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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets 1699871 Class II Platelet, with an unacceptable pH, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma 04FMOA1901; 04FMOA1730; 04FMOA1310; 04FMOA1176; 04FMOB1359; 04FMOB1509; 04FMOB1815 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. BioLife Plasma Services LP
Biologics Cryoprecipitated AHF 2109548 Class III Blood product was not frozen in required time, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2238974(Part A); 2238974(Part B); 2238974(Part C) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells V71278 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Delta Blood Bank
Biologics Red Blood Cells K14065 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Delta Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2418777 Class III Blood products, possibly contaminated with bacteria, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Leukocytes Reduced 2409017 Class II Blood products, which was identified as being contaminated by the BacT/ALERT system, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2401160 Class II Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Leukocytes Reduced 2401160 Class II Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2409193(Part A); 2409193(Part B) Class II Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2923709 Class II Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2582623 Class II Blood products, which gave a positive result by the BacT system, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2582623 Class II Blood products, which gave a positive result by the BacT system, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2554254(Part A); 2554254(Part B) Class II Blood products, with positive bacterial detection testing, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2626418 Class II Blood product, with positive bacterial detection testing, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2224422; 2224424; 2224425; 2224427; 2225134; 2225137; 2225139; 2225174; 2227106; 2227116; 2227127; 2227152; 2228116; 2228150; 2228152; 2228239; 2228255; 2228256; 2228285; 2228342; 2228349; 2228352; 2228364; 2228366; 2228367; 2228377; 2228381; 2228384; 2228387; 2229530; 2229532; 2229535; 2229552; 2229554; 2229559; 2229564; 2229568; 2229582; 2230415; 2230423; 2230437; 2230439; 2230476; 2230477; 2230479; 2230480; 2230485; 2230487; 2230490; 2230578;  ...
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Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Fresh Frozen Plasma 2224422; 2227113; 2227117; 2227152; 2228255; 2228256; 2228340; 2228345; 2228349; 2229530; 2229532; 2229533; 2229554; 2229579; 2229582; 2230411; 2230433; 2230656; 2230777; 2230779; 2230943; 2231222; 2231297; 2231314; 2231318; 2231320; 2231331; 2231334; 2232781; 2232789; 2232791; 2232793; 2232835; 2232837; 2232842; 2232843; 2232846; 2232853; 2232861; 2232868; 2232876; 2232893; 2232900; 2232909; 8814339; 8814344; W038608280210; W038608280338; W038608280340; W038608280342;  ...
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Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2224421; 2227153; 2228344; 2228348; 2229556; 2230421; 2230651; 2231443; 2232849; 2232854; 2232887; 2232910; W038608280358; W038608280420; W038608280456; W038608280581; W038608280672; W038608281606; W038608281612; W038608281891; W038608281922; W038608282360; W038608282666; W038608880242; W038608881051. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced 2224423; 2225130; 2225141; 2227075; 2227109; 2227113; 2227117; 2227120; 2227122; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228139; 2228145; 2228262; 2228277; 2228340; 2228345; 2228351; 2228360; 2228376; 2228389; 2229533; 2229570; 2229572; 2229574; 2229579; 2229584; 2230026; 2230411; 2230431; 2230433; 2230440; 2230653; 2230661; 2230664; 2230723; 2230729; 2230733; 2230769; 2230772; 2230773; 2230777; 2230779;  ...
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Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 8814517; 8814559; W038608880648. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Fresh Frozen Plasma (Apheresis) 8814559; W038608880648. Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Blood and Blood Products for Reprocessing 2224423; 2224424; 2224425; 2224427;2225130; 2225134; 2225137; 2225139; 2225174; 2227075; 2227106; 2227109; 2227116; 2227120; 2227122; 2227127; 2227132; 2227137; 2227140; 2227144; 2227149; 2227169; 2227176; 2227182; 2227189; 2228116; 2228139; 2228145; 2228150; 2228152; 2228239; 2228262; 2228277; 2228285; 2228342; 2228351; 2228352; 2228360; 2228364; 2228366; 2228367; 2228376; 2228377; 2228381; 2228384; 2228387; 2228389; 2229535; 2229552; 2229559; 2229564;  ...
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Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Suncoast Communities Blood Bank, Inc.
Food Trophy Nut Brand 1.5 oz. tube; Trophy Nut Brand 1.25 oz. tube; Nut Barrel Brand 5 oz. Fundraising bag; and Nut Barrel Brand 1.25 oz. tube. Trophy Nut Brand 1.5 oz. tube UPC 74249-50778 Code  ...
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Class I The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella. Trophy Nut Co Inc
Food Trophy Nut Brand 1.5 oz. Red Pistachio Tube and Nut Barrel Brand 1.25 oz. Red Pistachio Tube. Trophy Nut Brand 1.5 oz. Red Pistachio Tube UPC 74249-50779 Code Date 08/16/2009 thru 10/27/2009 and Nut Barrel Brand 1.25 oz. Red Pistachio Tube UPC 74249-27779 Code Date 8/16/2009 thru 10/6/2009. Class I The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella. Trophy Nut Co Inc
Food Trophy Nut Brand 6 oz. natural pistachios Trophy Nut Brand 6 oz. natural pistachios UPC 74249-19167 Code Date 0269 Class I The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella. Trophy Nut Co Inc
Food America's Choice 9 oz. Giant Pistachios America's Choice 9 oz. Giant Pistachios UPC 54807-51371 Code Date 1/19/2010 thru 1/23/2010 Class I The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella. Trophy Nut Co Inc
Food Wa Wa brand 6 oz. Pistachio Gusset Wa Wa brand 6 oz. Pistachio Gusset UPC 26191-07724 Code Date 11/15/2010 and 2/1/2010 Class I The product is being recalled because it was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA because it has the potential to be contaminated with Salmonella. Trophy Nut Co Inc
Biologics Source Plasma 08IIAE8374; 08IIAE7282; 08IIAE6595; 08IIAH2718; 08IIAH2425; 08IIAH1074; 08IIAH0557; 08IIAG9210; 08IIAG8336; 08IIAG7285; 08IIAG5669; 08IIAG5288; 08IIAG3787; 08IIAG3355; 08IIAG1886; 08IIAG1450; 08IIAF3267; 08IIAF2468; 08IIAE5604; 08IIAE5050; 08IIAE3681; 08IIAE2740; 08IIAE1500; 08IIAE0848; 08IIAD9640; 08IIAD8918; 08IIAD7411; 08IIAD6779; 08IIAD6080; 08IIAD5535; 08IIAD4770; 08IIAD3972; 08IIAD2489; 08IIAD1217; 08IIAD0504; 08IIAD0018; 08IIAC7994; 08IIAC7250; 08IIAC5888; 08IIAC5172; 08IIAC0381; 08IIAB9637; 08IIAB8792; 08IIAB7823; 08IIAB5804; 08IIAB5391; 08IIAB4303; 08IIAB3433; 08IIAB2935; 08IIAB2212;  ...
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Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. BioLife Plasma Services LP
Biologics Source Plasma 3830008531; 3830009771; 3830009865; 3830009612; 3830010411; 3830009520; 3830010295; 3830009775; 3830010581; 3830009051; 3830009695; 3830010420; 3830008640; 3830010711; 3830010383; 3830009301; 3830009844; 3830010915; 3830008657; 3830008535; 3830008540; 3830008794; 3830008643; 3830009187; 3830009876; 3830010693; 3830009853; 3830009512; 3830010602; 3830008504; 3830009036; 3830009296; 3830010414; 3830009601; 3830009899; 3830009341; 3830008775; 3830009060; 3830009772; 3830008808; 3830009792; 3830010384; 3830010204; 3830008770; 3830009037; 3830009686; 3830010360; 3830010112; 3830010254; 3830009776; 3830008664; 3830009525; 3830010065; 3830008822; 3830009025; 3830008999;  ...
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Class III Blood products, collected from donors whose donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 07 GDNBPZ, 07 GDSKNV, 07 GDSNJB, 07 GDSPMR, 07 GDSPYX,  ...
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Class III Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. Csl Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced W047010307591; W047009246899; W047009231214; W047010170102; W047010246859 Class II Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells W047010134887; W047009160659; W047008272554; 5648436 Class II Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Biologics Fresh Frozen Plasma 5648436 Class II Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Biologics Blood and Blood Products for Reprocessing W047009231214; W047009160659; W047008272554; W047010170102 Class III Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W047010134887; W047009246899; W047010246859; W047010307591 Class II Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W128710012578 Class II Blood product, collected from a donor based on travel to an area considered endemic for malaria, was distributed. Delta Blood Bank
Food The product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled "Karol" with the Lot No. "01W45" stamped in the upper, right-hand corner on the face of the box. The box states "Distributed by Interstate Fruit & Vegetable", which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container depending on the area and retailer. Lot No. "01W45" Class I Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in "Karol" brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Rio Queen Citrus, Inc
Biologics Item 27f Batch Numbers: 09104, 09106, 09114, 09115, 10115, 11103, 11117 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 27g Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10115, 11103, 11117, 11118, 12102 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 70a Batch Numbers: 09105, 09107, 09108, 09109, 09111, 09112, 09121, 10101, 10102, 10104, 10107, 10110, 10111, 10112, 10113, 10114, 10117, 10118 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 70 Batch Numbers: 09102, 09105, 09107, 09108, 09110, 09112, 09113, 09118, 10101, 10103, 10104, 10105, 10106, 10107, 10108, 10110, 10112, 10113, 10114, 10116, 10117 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 71 Batch Numbers: 09102, 09105, 09107, 09108, 09109, 09110, 09111, 09112, 09113, 09118, 09121, 10101, 10113 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 80a Batch Numbers: 09101, 09104, 09106, 09111, 09114, 09115, 10109, 10116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 83cx Batch Numbers: 09109, 09110, 09111 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 80a Batch Numbers: 091116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 27f Batch Numbers: 09116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 27g Batch Numbers: 09116 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Biologics Item 70 Batch Numbers: 09119, 19120 Class I Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. Pacific Coast Tissue Bank
Food Natures Path Hemp Plus Granola sold in bulk bins at Whole Foods PLU 8106 Best by June 12, 13, and 14, 2013 Class II The product has the potential to contain undeclared almond slices. Whole Foods Market
Drugs Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013 Lot 12G468, Exp. 07/2014. Class I Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) Advance Pharmaceutical Inc
Food "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Dulce de Leche Caramel Swirled in Caramel Ice Cream KEEP FROZEN 1.75 QUARTS (1.66L)" is displayed on the carton's label in error. The lid bears the label "Shurfine CREAMERY SELECT PREMIUM ICE CREAM Praline Pecan KEEP FROZEN 1.75 QUARTS (1.661L)". The product bears UPC 015400224840, a Best Buy date of NOV 8, 2014, and a Plant Code of 48-3202-F. UPC 015400224840, Best by NOV 8, 2014, and Plant Code 48-3202-F Class I Product may contain undeclared pecan, soy, and/or wheat allergens. Southwest Ice Cream Specialties
Veterinary All Sizes Milo's Kitchen home style dog treats - Chicken Jerky 3.3 oz UPC 079100504718, 14 oz. UPC 079100510771, 20 oz. UPC 079100504688 UPC:079100504718; UPC:079100510771; UPC:079100504688 Class II On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milos Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers. Del Monte Foods Corp
Veterinary All Sizes: Milo's Kitchen brand Chicken Grillers home style dog treats; Chicken Recipe with natural smoked flavor. 3.3 oz UPC 079100513109; 14 oz. UPC 079100513123; 20 oz UPC 079100513130. UPC ITEM CODES: UPC 079100513109; UPC 079100513123; UPC 079100513130 Class II On 01/07/2013, New York State's Department of Agriculture informed the U.S. Food and Drug Administration (FDA) and the Company that trace amounts of residual antibiotics had been found in several lots of MiIo's Kitchen Chicken Jerky and Chicken Grillers. After consultation with the New York Department of Agriculture and FDA, the company decided to voluntarily recall Milo's Kitchen Chicken Jerky and Chicken Grillers, which are both sourced from the same chicken suppliers. Del Monte Foods Corp
Veterinary Cadet Gourmet Chicken Breast a) Net Wt. 3.6 oz UPC 768303074929 b) Net Wt. 8 oz. UPC 768303074936 c) Net Wt. 1 Lb (454 g) tub - UPC 768303014352 UPC 768303014703 d) Net Wt. 1.25 Lb (567 g) UPC 768303014741 e) Net Wt. 1.5 Lb (681 g) UPC 768303014161 f) Net. Wt. 2.0 lb. UPC 768303014727 Product of China Not for Human Consumption. Distributed by: IMS Pet Industries, Inc., 34 Passaic Street, Wood-Ridge, NJ 07075 All codes Class II NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats. IMS Trading Corp.
Veterinary Shep Chicken Breast Fillets Net Wt. 3.5 oz (99g) Net Wt. 3. oz (99g) Product of China. Not for Human Consumption. Distributed by: ALDI Inc. Batavia, IL 60510-1477 All codes Class II NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats. IMS Trading Corp.
Veterinary Home 360 Pet Chicken Breast Fillets Oven Roasted a) Net Wt. 3.5 oz (99g) UPC 725439966429 b) Net Wt. 1 Lb (454 g) UPC 725439966436 Product of China. Not for Human Consumption. Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147 Product of China All codes Class II NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats. IMS Trading Corp.
Veterinary Companion Chicken Breast Fillet Jerky Strips Dog Treats a) Net Wt 3.3 oz (94 g) . UPC 688267076862 b) Net Wt 14 oz (397g) UPC 688267077449 Distributed by Foodhold USA, LLC Landover, MD 20785 Product of China All codes Class II NYSDAM Analysis has revealed the presence of unapproved antibiotics in Cadet Gourmet Chicken Breast Pet Treats. IMS Trading Corp.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W1657120277545 (Part 1), W1657120277545 (Part 2), W165712023964C Bag 1, W165712023964C Bag 2 Class II Blood products, collected from a potentially ineligible donor, were distributed. Our Lady Of The Lake Hospital Inc
Biologics Fresh Frozen Plasma W1657120266156, W165712026601I, W165712026599B, W165712024396S, W165712024395U, W165712024393Y, W1657120243903, W165712024368*, W1657120243671, W1657120243655, W1657120243647, W1657120250687, W165712024819E, W165712023827U, W165712027716H, W165712027712P, W165712027704P, W165712027700X, W1657120214666, W1657120213053, W165712021364I, W165712020867P, W165712019069A, W165712000939F, W165712019313Y, W165712018284C, W1657120182151, W165712018196C, W165712018100N, W165712018099E, W165712018097I, W1657120101824, W165712015088V, W165712016583M, W1657120149183, W165712007005W, W165712006336A, W165712006225O, W165712013834R, W165712013658R, W165712010491F, W165712010967C, W165712010925W, W165711028973L, W165712010427V, W1657120104240, W165712008629Q, W165712007439H, W165712006880*, W165712005346I,  ...
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Class II Blood products, collected from a potentially ineligible donor, were distributed. Our Lady Of The Lake Hospital Inc
Biologics Red Blood Cells Leukocytes Reduced W165712027965K, W165712027847W, W1657120268020, W1657120275793, W1657120243743, W165712024360F, W165712024396S, W165712024368, W1657120243663, W1657120243655, W1657120243647, W1657120243639, W165712027902D, W165712026691J, W1657120266228, W165712026191M, W1657120266164, W165712024260N, W1657120284020, W165712026586L Class II Blood products, collected from a potentially ineligible donor, were distributed. Our Lady Of The Lake Hospital Inc
Veterinary Hartz Oinkies wraps with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists - 3.1 oz UPC 3270003354 7 mini pig skin twists - 6 oz. All codes Class II Pet treats contain unapproved antibiotics Hartz Mountain Corp.
Veterinary Hartz Oinkies Pig Skin Twists wrapped with Chicken Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA and imported by Hartz Canada Inc., St. Thomas, Ontario N5P 3W7 , Canada 5 pig skin twists UPC 3270003354 7 mini pig twists UPC 3270003330 15 mini pig skin twists - 11.4 oz UPC 3270003331 20 pig skin twists - 4.9 oz. UPC 32700-13472 All codes Class II Pet treats contain unapproved antibiotics Hartz Mountain Corp.
Veterinary Hartz Chicken Chews Soft and Tender Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 3.5 oz. - UPC 3270011966 Net Wt. 8 oz - UPC 3270011967 Net Wt. 16 oz. - UPC 3270011953 Net Wt. 24 oz. - UPC 3270011954 All codes Class II Pet treats contain unapproved antibiotics Hartz Mountain Corp.
Veterinary Hartz Chicken Chews Bite Size Made in China for the Hartz Mountain Corporation, Secaucus, NJ 07094 USA Net Wt. 5.7 oz. - UPC 3270012856 Net Wt. 16 oz - UPC 3270012765 All codes Class II Pet treats contain unapproved antibiotics Hartz Mountain Corp.
Veterinary Pet Pride Chicken Breast Jerky Distributed by: The Kroger Co. Cincinnati OH, Made In China Net Wt. 16 oz. - UPC 1111087994 Net Wt. 24 oz - UPC 1111079250 All codes Class II Pet treats contain unapproved antibiotics Hartz Mountain Corp.
Veterinary Exer-hides Rawhide Twists Distributed by Wal-Mart Stores, Inc.. Bentonville, AR 72716 Made in China 25 pack 5" twists. Net Wt. 6 oz. UPC 8113143905 All codes Class II Pet treats contain unapproved antibiotics. Hartz Mountain Corp.
Devices BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip® Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). PC 864017D; Lots: HUWK1296, HUWK1297 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). Bard Peripheral Vascular Inc
Devices BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip® Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA). PC 863017D; Lot: HUWL0010 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). Bard Peripheral Vascular Inc
Devices MICROSHEATH® - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath® is a single lumen catheter that has a 123cm working length and a straight tip shape PC MS17123; Lot# FCWC10010 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). Bard Peripheral Vascular Inc
Devices USHER® Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher® Peripheral is a single lumen support catheter, with a standard luer fitting at the proximal end. The Usher® Peripheral is available in a length 130 cm with an angled tip shape. PC USH07AT; Lot# FCWC10009 Class II Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard® UltraClip® Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). Bard Peripheral Vascular Inc
Biologics Red Blood Cells Leukocytes Reduced W069112127383; Class II Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W280312101666; Class II Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed. Upstate New York Transplant Services
Biologics Source Plasma 12ANCE5442; Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. Plasma Biological Services
Biologics Red Blood Cells Leukocytes Reduced W333612086754; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Mississippi Valley Reg Bld Ctr
Drugs MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL All Lots Class I Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug. OLAAX International
Biologics Source Plasma 12HINC8697; Class II Blood product, collected from a donor who was suspected of receiving a piercing within 12 months of donating, was distributed. Bio-Blood Components, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W036312107843; W036312107843; W036312107843; Class II Blood products, collected from a donor who was taking Plavix, were distributed. BloodCenter of Wisconsin, Inc
Biologics Plasma Frozen W041513000604*, W041513000605Y, W041513000613Y, W041513000615U Class III Blood products, collected from donors whose body temperatures were determined incorrectly, were distributed. Blood Systems, Inc. dba United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W041513000604*, W041513000606W, W041513000609Q, W041513000612*, W041513000613Y, W0415130006015, W0415130006023, W041513000605Y, W041513000614W, W041513000615U Class III Blood products, collected from donors whose body temperatures were determined incorrectly, were distributed. Blood Systems, Inc. dba United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W045012008981 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W041013009100L Class II Blood product, with a low platelet concentration, was distributed. Blood Systems Inc
Biologics Red Blood Cells Leukocytes Reduced W038112319673 Class II Blood products, collected from a donor who deferred for receiving a piercing, were distributed. Florida's Blood Centers, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W038112319673 Class II Blood products, collected from a donor who deferred for receiving a piercing, were distributed. Florida's Blood Centers, Inc.
Veterinary Diggin Your Dog Strippin Chicks; USA Chicken Charki Strips for Dogs 100% Grown, Raised, Harvested in USA. Net Wt. 5 oz. Ingredients: Chicken, Vitamin E Supplement. UPC: 6-09788-82324-7 Diggin Your Dog USA, Reno, NV Lot Code # 250322 and USE BY 2-23-14 Class I Colorado Department of Agriculture collected a sample of Diggin Your Dog Brand Strippin Chicks at retail and had a positive result for Salmonella. Diggin Your Dog, LLC
Biologics Source Plasma CD0371015; CD0371217; CD0371723; CD0371909; Class II Blood products, collected from a donor who had been incarcerated, were distributed. DCI Biologicals Carbondale, LLC
Biologics Red Blood Cells Leukocytes Reduced W037711189379; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Whole Blood Leukocytes Reduced W069613000559; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Mercy Hospital St Louis
Biologics Whole Blood Leukocytes Reduced W069613000067; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mercy Hospital St Louis
Biologics Blood and Blood Products for Reprocessing W069613000067; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mercy Hospital St Louis
Biologics Red Blood Cells Leukocytes Reduced W036512134905 Class II Blood product, collected from a donor who visited a malarial endemic region, was distributed. LifeShare Blood Centers
Food Chicken Noodle Soup Mix, "9 oz cello bag, Contents: All natural enriched semolina flour***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PURELY AMERICAN SCHOOLHOUSE ON THE PRAIRIE UPC 7 92290 00179 8 and World's Best Teacher UPC 7 92290 00196 5. ITEM # CA103 and ITEM #179 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food Pasta Salad Mix, "10 oz cello bag, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, parsley, celery seed, garlic, paprika, and spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: PICNIC AT CAPE MAY UPC 7 92290 00143 9 and PICNIC AT FAIRMOUNT PARK UPC 7 92290 00138 5. ITEM # CA104, ITEM #146, ITEM #143, ITEM #145 and ITEM #138 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food Pasta Salad Mix, Contents: All natural enriched semolina flour, spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes and garlic***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com" Sold under the brand names: LIGHTS OF LAKE ERIE 10 oz cello bag, UPC 7 92290 00188 0, LIGHTS OF CAROLINA 10 oz cello bag, UPC 7 92290 00155 2, LIGHTS OF THE CHESAPEAKE 11 oz cello bag, UPC 7 92290 00160 6 and LIGHTS OF LAKE MICHIGAN 11 oz cello bag UPC 7 92290 00169 9 ITEM #188, ITEM #155, ITEM #160 and ITEM #169 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food ADIRONDACK GETAWAY PASTA TOSS MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried tomatoes, black pepper, onion powder, onion flakes, and garlic.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00164 9 ITEM #164 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food GILROY GARLIC PASTA STIR FRY MIX 11oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, black pepper, garlic powder, salt.***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00153 8 ITEM #153 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food LONG ISLAND BAYMEN SEAFOOD CHOWDER MIX 15 oz cello bag Contents: All natural enriched semolina flour***spray dried tomato, spinach and beet powders, water, spices, dried carrots, garlic, black pepper, jalapeno peppers, bay leaf***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00178 1 ITEM #178 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food MAMA MARINO'S MINESTRONE SOUP MIX 15 oz cello bag Contents: Assorted beans & barley, Enriched semolina flour***spray dried tomato, spinach and beet powders, water, dehydrated carrots, onions, peas, tomato flakes, celery flakes, bell peppers, parsley & spices***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00105 7 ITEM #105 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food SANTA FE CORNBREAD MIX 12.25 oz coffee bag Contents: Yellow corn meal, unbleached white flour; dehydrated garlic, onion, paprika, bell peppers, celery & parsley flakes, non-aluminum baking powder, baking soda, salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00126 2 ITEM #126 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food INDIAN RIVER ORANGE DROP COOKIES MIX 17 oz coffee bag Contents: Unbleached white flour; granulated sugar, confectioner's sugar, orange peel, baking powder, and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00135 4 ITEM #135 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food SHENANDOAH VALLEY APPLE AND SPICE CAKE MIX 15.5 oz coffee bag Contents: Unbleached white flour; cane sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00121 7 ITEM #121 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Food MARIN COUNTY CARROT CAKE MIX 18.5 oz coffee bag Contents: Unbleached white flour; whole wheat flour, sugar, spices, non-aluminum baking powder, baking soda and salt***PURELY AMERICAN 5991 Industrial Park Road, Athens, OH 45701 (800) 359-7873 www.purelyamerican.com UPC 7 92290 00131 6 ITEM #131 Class II The firm was notified by the Ohio Department of Agriculture that several of their labels are missing the the allergin declaration contains wheat. Purely American, Inc.
Biologics Trima Accel Automated Blood Component Collection System, catalog number 81000, all serial numbers, with software versions prior to 5.1.9 and 6.0.6. Catalog number 81000, ALL SERIAL NUMBERS. Class II Terumo BCT's Trima Accel systems, with a potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system, were distributed. Terumo Bct
Biologics Bone 123437106; 123437107; 123437109; 123437110; 123437111; 123437113; 123437114; 123437115; 123437116; 123437117; 123437118; 123437119; 123437126; 123437129; 123437130 Class I Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. AlloSource, Inc.
Biologics Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood Pack Unit, NDC#0942-6470-03, Rx, 4R1584 FM13A15027 Class III BLOOD-PACK Units in which the platelet container is incorrectly labeled as "AS-1 Red Blood Cell Adenine-Saline added", were distributed. Fenwal Inc
Devices BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610 Class II Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use. Bard Peripheral Vascular Inc
Drugs Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014. Class III Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. Teva Pharmaceuticals USA, Inc.
Food Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle. Lot codes being recalled are lots 243 and 050812, 012712A.. All Protein products manufactured prior to lot 243 are being recalled. Unfortunately the firm does not have records to indicate the lot numbers prior to lot 243. Class I Pure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product. Pure Herbs Ltd
Devices DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. Part Number 230795000/Lot Number 5120443 Class II The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant. DePuy Orthopaedics, Inc.
Devices 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. All lot numbers are affected. Catalog No. 00-1200-1000 Class II Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. OrthoPediatrics Corp
Devices 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. All lot numbers are affected. Catalog No. 00-1200-1001 Class II Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. OrthoPediatrics Corp
Devices 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. All lot numbers are affected. Catalog No. 00-1200-1002 Class II Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. OrthoPediatrics Corp
Food Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in parts: "***IN SHELL HAZELNUTS***HAZELNUT GROWERS OF OREGON***OREGON U.S. NO. 1***Hazelnut Growers of Oregon***401 N. 26 Avenue, Cornelius, Oregon 97113***". Lot A102112. This code represents day shift, date of production is October 21, 2012. There is no expiration date on the product. Class I Large and Jumbo in-shell Barcelona Hazelnuts (50 lbs. bulk bags) are recalled due to a potential contamination with Salmonella. Hazelnut Growers of Oregon
Devices TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery. Lot Numbers: 00312-07 00713-06 00912-01 01813-02 02413-04 03113-02 04213-01 05113-01 05113-02 05512-03 05713-03 06313-05 06512-08 06513-02 07213-04 07912-06 08212-07 09412-03 11412-06 11612-05 12912-04 14512-07 15312-03 16412-07 17412-01 18712-06 19812-13 20212-03 21412-03 22212-03 23412-06 24112-06 24212-04 24912-13 25712-01 26912-01 27712-05 28512-03 28912-03 29612-01 30512-02 31112-05 32112-03 33112-01 34712-05 36612-01 Class II American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device. American Optisurgical Inc
Food XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles All SKUs Class I Undeclared Soy and Milk on the label. Atlantic Pro Nutrients, Inc. dba XYMOGEN
Food IGA Brand Vanilla & Chocolate Ice Cream, 1.75 Quart UPC #4137046131, Plant Code 3783, Sell by dates: 06-08-13 07-19-13, 08-02-13, 08-13-13 and 08-27-13. Class I Undeclared allergens: Almonds, Coconut, Soy Lecithin Dairy Fresh LLC
Devices QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona­ pyrogenic in a sealed, peel-type pouch. Model QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841 Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853 Class II Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used. Edwards Lifesciences, LLC
Devices embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 RMIV019634 RMIV020254 1010005552 1010005585 1010002453 1010001588 135150668 1010003915 1010002669 RMIV019542 1010002370 UI018933 RMIV019638 RMIV019850 RMIV020166 UI012625 RMIV019235 166758580 1010007510 UI007649 RMIV020079 RMIV013196 1010002697 RMIV019658 UI016466 RMIV019659 1010002034 UI016112 UI018160 1010007423 RMRE007779 UI018158 RMIV020145 1010001332 1010002431 1010002432 1010001378 1010006090 1010007484 1010004750 1010003658 1010007351 1010002688 1010002699 UI008431 RMIV009745 RMIV019679 1010007005 1010002088 UI009365 1010003611 1010006891 UI018570 UI022540 1010002262 RMIV019517 RMIV019572 RMRE007959 UI006113 RMIV006948 UI013856 RMIV016367 RMIV019395 RMIV020112 1010005434 1010006883 RMRE007326 RMIV019237 1010006887 1010001991 1010003732 1010003984 UI002603 1010004266 1010006478 1010006800 RMIV019397 1010001928 1010001729 RMIV019166 RMIV019746 RMRE008072 UI016332 UI007631 1010002320 RMIV018044 RMRE007777 1010003067 1010005000 1010005287 RMIV019076 RMIV020194 1010000243 1010003543 1010006931 RMIV017565 RMIV019454 RMRE008087 156096 159046 RMIV020029 1010001256 1010003438 RMIV019940 RMRE008074 1010003546 UI012639 118018636 1010003507 RMIV003685 UI005216 1010003381 1010002913 1010002920 1010002845 168574112 1010006576 1010002702 1010005197 1010006074 UI012593 1010001937 1010003637 UI012586 1010002664 1010004535 1010003817 1010005998 1010006826 1010007710 1010003802 1010000965 1010001001 1010001006 1010001013 1010002659 1010002671 1010002698 1010002670 1010002646 1010002791 1010002835 1010002830 1010002793 1010003559 1010003562 1010003215 1010004145 1010004220 1010005580 1010005576 1010005464 1010005497 1010005469 1010005314 UI019628 UI007951 UI011892 RMRE004711 RMIV013784 UI015720 RMIV019570 RMRE008077 RMRE008073 1010001188 1010006437 1010004274 UI006849 UI009712 RMIV019889 UI003213 UI005546 UI011507 UI015675 RMIV019238 RMIV019254 RMIV019511 1010001255 1010003565 1010002955 UI018536 RMIV019954 RMIV019177 1010001217 UI008038 1010004985 1010002682 167617437 RMIV020243 1010005643 UI003679 1010000951 UI013298 RMIV020078 RMIV020247 1010005730 1010003680 RMIV020054 1010000199 1010007284 UI012571 UI012575 1010002675 UI014387 RMRE007776 IN000380 UI014119 UI016006 UI016355 UI017046 RMIV019982 UI005858 RMIV019919 101003924 1010002837 UI_000670 UI_001339 UI004904 RMIV007125 UI014813 UI017060 UI019513 RMIV019041 144913 RMIV019639 RMIV019778 1010002678 1010004325 1010004310 159699 1010003947 UI011502 UI020772 Serial Numbers: EBG-C1000497 C0914092-EBG EBG-C1002589 EBG-C1002598 EBG-C1001659 EBG-C1001832 EBG-C1001835 EBG-C1001843 EBG-C1001845 EBG-C1002253 EBG-C1002473 EBG-C1002504 EBG-C1002519 EBG-C1002537 EBG-C1002539 EBG-C1001367 EBG-C1001378 EBG-C1001763 EBG-C1000265 EBG-C1002607 EBG-C1002542 EBG-C1003212 EBG-C1001834 EBG-C1001858 EBG-C1001889 EBG-C1002445 EBG-C1003052 EBG-C1002502 EBG-C1002508 EBG-C1001776 C0901065-EBG EBG-C1003078 EBG-C1003084 EBG-C1003085 EBG-C1003161 EBG-C1003165 EBG-C1001230 EBG-C1001275 EBG-C1002688 EBG-C1002500 EBG-C1003055 EBG-C1001970 EBG-C1001972 EBG-C1001973 EBG-C1001983 EBG-C1001986 EBG-C1001518 EBG-C1000112  ...
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Class II Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary. Embla System Llc
Devices Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. Lot: 2013-11-13, Exp 11/13/2013. Class II The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction. Siemens Healthcare Diagnostics, Inc.
Food Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic Batch HZ Class III E. Coli contamination (non pathogenic) Berkshire Cheese LLC
Devices Applied Medicals Epix® and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. Model Numbers C4130 and C4140. MODEL NUMBERS C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper LOT NUMBERS 1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394,  ...
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Class II Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix® and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely; however, out of an abundance of caution for patient safety and a commitment to provide only the highest quality products, Applied has decided to recall all potentially affected units. Applied Medical Resources Corp
Devices Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction. Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845 Class I Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures. Endologix Inc
Devices StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures. Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and  ...
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Class II Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots. Dental EZ Stardental Division
Devices STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011. Class II Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Abbott Medical Optics, Inc.
Devices STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011. Class II Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Abbott Medical Optics, Inc.
Devices STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011. Class II Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Abbott Medical Optics, Inc.
Food Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton. The product is sold in a seafood retail case. Product labeled as:"WILD WHITE EZ PEEL SHRIMP 16/20 CT WILD CAUGHT PRODUCT OF USA CHEM FREE INGREDIENTS: Shrimp, Salt***PACKED BY: BLESSINGS, INC.***. Lot # 13047-1, 13048-1, and 13048-3 Class I Blessing Seafood, Inc. is voluntarily recalling one lot of Blessing Inc. Wild White EZ Peel Shrimp due to undeclared sulfites. Blessing Seafood, Inc.
Devices AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014 Class II Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the symbols used on the label. Fenwal Inc
Food Fresh Thai chili peppers. Loose fresh Thai chili peppers packaged with inner plastic mesh bag into paper carton cardboard boxes. Imported bulk. Outer carton labeling reads in part: "***PRODUCE OF MEXICO***JAMMIN PEPPERS***THAI CHILI***DISTRIBUTED BY: JT BROKERAGE 651 KOHLER ST. LOS ANGELES, CA 90021***WWW.JAMMINPEPPERS.COM***". Bulk outer carton labelets with Lot # 162. Sold to retail with no coding or marks. Class I The firm recalled the Thai chili peppers because FDA analytical results revealed the presence of Salmonella. Fruit Treasure Inc
Drugs Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box) Lot #: DB2208, Exp 01/16 Class II Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples. Sandoz Incorporated
Devices ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¬" lock-out feature is designed to prevent a used reload from being refired. The following lot numbers and associated expiration dates are affected by this recall: J4AY8Z 5/15/2013, J4C00J 6/15/2013, J4C87R 7/15/2013, J4CC1F 8/15/2013, J4CD2X 8/15/2013, J4CF3D 9/15/2013, J4CJ0E 9/15/2013, J4CJ78 9/15/2013, J4CK2P 9/15/2013, J4CM9X 10/15/2013, J4CR2H 10/15/2013, J4CT5H 11/15/2013, J4CU86 11/15/2013, J4CV1W 11/15/2013, J4CV5H 11/15/2013, K4C149 12/15/2013, K4C17W 12/15/2013, K4C33U 12/15/2013, K4C41C 12/15/2013,  ...
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Class II Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. Ethicon Endo-Surgery Inc
Drugs Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc. Lot #: Patch 453658; Carton 453658A, Exp 09/13 Class III Failed Impurities/Degradation Specifications Actavis
Food Uncle Eddies Vegan Oatmeal Chocolate Cookies, 12 oz. One shipping carton/case consists of 12bags. Product labeling reads in part:"uncle Eddies vegan oatmeal chocolate-chip cookies***net wt. 12 oz (340g)***MFG BY:INTERNATIONAL DESSERTS GLENDALE, CA 91203***(818) 549-0056***www.vegancookies.com***". Lot numbers #110813, and #58513 Class I International Desserts of Glendale, California is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies in 12 oz bags, because it may contain undeclared walnuts. International Desserts and Delicacies
Devices VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102). Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489 Class II International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to assure a tight seal while not allowing the component to be overtightened to the extent where an occlusion would occur. International Biomedical, Ltd.
Food Market Pantry, Sweet & Salty Mix, NET WT 3 oz (85g), UPC 0 85239 08131 0, INGREDIENTS: Peanuts (peanuts...) ...Honey Roasted Peanuts...Honey Roasted Soy Nuts(soybeans...)., CONTAINS PEANUTS AND SOY, May contain tree nuts, milk, wheat and eggs. Distributed by Target Corporation, Minneapolis, MN 55403. 074X348, 092X348, 105X348, 106X348, 107X348, 108X348, 109X348, 112X348, 120X348, 121X348, 122X348. Class II American Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts instead of , Honey Roasted Peanuts listed on the label. Butter Toffee Peanuts contain a very small amount of butter (0.5% to 1.0%) which is a milk allergen. American Importing Co, Inc
Devices Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals. Part number DPT-248A, lot number 1122508. Class II Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices. Utah Medical Products, Inc
Devices BARD PERIPHERAL VASCULAR VACCESS® PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess® PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess® PTA Balloon Dilatation Catheters are supplied sterile and intended for single use. Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090 Class II Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size. Bard Peripheral Vascular Inc
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