Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, collected from a donor with a history of surgery within 12 months, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from a donor who was taking Prednisone, were distributed.
The American National Red Cross - Southern Region
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected under conditions where the sterility of the products may have been compromised, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor taking the Prednisone, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, which failed to meet the minimum specification for 85% red blood cell recovery, was distributed.
Blood products,  in which instrument QC or validation was unacceptable were distributed.
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which tested reactive to HIV 1/2 and staff failed to quarantine units due to medical history, were distributed.
Blood product, which shipment exceeded time allowed for shipping, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, leukoreduced after five day timing requirement, was distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability were not adequately determined, was distributed.
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product was distributed to the 11 Servatii retail locations.
Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each
The firm had pecans and not walnuts listed in their ingredient statement.
Blood products, which may have reached an unacceptable temperature during shipment, were distributed..
Blood products, which were labeled with an incorrect expiration date, were distributed..
Blood products, collected from a donor taking the medication Enbrel, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
US States: CA, NV, OR, ID, WA, UT, and CO.
Miravalle brand ''Pan Rallado Sazonado'', 8 oz. Seasoned bread crumbs. Also packaged in 12 pack.  Product labeling reads in part:''Miravalle PAN RALLADO SAZONADO   SEASONED BREAD CRUMBS  Net Wt. 8 Oz.***Packed and Distributed by: Miravalle El Monte, CA 91733***''.
UPC: 7 12810-00812Lot numbers: 0010 Expiration date: 08/2013
In response to a FDA inspection, the firm initiated this recall due to undeclared wheat and no nutritional facts listed, for the product ''Pan Rallado Sazonado''.
Blood products, collected from a donor who had been incarcerated, were distributed.
Worldwide Distribution - USA (Nationwide) including CANADA.
Pyxis Anesthesia System Model 2000 (PAS 2000)  Product Usage:  The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed..
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood products, collected from a donor with a  permanent deferral history, were distributed
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from  a donor, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
CGMP Deviations: Shipment of product not approved for release.
Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista'' System.
Correlation slope bias and accuracy shift
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012.  Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available.  The ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) are not yet approved by the FDA for use on the ARCHITECT i1000SR, but they are under active review for approval. Abbott will notify you when FDA approval is obtained. This is a voluntary device recall.
Worldwide Distribution - USA (Nationwide) and the countries of Australia, Canada and Japan.
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)   Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 3FA40SSALot Numbers: all lot numbers less than or equal to 928782  Catalog Number: 3FM40SSA Lot Numbers: all lot numbers less than or equal to 911379
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: FA40SSALot Numbers: lot number 763998  Catalog Number: 4FM40SSA Lot Numbers: all lot numbers less than or equal to 933099
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA)  Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 4FS30SSALot Numbers: all lot numbers less than or equal to 848031  Catalog Number: 4FS31SSA Lot Numbers: lot number 739269  Catalog Number: 4MM30SSA Lot Numbers: all lot numbers less than or equal to 858154
Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)  Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 3FS60SSALot Numbers: all lot numbers less than or equal to 898712  Catalog Number: 3FS61SSA Lot Numbers: all lot numbers less than or equal to 898714  Catalog Number: 3MM60SSA Lot Numbers: all lot numbers less than or equal to 931754
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA)  Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 4FS60SSALot Numbers: all lot numbers less than or equal to 752068  Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581  Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 3FA70SSALot Numbers: all lot numbers less than or equal to 843761  Catalog Number: 3FM70SSA Lot Numbers: all lot numbers less than or equal to 933614
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 3FF80SSALot Numbers: all lot numbers less than or equal to 912899
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA)  Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 4FA70SSALot Numbers: all lot numbers less than or equal to 931750  Catalog Number: 4FM70SSA Lot Numbers: all lot numbers less than or equal to 912173
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Catalog Number: 4FM100SSALot Numbers: all lot numbers less than or equal to 847028
Multiple U.S. States; Philippines, Bermuda, India, Hong Kong, Japan, South Korea, Jamaica, Brazil
Insects (Whole Body), Mite Dermatophagoides farinae
Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed.
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Mindray DS USA, Inc. d.b.a. Mindray North America
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS,  KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.
The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
Norwegian Smoked Salmon Sides (2-3 lbs.)
UpRiver: 242.06 lbs.; Legendary 324 lbs.
Private lab result was positive for Listeria Monocytogenes
Scottish Style Smoked Salmon Pre-sliced Sides (2-3 lbs)
Pastrami Style Smoked Salmon Pre-sliced Sides(2.5-3.5 lbs. and 2-3 lbs.)
Prestige: 33.81 lbs.; UpRiver: 17.37 lbs.
Prestige Smoked Scottish 2.5-3.5  Smoked Salmon Sides    (2-3 lbs.)
UpRiver Tri-Peppered Vodka Smoked Salmon  (2-3 lbs)
UpRiver Tequila/Cilantro Smoked Salmon Sides( 2-3 lbs.)
Prestige Irish Style Smoked Salmon (4 oz..)
Prestige Nova Smoked Salmon retail packs (4 oz.)
UpRiver Norwegian Smoked Salmon Peppered (2-3 lbs.)
Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD)  test for detection of GBS DNA in Lim Broth cultures. The BD MAX'' PCR Cartridge is a consumable required for the BD MAX'' System.
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
University Of Miami Miller School of Medicine Tissue Bank
HCT/P allografts, mislabeled with an incorrect expiration date, were distributed.
Michigan; Nebraska; Florida; California; Kentucky
Walmart Distribution Center in Bentonville, AR
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps  20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
Failed Stability Specifications: The product had a stability failure at the 12 month time point for the active ingredient Phenylephrine HCL.
Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441;  (6) dc7100 8-port (refurbished), Cat. #W0441R;  (7) dc7700 8-port, Cat. #W0447;  (8) dc7700 8-port (refurbished), Cat. #W0447R;  (9) dc7800, Cat. #W0449; and  (10) dc7800 (refurbished), Cat. #W0449R.  VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Manufactured from September, 2004, to present.
For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441;  (6) dc7100 8-port (refurbished), Cat. #W0441R;  (7) dc7700 8-port, Cat. #W0447;  (8) dc7700 8-port (refurbished), Cat. #W0447R;  (9) dc7800, Cat. #W0449; and  (10) dc7800 (refurbished), Cat. #W0449R.  VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441;  (2) dc7100 8-port (refurbished), Cat. #W0441R;  (3) dc7700 8-port, Cat. #W0447;  (4) dc7700 8-port (refurbished), Cat. #W0447R;  (5) dc7800, Cat. #W0449;  (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700, Cat. #W0452; (8) rp5700 (refurbished), Cat. #W0452R; (9) rp5800 XPE, Cat. 413642; (10) rp5800WES7, Cat. #413862; (11) d530 6-port, Cat. #W0438; (12) d530 6-port (refurbished), Cat. #W0438R; and (13) d530 4-port, Cat. #W0437.  VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Product was distributed to 7 US consignees and 4 Canadian consignees.
Item #1815, Kettle brand Natural Chocolate Lovers Trail MixUPC 8411401910 Label reads in part ''8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs. ***''
Dried pineapple which contains sulfur dioxide was accidently used to manufacturer the trail mix.  The formula calls for untreated dried pineapple.
Item #1900 Kettle Brand Honey Roast Nuts and Fruit Trail Mix UPC 8411401900 Label reads in part ''8411401900 Honey Roast Nuts & Fruit Mix Net Weight 24 Lbs. ***''
Item #1910 Kettle brand Honey Roast Harvest trail mix UPC 8411401910Label reads in part ''8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs.***''
distributed directly to one sole consignee in Oregon
Ruthies Cranberry Orange Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: ''***Ruthies Cranberry Orange Breakfast COOKIE***INGREDIENTS***Butter (pasteurized cream, salt)***Contains the following allergens: Wheat, Eggs***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com******(888) 7-RUTHIE***''.
Ruthies Cranberry Orange Breakfast Cookie is recalled because butter (cream) is declared but milk is NOT declared on label.
Ruthies Cashew Raisin Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: ''***Ruthies Cashew Raisin Breakfast COOKIE***INGREDIENTS***Butter***Half & Half***NET WT. 4.9 Oz***Manufactured for Ruthie's, LLC***www.ruthiescookies.com***(888) 7-RUTHIE***''.
Ruthies Cashew Raisin Breakfast Cookie is recalled because butter and half & half are declared but milk is NOT declared on label.
Distribution was made to 212 retail stores in  IA, IL, MO, KS, NE, SD, MN and WI.
Hy-Vee Complete Dog, Complete Nutrition, 34-lb bag. UPC code: 07545005647
Lot # ending with 29812KC, Best by date: 11/24/13
The recalled products may contain elevated levels of Aflatoxin.
Hy-Vee Complete Dog, Complete Nutrition, 8-lb bag. UPC code: 07545005667
Hy-Vee Complete Dog, Complete Nutrition, 4.4-lb bag. UPC code: 07545005665
Lot # ending with 29812KC, Best by date: 11/24/13 and Lot # ending with 29912KC, Best by date: 11/25/13
Hy-Vee Complete Dog, Bones & Squares, 20-lb bag. UPC code: 07545005680
Lot # ending with 29312KC, Best by date:  11/19/13
Hy-Vee Complete Dog, Bones & Squares, 4.4-lb bag. UPC code: 07545005660
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc.,  Sanford, Florida --- NDC 28105-149-04
Worldwide Distribution - All states in continental USA including  DC, PR  and the countries of  ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC,  ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3  The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
Vital Images has found a potential error in  measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. We have found this orientation adjustment to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty-nine percent and in volume measurements of up to fifty percent, so please use caution when reviewing measurements of images reconstructed with orientations that are adjusted in such a manner. This issue was found through internal testing. No customer reports of the issue have been received.
Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.
Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10.  These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain.  This contamination could potentially lead to misdiagnosis and improper treatment of a patient. There have been no complaints or reports of death or injury due to this issue.
Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples.  The variation in reactivity can lead to invalid assays.  If an invalid assay is obtained, those results should not be reported and the test should be re-run.  An invalid assay would not result in significant harm to a patient.  However, some kits from this lot may produce false negative results.  A false negative result could contribute to a delay in diagnosis and initiation of alternative therapies, and may increase the risk of complications.
Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Incorrect size was printed on the outer product packaging.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, andThailand.
Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4'', 70mm. MilexPart Number: MXPCON04  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex:Part Number: MXPCONDS05  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. MilexPart Number: MXKPCONDS00  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. MilexPart Number: MXKPCOND00  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. MilexPart Number: MXPCOND00  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Gellhorn Flexible Pessary -2 3/4'', 70mm. MilexPart Number: MXPGE2-3/4  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Gellhorn Flexible Pessary 3'', 76mm. MilexPart Number: MXPGE3-  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Cube Pessary 1 5/8'''', 41mm. Milex Part Number: MXKPEC04  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Cooper Surgical Cube Pessary w/Drainage Holes #0''1'', 25mm. MilexPart Number: MXKPECH00  A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain
Opalescence treswhite Supreme Peach Patient Kit
Product was packaged into kits labeled as having a shelf life of 2103-05.  The correct shelf life is 2013-05.
Worldwide Distribution - USA (Nationwide) and countries of: DE, NL, CH, FR, GB, DK.
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated.  When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS  66211.
All lots distributed between 01/10 to 02/13
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI  48843.
a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11.
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS  66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS  66211.
a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS  66211.
All lots with expiry between 12/11 to 10/15.
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS  66211.
All lots with expiry between 09/11 to 09/13.
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS  66211.
All lots with expiry between 07/11 to 08/14.
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk.  Product Usage:  Preoperative skin product
Tincture Packaged: Product Number 260619 and Product ID D086353; Tincture 3,000 Bulk: Product Number 260520 and Product ID D086353.
An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized. Some product labeling states ''Sterility guaranteed unless seal broken'' or ''Contents sterile if package is intact.'' These claims were intended to indicate surface sterilization only but could mistakenly lead to the conclusion that the drug product solution is sterile. It was determined that labeling on certain products could be misleading in relation to sterility claims. There is no patient safety risk associated with these products.
Sonoma Mock Chix Salad  Ingredients:   Dist. by Whole Foods Market 525 N. Lamar Blvd, Austin, TX 78703.  Product is made in store and sold under the name of Sonma Mock Chix Salad. It comes in 6oz, 8oz, 16oz, and 24oz clear plastic hinged containers.
There are no lot numbers for the product, it is produced and packaged at the store level.  The product was produced on 02/27/13, packaged on 02/28/13 with a best-by date of 03/06/13. It was then removed from the store's shelves on 3/02/13.
The product is being recalled due to undeclared pecans.
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
ProtiDiet High Protein Chocolate Dream Bar
Recall was initiated after CFIA notified FDA of implicated products sold to the firm.  During a FDA visit, the firm discovered that they were selling product that were recalled in Canada by the manufacturer, ''Pro-Amino International Inc.'' because it may be contaminated with Salmonella. Upon further FDA investigation at the firm product was further distributed to a consignee in Canada.
Worldwide Distribution-USA (nationwide) and the countries of  Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
Continental USA (Schwan's Home Service, Inc.,  distributed to Residential customers)
LiveSmart Bruschetta Pizza #661, Contains 2 - 6.30 OZ PIZZAS, net WT 12.60 oz (357 G), UPC 631488,  Distributed by Schwan's Home Service, Marshall, MN 56258,
Schwan's is conducting a recall because they were informed by  one of their flour suppliers, Dakota Specialty Milling, Inc., that   a limited number of its flours and grains blends are being recalled due to the possible presence of fragments of thin metal wire from a defective screen on one of its manufacturing lines. As a precautionary measure, Schwan's   has chosen to voluntarily recall Schwan's LiveSmart'' Bruschetta Pizza #661 after being notified by Dakota Specialty Milling of their recall.
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of:  Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Viet Nam.
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models  ARCSJ200W, ARCSJ260W, and ARCDJ260W.  Sterile using ethylene oxide.   Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
Kameda Brand Rice Cracker Kotsubukko, 12/4.37 oz, Item #63018.
Nishimoto Trading Co. is recalling Kameda Brand Rice Cracker Kotsubukko because it contains undeclared milk.
Nationwide Distribution including  AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed.  Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
Toshiba Infinix-i X-Ray System.  A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Lost and incorrect images. When using the ''F-Rec'' fluoroscopy image acquisition recording option in the ''manual mode'' an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX.   Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX.
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only,  Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Meijer,  Spiced Jelly Beans, 32 oz, Product of Mexico, UPC 8-86926-50931-1.
32 oz bags of Meijer Spiced Jelly Beans contain undeclared Yellow # 6.
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Mainly in TX, but internet sales were nationwide.
Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.
The item code numbers are 71400 (1.25 lb) and 71410 (5.75 lb) with lot numbers from 010111 through 021313.
205 of the 1.25 lb and 310 of the 5.75 lb
Recently, DeCoty Taco Seasoning, 1.25 lb (Lot numbers 010111-021313) and 5.75 lb (Lot numbers 010111-021313), were recalled for the undeclared ingredient Soy. Tests show that these lot numbers of this product also contain the undeclared ingredient Wheat Gluten, therefore represents a potential health hazard.