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U.S. Department of Health and Human Services

Enforcement Report - Week of April 10, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated P39893 Class III Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed. Blood Center of Central Iowa (The)
Biologics Fresh Frozen Plasma 6771264 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 4225682 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 4225682 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed Community Blood Center of the Ozarks
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 06KC70987; 06KY05829 Class II Blood products, which did not meet acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 6576566 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6609847 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 6290021; 6336038 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 6336038; 6290021 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center of the Ozarks
Biologics Platelets Pheresis Leukocytes Reduced 9922637 Class II Blood product, which may have been unacceptable, was distributed. Community Blood Center of the Ozarks
Biologics Source Plasma 06FMOC2639; 06FMOC1026; 06FMOC0919; 06FMOC1518; 06FMOB8512; 06FMOC0513; 06FMOC3453; 06FMOB7547; 06FMOC0910; 06FMOC3177; 06FMOB9611; 06FMOC0477 Class III Blood products, collected from donors whose donor suitability was not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced GM10559 Class III Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing GM10559 Class III Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed. LifeServe Blood Center
Biologics Cryoprecipitated AHF LX68180 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced LX68180 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. LifeServe Blood Center
Biologics Platelets 01KK28241 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01KK28241 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 01KK28241 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen LX66756 Class II Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Blood Center of Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced LX66756 Class II Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Blood Center of Iowa (The)
Biologics Platelets pooled Leukocytes Reduced Irradiated LX66756 Class II Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Blood Center of Iowa (The)
Biologics Blood and Blood Products for Reprocessing 6816934 Class II Blood product, collected from a donor who reported post donation illness, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced FC12507 Class II Blood products, collected from a donor who reported a post donation illness, were distributed. Blood Center of Iowa (The)
Biologics Plasma Frozen FC12507 Class II Blood products, collected from a donor who reported a post donation illness, were distributed. Blood Center of Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced LF43720 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing 6883678 Class II Blood products, collected from a donor who was previously deferred, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells 6883678 Class II Blood products, collected from a donor who was previously deferred, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells LQ30802 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced GW23851 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W045008070736 Class III Blood product, labeled as an AS product but with no red cell preservative solution added, was distributed. Community Blood Center Of Gtr KC
Drugs Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15 Lot #: 835H, Exp 07/12 Class III Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product Fougera Pharmaceuticals Inc.
Biologics Red Blood Cells Leukocytes Reduced W035412056646; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced 2093149; 1506480; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF 8548170; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Plasma Frozen Cryoprecipitated Reduced 8548170; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 8548170; 8551762; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 2093149; 1506480; 8551762; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 8548170; 2093149; 1506480; 8551762; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W120612183019; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Michigan Blood
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W040712468837; W040712468837; Class II Blood products, collected from a donor who reported a post donation illness, were distributed. Indiana Blood Center
Biologics Source Plasma LR0398479; LR0398836; LR0400355; LR400556; LR0402075; LR0403071; LR0403464 Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. DCI Biologicals, LLC
Biologics Platelets Pooled Leukocytes Reduced 013FY04668; Class III Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed. American National Red Cross Southeastern Michigan Region
Biologics Red Blood Cells Leukocytes Reduced 013FY04668; Class III Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed. American National Red Cross Southeastern Michigan Region
Biologics Red Blood Cells Leukocytes Reduced W043812010523; Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed LifeShare Community Blood Services
Biologics Platelets Pooled Leukocytes Reduced W043812902467; Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed LifeShare Community Blood Services
Biologics Plasma Frozen within 24 hours (FP24) W038112278518; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells W036812530959; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812844471; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812530959; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W084312002713; Class III Blood products, collected from a paid donor but incorrectly labeled with the "volunteer donor" classification, were distributed. Central Blood Bank
Biologics Platelets W084312002713; Class III Blood products, collected from a paid donor but incorrectly labeled with the "volunteer donor" classification, were distributed. Central Blood Bank
Biologics Fresh Frozen Plasma W084312002713; Class III Blood products, collected from a paid donor but incorrectly labeled with the "volunteer donor" classification, were distributed. Central Blood Bank
Biologics Fresh Frozen Plasma W037711174629; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W043211091557; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211091557; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Fresh Frozen Plasma W036512102516 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. LifeShare Blood Centers
Biologics Recovered Plasma W036512102516 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W068512009222W (3 units) Class II Blood products, collected from a donor who had taken aspirin, were distributed. Inland Northwest Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W041512046908J (2 units) Class II Blood products, which were incorrectly labeled as negative anti-K, were distributed. Blood Systems, Inc. dba United Blood Services
Biologics Red Blood Cells W036810177987 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Community Blood Centers of Florida, Inc.
Biologics Recovered Plasma W036811070000 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W036811070000 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Devices Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking. Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #). Class III Dual Tip Marker has inconsistent ink flow on the black permanent ink side. Viscot Medical LLC
Food GREEN DAY DRIED COCONUT, Net Wt: 3oz (85g), UPC bar code 6 950296 800744 -- Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. -- Add: Donggua Hill, Beitou Village, Qibao, Xinhui District, Jiangmen City, Guangdong, Produce of P.R.C. -- Packed For: Domega NY International Co., Ltd., 1916 West 13th Street Brooklyn, N.Y. 11223 Tel: (646) 388-3032, Fax: (718) 499-2603 -- Nutrition Facts: Serving Size 100g -- Servings Per Container 0.9 --- The product is packed in a sealed, flexible plastic bag. Code: Exp 12/15/2014 --- 2/13/13 Expansion: MFD 09/14/2012 EXP 09/13/2014 Class I The products contained undeclared sulfites (251 ppm and 398 ppm respectively) based on sampling and analysis by New York State Department of Agriculture & Markets. Domega NY International Co Ltd
Drugs CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96 Lot # 32900136A, Exp. 05/14 Class II Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity. Teva Pharmaceuticals USA, Inc.
Devices Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part # 81600; All Serial Numbers Class II Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. Beckman Coulter Inc.
Devices Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part # 81600N, 386220, A12900, A69186; All Serial Numbers Class II Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. Beckman Coulter Inc.
Devices Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part # A15642; All Serial Numbers Class II Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. Beckman Coulter Inc.
Devices UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Part # A25640, A25638, A25656, A25637; All Serial Numbers Class II Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results. Beckman Coulter Inc.
Drugs TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel. LOT #201131320087 Exp 09/15 Class III Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A Ferring Pharmaceuticals Inc
Devices Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00. Serial Numbers: 62-00202-12 36-97839-12 01-05118-12 25-02849-12 63-99894-12 80-00093-12 37-04692-12 92-04130-12 27-99281-12 32-99198-12 81-00513-12 44-02998-12 46-99680-12 23-02928-12 03-04500-12 01-03079-12 79-00261-12 26-99273-12 16-03650-12 93-03219-12 12-02808-12 21-04715-12 34-98485-12 40-98917-12 19-03646-12 27-00988-12 09-02900-12 28-99437-12 96-05032-12 03-00908-12 25-98448-12 15-02913-12 33-99713-12 91-00632-12 71-01130-12 07-05064-12 15-00948-12 92-02246-12 36-98399-12 97-00740-12 75-00229-12 32-01986-12 80-02118-12 97-04135-12 26-00899-12 20-03654-12 44-99495-12 31-99285-12 23-01970-12 43-99575-12 48-99499-12 83-00191-12 11-00768-12 31-99461-12 88-02066-12 88-00189-12 34-02974-12 24-02950-12 54-99790-12 96-03067-12 91-04122-12 74-00235-12 23-02759-12 96-04127-12 11-02652-12 44-99488-12 09-00766-12 23-03569-12 99-00580-12 20-02918-12 12-04178-12 06-05063-12 75-00243-12 29-02874-12 96-00549-12 75-00074-12 76-02114-12 03-00739-12 04-04237-12 76-03005-12 99-00559-12 01-03086-12 32-99374-12 97-03244-12 97-02346-12 90-02251-12 94-02343-12 43-99818-12 07-00838-12 19-02850-12 77-00083-12 90-02075-12 21-01961-12 88-04200-12 90-03061-12 10-00767-12 33-02885-12 16-98520-12 05-02294-12 70-00231-12 58-01001-12 34-04682-12 10-04190-12 64-00204-12 96-03081-12 35-02982-12 02-00488-12 18-98508-12 82-00088-12 01-00649-12 26-02938-12 22-04716-12 11-03624-12 14-98511-12 95-03066-12 28-98553-12 00-05029-12 95-05031-12 08-98403-12 36-02990-12 24-04718-12 03-02278-12 92-00707-12 20-02932-12 49-99933-12 10-99215-12 35-98567-12 36-97853-12 10-02394-12 03-02609-12 76-01054-12 77-00245-12 09-02555-12 00-02532-12 25-02944-12 06-00844-12 25-02782-12 19-02917-12 39-02898-12 37-99481-12 25-03754-12 95-02351-12 33-99449-12 78-00239-12 20-00879-12 22-98526-12 39-98916-12 33-98389-12 12-99224-12 52-99679-12 17-02908-12 51-99678-12 05-05055-12 26-04572-12 24-99271-12 25-02937-12 32-01979-12 83-00089-12 13-98422-12 97-04128-12 06-04503-12 80-02051-12 18-99501-12 07-98402-12 84-02048-12 14-00873-12 56-00101-12 14-04701-12 55-00100-12 35-04683-12 56-04996-12 69-00216-12 18-02909-12 81-03024-12 02-04404-12 16-00699-12 51-99773-12 31-02883-12 11-98413-12 99-02281-12 20-04471-12 00-03342-12 01-00744-12 79-00078-12 39-04694-12 94-02350-12 41-99485-12 13-02647-12 75-01046-12 89-02250-12 20-04721-12 93-02247-12 37-97854-12 74-01133-12 96-00644-12 30-98562-12 23-99175-12 37-98488-12 15-99227-12 33-98910-12 39-04687-12 91-04210-12 51-98949-12 78-00091-12 11-03617-12 95-03080-12 03-00841-12 74-03003-12 04-00909-12 06-00763-12 21-00894-12 16-01942-12 16-99242-12 80-02301-12 08-00846-12 21-99504-12 07-99050-12 36-03948-12 28-04486-12 30-99460-12 66-99897-12 99-03077-12 23-00984-12 08-00765-12 95-00724-12 02-02284-12 28-98560-12 06-02390-12 21-03648-12 15-02818-12 15-02832-12 98-04143-12 82-03113-12 52-98890-12 97-02522-12 39-02986-12 34-03865-12 03-05060-12 09-00847-12 12-98421-12 26-00987-12 11-98420-12 19-98530-12 12-02396-12 86-02057-12 16-03636-12 73-00234-12 25-00986-12 96-02521-12 10-99208-12 88-02228-12 40-04688-12 57-01000-12 87-00702-12 21-00982-12 40-99565-12 28-98546-12 30-00998-12 07-05057-12 87-00195-12 75-01127-12 27-98538-12 60-01003-12 30-99284-12 03-00760-12 01-02364-12 05-04171-12 56-99697-12 92-02341-12 59-01002-12 12-02910-12 87-03125-12 18-03645-12 44-99833-12 99-05035-12 48-98696-12 29-02962-12 41-04689-12 89-04018-12 79-01138-12 01-02276-12 93-04117-12 09-05080-12 32-04497-12 34-99471-12 07-00926-12 07-99205-12 45-97869-12 98-05034-12 19-02829-12 02-02365-12 47-99829-12 99-02612-12 06-00837-12 20-98605-12 89-04120-12 71-00218-12 63-00210-12 39-99476-12 02-02622-12 22-00983-12 20-04383-12 07-02715-12 20-00893-12 86-00099-12 85-00362-12 16-98513-12 13-02485-12 26-98706-12 37-04685-12 22-99262-12 63-01006-12 04-02543-12 34-01995-12 83-03019-12 99-05042-12 79-02300-12 14-04606-12 34-02981-12 86-02307-12 06-99028-12 21-04722-12 11-01666-12 07-04166-12 76-01128-12 33-99463-12 29-02881-12 37-99900-12 82-00190-12 62-99886-12 23-02942-12 33-04917-12 84-00097-12 96-02352-12 14-02912-12 13-03721-12 09-02643-12 18-03652-12 00-04226-12 31-98725-12 16-02914-12 15-98505-12 19-99502-12 29-02948-12 36-02888-12 92-00538-12 03-02366-12 22-02927-12 32-99279-12 23-00991-12 95-00629-12 64-99895-12 05-02368-12 71-00232-12 28-98539-12 23-03657-12 10-00848-12 98-00646-12 05-00836-12 09-03358-12 10-02299-12 77-01129-12 85-00700-12 26-02783-12 02-00840-12 29-00997-12 11-04184-12 02-05052-12 35-02887-12 49-97975-12 31-04489-12 26-04477-12 00-05050-12 72-00233-12 40-03885-12 92-00633-12 14-01852-12 09-99207-12 03-00746-12 15-03716-12 33-04498-12 38-99475-12 95-02344-12 21-04472-12 25-04726-12 99-02355-12 63-99799-12 96-02345-12 04-04406-12 38-03890-12 27-99362-12 35-99296-12 94-04125-12 96-02271-12 37-02984-12 13-02911-12 34-99376-12 10-00693-12 19-04470-12 97-02353-12 37-99562-12 94-02248-12 37-99805-12 11-99135-12 97-02339-12 96-00563-12 40-99491-12 16-04608-12 29-02793-12 03-99106-12 08-03621-12 68-00215-12 01-01642-12 40-99477-12 88-00710-12 17-02760-12 56-05982-12 25-98712-12 95-02520-12 38-98489-12 94-00723-12 13-03626-12 29-98547-12 90-00712-12 26-01980-12 00-00581-12 71-01123-12 18-04374-12 29-04487-12 30-99189-12 22-03656-12 04-05054-12 40-98593-12 12-02653-12 58-99787-12 31-03950-12 99-00566-12 11-99061-12 04-04156-12 82-00271-12 23-03738-12 17-02922-12 21-98606-12 26-99266-12 62-99798-12 11-00937-12 22-04473-12 26-03586-12 20-04369-12 19-98509-12 94-00730-12 34-04499-12 08-02392-12 01-03343-12 35-98398-12 19-05097-12 08-00839-12 28-98391-12 07-00764-12 41-03893-12 16-04372-12 47-04980-12 10-00929-12 01-00832-12 58-99794-12 14-02648-12 23-04717-12 04-01645-12 23-02861-12 91-02245-12 22-02691-12 20-02851-12 40-03878-12 06-02369-12 98-02611-12 78-00084-12 22-02846-12 09-04168-12 00-02356-12 15-00874-12 09-00692-12 92-00552-12 44-98597-12 08-00934-12 13-04700-12 05-01727-12 69-00304-12 32-02965-12 06-05056-12 31-98563-12 07-04159-12 80-00079-12 04-05061-12 40-98498-12 Class I Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected. Animas Corporation
Devices ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60. All serial numbers Class III Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions. Horiba Instruments, Inc dba Horiba Medical
Devices Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Model #: 882456; Serial #: 2004 Class II Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues. Philips Medical Systems (Cleveland) Inc
Drugs Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807 Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114 Class II Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point. Dr Reddys Laboratories Tennessee LLC
Devices Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH Class II Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump Zyno Medical LLC
Devices Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas® CT/NG 4800 System, for in vitro diagnostics. Lot / SN : 477415,477416, 477898, and 477899 Class II Certain lots of Reagent reservoirs, 50mL used on the cobas® 4800 System, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent. Roche Diagnostics Operations, Inc.
Devices Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine. Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14. Class II Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent. Siemens Healthcare Diagnostics, Inc.
Drugs 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045 Lot #: 22-028-JT Exp 04/14 Class II Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal. Hospira Inc.
Biologics Reagent Red Blood Cells 830301100 Class II Biotest reagent A1 red blood cell, with higher than expected cell concentration, was distributed. Bio-Rad Medical Diagnostics GmbH
Devices BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing. Catalog #3694991 appears as Catalog #364953 (Lot #1335484) Class III The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible they would obtain an erroneous result since the Urinalysis Tube contained in the Kit does not contain any preservatives. Becton Dickinson & Company
Devices Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3. all Model 8930 radio frequency (RF) generators are affected Class II Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status. Medtronic Neuromodulation
Devices LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure. Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13 Class II LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label). Cooper Surgical, Inc.
Food Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water. Lot Code & Best By Date 3014SAECLP 1/14/2016 3015SA1CLP 1/15/2016 3015SA2CLP 1/15/2016 3015SA3CLP 1/15/2016 3015SA4CLP 1/15/2016 3015SA5CLP 1/15/2016 3015SAACLP 1/15/2016 3015SABCLP 1/15/2016 3015SACCLP 1/15/2016 3015SADCLP 1/15/2016 3015SAECLP 1/15/2016 3016SB1CLP 1/16/2016 3016SB2CLP 1/16/2016 3016SB3CLP 1/16/2016 3016SB4CLP 1/16/2016 3016SBACLP 1/16/2016 3016SBBCLP 1/16/2016 3016SBCCLP 1/16/2016 3016SBDCLP 1/16/2016 3016SBECLP 1/16/2016 3017SB1CLP 1/17/2016 3017SB3CLP 1/17/2016 3017SB4CLP 1/17/2016 3017SB5CLP 1/17/2016 3017SB6CLP 1/17/2016 3017SBACLP 1/17/2016 3017SBBCLP 1/17/2016 3017SBCCLP 1/17/2016 3017SBDCLP 1/17/2016 3017SBECLP 1/17/2016 3018SB1CLP 1/18/2016 3018SB2CLP 1/18/2016 3018SB4CLP 1/18/2016 3018SB5CLP 1/18/2016 3018SBACLP 1/18/2016 3018SBBCLP 1/18/2016 3018SBCCLP 1/18/2016 3018SBDCLP 1/18/2016 3018SBECLP 1/18/2016 Class II Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness. Bumble Bee International
Food Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable Oil Lot Code & Best By Date 3016SA1CLH 1/16/2018 3016SA5CLH 1/16/2018 3016SAACLH 1/16/2018 3016SABCLH 1/16/2018 3016SACCLH 1/16/2018 3016SADCLH 1/16/2018 3016SAECLH 1/16/2018 3016SAFCLH 1/16/2018 3016SAFCLH 1/18/2018 Class II Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness. Bumble Bee International
Food Bumble Bee Brand 5oz Chunk White Albacore in Water Lot Code & Best By Date 3016SA2CKP 1/16/2016 3016SA3CKP 1/16/2016 3016SA4CKP 1/16/2016 3017SA1CKP 1/17/2016 3017SA2CKP 1/17/2016 3017SA3CKP 1/17/2016 3017SA4CKP 1/17/2016 3017SA5CKP 1/17/2016 3017SADCKP 1/17/2016 3017SAECKP 1/17/2016 3017SAFCKP 1/17/2016 3017SABCKP 1/17/2016 3017SAACKP 1/17/2016 3017SACCKP 1/17/2016 3017SB2.CKP 1/17/2016 Class II Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness. Bumble Bee International
Devices Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces. Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M; Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M. Class II The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. Polymedco, Inc
Devices Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces. Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M. Class II The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. Polymedco, Inc
Food Kroger Value Wheat Bread, PAN DE TRIGO, net wt/peso neto 22.5 oz (1 lb 6.5 oz) 637g UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT AND SOY.*** DISTRIBUTED BY/DISTRIBUIDO OR THE KROGER CO., CINCINNATI, OHIO 45202. Sell By Mar 08 FK 053, UPC 0 11110 02199 1 Class II The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces. Kroger Co
Food Tender Twist Wheat Bread NET WT 20 OZ (1 LB 4 OZ) 566G and 22.5 oz (1 LB 6.5 OZ) 637 g plastic bags ***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202" Sold under the following brands: QFC Quality Food Centers & Fred Meyer UPC 0 11110 20231 4, Sell By Mar 08 FK 053 & UPC 0 11110 23006 6, Sell By Mar 08 FK 053 Class II The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces. Kroger Co
Food Tender Twist 100% Whole Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202" Sold under the following brand names: Fred Meyer & Goodyman UPC 0 11110 23005 8 Sell By Mar 08 FK 053 Class II The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces. Kroger Co
Food Fred Meyer Tender Twist Honey Cracked Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202" UPC 0 11110 23004 Sell By Mar 08 FK 053 Class II The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces. Kroger Co
Devices Smiths Medical, BCI® Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI® Remote Alarm Cable is designed for use with the 9004 Capnocheck® Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck® Capnography system to a remote alarm system. The BCI® Remote Alarm Cable and the 9004 Capnocheck® Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia. Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947. Class I In rare instances, the BCI® Remote Alarm Cables (BCI® Cable) are not transferring alarms when used with some remote nurse alarm systems. Smiths Medical ASD, Inc.
Food Chicken of the Sea Brand 5-ounce chunk white albacore tuna in water. UPC: 4800003355, Case UPC 4800003355: 24 cans per case, Shipper display UPC 4800016335: 80 cans per case, Pallet display UPC 4800023355: 1008 cans per pallet Product labeling reads in part:"***Chicken of the Sea CHUNK WHITE ALBACORE TUNA IN WATER***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***". 3018CA2CKP, 3018CA3CKP, 3018CA4CKP, 3018CAACKP, 3018CABCKP, 3018CACCKP, 3018CAECKP, 3018CB3CKP, 3018CADCKP BEST BY DATE: 01/18/17. Class II Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water and Chicken of the Sea brand 5-ounce cans chunk light tuna in oil, because the seams on the lids of the cans do not meet the standard for seam quality. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Food Chicken of the Sea 5-Ounce Chunk Light Tuna in Oil. Sold in single cans. 24 cans per case. UPC 48000 00195 Product labeling reads in part:"***Chicken of the Sea CHUNK LIGHT TUNA IN OIL***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***". 3015CB1CLH 3015CB2CLH 3015CB3CLH 3015CB4CLH 3015CBACLH 3015CBBCLH 3015CBCCLH 3015CBDCLH 3015CBECLH BEST BY DATE 01/15/17 and 01/18/17 Class II Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water and Chicken of the Sea brand 5-ounce cans chunk light tuna in oil, because the seams on the lids of the cans do not meet the standard for seam quality. Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Food CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: "***CHUMINH TOFU***Fresh Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate***NET WT. 16 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***". expiration date: 3/14 and 3/15 Class II All fresh tofu and fried tofu products are recalled because they were made in a facility with no available hot water. Chu Minh Corp
Food CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. The product is labeled in parts: "***CHUMINH TOFU***Fried Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate, Corn Oil***NET WT. 12 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***". expiration date: 3/14 and 3/15 Class II All fresh tofu and fried tofu products are recalled because they were made in a facility with no available hot water. Chu Minh Corp
Devices Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090 , N1830R80-080 , N1830R80-070 , N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, N182450-085, N182450-075, N182450-065, N182450-055, N182450-045. Retractor access system that allows placement of posterior spinal fixation implants. Lot Number 61225572 61664689 61664689 61657007 61657015 61657015 61267745 61267745 61267750 61267750 61267753 61267753 61657016 61657016 61801814 61895685 61657017 61657018 61657018 61267756 61267756 61267759 61267759 61267760 61267760 61267761 61267761 61267761 61873348 61657019 61657019 61657031 61657031 Class II Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may occur due to loss of product sterility. Zimmer, Inc.
Devices Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. Siemens Material Number 10486890 Class III Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue. Siemens Healthcare Diagnostics, Inc.
Devices Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids. Siemens Material Number 106393377 Class III Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue. Siemens Healthcare Diagnostics, Inc.
Devices Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids. Siemens Material Number 10636929 Class III Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue. Siemens Healthcare Diagnostics, Inc.
Devices Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography. Part Numbers --AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, AND AI-07138. Class II The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. Arrow International Inc
Food Mrs. Bridges Scottish Raspberry Preserve ("Jam"); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind Estate, Arbroath, Scotland UK DD113LR. L4 0110 20 APR 2014 Class III The firm is initiating the recall for Scottish Raspberry Preserve due to discovery of contaminants. The TJX Companies, Inc.
Drugs Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826 All lot codes. Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong. Lot HJLA, Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL All lot codes. Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 , All lot codes. Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. . All lot codes. Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826 All lot codes. Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Drugs Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 All lot codes Class II Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Palmer Natural Products
Food Propolis Powder -100% Standardized Bee-Propolis Lot #: 021113-55/60, EXP: 10/14 11# Bag & Lot#: 10081155/60-120612-100, EXP: 12/15, 1# BAG. 10081155/60-120612-100; 021113-55/60 Class II Beehive Botanical, Inc is recalling several lots of Propolis 55-60% due to positive identification of Fluvalinate. Beehive Botanicals, Inc.
Food Propolis Chunks-Coarse Ground, Standardized Bee Propolis Lot #: SDM-10081155/60, EXP: 10/14, 1# BAG. SDM-1008115/60 Class II Beehive Botanical, Inc is recalling several lots of Propolis 55-60% due to positive identification of Fluvalinate. Beehive Botanicals, Inc.
Devices Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures. Serial Number Range: 1010 through 1380 Class II If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury. Integra Burlington MA, Inc.
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. All units of these models. Class II Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device. Siemens Medical Solutions USA, Inc
Devices STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments. SO Numbers: 601918 601921 653618 658412 658619 663775 663605 670265 670983 676483 676976 677247 682484 683535 683401 685051 684706 684897 689791 693170 688731 695253 685242 695044 694872 694890 694933 700374 700420 687958 695322 698794 694561 696647 694903 697444 703236 704953 705019 704220 704997 684009 705131 705189 705395 706157 707254 707928 709374 710904 705394 710055 710381 711947 712233 712952 711466 713603 714781 714896 714927 714941 715465 714230 714936 715319 715471 680655 711359 715140 704508 715994 716005 715655 716503 716506 716482 716806 716925 716956 716977 717350 716504 717332 717457 717466 717456 717490 716774 717477 717487 717482 717472 716955 723403 718518 724650 717455 727905 717473 732354 726771 733003 733007 732940 735456 736315 736250 742622 742112 742351 740419 739924 747572 746618 746545 747670 747711 748911 734951 752042 752042 755131 752064 754673 755986 755473 755926 756407 756812 756765 756999 721585 760939 761382 761772 761799 761633 761658 761800 763129 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999609 989887 996490 1007883 989799 989128 1017330 1014929 1001454 989812 964035 1001445 1001445 1000552 1007891 986668 999879 1006666 1006666 1006666 1000578 957170 989318 989318 1001413 1012992 1008806 1006163 1023238 1024407 1001448 1001466 1003454 1012986 1040231 989220 1041871 1001456 1001457 1001457 1001410 1001355 1012173 988695 1054423 992073 993189 1001274 1053410 1044991 1044991 1020584 1012923 1063598 1063609 1025584 1024164 1027213 1031944 1039441 1044876 1059351 1063083 1050309 1025247 1022646 1014870 1064384 1064384 1064384 1026363 1026363 1060747 1052077 1021353 1021353 1071207 1071196 1071196 1071205 1070684 1055395 1048777 999854 1026526 1060114 1034760 1041418 1041418 1044166 1032936 1074229 1045691 1045605 1048609 1031369 1051854 1048602 1046765 1046322 1050312 1009104 1050324 1022589 1061945 1052225 1057933 1026470 1052014 1053463 1053045 1044719 1059451 1062104 1081143 1093893 1064383 1049778 1094906 1065140 1062472 1062472 1050285 1061990 1064451 1102330 1065168 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1374867 1384031 1387899 1391654 1385422 1394319 1394319 1394319 1395019 1353757 1326427 1373843 1360565 1388044 1343591 1354415 1397390 1396342 1396803 1399428 1401283 1402478 1400712 1397076 1397076 1402363 1396553 1402736 1373013 1405947 1406635 1406048 1407058 1392751 1353149 1403977 1407279 1374042 1374880 1405691 1397072 1406519 1402824 1406434 1407139 1407240 1407328 1407239 1407323 1413713 1413713 1412541 1412668 1412341 1396531 1407125 1397382 1395148 1416948 1407064 1405852 1406662 1407318 1407311 1418803 1418803 1420510 1407319 1374052 1405537 1399625 1399625 1399625 1399625 1422430 1419669 Class II The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. Advanced Sterilization Products
Devices STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments. Codes: 10217 10201-002 10201 10202-001 Class II The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. Advanced Sterilization Products
Food Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake, 14 oz, in a plastic clamshell package, UPC Code: 011225113833 Lots: 020313 and 030613 Class I Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake contains undeclared walnuts. Gold Standard Baking, Inc.
Devices LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures. LSG1130, exp. 2017-04; LSG1132, exp. 2017-11 Class II Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. LeMaitre Vascular, Inc.
Devices Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures. SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09 Class II Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. LeMaitre Vascular, Inc.
Food Happy Kids Creamy Peanut Butter, packed in 8 oz, 12 oz, 28 oz, 40 oz jars; packed 12 jars/box and 6 jars/box (40 oz), and labeled in part ******Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434*** EXP 02.13.2015 Class II Peanut butter may contain aflatoxins above allowable levels. Producers Peanut Company Inc
Food Happy Kids Crunchy Peanut butter, packed in 8 oz, 12 oz, 28 oz, packed 12 jars/cs and 40 oz jars, packed 6 jars/cs; jars are labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434*** EXP 02.13.2015 Class II Peanut butter may contain aflatoxins above allowable levels. Producers Peanut Company Inc
Food Bulk Creamy/Smooth Peanut butter, packed in plastic 4 lb tub, packed 6 tubs/box; 5 lb tub, packed 6 tubs/box, and 35 lb buckets under private labels: Peanut Kids, Eden and American Farm Peanut Butters, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434*** 2/12/2013, 2/13/2013, POD FEB 12 2013, POD FEB 2013, and 01.13.2015 Class II Peanut butter may contain aflatoxins above allowable levels. Producers Peanut Company Inc
Food America Farm Peanut Granules, bulk packed in 30 lb plastic bags in a box, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434*** 2/12/2013, 2/13/2013, POD FEB 12 2013, POD FEB 2013, and 01.13.2015 Class II Peanut butter may contain aflatoxins above allowable levels. Producers Peanut Company Inc
Drugs Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15. Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15. Class III Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. Dr. Reddy'S Laboratories
Drugs Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01. Lot #: 68028A, Exp 07/14 Class II Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. West-ward Pharmaceutical Corp.
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