0110-2015","Class II","Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. ","Unit Serial Number 113400177138 113400177139 114260218985 114260218986 114260218987 114360228306 114330225509 114330225510 114330225511 114330225512 114330225513 114330225514 114330225515 114330225516 113430180113 114100196465 114040191976 114090196324 113490185858 113490185860 112090110348 113030149744 113030149745 113460182773 113460182774 113460182775 113460182776 113460182777 113460182778 113460182779 113460182780 113460182781 113460182782 113460182783 113460182784 113460182785 113460182786 113470184344 112090110349 112090110359 112090110360 112100110533 112100110538 112480143971 112480143973 112480143974 112490144251 112490144252 112490144253 112490144254 112490144255 113030149224 113030149746 113030149747 113030149748 113030149749 113030149750 113110157148 113110157149 113230166552 113230166553 113230166554 113230166555 113230166556 113230166557 113280169582 113300171794 113300171795 113450181352 113450181353 113450181354 113450181355 113450181497 113450181498 113450181499 113450181500 113450181501 113450181502 113450181640 113450181641 113450181642 113450181643 113460182680 113460182681 113460182682 113460182683 113460182684 113460182685 113460182768 113460182769 113460182770 113460182771 113470184286 113470184290 113470184291 113490185852 113490185853 113490185857 114100200986 114150205554 114150205559 114150205560 114150205561 114180209641 114230216030 114230216031 114230216032 114230216033 114230216189 114230216190 114270220481 114270220482 114270220483 114270220484 114270220485 114270220486 114270220487 114270220488 114320223837 114320223838 114320223839 114320223840 114170207573 114170207578 114170207571 113400177141 113400177143 114200211466 114200211467 114200211468 114200211469 114200211470 114300222151 114300222152 114180209529 114200211644 114270220219 113500187610 113500187611 113500187612 113500187613 113500187614 114170207574 114170207575 114170207576 114180208865 114180208866 114170207572 114170207577 114110202128 114110202129 114110202130 114110202131 114110202132 113460182787 11347018428",,"624 ","Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the provided screws, it is then possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire.",10/7/2014,"10/07/2014",10/29/2014,"10/29/2014"
"Veterinary",69470,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","distributed in Oregon and Washington","V-208-2015","Class II","POLYSULF GLUCOSAMIN GLYCAN 10% INJECTABLE, 30 mL per package","Lot number: 20140820@7/30. Discard date: 11/18/2014",".","360 mL total","Unexpired veterinary sterile injectable drug is recalled due to lack of sterility assurance.",10/6/2014,"10/06/2014",11/19/2014,"11/19/2014"
"Veterinary",69470,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","distributed in Oregon and Washington","V-207-2015","Class II","CYCLOSPORINE-E PLUS 2% OPHTHALMIC, 5 mL per package","Lot number: 20140702@12. Discard date: 12/29/2014",".","55 mL total","Unexpired veterinary sterile ophthalmic drug is recalled due to lack of sterility assurance.",10/6/2014,"10/06/2014",11/19/2014,"11/19/2014"
"Veterinary",69470,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","distributed in Oregon and Washington","V-206-2015","Class II","APOMORPHINE HCL 3MG/ML INJECTABLE","Lot number: 20140818@37, Discard date: 11/16/2014",".","24 mL total ","Unexpired veterinary sterile injectable drug is recalled due to lack of sterility assurance.",10/6/2014,"10/06/2014",11/19/2014,"11/19/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0543-2015","Class II","Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.","1) Instrumed Product Name: Cushing Burr, 3/8'', 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 3/8'', 10 mm; Medfix International Item Number: MF223-1592; Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr, 5/8'', 16 mm; Instrumed Product Number: 600-00534; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 5/8'', 16 mm; Medfix International Item Number: MF223-1597; Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr, 3/4'', 20 mm; Instrumed Product Number: 600-00539; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Burr, 3/4'', 20 mm; Stealth Surgical Item Number: SS2133; Lot Number: 060311. ",".","4 Cushing burrs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0551-2015","Class II","Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.","1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Fixation Screws Fixation Screw Non-Springloaded; CareFusion Item Number: NL9506; Lot Numbers: 010113, 020512, 050514, 060213, 070213, 070413, 120413. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180; Boss Instruments Item Number: 74-0185; Lot Numbers: 010113, 020512, 060213, 120413. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Millennium Surgical Item Number: 6-1948; Lot Numbers: 020512, 070213, 120413. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Prezio Health; Prezio Health Product Name: Replacement Screw Non-Springloaded, Traction Tong; Prezio Health Item Number: 85-1296; Lot Number: 020512. 5) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193B; Lot Numbers: 020512, 120413. 6) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-1296; Lot Numbers: 010113, 010412, 020512.",".","67 replacement screw non-springloaded traction tongs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0542-2015","Class II","Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.","1) Instrumed Product Name: Cushing Perforating, Drill, 3/8'', 10 mm; Instrumed Product Number: 600-00509; Trade Name: Boss Industries; Boss Industries Product Name: Cushing Perforating, Drill, 3/8'', 10 mm; Boss Industries Item Number: 74-0100; Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Symmetry Surgical Item Number: 57-6034; Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Medfix International; Medfix International Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Medfix International Item Number: MF223-1577; Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Stealth Surgical Item Number: SS2122; Lot Number: 060212. 5) Instrumed Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; Instrumed Product Number: 600-00514; Trade Name: CareFusion; CareFusion Product Name: Cushing Perforating, Drill, 1/2'', 13 mm; CareFusion Item Number: VM85-1213; Lot Number: 060212, 110313.",".","9 perforating drills","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0549-2015","Class II","Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.","1) Instrumed Product Name: Galt Trephine, 5/8''; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8''; CareFusion Item Number: VM85-1273; Lot Number: 120411.",".","3 Galt trephines","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0547-2015","Class II","McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.","1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss InstrumentsItem Number: 74-0144; Lot Number: 060311.",".","3 McKenzie enlarging burrs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0552-2015","Class II","Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names","1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412. 2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412. 3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412. 4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412. 5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412. 6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.",".","49 lock nuts for titanium traction tongs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0535-2015","Class II","A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.","1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410. 2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410. 5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410. 6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.",".","11 trocars","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0556-2015","Class II","CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.","Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Pro",".","790 distractor screws","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0538-2015","Class II","A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.","1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp",".","421 clamps","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0545-2015","Class II","McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.","1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412. 3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111. 5) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Perforator Drill, 13 mm; Boss Instruments Item Number: 74-0140; Lot Number: 070412.",".","4 McKenzie perforator drills","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0558-2015","Class II","Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.","1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical Item Number: 3-5754; Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Schoitz Tonometer; Symmetry Surgical Item Number: 60-6031; Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Accutome; Accutome Product Name: Schoitz Tonometer; Accutome Item Number: AM0530; Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Boss Instruments; Boss Instruments Product Name: Schoitz Tonometer; Boss Instruments Item Number: 80-9010; Lot Number: 100312. 5) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Medline Industries; Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case; Medline Industries Item Number: MDG0781649; Lot Number: 030212, 040113, 100312, 120113.",".","23 tonometers","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0559-2015","Class II","Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.","1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed Product Number: 720-55812; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 7.5 grams; Ambler Surgical Item Number: 5754B; Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams; Instrumed Product Number: 720-55822; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 15.0 grams; Ambler Surgical Item Number: 5754F; Lot Number: 050411.",".","3 Schoitz weights","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0555-2015","Class II","Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.","1) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2''; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2''; CareFusion Item Number: VM85-12015; Lot Number: 011112. 2) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2''; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2''; CareFusion Item Number: NL9516-T; Lot Number: 011112.",".","2 Gardner-Wells wrenches","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0550-2015","Class II","Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.","Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 12-661025; Lot Numbers: 040313, 070512. 2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Echo Instruments; Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete; Echo Instruments Item Number: 576-804; Lot Numbers: 050413, 110212. 3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 6-1945; Lot Numbers: 030314, 040313, 050413, 110212. 4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete; Adler Instrument Item Number: ADR1945; Lot Number: 050413. 5) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Surgical Direct; Surgical Direct Product Name: Gardner-Wells Traction Tongs Complete; Surgical Direct Item Number: SD5861.100; Lot Number: 050413. 6) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs Complete; Stealth Surgical Item Number: SS2191; Lot Number: 110212. 7) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Complete; CareFusion Item Number: VM85-1291; Lot Numbers: 030314, 040313, 050413, 050512, 070212, 070512, 110212. 8) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion;",".","190 Gardner-Wells traction tongs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0536-2015","Class II","An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.","Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 6 1/4'' Retrograde; Symmetry Surgical Item Number: 55-8685; Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 6 1/4'' Retrograde; CareFusion Item Number: 55-8685; Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4'' Retrograde; Instrumed Product Number: 500-05626; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 6 1/4''; Boss Instruments Item Number: 65-7048; Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Phoenix Instruments Item Number: 155-8680; Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Autobahn Surgical Item Number: 352614A; Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Echo Instruments; Echo Instruments Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Echo Instruments Item Number: 558-690; Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-05631; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Symmetry Surgical Item Number: 155-8680; Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4'' reverse angle; Instrumed Product Number: 500-0",".","479 valvulotomes","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0534-2015","Class II","A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.","1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4''; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4''; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4''; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4''; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4''; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4''; Surgipro Item Number",".","81 clamps","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0539-2015","Class II","Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names."," Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Millennium Surgical Item Number: 0-48239; Lot Numbers: 020212, 120312. 2) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Symmetry Surgical Item Number: 57-6305; Lot Numbers: 020212, 100111, 100213, 120312. 3) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Medline Industries Item Number: MDG1806301; Lot Numbers: 020212, 100111. 4) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; CareFusion Item Number: VM85-1261; Lot Number: 100111. 5) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 6) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4'', shaft, 3/16'' OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 7) Instrumed Product Name: Michele Trephine, 6 1/4'', shaft, 7/32'' OD; Instrumed Product Number: 590-06496; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4'', shaft, 7/32'' OD; Millennium Surgical Item Number: 0-48240; Lot Numbers: 010312, 090113, 120312. 8) Instrumed Product Name: Michele Tr",".","74 trephines","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0541-2015","Class II","Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.","1) Instrumed Product Name: Hudson Cerebellar Extension; Instrumed Product Number: 600-00499; Trade Name: Boss Industries; Boss Industries Product Name: Hudson Cerebellar Extension; Boss Industries Item Number: 74-0132; Lot Number: 110411.",".","1 Hudson cerebellar extension","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0544-2015","Class II","Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.","1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 10 mm; Boss Instruments Item Number: 74-0125; Lot Number: 030305. 6) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 14 mm; CareFusion Item Number: H-0343; Lot Numbers: 110212, 120313. 7) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Medline Industries; Medline Industries Product Name: Hudson Burr, 14 mm; Medline Industries Item Number: MDG1199404; Lot Number: 030213. 8) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 14 mm; Boss Instruments Item Number: 74-0126; Lot Number: 120313. 9) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 600-00566; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 16 mm; Boss Instruments Item Number: 74-0128; Lot Number: 110111. 1",".","16 Hudson burrs","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0548-2015","Class II","Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.","1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212. 2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212. 3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212. 4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Boss Instruments Item Number: 74-0120; Lot Numbers: 030112, 110212.",".","5 Hudson cranial drill sets","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0554-2015","Class II","Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.","1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211.",".","17 traction tong replacement screws, non-springloaded","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0557-2015","Class II","Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.","1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8''; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8''; Boss Instruments Item Number: 74-1448; Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8''; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8''; CareFusion Item Number: VM85-2559; Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8''; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8''; Boss Instruments Item Number: 74-1449; Lot Number: 070412.",".","5 Cloward Spanner gauges","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0540-2015","Class II","Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.","1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211.",".","8 Hudson braces","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0553-2015","Class II","Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.","1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313. 2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments Item Number: 74-0184T; Lot Numbers: 020512, 100512. 3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical Item Number: SS2193AT; Lot Number: 020512. 4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion Item Number: VM85-12955; Lot Number: 050314, 110211, 110313.",".","22 titanium fixation screws, springloaded","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0533-2015","Class II","An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.","1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9''; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9'', 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9''; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9''; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.",".","26 endometrial suction curettes","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0546-2015","Class II","D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.","1) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: D'errico Perforator Drill, 16 mm; Symmetry Surgical Item Number: 57-6076; Lot Number: 110211. 2) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Teleflex Medical; Teleflex Medical Product Name: D'errico Perforator Drill, 16 mm; Teleflex Medical Item Number: P-22893; Lot Number: 110211. 3) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: CareFusion; CareFusion Product Name: D'errico Perforator Drill, 16 mm; CareFusion Item Number: VM85-1253.",".","2 D'errico perforator drills","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0532-2015","Class II","A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.","1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name: TeleFlex Medical; Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Teleflex Medical Item Number: VM29-7112; Lot Number: 100213. 3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt; Instrumed Product Number: 310-21113; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt; CareFusion Item Number: VM29-71131X; Lot Number: 110110. 4) Instrumed Product Name : Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5; Symmetry Surgical Item Number: 20-4205; Lot Number: 050412. 5) Instrumed Product Name: Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #5; CareFusion Item Number: GL804-001; Lot Number: 030313. 6) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; CareFusion Item Number: VM29-7112X; Lot Numbers: 110312, 110411. 7) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: EMMETT HOOK QUICK RELEASE, NO 1, BLUE RF COATED; CareFusion Item Number: GL805; Lot Numbers: 010214, 020314, 110312.",".","26 tenaculum hooks","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69471,"Ongoing","Instrumed International, Inc.","Schaumburg","IL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.","Z-0537-2015","Class II","Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.","1) Instrumed Product Name: Bunnell Drill, 5 3/4'', w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4''; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311.",".","13 drills","The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",9/8/2014,"09/08/2014",12/17/2014,"12/17/2014"
"Devices",69472,"Ongoing","Steris Corporation","Mentor","OH","US","Voluntary: Firm Initiated","Letter","US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.","Z-0196-2015","Class II","The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. ","5085 and 5085SRT",".","999","The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.",10/10/2014,"10/10/2014",11/19/2014,"11/19/2014"
"Devices",69473,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt, France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia, Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.","Z-0190-2015","Class II","MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.","Model Number: 728131, Serial Number(s): EP16E090001,EP16E090002,EP16E090003,EP16E090004,EP16E090006,EP16E090007,EP16E090008, EP16E090009,EP16E090010,EP16E090011,EP16E090012,EP16E090013,EP16E090015,EP16E100001, EP16E100004,EP16E100005,EP16E100006,EP16E100007,EP16E100008,EP16E100010,EP16E100011, EP16E100012,EP16E100013,EP16E100015,EP16E100016,EP16E100017,EP16E100018, EP16E100019,EP16E100020,EP16E100021,EP16E100022,EP16E100023,EP16E100024,EP16E100025, EP16E100026,EP16E100027,EP16E100028,EP16E100029,EP16E100030,EP16E100031,EP16E100032, EP16E100033,EP16E100034,EP16E100035,EP16E100036,EP16E100037,EP16E100038,EP16E100039, EP16E100041,EP16E100043,EP16E100044,EP16E100045,EP16E100046,EP16E100047,EP16E100048, EP16E100049,EP16E100051,EP16E100052,EP16E100055,EP16E100056,EP16E100057,EP16E100058, EP16E100059,EP16E100060,EP16E100061,EP16E100062,EP16E100063,EP16E100067,EP16E100069, EP16E100070,EP16E100071,EP16E100072,EP16E100073,EP16E100074,EP16E100075,EP16E100076, EP16E100077,EP16E100078,EP16E100079,EP16E100080,EP16E100081,EP16E100082,EP16E100083, EP16E100084,EP16E100085,EP16E100086,EP16E100087,EP16E100088,EP16E100090,EP16E100091, EP16E100092,EP16E100093,EP16E100094,EP16E100095,EP16E100096,EP16E100099,EP16E100100, EP16E100101,EP16E100102,EP16E100103,EP16E100104,EP16E100105,EP16E100106,EP16E100107, EP16E100108,EP16E100109,EP16E100110,EP16E100111,EP16E100112,EP16E100113,EP16E110003, EP16E110005,EP16E110006,EP16E110007,EP16E110009,EP16E110011,EP16E110012,EP16E110013, EP16E110014,EP16E110015,EP16E110017,EP16E110018,EP16E110019,EP16E110020,EP16E110021, EP16E110023,EP16E110024,EP16E110025,EP16E110026,EP16E110027,EP16E110028,EP16E110029, EP16E110030,EP16E110031,EP16E110032,EP16E110033,EP16E110034,EP16E110035,EP16E110037, EP16E110038,EP16E110039,EP16E110042,EP16E110043,EP16E110044,EP16E110045,EP16E110046, EP16E110047,EP16E110048,EP16E110049,EP16E110050,EP16E110051,EP16E110052,EP16E110054, EP16E110055,EP16E110056,EP16E110057,EP16E110058,EP16E110060,EP16E110062,EP16E110063, EP16E110064,EP16E110066,EP16E110067,EP16E110069,EP16E110070,EP",".","708",""The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longer than 557mm is stopped by using Abort function during the scan process, the position of scan box in surview image is not correct. "For dental applications, when a patient scan is taken with Gantry tilted, and the tilt angle falls in the range from 1 to -1 degree (not including 0 degree position), the data post-processing may not operate normally, the images may not be displayed. "If the user stops a surview using the Abort function during the second part of the scan the positions of the scan box are not consistent.",10/9/2014,"10/09/2014",11/19/2014,"11/19/2014"
"Devices",69474,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0192-2015","Class II","OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures","Serial No: P4-0490-R and P6-0705-L ",".","2","GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.",10/3/2014,"10/03/2014",11/19/2014,"11/19/2014"
"Devices",69474,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0194-2015","Class II","FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures. ","Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064 ",".","5","GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.",10/3/2014,"10/03/2014",11/19/2014,"11/19/2014"
"Devices",69474,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0193-2015","Class II","OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging. ","Serial No: 86-0039,86-0135,86-0191,86-0318,86-0334,86-0587,86-0611,86-0619,86-0758,86-0782,86-0931,86-0935-RC,86-1129,86-1220,86-1241,86-1376,86-1432,86-1503,86-1551,86-1614,86-1678,86-1702,86-1736,86-1959,86-2092,86-2119",".","26","GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.",10/3/2014,"10/03/2014",11/19/2014,"11/19/2014"
"Devices",69474,"Ongoing","GE OEC Medical Systems, Inc","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0195-2015","Class II","Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.","Serial No: 82-0013,82-0045,82-0061,82-0071,82-0085,82-0122,82-0133,82-0190,82-0246,82-0357,82-0528,82-0533,82-0597,82-0626,82-0699,82-0702,82-0707,82-0718,82-0805,82-0818,82-0854,82-0855,82-0946,82-1040,82-1052,82-1062,82-1106,82-1133,82-1199,82-1292,82-1324,82-1348,82-1411,82-1453,82-1460,82-1526,82-1542,82-1608,82-1651,82-1658,82-1679,82-1709,82-1731,82-1773,82-1822,82-1867,82-1882,82-1905,82-1914,82-1979,82-2017,82-2018,82-2024,82-2030,82-2036,82-2049,82-2165,82-2169,82-2206,82-2225,82-2241,82-2279,82-2356,82-2388,82-2398,82-2454,82-2455,82-2459,82-2474,82-2535,82-2565,82-2603,82-2650,82-2655,82-2735,82-2751,82-2761,82-2767,82-2783,82-2851,82-2855,82-2909,82-2930,82-2945,82-2975,82-3003,82-3094,82-3096,82-3169,82-3210,82-3226,82-3232,82-3241,82-3319,82-3325,82-3377,82-3389,82-3395,82-3406,82-3424,82-3430,82-3456,82-3459,82-3500,82-3523,82-3534,82-3539,82-3569,82-3571,82-3629,82-3713,82-3748,82-3774,82-3826,82-3837,82-3851,82-3895,82-7048-MH,82-7066-MH,82-7103-MH,89-0028,89-0034,89-0037,89-0072,89-0105,89-0113,89-0135-RC,89-0184,89-0192,89-0308,89-0311,89-0316,89-0318,89-0388,89-0396,89-0427,89-0517,89-0586,89-0600,89-0623,89-0624,89-0642,89-0643,89-0743,89-0825,89-0827,89-0840,89-0843,89-0846,89-0866,89-0881,89-0894,89-0930,89-0947,89-0995,89-1023,89-1145,89-1157,89-1202,89-1204,89-1209,89-1260,89-1308,89-1327,89-1375,89-1392,89-1408,89-1411,89-1544,89-1652,89-1671,89-1698,89-1751,89-1804,89-1849,89-1868,89-1956,89-1964,89-1984,89-1986,89-2031,89-2050,89-2083,89-2085,89-2094,89-2118,89-2142,89-2170,89-2199,89-2244,89-2250,89-2336,89-2354,89-2459,89-2550,89-2555,89-2598,89-2623,89-2674,89-2682,89-2690,89-2695,89-2767,89-2777,89-2850,89-2862,89-2900,89-3031,89-3032,89-3124-N,89-3165,89-3171,89-3222,89-3252,89-3254,89-3311,89-3318,89-3346,89-3359,89-3367,89-3368,89-3419,89-3438,89-3531,8S-0014-C,8S-0026,8S-0029,8S-0058,8S-0059,8S-0070,8S-0113,8S-0162,8S-0224,8S-0232,8S-0389,8S-0467,8S-0511,8S-0529,8S-0531,8S-0549,8S-0605,8S-0755,8S-0766,8S-0782,8S-0858,8S-0876,8S-0933-C,8S-0997,8S-1000,8S-1015,8S-1147,8S-1165,",".","311","GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.",10/3/2014,"10/03/2014",11/19/2014,"11/19/2014"
"Biologics",69475,"Terminated","BioLife Plasma Services, L.P.","Broken Arrow","OK","US","Voluntary: Firm Initiated","Other","CA","B-0125-15","Class III","Source Plasma","13BOKH8653; 13BOKG3136; 13BOKD3486; 13BOKD2652; 13BOKD2015",".","5 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",9/12/2014,"09/12/2014",12/10/2014,"12/10/2014"
"Biologics",69477,"Terminated","CSL Plasma, Inc.","Las Vegas","NV","US","Voluntary: Firm Initiated","Other","Germany, Federal Republic of; Switzerland","B-0122-15","Class II","Source Plasma","08101301408; 08101339297; 08101330428; 08101260546; 08101231489; 08101153206; 08101177662; 08101141694; ",".","8 units","Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.",8/18/2014,"08/18/2014",12/2/2014,"12/02/2014"
"Drugs",69479,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0235-2015","Class III","TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.","Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12",,"16,000 kits","Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.",10/10/2014,"10/10/2014",11/12/2014,"11/12/2014"
"Devices",69480,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico.","Z-0183-2015","Class II","Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.","model number 10280959, with serial numbers 1000-1599",".","164","A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.",9/23/2014,"09/23/2014",11/19/2014,"11/19/2014"
"Food",69481,"Ongoing","California Olive and Vine, LLC","Sutter","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All product was distributed at Williams Sonoma stores nationwide. A total of 460 jars were verified to have been sold to consumers.","F-0093-2015","Class II","Williams Sonoma Pumpkin Seed Pesto 8 oz. glass jar","SKU numbers 6404305, 6389043 Manufacture Date: August/September 2014",".","460 Jars","Firm is voluntarily recalling Pumpkin Seed Pesto because of irregular lab results. The company found that the jarred pesto may have been improperly processed, making it susceptible to contamination with Clostridium botulinum.",10/9/2014,"10/09/2014",11/5/2014,"11/05/2014"
"Food",69482,"Ongoing","Whole Foods Market Brand 365, Llc","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI.","F-0498-2015","Class II","365 Organic Raisin Granola in 17 ounce (482 gram) cardboard cartons; 12 cartons per case. UPC: 099482448738","Best By 22 Mar 2015, lot 0118416",".","20244 cartons","365 Organic Fruit and Nut Granola was packed in boxes labeled for 365 Organic Raisin Granola. 365 Organic Fruit and Nut Granola contains pecans, almonds, and coconut. The boxes of 365 Organic Raisin Granola only lists almonds in the warning statement. The affected product has the potential to contain additional tree nuts not listed in the warning statement.",10/10/2014,"10/10/2014",11/19/2014,"11/19/2014"
"Drugs",69483,"Ongoing","Teva Pharmaceuticals USA","Horsham","PA","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide including Puerto Rico.","D-0050-2015","Class II","DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.","Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016. ",".","19,545 Bottles","Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.",10/8/2014,"10/08/2014",11/5/2014,"11/05/2014"
"Drugs",69485,"Ongoing","Sagent Pharmaceuticals Inc","Schaumburg","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Puerto Rico","D-0027-2015","Class II","Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 ","Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16",".","69,050 vials","Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date. ",10/3/2014,"10/03/2014",10/22/2014,"10/22/2014"
"Food",69486,"Ongoing","J F C International Inc","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","nationwide in US","F-0075-2015","Class I","Hapi Pudding, 3-pack, net wt. 8.46oz, UPC 11152 13417, JFC item #13417","all lots",,"3400 units","Product's label fails to declare milk. ",10/14/2014,"10/14/2014",10/29/2014,"10/29/2014"
"Devices",69487,"Ongoing","Silver Star Brands","Oshkosh","WI","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.","Z-0216-2015","Class II","Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.","SKU 348709 404, SKU348709 605",".","129","Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels..",10/10/2014,"10/10/2014",11/26/2014,"11/26/2014"
"Devices",69488,"Ongoing","Medtronic Vascular","Danvers","MA","US","Voluntary: Firm Initiated","Visit","US Distribution including the states of NC, IA, IL and KS.","Z-0205-2015","Class II","Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K ","Lot Number: 0007244836 MODEL: LA6JR40K",".","11 devices","Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the distal tip of the catheter. The entire lot will be recalled from customer sites.",10/13/2014,"10/13/2014",11/19/2014,"11/19/2014"
"Biologics",69490,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","Montgomery","AL","US","Voluntary: Firm Initiated","FAX","AL","B-0146-15","Class II","Platelets Pheresis Leukocytes Reduced","W1151142066417",".","1 unit","Blood product, with a low platelet count, was distributed.",9/11/2014,"09/11/2014",12/10/2014,"12/10/2014"
"Biologics",69491,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","E-Mail","Austria","B-0109-15","Class II","Blood and Blood Products for Reprocessing","W116309192933; ",".","1 unit","Blood product, collected from a donor with a risk factor associated with Creutzfeldt-Jacob Disease, was distributed. ",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Biologics",69492,"Terminated","Eye Bank For Sight Restoration","New York","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-0211-15","Class II","Cornea","133214; ",".","1 cornea","Human Cornea, recovered from an ineligible donor, was distributed. ",8/27/2014,"08/27/2014",12/17/2014,"12/17/2014"
"Devices",69493,"Ongoing","Medacta Usa","Chicago","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.","Z-0202-2015","Class II","GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.","Model Number: 02.07.10.0162",".","1 rod (US); 145 rods (global)","Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.",9/22/2014,"09/22/2014",11/19/2014,"11/19/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0286-2015","Class II","0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.","Lot # 33-027-JT; Exp.09/15 Lot # 33-045-JT; Exp.09/15 Lot # 33-097-JT; Exp.09/15 Lot # 35-068-JT; Exp.11/15 Lot # 36-112-JT; Exp.12/15 Lot # 37-012-JT; Exp.01/15",".","784,920 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0282-2015","Class II","5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.","Lot # 32-104-JT; Exp. 08/15 Lot # 34-136-JT; Exp. 10/15 Lot # 36-092-JT; Exp. 12/15",".","340,272 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0285-2015","Class II","0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.","Lot # 32-044-JT; Exp. 08/15 Lot # 32-072-JT; Exp. 08/15 Lot # 32-102-JT; Exp. 08/15 Lot # 33-028-JT; Exp. 09/15 Lot # 33-046-JT; Exp. 09/15 Lot # 33-049-JT; Exp. 09/15 Lot # 33-061-JT; Exp. 09/15 Lot # 33-085-JT; Exp. 09/15 Lot # 33-096-JT; Exp. 09/15 Lot # 33-101-JT; Exp. 09/15 Lot # 33-102-JT; Exp. 09/15 Lot # 34-016-JT; Exp. 10/15 Lot # 34-085-JT; Exp. 10/15 Lot # 34-122-JT; Exp. 10/15 Lot # 34-123-JT; Exp. 10/15 Lot # 35-026-JT; Exp. 11/15 Lot # 35-030-JT; Exp. 11/15 Lot # 35-067-JT; Exp. 11/15 Lot # 36-002-JT ;Exp. 12/15 Lot # 36-029-JT; Exp. 12/15 Lot # 36-049-JT; Exp. 12/15 Lot # 36-058-JT; Exp. 12/15 Lot # 36-103-JT; Exp. 12/15 Lot # 37-013-JT; Exp. 01/16 ",".","16,487,040 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0277-2015","Class II","Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.","Lot # 32-082-JT; Exp. 08/15",".","152,172 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0281-2015","Class II","Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.","Lot # 34-134-JT Exp. 10/15 Lot # 34-166-JT Exp. 10/15",".","275,448 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0287-2015","Class II","Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.","Lot# 36-084-JT; Exp.12/15",".","153,504 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0284-2015","Class II","Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.","Lot # 32-081-JT; Exp. 08/15 Lot # 34-115-JT; Exp. 10/15 ",".","305,664 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0278-2015","Class II","Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.","Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15",".","836,460 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0279-2015","Class II","5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.","Lot # 33-094-JT; Exp. 09/15 Lot # 35-028-JT; Exp. 11/15",".","301,560 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0280-2015","Class II","5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.","Lot # 33-095-JT; Exp. 09/15 Lot # 36-030-JT; Exp. 12/15",".","823,296 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69494,"Ongoing","Hospira Inc.","Lake Forest","IL","US",,"Letter","Nationwide, Puerto Rico, and U.S. Virgin Islands.","D-0283-2015","Class II","Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.","Lot # 32-099-JT; Exp. 08/15 Lot # 32-103-JT; Exp. 08/15 Lot # 34-070-JT; Exp. 10/15 Lot # 34-086-JT; Exp. 10/15 Lot # 34-165-JT; Exp. 10/15 Lot # 35-085-JT; Exp. 11/15 Lot # 35-115-JT; Exp. 11/15 Lot # 35-121-JT; Exp. 11/15 Lot # 36-057-JT; Exp. 12/15",".","6,193,416 bags","Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.",10/14/2014,"10/14/2014",12/2/2014,"12/02/2014"
"Drugs",69495,"Ongoing","Actavis Laboratories, FL, Inc.","Davie","FL","US","Voluntary: Firm Initiated","Letter","U.S. Nationwide including Puerto Rico.","D-0258-2015","Class II","Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6. ","Lot # 694320A, Expiry: 02/28/2015.",".","5,451 Bottles","Failed Tablet/Capsule Specifications: Presence of split or broken tablets.",9/26/2014,"09/26/2014",12/2/2014,"12/02/2014"
"Devices",69496,"Ongoing","Cooper Vision Caribbean Corp.","Juana Diaz","PR","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0529-2015","Class II","Soft Contact Lens","Lots # 8246525202 & 8255525096 ",".","1170","Portions of the lots may contain units with an incorrect lens axis condition.",10/28/2014,"10/28/2014",12/17/2014,"12/17/2014"
"Drugs",69497,"Ongoing","Wisconsin Pharmacal Company","Jackson","WI","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-0047-2015","Class II","CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1 ","Lots 61443, 61444, 61454 Exp. 06/16",".","20,032 bottles","Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth. ",10/3/2014,"10/03/2014",11/5/2014,"11/05/2014"
"Food",69498,"Ongoing","AMS Health Sciences","Oklahoma City","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US and in Canada","F-0462-2015","Class I","Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105","Lot number 416349, 08/16",,"2,014 bottles","The product is being recalled due to the potential presence of Salmonella.",10/15/2014,"10/15/2014",11/12/2014,"11/12/2014"
"Devices",69499,"Ongoing","St Jude Medical","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.","Z-0108-2015","Class II","St Jude Medical, 10F Fast-Cath Trio'' Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio'' Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock''), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.","Batch 4641580",,"220","St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio'' Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.",10/14/2014,"10/14/2014",10/29/2014,"10/29/2014"
"Devices",69500,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL","Z-0208-2015","Class III","CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues ","Lot Number: 142921",".","6 units","Incorrect expiration date printed on the MILEX PESSARY KIT packaging",9/30/2014,"09/30/2014",11/19/2014,"11/19/2014"
"Devices",69500,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL","Z-0207-2015","Class III","CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues ","Lot Number: 146351",".","17 units","Incorrect expiration date printed on the MILEX PESSARY KIT packaging",9/30/2014,"09/30/2014",11/19/2014,"11/19/2014"
"Biologics",69501,"Terminated","DCI Biologicals Orlando LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","FAX","United Kingdom","B-0108-15","Class II","Source Plasma","JV0187449; ",".","1 unit","Blood product, for which donor eligibility was not complete, was distributed.",8/1/2014,"08/01/2014",11/19/2014,"11/19/2014"
"Biologics",69502,"Terminated","Belle Bonfils Memorial Blood Center","Denver","CO","US","Voluntary: Firm Initiated","Telephone","Colorado","B-0107-15","Class II","Red Blood Cells Leukocytes Reduced","W036214236738; W036214150499; ",".","2 units","Blood products, for which routine testing was not documented, were distributed.",8/27/2014,"08/27/2014",11/19/2014,"11/19/2014"
"Biologics",69503,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; MS","B-0145-15","Class II","Blood and Blood Products for Reprocessing","W069114182541 ",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/13/2014,"08/13/2014",12/10/2014,"12/10/2014"
"Biologics",69503,"Terminated","Mississippi Blood Services Inc.","Flowood","MS","US","Voluntary: Firm Initiated","FAX","Switzerland; MS","B-0144-15","Class II","Red Blood Cells Leukocytes Reduced","W069114182541",".","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.",8/13/2014,"08/13/2014",12/10/2014,"12/10/2014"
"Devices",69504,"Ongoing","Masimo Corporation","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom.","Z-0213-2015","Class II","Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile. "," V35685 3636 V35686 3636 V35691 3636 V35693 3636 V35694 3636 V35696 3636 V35697 3636 V35698 3636 V35701 3636 V35702 3636 V35708 3636 V35716 3636 V35717 3636 V35726 3636 V35742 3636 V35743 3636 V35748 3636 V35750 3636 V35752 3636 V35756 3636 V35762 3636 V35765 3636 V35768 3636 V35769 3636 V35771 3636 V35773 3636 V36049 3636 V36054 3636 V36057 3636 V36058 3636 V36060 3636 V36061 3636 V36062 3636 V36063 3636 V36064 3636 V36066 3636 V36068 3636 V36070 3636 V36071 3578 V27744 3578 V27745 3578 V27746 3578 V27747 3578 V27748 3578 V27749 3578 V27750 3578 V27751 3578 V27752 3578 V27753 3578 V27754 3578 V27755 3578 V27756 3578 V27757 3578 V27758 3578 V27759 3578 V27760 3578 V27761 3578 V27762 3578 V27763 3578 V27764 3578 V27765 3578 V27766 3578 ",".","21,754 units (21,222) in the U.S. and Puerto Rico)","Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.",9/30/2014,"09/30/2014",11/19/2014,"11/19/2014"
"Devices",69505,"Completed","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom","Z-0421-2015","Class II","GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours.","List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers",".","Not Applicable","The GemStar User/Service Manual should be removed from these websites as soon as possible to ensure that individuals will not have access to the codes that would allow them to manipulate the infusion rates set by their physicians. The dosage reset codes required to change the settings on GemStar infusion pumps have been accessed via website sponsors (by downloading the GemStar User/Service Manual featured on the sponsors' websites) and subsequently used in changing the infusion rate set by their doctors.",3/19/2013,"03/19/2013",12/2/2014,"12/02/2014"
"Devices",69505,"Completed","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom","Z-0422-2015","Class II","GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours.","List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers",".","Not Applicable","The GemStar User/Service Manual should be removed from these websites as soon as possible to ensure that individuals will not have access to the codes that would allow them to manipulate the infusion rates set by their physicians. The dosage reset codes required to change the settings on GemStar infusion pumps have been accessed via website sponsors (by downloading the GemStar User/Service Manual featured on the sponsors' websites) and subsequently used in changing the infusion rate set by their doctors.",3/19/2013,"03/19/2013",12/2/2014,"12/02/2014"
"Food",69507,"Ongoing","Z Natural Foods","West Palm Beach","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and UT Republic of Korea","F-0473-2015","Class I","Lightly Roasted Organic Carob Powder, 1lb and 5lb bags","Lot #ZNCARB39513, Best by: 12/5/2016",".","13 lbs","Possible risk of contamination from Salmonella",7/22/2014,"07/22/2014",11/19/2014,"11/19/2014"
"Devices",69508,"Terminated","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Visit","US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.","Z-0223-2015","Class II","Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.","Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155 ",".","14 units","Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.",8/6/2012,"08/06/2012",11/26/2014,"11/26/2014"
"Food",69509,"Ongoing","New Hope Mills Mfg., Inc.","Auburn","NY","US","Voluntary: Firm Initiated","Telephone","NY, PA, NH, OK and FL","F-0513-2015","Class I","NEW HOPE MILLS GLUTEN FREE CHIA PANCAKE & WAFFLE MIX, NET WT 16 OZ (1 LB) 454g, UPC 074703530126. Packed as 8 units per carton. Each unit is held within a red and white front box. Made in the USA.","Best By Dates: 11/13/2014, 11/14/2014, 2/26/2015, 7/29/2015, 10/4/2015, 12/13/2015",".","8,872 retail units total (1109 cases of 8)","New Hope Mills, Inc. has recalled New Hope Mills Gluten Free Chia Pancake and Waffle Mix due to the presence of Undeclared Soy.",10/15/2014,"10/15/2014",11/26/2014,"11/26/2014"
"Food",69510,"Ongoing","Herb Garden Productions","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV and internet sales.","F-0083-2015","Class I","WildForce Super Plant Protein, 2 lbs (32 oz) Bottled in 2500cc food grade white plastic bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102","LOT#: 821009-009 EXP.:07/2015 Manufacture Date: 07/2014 UPC CODE: 96859208416",".","1020 x 32 oz bottles.","Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.",10/14/2014,"10/14/2014",11/5/2014,"11/05/2014"
"Food",69510,"Ongoing","Herb Garden Productions","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV and internet sales.","F-0081-2015","Class I","Herbally Grounded Hello Blossom 120 ct Vegetarian Capsule Formula, bottle in 20cc food grade amber glass bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102","LOT#: 721002-013 EXP.:04/2017 Manufacture Date: 04/2014 UPC CODE: 718122297528",".","488 bottles","Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.",10/14/2014,"10/14/2014",11/5/2014,"11/05/2014"
"Food",69510,"Ongoing","Herb Garden Productions","Las Vegas","NV","US","Voluntary: Firm Initiated","Letter","NV and internet sales.","F-0082-2015","Class I","WildForce Green Formula, The Power of Wild Plants, 430 grams. bottles in 2500cc food grade white plastic bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102","LOT#: 821010-009 EXP.:06/2015 Manufacture Date: 06/2014 UPC CODE: 96859201233",".","1000 x 430 gram. containers.","Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.",10/14/2014,"10/14/2014",11/5/2014,"11/05/2014"
"Drugs",69511,"Ongoing","American Health Packaging","Columbus","OH","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0043-2015","Class III","MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11 ","AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11 ",,"2,005 cartons","Subpotent; 6 month stability time point",10/10/2014,"10/10/2014",10/29/2014,"10/29/2014"
"Devices",69512,"Ongoing","St Jude Medical","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of CA, GA, NJ, NY, OR and PA.","Z-0177-2015","Class II","St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353","Batch # 4671318",,"26","St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue",10/14/2014,"10/14/2014",11/12/2014,"11/12/2014"
"Food",69513,"Ongoing","United Natural Trading","Edison","NJ","US","Voluntary: Firm Initiated","E-Mail","CT, FL, ME, RI, VT & WI","F-0458-2015","Class II","The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # 04970540898 ","Lot# 14248 ",,"76 cases (containing 12 oz tubs)","A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Food",69513,"Ongoing","United Natural Trading","Edison","NJ","US","Voluntary: Firm Initiated","E-Mail","CT, FL, ME, RI, VT & WI","F-0459-2015","Class II","Asian 7 Rice Cracker Mix in Bulk 22 lb. cases; Wood Stock Farms Lot # YOUI03 sold to Publix Bakery Plant in Lakeland, FL, and to The Nutman Company - USA Inc., in Hubertus, WI.","Lot# YOUI03 ",,"359 cases","A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Devices",69514,"Completed","Monteris Medical Corp","Plymouth","MN","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA","Z-0228-2015","Class II","FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone. ","serial numbers: 20414-1-C1274-03, 20414-1-C1274-04, 20414-1-C1274-06, 20414-1-C1274-07, 20414-1-C1274-08, 20414-1-C1274-09, 20414-1-C1274-11, 20414-1-C1274-12, 20414-1-C1274-13, 20414-1-C1274-17, 20414-1-C1274-19, 20414-1-C1274-20, 20414-1-C1367-01, 20414-1-C1367-02, 20414-1-C1367-04, 20414-1-C1367-05, 20414-1-C1367-06, 20414-1-C1367-07, 20414-1-C3302-02, 20414-1-C3302-05, 20414-1-C3302-08, 20414-1-C3302-10, 20414-1-C3302-12, 20414-1-C3302-13, 20414-1-C3302-14, 20414-1-C3302-15, 20414-1-C3302-16, 20414-1-C3302-17, 20414-1-C3502-01, 20414-1-C3502-02, 20414-1-C3502-03, 20414-1-C3502-05, 20414-1-C3502-06, 20414-1-C3502-07, 20414-1-C3502-08, 20414-1-C3502-09, 20414-1-C3502-10, 20414-1-C3502-11, 20414-1-C3502-12, 20414-1-C3502-13, 20414-1-C3502-14, 20414-1-C3502-15, 20414-1-C3502-16, 20414-1-C3502-17, 20414-2-C1275-01, 20414-2-C1275-02, 20414-2-C1275-03, 20414-2-C1275-04, 20414-2-C1275-05, 20414-2-C1275-06, 20414-2-C1275-07, 20414-2-C1275-08, 20414-2-C1275-09, 20414-2-C1275-11, 20414-2-C1275-12, 20414-2-C1275-13, 20414-2-C1275-15, 20414-2-C1275-16, 20414-2-C1275-17, 20414-2-C1275-18, 20414-2-C1275-19, 20414-2-C1275-20, 20414-2-C1404-01, 20414-2-C1404-02, 20414-2-C1404-03, 20414-2-C1404-04, 20414-2-C1404-06, 20414-2-C1404-07, 20414-2-C1404-08, 20414-2-C1431-08, 20414-3-C1277-01, 20414-3-C1277-02, 20414-3-C1277-03, 20414-3-C1277-04, 20414-3-C1277-05, 20414-3-C1277-06, 20414-3-C1277-07, 20414-3-C1277-08, 20414-3-C1277-09, 20414-3-C1277-10, 20414-3-C3154-01, 20414-3-C3154-02, 20414-3-C3154-03, 20414-3-C3154-04, 20414-3-C3154-05, 20414-3-C3154-06, 20414-3-C3154-08, 20414-3-C3154-09, 20414-3-C3154-10, 20414-3-C3154-11, 20414-3-C3154-12, 20414-3-C3154-13, 20414-3-C3154-14, 20414-3-C3154-15, 20414-3-C3154-16, 20414-3-C3154-17, 20414-3-C3154-18, 20414-3-C3154-19, 20414-3-C3309-01, 20414-3-C3309-03, 20414-3-C3309-05, 20414-3-C3442-01, 20414-3-C3442-02, 20414-4-C1278-01, 20414-4-C1278-02, 20414-4-C1278-03, 20414-4-C1278-04, 20414-4-C1278-05, 20414-4-C1278-06, 20414-4-C1278-07, 20414-4-C1278-08, 20414-4-C1278-09, 20414-4-C127",".","133 devices","Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.",10/3/2014,"10/03/2014",11/26/2014,"11/26/2014"
"Devices",69514,"Completed","Monteris Medical Corp","Plymouth","MN","US","Voluntary: Firm Initiated","Telephone","US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA","Z-0227-2015","Class II","SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone. ","serial numbers: 20368-1-C1112-01, 20368-1-C1112-02, 20368-1-C1112-03, 20368-1-C1112-04, 20368-1-C1112-05, 20368-1-C1112-06, 20368-1-C1112-07, 20368-1-C1112-08, 20368-1-C1112-09, 20368-1-C3173-02, 20368-1-C3173-03, 20368-1-C3173-04, 20368-1-C3173-05, 20368-1-C3173-06, 20368-1-C3173-07, 20368-1-C3173-08, 20368-1-C3173-09, 20368-1-C3173-10, 20368-1-C3173-11, 20368-1-C3173-12, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11, 20368-1-C3462-12, 20368-1-C3462-13, 20368-1-C3462-14, 20368-1-C3462-16, 20368-1-C3462-17, 20368-1-C3462-18, 20368-1-C3462-19, 20368-1-C3462-22, 20368-1-C3462-24, 20368-1-C3462-25, 20368-1-C3756-01, 20368-1-C3756-02, 20368-1-C3756-04, 20368-1-C3756-05, 20368-1-C3756-06, 20368-1-C3756-07, 20368-1-C3756-08, 20368-1-C3756-11, 20368-1-C3756-12, 20368-2-C1276-02, 20368-2-C1276-04, 20368-2-C1276-05, 20368-2-C1276-06, 20368-2-C1276-07, 20368-2-C1276-08, 20368-2-C1276-09, 20368-2-C1276-11, 20368-2-C1276-12, 20368-2-C1276-13, 20368-2-C1276-14, 20368-2-C1276-15, 20368-2-C1276-16, 20368-2-C1276-17, 20368-2-C1276-18, 20368-2-C1276-19, 20368-2-C1276-20, 20368-2-C1276-21, 20368-2-C1276-22, 20368-2-C3287-01, 20368-2-C3287-02, 20368-2-C3287-03, 20368-2-C3287-04, 20368-2-C3287-05, 20368-2-C3287-06, 20368-2-C3287-07, 20368-2-C3287-08, 20368-2-C3287-09, 20368-2-C3287-10, 20368-2-C3287-11, 20368-2-C3287-12, 20368-2-C3287-13, 20368-2-C3287-14, 20368-2-C3287-15, 20368-2-C3287-16, 20368-2-C3287-17, 20368-2-C3287-19, 20368-2-C3287-20, 20368-2-C3287-21, 20368-2-C3287-22, 20368-2-C3472-01, 20368-2-C3472-02, 20368-2-C3472-03, 20368-2-C3472-04, 20368-2-C3472-05, 20368-2-C3472",".","234 devices ","Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.",10/3/2014,"10/03/2014",11/26/2014,"11/26/2014"
"Devices",69515,"Ongoing","Vision Rt Inc","Columbia","MD","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.","Z-0464-2015","Class II","AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. ","Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139. ","."," 7 (Six Units distribited in the US and One in OUS.) ","Potential failure of AlignRT to assert interlock.",10/15/2014,"10/15/2014",12/2/2014,"12/02/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0600-2015","Class I","Queso Cuzcatlan (Salvadorean Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Cuzcatlan Salvadorean Flavor Cheese Net Wt 1LB (16oz) ","UPC 635349 000413 Best By dates: 07/01/14 thru 12/31/14 ",".","210 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0605-2015","Class I","Mantequilla Hondurena (Honduran Style Butter Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Mantequilla Hondurena Honduran Style Cream Net WT 1 LB (16 oz) ","UPC 635349 000772 Best By dates: 07/01/14 thru 12/31/14 ",".","2,371 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0609-2015","Class I","Crema GuateLinda (Guatemalan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema GuateLinda Guatemalan Style Cream Net WT 1 LB (16 oz) ","UPC 635349 000390 Best By dates: 07/01/14 thru 12/31/14 ",".","144 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0598-2015","Class I","Quesito Casero (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Quesito Casero Fresh Curd Net Wt 12oz. (340g)","UPC 635349 000420 Best By dates: 07/01/14 thru 12/31/14 ",".","375 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0607-2015","Class I","HonduCrema (Hunduran Olanchana Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha HonduCrema Crema Olanchana Olanchana Style Soft Blend Dairy Spread Net WT 1 LB (16 oz) ","UPC 635349 000598 Best By dates: 07/01/14 thru 12/31/14 ",".","1,323 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0602-2015","Class I","Queso Fresco (Fresh Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Fresco Fresh Cheese Net Wt 12oz (340g) ","UPC 635349 000703 Best By dates: 07/01/14 thru 12/31/14 ",".","267 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0606-2015","Class I","Crema Nica (Nica Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Nica Grade A Cultured Cream Net WT 1 LB (16 oz) ","UPC 635349 000468 Best By dates: 07/01/14 thru 12/31/14 ",".","2,212 pieces ","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0601-2015","Class I","Queso Para Freir (Cheese for Frying) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso para Freir Cheese for Frying Net Wt 1LB (16oz) ","UPC 635349 000758 Best By dates: 07/01/14 thru 12/31/14 ",".","208 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0599-2015","Class I","My Queso (Latin Flavor Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha My Queso Latin Flavor Cheese Net Wt 1LB (16oz) ","UPC 635349 000406 Best By dates: 07/01/14 thru 12/31/14 ",".","84 pcs","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0610-2015","Class I","Crema Cuzcatlan (Salvadorean Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Cuzcatlan Salvadorean Style Cream Net WT 1 LB (16 oz) ","UPC 635349 000444 Best By dates: 07/01/14 thru 12/31/14 ",".","384 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0603-2015","Class I","Cuajada en Hoja (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd Net Wt 12oz (340g) ","UPC 635349 000895 Best By dates: 07/01/14 thru 12/31/14 ",".","37,126 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0597-2015","Class I","Queso Seco Hondureno (Honduran Style Dry Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Hondureno Dry Cheese Net Wt 12oz (340g)","UPC 876593 001690 Best By dates: 07/01/14 thru 12/31/14 ",".","989 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0608-2015","Class I","Crema Guatemalteca (Guatemaltecan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Guatemalteca Guatemalan Style Cream Net WT 1 LB (16 oz) ","UPC 635349 000819 Best By dates: 07/01/14 thru 12/31/14 ",".","1,354 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0595-2015","Class I","Queso Seco Centroamericano (Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Centroamericano Dry White Cheese Net Wt 1LB (16oz)","UPC 876593 001874 Best By dates: 07/01/14 thru 12/31/14 ",".","1,921 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd; FDA made an inspection, were the environmental samples that came up positive also for Listeria monocytogenes, also the firm sent samples to a private lab that came positive for Listeria monocytogenes in various products. The firm is voluntarily recalling all their Lacteos Santa Martha products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0604-2015","Class I","Crema Centroamericana (Centroamerican Style Soft Blend Dairy Spread) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Centroamericana Net Wt 1LB (16oz) ","UPC 876593 001898 Best By dates: 07/01/14 thru 12/31/14 ",".","6,369 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Food",69516,"Ongoing","Oasis Brands, Inc","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA. NC, and TN","F-0596-2015","Class I","Queso Seco Olanchano (Olanchano Style Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Olanchano Dry Cheese Net Wt 1LB (16oz)","UPC 635349 000840 Best By dates: 07/01/14 thru 12/31/14 ",".","854 pieces","Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date. ",10/10/2014,"10/10/2014",12/10/2014,"12/10/2014"
"Drugs",69518,"Ongoing","Baxter Healthcare Corp.","Deerfield","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0256-2015","Class II","Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.","Lot #: P319160, Exp 06/30/15",".","63,360 container bags","Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.",11/10/2014,"11/10/2014",12/2/2014,"12/02/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0221-2015","Class II","PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140715@18, discard date: 10/13/2014; Lot #: 20140917@18, discard date: 12/16/2014; ",".","660 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0199-2015","Class II","HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140729@18, discard date: 10/27/2014 ",".","570 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0193-2015","Class II","GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@29/150, discard date: 10/16/2014 ",".","300 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0181-2015","Class II","CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140728@55, discard date: 1/14/2015; Lot #: 20140915@14, discard date: 3/8/2015. ",".","145 vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0185-2015","Class II","DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140903@10, discard date: 10/18/2014 ",".","4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0209-2015","Class II","PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140827@30, discard date: 10/11/2014; Lot #: 20140910@28/1.7, discard date: 10/25/2014; Lot #: 20140917@2/1.25, discard date: 11/1/2014. ",".","25 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0224-2015","Class II","TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140714@51, discard date: 1/10/2015 ",".","85 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0190-2015","Class II","GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140916@16, discard date: 10/31/2014 ",".","40 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0204-2015","Class II","METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015. ",".","119/0.3 mL vials and 106/1 mL vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0180-2015","Class II","CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@33, discard date: 10/20/2014 ",".","12 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0226-2015","Class II","TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140909@6, discard date: 10/24/2014 ",".","2 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0220-2015","Class II","PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@11/10, discard date: 12/4/2014 ",".","540 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0175-2015","Class II","ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140821@17, discard date:10/20/2014 ",".","2500 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0179-2015","Class II","CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140815@47, discard date: 1/28/2015 ",".","580 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0186-2015","Class II","DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140828@14; discard date: 11/26/2014 ",".","210 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0195-2015","Class II","GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014. ",".","2200 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0212-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140901@3, discard date: 10/19/2014 ",".","10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0208-2015","Class II","OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015. ",".","680 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0225-2015","Class II","TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@16, discard date: 10/17/2014 ",".","1000 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0216-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140728@39, discard date: 12/3/2014; ",".","103.4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0210-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@16/1.7, discard date: 12/3/2014; Lot #: 20140728@43/2, discard date: 12/3/2014. ",".","43 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0201-2015","Class II","LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140815@12, discard date: 2/16/2015 ",".","49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0217-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140910@42, discard date: 1/25/2015 ",".","10 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0187-2015","Class II","DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140724@24/5, discard date: 10/22/2014; Lot #: 20140724@25, discard date: 10/22/2014; Lot #: 20140826@12, discard date: 11/24/2014. ",".","280 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0182-2015","Class II","CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015. ",".","117 vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0178-2015","Class II","BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140916@3, discard date: 12/15/2014. ",".","2.65 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0200-2015","Class II","HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140718@1/5, discard date: 1/14/2015; Lot #: 20140813@25, discard date: 2/9/2015; Lot #: 20140903@32, discard date: 3/2/2015. ",".","520 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0176-2015","Class II","ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014. ",".","7900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0223-2015","Class II","TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140812@7, discard date: 2/8/2015; Lot #: 20140910@41, discard date: 3/9/2015; ",".","175 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0189-2015","Class II","ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140828@15, discard date: 10/12/2014 ",".","4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0174-2015","Class II","ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140902@17/1.25; discard date: 10/17/2014 ",".","5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0215-2015","Class II","PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140910@48/1.25, discard date: 10/25/2014; Lot #: 20140911@11/1.25, discard date: 10/26/2014; Lot #: 20140916@17/1.25, discard date: 10/31/2014. ",".","15 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0192-2015","Class II","GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140917@27, discard date: 10/22/2014 ",".","800 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0213-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140708@30, discard date: 12/2/2014 ",".","46.7 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0184-2015","Class II","COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140919@21, discard date: 11/3/2014 ",".","600 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0207-2015","Class II","MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140913@4, discard date: 10/28/2014 ",".","8 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0202-2015","Class II","METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140729@16/1, discard date: 11/26/2014 ",".","120 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0222-2015","Class II","SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140916@23, discard date: 10/31/2014 ",".","180 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0198-2015","Class II","HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140717@6, discard date: 10/15/2014 ",".","58 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0197-2015","Class II","HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140818@27, discard date: 2/21/2015 ",".","10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0211-2015","Class II","PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140903@14/1.25, discard date: 10/18/2014 ",".","5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0183-2015","Class II","CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140908@2, discard date: 10/23/2014 ",".","900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0205-2015","Class II","METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140715@2, discard date: 10/13/2014; Lot #: 20140724@10, discard date: 10/22/2014; Lot #: 20140812@14, discard date: 11/1/2014; Lot #: 20140826@5, discard date: 11/1/2014; ",".","1320 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0227-2015","Class II","VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@32, discard date: 10/20/2014 ",".","12 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0206-2015","Class II","MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140913@1, discard date: 10/28/2014 ",".","5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0214-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@25, discard date: 10/27/2014 ",".","5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0173-2015","Class II","ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.","Lot #: 20140913@10, discard date 10/28/2014 ",".","5 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0194-2015","Class II","GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014. ",".","250 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0191-2015","Class II","GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140911@9, discard date: 10/26/2014 ",".","20 Syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0218-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140828@4/1.7, discard date: 10/15/2014 ",".","1.7 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0228-2015","Class II","VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140811@5, discard date 10/16/2014 Lot #: 20140827@12, discard date 11/25/2014",".","490 mL total","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0177-2015","Class II","AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140715@13, discard date: 11/3/2014; Lot #: 20140716@25, discard date: 10/14/2014; Lot #: 20140717@7, discard date: 10/15/2014; Lot #: 20140724@14, discard date: 10/22/2014; Lot #: 20140724@15, discard date: 10/22/2014; Lot #: 20140729@11, discard date: 10/27/2014; Lot #: 20140801@17, discard date: 10/30/2014; Lot #: 20140805@1, discard date: 11/3/2014; Lot #: 20140807@13, discard date: 11/5/2014; Lot #: 20140811@30, discard date: 11/9/2014; Lot #: 20140813@10, discard date: 11/11/2014; Lot #: 20140825@8, discard date: 11/23/2014; Lot #: 20140904@46, discard date: 12/3/2014; Lot #: 20140909@12, discard date: 12/8/2014; Lot #: 20140909@21, discard date: 12/8/2014; Lot #: 20140912@30, discard date: 12/11/2014; Lot #: 20140917@11, discard date: 12/16/2014; Lot #: 20140917@9, discard date: 12/16/2014; Lot #: 20140922@30, discard date: 12/21/2014; Lot #: 20140814@15, discard date: 11/12/2014. ",".","5483/0.5 mL syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0203-2015","Class II","METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@2/2, discard date: 1/18/2015; Lot #: 20140910@40/2, discard date: 3/9/2015. ",".","516 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0196-2015","Class II","GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140718@4, discard date: 10/16/2014 ",".","900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0219-2015","Class II","PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140902@22, discard date: 10/17/2014 ",".","10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0188-2015","Class II","EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140913@2, discard date: 10/18/2014 ",".","10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/5/2014,"11/05/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0221-2015","Class II","PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140715@18, discard date: 10/13/2014; Lot #: 20140917@18, discard date: 12/16/2014; ",,"660 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0175-2015","Class II","ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140821@17, discard date:10/20/2014 ",,"2500 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0183-2015","Class II","CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140908@2, discard date: 10/23/2014 ",,"900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0192-2015","Class II","GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140917@27, discard date: 10/22/2014 ",,"800 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0185-2015","Class II","DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140903@10, discard date: 10/18/2014 ",,"4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0202-2015","Class II","METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140729@16/1, discard date: 11/26/2014 ",,"120 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0176-2015","Class II","ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014. ",,"7900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0193-2015","Class II","GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@29/150, discard date: 10/16/2014 ",,"300 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0191-2015","Class II","GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140911@9, discard date: 10/26/2014 ",,"20 Syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0225-2015","Class II","TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@16, discard date: 10/17/2014 ",,"1000 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0179-2015","Class II","CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140815@47, discard date: 1/28/2015 ",,"580 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0207-2015","Class II","MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140913@4, discard date: 10/28/2014 ",,"8 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0189-2015","Class II","ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140828@15, discard date: 10/12/2014 ",,"4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0190-2015","Class II","GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140916@16, discard date: 10/31/2014 ",,"40 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0211-2015","Class II","PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140903@14/1.25, discard date: 10/18/2014 ",,"5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0206-2015","Class II","MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140913@1, discard date: 10/28/2014 ",,"5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0217-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140910@42, discard date: 1/25/2015 ",,"10 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0184-2015","Class II","COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140919@21, discard date: 11/3/2014 ",,"600 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0220-2015","Class II","PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@11/10, discard date: 12/4/2014 ",,"540 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0204-2015","Class II","METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015. ",,"119/0.3 mL vials and 106/1 mL vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0187-2015","Class II","DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140724@24/5, discard date: 10/22/2014; Lot #: 20140724@25, discard date: 10/22/2014; Lot #: 20140826@12, discard date: 11/24/2014. ",,"280 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0173-2015","Class II","ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.","Lot #: 20140913@10, discard date 10/28/2014 ",,"5 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0182-2015","Class II","CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015. ",,"117 vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0227-2015","Class II","VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@32, discard date: 10/20/2014 ",,"12 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0194-2015","Class II","GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014. ",,"250 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0196-2015","Class II","GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140718@4, discard date: 10/16/2014 ",,"900 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0200-2015","Class II","HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140718@1/5, discard date: 1/14/2015; Lot #: 20140813@25, discard date: 2/9/2015; Lot #: 20140903@32, discard date: 3/2/2015. ",,"520 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0215-2015","Class II","PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140910@48/1.25, discard date: 10/25/2014; Lot #: 20140911@11/1.25, discard date: 10/26/2014; Lot #: 20140916@17/1.25, discard date: 10/31/2014. ",,"15 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0216-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140728@39, discard date: 12/3/2014; ",,"103.4 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0219-2015","Class II","PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140902@22, discard date: 10/17/2014 ",,"10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0228-2015","Class II","VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140811@5, discard date 10/16/2014 Lot #: 20140827@12, discard date 11/25/2014",,"490 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0218-2015","Class II","PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140828@4/1.7, discard date: 10/15/2014 ",,"1.7 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0181-2015","Class II","CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140728@55, discard date: 1/14/2015; Lot #: 20140915@14, discard date: 3/8/2015. ",,"145 vials","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0180-2015","Class II","CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140905@33, discard date: 10/20/2014 ",,"12 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0178-2015","Class II","BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140916@3, discard date: 12/15/2014. ",,"2.65 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0197-2015","Class II","HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140818@27, discard date: 2/21/2015 ",,"10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0213-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140708@30, discard date: 12/2/2014 ",,"46.7 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0222-2015","Class II","SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140916@23, discard date: 10/31/2014 ",,"180 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0208-2015","Class II","OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015. ",,"680 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0210-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@16/1.7, discard date: 12/3/2014; Lot #: 20140728@43/2, discard date: 12/3/2014. ",,"43 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0199-2015","Class II","HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140729@18, discard date: 10/27/2014 ",,"570 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0195-2015","Class II","GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014. ",,"2200 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0212-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140901@3, discard date: 10/19/2014 ",,"10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0205-2015","Class II","METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140715@2, discard date: 10/13/2014; Lot #: 20140724@10, discard date: 10/22/2014; Lot #: 20140812@14, discard date: 11/1/2014; Lot #: 20140826@5, discard date: 11/1/2014; ",,"1320 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0223-2015","Class II","TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140812@7, discard date: 2/8/2015; Lot #: 20140910@41, discard date: 3/9/2015; ",,"175 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0201-2015","Class II","LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140815@12, discard date: 2/16/2015 ",,"49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0214-2015","Class II","PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140912@25, discard date: 10/27/2014 ",,"5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0226-2015","Class II","TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140909@6, discard date: 10/24/2014 ",,"2 syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0174-2015","Class II","ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140902@17/1.25; discard date: 10/17/2014 ",,"5 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0188-2015","Class II","EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140913@2, discard date: 10/18/2014 ",,"10 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0203-2015","Class II","METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140722@2/2, discard date: 1/18/2015; Lot #: 20140910@40/2, discard date: 3/9/2015. ",,"516 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0186-2015","Class II","DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070","Lot #: 20140828@14; discard date: 11/26/2014 ",,"210 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0198-2015","Class II","HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140717@6, discard date: 10/15/2014 ",,"58 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0224-2015","Class II","TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140714@51, discard date: 1/10/2015 ",,"85 mL","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0209-2015","Class II","PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 ","Lot #: 20140827@30, discard date: 10/11/2014; Lot #: 20140910@28/1.7, discard date: 10/25/2014; Lot #: 20140917@2/1.25, discard date: 11/1/2014. ",,"25 mL ","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Drugs",69519,"Ongoing","Oregon Compounding Centers, Inc. dba Creative Compounds","Wilsonville","OR","US","Voluntary: Firm Initiated","Press Release","Oregon, Washington","D-0177-2015","Class II","AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. ","Lot #: 20140715@13, discard date: 11/3/2014; Lot #: 20140716@25, discard date: 10/14/2014; Lot #: 20140717@7, discard date: 10/15/2014; Lot #: 20140724@14, discard date: 10/22/2014; Lot #: 20140724@15, discard date: 10/22/2014; Lot #: 20140729@11, discard date: 10/27/2014; Lot #: 20140801@17, discard date: 10/30/2014; Lot #: 20140805@1, discard date: 11/3/2014; Lot #: 20140807@13, discard date: 11/5/2014; Lot #: 20140811@30, discard date: 11/9/2014; Lot #: 20140813@10, discard date: 11/11/2014; Lot #: 20140825@8, discard date: 11/23/2014; Lot #: 20140904@46, discard date: 12/3/2014; Lot #: 20140909@12, discard date: 12/8/2014; Lot #: 20140909@21, discard date: 12/8/2014; Lot #: 20140912@30, discard date: 12/11/2014; Lot #: 20140917@11, discard date: 12/16/2014; Lot #: 20140917@9, discard date: 12/16/2014; Lot #: 20140922@30, discard date: 12/21/2014; Lot #: 20140814@15, discard date: 11/12/2014. ",,"5483/0.5 mL syringes","Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",10/6/2014,"10/06/2014",11/12/2014,"11/12/2014"
"Food",69520,"Ongoing","Publix Bakery Plant","Lakeland","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, SC, AL, TN and NC","F-0469-2015","Class II","Publix Asian Mix, 14 oz. clamshell containers","UPC: 41415-20286, All sell by dates between 01/03/15 and 02/03/15, All Lot Codes.",".","1002 cases","Product contains peanuts that are not declared on the label.",10/16/2014,"10/16/2014",11/19/2014,"11/19/2014"
"Devices",69521,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Distributed in the states of ND, VT and TX.","Z-0200-2015","Class II","Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.","Lot Number: 1451506 Expiration: 26Feb2016",".","16/10/100 ml, vial, pkgs","Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.",10/17/2014,"10/17/2014",11/19/2014,"11/19/2014"
"Biologics",69522,"Terminated","Amer. National Red Cross-Greater Chesapeake & Potomac Reg.","Baltimore","MD","US","Voluntary: Firm Initiated","Other","CA","B-0147-15","Class III","Blood and Blood Products for Reprocessing","W205314085022",".","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.",8/20/2014,"08/20/2014",12/10/2014,"12/10/2014"
"Biologics",69523,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","NC","B-0148-15","Class II","Red Blood Cells Leukocytes Reduced","W051514077541",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",9/4/2014,"09/04/2014",12/10/2014,"12/10/2014"
"Biologics",69524,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","MN","B-0149-15","Class II","Red Blood Cells Leukocytes Reduced","W051514092327",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",9/4/2014,"09/04/2014",12/10/2014,"12/10/2014"
"Biologics",69525,"Terminated","Community Blood Center, Inc.","Appleton","WI","US","Voluntary: Firm Initiated","Letter","WI, IL, MS and Switzerland","B-0150-15","Class III","Cryoprecipitated AHF","W053311505043",".","1 unit","Blood product, collected from a donor with an invalid result for body temperature, was distributed",9/9/2014,"09/09/2014",12/10/2014,"12/10/2014"
"Biologics",69525,"Terminated","Community Blood Center, Inc.","Appleton","WI","US","Voluntary: Firm Initiated","Letter","WI, IL, MS and Switzerland","B-0151-15","Class III","Red Blood Cells Leukocytes Reduced","W053311505043; W053311822916",".","2 units","Blood product, collected from a donor with an invalid result for body temperature, was distributed. ",9/9/2014,"09/09/2014",12/10/2014,"12/10/2014"
"Biologics",69526,"Terminated","LifeShare Blood Centers","Beaumont","TX","US","Voluntary: Firm Initiated","Letter","LA","B-0152-15","Class II","Red Blood Cells Leukocytes Reduced","W036514034308",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.",7/2/2014,"07/02/2014",12/10/2014,"12/10/2014"
"Biologics",69527,"Terminated","LifeShare Blood Centers","Monroe","LA","US","Voluntary: Firm Initiated","Letter","AR","B-0153-15","Class II","Red Blood Cells Leukocytes Reduced","W036514009542",".","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed",5/12/2014,"05/12/2014",12/10/2014,"12/10/2014"
"Biologics",69528,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","NY","B-0154-15","Class II","Red Blood Cells Leukocytes Reduced","W051514087673",".","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.",9/4/2014,"09/04/2014",12/10/2014,"12/10/2014"
"Biologics",69529,"Terminated","Innovative Blood Resources","Saint Paul","MN","US","Voluntary: Firm Initiated","Letter","Minnesota","B-0114-15","Class II","Red Blood Cells Leukocytes Reduced Irradiated","W051514081844; ",".","1 unit","Blood product, collected from a donor who travelled to an area considered endemic for malaria, was distributed.",9/18/2014,"09/18/2014",11/19/2014,"11/19/2014"
"Biologics",69530,"Terminated","Blood Bank Of Hawaii","Honolulu","HI","US","Voluntary: Firm Initiated","FAX","Hawaii","B-0133-15","Class II","Red Blood Cells Leukocytes Reduced","W088414100739; ",".","1 unit","Blood product, collected from a donor whose travel history was not complete, was distributed.",9/23/2014,"09/23/2014",12/17/2014,"12/17/2014"
"Devices",69531,"Terminated","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Visit","US Distribution in the states of: CA, NE, and NY.","Z-0222-2015","Class II","MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.","MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609",".","5","Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.",5/24/2013,"05/24/2013",11/26/2014,"11/26/2014"
"Devices",69532,"Ongoing","Biosense Webster, Inc.","Irwindale","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0139-2015","Class II","ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.","Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)",".","173,329 units total (21,812 units in US)","The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.",10/19/2014,"10/19/2014",11/5/2014,"11/05/2014"
"Devices",69535,"Ongoing","Dokitz NovoSci","Conroe","TX","US","Voluntary: Firm Initiated","Letter","MO, TX, PA, IL, MD, UT","Z-0178-2015","Class II","Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014","Model No. 321334-000, lot number 295424",,"240 units","The single leg of the PAY connector has been observed to become detached.",9/18/2014,"09/18/2014",11/12/2014,"11/12/2014"
"Devices",69536,"Ongoing","American Medical Systems, Inc.","Minnetonka","MN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA.","Z-0209-2015","Class II","AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa. ","Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 886260024 886260025 886261024 886262010 886263002 886263017 886264010 886264024 886848011 886848012 886849016 886855001 886855019 886858004 886858011 886858014 887908021 887909002 887909003 887909008 887910017 887912005 887912006 887915009 887917021 888755008 888755012 888758013 888762005 888762015 889654010 889656003 889656005 889656006 889656023 889657013 889657014 890573015 890573017 890576003 890577015 890578013 890579011 890579016 890580017 890581001 890581002 890581003 890581004 890581005 890581006 890581007 890581018 890581024 890582011 890582012 890582013 891506011 891506012 891507012 891507014 891507021 891508002 891508019 891508020 891508021 891509005 891509006 891510011 891511001 891511002 891513002 891513003 891513024 891515003 891516015 892497013 892497014 892498002 892501001 892501002 892501003 892501004 892501012 892501016 892501017 892501018 892501019 892501020 892501021 892501022 892501023 892501024 892501025 ",".","184 (110 US, 74 OUS)","AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.",10/10/2014,"10/10/2014",11/19/2014,"11/19/2014"
"Devices",69537,"Terminated","Nidek Inc","Fremont","CA","US","Voluntary: Firm Initiated","Visit","US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.","Z-0224-2015","Class II","Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.","Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382, ",".","21affected devices","When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.",10/24/2012,"10/24/2012",11/26/2014,"11/26/2014"
"Drugs",69538,"Ongoing","Zee Medical Products Inc","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide in US","D-0041-2015","Class II","ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528","Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062",,"43,752 boxes","Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.",10/7/2014,"10/07/2014",10/29/2014,"10/29/2014"
"Drugs",69539,"Ongoing","West-Ward Pharmaceutical Corp.","Eatontown","NJ","US","Voluntary: Firm Initiated","Letter","GA","D-0172-2015","Class II","VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01 ","Lot #68975A, #68976; Exp. 07/15 ",".","5,596 HDPE bottles","Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.",10/2/2014,"10/02/2014",11/5/2014,"11/05/2014"
"Devices",69540,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.","Z-0171-2015","Class I","Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.","Catalog number: B1017-167, Siemens Material number 1044652, lot numbers: 2014-11-01, Exp. 2014-11-01; 2015-01-03, Exp 2015-01-03; 2015-02-14, Exp 2015-02-14; 2015-03-21, Exp 2015-03-21; 2015-05-20, Exp 2015-05-20; 2015-06-18, Exp 2015-06-18; 2015-07-18, Exp 2015-07-18; 2015-08-11, Exp 2015-08-11/",".","2239","An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.",10/17/2014,"10/17/2014",11/19/2014,"11/19/2014"
"Devices",69540,"Ongoing","Siemens Healthcare Diagnostics, Inc. ","West Sacramento","CA","US","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.","Z-0170-2015","Class I","Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.","Catalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.",".","1381","An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.",10/17/2014,"10/17/2014",11/19/2014,"11/19/2014"
"Devices",69541,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.","Z-0491-2015","Class II","Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval "," Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410",".","6,358 tubing kits","Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.",9/29/2014,"09/29/2014",12/10/2014,"12/10/2014"
"Devices",69542,"Ongoing","Abbott Molecular","Des Plaines","IL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution in states of: CA, CT, FL, NC, PA, SC + Washington DC; and countries of: Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Columbia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , and Vietnam.","Z-0463-2015","Class II","Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing.","List Number: 09K14; Models: E series, G series",".","9 CD ROMs (US); 1,273 CD ROMs (Foreign)","Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause Error Code 9000 ("An unexpected error has occurred: Software error") to generated when <Available Reagent Packs> screen is selected.",10/23/2014,"10/23/2014",12/2/2014,"12/02/2014"
"Food",69543,"Completed","Pacific Sun Distributing","Bell","CA","US","Voluntary: Firm Initiated","Letter","North Carolina","F-0094-2015","Class I","Serrano Chili, 38 lbs. ","Lot No. 42916",".","384 cases","Pacific Sun Distributing is recalling serrano peppers because they may be contaminated with Salmonella.",10/20/2014,"10/20/2014",11/5/2014,"11/05/2014"
"Food",69544,"Ongoing","Family Dollar Stores - NC Distribution Center","Matthews","NC","US","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE,NV, NH, NJ, NM, NY, NC,ND,OH, OK, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WI, WY","F-0090-2015","Class III","Family Gourmet Long Grain Enriched White Rice in 32 oz. clear plastic bags (SKU: 1218898) and 80 oz. clear plastic bag (SKU: 1218870).","202GP14, Exp. July 21, 2016; 203GP14, Exp. July 22, 2016; 204GP14, Exp. July 23, 2016; 230GP14, Exp. August 18, 2016; 231GP14, Exp. August 19, 2016; 246GP14, Exp. September 3, 2016",".","423,505 units","Possible insect infestation",10/2/2014,"10/02/2014",11/5/2014,"11/05/2014"
"Drugs",69546,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide.","D-0243-2015","Class III","Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326","Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15 ",,"11,062 bottles","Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Drugs",69546,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide.","D-0241-2015","Class III","Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3","Lot #: KR3924, KR3926; Exp. 11/15",,"13,177 bottles","Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Drugs",69546,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide.","D-0244-2015","Class III","Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326","Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15 ",,"22,710 bottles","Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Drugs",69546,"Ongoing","Apotex Inc.","Toronto",,"CA","Voluntary: Firm Initiated","Letter","Nationwide.","D-0242-2015","Class III","Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3","Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15",,"18,493","Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Drugs",69547,"Ongoing","Pharmaceutical Associates Inc","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0240-2015","Class II","Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10","Lot 3H43, Exp. 02/15",,"9,640 unit dose cups ","Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.",10/16/2014,"10/16/2014",11/12/2014,"11/12/2014"
"Biologics",69548,"Terminated","American Red Cross Blood Services Appalachian Region","Roanoke","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-0126-15","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W202714025178; ",".","1 unit","Blood product, labelled with incorrect expiration date, was distributed.",9/11/2014,"09/11/2014",11/19/2014,"11/19/2014"
"Biologics",69549,"Terminated","Lane Memorial Blood Bank","Eugene","OR","US","Voluntary: Firm Initiated","FAX","Washington","B-0128-15","Class II","Red Blood Cells Leukocytes Reduced","W137514207061; ",".","1 unit","Blood product, collected from an unsuitable donor, was distributed.",9/3/2014,"09/03/2014",12/17/2014,"12/17/2014"
"Biologics",69551,"Terminated","The Blood Alliance, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0127-15","Class III","Red Blood Cells Leukocytes Reduced Irradiated","W118814662726; W118814702706; ",".","2 units","Blood products, not prepared in accordance with specifications, were distributed.",9/4/2014,"09/04/2014",11/19/2014,"11/19/2014"
"Biologics",69552,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; New Jersey; Maryland","B-0210-15","Class II","Cryoprecipitated AHF","W050911077526; ",".","1 unit","Blood products, collected from ineligible donors, were distributed. ",6/3/2014,"06/03/2014",12/17/2014,"12/17/2014"
"Biologics",69552,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; New Jersey; Maryland","B-0206-15","Class II","Platelets Pheresis Leukocytes Reduced","W050911078648; ",".","1 unit","Blood products, collected from ineligible donors, were distributed. ",6/3/2014,"06/03/2014",12/17/2014,"12/17/2014"
"Biologics",69552,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; New Jersey; Maryland","B-0207-15","Class II","Red Blood Cells (Apheresis)","W050911078648; ",".","1 unit","Blood products, collected from ineligible donors, were distributed. ",6/3/2014,"06/03/2014",12/17/2014,"12/17/2014"
"Biologics",69552,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; New Jersey; Maryland","B-0209-15","Class II","Red Blood Cells","W050911077526; ",".","1 unit","Blood products, collected from ineligible donors, were distributed. ",6/3/2014,"06/03/2014",12/17/2014,"12/17/2014"
"Biologics",69552,"Terminated","HCSC-Blood Center","Bethlehem","PA","US","Voluntary: Firm Initiated","Letter","Pennsylvania; New Jersey; Maryland","B-0208-15","Class II","Red Blood Cells Leukocytes Reduced","W050911078718; ",".","1 unit","Blood products, collected from ineligible donors, were distributed. ",6/3/2014,"06/03/2014",12/17/2014,"12/17/2014"
"Drugs",69553,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0233-2015","Class II","Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1 ","3101178, exp Aug 2014, 3104318, exp Aug 2014, 3104319, exp Oct 2014, 3104889, exp Oct 2014, 3104891, exp Oct 2014, 3104893, exp Oct 2014, and 3106651, exp Dec 2014",".","46,676 cartons","Subpotent Drug",8/25/2014,"08/25/2014",11/5/2014,"11/05/2014"
"Drugs",69553,"Ongoing","Actavis Inc","Parsippany","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0232-2015","Class II","Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4 ","3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, exp Dec 2014 ",".","26,663 cartons","Subpotent Drug",8/25/2014,"08/25/2014",11/5/2014,"11/05/2014"
"Drugs",69554,"Ongoing","Contract Packaging Resources Inc.","Greensboro","NC","US","Voluntary: Firm Initiated","Telephone","Nationwide","D-0248-2015","Class II","Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320","Lot FH4102A UPC #639277223685, Exp. Date 3/16",".","11,640 boxes","Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into boxes of Assured Naproxen Sodium Tablets, USP",10/10/2014,"10/10/2014",11/19/2014,"11/19/2014"
"Food",69556,"Ongoing","MASIERO BROS.INC","Fairfield","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY","F-0505-2015","Class III","Oven Fresh Lemon Pound Cake, Net Wt. 5 oz., Oven Fresh Baking, LLC, 70 Clinton Road. Fairfield, NJ 07004, UPC 089595901145","None",".","32 cases (12 pieces per case)","Masiero Brothers LLC initiated a voluntary recall for their Lemon Pound Cake because of misbranding.",9/12/2014,"09/12/2014",11/26/2014,"11/26/2014"
"Devices",69557,"Ongoing","Maquet Cardiovascular Us Sales, Llc","Wayne","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-0211-2015","Class II"," Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).","90410803 90410984 90410456 90410609 90410610 90410740 90410737 90410738 90410733 90410865 90411005 90410552 90410572 90410849 90410864 90410867 90410796 90410481 90410319 90410328 90411176 90410988 90410703 90410431 90411186 90411188 90411191 90410800 90410611 90410669 90410517 90410692 90410499 90410500 90410739 90410612 90410714 90410759 90410771 90410430 90410276 90410576 90410482 90410749 90410774 90410859 90410860 90410863 90411088 90411082 90411087 90411091 90411089 90410866 90411144 90410970 90411023 90411033 90411038 90411032 90410974 90410962 90410455 90410448 90410449 90411175 90410524 90411007 90410353 90410433 90410435 90410770 90410785 90410440 90410932 90410968 90410732 90411035 90411028 90410736 90410249 90410410 90410411 90411169 90411157 90410963 90411078 90410237 90410284 90410786 90410772 90410922 90411093 90411192 90411193 90410582 90410516 90410662 90410666 90410664 90410665 90410235 90411189 90411187 90411154 90411179 90411178 90410580 90410596 90410599 90410651 90410646 90410735 90410787 90410839 90410851 90410848 90410852 90410845 90411105 90411143 90411145 90411141 90410530 90410584 90410607 90410575 90410581 90410498 90410756 90410936 90410663 90410909 90410746 90410744 90410450 90410606 90410979 90411004 90411009 90411006 90411010 90410398 90410400 90410399 90410713 90410973 90410351 90410352 90410840 90410242 90410252 90410239 90410426 90410427 90410754 90410503 90410518 90411008 90410573 90410577 90410585 90410668 90410408 90410409 90410653 90410961 90410982 90411174 90410568 90410406 90410640 90410644 90410534 90410537 90410780 90411146 90411181 90411184 90411108 90411107 90411171 90410986 90411003 90410716 90410638 90410717 90411036 90411037 90410847 90410231 90410458 90410779 90410783 90411168 90411170 90410975 90410782 90410846 90410838 90410650 90410608 90410844 90410745 904109",".","331 units","Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power",10/17/2014,"10/17/2014",11/19/2014,"11/19/2014"
"Food",69558,"Terminated","High Quality Organics, Inc.","Reno","NV","US","Voluntary: Firm Initiated","Telephone","One customer in NJ.","F-0456-2015","Class I","Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506","GINTBC lot 13118; GINOV lot 13613; both with expiry dates of 9/24/16.",,"780 lbs.","High Quality Organics was notified by customer that representative sample of Organic Ginger (Tea Bag Cut) tested positive for Salmonella",10/14/2014,"10/14/2014",11/12/2014,"11/12/2014"
"Food",69559,"Ongoing","Health Wise","Grovetown","GA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DE, FL, GA, SC, TX and UT.","F-0497-2015","Class II","Vanilla Pro-Med. 100, Vanilla Pro, High Protein Instant Shake, Net Weight .0935 oz, Distributed by Our Life Health, Savannah, GA","Lot # 153-51474",".","12,196 containers","Foreign matter found in product; steel wool.",10/21/2014,"10/21/2014",11/19/2014,"11/19/2014"
"Food",69561,"Ongoing","Premier Research Labs LP","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.","F-0592-2015","Class II","Premier Research Labs BiliVen, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each);Item Number 2411","Lot Number: 111202-2411, 130411-2411, 130612-2411, 130708-2411; UPC 0773502411",".","49,830 bottles","Undeclared wheat",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Food",69561,"Ongoing","Premier Research Labs LP","Austin","TX","US","Voluntary: Firm Initiated","E-Mail","Gallbladder Support products were distributed in all states in the US as well as internationally to Canada, Ecuador, and Singapore. BiliVen products were distributed in all states in the US as well as internationally to Canada, Hong Kong, Ireland, New Zealand, Singapore, United Arab Emirates, United Kingdom, Australia, Bermuda, Fiji, and Israel.","F-0591-2015","Class II","Quantum Gallbladder Support, 60 capsules in dark plastic container, each capsule is 460 mg or 427 mg each; Item Number 12411; UPC 0773512411","Lot Number: 111202-12411, 130411-12411, 130612-12411, 130708-12411",".","7101 bottles","Undeclared wheat",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69565,"Ongoing","Edwards Lifesciences, LLC","Draper","UT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia. US Territory: Puerto Rico and Internationally to Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Singapore, South Korea, Sri Lanka, Taiwan, and Venezuela.","Z-0217-2015","Class II","Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy. ","Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138592;59199148;59202405;59370449;59528372;59625386;59723318;59148881;59207364;59222648;59409903;59528392;59634884;59735991;59149673;59211452;59245610;59414824;59541717;59651860;59747795;59149675;59211456;59245648;59453572;59555076;59662625;59758989;59151406;59216325;59266772;59456447;59563964;59680248;59769429;59161706;59218844;59283731;59458072;59568501;59691477;59774986;59163769;59229509;59309184;59463365;59577224;59695811;59791798;59179981;59229512;59319451;59490087;59604744;59706987;59813426;59182987;59232182;59342295;59491855;59604746;59717942;59839270;59192002;59235535;59245625;59328438;59409901;59509316;59615872;59680180;59758991;59245650;59328440;59413359;59518784;59615876;59680270;59759002;59245652;59329235;59414819;59523751;59620242;59684868;59763554;59258285;59346138;59431972;59531242;59620243;59702379;59774995;59271794;59346146;59453598;59536690;59620327;59706982;59780342;59271795;59350911;59456450;59541842;59630423;59706985;59786179;59283729;59350921;59458056;59555081;59634892;59712080;59796688;59287254;59354987;59458061;59563850;59634893;59712081;59796692;59290438;59354988;59463367;59568469;59640081;59723317;59801791;59295439;59365157;59473421;59572996;59640085;59723320;59813418;59295506;59365159;59473422;59577180;59640108;59729757;59824882;59299876;59378069;59484139;59581494;59651780;59729759;59824891;59304307;59383861;59490088;59581564;59651850;59729761;59836965;59304308;59390115;59490089;59583327;59662626;59735981;59839272;59304310;59390121;59491856;59589933;59662638;59735983;59844549;59312984;59391051;59491858;59589951;59675187;59735987;59319447;59404539;59499480;59604747;59680142;59747805;59321329;59409878;59504238;59609041;59680148;59751061;",".","157,305","Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.",10/8/2014,"10/08/2014",11/26/2014,"11/26/2014"
"Devices",69566,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.","Z-0466-2015","Class II","Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd.","DR0800M box lot 1316151, Exp. 30Sep2014 ",".","59/50 test boxes","A reagent within the test may return false negative results. ",10/23/2014,"10/23/2014",12/2/2014,"12/02/2014"
"Devices",69566,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.","Z-0465-2015","Class II","Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains. ","DR0802M box lot 1301909, Exp. 30Sep2014 ",".","2/50 test boxes","A reagent within the test may return false negative results. ",10/23/2014,"10/23/2014",12/2/2014,"12/02/2014"
"Devices",69568,"Ongoing","Philips Medical Systems, Inc.","Andover","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to: Canada, Australia, Austria, Belgium, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.","Z-0206-2015","Class I","Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.","All lot codes",".","336,695 units","Mold on gel filled Gel-E and Squishon products",10/10/2014,"10/10/2014",12/2/2014,"12/02/2014"
"Drugs",69569,"Ongoing","Obagi Medical Products","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Nationwide and Mexico and Slovenia","D-0234-2015","Class II","Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36 ","Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016 ",,"975 bottles","Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte. ",10/17/2014,"10/17/2014",11/12/2014,"11/12/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0187-2015","Class II","Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.","22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22063 707961D630 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 956523D630 22072 POIN630 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143 203384D630 22144 WH231NM630 22145 603354NM630 22148 302430NUC630 22149 229259D630 22150 910FHHOKENM630 22151 479967DSC 22156 607763DIS630 22163 262798D630 00107BH3 DZ1060NM01 22090 NM22090 22003 030359NU07 22038 030029NU05 22080 030151NU15 22073 NM22073 22074 NM22074 22118 NM22118 22120 NM22120 22130 NM22130 22051 905684D630 22114 514843AD630 22102 NM22102 22116 NM22116 22129 NM22129 22161 NM22161 00000000083BH6 EG1040NM01 22014 M4216453 22016 M4476428 22079 V6414107 22084 M45052111 22121 M2148252 22001 TP0004NU01 22011 PMAB01NU04 22023",".","147","GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0184-2015","Class II","GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. ","NIA1 17331 863680INF1 17348 281420INF 17349 423553INF 17358 662377INFINIA 17373 916453IN 17381 248465INF 17382 937832INF1 17383 813USFINF1 17384 540536OCHAWK 17389 317338HAWK 17390 832824INF 17392 4082IN 17400 361881SSINF1 17410 626573INF1 17412 732937INFINIA 17442 816271SJINF 17447 607274INF 17469 606878INF1 17477 559225IN 17479 650858IN1 17485 404605INF 17488 480323INFRM3 17491 920729INF 17492 562826INFINIA 17494 518626INF 17496 615893NM1 17497 423472INF 17499 650858IN3 17502 478633INFINIA2 17509 864675HAWK 17510 508427INF2 17517 901516UINFHK 17522 731425INFH1 17531 937440INF1 17532 802257INF 17544 305575INF2 17567 412692INF1 17568 828298HAWK1 17569 262329INF 17571 205783INF1 17572 703858HAWK 17573 801299INF1 17574 VVMCINF1 17575 503561HK4 17576 828298HAWK2 17578 623207INF 17579 408315IN 17580 412692INF2 17581 507402INF1 17582 718630INF1 17583 801584INF3 17596 814889INFINIA 17598 717633INF1 17615 717633INF2 17633 410822HK1 17634 513298INF2 17637 607274INF2 17638 505609INFINIA 17641 540741INF1 17649 920456INF 17650 513298INF1 17651 901523INF1 17654 610402INFINIA2 17655 718405INF1 17659 262656INF1 17664 540741HAWK1 17668 615769NM1 17670 502287INF 17677 713456INF 17678 901523INF2 17680 6502IN1 17697 315425INF 17699 916703IN2 17701 650725IN2 17702 785462CI 17703 901516NINFHK 17704 903UTINF 17707 801RHINF 17710 920288INF2 17714 262434INF1 17737 228523HWK 17758 215427INFINIA 17759 832505NM1 17786 570501INF 17792 540332INF2 17801 610278INFINIA 17804 718250INF1 17809 401444INF 17813 864560HAWK1 17841 262434INF2 17890 212686INF1 17896 724357INF1 17898 520VAINF1 17903 JOHNINF 17916 864SPAHK1 17922 419383NM1 17923 540689INF1 17926 541296HK4 17932 540689INF2 17933 304623INF1 17935 304623INF2 17937 937268INF1 17940 VCWESTINF 17954 801357INF2 17960 312996INF 17967 435781INF1 17973 916782IN1 17977 864SPAHK2 17979 301295INF1 17985 206223INF2 17986 916537IN 17987 916782IN2 17995 559353IN 18000 215728INFINIAJ 1800",".","2479","GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0186-2015","Class II","Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. ","21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21188 415353D670 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 SAN00215 615893MMCT1 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 00000000096BH8 0910265076 21001 010120NU19 21008 110022NU05 21034 030133NU13 21050 210060NU02 21056 110017NU06 21104 030082NU13 21132 100032NU05 21162 190163NU04 21167 190163NU06 21178 080041NU04 21179 030360NU01 21214 030037NU08 210088 190052NU09 21164 BG4009NM01 21042 204726D670NM 21048 514848D670 21058 AM1-122ANKH9 21061 514281D670 21077 514842AD670 21085 905883D670 21094 519973D670 21115 613548D670 21122 418549D670A 21123 418549D670B 21135 905684D670A 21137 514338D670 21139 905684D670B 21143 250370D670 21156 905472D670 21184 403943D670 21194 403943D670B 21198 819563D670B 21200 403343D670 21210 514876D670 00",".","255","GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0188-2015","Class II","Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies","25018 816234D640 26004 815564O640 26007 817250NM640 26010 717782640NM 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 309672NM2 26021 215728OPT640 26025 410543NUC640 26026 928214NMCT 26028 715735OPT1 26002 0910263256 26005 0910263253 22020 030232NU15 26009 DK1054NM03 26001 XM203401 26003 ULUE01NU02 26015 915839NU01 26024 083026800008113 26006 A5639613 26008 A5366308 25023 RTD0782 26030 NM26030 26023 BD003NU01 26017 00162NUC11 26019 00203NUC06 26022 00139NUC08 ",".","29","GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0185-2015","Class II","GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. ","0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 10269 208529VG 1078 209334LNVG1 10340 209526milvg 10541 212562VG 1081 225763MVG 000003100-1829 228818MILLVG 00008125-18-18 248338MLO02 10237 248828VG 10326 248937VG 1538 256235OPNM1 10171 262785vg 1039 2894872VG2 1080 2894872VG3 10316 301896VG 10177 304256VG 00000000010-15 304487VG 10156 305612VG 10197 309662SJVG 10539 310231VGH1 10395 312864VG 1058 313299VG 00000000010-63 334794MILVG 1372 361575VG 000000099-4-04 402449SJVG 10189 404605PVGH 1107 407277fvg2 1132 407896FVG1 10211 407933KVG 10438 408947VG 10199 409291HVG 10460 410955VG1 10359 410955VH 10406 412359VG 00000000010-31 413781VG1 00000000010-82 413781VG2 10547 414219VG 10375 414328VG 10534 414384vg 10182 414447VG 3874990 414544VG 5007 414777MIL 10139 414777VG2 10555 414961vg 1141 443643VG 10347 480981NM1 10354 508997VG 10338 510486VG1 1056 512753VG 10481 515263LVG 1035 516256VG 10210 520757NM1 10572 530529VG 10281 540596N3 10190 540953VG 10179 559688NM1 10150 570791HAWK 10193 580355VGACQ 00008125-16-70 58510 00008125-16-89 58582 00008125-18-09 58711 00008125-18-16 58919 00000000017-64 58958 1016 601426VG 10300 602870NM1 10501 605333HAWKEYE 10284 608263VG 10446 608364VG 1119 609267VG 10146 610954VG 1100 615322NM2 10178 615791VG 10041 630801VG 10280 706845VG 10267 707554VG 00000011278NU9 708783VG 3003 714774VG 1126 716694VG 10235 716859VG 1013 718759VG 10263 781278VG 10526 781744VG2 10488 781744VH 10507 804281VG1 00000000010-05 812537VG 10165 813725vg 36478041 813788VG 10307 815842SJVG 10239 828213VG 10398 845437VG 1025 847695MILMVG 10459 847842VG 10143 860343VGOPC 00000000010-30 860344VG 10390 863494VG 10260 904202VG 10435 914734VG 10422 920459VG 10309 920887vg 10445 949760vg1 10222 956632MVG 000003681-1803 970491VG1 1075 978466VG 10357 978741VG 10218 979764VGH1 10409 FHORLVGH1 1046 MAYO4VG3 10491 NM73049 10353 NM81394 10180 RADNETNM1724 10530 509575PYVGH 00000000010-54 203932VG 00000000018-24 59012 5004 912633MCVG 000003100-1840 919684VG1 000000",".","478","GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Devices",69570,"Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.","Z-0189-2015","Class II","Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories","Mfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM615 24019 030151NU17 24011 NM24011 24014 NM24014 24020 NM24020 24015 NM24015 24016 GON1427120 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 24007 083026241010212 00000000116BH4 083026040018413 00000000117BH2 083026020020313 24008 A5635609 24017 NM24017 00000000084BH4 PK1267NM01 24005 ZA2446NM01 24012 ZA1819NM04 ",".","22","GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.",10/14/2014,"10/14/2014",11/19/2014,"11/19/2014"
"Food",69571,"Ongoing","John Vena, Inc.","Philadelphia","PA","US","Voluntary: Firm Initiated","E-Mail","PA","F-0508-2015","Class I","Raw Serrano Peppers packed in white cardboard box with label reading: John Vena, Inc. Serrano 5 lb Product of Mexico Packed by John Vena, Inc. Philadelphia, PA 19153 101570 or 101619","101570 101619",".","20 - 5 lb. cases ","John Vena repacked Serrano Peppers currently being recalled by Bailey Farms, Oxford, NC. ",10/21/2014,"10/21/2014",11/26/2014,"11/26/2014"
"Drugs",69572,"Ongoing","Prometheus Laboratories Inc.","San Diego","CA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0249-2015","Class II","Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121","Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.",".","16,296 bottles (60-count), 5,166 bottles (250-count)","Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. ",10/22/2014,"10/22/2014",11/26/2014,"11/26/2014"
"Biologics",69574,"Terminated","Indiana Blood Center","Indianapolis","IN","US","Voluntary: Firm Initiated","Telephone","Indiana","B-0142-15","Class II","Red Blood Cells","W040714537077; ",".","1","Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.",9/19/2014,"09/19/2014",12/17/2014,"12/17/2014"
"Biologics",69575,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0135-15","Class II","Red Blood Cells Leukocytes Reduced","2538410; ",".","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.",9/19/2014,"09/19/2014",12/17/2014,"12/17/2014"
"Biologics",69576,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","Letter","Florida; Switzerland","B-0137-15","Class II","Red Blood Cells","W038113215637; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",9/15/2014,"09/15/2014",12/17/2014,"12/17/2014"
"Biologics",69576,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","Letter","Florida; Switzerland","B-0138-15","Class III","Blood and Blood Products for Reprocessing","W038113215637; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",9/15/2014,"09/15/2014",12/17/2014,"12/17/2014"
"Biologics",69576,"Terminated","OneBlood, Inc.","Lake Park","FL","US","Voluntary: Firm Initiated","Letter","Florida; Switzerland","B-0136-15","Class II","Plasma Frozen within 24 hours (FP24)","W038114036456; ",".","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. ",9/15/2014,"09/15/2014",12/17/2014,"12/17/2014"
"Devices",69579,"Ongoing","Biomerieux","Letoile",,"FR","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.","Z-0231-2015","Class III","Etest Ceftaroline (CPT32) WWB100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. ","Ref #537508, Lot #1003160510, Right Expiry date: 27-APR-2016",".","652 devices","The products have a wrong expiration date on their labeling, 5 years instead of 2 years.",10/16/2014,"10/16/2014",11/26/2014,"11/26/2014"
"Devices",69579,"Ongoing","Biomerieux","Letoile",,"FR","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.","Z-0234-2015","Class III","Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. ","Ref #537540, Lot #1003301830, Right Expiry date: 30-APR-2016",".","652 devices","The products have a wrong expiration date on their labeling, 5 years instead of 2 years.",10/16/2014,"10/16/2014",11/26/2014,"11/26/2014"
"Devices",69579,"Ongoing","Biomerieux","Letoile",,"FR","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.","Z-0232-2015","Class III","Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. ","Ref #537540, Lot #1003202200, Right Expiry date: 27-APR-2016",".","652 devices","The products have a wrong expiration date on their labeling, 5 years instead of 2 years.",10/16/2014,"10/16/2014",11/26/2014,"11/26/2014"
"Devices",69579,"Ongoing","Biomerieux","Letoile",,"FR","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.","Z-0230-2015","Class III","Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. ","Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016",".","652 devices","The products have a wrong expiration date on their labeling, 5 years instead of 2 years.",10/16/2014,"10/16/2014",11/26/2014,"11/26/2014"
"Devices",69579,"Ongoing","Biomerieux","Letoile",,"FR","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.","Z-0233-2015","Class III","Etest Ceftaroline (CPT32) US B100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. ","Ref #537548, Lot #1003202820, Right Expiry date: 27-APR-2016",".","652 devices","The products have a wrong expiration date on their labeling, 5 years instead of 2 years.",10/16/2014,"10/16/2014",11/26/2014,"11/26/2014"
"Devices",69580,"Ongoing","Skeletal Dynamics","Miami","FL","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico.","Z-0582-2015","Class II","Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection.","Cat #s: ALN-RST-0700, ALN-RST-0702, ALN-RST-0704, ALN-RST-0706, ALN-RST-0708, ALN-RST-0800, ALN-RST-0802, ALN-RST-0802, ALN-RST-0804, ALN-RST-0806, ALN-RST-0808, ALN-RST-0900, ALN-RST-0902, ALN-RST-0904, ALN-RST-0906, ALN-RST-0908, ALN-RST-1000, ALN-RST-1002, ALN-RST-1004, ALN-RST-1006, ALN-RST-1008, ALN-RST-1100, ALN-RST-1102, ALN-RST-1104, ALN-RST-1106, ALN-RST-1108; Lot #s: AN0610023, AN0212065, AN0913033, AN0913034, AN0610024, AN0913035, AN0913036, AN0610025, AN0913037, AN0913038, AN0610026, AN0913039, AN0913040, AN0610027, AN0913041, AN0913042, AN0610028, AN0212066, AN0913043, AN0913044, AN0610029, AN0913045, AN0913046, AN0610030, AN0913047, AN0913048, AN0610031, AN0913049, AN0913050, AN0610032, AN0913051, AN0913052, AN0610033, AN0212067, AN0913053, AN0913054, AN0610034, AN0913055, AN0913056, AN0610035, AN0913057, AN0913058, AN0610036, AN0913059, AN0913060, AN0610037, AN0913061, AN0913062, AN0610038, AN0212068, AN0913063, AN0913064, AN0610039, AN0212069, AN0913065, AN0913066, AN0610040, AN0913067, AN0913068, AN0610041, AN0913069, AN0913070, AN0410008, AN0610042, AN0410009, AN0913071, AN0913072, AN0610043, AN0212070, AN0913073, AN0913074, AN0610044, AN0913075, AN0913076, AN0610045, AN0913077, AN0913078, AN0610046, AN0913079, AN0913080, AN0610047, AN0913081, AN0913082.",".","1700","Report received where the Align Radial Stem fractured.",10/16/2014,"10/16/2014",12/17/2014,"12/17/2014"
"Food",69581,"Ongoing","Chetak New York, LLC","Edison","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","F-0612-2015","Class I","Deep Raw Cashew Pieces Distributed by Chetak New York LLC Edison, NJ 08837 USA 7 oz. - UPC 011433133104 - 20 per case 14 oz. - UPC 011433133111 - 20 per case 28 oz. - UPC 011433133128 - 10 per case packaged in a plastic bag; for dry storage","All lots",".","11320 packages","Deep Raw Cashew Pieces may be contaminated with Salmonella.",10/23/2014,"10/23/2014",12/10/2014,"12/10/2014"
"Devices",69583,"Ongoing","Iba Dosimetry Gmbh","Schwarzenbruck",,"DE","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.","Z-0168-2015","Class II","COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological","N/A",,"124 units","Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.",9/25/2014,"09/25/2014",11/12/2014,"11/12/2014"
"Devices",69584,"Ongoing","Gyrus Acmi, Incorporated","Southborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Canada, Vietnam, and Europe.","Z-0419-2015","Class II","Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).","All lots",".","74,792 units","All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Drugs",69585,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","US Nationwide including Puerto Rico","D-0289-2015","Class III","BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01","Lot #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14; Lot #: MM8553, Expiry: 09/14; Lot #: MM8554, Expiry: 09/14.",".","63,648 Bottles","Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. ",9/24/2014,"09/24/2014",12/10/2014,"12/10/2014"
"Devices",69588,"Ongoing","Siemens Healthcare Diagnostics, Inc.","Tarrytown","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of FL, KY, MN, MA, PA, UT, NY, VA and CA., and the countries of Algeria, Australia, Argentina, Austria, Belgium, Brazil, Bulgaria, Cameron, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Latvia, Macedonia, Mexico, Netherlands,Pakistan, Peru, Poland, Portugal, Rep. Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tadjikistan, Taiwan,Turkey, Unit. Arab Emir and Vietnam.","Z-0212-2015","Class III","IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.","Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19; PINLCLCM-11{24}, 2014-02-19; PIELCLCM-9{24}, 2014-02-19",".","2212 units (92 units domestically & 2120 units internationally)","A typographical error regarding the expiration date was identified in the control module instructions for use.",10/20/2014,"10/20/2014",11/19/2014,"11/19/2014"
"Food",69589,"Ongoing","Rome Packing Co., Inc.","E Providence","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the US in the following states: CA, FL, IL, MA, ME, NY, PA, RI","F-0613-2015","Class I"," Oceans Catch All Natural Jonah Crab Combo Meat, Packaged in round plastic containers (tub with snap-on lid), sold refrigerated: 6 ounce, 8 ounce, and 16 ounce","6 ounce: lot number 0104791, with a sell by date before 10/13/14; lot number 0104666, with a sell by date before 10/15/14; 8 ounce: lot number 0104787, with a sell by date before 10/14/14; 16 ounce: lot number 0104806, with a sell by date before 10/14/14; lot number 0104845, with a sell by date before 10/16/14",".","185 pounds","Product may be be contaminated with Listeria monocytogenes. ",10/24/2014,"10/24/2014",12/17/2014,"12/17/2014"
"Food",69589,"Ongoing","Rome Packing Co., Inc.","E Providence","RI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the US in the following states: CA, FL, IL, MA, ME, NY, PA, RI","F-0614-2015","Class I","Oceans Catch All Natural Fresh Jonah Crab Leg Meat, Packaged in round plastic containers (tub with snap-on lid), sold as refrigerated: 5 ounce, 8 ounce, and 16 ounce","5 ounce: lot number 0104804, with a sell by date before 10/15/14; 8 ounce: lot number 0104665, with a sell by date before 10/13/14; lot number 0104665, with a sell by date before 10/14/14; lot number 0104804, with a sell by date before 10/14/14; lot number 0104842, with a sell by date before 10/16/14; 16 ounce: lot number 0104659, with a sell by date before 10/13/14; lot number 0104665, with a sell by date before 10/14/14; lot number 0104842, with a sell by date before 10/16/14",".","1,124.5 pounds","Product may be be contaminated with Listeria monocytogenes. ",10/24/2014,"10/24/2014",12/17/2014,"12/17/2014"
"Drugs",69590,"Ongoing","Micro Labs Usa, Inc S","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","U.S. Including: New York","D-0253-2015","Class II","LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10","Lot #LJAG003, Expiry: 05/2015",".","144 bottles","Failed Content Uniformity Specifications; Dry mix failed blend uniformity.",9/22/2014,"09/22/2014",11/26/2014,"11/26/2014"
"Food",69591,"Ongoing","Giorgio Foods Inc","Reading","PA","US","Voluntary: Firm Initiated","E-Mail","MO, PA","F-0463-2015","Class II","Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed by: Giorgio Foods, Inc., PO Box 96, Temple, PA 19560 Manufactured 3/27/2014 Best by 3/27/2015 Product 8512 Lot 14086","Best by 3/27/2015 Product 8512 Lot 14086",,"127 cases","Calzone recalled due to potential metal contamination. Product manufactured for the National School Lunch Program.",10/21/2014,"10/21/2014",11/12/2014,"11/12/2014"
"Food",69592,"Terminated","Whole Food Market","Cambridge","MA","US","Voluntary: Firm Initiated","E-Mail","MA","F-0461-2015","Class I","Whole Foods Vegan Gingersnap Cookies, 6pk (10-oz), packaged in flexible plastic with twist tie","Sell By date October 28, 2014",,"8 units","Product mislabeled- undeclared walnut, almond, milk, soy and egg.",10/26/2014,"10/26/2014",11/12/2014,"11/12/2014"
"Food",69594,"Ongoing","Wehah Farms","Richvale","CA","US","Voluntary: Firm Initiated","Press Release","AR, CA, CO, HI, PA, TN and Canada.","F-0535-2015","Class I","Lundberg Rice Chips (Croustilles de Riz), Sea Salt (Sel Marin) 6 oz. (170 g) package; Wheat Free, Gluten Free (Sans Ble, Sans Gluten); US product number: F11070; Canadian Product number: F11160. Ingredient: Organic Whole Grain Brown Rice, Organic Rice Flour (Organic Whole Brown Rice Flour, Organic Rice Flour), Organic High Oleic Expeller-Pressed Safflower or Sunflower Oil, Organic Whole Masa Corn Flour, Organic Sesame Seeds, Sea Salt, Natural Caramel Color. Contains Sesame. Lundberg Family Farms Richvale, CA 95974","Code: 140811; Best Befroe Date: 2015-JUN 08; Case Code : 200-73416-03530-4; UPC - US: 0-73416-03530-0; UPC - CANADA: 0-73416-03540-9",".","413 cases , 4956 bags US product; 256 cases, 3072 bags Canadian product.","Recall Sea Salt Rice Chips (6 oz.) due to presence of undeclared allergen - customer found a ranch flavor chip in the bag which contains dairy.",10/24/2014,"10/24/2014",11/26/2014,"11/26/2014"
"Drugs",69595,"Ongoing","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0239-2015","Class III","Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00 ","Lot #: 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13 Lot #: 6BYA, 6CVI, 6FVX, 6CVH, 6D1W, 6DSH, 6E2V, 6E9W; Exp. 10/13 Lot #: 6HO2, 6I1F; Exp. 11/13 Lot #: 6IG5, 6ILV, 6HCE, 6I7B; Exp. 12/13 Lot #: 6TKA, 6TSZ, 6TUO, 6TXT; Exp. 05/14 Lot #: 6V2S, 6WWJ, 6U9L, 6UQP, 6VJM, 6VSS, 6W3J; Exp. 07/14 Lot #: 6WVP, 6XFX, 6Y99; Exp. 08/14 Lot # :6Y7A; Exp. 10/14",,"7,740 pills ","Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.",9/11/2013,"09/11/2013",11/12/2014,"11/12/2014"
"Devices",69596,"Ongoing","Integra LifeSciences Corp.","Plainsboro","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.","Z-0197-2015","Class II","Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.","Lot Numbers PM0278 and PM0277",".","12 units","A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.",10/24/2014,"10/24/2014",11/19/2014,"11/19/2014"
"Drugs",69597,"Ongoing","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Letter","Distributed in Georgia and Missouri.","D-0237-2015","Class II","CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233","Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)",,"340 capsules (17 bottles containing 20 capsules each)","CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.",9/22/2014,"09/22/2014",11/12/2014,"11/12/2014"
"Veterinary",69598,"Ongoing","Loving Pets","Cranbury","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","V-209-2015","Class III","Simply Nourish Dog Treats Biscotti with Beef & Sweet Potato Net Wt. 4 oz. Distributed by: Simply Nourish Pet Food Company 19601 N. 27th Avenue, Phoenix, AZ USA 85027 Made in USA UPC 73725747061","Lot 021114 and Lot 021414 Exp 2/16",".","4,951 units","Simply Nourish Beef Biscotti with Sweet Potatoes contain improper bag seals which allow moisture into the packaging.",10/1/2014,"10/01/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0565-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","BWPB sold between 4/21/13 to 10/21/14",".","868","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0567-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","1977","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0569-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","657","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0571-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","1201","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0566-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","892","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0568-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","525","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Food",69599,"Ongoing","Los Chileros De Nuevo Mexico, LTD","Albuquerque","NM","US","Voluntary: Firm Initiated","Telephone","NM, CO, WA, KS, LA, NY, TX, AZ, NC, OH; potentially nationwide; Australia (relabeled by the distributor in Australia). No govt/VA/military","F-0570-2015","Class II","Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502","All products sold between 4/21/13 to 10/21/14",".","897","Los Chileros De Nuevo Mexico is conducting a field action for Blue Corn Waffle & Pancake Mix (BWPB), Sopaipilla Mix (SOPP), Santa Fe Chile Seasoning (SFCS), Green Chile Blue Cornbread (GCBB), Cream of Green Chile Chicken Soup (GCCS), Green Chile Stew with Tortilla Mix (GCSB) and Carne Adovada with Sopaipilla Mix (CADB) due to undeclared wheat.",10/21/2014,"10/21/2014",12/2/2014,"12/02/2014"
"Devices",69600,"Ongoing","Aesculap, Inc.","Center Valley","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in Kansas only.","Z-0502-2015","Class II","The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus. ","Item Number FV129 Lot Number 4506244166 Serial Number A10150",".","1","Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.",10/24/2014,"10/24/2014",12/10/2014,"12/10/2014"
"Devices",69601,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.","Z-0235-2015","Class II","Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.","Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001 ",".","6","Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.",10/10/2014,"10/10/2014",11/26/2014,"11/26/2014"
"Devices",69602,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombia, Czech Republic,Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Kenya, Korea, Kazakhstan, Malaysia, Netherlands, Norway, New Zealand, Philippines, Pakistan, Poland, Palestina, Portugal, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, Vietnam and South Africa.","Z-0486-2015","Class II","The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.","model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317 146121 146710 146945 153992 147084 147189 147190 153335 153695 135120 135322 146679 153102 153101 146232 157660 153727 146728 146408 146409 157458 153216 146335 153779 146659 146993 153280 153648 153674 160395 153166 146898 146965 160484 135757 136513 153700 154096 135000 136562 146221 147273 157698 146871 146814 146952 147239 147030 135914 153834 146988 160348 157532 160502 146899 153194 153169 135102 146643 146650 136085 146980 146361 146365 146366 146369 146912 147036 135927 153110 146116 146164 146168 157657 160392 153890 157136 154157 153199 135209 140106 147371 153887 160115 146156 146342 146343 135986 153269 154074 157690 135935 135953 154012 147129 135841 153191 153252 135200 135201 135279 157616 153732 147210 135169 135879 160449 153274 157710 153717 153239 157560 157509 146192 157436 147081 160463 135990 154090 147267 153227 146235 153967 153655 146201 157677 153285 153234 153236 146249 146260 146277 146868 146818 146758 157528 146741 153273 153130 153129 153138 153686 146719 160139 153251 153254 146245 146217 153344 147047 157503 154095 160406 153342 140115 153328 146195 153106 153171 153197 153916 146187 146188 146189 136710 146113 146171 146173 146176 146186 146636 147042 157615 160134 160136 160106 146630 136103 157448 146766 135862 146266 157165 154086 146154 146298 146305 146908 153831 135235 135117 146267 147208 147247 135358 146219 146272 160338 146780 146274 153256 147096 160347 135920 153154 140101 147236 140205 136168 146193 146761 135148 157700 147175 153139 146637 135939 153882 146972 147078 160506 153311 135366 146327 146333 146338 153211 136568 147022 160312 147023 157602 146851 147249 147255 146410 146676 146248 146286 146292 135843 146688 146144 157168 154053 147188 147165 160488 135779 136224 153740 153709 146715 146355 160142 146293 146308 146968 1",".","1131","There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This would result in no X-ray release and a delay in procedure.",9/11/2013,"09/11/2013",12/10/2014,"12/10/2014"
"Devices",69603,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in states of: MI, MT, and CO.","Z-0226-2015","Class I","Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).","Part Number 04.634.002 Lot Number 6816781 ",".","24","Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.",10/23/2014,"10/23/2014",12/2/2014,"12/02/2014"
"Devices",69604,"Ongoing","Becton Dickinson & Company","Franklin Lakes","NJ","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.","Z-0572-2015","Class II","BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples. ","Distributed in USA REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17 REF 381434 20 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17; Distributed outside of USA REF# 381833 20G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min Lot4143917, May -17 REF 3811834 20 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17",".","US- 296,800 devices; OUS - 3,250,150 devices","BD Insyte Autoguard may have potential damage along the body of the catheter.",10/9/2014,"10/09/2014",12/17/2014,"12/17/2014"
"Drugs",69605,"Ongoing","CareFusion 213, LLC","El Paso","TX","US","Voluntary: Firm Initiated","Letter","Nationwide; Mexico, Philippines","D-0298-2015","Class III"," Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25","All Lots ",".","20,556,000 scrubs","Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.",10/24/2014,"10/24/2014",12/17/2014,"12/17/2014"
"Food",69606,"Ongoing","M & M Farm Inc.","Miami","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida","F-0511-2015","Class I","M & M brand Number 2 Florida Avocados, packed in 50 lb cardboard boxes","Lot # 101315 and 101326",".","30,000 lbs","Samples of avocados tested by FDA were positive for Salmonella.",10/17/2014,"10/17/2014",11/26/2014,"11/26/2014"
"Biologics",69608,"Terminated","Central Shared Services, LLC.","Ogden","UT","US","Voluntary: Firm Initiated","Letter","Utah","B-0134-15","Class II","Platelets Pheresis Leukocytes Reduced","W116514207796Q; ",".","1","Blood product, with platelet concentration below the specified minimum requirement, was distributed.",7/9/2014,"07/09/2014",12/17/2014,"12/17/2014"
"Drugs",69611,"Ongoing","Nanophase Technologies Corporation","Romeoville","IL","US","Voluntary: Firm Initiated","E-Mail","NJ","D-0238-2015","Class III","Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ","Lot Codes: CNNI2901, CNNI2902",,"1,596 Kg","cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.",10/20/2014,"10/20/2014",11/12/2014,"11/12/2014"
"Biologics",69612,"Terminated","AlloSource, Inc.","Centennial","CO","US","Voluntary: Firm Initiated","E-Mail","Nationwide, including foreign and govt/VA/military consignees.","B-0141-15","Class III","Cartilage","144097101 to 144097211",".","111 lots","Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",9/12/2014,"09/12/2014",12/17/2014,"12/17/2014"
"Devices",69613,"Completed","Zimmer, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","E-Mail","US nationwide distribution.","Z-0574-2015","Class II","Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures. ","Lot: L75066",".","14 devices","Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.",8/26/2013,"08/26/2013",12/17/2014,"12/17/2014"
"Devices",69615,"Ongoing","Biomet Spine LLC.","Broomfield","CO","US","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,","Z-0220-2015","Class II","LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1. ","Lot numbers L532655, L532690, Product code 8503XXXX",".","120","Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.",3/9/2011,"03/09/2011",11/26/2014,"11/26/2014"
"Food",69618,"Ongoing","U.B.C Food Distributors, LLC","Dearborn","MI","US",,"Telephone","National: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, TN, TX, U.S.VIRGIN ISLANDS, VA, WA, WI INTNL: CANADA","F-0468-2015","Class II","Mango flavored gelatin mix desert","Best Before / APRIL /2016 B.NO:BA (MAN)",,"316","Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6. ",10/15/2014,"10/15/2014",11/12/2014,"11/12/2014"
"Food",69618,"Ongoing","U.B.C Food Distributors, LLC","Dearborn","MI","US",,"Telephone","National: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, TN, TX, U.S.VIRGIN ISLANDS, VA, WA, WI INTNL: CANADA","F-0467-2015","Class II","Strawberry flavored gelatin mix desert","BEST BEFORE/APRIL/2016 B.NO:BA-(STR)",,"735 cases","Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6. ",10/15/2014,"10/15/2014",11/12/2014,"11/12/2014"
"Devices",69619,"Ongoing","Soma Access Systems LLC","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.","Z-0215-2015","Class II","AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.","Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014, Lot #62193-000, Expiration Date: 2/28/2014, Lot #62360-000, Expiration Date: 2/28/2014, Lot #62922-000, Expiration Date: 4/30/2014, Lot #63191-000 and Expiration Date: 10/31/2014 (24/case labeled for US); Product Ref#70957, Lot # 62188-000, Expiration Date: 2/28/2014, Lot # 62435-000, Expiration Date: 2/28/2014, Lot # 62489-000 Expiration Date: 3/31/2014 and Lot # 63191-000, Expiration Date: 10/31/2014 (5/case labeled for US); Product Ref#71489, Lot # 63191-000, Expiration Date: 10/31/2014 (24/case labeled for EU) and Product Ref#71489, Lot # 62489-000, Expiration Date: 3/31/2014, Lot # 62529-000, Expiration Date: 3/31/2014 and Lot # 63191-000 Expiration Date: 10/31/2014 (5/case labeled for EU). ",".","3530 units","There is a possibility the sterile packaging may fail before the expiration date specified on the package.",3/24/2014,"03/24/2014",11/26/2014,"11/26/2014"
"Devices",69621,"Ongoing","Biomerica","Irvine","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.","Z-0467-2015","Class II","Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.","Lot No. 2180, 2178, 2167, 2124, 2089, 2071 and 2041.",".","1,062 units","A potential issue with false high values.",9/18/2014,"09/18/2014",12/2/2014,"12/02/2014"
"Food",69623,"Ongoing","Bailey Farms, Inc.","Oxford","NC","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, GA, LA, MA, MD, MI, NC, NY, PA, SC, VA, and WI.","F-0455-2015","Class I","Bailey Farms, Fresh Serrano Chile Peppers, Oxford, NC 27565.","Lot #1460410, Date: 10/05/2014",,"6,215 lbs","Product was found to be contaminated with Salmonella",10/20/2014,"10/20/2014",11/12/2014,"11/12/2014"
"Food",69624,"Ongoing","International Sprout Holding Inc.","Cookeville","TN","US","Voluntary: Firm Initiated","Telephone","CA, FL, MD, NY, OH, PA, TN, UT, WI International: Quebec, CN; Delta, BC, CN; Bermuda","F-0538-2015","Class I","Alfalfa seed: Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty Supply","SAL1-3BL",".","35,926 lbs","A sample taken by FDA of one lot of alfalfa seed tested positive for Salmonella",10/27/2014,"10/27/2014",12/2/2014,"12/02/2014"
"Devices",69625,"Ongoing","Discus Dental LLC","Ontario","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey, Egypt, Jordan, Thailand, Lebanon, Kuwait, Tunisia, India, and Dominican Republic.","Z-0425-2015","Class II","Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits ","- List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666 14139005 DSH1001 14113006 DHS1001 14127007 List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number ZME2665 14143017 ZME2665 14143024 ZME2631 14132015 ZME2645R 14153007 ZME2667 14147003 ZME2667 14132016 ZME2667 14141020 ZME2667 14143009 ZME2667 14164002 ZME2667 14169008 881056701531 14135016 881057001531 14135007 ",".","20,251 distributed in U.S. on nationwide level and 14,653 internationally","Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.",10/24/2014,"10/24/2014",12/2/2014,"12/02/2014"
"Food",69626,"Ongoing","Marathon Ventures Inc","Bellevue","NE","US","Voluntary: Firm Initiated","Telephone","Product was distributed nationwide.","F-0589-2015","Class I","Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 86635 4 (3.) HyVee Macadamia Nuts, Net Wt 2 oz. plastic bags. Distributed by:Hy-Vee Inc, West Des Moines Iowa, UPC 0 75450 13287 815400 16635 (4.) market pantry Chopped Macadamia Nuts, Net Wt 2.25 oz. plastic bags. Distributed by:Target Corp., MN, UPC 0 85239 52108 3 (5.) Pears Gourmet Macadamia Nuts Raw, Net Wt 1 LB, plastic bags with gold adhesive label. Distributed by:Marathon Ventures, Bellevue, NE UPC 0 75049 42186 4 (6.) CWD Cash-Wa Distributing, Co. Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Cash-Wa Distributing, Co, Kearney, North Platte and Sidney, NE (7.) Macadamia Nuts Raw, Net Wt 5 LBS, Distributed by:Pegler Sysco, Lincoln, NE (8.) Bulk Case Mayan Gold Macadamia Nuts Style #5, Net Wt 25 LBS, Distributed by:Marathon Ventures, Bellevue, NE.","Macadamia nuts in various formats: (1.) ''Western Family'' Best by Dates: 11MAR2014, 23JUN2014, 11AUG2015 and 6OCT2015 (2.) ''Shur Fine'' Best by Dates: 11MAR2015, 23JUN2015 and 11AUG2015 (3.) ''HyVee'' Best by Dates: 27AUG2015, 28AUG2015 and 10OCT2015 (4.) ''market pantry'' Best by Dates: 28APR2015, 1MAY2015, 28MAY2015, 1JUL2015, 23JUL2015, 21AUG2015 and 16OCT2015 (5.) ''Pears Gourmet'' Best by Date: 23JUL2015 (6.) ''CWD Cash-Wa Distributing, Co.'' , 14170 and 14261 (7.) ''Pegler Sysco'', 14052, 14094, 14128, 14181 and 14267 (8.) Bulk Case ''Mayan Gold'', SDC 0034",".","5200 pounds ","Macadamia nuts may have possible contamination with Salmonella florida.",10/28/2014,"10/28/2014",12/2/2014,"12/02/2014"
"Devices",69627,"Completed","Beevers Manufacturing & Supply, Inc.","McMinnville","OR","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.","Z-0483-2015","Class II","Cannulaide, Model 101, 102, 103. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device.","CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;",".","16,575 units total (15,625 units in US and 950 units outside US)","Cannulaide recalled May 2008 due to improper seal of the pouch.",5/13/2008,"05/13/2008",12/2/2014,"12/02/2014"
"Biologics",69628,"Terminated","American National Red Cross (the)","West Henrietta","NY","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; New York","B-0115-15","Class III","Platelets Pheresis Leukocytes Reduced","W2001148110631; W2001148110632; W2001148110633; W2001148110721; W2001148110722; W200114811083; ",,"6 units","Plateletphereis products lacking assurance of proper leukoreduction were distributed. ",9/3/2014,"09/03/2014",11/12/2014,"11/12/2014"
"Devices",69629,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.","Z-0449-2015","Class II","Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.","Lot: 293086 Expiration 01Apr2015",".","79/5/250- packages/bottles/ml","The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.",10/29/2014,"10/29/2014",12/2/2014,"12/02/2014"
"Devices",69630,"Ongoing","Zimmer CAS","Montreal",,"CA","Voluntary: Firm Initiated","Letter","US Distribution in states of: AZ, CO, IL, OR, and WA.","Z-0495-2015","Class II","PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.","BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15",".","15","Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.",11/3/2014,"11/03/2014",12/10/2014,"12/10/2014"
"Devices",69631,"Ongoing","Summit Industries Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.","Z-0468-2015","Class II","The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.","Model Numbers: J700-01, J700-02, J700-03, J700-04",".","32 ","The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.",10/28/2014,"10/28/2014",12/2/2014,"12/02/2014"
"Devices",69632,"Completed","Materialise USA LLC","Plymouth","MI","US",,"Telephone","Nationwide Distribution to MN only","Z-0418-2015","Class II","Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur adn Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.","00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902",".","1","The box of guides for case JTOMA-JL-0636-L contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.",10/16/2014,"10/16/2014",12/2/2014,"12/02/2014"
"Drugs",69634,"Ongoing","Baxter Healthcare Corporation","Jayuya","PR","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0276-2015","Class II","Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container","Lot #: N003061; N003079; and N003087.",".","127,746","Subpotent Drug: Heparin raw material was found to have low potency ",10/30/2014,"10/30/2014",12/2/2014,"12/02/2014"
"Devices",69635,"Completed","INO Therapeutics (dba Ikaria)","Madison","WI","US","Voluntary: Firm Initiated","Telephone","US Distribution in states of: VA and PA only.","Z-0575-2015","Class II","INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.","Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.",".","9","An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69636,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.","Z-0484-2015","Class II","CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract. ","Lot 159621 Exp Date: 2017-05",".","595 units","Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode",10/27/2014,"10/27/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0428-2015","Class II","8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470006-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 - total all affected instruments","Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0445-2015","Class II","8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0440-2015","Class II","8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affeced devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0448-2015","Class II","8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices.","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0438-2015","Class II","8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0439-2015","Class II","8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470207-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units - all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0430-2015","Class II","8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 units - total all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0443-2015","Class II","8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470249-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 Total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0447-2015","Class II","8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0433-2015","Class II","8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","5-9 units - total all devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0429-2015","Class II","8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 units - total all affected instruments","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0427-2015","Class II","8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470001-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 - total all affected instruments","Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0441-2015","Class II","8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices",,11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0431-2015","Class II","8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470171-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 Units, total all affected units","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0435-2015","Class II","8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470181-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 Total Devices, all affected units","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0434-2015","Class II","8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470179-04 All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units - all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0442-2015","Class II","8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470246-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 Total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0437-2015","Class II","8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units - all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0436-2015","Class II","8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number:470183-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total devices, all affected units","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0446-2015","Class II","8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470327-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 total units, all affected devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0444-2015","Class II","8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".","509 units, total all devices","Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Devices",69638,"Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.","Z-0432-2015","Class II","8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.","Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.",".",,"Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.",11/3/2014,"11/03/2014",12/2/2014,"12/02/2014"
"Food",69639,"Completed","Saxon Cheese, LLC","Cleveland","WI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI","F-0528-2015","Class II","Saxon Creamery Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese, 7 lb wheel. Ingredients: Pasteurized Cow's Milk, culture, salt, enzymes, contains milk. Keep Refrigerated.","259010114",".","458 lbs","Saxon Cheese LLC is recalling one lot of GreenFields Monastery Washed Rind Wisconsin handcrafted Cheese because product tested positive for E.coli. ",10/27/2014,"10/27/2014",11/26/2014,"11/26/2014"
"Food",69641,"Ongoing","Mt. Olive Pickle Company Inc","Mount Olive","NC","US","Voluntary: Firm Initiated","Letter","AL, AR, AZ, CA, CO, CT, FL, GA, IN, KS, LA, MI, MO, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.","F-0507-2015","Class II","Mt. Olive, Kosher Dill Chips in 1 gallon glass jars, UPC 09300 12841, Mt. Olive, Corner of Cucumber & Vine, P.O. Box 609, Mt Olive, NC 28365-0609.","Production Code: 1FE1624A and 1FE1624B, Best by May 31, 2016; Production Code: 1FE1634A and 1FE1634B, Best by June 01, 2016; Production Code: 1FE1744C and 1FE1744D, Best by June 12, 2016; Production Code: 1FE1814C and 1FE1814D, Best by June 19, 2016; Production Code: 1FE1984C and 1FE1984D, Best by July 16, 2016; Production Code: 1FE2094C and 1FE2094D, Best by July 17, 2016; Production Code: 1FE2114C and 1FE2114D, Best by July 19, 2016; Production Code: 1FE2164C and 1FE2164D, Best by July 24, 2016; Production Code: 1FE2234C and 1FE2234D, Best by July 31, 2016; Production Code: 1FE2244C and 1FE2244D, Best by Aug 01, 2016 and Production Code: 1FE2324C and 1FE2324D, Best by Aug 09, 2016.",".","40,532 cases (162,128 jars)","Product may contain glass fragments.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Devices",69642,"Ongoing","CooperSurgical, Inc.","Trumbull","CT","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of NY, MO and NV.","Z-0488-2015","Class III","Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved. ","Lot Code: 147234",".","30","The product has been identified to contain an incorrect curette type.",10/27/2014,"10/27/2014",12/10/2014,"12/10/2014"
"Food",69643,"Ongoing","Exotic Superfoods New York, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Distribution pattern indicates distributors located in CA and CO; however the firm also sold 135 cases online via their website.","F-0495-2015","Class II","Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz. SKU: 7 05105 50161 1 Description of the Product: - 32 oz (1 quart): - The product is consumed in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case. - 11.7 oz: - The product is sold in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case Product of Thailand Distributed by Exotic Superfoods www.exoticsuperfoods.com NY e-mail: info@exoticsuperfoods.com CA e-mail: caliinfo@exoticsuperfoods.com","Lot Numbers: - 343592 (32 oz) - 340073 (11.7 oz) ",".","Lot 343592 (32 oz): 168 cases Lot 300473 (11.7 oz): 227 case all within U.S.","It appears that these batches were not subjected to 5-log reduction as part of their processing.",10/24/2014,"10/24/2014",11/19/2014,"11/19/2014"
"Food",69643,"Ongoing","Exotic Superfoods New York, Inc.","Los Angeles","CA","US","Voluntary: Firm Initiated","Letter","Distribution pattern indicates distributors located in CA and CO; however the firm also sold 135 cases online via their website.","F-0495-2015","Class II","Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz. SKU: 7 05105 50161 1 Description of the Product: - 32 oz (1 quart): - The product is consumed in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case. - 11.7 oz: - The product is sold in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case Product of Thailand Distributed by Exotic Superfoods www.exoticsuperfoods.com NY e-mail: info@exoticsuperfoods.com CA e-mail: caliinfo@exoticsuperfoods.com","Lot Numbers: - 343592 (32 oz) - 340073 (11.7 oz) ",".","Lot 343592 (32 oz): 168 cases Lot 300473 (11.7 oz): 227 case all within U.S.","It appears that these batches were not subjected to 5-log reduction as part of their processing.",10/24/2014,"10/24/2014",11/26/2014,"11/26/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0521-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint","Model 24-6546TI, Lot #s: 526040B, 526050A, 526040A, 526050B.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0510-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint","Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0519-2015","Class II","Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint","Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0516-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint","Model 24-6650TI, Lot #s: 531960A, 531960B.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0512-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint","Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B, ",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0511-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint","Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0520-2015","Class II","Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint","Model 24-6555TI, Lot #s: 525210B, 525200A, 525200B, 525210A.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0514-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint","Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0515-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint","Model 01-6550TI, Lot #s: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, 544220A.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0509-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand","Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0518-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint","Model 24-6551TI, Lot #s: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, 544180A.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0522-2015","Class II","Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint","Model 24-6545TI, Lot #s: 520220B, 520220A, 520210A, 520210B",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0513-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint","Model 01-6551TI, Lot #s: 535370A, 535370B, 535370C, 535370D.",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69644,"Ongoing","Biomet Microfixation, LLC","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.","Z-0517-2015","Class II","Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint","Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B, ",".","42","Laser etching on the parts is wider and deeper than the conditions previously validated.",10/17/2014,"10/17/2014",12/17/2014,"12/17/2014"
"Devices",69645,"Ongoing","Accuray Incorporated","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium.","Z-0218-2015","Class II","CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.","Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199 C0151 C0179 C0226 C0158 C0131 C0144 C0223 C0071 C0094 C0183 C0143 Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial # C0175 C0189 C0191 C0215 C0227 C0187 C0242 C0185 C0218 C0237 C0240 C0265 C0268 C0251 C0235 C0229 C0212 C0239 Serial # C0043 C0211 C0255 C0270 C0176 C0093 C0234 C0221 C0249 C0232 C0180 C0238 C0231 C0202 C0230 C0264 C0266. ",".","84 devices subject to correction.","Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.",10/31/2014,"10/31/2014",11/26/2014,"11/26/2014"
"Food",69646,"Ongoing","Raymond-Hadley Corp.","Spencer","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DE, GA, IL, MA, MD, ME, NJ, NY, TX","F-0471-2015","Class II","Pride of Africa brand Farina, Net Wt. 5 lb. (2.27 kg), UPC 016712016840 --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252-5220","Lot/Codes: 2/18/2014, 9-13-12 = 8, 13214-1, 268141, 132141 = 3, 6-6-13 = 1, 132141, MFG 2/18/14 =15, 268141= 2, 7-23-13 = 14, 125141, 12514 = 11, 9-13-12, 4-23-13, 12514, 132141 = 34, 7-23-13, 3-15-2013, 11-28-12, 7/23/13, 3-15-13 = 2, 11/22/13, 6-8-12 = 7, 4-23-13 =1, 04914 =1, 9-13-12 = 13, 3-15-13, 12514 =41, 6-8-12 = 5, 20413-2, 04914 2/18/14, 4-8-12 = 2, 2/18/14, 4914",".","3,972 units ","Label review revealed the product contains undeclared wheat. ",11/3/2014,"11/03/2014",11/19/2014,"11/19/2014"
"Food",69646,"Ongoing","Raymond-Hadley Corp.","Spencer","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DE, GA, IL, MA, MD, ME, NJ, NY, TX","F-0470-2015","Class II","Pride of Africa brand Semo ''Semolina'', Net Wt. 5 lb., UPC 016712016918 --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252-5220","Lot/Codes: 7614, 10-26-12, 2/18/14 049147/30/13 = 1, 12514, 10-26-12 = 6, 3-18-13, 10/4/13 = 2, 125141, 12-26-12 = 9, 3-18-13 = 2, 9-13-12, 202141, 11/20/13, 4-24-13 = 4, 9-13-2012, 287141, 11413-1, 4-18-12, 7-30-13, 04914 2/18/14, 12-26-12, 4-24-13, 1/07/2014 -1, 07614 = 29, 139141 = 51, 4-24-13-1, 2/18/14 =1, 2/18/14-1= 8, 6-20-12 = 8, 1/7/14, 12514-1 = 1, 9-13-12 = 6, 10/4/13, 2/18/14, 7/30/13",".","5,706 units ","Label review revealed the product contains undeclared wheat. ",11/3/2014,"11/03/2014",11/19/2014,"11/19/2014"
"Food",69647,"Ongoing","Latin Specialties, Inc","Houston","TX","US","Voluntary: Firm Initiated","Visit","Texas","F-0472-2015","Class I","Avocados packed in a brown cardboard box with green print. Unity Groves Pride of the Redlands Florida Avocados 25399 SW 157 Ave Homestead, FL 33031 ","No known lot codes. The avocaods were recieved by the recalling firm on 10/10/14.",".","80 cases/32 pieces each","The recalled product tested positive for Salmonella contamination.",10/30/2014,"10/30/2014",11/19/2014,"11/19/2014"
"Devices",69648,"Terminated","Beevers Manufacturing & Supply, Inc.","McMinnville","OR","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) and country of: ME-Musaffah.","Z-0487-2015","Class II","Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.","Lot 20060928. Product expired in 2009.",".","393 units","Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.",1/18/2007,"01/18/2007",12/10/2014,"12/10/2014"
"Biologics",69649,"Terminated","BTG International Inc.","Wales",,"GB","Voluntary: Firm Initiated","E-Mail","Multiple Countries; Multiple U.S. States","B-0129-15","Class III","Digoxin Immune Fab (Ovine)","BN201204; BN201205; BN201206; BN201206B; BN201207; ",".","BN 201204; 10,999 Vials; BN 201205; 14,691 Vials; BN 201206; 15,044 Vials; BN 201206B 3996 Vials; BN 201207 - 5708 Vials ","Digoxin Immune Fab (Ovine), with incorrect prescribing information, was distributed. ",9/25/2014,"09/25/2014",11/19/2014,"11/19/2014"
"Biologics",69650,"Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","E-Mail","Norway","B-0130-15","Class II","Cornea","090283OD; 090283OS",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",10/3/2014,"10/03/2014",11/19/2014,"11/19/2014"
"Devices",69656,"Ongoing","Elekta, Inc.","Atlanta","GA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA","Z-0221-2015","Class II","MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. ","MOSAIQ Release 2.60.257",".","15","A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.",11/3/2014,"11/03/2014",11/26/2014,"11/26/2014"
"Cosmetics",69657,"Ongoing","Sage Products Inc","Cary","IL","US","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV) ; *** FOREIGN: Canada","F-0506-2015","Class III","Comfort Rinse-Free Shampoo Caps, fabric-lined caps pre-moistened with rinse-free shampoo used to cleanse hair, individually packaged in a film packet. There are 40 packets per carton.","Product Code: 7909; Lot Numbers: 45812, 45923",".","2,620 cartons","A preservative ingredient was not added during the manufacture of two lots of product.",10/24/2014,"10/24/2014",11/26/2014,"11/26/2014"
"Devices",69658,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.","Z-0504-2015","Class II","Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology. ","Product No. 043128, Lot # 02E1200719, 02E1200720, 02E1201281, 02F1200964, 02K1201946, 02E1201808, 02E1203097, 02G1300256, 02G1301048, & 02M1201691; Product No. 403133, Lot # 02E1201282, 02K1201948, 02F1200965, 02L1201194, 02M1200230, & 02F1302063; Product No. 031-28, Lot # 02D1202234, 02A1202383, 02A1202382, 02B1201069, 02D1200247, 02D1200248, 02D1201944, 02D1202274, 02D1202733, 02D1202236, 02D1202734, 02D1202735, 02D1202233, 02G1200664, 02G1200678, 02G1201016, 02G1201698, 02F1200961, 02G1200676, 02M1200585, 02L1200927, 02M1200749, 02M1201693, 02A1300194, 02A1300457, 02D1301655, 02D1301191, 02D1300864, 02D1301192, 02D1302730, 02F1301742, 02E1302765, 02F1300739, 02F1302062, & 02D1200249; Product No. 031-28F, Lot # 02E1200717, 02K1201947, 02F1200962, & 02E1202197; Product No. 031-33, Lot # 02E1200718, 02A1202384, 02E1202198, 02F1200963, 02G1200666, 02J1202240, 02M1200584, 02M1200748, 02M1201771, 02D1302731, 02A1300458, 02B1300718, & 02M1201692; Product No. 031-33J, Lot # 02D1202258, 02D1202260, 02D1202259, 02D1202261, 02E1201563, 02E1201279, 02E1203866, 02M1200747, 02B1300717, 02B1301203, 02E1301554, 02B120342, 02J1201473, 02J1202736, 02F1201179, & 02M1200057.",".","3,193,548 ea","Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.",9/3/2014,"09/03/2014",12/10/2014,"12/10/2014"
"Devices",69658,"Ongoing","Teleflex Medical","Durham","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.","Z-0505-2015","Class II","Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.","Product No. 403728, Lot #104120, 114120, 132120, 120120, 155120, 158120, 144120, 164120, 008130, 013130, 023130, 035130, 038130, 049130, 060130, 072130, 054130, 100130, 115130, 128130, 142130 & 020140; Product No. 404128, Lot #065123, 068123, 051123, 077123, 060123, 087123, 005133, 082123, 035133, 029133, 048133, 053133, 056133, 063133, 068133, 076133, 083133, 055123 & 052123; Product No. 404428, Lot #041124, 080124, 002134, 085124, 009134, 019134, 025134, 035134, 049134, 039134, 044134, 056134, 061134, 060134, 003144 & 046124; Product No. 037-28, Lot #083120, 069120, 081120, 068120, 050120, 024120, 023120, 030120, 040120, 042120, 031120, 041120, 051120, 049120, 053120, 052120, 064120, 070120, 071120, 075120, 072120, 078120, 077120, 080120, 034123, 129120, 082120, 084120, 079120, 067120, 076120, 092120, 090120, 094120, 096120, 085120, 091120, 131120, 130120, 095120, 133120, 138120, 097120, 145120, 098120, 134120, 139120, 147120, 146120, 141120, 151120, 152120, 153120, 157120, 159120, 160120, 173120, 166120, 167120, 172120, 174120, 004130, 002130, 177120, 007130, 006130, 005130, 015130, 019130, 010130, 011130, 017130, 016130, 020130, 018130, 021130, 033130, 022130, 024130, 025130, 026130, 036130, 028130, 032130, 027130, 040130, 051130, 041130, 042130, 050130, 052130, 062130, 063130, 064130, 066130, 067130, 077130, 073130, 074130, 075130, 078130, 089130, 118130, 090130, 091130, 119130, 092130, 102130, 103130, 104130, 113130, 110130, 111130, 112130, 114130 & 117130; Product No. 037-28C, Lot #073120, 103120, 093120, 142120, 162120, 012130, 055120, 061130, 039130, 121130, 105120, 169120, 170120, 034130, 099130, 003130, 071130 & 076130; Product No. 037-28F, Lot #140120, 143120, 106120, 119120, 165120, 085130, 161120, 116130, 129130, 045140, 120140 & 128140; Product No. 037-33, Lot #094120, 049120, 074120, 067120, 113120, 123120, 121120, 157120, 172120, 177120, 015130, 032130, 036130, 040130, 089130, 101130, 102130 & 117130; Product No. 037-35, Lot #002220, 004220, 006220, 001220, 065120, 005220 & 007220; Product N",".","3,193,548 ea.","Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.",9/3/2014,"09/03/2014",12/10/2014,"12/10/2014"
"Drugs",69659,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide.","D-0254-2015","Class III","Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.","Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16 ",".","316,640 vials","Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.",11/7/2014,"11/07/2014",11/26/2014,"11/26/2014"
"Food",69661,"Ongoing","Taylor Farms New Jersey, NJ","Swedesboro","NJ","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD, PA & NJ","F-0529-2015","Class I","Wawa Garden Rotini Salad with Lite Creamy Caesar Dressing, Net Wt 8 oz. (227 g) Bottom of container - Wawa Kale & Quinoa Salad Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191066402","sell by 11/04/2014 TFNJ 303 1 5:00am ",".","1,510 units","Product recalled due to the potential of undeclared fish, wheat and egg allergens.",11/2/2014,"11/02/2014",11/26/2014,"11/26/2014"
"Food",69664,"Ongoing","Unity Groves Corporation","Homestead","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and TX","F-0509-2015","Class I","Avocado label: Unity Groves Avocados # 4221 Born in the USA Box label: Pride of the Redlands brand 32ct Green skin avocados, packaged in 1/2 BU Box","Lot # 14061006",".","80 Cases","FDA sample positive for Salmonella.",10/31/2014,"10/31/2014",11/26/2014,"11/26/2014"
"Devices",69665,"Completed","Snug Seat Inc","Matthews","NC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA & WV; International: Australia, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK","Z-0503-2015","Class II","Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years. ","GMDN code; 31119",".","726 units","The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.",8/26/2013,"08/26/2013",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0564-2015","Class II","6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter. ","Lot No. 1301-038",".","90 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0567-2015","Class II","Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity. ","Lot No. 1212-005",".","85 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0562-2015","Class II","ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.","Lot No. 1307-065, 1301-009",".","1470 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0563-2015","Class II","Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.","Lot No. 1302-014",".","100 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0560-2015","Class II","Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage","Lot No. 1401-040",".","480 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0565-2015","Class II","ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. ","Lot No. 1211-002, 1210-016",".","83 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0566-2015","Class II","Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage. ","Lot No. 1212-001, 1212-034",".","75 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0568-2015","Class II","ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. ","Lot No. 1210-028",".","370 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69666,"Ongoing","Pfm Medical Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.","Z-0561-2015","Class II","ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions. ","Lot No. 1307-024, 1302-031, 1210-015",".","120 units","PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",10/20/2014,"10/20/2014",12/17/2014,"12/17/2014"
"Devices",69667,"Ongoing","ArthroCare Medical Corporation","Austin","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.","Z-0579-2015","Class II","Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.","Model Number ASHA4730-01 (HipVac) lot numbers: 1021255, 1021620, 1022188, 1022482, 1022636, 1023089, 1024067, 1025482, 1025480, 102481, 1025764, 1025765, 1026875, 1027163, 1027702, 1028327, 1029265, 1030025, 1031353, 1031759, 1031760, 1032765, 1032766, 1033773, 1033974, 1034227, 1034451, 1035036, 1035295, 1038550, 1039318, 1039903, 1042371, 1042370, 1043421, 1044678, 1045361, 1046599, 1047067, 1050441, 1053407, 1053408, 1052669, 1054471, 1056213, 1057010, 1055117, 1058810, 1058291, 1059396, 1061007, 1061008, 1064276, 1064641, 1065989, 1070710, 1070711, 1071321, 1071322, 1071360, 1071361, 1073431, 1073432, 1074079, 1074140, 1076027, 1077459, 1078013, 1078911 Model Number ASHA5050-01 (KVac) lot numbers: 1044887, 1050012, 1053720, 1054965, 1055700, 1068390, 1068391, 1068392, 1068393, 1076028, 1078916, 1078918",".","23,119 devices","Potential breach of sterile barrier due to defective product tray.",10/27/2014,"10/27/2014",12/17/2014,"12/17/2014"
"Devices",69668,"Ongoing","Fisher & Paykel Healthcare, Ltd.","Auckland",,"NZ","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.","Z-0210-2015","Class II","Fisher & Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher & Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142","Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ Spare Parts: 071116 - 090810",".","Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts","Fisher & Paykel Healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. Breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. The heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. Our investigation has determined that the cause of the incidents is a manufacturing fault that is limited to two batches of nuts used only in the manufacture of certain lot numbers of Infant Warmers and spare parts.",11/6/2014,"11/06/2014",11/19/2014,"11/19/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0479-2015","Class II","GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable ","Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/2/2014,"12/02/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0480-2015","Class II","GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable ","Model M00334820330, Lot number: 12881100; Exp. Jul 2012. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/2/2014,"12/02/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0481-2015","Class II","Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: '' Intracranial aneurysms '' Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae '' Arterial and venous embolizations in the peripheral vasculature ","Model M0035461230, Lot number: 13817326; Exp. Oct 2013. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/2/2014,"12/02/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of: VA, NH, OH and TX.","Z-0478-2015","Class II","GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or( b) inoperable ","Model M003347306SRO, Lot number: 14467382; Exp. May 2014. ",".","1 Unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/2/2014,"12/02/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of: VA, NH, OH and TX.","Z-0482-2015","Class II","Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.","Model M00320072209270, Lot number: 12693091; Exp. Jun 2012. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/2/2014,"12/02/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution to the states of: VA, NH, OH and TX.","Z-0482-2015","Class II","Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.","Model M00320072209270, Lot number: 12693091; Exp. Jun 2012. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0481-2015","Class II","Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: '' Intracranial aneurysms '' Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae '' Arterial and venous embolizations in the peripheral vasculature ","Model M0035461230, Lot number: 13817326; Exp. Oct 2013. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0480-2015","Class II","GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable ","Model M00334820330, Lot number: 12881100; Exp. Jul 2012. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0479-2015","Class II","GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable ","Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013. ",".","1 unit","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69669,"Ongoing","Stryker Neurovascular","Fremont","CA","US","Voluntary: Firm Initiated","Letter","US Distribution including the states of and in only five locations in VA, NH, OH and TX.","Z-0478-2015","Class II","GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable ","Model M003347306SRO, Lot number: 14467382; Exp. May 2014. ",".","1","Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.",10/22/2014,"10/22/2014",12/10/2014,"12/10/2014"
"Devices",69670,"Ongoing","Microgenics Corporation","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.","Z-0501-2015","Class II","MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations. ","Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.",".","2135 vials.","MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32). ",10/20/2014,"10/20/2014",12/10/2014,"12/10/2014"
"Devices",69673,"Ongoing","Alcon Research, Ltd.","Fort Worth","TX","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Australia, Belgium, Hong Kong, Japan, Bosnia, France, Estonia, Germany, Greece, Hungary, Iceland, Israel, Iraq, Latvia, Saudi Arabia, Spain, UAE, Paraguay, Pakistan, Vietnam, and Kurdistan.","Z-0506-2015","Class II","INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model Numbers: 8065741080, 8065741081, 8065741082, 8065741083, 8065741085, 8065741087, 8065741088, 8065741089, 8065741093, 8065741096, 8065741097, 8065741099, 8065750266, 8065750268, 8065750274, 8065750278, 8065750280, 8065750281, 8065751009, 8065751010, 8065751011, 8065751716, 8065751717, 8065751718, 8065751719, 8065751720, 8065751721, 8065751722, 8065751723, 8065751724 The INFINITI Vision system is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. ","Lot Numbers: 1623755H, 1623756H, 1637071H, 1637072H, 1637073H, 1642718H, 1642719H, 1642720H, 1642721H, 1644878H, 1647623H, 1647624H, 1647625H, 1647626H, 1647627H, 1647628H, 1647973H, 1647974H, 1647975H, 1647976H, 1647977H, 1652900H, 1652901H, 1652904H, 1652905H, 1652906H, 1653115H, 1653116H, 1653117H, 1653119H, 1653357H, 1653358H, 1653359H, 1628801H, 1634593H, 1634594H, 1634595H, 1634596H, 1634597H, 1634598H, 1636464H, 1636465H, 1636466H, 1636467H, 1636468H, 1636469H, 1637069H, 1637070H, 1642428H, 1642429H, 1642430H, 1642431H, 1642432H, 1642433H, 1642478H, 1642479H, 1642480H, 1642481H, 1642482H, 1642919H, 1642920H, 1645688H, 1645689H, 1645690H, 1647792H, 1647793H, 1647794H, 1652897H, 1652898H, 1652899H, 1652902H, 1652903H, 1647572H, 1647573H, 1647789H, 1647790H, 1647791H, 1623130H, 1639845H, 1639846H, 1639847H, 1639848H, 1642518H, 1647969H, 1647970H, 1647971H, 1647972H, 1631281H, 1631566H, 1631567H, 1631568H, 1645638H, 1645752H, 1647576H, 1650024H, 1642677H, 1647896H, 1634767H, 1637202H, 1640123H, 1642678H, 1642724H, 1642725H, 1645640H, 1634748H, 1634749H, 1637201H, 1647571H, 1642728H, 1645753H, 1650025H, 1634768H, 1642680H, 1647569H, 1647570H, 1650440H, 1634750H, 1645754H, 1652969H, 1642682H, 1650844H, 1650845H, 1642683H, 1623132H, 1623761H, 1645641H, 1650608H, 1623134H, 1628712H, 1628713H, 1628714H, 1631846H, 1637064H, 1637065H, 1637203H, 1637204H, 1642684H, 1642688H, 1642723H, 1643014H, 1645642H, 1645643H, 1650026H, 1650027H, 1650430H, 1650609H, 1650610H, 1653317H, 1653318H, 1610411H, 1636450H, 1636451H, 1642534H, 1642535H, 1628716H, 1640124H, 1640125H, 1640126H, 1640127H, 1650847H, 1653070H, 1634763H, 1634764H, 1647786H, 1647785H, 1650848H, 1653069H, 1628072H, 1628073H, 1636431H, 1637205H, 1645646H, 1650611H, 1631847H, 1637066H, 1637067H, 1652950H, 1652958H, 1652959H, 1634765H, 1636429H, 1636430H, 1639661H, 1639662H, 1642537",".","147,473 units","Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.",10/30/2014,"10/30/2014",12/10/2014,"12/10/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0274-2015","Class II","HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49","141021CC, 11/21/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0264-2015","Class II","Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71","141013DD, 11/13/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0275-2015","Class II","Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90","141030FF, 11/30/14",".","20 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0271-2015","Class II","Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67","141013CC, 11/13/14",".","3 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0262-2015","Class II","Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57","141007DD, 11/7/14; 141015GG, 11/15/14; 141031II, 12/1/2014; 141031AA, 11/31/14; 141031JJ, 12/1/14;",".","5 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0263-2015","Class II","Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12","141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14",".","8 prefilled syringes","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0273-2015","Class II","Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49","141021FF, 11/21/14; 141028CC, 11/28/14",".","20 prefilled syringes","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0261-2015","Class II","Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09","141008BB, 11/8/14; 141008CC, 11/8/14; 141010G, 11/10/14; 141010J, 11/10/14; 141010K, 11/10/14; 141013GG, 11/13/14; 141015DD, 11/15/14; 141015BB, 11/15/14; 141020GG, 11/20/14; 141024HH, 11/24/14; 141024II, 11/24/14; 141024JJ, 11/24/14; 141028BB, 11/28/14; 141028CC, 11/28/14; 141031GG, 12/1/14;",".","17 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0269-2015","Class II","HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34","141015FF, 11/15/14; 141024KK, 11/24/14; 141031CC, 12/1/14",".","3 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0266-2015","Class II","Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17","141010K, 11/10/14",".","10 prefilled syringes","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0270-2015","Class II","2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17","141016A, 11/16/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0265-2015","Class II","HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54","141009DD, 11/9/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0268-2015","Class II","HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68","141015DD, 11/15/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0259-2015","Class II","Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44","141006HH, 11/6/14",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0267-2015","Class II","HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17","141010I, 11/10/14; 141017F, 11/17/14; ",".","2 vials","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0272-2015","Class II","HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47","141021DD, 11/21/14; ",".","1 vial","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69674,"Ongoing","Perry Drug Inc.","Overland Park","KS","US","Voluntary: Firm Initiated","Letter","Kansas and Missouri","D-0260-2015","Class II","Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37","141006GG, 11/6/14; 141009FF, 11/9/14; 141014BB, 11/9/14; 141014BB, 11/14/14; 1410164, 11/16/14; 141021GG, 11/21/14; 141030DD, 11/30/14",".","186 prefilled syringes","Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.",11/7/2014,"11/07/2014",12/2/2014,"12/02/2014"
"Drugs",69676,"Ongoing","Zydus Pharmaceuticals USA Inc","Pennington","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0257-2015","Class III","Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16","Lot #: MP4344, Exp 04/2016",".","15,144 bottles","Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.",10/1/2014,"10/01/2014",12/2/2014,"12/02/2014"
"Food",69677,"Ongoing","International Sprout Holding Inc.","Cookeville","TN","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL, HI, IA, MA, MD, MT, NY, OH, and Canada","F-0539-2015","Class I","Alfalfa Seed in plastic lined bags labeled in part *** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Specialty Supply ***","SAL2-3BJ",".","22,000 lbs.","A sample of one lot of product tested positive for salmonella.",11/4/2014,"11/04/2014",12/2/2014,"12/02/2014"
"Biologics",69681,"Terminated","Tissue Banks International - National","San Rafael","CA","US","Voluntary: Firm Initiated","Telephone","Jordan","B-0131-15","Class III","Cornea","SF201405111; SF201405112",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/25/2014,"07/25/2014",11/19/2014,"11/19/2014"
"Biologics",69682,"Terminated","TBI dba New England Eye & Tissue Transplant Bank","Boston","MA","US","Voluntary: Firm Initiated","Telephone","Florida; California","B-0132-15","Class II","Cornea","NE201407101; NE201407102",".","2 corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ",7/25/2014,"07/25/2014",11/19/2014,"11/19/2014"
"Devices",69683,"Ongoing","Bard Access Systems","Salt Lake City","UT","US","Voluntary: Firm Initiated","Letter","US Distribution to state of: TX, OK, LA, and AR.","Z-0493-2015","Class II","GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006."," Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016",".","2532 units","Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically.",11/3/2014,"11/03/2014",12/10/2014,"12/10/2014"
"Devices",69685,"Ongoing","Synthes, Inc.","West Chester","PA","US","Voluntary: Firm Initiated","Letter","US Distribution in the states of: AK, FL, OH, OK, and TX.","Z-0219-2015","Class II","10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur","part number: 456.316S, lot number: 7782247",".","6","The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Devices",69686,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the state of: WV, NY, and FL..","Z-0523-2015","Class II","Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. ","model number: 10140000",".","3","It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.",10/28/2014,"10/28/2014",12/17/2014,"12/17/2014"
"Drugs",69688,"Ongoing","Sandoz, Inc","Princeton","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0288-2015","Class III","candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92","Lot #: 3007330, Exp 11/2014",".","6,336 bottles","Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.",10/2/2014,"10/02/2014",12/10/2014,"12/10/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0519-2015","Class I","Coconut Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92212 00275 4, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0523-2015","Class I","Wheat Bran Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92228 00275 5, sell by dates up to and including 11/4/2014",".","31331 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0522-2015","Class I","Cheese Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92213 00275 3, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0516-2015","Class I","U-TA-NE Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92223 00275 0, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0524-2015","Class I","Red Bean Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92209 00275 0, sell by dates up to and including 11/4/2014",".","31313 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0521-2015","Class I","Multi-9 Grain, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92203 00275 6, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0517-2015","Class I","Raisin Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92208 00275 1, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0518-2015","Class I","Green Onion Porksung Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92219 00275 7, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0520-2015","Class I","Pineapple Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92211 00275 5, sell by dates up to and including 11/4/2014",".","3133 loaves, total all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0514-2015","Class I","Taro Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92210 00275 6, sell by dates up to and including 11/4/2014",".","3133 loaves, all varieites","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Food",69689,"Ongoing","Welcome Market Inc","Union City","CA","US","Voluntary: Firm Initiated","Press Release","Northern CA and WA (2 locations)","F-0515-2015","Class I","Family Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035","UPC 2 92216 00249 1, sell by dates up to and including 11/4/2014",".","3133 total loaves, all varieties","Various varieties of Toast products are being recalled due to lack of allergen statement for wheat, soy, and/or milk.",10/29/2014,"10/29/2014",11/26/2014,"11/26/2014"
"Devices",69693,"Ongoing","Medacta Usa","Chicago","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.","Z-0225-2015","Class II","The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants. ","Model Number: 03.22.10.0262; Lot Number: 1314256",".","32 oblique handles","The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.",10/21/2014,"10/21/2014",11/26/2014,"11/26/2014"
"Biologics",69694,"Terminated","South Texas Blood & Tissue Center","San Antonio","TX","US","Voluntary: Firm Initiated","Telephone","Texas","B-0143-15","Class II","Platelets Irradiated","W140914189614; ",".","1 unit","Platelet product, collected from a donor who disclosed a history of drug use, was distributed.",9/19/2014,"09/19/2014",12/17/2014,"12/17/2014"
"Biologics",69695,"Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-0165-15","Class II","Platelets Pheresis Leukocytes Reduced","W043214013968; ",".","1 unit","Platelet product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, was distributed.",10/22/2014,"10/22/2014",12/17/2014,"12/17/2014"
"Biologics",69696,"Terminated","Suncoast Communities Blood Bank, Inc.","Sarasota","FL","US","Voluntary: Firm Initiated","Other","Florida","B-0170-15","Class II","Platelets Pheresis Leukocytes Reduced","W038614846786; ",".","1 unit","Platelet product that did not meet specifications, was distributed.",9/15/2014,"09/15/2014",12/17/2014,"12/17/2014"
"Devices",69704,"Ongoing","Abbott Medical Optics Inc (AMO)","Santa Ana","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.","Z-0530-2015","Class II","Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)","Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012) Healon EndoCoat Device identification: For Healon EndoCoat, each lot is assigned a unique lot number for traceability. The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned. The numbers 1-6 are sequentially increased representing the manufacturing order number. Example: Lot 024992. For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha unique batch number. The batch number consists of two alphabetic characters followed by five numeric characters. The first alphabetic character of each batch number designates the manufacturing site. The second alphabetic character of each batch number shall be sequential numbers starting with 30001. Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014). ",".","484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally","AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.",11/6/2014,"11/06/2014",12/17/2014,"12/17/2014"
"Food",69706,"Terminated","Schwartz Brothers Restaurants dba Schwartz Brothers Bakery","Seattle","WA","US","Voluntary: Firm Initiated","Press Release","distributed in Oregon and Washington","F-0704-2015","Class II","''Everything Bagels'' product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels. This product has the UPC number 7 17887 23121 1. The product is labeled in parts: ''***Everything Bagels***Net Wt. 16 oz (1 lb) 454 g***Produced By Schwartz Brothers Bakery Seattle, Renton WA***7 17887 23121 1***Schwartzbros.com***.","Best By dates of 10/14/14 to 11/10/14",".","321 bags","Mislabeling. Product inside a plastic bag actually contains milk but mis-labeled as ''Everything Bagels'' and this label does not declare milk.",11/6/2014,"11/06/2014",12/17/2014,"12/17/2014"
"Biologics",69711,"Terminated","Octapharma Plasma, Inc.","Charlotte","NC","US","Voluntary: Firm Initiated","E-Mail","Austria","B-0171-15","Class III","Source Plasma","4570434871; 4570433054; 4570431561; 4570429605; 4570416637; ",".","5 units","Blood products, collected from a donor who should have been deferred due to history, were distributed.",10/8/2014,"10/08/2014",12/17/2014,"12/17/2014"
"Food",69716,"Ongoing","Nature's Way Purewater Systems, Inc.","Pittston","PA","US","Voluntary: Firm Initiated","Telephone","CT, DE, GA, IA, IL, IN, MA, MD, ME, MI, MN, NC, NH, NY, PA, VA, and WI","F-0615-2015","Class II","ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021 Packaging: For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sale: 6-packs of 1 liter bottles and as individual bottles. For the 50.7 fl oz. (1.5 liter) plastic bottles: Wholesale: packed in 12 bottles per case. Retail sale: Individual bottles. For the 20 fl oz plastic bottles: Wholesale: 24 bottle case; 24 bottle tray; 4 - 6 pack trays. Retail sale: Individual bottles and 6-packs (retail).","JUL 22 2014 time NW1 Best by Jul 21 2016; Jul 23 2014 time NW1 Best by Jul 22 2016; Jul 24 2014 time NW1 Best by Jul 23 2016; and Jul 25 2014 time NW1 Best by Jul 24 2016",".","1.5 L - 10,890 cs, 12 bottles per case; 1L - 14,270 cs, 12 bottles per case; 20 oz. - 5724 cs, 24 bottle per case","Product may contain mold.",10/31/2014,"10/31/2014",12/17/2014,"12/17/2014"
"Devices",69720,"Ongoing","Medtronic Mimed","Northridge","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution. US Nationwide and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lativa, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, and Venezuela.","Z-0524-2015","Class II","Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.","This field correction involves all models of Silhouette and Sure-T insulin infusion sets.",".","US 12,400,098 and Internationally 8,266,733","Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).",11/4/2014,"11/04/2014",12/17/2014,"12/17/2014"
"Biologics",69722,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0173-15","Class II","Plasma Frozen within 24 hours (FP24)","W038113272890; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/10/2014,"10/10/2014",12/17/2014,"12/17/2014"
"Biologics",69722,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0172-15","Class II","Red Blood Cells","W038113272890; ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/10/2014,"10/10/2014",12/17/2014,"12/17/2014"
"Biologics",69722,"Terminated","OneBlood, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-0174-15","Class II","Platelets Pooled Leukocytes Reduced","W038113985801 ",".","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.",10/10/2014,"10/10/2014",12/17/2014,"12/17/2014"
"Drugs",69724,"Ongoing","Pfizer Inc.","New York","NY","US","Voluntary: Firm Initiated","Letter","Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.","D-0292-2015","Class II","Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. ","Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15 ",".","31,569 HDPE Bottles","Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. ",12/3/2014,"12/03/2014",12/17/2014,"12/17/2014"
"Devices",69726,"Terminated","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and countries of: Australia and Japan.","Z-0570-2015","Class II","1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.","Model 1488-710-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12F016274 12F016294 12F055824 12F055844 12F055874 12F055884 12F055894 12F055904 12F055914 12F055924 12F055934 12F055954 12F055964 12F055974 12F055994 12F056004 12F056024 12F056034 12F056054 12F056064 12F056094 12F056104 12F056124 12F056154 12F056164 12F056174 12F056184 12F056194 12F056204 12F056664 12F056674 12F056684 12F056694 12F056704 12F056714 12F056744 12F058884 12F058894 12F058904 12F058924 12F058934 12F058944 12F058964 12G054154 12G054174 12G054194 12G054214 12G054224 12G054234 12G054244 12G054264 12H011414 12H011434 12H011444 12H011454 12H011474 12H011494 12H050834 12H050844 12H050854 12I039444 12I039454 12I039464 12I039474 12I039494 12I039504 12I039524 12I039534 12I040844 12I040854 12I040864 12I040874 12I040894 12I040924 12I040934 12I047324. 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454",".","1965 cameras","In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period",3/5/2013,"03/05/2013",12/17/2014,"12/17/2014"
"Devices",69726,"Terminated","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and countries of: Australia and Japan.","Z-0569-2015","Class II","1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.","Model 1488-210-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12D020574 12D020584 12D020594 12D020614 12D020624 12D020634 12D020704 12D020714 12D020734 12E036114 12E036124 12E036134 12E036144 12E036154 12E036164 12E036174 12E036184 12E036204 12E036214 12E036244 12E036254 12E036264 12E036274 12E036284 12E036294 12E036314 12E036324 12E036334 12E036354 12E036374 12E036384 12E036394 12E036404 12E036414 12E036434 12E036444 12E036454 12E038334 12E038344 12E038354 12E038364 12E038374 12E038384 12E038394 12E038404 12E038414 12E038674 12E038684 12E038714 12E038724 12E038754 12E038764 12E039074 12E039084 12E039094 12E039104 12E039114 12E039124 12E039154 12E039164 12E039184 12E039194 12E039204 12E039214 12E039234 12E039244 12E039254 12E039274 12E039284 12E039294 12E039324 12E039334 12E039344 12E039364 12E040514 12E040524 12E040534 12E040544 12E040564 12E040584 12E040594 12E040604 12E040624 12E040634 12E040644 12E040654 12E040694 12E040714 12E040724 12E040744 12E040764 12E040774 12E040804 12E040814 12E041624 12E041644 12E041654 12E043194 12E043204 12E043234 12E043244 12E043264 12E043274 12E043294 12E043304 12E043314 12E043324 12E043344 12E043364 12E047664 12E047674 12E047684 12E047724 12E047734 12E047744 12E047774 12E047784 12E047794 12E047804 12E047834 12E050174 12E050184 12E050194 12E050204 12E050244 12E050274 12E050284 12E050294 12E050304 12E050314 12E050334 12E050444 12E050454 12E050474 12E050484 12E050504 12E050544 12E050554 12E050564 12E050574 12E050594 12E050614 12E055784 12E055814 12E055824 12E055834 12E055844 12E055864 12E055884 12E055894 12E055914 12E055944 12E055964 12F000014 12F000044 12F000064 12F000094 12F000104 12F000124 12F000134 12F000144 12F000154 12F000174 12F000194 12F000204 12F000224 12F000234 12F000244 12F000254 12F000264 12F000284 12F000294 12F000304 12F000314 12F000324 12F000334 12F000354 12F000364 12F000384 12F000414 12F001764 12F001784 12F001794 12F001814 12F001824 12F001834 12F001854 12F001864 12F001874 12F001884 12F001894 12F001904 12F003274 12F003314 12F003324 12F003344 12F003354 12",".","1965 cameras","In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period",3/5/2013,"03/05/2013",12/17/2014,"12/17/2014"
"Devices",69726,"Terminated","Stryker Endoscopy","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and countries of: Australia and Japan.","Z-0571-2015","Class II","1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.","Model 1488-610-122: 1488 HD 3-Chip Camera Head with Integrated Coupler. Serial numbers: 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454 12I016464 12I016474 12I016484 12I016494 12I016504 12I016514 12I016524 12I016534 12I016544 12I016554 12I016564 12I018674 12I018684 12I018694 12I018704 12I018714 12I018724 12I018734 12I018744 12I018754 12I018764 12I018774 12I018784 12I018794 12I018804 12I018814 12I018824 12I018834 12I018844 12I018854 12I018864 12I018874 12I018884 12I018894 12I018904 12I018914 12I018924 12I018934 12I018944 12I019254 12I019264 12I019274 12I019284 12I019294 12I019304 12I019314 12I019324 12I019334 12I019344 12I033824 12I033874 12I033894 12I033904 12I033914 12I033924 12I033934 12I033944 12I033954 12I033964 12I033974 12I033984 12I033994 12I034004 12I034214 12I034224 12I034234 12I034244 12I034254 12I034264 12I034274 12I034284 12I034304 12I034814 12I034824 12I03483",".","1965 cameras","In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period",3/5/2013,"03/05/2013",12/17/2014,"12/17/2014"
"Devices",69728,"Ongoing","Respironics California Inc","Carlsbad","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.","Z-0485-2015","Class II","Esprit V1000 Ventilator, Model No. V1000 and Esprit/V200 Conversions The Esprit V1 000 and EspriW200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients. ","All Esprit V1000 ventilators manufactured prior to December 31, 2004 and those units manufactured prior to 12/2004 that have been converted to V200.",".","3,943 units total (3,071 units in US)","If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted..",10/29/2014,"10/29/2014",12/2/2014,"12/02/2014"
"Biologics",69730,"Terminated","OneBlood, Inc.","St Petersburg","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-0175-15","Class II","Platelets Pheresis Leukocytes Reduced","W03941423783600; ",".","1 unit","Platelet product, which failed leukoreduction testing, was distributed.",11/4/2014,"11/04/2014",12/17/2014,"12/17/2014"
"Biologics",69732,"Terminated","OneBlood, Inc.","Lauderhill","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-0183-15","Class II","Red Blood Cells Leukocytes Reduced","W036813169207; ",".","1 unit","Blood product, labeled as antigen negative but subsequently tested as antigen positive, was distributed.",9/17/2014,"09/17/2014",12/17/2014,"12/17/2014"
"Devices",69735,"Terminated","ZOLL Circulation, Inc.","San Jose","CA","US","Voluntary: Firm Initiated","Letter","US Distribution in NC only.","Z-0477-2015","Class II","7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.","Model 1027, Catalog number 8700-000775-01, lot 0021.",".","1 device","After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.",4/1/2014,"04/01/2014",12/2/2014,"12/02/2014"
"Food",69736,"Ongoing","Karlsburger Foods, Inc.","Monticello","MN","US","Voluntary: Firm Initiated","Telephone","CA only","F-0512-2015","Class I","InHarvest Garden Vegetable Seasoning, Item 61104, Net Wt 4 oz.","Lots 4020501 and 4041401",".","25,651 packets","Firm is recalling Garden Vegetable Seasoning due to an undeclared milk allergen.",11/10/2014,"11/10/2014",11/26/2014,"11/26/2014"
"Devices",69737,"Ongoing","Cure Medical LLC","Newport Beach","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0496-2015","Class II","Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage ","Lot Number: 140417-3",".","192 cases = 1,920 boxes = 57,600 each","Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.",11/11/2014,"11/11/2014",12/10/2014,"12/10/2014"
"Devices",69740,"Ongoing","Arrow International Inc","Reading","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0573-2015","Class II","Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.","Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689 ",".","786","Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.",11/10/2014,"11/10/2014",12/17/2014,"12/17/2014"
"Devices",69743,"Ongoing","Alcon Research, Ltd.","Fort Worth","TX","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.","Z-0527-2015","Class II","Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.","Lot numbers 061814-95 and 080614-91",".","2321","The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.",11/11/2014,"11/11/2014",12/17/2014,"12/17/2014"
"Food",69744,"Ongoing","InHarvest, Inc.","Woodland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0533-2015","Class I","Whole Grain 5 Blend/Garden Vegetable 12/36 oz Product number 12410; Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. ","Seasoning lot: 4020501 - InHarvest lot numbers: 140218, 131114, 140513,140623 Seasoning lot 4041401 - InHarvest lot numbers: 140820",".","660 cases","Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label.",11/11/2014,"11/11/2014",11/26/2014,"11/26/2014"
"Food",69744,"Ongoing","InHarvest, Inc.","Woodland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0534-2015","Class I","Garden Vegetable seasoning Mix 12/4 oz. Product number 141000 Garden Vegetable seasoning mix. 4 oz..; Product number 14000 Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. ","Seasoning lot: 4020501 - InHarvest lot numbers: 4020501, Seasoning lot 4041401 - InHarvest lot numbers: 4041401.",".","4474 4 oz packages","Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label.",11/11/2014,"11/11/2014",11/26/2014,"11/26/2014"
"Food",69744,"Ongoing","InHarvest, Inc.","Woodland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0530-2015","Class I","White and Wild Medley/Garden Vegetable 12/36 oz; Product number 10410. Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. In Harvest, Inc. Bemidji, MN. ","Seasoning lot: 4020501 - InHarvest lot number 140217; Seasoning lot 4041401 - InHarvest lot numbers: 140624 and 140908",".","245 cases","Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label.",11/11/2014,"11/11/2014",11/26/2014,"11/26/2014"
"Food",69744,"Ongoing","InHarvest, Inc.","Woodland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0531-2015","Class I","Caviar Medley/Garden Vegetable 12/36 oz Product number 10610; Caviar Medley/Garden Vegetable 6/26 oz. Product number 10644 Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. ","Seasoning lot: 4020501 - InHarvest lot numbers: 140214, 140325, 140211; Seasoning lot 4041401 - InHarvest lot numbers: 140211, 140325, 141029",".","777 cases","Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label.",11/11/2014,"11/11/2014",11/26/2014,"11/26/2014"
"Food",69744,"Ongoing","InHarvest, Inc.","Woodland","CA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0532-2015","Class I","Rio Medley/Garden Vegetable 12/36 oz; Product number 12310; Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each of the following: dehydrated tomato, spices, natural flavor, Citric Acid, Soybean Oil, Silicon Dioxide (anticaking agent) Seasoning is added to 2 lbs of rice/grain/legume and water. InHarvest, Inc. Bemidji , MN. ","Seasoning lot: 4020501 - InHarvest lot numbers:130304, 140128, 140626.. Seasoning lot 4041401 - InHarvest lot numbers: 140626, 140128, 140827.",".","111 cases","Firm was notified by supplier of Garden Vegetable Seasoning that the product has an ingredient that contains milk, and milk is not declared on the label.",11/11/2014,"11/11/2014",11/26/2014,"11/26/2014"
"Food",69745,"Ongoing","Kent Precision Foods Group, Inc.","Bolingbrook","IL","US","Voluntary: Firm Initiated","Letter","US: Nationwide (AZ, IA, IL, IN, MA, MD, MI, MN, NE, NH, NJ, NV, NY, PA, SC, TN, WI)","F-0705-2015","Class II","Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars.","Product Code: L334 12233. UPC: 0 72058 60864 4. Lot Number: B4036P. Best By: AUG 2015.",".","13,572 jars","Orrington Farms Chicken Flavored Broth Base & Seasoning, Low Sodium labels were placed on jars of Orrington Farms Beef Flavored Broth Base & Seasoning, Low Sodium.",10/27/2014,"10/27/2014",12/17/2014,"12/17/2014"
"Devices",69746,"Ongoing","Medtronic Perfusion Systems","Brooklyn Park","MN","US","Voluntary: Firm Initiated","Visit","US Distribution to states of: CA and FL.","Z-0531-2015","Class II","The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging. ","Lot number 12981001 with the following Serial Numbers: 8110138055 8110141155 8110141281 8110141459 8110138056 8110141162 8110141304 8110141469 8110138061 8110141167 8110141305 8110141471 8110138096 8110141168 8110141315 8110141497 8110139306 8110141182 8110141320 8110141518 8110139330 8110141184 8110141331 8110141527 8110139856 8110141188 8110141335 8110141533 8110140819 8110141193 8110141342 8110141587 8110140824 8110141215 8110141368 8110141604 8110140985 8110141219 8110141380 8110141605 8110141045 8110141222 8110141391 8110141613 8110141082 8110141230 8110141403 8110141616 8110141083 8110141238 8110141415 8110141621 8110141114 8110141240 8110141416 8110141705 8110141119 8110141244 8110141418 8110141731 8110141127 8110141247 8110141421 8110141739 8110141128 8110141253 8110141423 8110141750 8110141138 8110141258 8110141431 8110141782 8110141142 8110141260 8110141445 8110141788 8110141153 8110141279 8110141452 8110141798",".","66","Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7.",10/31/2014,"10/31/2014",12/17/2014,"12/17/2014"
"Devices",69748,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, MA, MD","Z-0471-2015","Class II","Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.","Item CFA Software Serial Number: Description TSX-301C/2D 2BA1362093 Aquilion One Vision",".","1 unit within the U.S. only","This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.",11/5/2014,"11/05/2014",12/2/2014,"12/02/2014"
"Devices",69748,"Ongoing","Toshiba American Medical Systems Inc","Tustin","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, MA, MD","Z-0472-2015","Class II","Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.","Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One",".","2 units within the U.S. only","This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.",11/5/2014,"11/05/2014",12/2/2014,"12/02/2014"
"Food",69749,"Ongoing","Heartlight Seafood LLC","Pembroke Pines","FL","US","Voluntary: Firm Initiated","E-Mail","CA, NY, and NJ","F-0707-2015","Class II","HeartLight Seafood brand Frozen Yellowfin Tuna Ground Meat (Thunnus albacares), IQF packed in a master carton of 10 x 1 lbs HDPE bags","Lot numbers: 155080514161, 156080514161, and 157608051461; Raw material lot numbers: 1415505, 141560, and 14157605",".","42,000 lbs/ 4,200 cases","Product may have high histamine levels and may be unfit for human consumption.",11/11/2014,"11/11/2014",12/17/2014,"12/17/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0454-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0456-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0458-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0462-2015","Class I","CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO - Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. Because of this change, some ConMed's multifunction electrodes will not connect to these AEDs. The HeartStart FRx AED unit requires the pads to be pre-connected, and will issue an alarm chirp to alert the user that the proper pads are not connected to the unit. The HeartStart FR3 however, does not require pre-connection and the user will not discover the compatibility issue until the AED is to be used. In this circumstance, the failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0461-2015","Class I","CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO - Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. Because of this change, some ConMed's multifunction electrodes will not connect to these AEDs. The HeartStart FRx AED unit requires the pads to be pre-connected, and will issue an alarm chirp to alert the user that the proper pads are not connected to the unit. The HeartStart FR3 however, does not require pre-connection and the user will not discover the compatibility issue until the AED is to be used. In this circumstance, the failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0455-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0459-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0460-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69752,"Ongoing","ConMed Corporation","Utica","NY","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.","Z-0457-2015","Class I","MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR-Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.","All Lot Codes",".",,"Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.",11/6/2014,"11/06/2014",12/10/2014,"12/10/2014"
"Devices",69759,"Ongoing","Smith & Nephew, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.","Z-0591-2015","Class II","LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. ","Lot Number 14EM23391",".","23 units","The stem taper on this device is undersized; the gauge point is not deep enough.",11/4/2014,"11/04/2014",12/17/2014,"12/17/2014"
"Devices",69759,"Ongoing","Smith & Nephew, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.","Z-0590-2015","Class II","LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. ","Lot Numbers: 14EM16708, 14EM21988, 14DM22269",".","45 units","The stem taper on this device is undersized; the gauge point is not deep enough.",11/4/2014,"11/04/2014",12/17/2014,"12/17/2014"
"Devices",69759,"Ongoing","Smith & Nephew, Inc.","Memphis","TN","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.","Z-0589-2015","Class II","LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. ","Lot Number 14FM05730",".","24 units","The stem taper on this device is undersized; the gauge point is not deep enough.",11/4/2014,"11/04/2014",12/17/2014,"12/17/2014"
"Food",69761,"Ongoing","SUSHI HOUSE INC.","Palisades Park","NJ","US","Voluntary: Firm Initiated","Telephone","CT, NJ and NY","F-0574-2015","Class II","Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by 06/10/2016, UPC 207935110006","Lot #128578",".","280 boxes","Sushi House Inc. is conducting a voluntary recall of Heartlight Ground Tuna because it may contain histamines which exceed 50 ppm.",11/5/2014,"11/05/2014",12/2/2014,"12/02/2014"
"Devices",69764,"Terminated","Concentric Medical Inc","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.","Z-0525-2015","Class II","Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.","Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014",".","87 units","Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.",9/26/2013,"09/26/2013",12/17/2014,"12/17/2014"
"Food",69765,"Ongoing","R and S Gourmet Warehouse","Hilton Head Island","SC","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, NC, SC and TN.","F-0593-2015","Class II","Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vinegar, Worcestershire Sauce, Onions and Spices, P.O. Box 22764, Hilton Head Island, SC 29925.","Expiration date of 08-31-2016 through 11-03-2016",".","698 bottles","Undeclared non-allergens, soy, wheat, anchovies.",11/4/2014,"11/04/2014",12/10/2014,"12/10/2014"
"Food",69765,"Ongoing","R and S Gourmet Warehouse","Hilton Head Island","SC","US","Voluntary: Firm Initiated","E-Mail","AL, FL, GA, NC, SC and TN.","F-0594-2015","Class II","Gourmet Warehouse, Island Jerk Marinade, 16 fl oz. (473 mL), Ingredient: Soy Sauce, Lemon Juice, Thyme, Allspice, Onion, Garlic, Cayenne Pepper, Salt, Savory Paprika, Spices, P.O. Box 22764, Hilton Head Island, SC 29925.","Expiration date of 08-31-2016 through 11-03-2016",".",,"Undeclared non-allergens, soy, wheat, anchovies.",11/4/2014,"11/04/2014",12/10/2014,"12/10/2014"
"Devices",69771,"Ongoing","Remel Inc","Lenexa","KS","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution to FL","Z-0578-2015","Class II","Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.","Lot number: 1374439, Exp: 31 Aug 2015",".","1/10/100 ml/vials/packs","Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.",11/13/2014,"11/13/2014",12/17/2014,"12/17/2014"
"Devices",69778,"Ongoing","Mevion Medical Systems, Inc.","Littleton","MA","US","Voluntary: Firm Initiated","E-Mail","US Distribution in the state of MO","Z-0588-2015","Class II","MEVION S250, used for proton radiation therapy. ","Serial Number: S250-0001",".","1","Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.",11/10/2014,"11/10/2014",12/17/2014,"12/17/2014"
"Food",69780,"Ongoing","Wehah Farms","Richvale","CA","US","Voluntary: Firm Initiated","Press Release","CA, HI, AZ, MA, NV","F-0536-2015","Class I","Organic Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 6) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. ","lot # 141027 exp. 10/27/2015 lot # 141028, exp. 10/28/2015 Lot # 141029 exp. 10/29/2015 . Sold between November 4 and November 12, 2014.",".","629 x 25 lb. bags. ","Customer notified Lundberg Family Farms of a positive Salmonella test on Organic Brown Rice Flour. ",11/14/2014,"11/14/2014",12/2/2014,"12/02/2014"
"Food",69780,"Ongoing","Wehah Farms","Richvale","CA","US","Voluntary: Firm Initiated","Press Release","CA, HI, AZ, MA, NV","F-0537-2015","Class I","Eco Farm Fine Brown Rice Flour; 25 lb. bulk bags Organic Brown Rice Flour ( UPC # 073416 00500 1) were distributed in retail store bulk bins. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Lundberg Family Farms, Richvale, CA","lot # 141029 exp. 10/29/2015; Lot # 141030 exp. 10/30/2015 . Sold between November 4 and November 12, 2014.",".","210 X 25 lb bags","Customer notified Lundberg Family Farms of a positive Salmonella test on Organic Brown Rice Flour. ",11/14/2014,"11/14/2014",12/2/2014,"12/02/2014"
"Devices",69783,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.","Z-0450-2015","Class II","BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454","BrightView: 11000022, 11000028, 11000050, 1000067, 11000070, 11000073, 1000079, 11000080, 11000084, 11000088, and 11000109. BrightView X:4000007, 4000034, 4000045, 4000049, 4000050, 4000052, 4000055, 4000057, 4000062, 4000091, 4000110, 4000119, 4000145, 4000178, 4000186, 4000192, 4000203, 4000215, 4000221, 4000234, 4000267, 4000268, 4000273, 4000315, 4000332, 4000335, 4000337, 4000340, 4000343, 4000349, 4000351, 4000359, 4000391, 4000404, 4000436, 4000447, 4000493, 4000497, 4000500, 4000517, 4000595, 4000599, 4000605, 4000609, 4000616, 4000617, 4000622, 4000648, 4000653, and 4000675. BrightView XCT: 6000018, 6000024, 6000025, 6000029, 6000059, 6000072, 6000074, 6000096, 6000097, 6000106, 6000155, 6000170, 6000179, 6000217, 6000255, 6000259, 6000272, 6000328, 6000342, 6000357, 6000388, 6000405, 6000412, 6340011, and 11000082.",".","85","Software issues",11/4/2014,"11/04/2014",12/2/2014,"12/02/2014"
"Devices",69786,"Ongoing","Gambro Renal Products Inc","Opelika","AL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.","Z-0490-2015","Class II","Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.","Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001",".","20 million dialyzers","Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.",11/5/2014,"11/05/2014",12/10/2014,"12/10/2014"
"Devices",69786,"Ongoing","Gambro Renal Products Inc","Opelika","AL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.","Z-0489-2015","Class II","Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.","Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001",".","20 million dialyzers","Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.",11/5/2014,"11/05/2014",12/10/2014,"12/10/2014"
"Devices",69787,"Ongoing","Ethicon, Inc.","Somerville","NJ","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0492-2015","Class II","Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA."," PERMA-HAND'' Silk Suture [Siliconized black braided] Product Code - 10Q06 Lots and Expiration Dates- GPP528 JUL 2018 GPP908 JUL 2018 HAB605 JAN 2019 HAE019 JAN 2019 HAE964 JAN 2019 HAP987 JAN 2019 HBB681 JAN 2019 HBB952 JAN 2019 HBE186 JAN 2019 HCB084 JAN 2019 HCB972 JAN 2019 HCE266 JAN 2019 HCE980 JAN 2019 PERMA-HAND'' Silk Suture [Siliconized black braided] Product Code - 10Q07 Lots and Expiration Dates- GPB984 JUL 2018 GPE919 JUL 2018 HAP822 JAN 2019 HBP781 JAN 2019 HCP953 JAN 2019 HCR677 JAN 2019",".","2,508 each","Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.",10/17/2014,"10/17/2014",12/10/2014,"12/10/2014"
"Food",69789,"Completed","Baptista's Bakery, Inc","Franklin","WI","US","Voluntary: Firm Initiated","E-Mail","CA only","F-0709-2015","Class I","Houdini, 3 oz Honey Mustard Pretzel Nuggets, item # COM 562","Lot 30014",".","10,589 lbs","The wrong seasoning was used on the pretzels, which contains whey, that is not declared on the label.",11/14/2014,"11/14/2014",12/17/2014,"12/17/2014"
"Devices",69793,"Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Viet Nam.","Z-0473-2015","Class II","IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030","IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382. IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178. IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290. IntelliSpace Portal IX: 50306, 40219, and 40368. IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030",".","32","Software defect",11/9/2014,"11/09/2014",12/2/2014,"12/02/2014"
"Food",69797,"Ongoing","Cheesecake Royale, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, AR, and TX","F-0624-2015","Class II","Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041","MFG#041",".","256 units","Recalled product contains undeclared wheat.",11/17/2014,"11/17/2014",12/17/2014,"12/17/2014"
"Food",69797,"Ongoing","Cheesecake Royale, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, AR, and TX","F-0623-2015","Class II","CARROT CAKE, Weight: 8 lbs. (112 oz.) - 3.6 kg, UPC#85538300025 ","MFG#025",".","501 cakes","Recalled product contains undeclared walnuts. Walnut is not listed on the ingredients statement, however pecans are listed as an ingredient. ",11/17/2014,"11/17/2014",12/17/2014,"12/17/2014"
"Food",69797,"Ongoing","Cheesecake Royale, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, AR, and TX","F-0622-2015","Class II","Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. Dallas, TX 75218, www.CheesecakeRoyale.com ","MFG#10204",".","70 cakes","Recalled product contains undeclared FD&C Yellow #5 and wheat.",11/17/2014,"11/17/2014",12/17/2014,"12/17/2014"
"Food",69797,"Ongoing","Cheesecake Royale, Inc.","Dallas","TX","US","Voluntary: Firm Initiated","Letter","FL, AR, and TX","F-0625-2015","Class II","Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042 ","MFG#242",".","31 units","Recalled product contains undeclared wheat.",11/17/2014,"11/17/2014",12/17/2014,"12/17/2014"
"Devices",69799,"Terminated","Concentric Medical Inc","Mountain View","CA","US","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, IN, PA, AL, and NJ.","Z-0528-2015","Class II","Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. ","Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015 ",".","10 units","Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.",11/13/2013,"11/13/2013",12/17/2014,"12/17/2014"
"Cosmetics",69800,"Ongoing","Medline Industries, Inc.","Waukegan","IL","US","Voluntary: Firm Initiated","Letter","*** US: AK, ID, OR, WA; *** FOREIGN: Canada","F-0706-2015","Class III","ReadyBath Shampoo Caps, Scented are fabric-lined caps are pre-moistened rinse-free shampoo caps used to cleanse hair and are individually packaged in a film packet. There are 30 packets per carton.","Product Code: MSC095230. Lot Number: 14IE0027. Expiration Date: September 2016. ",".","32 cases (960 cartons)","The shampoo caps may contain broken needles.",11/17/2014,"11/17/2014",12/17/2014,"12/17/2014"
"Devices",69802,"Ongoing","Siemens Medical Solutions USA, Inc","Malvern","PA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0576-2015","Class II","Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. ","model numbers: 10592457, 10863171, 10863172, 10863173, 7502029 , 10496279, with multiple serial numbers: 1187, 3182, 3183, 3212, 3206, 3207, 1361, 10870, 12068, 10733, 3052, 2323, 1496, 3246, 2254, 1089, 1213, 14898, 2626, 1624, 2365, 3087, 13504, 11795, 13921, 2971, 12271, 13090, 9594, 2890, 1372, 12789, 3062, 1856, 2500, 13591, 14005, 3017, 3010, 1373, 9792, 13727, 1374, 14292, 2562, 3165, 2098, 2698, 3211, 2769, 1382, 1165, 2310, 13480, 2324, 2751, 2901, 2897, 2981, 3093, 3050, 3085, 14328, 100544, 100566, 100198, 100600, 100259, 100135, 100133, 100031, 100084, 100233, 200308, 200309, 200310, 200311, 200312, 200313, 200314, 200315, 200316, 200317, 200318, 200319, 200320, 200321, 200322, 200323, 200324, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100245, 100314, 200277, 100139, 100177, 100027, 100601, 100170, 100025, 100174, 100033, 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100306, 100232, 100185, 100596, 100256, 100599, 100193, 100257, 100198, 100226, 100198, 100181, 100029, 100253, 100301, 100132, 100247, 100248, 100139, 100215, 100230, 100146, 100212, 100539. ",".","149","Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.",11/11/2014,"11/11/2014",12/17/2014,"12/17/2014"
"Devices",69805,"Ongoing","Aircraft Medical Limited","EDINBURGH",,"GB","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.","Z-0494-2015","Class II","McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes","Product Code: 350-017-000. Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.",".","40,900 blades (US); 16,000 blades (Foreign)","The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.",11/4/2014,"11/04/2014",12/10/2014,"12/10/2014"
"Drugs",69808,"Completed","Spectrum Laboratory Products","Gardena","CA","US","Voluntary: Firm Initiated","Letter","U.S.: California.","D-0255-2015","Class II","Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.","Lot #: 1BJ0479; Expiry: 06/2017",".","16 Bottles","CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. ",7/18/2014,"07/18/2014",11/26/2014,"11/26/2014"
"Drugs",69810,"Ongoing","Fresenius Kabi USA, LLC","Melrose Park","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0290-2015","Class II","GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20","Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015",".","92,125 vials","Defective Container: Vials may be missing stoppers.",11/12/2014,"11/12/2014",12/17/2014,"12/17/2014"
"Biologics",69817,"Terminated","CSL Plasma","Fort Worth","TX","US","Voluntary: Firm Initiated","Other","Germany, Federal Republic of; Switzerland","B-0212-15","Class III","Source Plasma","41908070385; 41908016530; 41908016530; 41908014236; 41908014236; 41908017269; 41908011676; 41908017461; 41908011975; 41908011094; 41908107862; 41907955190; 41907955190; 41908109420; 41908109420; 41908109577; 41908107440; 41908102156; 41908132822; 41908134529; 41908167638; 41908083370; 41908112928; 41908111386; 41908118481; 41908110834; ",".","26 units","Plasma products, collected from donors whose suitability to donate was not adequately determined, were distributed.",9/18/2014,"09/18/2014",12/17/2014,"12/17/2014"
"Devices",69818,"Ongoing","Boston Scientific Corp","San Jose","CA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.","Z-0580-2015","Class II","IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.","Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, and 17308586. Expiry Dates from June 25, 2015 to September 24, 2015. ",".","184 units","Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field. ",11/20/2014,"11/20/2014",12/17/2014,"12/17/2014"
"Devices",69839,"Ongoing","Novadaq Technologies, Inc.","Richmond","BC","CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.","Z-0469-2015","Class III","LUNA Chest, Model No. LU4006 ","Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282",".","828 units","Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.",11/4/2014,"11/04/2014",12/2/2014,"12/02/2014"
"Devices",69839,"Ongoing","Novadaq Technologies, Inc.","Richmond","BC","CA","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.","Z-0470-2015","Class III","Non-sterile drape","Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282 ",".","324 units","Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.",11/4/2014,"11/04/2014",12/2/2014,"12/02/2014"
"Food",69840,"Ongoing","Tristar Food Wholesale Co Inc","Jersey City","NJ","US","Voluntary: Firm Initiated","Letter","NY","F-0701-2015","Class II","Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ","Batch No. 2013/12/14, Best before: Jun 8, 2015",".","20 cartons","Dried Plum Candy contains non-permitted cyclamates, undeclared benzoic acid and undeclared Yellow #5.",10/24/2014,"10/24/2014",12/17/2014,"12/17/2014"
"Food",69841,"Ongoing","Karlsburger Foods, Inc.","Monticello","MN","US","Voluntary: Firm Initiated","Telephone","AK, AZ, FL, IA, IL, KS, MD, MI, MN, MO, NE, NM, OH, PA, SD, and WI.","F-0573-2015","Class I","Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged in 6.8 lb. resealable plastic containers), and Item #16425 (Packaged in 25 lb. bag in a box)."," Item Numbers 16423, 16465, and 16425.",".","1491 units","Taco Seasoning has an allergen of milk in the product that is not declared on the label.",11/17/2014,"11/17/2014",12/2/2014,"12/02/2014"
"Food",69841,"Ongoing","Karlsburger Foods, Inc.","Monticello","MN","US","Voluntary: Firm Initiated","Telephone","AK, AZ, FL, IA, IL, KS, MD, MI, MN, MO, NE, NM, OH, PA, SD, and WI.","F-0572-2015","Class I","Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box)."," Item Numbers 43823, 43807, 43825, and 43850.",".","1122 units","Taco Seasoning has an allergen of milk in the product that is not declared on the label.",11/17/2014,"11/17/2014",12/2/2014,"12/02/2014"
"Food",69850,"Ongoing","Coca Cola Bottling Company United, LLC","Birmingham","AL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Georgia, Tennessee, Florida","F-0611-2015","Class III","DASANI (R) PURIFIED WATER, 16.9 FL OZ (1.06 PT) 500 mL, BOTTLED BY A MEMBER OF THE COCA-COLA BOTTLERS' ASSOCIATION, ATLANTA, GA 30313, UPC 24pk- 2 4900003165 2","DATE CODE/TIME STAMP OCT1915EHC3/1015 - 1115, OCT1915EHC3/1230 - 1330, OCT1915EHC3/2200 - 2300, OCT1915EHB3/0030 - 0130, OCT0515EHB3/1500 - 1600",".","4136 cases (24 bottles/case)","An equipment malfunction during production that may have led to the appearance of mold in some product.",11/24/2014,"11/24/2014",12/10/2014,"12/10/2014"
"Devices",69854,"Ongoing","TomoTherapy Incorporated","Madison","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITALY, GERMANY, KOREA, FRANCE, SWITZERLAND, ENGLAND, CANADA, MEXICO, HONG KONG, AUSTRALIA, SRI LANKA, GREECE, CHINA, PHILIPPINES, MARTINIQUE, ROMANIA, SPAIN and TURKEY.","Z-0507-2015","Class II","TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)","SN 110441 110403 110485 110055 110394 110126 110266 110511 110332 110333 110499 110468 110508 110470 110505 110507 110522 110385 110388 110228 110334 110494 110480 110109 110462 110471 110501 110469 110356 110478 110260 110275 110457 110430 110315 110447 110314 110506 110170 110465 110510 110496 110472 110077 110347 110124 110259 110117 110294 110146 110419 110189 110446 110422 110467 110353 110364 110384 110410 110363 110300 110162 110267 110428 110405 110299 110246 110429 110071 110232 110200 110305 110330 110407 110361 110136 110413 110458 110231 110371 110211 110304 110479 110409 110466 110437 110164 110205 110392 110487 110489 110184 110397 110036 110451 110427 110426 110327 110475 110454 110093 110476 110400 110377 110484 110455 110453 110486 110393 110498 110085 110229 110412 110425 110434 110459 110088 110386 110301 110448 110481 110328 110504 110068 110078 110474 110482 110491 110464 110387 110137 110290 110308 110285 110445 110497 110503 110206 110463 110038 110502 110060 110500 110106 110180 110013 110081 110033 110490 110420 110368 110492 110402 110115 110040 110210 110509 110438 110415 110050 110396 110424 110097 110202 110349 110203 110408 110090 110244 110456 110084 110027 110029 110473 110209 110091 110281 110286 110094 110155 110381 110100 110271 110390 110493 110174 110483 110452 110268 110360 110176 110516 110269 110367 110227 110369 110323 110461 110254 110395 110383 110348 110515 110477 110488 110021 110196 110298 110158 110495 ",".","210 ( 72 USA; 138 OUS ) ","Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.",11/21/2014,"11/21/2014",12/17/2014,"12/17/2014"
"Biologics",69857,"Terminated","NOVARTIS VACCINES AND DIAGNOSTICS S.r.l","SOVICILLE",,"IT","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0214-15","Class II","Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined","M12115",".","1,687 boxes (each box has 5 doses) which equates to 8,435 doses","Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed. ",12/2/2013,"12/02/2013",12/17/2014,"12/17/2014"
"Devices",69867,"Completed","ConforMIS, Inc.","Bedford","MA","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution in the state of IN only.","Z-0581-2015","Class II","Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.","Serial Number: 0340552",".","1 unit","Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting",11/19/2014,"11/19/2014",12/17/2014,"12/17/2014"
"Food",69876,"Ongoing","Whole Food Market","Austin","TX","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, AR, LA, OK","F-0708-2015","Class I","Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699.","Best Buy dates of 10/27-11/30. ",".","1,144 Pies","Pies labeled in-store did not have the allergen ''walnuts'' declared in a contains statement or in the ingredient list.",11/26/2014,"11/26/2014",12/17/2014,"12/17/2014"
"Drugs",69942,"Ongoing","Sandoz Incorporated","Broomfield","CO","US","Voluntary: Firm Initiated","Letter","AZ","D-0291-2015","Class III","Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01","Lot ET5122, Exp. 10/17",".","1,008 bottles","Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.",12/5/2014,"12/05/2014",12/17/2014,"12/17/2014"
"Drugs",69971,"Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide","D-0294-2015","Class II","Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61","Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61",".","62,650 vials","Lack of Assurance of Sterility; improperly crimped fliptop vials",12/3/2014,"12/03/2014",12/17/2014,"12/17/2014"