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U.S. Department of Health and Human Services

Enforcement Report - Week of December 18, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 372083439, 372078475, 372086936, 372086362, 372084077, 372082405, 372081944, 372079984, 372079090, 372081065, 372076885, 372076405, 372075324, 372074827, 372073497, 372070194, 372069368, 372067971, 372067072, 372046115, 372044282, 372043673, 372042681, 372041350, 372039384, 372038239, 372036736, 372036294 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Biologics Platelets Pheresis 368520428 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Blood Systems, Inc.
Biologics Source Plasma 05LWYE3208, 05LWYE4414, 05LWYE4775 Class II Blood products, collected from a donor who received a MMR vaccine prior to donation, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 3531537 Class II Blood product, collected from a donor who traveled to potential malaria endemic areas, was distributed Community Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced 50X32932, 50X32933, 50X32936, 50X32937, 50X32938, 50X32939, 50X32940, 50X32941, 50X32942, 50X32945, 50X32946 Class III Blood products, collected using a scale for which the quality control results were not documented, were distributed. American National Red Cross
Biologics Red Blood Cells, Leukocytes Reduced 20E65198 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 20E65198 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 20LZ33722. Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LZ33722. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Bone UBI0090690110; UBI0090690111; UBI0090690112; UBI0090690113; UBI0090690116; UBI0090690117; UBI0090690118; UBI0090690119; UBI0090690120; UBI0090690121; UBI0090690122; UBI0090690123; UBI0090690124; UBI0090690126; UBI0090690127; UBI0090690128; UBI0090690129; UBI0090690131; UBI0090690132; UBI0090690133; UBI0090690134; UBI0090690135; UBI0090690136; UBI0090690137; UBI0090690138; UBI0090690139; UBI0090690140; UBI0090690141; UBI0090690142; UBI0090690144; UBI0090690145; UBI0090690146; UBI0090690147; UBI0090690148; UBI0090690149; UBI0090690150; UBI0090690151; UBI0090690152; UBI0090690153; UBI0090690154; UBI0090690156; UBI0090690157; UBI0090690158; UBI0090690159; UBI0090690160; UBI0090690161; UBI0090690162; UBI0090690163; UBI0090690165; UBI0090690166;  ...
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Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0089550057; UBO0089550058; UBO0090690078 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0090690064; UBO0090690065; UBO0090690066; UBO0090690067; UBO0090690068; UBO0090690069; UBO0090690070; UBO0090690071; UBO0090690072; UBO0090690073; UBO0090690074; UBO0090690075; UBO0090690076; UBO090690077. Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone USK0090690038; USK0090690039; USK0090690040; USK0090690041 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UDM0089550031; UDM0089550032; UDM0089550033; UDM0089550034; UDM0089550035; UDM0089550037 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0082610001; UBO0082610002; UBO0082610003; UBO0082610005; UBO0082610010; UBO0082610011; UBO0082610012; UBO0082610013; UBO0082610014; UBO0082610015; UBO0082610016; UBO0082610020; UBO0082610021; UBO0082610022; UBO0082610023; UBO0082610024; UBO0082610028; UBO0082610029; UBO0082610034; UBO0082610035; UBO0082610036; UBO0082610037; UBO0082610039; UBO0082610040; UBO0082610041; UBO0082610042; UBO0082610043; UBO0082610044; UBO0089580080; UBO0089580081; UBO0089580082; UBO0089580084; UBO0089580085; UBO0089580086; UBO0089580087; UBO0089580094; UBO0089580094; UBO0089580095; UBO0089580096; UBO0089580097; UBO0089580098; UBO0089580099; UBO0089580100; UBO0089580101; UBO0089580102; UBO0089580103; UBO0089580105; UBO0089580106; UBO0089580107; UBO0089580109;  ...
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Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0089580061; UBO0089580062; UBO0089580063 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0082610006; UBO0082610009; UBO0082610030; UBO0082610031; UBO0082610032; UBO0082610033; UBO0082610046; UBO0089580052; UBO0089580053; UBO0089580054; UBO0089580055; UBO0089580056; UBO0089580057; UBO0089580058; UBO0089580059; UBO0082610004; UBO0082610007; UBO0082610008; UBO0082610045; UBO0089580050; UBO0089580051 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone USK0056960001; USK0056960002; USK0056960003; USK0056960004; USK0056960005; USK0056960006; USK0056960007; USK0089580064; USK0089580065; USK0089580066; USK0089580067; USK0089580068; USK0089580069; USK0089580070; USK0089580071; USK0089580072; USK0089580073; USK0089580074; USK0089580075; USK0089580076. Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone UBO0082610038 Class II Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. University of Miami Miller School of Medicine Tissue Bank
Biologics Bone 103940051; 103940052; 103940053; 103940054; 103940055; 103940056; 103940057; 103940058; 103940059; 103940060; 103940061; 103940062; 103940063; 103940064; 103940065; 103940066; 103940067; 103940068; 103940069; 103940070; 103940071; 103940072; 103940073; 103940074; 103940075; 103940076; 103940077; 103940078; 103940079; 103940080; 103940081; 103940082; 103940083; 103940084; 103940085; 103940086; 103940087; 103940088; 103940089; 103940090; 103940091; 103940092; 103940093; 103940094; 103940095; 103940096; 103940097; 103940098; 103940099; 103940100; 103940101; 103940102; 103940103; 103940104; 103940105; 103940106; 103940107; 103940108; 103940109;  ...
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Class II Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. University of Miami Miller School of Medicine Tissue Bank
Drugs Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0. All lots including 0312-K2, Exp 11/14 Class I Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs. Myson Corporation, Inc.
Drugs Volcano Male Enhancement (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase) Capsules,1500 mg, 1-count capsule packaged in a black round plastic pop top container No codes or lots listed on products. Class I Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs. Myson Corporation, Inc.
Drugs Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07 Product code: 704412; Lot Number: F1186, Exp 03/31/2014; F1127, F1127A, Exp 07/31/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07 Product code: 704414; Lot Number: F1027; Exp 2/28/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07 Product code: 709999 & 725275; Lot Number: F0048A, Exp 08/31/2013; F0056A, Exp 10/31/2013; F0084, F0085, Exp 01/31/2014; F0059A, F0088, Exp 02/28/2014; F0086, F0087, Exp 03/31/2014; F0061A, F0063W1, Exp 05/31/2014; F0070A, Exp 09/30/2014; F0082A, Exp 02/28/2015 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07 Product code: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp 02/28/2014; F0121, F0122, Exp 05/31/2014; F0125A, F0125W1, Exp 07/31/2014; F0137, F0139, F0140, F0141, F0142, F0144; Exp 11/30/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9563-89 Product code: 715512 & 725276; Lot Number: F0034, Exp 08/31/2013; F0035, F0036, F0036A, Exp 10/31/2013; F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013; F0043, Exp 01/31/2014; F0045, Exp 03/31/2014; F0044, F0046, Exp 04/30/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9559-89 Product code: 715523 & 725278; Lot Number: F0019, F0019A, Exp 08/31/2013; F0020, Exp 09/30/2013; F0021, F0021A, Exp 10/31/2013; F0022, F0025, Exp 11/30/2013; F0024, F0026, Exp 12/31/2013; F0027, Exp 09/30/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89 Product code: 715515; Lot Number: F0012, Exp 10/31/2013; F0013, Exp 02/28/2014; F0014, Exp 03/31/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07 Product code: 710011; Lot Number: F0060, Exp 01/31/2014; F0028A, Exp 02/28/2014; F0061, Exp 03/31/2014; F0062, Exp 05/31/2014; F0033A, Exp 10/31/2014; F0037A, Exp 01/31/2015 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07 Product code: 710007 & 725277; Lot Number: F0131, Exp 11/30/2013; F0138, Exp 01/31/2014; F0137, F0139, F0140, F0141, F0142, F0142A, Exp 02/28/2014; F0145, F0150, F0157, F0158, Exp 04/30/2014; F0159, F0160, Exp 05/31/2014; F0163, F0165, Exp 07/31/2014; F0184, Exp 01/31/2015 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07 Product code: 707136; Lot Number: F0017, Exp 01/31/2015 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01 Product code: 707156; Lot Number: F0012, Exp 02/28/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07 Product code: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07 Product code: 708239; Lot Number: F0140, F0140W1, Exp 09/30/2013; F0142, Exp 07/31/2014; F0143, Exp 08/31/2014; F0144, Exp 10/31/2014; F0145; Exp 01/31/2015. Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , NDC # 0078-9521-89 Product code: 712396; Lot Number: F0026, F0027; Exp 07/31/2014 Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89 Product code: 712427; Lot Number: F0036, F0036W1, Exp 08/31/2013; F0038, Exp 06/30/2014; F0039, Exp 08/31/2014. Class II Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves. Novartis Pharmaceuticals Corp.
Drugs Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. Lot #: 3122856, Exp 05/14 Class III Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. Lupin Pharmaceuticals Inc.
Biologics Red Blood Cells Leukocytes Reduced W20191300759300; Class III Blood component, prepared from Whole Blood that was centrifuged at room temperature, was distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Red Blood Cells Leukocytes Reduced W071213029113; Class II Blood product, manufactured from a unit of Whole Blood designated as a low volume collection, was distributed. Medic Inc
Drugs Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216 Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014 Class III SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets. Boehringer Ingelheim Roxane Inc
Food Sugar free cake: Carrot flavor, Package size: 4 oz, 12 oz. no codes Class III Lack of phenylketonuric warning in products containing aspartame. Cakes & More Delight's
Food Sliced Sugar free cake: almond flavor with cinnamon. Package size: 16 oz each. no codes Class III Lack of phenylketonuric warning. The main ingredient "Sugar Free RichCreme Base' contains aspartame. Cakes & More Delight's
Food Sugar free cake: Vanilla flavor. Package size: 4 oz, 12 oz; Sliced Sugar-free cake: Vanilla flavor 16 oz. no codes Class III Lack of phenylketonuric warning. The main ingredient "Sugar Free RichCreme Base' contains aspartame. Cakes & More Delight's
Food Sugar free cake: Pistachio flavor. Package size: 4 oz, 12 oz no codes Class III Lack of phenylketonuric warning. The main ingredient "Sugar Free RichCreme Base' contains aspartame. Cakes & More Delight's
Food Sugar free cake: Corn. Package size: 4 oz, 12 oz no codes Class III Lack of phenylketonuric warning. The main ingredient "Sugar Free RichCreme Base' contains aspartame. Cakes & More Delight's
Food Sugar free cake: Almond flavor. Package size:12 oz no codes Class III Lack of phenylketonuric warning. The main ingredient "Sugar Free RichCreme Base' contains aspartame. Cakes & More Delight's
Biologics Platelets Pheresis Leukocytes Reduced W116313742872; Class II Blood product, with unacceptably high platelet count, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W270113596965; Class II Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed. Central Pennsylvania Blood Bank
Devices Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur. Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21. Class II Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. Synthes USA HQ, Inc.
Devices Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment. *** DOMESTIC PRODUCT *** List Numbers: 43449-04-11 and 43449-04-01; Lot Numbers: All; *** FOREIGN PRODUCT *** List Numbers: 0L21297W1, 0L2129701, 0L2139701, 43449001L, 434490101, 434490102, 434490181, 434490181, 434490182, 4344901DX, 434496101, 434496161, 4344961A1, 434499090; Lots: All Class II Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating. Hospira Inc.
Biologics Fresh Frozen Plasma 2411016; 2321193; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2411016; 2321193; 2046554; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2046554; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets 2046554; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 2046554; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 017LN04903; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American National Red Cross (The) - North Central Region
Biologics Red Blood Cells Leukocytes Reduced W037712069983; Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Hoxworth Blood Center
Biologics Cryoprecipitated AHF, Pooled W037712069983; Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W03771208775; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Hoxworth Blood Center
Drugs Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8. Lot #: H3135, Exp. January 2015 Class III Subpotent. drug Taro Pharmaceuticals U.S.A., Inc.
Food Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295 Lot No: 131623, EXP. DATE 05/15, Item #: VCT7015191 Class II Nature's Value Inc. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. Nature's Value Inc.
Food Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form. Manufactured For: Indiana Botanic. Manufactured by Nature's Value Inc. 468 Mill Road, Coram, NY 11727, Telephone: 631-846-2500. Lot No: 132337 Class II Nature's Value Inc. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. Nature's Value Inc.
Food Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle, UPC Code: 844197017164. Manufactured for Vitacost Lexington, NC 27295. Lot No: 1) 132176, EXP. DATE 06/15, Item #: VCT 7017164 and 2) Lot No: 132843, EXP. DATE 07/15, Item #: VCT7017164 Class II Nature's Value Inc. has recalled three Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. Nature's Value Inc.
Devices Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. all GN161's distributed between 4/28/2009 and 5/22/2013. Class II Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control. Aesculap, Inc.
Biologics Red Blood Cells Leukocytes Reduced W0410130438031 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Systems Inc
Food 1) 8" Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10" Coconut Custard Pie, Net Wt 42 oz (2 lb 10oz), UPC number 4173523713 n/a Class II Products lack an ingredient statement - undeclared eggs, tree nuts, milk, wheat and soy. Price Chopper Supermarkets
Devices Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis. J5606-C Class II A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present. Synthes USA HQ, Inc.
Biologics Tendon IBM1346174008; Class II Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed. International Biologics LLC
Biologics Cornea 095113; Class II Human allograft, recovered from a donor who may have participated in high risk behavior, was distributed. Eye Bank For Sight Restoration
Devices Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. Multiple: Expressed as Catalog # (AA#) lot number (RF#), and expiration date (year-month) : AA-15611-S RF0018142 2015-01 AA-15611-S RF1069509 2016-06  ...
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Class II There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient. Arrow International Inc
Devices Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx. catalog # OMN-1005056-1, K1600LH, DPS 1.1 Class II There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions. Omnyx Llc
Food Garden-Fresh German Potato Salad, UPC 0 11596 14017 9, 16 oz, product code 4017 Code Date 9/25/2013 - 9/30/2013 9/25/2013 - 9/30/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Macaroni Salad, UPC 0 85239 24105 9, 16 oz, Product Code 24105. Weis Original Macaroni Salad, UPC 0 41497 05839 6, 16 oz, Product Code 5839. Spartan Macaroni Salad, UPC 0 11213 90321 7, 16 oz, Product Code 4073. Grandpa's Macaroni Salad, UPC 0 11596 14066 7, 16 oz, Product Code 4066. Finest Traditions Macaroni Salad, UPC 7 33147 00018 2, 16 oz, Product Code 38856. 9 Market Pantry Macaroni Salad, UPC 0 85239 24101 1, 3 lb. , Product Code 24101. Weis Original Macaroni Salad, UPC 0 41497 05904 1, 3 lb. Product Code 05904. Weis Original Macaroni Salad, UPC 0 11596 52106 0, 2/5 lb., Product Code 2106. Dairy Fresh Macaroni Salad, UPC 0 70163 56415 2, 2/5 lb. , Product Code 407364. Family Style Macaroni Salad, UPC 0 11596 52060 5, 2/5 lb., Product code 2060. Garden-Fresh Macaroni Salad, UPC 0 11596 34305 1, 3 lb., Product Code 4305. Garden-Fresh Macaroni Salad, UPC 0 11596 52005 6, 2/5 lb., Product Code 2005. Spoon River Signature Macaroni Salad, UPC 0 11596 55690 1, 2/5 lb., Product Code 5690. Code Date: 24105 = 9/24/2013 - 10/10/2013 5839 = 09/24/2013 - 10/10/2013 4073 = 09/23/2013 - 10/10/2013 4066 = 9/23/2013 - 10/9/2013 38856 = 9/23/2013 - 10/3/2013 24101 = 10/2/2013 - 10/13/2013 05904 = 10/2/2013 - 10/10/2013 2106 = 10/2/2013 - 10/10/2013 407364 = 10/1/2013 2060 = 9/30/2013 - 10/10/2013  ...
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Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Mustard Potato Salad , UPC 0 85329 24104 2, 16 oz, Product Code 24104. Garden-Fresh Mustard Potato Salad, UPC 0 11596 14010 0, 16 oz, Product Code 4010. Spartan Mustard Potato Salad, UPC 0 11213 90319 4, 16 oz, Product Code 4071. Garden-Fresh Mustard Potato Salad, UPC 0 11596 24215 6, 2 lb., Product Code 4215. Garden-Fresh Mustard Potato Salad , UPC 0 11596 34313 6, 3 lb., Product Code 4313. Garden-Fresh Mustard Potato Salad, UPC 0 11596 51013 2, 2/5 lb., Product Code 1013. Market Pantry Mustard Potato Salad, UPC 0 85239 24100 4, 3 lb., Product Code 24100. Dairy Fresh Mustard Potato Salad , UPC 0 70163 89090 9, 2/5 lb., Product Code Date Code 24104 = 9/25/2013 - 10/15/2013 4010 = 9/24/2013 - 10/10/2013 4071= 09/23/2013 - 10/08/2013 4215. = 10/4/2013 4313. = 9/28/2013 - 10/10/2013 1013.= 9/28/2013 - 10/10/2013 24100.= 9/30/2013 - 10/13/2013 401536= 10/1/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Reduced Fat Mustard Potato Salad, UPC 0 85329 20016 2, 16 oz, Product Code 200162 Code Date 10/4/2013 - 10/18/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry American Style Potato Salad, UPC 0 85239 24107 3, 16 oz, Product Code 24107. Garden-Fresh American Potato Salad, UPC 0 11596 14015 5, 16 oz, Product Code 4015. Spartan American Potato Salad, UPC 0 11213 90320 0, 16 oz, Product Code 4070. Market Pantry American Potato Salad, UPC 0 85239 24102 8, 3 lb. Product Code 24102. Garden-Fresh American Potato Salad, UPC 0 11596 24200 2, 2 lb., Product Code 4200. Garden-Fresh American Potato Salad, UPC 0 11596 34310 5, 3 lb, .Product Code 4310. Garden-Fresh American Potato Salad, UPC 0 11596 51010 1, 2/5 lb., Product Code 1010. Garden-Fresh Large Diced American Potato Salad, UPC 0 11596 91018 5, 2/5 lb., Product Code 1018 Code Date: 24107 = 9/28/2013 - 10/15/2013 4015 = 9/24/2013 - 10/10/2013 4070 = 09/24/2013 - 10/02/2013 24102 = 9/30/2013 - 10/15/2013 4200 = 10/3/2013 4310 =9/28/2013 - 10/10/2013 1010 =9/28/2013 - 10/10/2013 1018.=10/1/2013 - 10/4/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Reduced Fat American Potato Salad, UPC 0 85239 20115 2, 16 oz, Product Code 201152. Code Date10/4/2013 - 10/18/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Steakhouse Potato, UPC 0 85239 40219 1, 16 oz, Product Code 402191. Archer Farms Steakhouse Potato, UPC 0 85239 40218 4, 8 oz, Product Code 402184. Grandpa's Steakhouse Potato Salad, UPC 0 11596 14068 1, 16 oz, Product Code 4068, Code Date 402191= 9/28/2013 - 10/14/2013 402184 = 09/22/2013 - 10/14/2013 4068 = 9/24/2013 - 10/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Grandpa's Deviled Egg Potato Salad , UPC 0 11596 14012 4, 16 oz, Product Code 4012. Grandpa's Deviled Egg Potato Salad, UPC 0 11596 51065 1, 2/5 lb., Product Code 1065. Grandpa's Deviled Egg Potato Salad, 0 00 11596 51065 1, 4/5 lb., Product Code 1068. Code Date 4012 = 9/24/2013 - 10/3/2013. 1065.= 10/3/2013 - 10/10/2013 1068.= 10/3/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Grandpa's Potato Salad, UPC 0 11596 14027 8, 16 oz, Product Code 4027. Marsh Signature Potato Salad, UPC 0 11596 51085 9, 2/5 lb. , Product Code 1085. Family Style Potato Salad, UPC 0 11596 51061 3, 2/5 lb., Product Code 1061. Grandpa's Potato Salad, UPC 0 11596 24227 9, 2 lb., Product Code 4227. Grandpa's Potato Salad, UPC 0 11596 34326 6, 3 lb., Product Code 4326. Grandpa's Potato Salad, UPC 0 11596 91026 0. , 2/5 lb., Product Code 1026. Spoon River Potato Salad, UPC 0 11596 51032 3, 2/5 lb., Product Code 1032. Code Date 4027 = 9/24/2013 - 10/9/2013. 1085.=10/9/2013 1061.=10/3/2013 - 10/9/2013 4227.=10/3/2013 - 10/9/2013 4326.=9/30/2013 - 10/10/2013 1026=. 9/30/2013 - 10/10/2013 1032.= 10/3/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Grandpa's Red Skin Potato Salad, UPC 0 11596 14061 2, 16 oz, Product Code 4061. Weis Red Potato Salad, UPC 0 41497 05848 8, 16 oz, Product Code 05848. Portillo's Gourmet Red Skin Potato Salad, UPC 0 11596 14060 5, 16 oz, Product code4060. Weis Red Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1105. Grandpa's Red Skin Potato Salad, UPC 0 11596 51080 4, 2/5 lb., Product Code 1080 Code Date 4061 = 9/24/2013 - 10/9/2013; 05848 = 09/24/2013 - 10/08/2013; 05848 = 9/26/2013 - 10/10/2013. 1105.-=10/2/2013 - 10/9/2013 1080. =10/3/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Deluxe Potato Salad, UPC 7 33147 00007 6, 16 oz, Product Code 38768. Chef's Kitchen Deluxe Egg Salad, UPC 0 11596 52044 5, 1/5 lb., Product Code 2044. Finest Traditions Deluxe Potato Salad, UPC 7 33147 00030 4, 3 lb., Product Code 38768. Garden-Fresh Deluxe Egg Salad, UPC 0 11596 52043 8, 1/5 lb., Product Code 2043. Code Date 38768 = 9/23/2013 - 10/3/2013. 2044.= 9/29/2013 - 10/3/2013 38768. = 10/2/2013 2043.= 10/3/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Homestyle Potato Salad, UPC 7 33147 00019 9, 16 oz, Product Code 38860. Acme Homestyle Potato Salad, UPC 0 11596 91029 1, 2/5 lb. , Product Code 1029. Dairy Fresh Homemade Potato Salad, UPC XXXX, 2/5 lb., Product Code 410055. Finest Traditions Homestyle Potato Salad, UPC 7 33147 00031 1, 3 lb., Product Code 38980. Our Own Homestyle Potato Salad, UPC 0 11596 51042 2, 4/5 lb. , Product Code 1042 Code Date 38860 = 9/25/2013 - 10/10/2013. 1029.= 9/28/2013 - 10/9/2013 410055=. 10/9/2013 38980.= 10/2/2013 1042. = 9/28/2013-10/5/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Weis Potato with Egg Salad, UPC 0 41497 05841 9, 16 oz, Product Code 05841. Weis Potato Salad with Egg, UPC 0 41497 05902 7, 3 lb., Product Code 05902. Weis Potato Salad with Egg, UPC 0 11596 51101 6, 2/5 lb., Product Code 1101 Code Date 05841 = 09/24/2013 - 10/10/2013. 05902 = 10/2/2013 - 10/10/2013 1101 = 10/2/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Weis Amish Potato Salad, UPC 0 41497 05845 7, 16 oz, Product Code 05845. Weis Amish Potato Salad, UPC 0 41497 05901 0, 3 lb., Product Code 05901. Weis Amish Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1103. Garden-Fresh Amish Country Potato Salad, UPC 0 11596 51005 7, 2/5 lb., Product Code 1005. 9/28/2013 Code Date 05845 = 09/24/2013 - 10/10/2013. 05901.= 10/2/2013 - 10/10/2013 1103.= 10/2/2013 - 10/10/2013 1005.= 9/28/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Weis Original Potato Salad, UPC 0 41497 05838 9, 16 oz, Product Code 05383. Weis Original Potato Salad, UPC 0 41497 05900 3, 3 lb., Product Code 05900. 10/1/2013 - 10/10/2013 Weis Original Potato Salad, UPC 0 11596 51102 3, 2/5 lb., Product Code 1102. 10/1/2013 - 10/10/2013 Code Date 05383 = 09/24/2013 - 10/10/2013. 05900.= 10/1/2013 - 10/10/2013 1102.= 10/1/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Coleslaw, UPC 0 85239 24106 6, 15 oz, Product Code 24106. Spartan Cole Slaw, UPC 0 11213 90322 4, 16 oz, Product Code 4072. Market Pantry Coleslaw, UPC 0 85239 24114 1, 44 oz., Product Code 24114. Family Style Cole Slaw, UPC 0 11596 53060 4, 2/5 lb., Product Code 3060. Grandpa's Cole Slaw, UPC 0 11596 08006 2, 3.5 oz, Product Code 8006. Grandpa's Cole Slaw, UPC 0 11596 24237 8, 2 lb., Product Code 4325. Grandpa's Cole Slaw, UPC 0 11596 34325 9, 3 lb., Product Code 4237. Grandpa's Cole Slaw, UPC 0 11596 93021 3, 2/5 lb., Product Code 3021. Code Date 24106 = 10/1/2013 - 10/13/2013; 4072 = 9/23/2013 - 10/08/2013. 24114= 10/8/2013 - 10/14 2013 3060 =9/30/2013 8006 = 10/4/2013 4325 = 10/1/2013 - 10/9/2013 4237 = 10/1/2013 - 10/4/2013 3021 = 10/1/2013 - 10/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Reduced Fat Coleslaw, UPC 0 85239 20117 6 15 oz, Product Code 201176. Code Date 9/30/2013 - 10/18/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Homemade-Style Cole Slaw, UPC 7 33147 00025 0, 16 oz, Product Code 38858. Product Code 9/23/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Creamy Cole Slaw, UPC 0 11596 14022 3, 16 oz, Product Code 4022. Weis Creamy Coleslaw, UPC 0 41497 05906 5, 3 lb., Product Code 05906. Weis Creamy Coleslaw, UPC 0 11596 53101 4, 2/5 lb., Product Code 3101. Copperwood Kitchens Creamy Chopped Cole Slaw, UPC 8 11839 01020 3, 2/5 lb., Product Code 01020. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 24203 3, 2 lb., Product Code 4203. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 34309 9, 3 lb.,Product Code 4309. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 93014 5, 2/5 lb., Product Code 3014. Code Date 4022 = 9/25/2013 - 10/9/2013. 05906 = 10/1/2013 - 10/2/2013 3101.= 9/30/2013 - 10/10/2013 01020. = 10/1/2013 - 10/9/2013 4203. 9/28/2013 - 10/4/2013 43 09=. 9/28/2013 - 10/10/2013 3014.= 9/30/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Weis Old Fashion Cole Slaw, UPC 0 41497 05849 5, 16 oz, Product Code 05849. Weis Old Fashion Coleslaw, UPC 0 11596 53100 7, 2/5 lb., Product Code 3100. Code Date 05849 = 09/24/2013 - 10/10/2013. 3100.= 10/2/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Italian Style Pasta Salad, UPC 0 85239 20119 0, 14 oz, Product Code 201190. Code Date9/20/2013 - 10/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Baked Beans, UPC 0 85239 24110 3, 16 oz, Product Code 24110 Code Date 9/29/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Egg Salad, UPC 0 85239 24109 7, 12 oz., Product Code 24109, Weis Egg Salad, UPC 0 11596 55221 7, 1/5 lb., Product Code 5221. Garden-Fresh Egg Salad, UPC 0 11596 52022 3, 1/5 lb. , Product Code 2022. . Code Date 24109 = 9/26/2013. 5221.= 9/28/2013 - 10/5/2013 2022.= 9/29/2013 - 10/5/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Artichoke Spinach Dip, UC 0 85239 99015 5, 11 oz, Product Code 99015. Archer Farms Artichoke Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69053. Roundy's Artichoke Spinach Dip , UPC 0 11596 06170 2, 12 oz. Product Code 6170. Code Date for 99015 = 09/26/2013 - 10/20/2013; 69053 = 09/26/2013 - 11/2/2013; 6170 = 10/7/2013 - 11/3/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Smoked Salmon Dip , UPC 0 85239 99019 3, 11 oz, Product Code 99019 Code Date 10/11/2013 - 11/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Bacon Parmesan Dip, UPC 0 85239 99017 9, 11 oz, Product Code 99017. Code Date 10/12/2013 - 11/8/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Spinach Dip, UPC 0 85239 69052 9, 11 oz, Product Code 99010. Archer Farms Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69052. Finest Traditions Spinach Dip, UPC 7 33147 10538 2, 8 oz. Product Code 38992. Our Own Spinach Dip, UPC 0 11596 55149 4, 1/5 lb., Product Code 5149 Code Date 99010 / 69052 = 10/5/2013 - 10/26/2013.; 38992 =9/23/2013 - 10/10/2013 5149. =1 0/11/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Feta & Roasted Red Pepper Dip, UPC 0 85239 69048 2, 11 oz, Product Code 69048 Code Date10/5/2013 - 11/2/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Vanilla Crème Dip, UPC 0 85239 99014 8, 12 oz, Product Code 99014. Code Date 10/4/2013 - 11/2/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Roundy's Taco Dip, UPC 0 11150 52604 3, 12 oz , Product Code 52604. Maggie's Taco Dip, UPC 0 11596 06201 3, 12 oz , Product Code 6201. Finest Traditions Taco Dip, UPC 7 33147 10556 6. 8 oz, Product Code 38984. Code Date for 52604 = 10/8/2013 - 11/4/2013; 6201= 10/8/2013 - 11/4/2013; 38984 =9/23/2013 - 10/10/2013. Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Roundy's Dill Dip, UPC 0 11150 52603 6, 12 oz, Product Code 52603. Finest Traditions Dill Dip, UPC 7 33147 10554 2, 8 oz, Product Code 38988 Code Date for 52603 = 10/11/2013 - 11/3/2013; 38988 = 9/23/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Maggie's White Fruit Dip, UPC 0 11596 06200 6, 12 oz, Product Code 6200. Code Date 9/25/2013 - 10/3/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Fresh Salsa Serrano Spicy, UPC 0 11596 06143 6, 15 oz, Product Code 6143 Code Date 9/28/2013 Class II Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Southwest Dip, UPC 7 33147 10540 5, 8 oz , Product Code 38996 Code Date 9/23/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Smoky Baked Beans,UPC 7 33147 00161 5, 16 oz, Product Code 38854 Code Date 9/23/2013 - 9/30/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Chef's Kitchen Cucumber Dill Dip, UPC 0 11596 06180 1, 12 oz, Product Code 6180 Code Date 10/18/2013 - 11/3/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Dairy Fresh Deluxe BLT Pasta Salad, UPC 0 70163 50074 7, 1/5 lb, Product Code .410074. Garden-Fresh Deluxe BLT Pasta Salad, UPC 0 11596 52039 1, 1/5 lb., Product Code 2039. Code Date 410074.= 10/1/2013 2039. = 9/30/2013 - 10/4/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Dairy Fresh Homemade Dixie Cole Slaw, UPC 0 70163 55890 8, 2/5 lb., Product Code 405890. 9/30/2013 - 10/6/2013 Code Date . 405890. = 9/30/2013 - 10/6/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Dairy Fresh Homemade Mustard Potato Salad, UPC 0 70163 56700 9, 2/5 lb., Product Code 410059. Our Own Homestyle Mustard Potato Salad, UPC 0 11596 51047 7, 4/5 lb., Product Code 1047. Date Code 410059. = 9/29/2013. 1047 = 10/3/2013 - 10/4/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Dairy Fresh Sour Cream Mac & Cheddar, UPC 0 70163 50043 3, 2/5 lb., Product Code 410043. Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb. , Product Code 2031. Code Date 410043.-= 10/1/2013 - 10/10/2013 2031.= 10/1/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Broccoli Bacon Toss Kit, UPC 0 85239 24105 9, 2/2.35 lb., Product Code 040409 Code Date: 040409 = 10/6/2013 - 10/14/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Amish Country Cole Slaw, UPC 0 11596 53010 9, 2/5 lb., Product Code 3010. Code Date: 3010.= 9/30/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Rogge's White Potato Salad, UPC 0 11596 51052 1, 2/5 lb. , Product Code 1052. Date Code: 1052.= 9/29/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Old Tyme Sweet Bow Tie Pasta with Bacon, UPC 0 94776 03409 3, 1/5 lb., Product Code 03409. Garden-Fresh Sweet Bow Tie Pasta with Bacon, UPC 0 11 11596 52047 2, 1/5 lb., Product Code 2047. 9/30/2013 - 10/9/2013 Code Date: 03409.= 9/30/2013 - 10/9/2013 2047. = 9/30/2013 - 10/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Tuna Salad, UPC 0 85239 24108 0, 12 oz., Product Code 24108. Weis Tuna Salad, UPC 0 41497 05345 2, 6 x 8 oz, Product Code 05345 Code Date for 24108 = 9/24/2013 - 10/10/2013; 05345 = 09/24/2013 - 10/14/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Finest Traditions Tuna Salad Spread, UPC 7 33147 10487 3 6 x 12 oz. Product code 38622. Code Date:10/01/2013 - 10/02/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Market Pantry Reduced Fat Macaroni Salad, UPC 0 85239 20118 3, 16 oz, product code 201183. Code date: 10/6/2013 - 10/15/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Archer Farms Garlic Herb Cheese Dip, no UPC, 7 oz, Product code 6186 Code date: 11/7/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Weis Amish Macaroni Salad, UPC 0 41497 05844 0, 16 oz, Product Code 05844. Weis Amish Macaroni Salad, UPC 0 41497 05905 8, 3 lb. Product Code 05905. Weis Amish Macaroni Salad, UPC 0 11596 52105 3, 2/5 lb., Product Code 2105. Garden-Fresh Amish Country Macaroni Salad, UPC 0 11596 52010 0, 2/5 lb., Product Code 2010 Product Code = Code Date 05844 = 09/24/2013 - 10/10/2013 05905 = 10/2/2013 - 10/10/2013 2105 = 9/30/2013 - 10/3/2013. 2010.= 10/2/2013-10/09/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Grandpa's German Potato Salad, 16 oz, UPC 0 11596 14016 2, product code 4016. Code Date 9/23/2013 -10/18/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Country Style Potato Salad, UPC 0 11596 51075 0, 2/5 lb., Product Code 1075. 10/10/2013 Code Date 1075.= 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Our Own Premium Potato Salad, UPC 0 11596 91045 1, 4/5 lb. , Product Code 1045. 9/28/2013-10/5/2013 Code Date 1045. = 9/28/2013-10/5/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Asiago Pasta, UPC 0 11596 52069 8, 1/5 lb., Product Code 2069. 10/1/2013 - 10/9/2013 Code Date 2069.= 10/1/2013 - 10/9/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Broccoli Cheese Salad Base, UPC 0 11596 55136 4, 1/5.25 lb., Product Code 5136. 9/30/2013 - 10/4/2013 Code Date 5136. = 9/30/2013 - 10/4/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Foods Broccoli Cheese Salad Kit, UPC 0 11596 93038 1, 1/11.25 lb., Product Code 3038. 9/30/2013 Code Date 3038. = 9/30/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Chopped Broccoli Cauliflower Salad Base, UPC 0 11596 55188 3, 1/5.25 lb., Product Code 5188. 10/1/2013 - 10/14/2013 Code Date 5188.= 10/1/2013 - 10/14/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Foods Chopped Broccoli Cauliflower Salad Kit , UPC 0 11596 93046 6, 1/11.25 lb., Product Code 3046. 10/2/2013 Code Date 3046.= 10/2/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Creamy Cole Slaw Dressing, UPC 0 11596 43200 7, 4/2 lb., Product Code 3200. 10/26/2013 - 11/2/2013 Code Date 3200. = 10/26/2013 - 11/2/2013 Class II Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Dixie Style Cole Slaw, UPC 0 11596 93007 7, 2/5 lb., Product Code 3007. 9/30/2013 - 10/10/2013 Code Date 3007=. 9/30/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Gourmet Dill Potato Salad, UPC 0 11596 55137 1, 2/5 lb., Product Code 5137. 10/4/2013 Code Date 5137=. 10/4/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Greek Style Pasta Salad, UPC 0 11596 52035 3, 1/5 lb., Product Code 2035. 9/30/2013 - 10/8/2013 Code Date 2035.= 9/30/2013 - 10/8/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Seven Layer Salad Kit, UPC 0 11596 85161 7, 2/3.25 lb., Product Code 5161. 10/11/2013 Code Date 5161. = 10/11/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb, Product Code 2031. 10/1/2013 - 10/10/2013 Code Date 2031.= 10/1/2013 - 10/10/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Garden-Fresh Taco Pasta Salad, UPC 0 11596 52076 6, 1/5 lb., Product Code 2076. 10/1/2013 Code Date 2076.= 10/1/2013 Class I Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Devices Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate. K113004 D183642 All product codes beginning with SXPP1A. Class II Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions. Ethicon, Inc.
Biologics Red Blood Cells 2055363 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. OneBlood / dba CBCF
Biologics Red Blood Cells 2199067 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 2199067 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets 2199067 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2482690 (2 units), 2124835 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 2240024 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2240024, 2279914 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2279914 Class II Blood products collected from a donor for whom donor suitibility was not adequately determined were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2758681 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2758681 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 1567739 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 1567739 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Food Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying quantities in poly bags within corrugated containers. Lot Numbers: 53379030, 53379031, 53379032, 53379034, 53379035, 53379036, 53379037, 53379038, 53379039, 53379040, 53379041, 53380079, 53380081, 53380083, 53380085, 53380086, 53380087, 53380088, 53380089, 53380090, 53380091, 53380092, 53380093, 53380094, 53380095, 53380096, 53380097, 53380098, 53380099, 53380100, 53380101, 53380102, 53380103, 53380104, 53380105, 53380106, 53380107, 53380108, 53380109, 53380110, 53380111, 53380113, 53380114, 91980002, 91980003, and 91980004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement packaged in the following configuration: (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO (2) Positive Changes Hypnosis Centers Enzymes Digestion Dietary Supplement packaged in 60-(SKU 53793) and 180-(SKU 53794) capsule bottles. The firm name on the bottle is Positive Changes Hypnosis Center Dublin, OH 43017 Lot Numbers: 51832027, 53793001, 53793002, 53794001, and 54426000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO Lot#: 51855019 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO Lot#: 52083008 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food 3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814 Lot#: 81814110 and 81814111 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX; (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles; (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label; (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL; (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL. (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot Numbers: 52413126, 52413128, 52413129, 52413130, 52413131, 52413132, 52413133, 52413134, 52413138, 52520124, 52520126, 52520127, 52520128, 52520129, 52520130, 52520131, 52520135, 53098131, 53098133, 53098134, 53098135, 53098136, 53098137, 53098138, 53098139, 53098141, 53098145, 53571110, 53571111, 53571112, 53571116, 54599000, 54646000, 54646001, 54646005, 54752000, 54914002, 92494001, and 92494002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles. Lot Numbers: 52270018, 52270019, and 54929000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food WELLZYMES, Digestive Health, Enzyme Supplement packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO Lot Numbers: 52235014, 52235015, and 52235016 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food WELLZYMES, Gastric Ease, Enzyme Supplement packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO Lot Numbers: 52238012 and 52238013 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food 4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export. Lot #'s: 91397048, 91397050, 91397053, 91397054, 91397055, 91397056, and 91397057 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ. Lot #'s: 53623003 and 53623004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR; (2) 5327 Houston NO-FENOL blk 1v, Bulk Capsules (SKU 91456) Lot #'s: 52437042, 52437043, 52437044, 52437045, 52437046, 52437047, 52437048, 52437049, 52437050, 52437051, 52437052, 52437053, 52437054, and 91456000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028); (3) NWC Naturals Ultra Enzyme Support packaged in 200-(SKU 52466) and 90-(SKU 52467) count capsule bottles. Manufactured exclusively for Natural Wellness Centers of America, Laguna Hills, CA. Lot #'s: 50027001, 50028001, 52466045, 52466046, 52466047, 52466048, 52466049, 52466050, 52466052, 52467041, 52467042, 52467043, 52467044, and 52467046 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement packaged in the following configurations: (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR; (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR; Lot #'s: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 52588051, 53853006, 53853007, 53853008, 53853009, 53853010, and 54956000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.; Lot #: 53343006 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO. Lot #: 52643002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.; (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799); Lot #'s 52644004 and 54799000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement packaged in the following configurations: (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.; (2) 6379 Kirk Phenol Assist UNL, packaged in 90-capsule unlabeled bottles (SKU 53855) Lot #'s: 52640015, 53855003, and 53855004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN; (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328) Lot #'s: 52896006 and 54328000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274); (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426); Lot #'s: 83274014, 83274015, 83274016, 83274017, 83274018, 83274019, 83274020, 83274021, 83274022, 83274023, 83274025, 83274026, 83274027, 83274028, 83274035, 82426059, and 82426060 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC; (2) 6926 Crusador TempleBuilders, packaged in unlabeled 90 capsule bottles (SKU 54335); Lot #'s: 52785003 and 54335000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939); (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852); Lot #'s: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, and 53852016 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566) Lot #: 82566000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food 8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854) Lot #'s: 53854008, 53854010, 53854012, 53854013, and 53854014 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461) Lot #'s: 90461064, 90461065, 90461066, 90461067, and 90461068 Class I Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA; (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756); Lot #'s: 54654001 and 54756000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN; Lot #: 53373006 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993); Lot #'s: 82993011, 82993012, and 82993013 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food 9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666); Lot #'s: 53666006, 53666007, 53666008, and 53666009 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033); Lot #: 92033003 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056); Lot #: 83056004; Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093); Lot #'s: 92093010, 92093011, 92093012, 92093013, 92093014, 92093015, and 92093016 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL Lot #'s: 53557003 and 53557004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103). Lot #'s: 92103002, 92103004, 92103005, 92103006, 92103007, and 92103008 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103). Lot #'s: 92099007 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085). Lot #'s: 92085023, 92085025, 92085026, and 92085027 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101). Lot #'s: 92101011, 92101013, and 92101014 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115). Lot #'s: 92115011, 92115012, 92115013, 92115014, 92115015, and 92115016 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131). Lot #'s: 92131009 and 92131010 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, CA; Lot #'s: 53770004 and 53770005 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #'s: 83202029, 83202031, 83202032, 83202033, 83202034, 83202035, 83202036, 83202038, 83202039, 83202040, and 83202041 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #'s: 83196007, 83196008, 83196009, and 83196011 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement Formula ID A200; Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #: 92132004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #: 92123004 and 92123005 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #: 83217005 and 83217006 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) Lot #'s: 83226010, 83226011, 83226012, 83226013, 83226014, and 83226015 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO; Lot #'s: 53830001 and 53830002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287); Lot #'s: 83287006, 83287007, 83287008, 83287009, 83287010, 83287011, and 83287012; Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318); Lot #'s: 83318002, 83318003, and 83318004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314); Lot #'s: 83314009, 83314010, 83314011, 83314012, 83314013, 83314014, 83314015, 83314016, 83314017, 83314018, 83314019, 83314020, 83314021, 83314022, 83314023, and 83314024 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA; (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC; (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO; (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO; (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO; (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS; (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA; (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA; Lot #'s: 54770000, 54626000, 54626001, 54626002, 54555002, 54784000, 54169005, 54169006, 54608001, 54512002, 54512003, 54512004, 54512005, 54512006, 54512007, and 54872000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO; Lot #: 53985002, 54389001, and 54632000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342). Lot #: 83342001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA. Lot #'s: 92275001, 92275003, and 54955000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR; Lot #'s: 54045003, 54045005, 54045006, 54045007, and 54045008 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377); Lot #: 83377001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112); Lot #: 54112001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381); Lot #: 83381000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255); Lot #: 54255000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408); Lot #: 83408000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT; Lot #'s: 54179002, 54179003, and 54179004 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT; Lot #: 54217002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438); Lot #'s: 92438001, 92438002, 92438004, and 92438005 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403); Lot #: 83403000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA; Lot #: 54451002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bellevue, WA; (2) Bulk C269 Shanghai Digestive Blen capsules, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92473); Lot #: 54440000 and 92473000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419); Lot #: 83419000 and 83419001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company; Lot #: 54513000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544); Lot #: 92544001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) C560 NEC Carb Converter Blen packaged in unlabeled, 25 gram bottles. Lot #: 54663000 and 54665000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN; Lot #: 54553000 and 54553001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN; Lot #: 54554000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR; (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451); (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566); Lot #'s: 54651001, 83451000, and 92566001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000) Lot #: 72456000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83430) Lot #: 83430001 and 83430002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438) Lot #: 83438000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label; Lot #'s: 54825002 and 54826002 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA; Lot #'s: 54897000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453) Lot #'s: 83453000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466). Lot #'s: 83466000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Food Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453); (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073); (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077); (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080); (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72106); Lot #'s: 71453155, 72073003, 72073004, 71453148, 71453138, 71453142, 71453143, 71453144, 71453137, 71453139, 71453145, 71453146, 71453147, 71453149, 71453152, 71453153, 71453156, 72106012, 72106013, 72106014, 72106015, 72106018, 72106019, 72106020, 72106021, 72106022, 72106024, 72106025, 71453141, 71453154, 72077001, 72080006, 72080007, 72080008, and 72080009 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol National Enzyme Co
Veterinary Hubbard Grolean 16% B91Aureo 140+Vit A, medicated, contains Lasalocid, 91g/ton and Chlortetracycline 140 g/ton, vitamin A, vitamin D, and vitamin E, packaged in 50 lb/bags. Hubbard Feeds Inc., Mankato, MN. Lot B00603274 Class II The product is being recalled because a routine sample analyzed by the Nebraska Department of Agriculture was found to contain Oxytetracycline. Ridley Block Operations, Inc.
Devices Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. Serial Numbers: TS10140 TS10052 TS10107 TS10161 TS10086 TS10136 TS10083 TS10045 TS10032 TS10075 TS10100 TS10070 TS10129 TS10049 TS10040 TS10055 TS10160 TS10046 TS10117 TS10137 TS10141 TS10080 TS10097 TS10037 TS10131 TS10138 TS10119 TS10088 TS10074 TS10114 TS10145 TS10066 TS10106 TS10155 TS10056 TS10094 TS10139 TS10022 TS10128 TS10112 TS10068 TS10124 TS10078 TS10134 TS10079 TS10002 TS10109 TS10156 TS10135 TS10110 TS10008 TS10115 TS10093 TS10146 TS10050 TS10017 TS10054 TS10029 TS10104 TS10048 TS10090 TS10062 TS10024 TS10158 TS10071 TS10035 TS10059 TS10153 TS10025 TS10087 TS10130 TS10133 TS10101 TS10103 TS10125 TS10018 TS10089 TS10023 TS10147 TS10033 TS10015 TS10014 TS10039 TS10085 Class II Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin. Cutera, Inc.
Devices NexGen® Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities. 00-5980-037-02; lot 6228417 Class II Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010. Zimmer, Inc.
Devices Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only. Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 00450001200 62290833 00450001200 62290835 00450001200 62372414 00450001200 62375863 00450001200 62397414 00450001200 62405304 00450001200 62416035 00450001200 62419530 00450001200 62430804 00450001300 62160227 00450001300 62163379 00450001300 62215393 00450001300 62264834 00450001300 62267628 00450001300 62267629 00450001300 62279045 00450001300 62279051 00450001300 62285548 00450001300 62290836 00450001300 62299551 00450001300 62331811 00450001300 62337756 00450001300 62349856 00450001300 62349857 00450001300 62368383 00450001300 62375865 00450001300 62375868 00450001300 62378060 00450001300 62397415 00450001300 62397416 00450001300 62409032 00450001300 62409033 00450001300 62416036 00450001300 62419532 00450001300 62430805 00450001400 11007904 00450001400 11008529 00450001400 62163382 00450001400 62208153 00450001400 62239776 00450001400 62239786 00450001400 62264835 00450001400 62279052 00450001400 62290829 00450001400 62299552 00450001400 62305739 00450001400 62310750 00450001400 62316168 00450001400 62316169 00450001400 62343549 00450001400 62343550 00450001400 62343551 00450001400 62349858 00450001400 62368384 00450001400 62372415 00450001400 62378062 00450001400 62393803 00450001400 62393804 00450001400 62397417 00450001400 62405306 00450001400 62409034 00450001400 62416038 00450001400 62416039 00450001400 62416040 00450001400 62419533 00450001400 62459855 00450001500 62072172 00450001500 62208154 00450001500 62215392 00450001500 62220672 00450001500 62220674 00450001500 62226570 00450001500 62279046 00450001500 62279053 00450001500 62285550 00450001500 62290842 00450001500 62331809 00450001500 62349859 00450001500 62349861 00450001500 62357498 00450001500 62358906 00450001500 62378063 00450001500 62393805 00450001500 62397418 00450001500 62405308 00450001500 62416042 00450001500 62439673 00450001600 11007906 Part Number Lot Number 00830001100 62264850 00830001100 62316172 00830001100 62323776 00830001100 62337212 00830001100 62357509 00830001200 62204729 00830001200 62215395 00830001200 62316173 00830001200 62323778 00830001200 62331816 00830001200 62343559 00830001300 11008422 00830001300 62204730 00830001300 62220676 00830001300 62267038 00830001300 62267040 00830001300 62323781 00830001300 62331817 00830001300 62337216 00830001300 62349869 00830001300 62409040 00830001400 62208150 00830001400 62264851 00830001400 62310756 00830001400 62316177 00830001400 62323783 00830001400 62343560 00830001400 62343561 00830001400 62368388 00830001500 62204731 00830001500 62215396 00830001500 62305743 00830001500 62323784 00830001500 62343563 00830001500 62357510 00830001500 62428994 00830001600 62264852 00830001600 62299553 00830001600 62316174 00830001600 62323786 00830001600 62337210 00830001600 62343565 00830001600 62357511 Class II As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder. Zimmer, Inc.
Devices Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only. Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 00450002300 62337759 00450002300 62349864 00450002300 62357505 00450002300 62357506 00450002300 62372417 00450002300 62375873 00450002300 62378065 00450002300 62409035 00450002300 62409036 00450002300 62416044 00450002300 62419537 00450002300 62453778 00450002400 62163383 00450002400 62208155 00450002400 62239778 00450002400 62267035 00450002400 62267036 00450002400 62267637 00450002400 62267638 00450002400 62297851 00450002400 62305741 00450002400 62305742 00450002400 62310754 00450002400 62316171 00450002400 62343554 00450002400 62343555 00450002400 62349866 00450002400 62368385 00450002400 62372419 00450002400 62375874 00450002400 62378066 00450002400 62393806 00450002400 62397421 00450002400 62405314 00450002400 62405315 00450002400 62409037 00450002400 62409038 00450002400 62416045 00450002400 62416047 00450002400 62419538 00450002400 62453782 00450002400 62459863 00450002400 62459864 00450002400 62459866 00450002500 11008421 00450002500 11008423 00450002500 62163384 00450002500 62208156 00450002600 62297850 00450002600 62310755 00450002600 62331806 00450002600 62331812 00450002600 62337209 00450002600 62349867 00450002600 62357508 00450002600 62358902 00450002600 62368387 00450002600 62405319 00450002600 62419540 00830002100 62264853 00830002100 62316175 00830002100 62323787 00830002100 62337211 00830002100 62349871 00830002100 62459838 00830002200 11009324 00830002200 62204732 00830002200 62215397 00830002200 62323788 00830002200 62331820 00830002200 62343566 00830002200 62430807 00830002300 62204765 00830002300 62220678 00830002300 62297852 00830002300 62323789 00830002300 62323794 00830002300 62331822 00830002300 62349872 00830002300 62357512 00830002300 62419528 00830002400 62208151 00830002400 62264855 00830002400 62316178 00830002400 62323790 00830002400 62343567 00830002400 62349873 00830002400 62405298 00830002500 62204734 00830002500 62215398 00830002500 62316176 00830002500 62323792 00830002500 62331823 00830002500 62337217 00830002500 62357513 00830002600 62239781 00830002600 62305744 00830002600 62316179 00830002600 62323796 00830002600 62337220 00830002600 62349874 00830002600 62393802 00830002600 62428995 Class II As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder. Zimmer, Inc.
Devices Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only. Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 00450004400 62208160 00450004400 62215403 00450004400 62220686 00450004400 62232378 00450004400 62267647 00450004400 62297853 00450004400 62299546 00450004400 62299547 00450004400 62299548 00450004400 62343569 00450004400 62349879 00450004400 62372420 00450004400 62393809 00450004400 62397423 00450004400 62405323 00450004400 62409043 00450004500 62143215 00450004500 62215404 00450004500 62220688 00450004500 62232379 00450004500 62248810 00450004500 62254967 00450004500 62279058 00450004500 62299549 00450004500 62368390 00450004500 62378071 00450004600 62143216 00450004600 62239795 00450004600 62239796 00450004600 62248811 00450004600 62254968 00450004600 62285640 00450004600 62290855 00450004600 62405325 00830004100 62208152 00830004100 62316180 00830004100 62363978 00830004200 62204737 00830004200 62226574 00830004200 62239798 00830004200 62316181 00830004200 62337230 00830004200 62375878 00830004300 62204736 00830004300 62226575 00830004300 62232380 00830004300 62297854 00830004300 62323804 00830004300 62343570 00830004300 62372421 00830004300 62439685 00830004400 62204738 00830004400 62226576 00830004400 62232381 00830004400 62267658 00830004400 62323802 00830004400 62337231 00830004400 62375879 00830004500 62204739 00830004500 62232382 00830004500 62310759 00830004500 62331825 00830004500 62363980 00830004600 62239782 00830004600 62331826 00830004600 62357516 Class II As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media is comprised of aluminum oxide and a polyester resin binder. Zimmer, Inc.
Biologics Red Blood Cells Leukocytes Reduced W20841304118800; Class II Misbranded red blood cell was distributed. American National Red Cross (The)
Devices 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures. 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405 Class II Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. Stryker Howmedica Osteonics Corp.
Devices Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. Unknown Class II Possible fatigue failure of the plastic joint may occur after an average use of seven years. Trumpf Medical Systems, Inc.
Drugs Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 Lot #: a) CU6131, b) CW1161 Class III Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions. Sandoz Inc
Biologics Blood Grouping Reagent, Anti-s LS164A Class II IVD with weakened reactivity was distributed. Ortho Clinical Diagnostics Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W200613057845, W200613038754, W200613068033, W200613055708, W200613057827, W200613057827, W200613038772, W200613078697, W200613060649, W200613060649, W200613056897, W200613068040, W200613068040, W200613046263, W200613065134, W200613060690, W200613068031, W200613060680, W200613060680, W200613077476, W200613060658, W200613060648, W200613060681, W200613060681, W200613080591, W200613062914, W200613080603, W200613080614, W200613080633, W200613080635 Class III Red Blood Cells, with discrepant labeled volumes, were distributed. American National Red Cross The
Devices iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological SW Version 3.0. Catalong Number CS10-100 Class II The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs. Iba Dosimetry Gmbh
Devices NexGen® Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts. Part Number 00-5879-067-26 Class II This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. Zimmer, Inc.
Devices NexGen® Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts. Part Number 00-5879-067-29 Class II This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. Zimmer, Inc.
Devices NexGen® Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts. Part Number 00-5971-020-09 Class II This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. Zimmer, Inc.
Devices NexGen® Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts. Part Number 00-5971-031-09 Class II This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. Zimmer, Inc.
Devices NexGen® Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts. Part Number 00-5971-041-09 Class II This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue. Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components. Given this, all lots of these additional instruments are now being recalled as well. There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall. Zimmer, Inc.
Food HyVee Chocolate Caramel Clusters, packaged in 9-oz. clear plastic clamshell containers (UPC 077232125153), 16 containers/case (UPC 10077232125150). The firm name on the label is HyVee, West Des Moines, IA. Sell by 04/07/14 F30202 Class I Chocolate caramel clusters containing peanuts were mislabeled as chocolate covered caramels, which do not contain peanuts. Palmer Candy Co
Food HyVee Chocolate Covered Caramels, packaged in 12-oz. clear plastic clamshell containers (UPC 077232125207), 16 containers/case (UPC 10077232125204). The firm name on the label is HyVee, West Des Moines, IA. Sell by 10/07/14 F30202 Class I Chocolate caramel clusters containing peanuts were mislabeled as chocolate covered caramels, which do not contain peanuts. Palmer Candy Co
Biologics Pooled cryoprecipitated AHF W050912103012, W050912103013, W050912078263, W050912078284, W050912040349, W050912040351, W050912078217, W050912078218, W050912078251, W050912078255, W050912078262, W050913004147, W050913004185, W050913019516, W050913029016, W050912040352, W050912078212, W050912078214, W050912078219, W050912013984, W050912013986, W050912013987, W050912013989, W050912078256, W050912078257, W050912078260, W050912078261, W050912040374, W050912040380, W050912040398, W050913004149, W050913004150, W050913004154, W050912103019, W050913004128, W050913019528, W050913019529, W050913041907, W050913041928, W050913041935, W050913041949, W050913041931, W050913041970, W050913047912, W050913047916, W050913055388, W050913055389, W050913055392, W050913047964, W050913047967,  ...
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Class III Unlicensed blood products were distributed in interstate commerce. HCSC-Blood Center
Devices Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue. Lot Code YX Class II KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps. Karl Storz Endoscopy America Inc
Devices Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter® LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids n/a Class II Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes. Beckman Coulter Inc.
Devices Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter® LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. n/a Class II Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes. Beckman Coulter Inc.
Biologics Micro SSP" DNA Typing Trays, Micro SSP High Resolution HLA Class II Tray, Catalog Identification: SSP2H. 510(K) Number: BK960062 Micro SSP High Resolution HLA Class II Tray; Catalog Identification: SSP2H Article Number: SSP_DNAT_PI Rev 18 Lot number: 005, batches 003-034 Class III HLA typing assay, in certain instances associated with incorrect typing results, was distributed. One Lambda Inc
Devices Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure EB84, Lot 2013041801 Expriation 2018/03 Class II Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies. Centurion Medical Products Corporation
Food Dawn's Vidalia Onion Dip, Net Wt. 5 lbs. (2.27 kg) Use By: 11/27/13 - 1/15/14 Class I Dawn's Foods is recalling Vandellia Onion Dip due to undeclared egg. Dawn's Foods, Inc.
Devices VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. Lot No. WC0181H, WC0181J, WC0181K Class II Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample. Accumetrics Inc
Biologics Mixed Vespid Venom Protein A1300105; A1300104; Class III Misbranded venomil maintenance kits were distributed. Jubilant HollisterStier, LLC
Devices AMSCO® Evolution® steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units. Serial Number Range: 030061103 - 0535531220 Class II The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. Steris Corporation
Food Chocolate La Boulange Soft Caramel, Net WT. 8.4 oz. (238 g); Cooked in small batches in copper pots; all natural La Boulange South San Francisco, CA Lot code 822713 Class I Firm discovered that 8.4 oz. jars of Hazelnut Jam were produced on 8/15/13 and were mislabeled as La Boulange Soft Caramel. the Hazelnut jam contains hazelnuts which were undeclared on the label. The New French Bakery
Devices Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation. 510K # K894124 1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1 Class II Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm. Stryker Howmedica Osteonics Corp.
Food Trader Joe's Authentically Korean Seaweed Salad with Spicy Dressing, Net Wt. 3.5oz (99g), SKU 97677. Lot Code: 04.24.2014 07.20.2014 10.02.2014 02.14.2015 03.13.2015 04.24.2015 05.12.2015 05.06.2015 06.25.2015 07.07.2015 07.31.2015 08.19.2015 Class I Jayone Foods is recalling Trader Joe's Dried Seaweed Salad with Spicy Dressing because it may contain traces of undeclared peanuts. Jayone Foods, Inc.
Drugs Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50 Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15 Class II Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint. VistaPharm, Inc.
Devices Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall. Catalog number VH-3000 (US) Lot numbers 25081686, 25081595, 25081460, 25081204, 25080939, 25080744, 25080418, 25080351, 25080264, 25079982, 25079913, 25073724, 25079449, 25079363, 25079086, 25078931, 25078713, 25078463, 25078291, 25078104, 25077927,25077643, 25077563, 25077123, 25076989, 25076372, 25076371, 25076133, Catalog number VH-3000W (Foreign) Lot numbers 25080938, 25080661, 25080311, 25078777, 25078289, 25078103 and 25077051 Class II Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1" Maquet Cardiovascular, LLC
Devices HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS) Mfg Lot or Serial # SG212501463WA SG213142063WA SG212491284WA SG212491286WA SG212491320WA SG212491328WA SG213091890WA SG213142034WA SG213142065WA SG213172123WA SG213172126WA SG213172141WA SF311283756WA SF312205556WA SG212190622WA SG212190623WA SG212190624WA SG212190625WA SG212190626WA SG212190627WA SG212190628WA SG212190629WA SG212190630WA SG212190631WA SG212160603WA SG212160606WA SG212230660WA SG212260716WA SG212260735WA SG212260737WA SG212260739WA SG212270742WA SG212270747WA SG212491329WA SG212491346WA SG212421031WA SG212431128WA SG212421034WA SG213021574WA SG213031688WA SG212521557WA SG212521545WA SF312396183WA SF312396187WA SF312396189WA  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The additional 0.5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values. The ST-elevation measurement can be under estimated in this situation and therefore the treatment of the patient can be delayed. GE Healthcare, LLC
Biologics SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x SoftBank II version 23.1; 23.2; 25.0; 25.1; 25.2 and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Class II Blood Bank software with a defect or glitch, was distributed. SCC Soft Computer
Devices Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624 Class III Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. Ultradent Products, Inc.
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