Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, collected from donors whose hemoglobin determination was performed using expired microcuvettes, were distributed.
Blood products, collected using scales for which the quality control results were not documented, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, in which quality control and distribution  of products did not meet specifications, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which quality control and distribution of products did not meet specifications, were distributed.
Blood products, not prepared in accordance with specifications, were distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
Blood products, possibly air contaminated, were distributed.
Red Cell product, lacking a proper visual inspection for clots, was distributed.
Blood products, which exceeded time limits taken out of storage for labeling, were distributed.
Cryoprecipitated AHF, Pooled, Code: PCRY
Red Blood Cells Leukocytes Reduced, codes: LRC6, LRC5, LRC3
Blood product, collected from an ineligible donor, was distributed.
Platelets Pheresis Leukocytes Reduced, Codes: LPAA, LPAB, LPA, LPAC
Platelets Pheresis Leukocytes Reduced Irradiated, Code: ILPAA
Blood products, for which the quality control testing was not performed, were distributed.
Blood products, collected from donors who did not have a complete physical examination, were distributed.
Blood products, collected from donors who may not have had a complete physical examination, were distributed.
Sight Society of Northeastern New York Lions Eye Bank@Albany
Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye Bank at Albany 518-489-7606
Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY,  District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Internationally to Austria, Azerbaijan, Bahrain, Belgium, Bosnia, Brazil, Canada, Columbia, Egypt, France, Germany, Ghana, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Lithuania, Mexico, Netherlands, Nigeria, Palestine, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uzbekistan,  and Yemen.    Center Recommended Depth - Consumers/User**
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include:   1) With Auto-Fetch in use another patient's image may appear without user's intention.     2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixel.     2.b) Decay correction tag (0054,1102) has a value ''ADMIN'' and the value reported will be exceedingly high.     2.c) In the ''BQML'' case where StartDateTime tag (0018,1078) is provided in place of StartTime (0018,1078) no value is reported and instead shows as ''not calibrated''.     3) For multi-frame images that contain more than one overlay, studies with frames where overlays overlap, the wrong overlay is displayed. For studies with frames that should display one overlay for specified amount of frames and a second overlay for specified amount of frames, no overlays are displayed at all.
Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.
Carestream DRX-Revolution Mobile X-ray System.   Produces radiographic images.
Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows:    1) In Centricity RIS-IC, and a RIS-Driven integration, the ''close'' button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation.     2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation.     3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation.
Blood products, collected from an ineligible donor, were distributed.
Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada.
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3'' x 13.8'' x 18.1'' / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A.   The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined
Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, wwas distributed.
The American National Red Cross - Southern Region
Blood and Blood Products for Reprocessing
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R  CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS   CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L   CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS   CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT).    Provides increased flexion capability.
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-
Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM  VERSYS BEADED FC 12X200MM 8 ST   POR FULLCT FEM ST 12 LOW EXT  POR FLCT FEM ST 12.0X190 STR  POR FULLCT FEM ST 12 EXT  POR FULL-CT FEM ST LM 12X160MM  POR FULLCT LM FEM ST 12 EXT  POR FULL-CT FEM ST 13X160MM  VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL   POR FULLCT FEM ST 13 LOW EXT  POR FLCT FEM ST 13.5X190 STR  POR FULLCT FEM ST 13 EXT  POR FULL-CT FEM ST LM 13X160MM  POR FULLCT LM FEM ST 13 EXT  POR FULL-CT FEM ST 14X160MM  VERSYS BEADED FC 14X200MM 8 ST   POR FULLCT FEM ST 14 LOW EXT  POR FULLCT FEM ST 14 EXT  POR FULL-CT FEM ST LM 14X160MM  POR FULLCT LM FEM ST 14 EXT  POR FULL-CT FEM ST 15X160MM  VERSYS BEADED FC 15X200MM 8 ST   POR FULLCT FEM ST 15 LOW EXT  POR FLCT FEM ST 15.0X190 STR  POR FLCT FEM ST 15.0X250 STR  POR FULLCT FEM ST 15 EXT  POR FULL-CT FEM ST LM 15X160MM  POR FULLCT FEM ST 15 XEXT  POR FULLCT LM FEM ST 15 EXT  POR FULL-CT FEM ST 16X160MM  VERSYS BEADED FC 16X200MM 8 ST   POR FULLCT FEM ST 16 LOW EXT  POR FLCT FEM ST 16.5X190 STR  POR FLCT FEM ST 16.5X250 STR  POR FULLCT FEM ST 16 EXT  POR FULL-CT FEM ST LM 16X160MM  POR FULLCT FEM ST 16 XEXT  POR FULLCT LM FEM ST 16 EXT  POR FULL-CT FEM ST 17X160MM  VERSYS BEADED FC 17X200MM 8 ST   POR FULLCT FEM ST 17 EXT  POR FULL-CT FEM ST LM 17X160MM  POR FULLCT FEM ST 17 XEXT  POR FULLCT LM FEM ST 17 EXT  POR FULL-CT FEM ST 18X160MM  VERSYS BEADED FC 18X200MM 8 ST   POR FLCT FEM ST 18.0X190 STR  POR FLCT FEM ST 18.0X250 STR  POR FULLCT FEM ST 18 EXT  POR FULL-CT FEM ST LM 18X160MM  POR FULLCT FEM ST 18 XEXT  POR FULLCT LM FEM ST 18 EXT  POR FULL-CT FEM ST 19X160MM  POR FLCT FEM ST 19.5X190 STR  POR FLCT FEM ST 19.5X250 STR  POR FULLCT FEM ST 19 EXT  POR FLCT FEM STEM LM 19X160MM  POR FULLCT FEM ST 19 XEXT  POR FULLCT LM FEM ST 19 EXT  POR FULL-CT FEM ST 20X160MM  VERSYS BEADED FC 20X200MM 8 ST
Metasul Head.   Intended for use either with or without bone cement in total hip arthroplasty.
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
CoCr Head (Not distributed in the United States)   Used in total hip replacement.
Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD.   Indicated in fracture dislocation of the hip.
CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR).    Indicated for cemented use in patients suffering from severe hip pain.
Zimmer Unicompartmental Knee Femoral Component.   Indicated for patients with painful and/or disabling knee joint.
Natural-Knee Flex Femoral Component.   Provides increased flexion capability.
Sidus'' Head (Not distributed in the United States)
Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608   Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150     The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
23 units installed total (11 domestically & 12 internationally)
During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact.  This issue was discovered in manufacturing.  It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated   The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, Holding Clip   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated   The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
US nationwide and international: Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, Romania, Slovenia, Netherlands, Russia, Finland, Sweden, Spain and Portugal, Brazil, Chile, Bolivia, Paraguay, Costa Rica, Japan, South Africa, Turkey, Vietnam, China, and Malaysia.
HLA Fusion Software;  version 2.0.0 SP4.1, Catalog ID FUSPGR
HLA Fusion Software (version 2.0.0, SP4.1;  Catalog ID FUSPGR (With Luminex xPONENT Software 3.1)
HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed.
HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden   The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
Worldwide Distribution - Nationwide Distribution including the states of  AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of  Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia.
HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.
Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of  Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.
HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Worldwide Distribution - US (nationwide) and country of Mexico
Synthes Application Instrument Sternal Zip Flex System   intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
Nationwide Distribution including and US Territory Puerto Rico
Aplio MX Diagnostic Ultrasound System SSA-780A   Used for routine diagnostic imaging
Diluent containing phenol failed an apperance test on stability.  The Diluent is included in the JHS licensed venomil kits that were distributed.
Aplio XG Diagnostic Ultrasound System SSA-790A   Used for routine diagnostic imaging
The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) ''IQBalance BD'' or ''IQ Balance'' BCD'' is displayed on the touch panel as a result of scale setting for PW mode.
Xario XG Diagnostic Ultrasound System SSA-680A   Used for routine diagnostic imaging
Xario Diagnostic Ultrasound System SSA-660A   Used for routine diagnostic imaging
Canada; Multiple U.S. States and Multiple Countries
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Amport Foods Chocolate Raisins.  Net Wt. 12 oz (340g).  UPC 71725-71190.  Allergy Information:  This product is produced on equipment shared with peanuts and tree nut products.
It was discovered that a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins.
All VERSEIA Pipetters with software Versions 2.2, 2.3, 3.0 and 3.1;  (Product Code:  5561701) There is no expiration date for these serialized products.
ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results.
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Fujinon/Fujifilm Ultrasonic Endoscope   Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
Model Number EG-530UT2.  Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,
Siemens  RAPIDLab 1245 system  blood gas analyzer     Product Usage:  RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Siemens RAPIDPoint 400 system blood gas analyzer   Product Usage:  These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Siemens  RAPIDLab 1265 system  blood gas analyzer   Product Usage:  RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Siemens  RAPIDLab 1240 system  blood gas analyzer   Product Usage:  RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Siemens RAPIDPoint 405 system blood gas analyzer   Product PUsage:  These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Siemens  RAPIDLab 1260 system  blood gas analyzer   Product Usage:  RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Siemens RAPIDPoint 500 system blood gas analyzer   Product Usage:  RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.
Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands.
Ingenuity TF PET/CT   Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a ''fused'' (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.
Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA.   An IV transfer device, used to transfer fluids in pharmacy compounding system.
Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
US Distribution including the states of  OK, GA, CA, MN, TX and  HI.
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0'' (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015.   For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.
The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters.  Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are  also provided as a component in kits that contain other cranial  access devices. These kits are Catalogue No. 110-4BC, 110-  4HC, and 110-4LC respectively.    Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits  Classification Name: Device, Monitoring, Intracranial Pressure  510(k) Number: K102875    The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.
Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate  they are UNSAFE in an MR environment.  Only the following Camino Intracranial Pressure Monitoring Kits are affected:  110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
The product was shipped to the following states: IN, MI, NY, OH, PA & WV.
Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, ''INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501''
Lot #CAFC8W, Best By Sept 21, Lot #CAFC7B, Best By Sept 20
Globus Medical MicroFuse Putty, 2.5cc and 10cc.   Product Usage:  MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft
Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013.
The sterility of the product cannot be assured.
chromID Salmonella Agar, Reference No. 43621.   A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies.  This could potentially lead to Salmonella colonies not being detected.
Worldwide distribution: US (nationwide) and country of: Canada.
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.   The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
The product was distributed to AL, AR, AZ, CA, CO, CN, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MI, NC, NE, NM, NV, NY, OH, OK, PE, SC, TN, TX, UT, VI, WA, WI and WY.  No foreign distribution was made, including Canada.  There may be one military client.  The firm is gathering the distribution information and will forward that to KAN-DO as soon as it is ready.
P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8
The firm is recalling Pork & Leek Dumplings because Shrimp & Pollack Fish dumplings were inadvertently packaged in the Pork & Leek Dumpling packaging.  Undeclared allergens.
International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125  3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient.
Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for:  MAQUET Cardiopulmonary AG Made in Germany.   Cardiopulmonary support system.
It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating ''battery defective.''  The alarm will occur-upon start up or when the main power supply is unplugged from the main power source.  The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125  3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient.
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125  3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report ''For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action.'' A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2.
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125  3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications.
Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
Stryker Instruments Div. of Stryker Corporation
Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
REF 5100-088,  TPS Micro Driver, For Use with Stryker Total Performance System   Caution Federal Law (USA) restricts the device to use by or on the order of a physician    Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess.  The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA).  Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical malfunction (primarily loss of function).  Two batches of silicone potting have been identified, by the supplier, as having cure properties that were outside of the specified range.
Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box.
The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
PENTAX Endoscopic Accessories.  OF-B194.  Made in Japan.   PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve.  A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
Worldwide Distribution - Nationwide Distribution and the country of Canada..
COULTER LH 750 and LH 780 Analyzers.    The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Beckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States.
Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin.
Breeze C Scooter is a motorized  electric scooter for elderly people.  Brand name Breeze, model C.  It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living.   Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
USA Nationwide Distribution in the states of:  AL, CA, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, ND, NJ, NV, NY, OK, PA, SC, TN, TX, UT, VA, WA, Washington DC, and Puerto Rico.
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy.   The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit  has the following codes:    PRODUCT CODE: AG-MASCT; AG-FC5;  DTG-MASCT, DTG-FC5, and NRLBH-5.    PART NUMBER: 9002513; 9002513MD;  9002528; 9002528MD; 9002587;   9002614; and 9002717MD.    THE MASCT SYSTEM KIT CONSISTS OF:    1. MASCT Breast Pump;  2. Instructions for Use (IFU);  3. Heating Pad;  4. Timer;  5. Saccomono's Fixative;  6. Nu Prep Gel;  7. Welcome and Training Materials Coversheet;  8. MASCT System Order Form;  9. ForeCYTE Training Video DVD;  10. MASCT System Instructions with pictures - pink;    THE PATIENT SAMPLE KIT CONSISTS OF:    1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder);  2. Instructions for Use (IFU);  3. Two (2) specimen collection devices;  4. Two (2) breast bags for transporting the specimen collection container;  5. Barcode labels;  6. Saccomono's Fixative;  7. Nu Prep Gel;  8. MASCT System package insert;  9. ForeCYTE Test Requisition Form;  10. Patient Information Sheet;  11. Atossa Patient Information;  12. FED EX Clinical PAK;  13. MASCT System Order Form;  14. FED EX Pouch;  15. FED EX Airbill;    Product Usage:  The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)
Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013.  The FDA raised concerns about (1) the current Instructions for Use (IFU); (2) certain  promotional claims used to market these devices; and (3)  the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer.   Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
model numbers 380610-04 through 38-610-14.
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Distribution was made to IA, UT, NV, NE and CA.
NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A
15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104.   **Lot ALI13212-04 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **Lot ALI13036-01 mathmatical analysis tested  ''probably NOT < 0.3 ppb in final product''
The products may be contaminated with Chloramphenicol.
Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A
Lot ALI13206-05; re-evaluation date 1/25/2015   **sample only - not tested
Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A
Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014   **sample only - not tested
Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A
Lot ALI13157-11; re-evaluation date 12/6/2014   **sample only - not tested
PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A
9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014.   **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **Lot ALI13036-01 mathmatical analysis tested  ''probably NOT < 0.3 ppb in final product''
EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C
Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014.   **Lot ALI13200-09 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''
Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
Lot ALI13157-09; re-evaluation date 12/6/2014.   **sample only - not tested    On 10/22/2013 American Laboratories provided CFSAN  a customer distribution list for the Chloramphenicol Contamination.  This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet
EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C
Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014.   **Lot ALI13200-08 mathmatical analysis tested ''probably < 0.3 ppb in final product''    **the other three lots mathmatical analysis tested ''probably NOT < 0.3 ppb in final product''
Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.
Lot # ALI13053-05; re-evaluation date 8/22/2104   **Lot ALI13053-05 mathmatical analysis tested  ''VERY probable NOT < 0.3 ppb in final product''
Orange County Produce, LLC is recalling fresh red and green Bell Peppers because they may have the potential to be contaminated with Salmonella.
St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge  Fromagerie Qurtet 38470 VINAY
The French Ministry of Food, Agriculture is requiring cheese to be withdrawn from sales at all levels of distribution as L. monocytogenes was detected in thermised (heat-treated/not pasteurized) product in France which was not exported.
10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label.
All Sell By dates from Sept 25, 2013 through Oct 9, 2013
96 pies were shipped to the stores but only 6 affected pies were sold
Worldwide Distribution - USA including  AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.     Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators.  Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.     Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)
Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass,  Jackson, TN, USA 38301-5072
All lot codes and best before dates currently on shelf of the following product, where milk is not declared on the list of ingredients
There was a change in Canadian labeling regulations where lactose was no longer sufficient, the label needed to stated ''contains milk''
Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.
Cordis OPTEASE Vena Cava Filter   Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction.  The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.
Retail Stores located in Colorado, Nebraska, New Mexico, South Dakota, and Wyoming.
the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106.  Distributed by Safeway, Inc. Pleasanton, CA  94566
Undeclared Milk.  BBQ flavored potato chip bags inadvertently contain Sour Cream & Onion flavored potato chips, which contain milk.
Products distributed to Utah and California.  No foreign, military/govt/VA consignees.
Western Nut Salt Lake City Roasted and Salted Inshell Peanuts, 6 oz (170g).  Packaged in OPP (oriented polypropylene) bags.  Receive bulk roasted/salted inshell peanuts from US Foods in 25 lb lined cases. Manufactured by Hampton Farms, Portales, NM for Western Nut.
Western Nut is recalling certain lots of Roasted/Salted Inshell Peanuts due to unacceptable levels of Aflatoxin.
Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom.  .
Single Site Curved Needed Driver   Intuitive Surgical, Sunnyvale, CA. 94086    The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
504 devices for a total of 2,220 affected clinical product.
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
Single Site Bipolar Maryland Forceps   Intuitive Surgical, Sunnyvale, CA. 94086    The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.
286 boxes ( 6 instruments per box)  for a total of 2,220 affected clinical product