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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 007FN52555 Class II Blood product, collected from a donor who traveled to a malaria endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 007GG15294 Part 1;007GG15294 Part 2 Class III Blood products, in which extra amount of red cell preservative solution was added, were distributed. American National Red Cross (The)
Biologics Red Blood Cells KK15215; KK15213; KK15186 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Plasma Frozen KK15215; KK15186; KK13926; KK13907; KK13906; KK13867; KK13868; KJ42191; KK13869 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells FJ62759 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Bank
Biologics Fresh Frozen Plasma FJ62759 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Bank
Biologics Platelets Pheresis GP13388A; GP13388B; GP13276; GP13234 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Southern California Permanente Medical Group Blood Donor Ctr
Biologics Red Blood Cells GQ24012; GQ16732; GL53069 Class II Blood products, collected from a donor taking the medication Purinethol, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Fresh Frozen Plasma GQ24012; GL53069 Class II Blood products, collected from a donor taking the medication Purinethol, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GQ46933; GQ42775 Class II Blood products, collected from a donor taking the medication Purinethol, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Fresh Frozen Plasma 40225560 Class II Blood products, labeled with an incorrect ABO type, were distributed. HemaCare Corporation
Biologics Red Blood Cells Leukocytes Reduced 4025560 Class II Blood products, labeled with an incorrect ABO type, were distributed. HemaCare Corporation
Biologics Red Blood Cells FJ62632 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Bank
Biologics Fresh Frozen Plasma FJ62632 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Southern California Permanente Medical Group Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 36LE12634 Part 1, 36LE12634 Part 2 Class II Blood products, which did not meet the acceptable product specifications, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells 6647950 and 6608685. Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. BloodNetUSA, Inc.
Biologics Platelets 01KH99185; 01KK22409; 01KK22422; 01KK22414; 01W28412; 01W28416; 01FW27321; 01KH99018; 01KH99164; 01KH99173; 01KK22425; 01Y68661; 01Y68675 01Y68678; 01Y68681; 01Y68689; 01Y68693; 01Y68695 Class II Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 01KK22409; 01KK22414; 01KM36647; 01KM36670; Class II Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 01KH99018 Class II Blood products, collected from donors who traveled to potential malaria endemic areas, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 0726836; 0726836; 0726836 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Red Blood Cells FV87754 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Southern California Permanente Medical Group Blood Bank
Biologics Blood and Blood Products for Reprocessing GZ21115 Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GZ21115 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced 36L92853 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Plasma Frozen 36L92853 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells 2545079 Class II Blood product, identified unsuitable due to a donor screening deviation, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W071808005080 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells Leukocytes Reduced GN91057 Class II Blood product, collected from a donor with a history of Hepatitis A, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced W07180800087 Class II Blood product, which did not meet the acceptable product specifications for release, was distributed. Southern California Permanente Medical Group Blood Donor Center
Biologics Red Blood Cells Leukocytes Reduced 036KC23040, 036KC23041, 036KC23042, 036KC23043, 036KC23044, 036KC23045, 036KC23046, 036KC23047, 036KC23049, 036KC23050, 036KC23051, 036KC23052, 036KC23053, 036KC23054, 036KC23055, 036KC23056 Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. The American National Red Cross South Carolina Region
Biologics Plasma Frozen 36KC23043, 036KC23053, 036KC23054 Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells Leukocytes Reduced 01KX94084 Class II Blood products, in which routine testing interpreted or documented incorrectly, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 01Q20922 Class II Blood products, in which routine testing interpreted or documented incorrectly, were distributed. American National Red Cross (The)
Biologics Source Plasma 0481140752, 0481144544, 0481143405, 0481139746, 0481136797, 0481135692, 0481133547, 0481131926, 0481130470, 0481128779, 0481127338, 0481124821, 0481123835, 0481121841 0481120824, 0481118127, 0481117175, 0481114690, 0481112748, 0481110630, 0481108999, 0481107026, 0481106141, 0481102517, 0481100805, 0481098555, 0481097037, 0481095951, 0481092615, 0481092031, 0481088182, 0481087379, 0481084331, 0481081938, 0481078834, 0481077362, 0481075084, 0481070832, 0481070128, 0481068129, 0481066918, 0481066257, 0481064907, 0481064382, 0481063187, 0481062597, 0481061449, 0481060853, 0481059667, 0481059086,  ...
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Class II Blood products, collected from donors whose scheduled physical examinations were incomplete, were distributed. CSL Plasma Inc
Biologics Red Blood Cells W020408003424, W020408003428, W020408003445, W020408003447, W020408003436, W020408003443, W020408003432, W020408003427, W020408003230, W020408003426, W020408003450, W020408003444, W020408003440, W020408003439, W020408003437, W020408003435, W020408003434, W020408003433, W020408003429, W202408003431, W020408003425 Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Department of the Navy
Biologics Red Blood Cells Leukocytes Reduced 020LE28771, 020LE28776, 020LE28796, 020LE28802, 020LE29112, 020LE29116, 020LE29155, 020LE29169, 020LE29183, 020LP96569, 020LP96576, 020LP96605, 020LQ28067, 020LQ28078, 020LQ28224, 020LQ28248, 020LQ28298. Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Plasma Frozen within 24 hours (FP24) 020LE28771, 020LE28776 , 020LE28802 , 020LE29112 , 020LE29122, 020LE29126, 020LE29142, 020LQ28072, 020LQ28078, 020LQ28224, 020LQ28259. Class II Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W045009005846; W045009005849; W045009005855; W045009006140; W045009055966; W045009055994; W045009060785; W045009064974; W045009068435; W045009069882; W045009070592; W045009074872; W045009077325; W045009079051; W045009080374; W045009081796; W045009081796; W045009082500; W045009084700; W045009084708; W045009084878; W045009084880; W045009085097; W045009085097; W045009085694; W045009085881; W045009086095; W045009086662; W045009086662; W045009087089; W045009087238; W045009087846; W045009089462; W045009090898; W045009091113; W045009091309; W045009092210; W045009094625; W045009096808; W045009096869; W045009096871; W045009097845; W045009097995; W045009099542; W045009100893; W045009101833; W045009102557; W045009102568; W045009102764; W045009102823;  ...
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Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 012LV66398, 012LV66403, 012LV66405, 012LV66408, 012LV66409, 012LV66410, 012LV66413, 012LV66414, 012LV66417, 012LV66418, 012LV66419, 012LV66421, 012LV66422, 012LV66424, 012LV66425, 012LC66429 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 Fresh Frozen Plasma 012LV66409, 012LV66410, 012LV66417, 012LV66418, 012LV66422, 012LV66425 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)
Food Caribena Brand papayas packed in 35 lb. cartons marked with the brand "Caribena" and "Product of Mexico" stamped on the side. Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com" Papayas are packed in boxes of 8-12 papayas per box Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com". Lot # 115123 Class I Product has the potential to be contaminated with salmonella. Caribe Produce
Food Christian Cheese Ranch Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, and Ranch Dressing. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II Undeclared Soy lecithin Christian Cheese, LLC
Food Christian Cheese Vegetable Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Onion, Garlic, Basil, Red Bell Pepper, Black Pepper, Tomato, Vinegar, Parsley, Ginger, and Rosemary. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II Undeclared Soy lecithin and Soybean Oil Christian Cheese, LLC
Food Christian Cheese Ranch Bacon Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Ranch Dressing and Bacon Bits. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II undeclared Soy lecithin, Soybean Oil, and sulfites Christian Cheese, LLC
Food Christian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Sun-Dried Tomato and Salt. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II Undeclared Sulfites Christian Cheese, LLC
Food Christian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, Blackberry Wine. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II Undeclared sulfites Christian Cheese, LLC
Food Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, and Horseradish. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. No codes are used at the facility. All product made approximately on June 7, 2012. Class II Undeclared Soy lecithin and Soybean Oil Christian Cheese, LLC
Food Tomorrow's Tropicals Mangos Distributed by FoodSource A C.H. Robinson Company Edinburg, Texas 78539 All product sourced by Agricola Daniella, produced 7/16/12-9/14/12. Class I Out of an abundance of caution, the firm is voluntarily recalling mangoes that have been sourced from Agricola Daniella. The recall was initiated after the FDA warning to consumers not to eat any mangoes from Agricola Daniella was issued. Food Source, Inc
Food Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Island Medley Net Wt. 1 lb (454g) Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC Code: 826766201044 Best if Sold By 9/8/12, 9/13/12. and 9/15/12 Class I The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella. GHSW, LLC
Food Fruit Burst, ingredients: Cantaloupe, Pineapple, Honeydew, Watermelon, Red Grapes, Mango, Strawberries, Blueberries: 1) Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated, Net Wts 1 lb, UPC 826766241071 and 1.5 lbs., UPC 826766241279; 2) Fruit Burst Net Wt. 1 lb Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com. Packed in its own juice., UPC 826766241279; 2) Winn-Dixie, Jacksonville, FL 32254 Perishable, Keep Refrigerated Net Wts 1 lb (454g) UPC 021140017017, and 1.5 lb (680g), UPC 021140017079 1) 1 lb. and 1.5 lb., Best if Sold By: 9/8/12, 9/13/12, and 9/15/12 2) 1 lb Containers: , Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, and 9/15/12. 1.5 lb Containers: Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12 Class I The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella. GHSW, LLC
Food Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Mango Medley Net Wt. 10 oz (284g) Renaissance Food Group LLC, Rancho Cordova, CA 95670, UPC: 826766214334 www.gardenhighway.com Ingredients: Cantaloupe, Pineapple, Mango, Red Grapes Packed in its own juice Best if Sold By: 9/8/12, 9/9/12, 9/11/12, 9/13/12 Class I The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella. GHSW, LLC
Food Mango Spears: 1) Garden Highway Fresh Fruit Perishable Keep Refrigerated Mango Spears Net Wt 1 LB (454g) Renaissance Food Group LLC ,Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Mango Packed in its own juice; UPC: 826766268498 2) Mango Spears 1 lb (454g) Ingredients: Mango Packed in its own juice. Distributed By: Winn-Dixie Stores, Inc. Jacksonville, FL 32254 Perishable Keep Refrigerated, UPC: 021140016942 1) Best if Sold By: 9/8/12, 9/11/12, and 9/13/12 2) Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12 Class I The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella. GHSW, LLC
Food Signature CAFE Fruit Basket Medley Perishable Keep Refrigerated NET WT 30 oz (1 LB 14 OZ) 850g Ingredients: Red Grapes, Pineapple, Cantaloupe, Mango, Watermelon, Apples (Apples, Calcium Ascorbate [a blend of calcium and vitamins to maintain color] Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, UPC 021130069187 Use By: SEP 7 12, SEP 10 12, and SEP 12 12 Class I The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella. GHSW, LLC
Food Mango (Fresh Cut): Del Monte brand slices, 32 oz., UPC 7-62357-07532-1, 32 oz., UPC 7-17524 72503-5; 16 oz., UPC 7-17524-71902-7, 8 oz., UPC 7-17524-72506-7, UPC 7-17524-72506-6; Del Monte brand chunks, 7 oz., 7 Eleven brand chunks, 6 oz., UPC 0-52548-52070-0 Del Monte, 32 oz., best by 9/26/12, 9/27/12 and 9/28/12; 16 oz., best by 9/26/12 and 9/27/12; 8 oz., best by 9/26/12; chunks 7 oz., Lot 05262101 7 Eleven chunks, 6 oz., best by 9/28/12 and 9/29/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Del Monte brand Tropical Fruit Medley, 16 oz., UPC 7-17524-77649-5 best by 9/26/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Del Monte brand Tropical Fruit Bowl, 28 oz., UPC 7-17524-77651-8; 64 oz., UPC 7-17524-77834-5 both sizes, best by 9/26/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Del Monte brand Tropical Blend, 7 oz., Lot number 05262101; 16 oz., UPC 7-17524-77868-7 both sizes, best by 9/27/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Seasonal Blend: Del Monte brand, 32 oz., UPC 7-17524-77604-4; 7 Eleven brand, 6 oz., UPC 7-17524-77647-1; 16 oz., UPC 7-17524-77647-1; Wal-Mart, 10 oz., UPC 7-17524-77815-4; 16 oz., UPC 7-17524-77603-7; 32 oz., UPC 7-17524-77604-4 Del Monte, best by 9/27/12; 7 Eleven, 6 oz., best by 9/29/12, 16 oz., best by 9/27/12 and 9/29/12; Wal-Mart, all sizes, best by 9/26/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food 7 Eleven brand Pineapple/Mango/Grape, 6 oz., UPC 0-52548-51986-5 6 oz., best by 9/28/12 and 9/29/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food 7 Eleven brand Strawberry/Kiwi/Mango, 6 oz., UPC 0-52548-51979-7 6 oz., best by 9/28/12 and 9/29/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Apple Blend, generic, 16 oz., sold at Wal-Mart, UPC 7-17524-77626-6 best by 9/26/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Food Fruit Bowl, generic, 48 oz., sold at Wal-Mart, UPC 7-17524-77687-7 best by 9/26/12 Class I In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is 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. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico. Del Monte Fresh Produce North America, Inc
Drugs Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58 Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58 Lot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67 NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58 NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66 NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Drugs Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58 NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013. Class III Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing Teva Pharmaceuticals USA, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W230813809663; W230813809663; Class II Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed. Coastal Bend Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated 004LN27612; 004LS39882 Class II Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced 004FM18651; 004FM18653; 004FW12875; 004FW12880; 004FW12920P1; 004FW12920P2; 004FW13213; 004GH23026; 004GH24503; 004GH25651; 004GH26351; 004GH26455; 004GH26464; 004GH26469; 004GH26474; 004GQ14814; 004GQ14822; 004KF92568; 004LH16537; 004LH18502; 004LH18814; 004LH19273; 004LH19285; 004LN29942; 004LN29944; 004LS40757 Class II Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Devices TOSHIBA Kalare Diagnostic X-Ray System K110785 DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X  ...
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Class II Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired. Toshiba American Medical Systems Inc
Biologics Fascia 0087040077 Class II Human tissue allograft, 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, was distributed. University Of Miami Miller School of Medicine Tissue Bank
Devices Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T Part Number: 640919 Class II Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber) Fresenius Medical Care Holdings, Inc.
Devices Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study. Model: 1.1 Lot numbers: 13367 and 13710 Class II The outer jacket is receding away from the black sensor prematurely. SagaTech Electronics, Inc.
Biologics Bone 0093440125 Class II Human tissue allograft, 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, was distributed. University Of Miami Miller School of Medicine Tissue Bank
Devices Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. UR175554 UR176743 UR182030 UR188144 UR192047 UR192096 UR192260 UR194951 UR202044 UR204032 UR211698 UR214312 UR216069 UR222471 UR225334 UR229294 UR233569 UR233700 UR238915 UR243022 UR246009 UR249383 UR255802 UR260273 UR262980 UR263004 UR265918 UR283580 UR287284 UR288746 UR298216 UR304246 UR307249 UR314328 UR318063 UR321000 UR325464 UR334151 UR339317 UR344234 UR352484 UR352567 UR360255 UR363432 UR366161 UR375857 UR383794 UR385534 UR07J19029 UR07K29059 UR07L21039 UR08B21053 UR08C25151 UR08E15157 UR08G22167 UR08I12065 UR08K13086 UR08L18158 UR09A21211 UR09D02157 UR09E14084 UR09G17125 UR09H26140 UR09J30040 UR09J30065 UR09J30107 UR09L01146 UR10C25033 UR10D09142 UR10E21037 UR10G28129 UR10I28034 UR10L03024 UR10L22024 UR11A14022 UR11B24086 UR11B25125 UR11C25032 UR11F01028 UR11G08088 UR11H08011 UR11H09019 UR11I08043 UR11I23026 UR12A25043 UR12E18502 UR12H03011 UR12H17045 UR12I05030 UR12I06053 UR12I21052 UR12J18040 UR12J26019 UR12L12023 UR13B08053 UR13B15041 UR13C08036 Class II A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. Baxter Healthcare Corp.
Devices Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. R06K01067 R06K01075 R06K01083 R07B02013 R07C14065 R07C22035 R07D19088 R07E07015 R07E20935 R07E29050 R07F02063 R07F05025 R07I22065 R07J01019 R07J28012 R07L05073 R08A14027 R08A28019 R08B04026 R08B05031 R08C18040 R08C24022 R08D12066 R08D15085 R08F28075 R08G19122 R08G21029 R08G21037 R08H21019 R08H27065 R08I20076 R08J10175 R08K04010 R08L05205 R09A17060 R09A28109 R09B16086 R09C16100 R09C30119 R09D14012 R09E19026 R09E25122 R09F10148 R09F16087 R09G14072 R09G27025 R09H27080 R09I28094 R09J13103 R09K11154 R09K30014 R09L09032 R09L16227 R10A08264 R10A19188 R10A21630 R10B13122 R10B16158 R10C10118 R10C13096 R10C24044 R10C27179 R10D05041 R10D26047 R10E11087 R10F05152 R10F19054 R10G27014 R10H17211 R10H31212 R10I01106 R10I07129 R10I27036 R10J19024 R10J19149 R10J23067 R10K02226 R10K13066 R10K25029 R10L04071 R10L23048 R11A11010 R11A15078 R11A31224 R11B07172 R11C01223 R11C15157 R11C22294 R11D04167 R11D16062 R11E12159 R11E21077 R11F24103 R11G18020 R11G18103 R11G19077 R11J24189 R11K22140 R11L22114 R12A04113 R12A11134 R12A23113 R12A31124 R12B15117 R12B27070 R12C08144 R12E17116 R12E18056 R12F07057 R12F09087 R12F11067 Class II A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. Baxter Healthcare Corp.
Devices Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers. R08D28039 R08D28047 R08D28054 R08H20094 R08H22124 R08H25010 R08H28113 R08I06083 R08I08097 R08I09087 R08J06124 R08J13088 R08K21139 R08K29074 R08L08092 R08L12110 R09A16013 R09A27101 R09A31079 R09B17043 R09B26010 R09C02084 R09C15029 R09D13089 R09E12120 R09E19133 R09F13068 R09F22028 R09G13108 R09H05037 R09H06134 R09H19111 R09I08096 R09I27013 R09J08038 R09J14010 R09J27103 R09J28119 R09K12129 R09L04017 R09L22035 R10A06011 R10A08165 R10A19113 R10A21655 R10B17024 R10C11033 R10C11116 R10C15026 R10D15081 R10D16063 R10D16154 R10D24067 R10E03035 R10G21108 R10G27089 R10H21064 R10H23110 R10I02138 R10I04068 R10I25071 R10J19123 R10J25096 R10K17984 R10K25094 R10L03065 R10L06019 R10L21174 R11B16165 R11B23161 R11C15165 R11C22229 R11D04084 R11D12038 R11E04115 R11E13066 R11E28072 R11E30086 R11F08171 R11H05041 R11H16071 R11H22053 R11I06039 R11I16095 R11I28249 R11J12093 R11J13158 R11J14081 R11K19054 R11K21183 R12A09070 R12A09112 R12B25058 R12C28142 R12E19070 R12E21076 R12E31125 R12F11109 R12F12081 Class II A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. Baxter Healthcare Corp.
Biologics Amniotic membrane 12NX10252500519, 12NX10252500520 Class III Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. TissueTech, Inc. dba Bio-Tissue, Inc.
Biologics Amniotic membrane 2012AG1510F06969, 2012AG1510F06970, 2012AG1510F06974, 2012AG1510F06976, 2012AG1510F06977, 2012AG1510F06979, 2012AG1510F06980, 2012AG1510F06981, 2012AG1510F06984, 2012AG1510F06988, 2012AG1510F06991, 2012AG1510F06992, 2012AG1510F06994, 2012AG1510F07000, 2012AG1510F07001, 2012AG1510F07002, 2012AG1510F07005, 2012AG1510F07007, 2012AG1510F07008, 2012AG1510F07010, 2012AG1510F07011, 2012AG1510F07012, 2012AG1510F07019, 2012AG1510F07020, 2012AG1510F07021, 2012AG1510F07025, 2012AG1510F07026, 13NX10252500019, 2012AG1510F06978, 2012AG1510F06993, 2012AG1510F07003, 2012AG1510F07004, 2012AG1510F07014, 2012AG1510F07015, 2012AG1510F07016, 2012AG1510F07017, 2012AG1510F07018, 2012AG1510F06971, 2012AG1510F06972, 2012AG1510F06973, 2012AG1510F06975, 2012AG1510F06982, 2012AG1510F06983, 2012AG1510F06985, 2012AG1510F06986, 2012AG1510F06987, 2012AG1510F06989, 2012AG1510F06990, 2012AG1510F06995, 2012AG1510F06997,  ...
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Class II Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. TissueTech, Inc. dba Bio-Tissue, Inc.
Food Eco-Cuisine Betty Brownie Mix with Vanilla, Pack size 1.09 lb bag, 10 bags per case or 25 lbs bulk, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3333 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Chocolate Brownie Mix, SKU: AA01BRWN, Pack size 1 lb bag, 10 bags per case, and SKU: AA25BRWN 25 lbs bulk bag, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3314 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Reduced Sodium "Ground Beef Style" Quick Mix, SKU: AA10GBQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO; and TV10GBQM 10 lb bag distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY. SKU: AA10GBQM, item number T3388 all lots, SKU: TV10GBQM, lot 26122481A. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Reduced Sodium "Sausage Style" Quick Mix, SKU: AA10SGQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3394 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Chocolate Chip Cookie Mix, SKU: AA01COOK-CC, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3416 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Lemon Muffin Mix, SKU: AA01MUFF-LM, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3417 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. Item number T3418 all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Basic English Scone Mix, SKU: CM25SCONE, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling. Item number CM25SCONE all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Cookie Mix, SKU: CM25COOK, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling. Item number CM25COOK all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Muffin Mix, SKU: CM25MUFF, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling. Item number CM25MUFF all lots. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine Basic Pancake Mix, SKU: TV25PANC, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY. Item number TV25PANC, lot 001122331A Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Food Eco-Cuisine "Chicken Style" Quick Mix, SKU: RM10CKQM, Pack size 10 lb bag, Distributed by Eco-Cuisine and manufactured by Rocy Mountain Spice, and SKU: TV10CKQM, package size 10 lb bag, distributed by Eco-Cuisine and manufactured by TOVA. Item number RM10CKQM lots E3112, G0312, G2412, H1612, J0912, B0813. Class II Eco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier. Eco-Cuisine
Drugs Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11 Lot #: 6103883, Exp 10/2013 Class III Failed Impurities/Degradation Specification Fresenius Kabi USA, LLC
Drugs Gentamicin Sulfate Injection USP 80 mg/2mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA. Lot 07-067-DK Exp. 07/13 Class II Presence of Particulate Matter: Confirmed customer report where visible particles were identified floating in the primary container. Hospira Inc.
Food Solbar Q Soy Protein Isolates. Item No. / Item Description: 22843 / Solbar Q 843 GMO, 22910 / Solbar Q 910 GMO, 22942 / Solbar Q 842 GMO, 22943 / Solbar Q 842 NGMO, 3323912 / Solbar Q 910, 3323920 / Solbar Q 920, 3323932 / Solbar Q 842, and 3323973 / Solbar Q 842 IP Item No.22843, Batch Code: PDSP843040712 Item No. 22910, Batch Codes: SP910031212, SP910071212, SP910090812, SP910201112, SP910260612, SP910270412, SP910270612, SP910300712. Item No. 22942, Batch Codes: sp842010113, SP842010512, SP842010712, SP842030812, SP842040212, SP842040812, SP842041111, SP842050812, SP842071111, SP842090212, SP842090712, SP842100212, SP842100712, SP842140212, SP842141112, SP842160112, SP842160212, SP842170112, SP842180112, SP842190712, SP842200212, SP842200712, SP842201111, SP842220712, SP842220912, SP842230612, SP842230912, SP842260112, SP842270112,  ...
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Class I Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella Chs Inc
Food Solcon Soy Protein Concentrates. Item No. / Item Description: 12110 / Solcon F GMO, 3112030 / Solcon F Soy Protein Concentrate, 12100 / Solcon GMO, and 3112002 / Solcon GMO Soy Protein Concentrate Item No. 12110, Batch Codes: SF011111, SF040811, SF121111, SF130112, SF131111, SF131212, SF140112, SF180712, SF190612, SF210512, SF240112, SF251011, SF251112, , SF310511. Item No. 3112030, Batch Codes: SF190911, SF200313, SF251112, SF270113, SF270711/1. Item No. 12100, Batch Codes: S010812, S020612, S020712, S020812, S021211, S030412, S030612, S040412, S050112, S050712, S060212, S060612, S061211, S080512, S080812, S090812, S100312,  ...
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Class II Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella Chs Inc
Food Solcon S Functional Soy Protein Concentrates. Item No. / Item Description: 3232212 / Solcon S 110 GMO, and 32211 / Solcon S110 GMO Item No. 3232212, Batch Codes: SS110010113, SS110030113, SS110111212/1, SS110271212. Item No. 32211, Batch Codes: SS110150812, SS110160712, SS110170712, SS110180712, SS110210612, SS110220612, SS110280812. Class II Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella Chs Inc
Food Contex - Textured Soy Protein Concentrates Item No. / Item Description: 3411112 / Contex 120 Textured Soy Protein, 3411124 / Contex 25 Textured Soy Protein, 3411129 / Contex 31 CL Textured Soy Protein, 3411142 / Contex 120CL IP Textured Soy Protein, 3411144 / Contex 240 Textured Soy Protein, 3411161 / Contex 25 CLH, 51026 / Contex 25 Textured NGMO Soy Protein, 52031 / Contex 31 GMO Textured Soy Protein, 52032 / Contex 31 CL GMO Textured Soy Protein, 52034 / Contex 31PV GMO Textured Soy Protein, 52035 / Contex 31NP GMO Textured Soy Protein, 52121 / Contex 120CL IP Textured Soy Protein, and 52248 / Contex 240CL GMO Textured Soy Protein. Item No. 3411112, Batch Codes: C120031012, C120080413, C120080911, C120110213, C120110213/1, C120161111/1, C120171111, C120180412, C120190112, C120221012, C120240811, C120270612, C120280612, C120300512, C120310512. Item  ...
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Class II Certain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella Chs Inc
Biologics Red Blood Cells 2182124; 1799950 Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 2182124 Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Food Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack. They use a manufacture date code. 712 means July 2012. Their customer letter states product manufactured July 1, 2012 to present. Class II The product was manufactured with a Soy Protein Isolate manufactured by CHS, Inc and may be contaminated with Salmonella. Mother Earth International LLC
Biologics Red Blood Cells 1741752; W036813022451; W036812642595; 1484265; Class II Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF, Pooled W036813801696 Class II Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812852142 Class II Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812642595 Class III Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF 1741752 Class II Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 1484265 Class II Blood products, collected from an ineligible donor, was distributed. Community Blood Centers of South Florida, Inc.
Drugs Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10 Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014 Class III Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D) West-ward Pharmaceutical Corp.
Devices Bigliani/Flatow® The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic. Item 00-4301-012-17; lot 62283991 Class II The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices. Zimmer, Inc.
Devices Sovereign® Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. Product Name: Sovereign® Compact Console Universal, Part Number: CMP680300. The Sovereign® Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign® Compact systems  ...
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Class II Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign® Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery. Abbott Medical Optics, Inc.
Food "***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 364-5569** SOCKEYE LOX Net Wt. 4 oz***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class I Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Food SOCKEYE SALMON: 1) "***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: SOCKEYE SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 2) "***SOCKEYE SMOKED SALMON TRIM***NET WT: 2 lbs (908g)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. (No Preservatives or Artificial Colors)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SOCKEYE SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Alaskan Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44900 8***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class II Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Food ATLANTIC SALMON: 1) "***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR, SODIUM NITRITE, NATURAL WOOD SMOKE. CONTAINS: SALMON (FISH)***READY TO EAT***REFRIGERATED BELOW 38F***Proudly Distributed By: Raley's, 500 West Capitol Avenue, West Sacramento, CA 95605***0 46567 50029 4***". 2) "***LOX TRIM*** NET WT: 2 lbs (908g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: ATLANTIC SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SALMON NOVA LOX (Pre-Sliced)***NET WT: 3 lbs ( 1 .36kg)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***0 16468 42072 4***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class II Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Food KETA SALMON: 1) "***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44294 8***". 2) "***WILD KETA SMOKED SALMON (NOVA LOX) TRIM***NET WT: 2 lbs (908g)***INGREDIENTS. Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40. Natural Wood Smoke. CONTAINS: WILD KETA SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: KETA SALMON (FISH)***0 16468 44305 1***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class II Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Food "***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD&C Red #40 (color enhancers), Natural Wood Smoke. CONTAINS: FISH (SALMON)*** Salmolux Federal Way, WA 98003***0 16468 44543 7***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class II Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Food "***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44328 0***". Production Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product. Class II Cold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes. Salmolux (A Pacific Seafood Group Company)
Devices NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract. Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798 Class II Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. Boston Scientific Corporation
Devices NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract. Lot Number: 15982017, 15963887, 16034014 Class II Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. Boston Scientific Corporation
Devices ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. C7120 Lot's #: 1301184, 1301214, 1301254, 1301284, 1301294, 1302014, 1302044, 1302054, 1302064, 1302074, 13020124, 1302134, 1302144, 1302194, 1302204, 1302214, 1302224, 1302254, 1302264, 1303014, 1303054, 1303064, 1303074, 1303114, 1303124, 1303204, 1303214, 1303264, 1303274, 1303284, 1304014, 1304034, 1304054, 1304154, 1304294, 1304304, and 1305014. Class II Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. Linvatec Corp. dba ConMed Linvatec
Devices ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. C7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024 Class II Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. Linvatec Corp. dba ConMed Linvatec
Food Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGEN ROAD TRUMANBURG, NY 14886. Ingredients: raw milk, rennet, calcium chloride, culures, salt under investigation Class I Listeria monocytogenes contamination. Finger Lakes Farmstead Cheese Company Llc
Food Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt under investigation Class II Listeria monocytogenes contamination. Finger Lakes Farmstead Cheese Company Llc
Food Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls. All Lots 03-25-11 t0 05-21-13 Class II ABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility. ABCO Laboratories, Inc.
Devices Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. Lot 11PR08083 Class II Cassette may leak during set up or during peritoneal dialysis treatment Fresenius Medical Care Holdings, Inc.
Devices RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. Lot/Batch Number: 091541 Class III Product labeled with incorrect expiration date. Boston Scientific Corporation
Food Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869 None, the product is not lot coded Class I Product which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence. Creole & Company, LLC
Food ARO Pistachios, Pistachios raw kernel - no salt; Sold in 9 oz. raw kernel, no salt airtight jar; 2.5 lb raw Kernel, no salt, air tight jar; 30 lb Bulk raw kernel, no salt. all codes in 2012 crop year. Class I Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm. ARO Pistachios, Inc.
Food ARO Pistachios, Inc., Pistachios roasted/salted, in shell; sold in 6 oz. in shell R/S Poly Resealable bag; 1 lb. in shell R/S Poly Resealable bag; 2 lb. R/S airtight Jar 5 lb. in shell R/S Poly Resealable bag 25 lb bulk in shell R/S All codes from 2012 crop year. Class I Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm. ARO Pistachios, Inc.
Food ARO Pistachios, Inc., Pistachios roasted inshell - no salt; 25 lb bulk . All codes from 2012 crop year. Class I Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm. ARO Pistachios, Inc.
Food ARO Pistachios, Inc., Pistachios inshell - raw; 25 lb bulk . All codes from 2012 crop year. Class I Epidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm. ARO Pistachios, Inc.
Food Item Number: 101643 Item Description: TUB CHOC DD PEANUTS Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Tub (Zoppity Label on Top, Nutritional Label on Bottom) UPC Number: 094776095575 Lot Number: 22201304 Best By Date: 4/22/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192772 Item Description: BAG CLR SUNFLOWER R/SEA SALT Case Pack: 12 Package Size: 11 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018849 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192806 Item Description: BAG CLR PUMPKIN SD R/SEA SALT Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018832 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192874 Item Description: BAG CLR SUNFLOWER MEAT W/SLT Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000424 Lot Number: 15201304 Best By Date: 4/15/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192959 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 2.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207022501 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192976 Item Description: BAG CLR SUNFLOWER MEAT RAW PP Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000202 Lot Numbers: 08201304, 15201304, 23201305, 03201306, 06201306 Best By Dates: 4/8/2014, 4/15/2014, 5/23/2014, 6/3/2014, 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 192993 Item Description: BAG CLR SESAME STX OAT BRAN PP Case Pack: 12 Package Size: 4.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000011 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193010 Item Description: BAGS SM CASHEW JUMBO R/S Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207022068 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193044 Item Description: BAGS LG PECAN PIECES Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207016227 Lot Number: 08201304 Best By Date: 4/8/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193061 Item Description: BAG CLR ALMOND SLICED RAW PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000110 Lot Numbers: 08201304, 23201305, 03201306 Best By Dates: 4/8/2014, 5/23/2014, 6/3/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193078 Item Description: BAGS SM SUNFLOWER SHELLED R/S Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207029029 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193095 Item Description: BAGS LG SESAME STIX HONEY Case Pack: 12 Package Size: 4.5 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207004484 Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193129 Item Description: BAGS LG CASHEW JUMBO R/S Case Pack: 12 Package Size: 6 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207022853 Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193282 Item Description: BAG CLR CASHEW JUMBO N/SALT PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000288 Lot Number: 06201306 Best By Date: 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193333 Item Description: BAGS LG WALNUT HALVES & PIECES Case Pack: 12 Package Size: 6.5 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015206 Lot Numbers: 08201304, 06201306 Best By Dates: 4/8/2014, 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193435 Item Description: BAGS LG PUMPKIN SEEDS I/S R/S Case Pack: 12 Package Size: 7 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025151 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193673 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025106 Lot Number: 23201305 Best By Date: 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193775 Item Description: BAGS SM ALMOND SLIVERED Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018412 Lot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193843 Item Description: BAGS SM ALMONDS SLICED RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018351 Lot Numbers: 08201304, 03201306, 06201306 Best By Dates: 4/8/2014, 6/3/2014, 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 193894 Item Description: BAGS SM ALMONDS WHOLE RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018405 Lot Number: 06201306 Best By Date: 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 196274 Item Description: BAGS LG ALMOND SLICED Case Pack: 12 Package Size: 3.25 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018207 Lot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 196291 Item Description: BAGS SM WALNUT HALVES & PIECES Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015121 Lot Number: 08201304 Best By Date: 4/8/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 196325 Item Description: BAG CLR ALMOND SLIVERED Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000127 Lot Number: 06201306 Best By Date: 6/6/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 201612 Item Description: BAGS SM PISTACHIO SHELLED R/S Case Pack: 12 Package Size: 0.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207020217 Lot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 204128 Item Description: TUB PAN MD ALMOND ROASTED N/S Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005030 Lot Number: 30201305 Best By Date: 05/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 204145 Item Description: TUB PAN MD CASHEW JUMBO N/S Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005061 Lot Number: 30201305 Best By Date: 05/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 208903 Item Description: TUB SM PEPITA ROASTED W/SALT Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208113017 Lot Number: 09201305 Best By Date: 5/9/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 224411 Item Description: MIX CHERRY BERRY DELITE Case Pack: 1 Package Size: 25# Cardboard Box with Plastic Liner UPC: 094776121793 Lot Number: 15201304 Best By Date: 04/15/14 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 333803 Item Description: TUB SM PISTACHIO MEAT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208123818 Lot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 357642 Item Description: TUB SM ALMOND WHOLE RAW Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208107450 Lot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 364761 Item Description: BAGS SUNFLOWER KERNEL RAW PP Case Pack: 12 Package Size: 12 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110452 Lot Numbers: 08201304, 30201304, 05201306 Best By Dates: 4/8/2014, 4/30/2014, 6/5/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 364773 Item Description: BAGS PUMPKIN SEEDS NATURAL PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110353 Lot Number: 05201306 Best By Date: 6/5/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 364926 Item Description: BAGS PEAS WASABI PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110582 Lot Number: 08201304 Best By Date: 4/8/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 364932 Item Description: BAGS PRETZELS YOGURT PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110599 Lot Number: 08201304 Best By Date: 4/8/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 365163 Item Description: BAGS BANANA CHIPS PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110186 Lot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 365172 Item Description: BAGS MIX CHERRY BERRY DELIGHT PP Case Pack: 12 Package Size: 9.5 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110209 Lot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 366568 Item Description: TUB LG MIX DIET DELIGHT Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081769 Lot Numbers: 09201304, 20201305 Best By Dates: 4/9/2014, 05/20/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 368712 Item Description: TUB MD GOOD & PLENTY Case Pack: 12 Package Size: 16 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110032 Lot Number: 30201305 Best By Date: 05/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 368729 Item Description: TUB MD HAZELNUT/FILBERT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110049 Lot Number: 30201305 Best By Date: 05/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 368768 Item Description: TUB LG SUNFLOWER MEAT R/NS Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081752 Lot Numbers: 09201304, 24201304, 20201305, 30201305 Best By Dates: 4/9/2014, 04/24/2014, 05/20/2014, 05/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 373703 Item Description: TUB LG ALMOND ROASTED N/SLT Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776076116 Lot Number: 01201305 Best By Date: 05/01/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 374103 Item Description: TUB LG ALMOND WHOLE RAW Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081820 Lot Number: 09201304 Best By Date: 4/9/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 374903 Item Description: TUB LG MIXED NUTS DELUXE W/S Case Pack: 12 Package Size: 13 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081707 Lot Number: 24201304 Best By Date: 04/24/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 379235 Item Description: BAG CLEAR PINE NUTS Case Pack: 12 Package Size: 3 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 094776110087 Lot Number: 03201306 Best By Date: 6/3/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 392103 Item Description: TUB LG CASHEW RAW WHOLE 320 Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208124983 Lot Number: 09201304 Best By Date: 4/9/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 395203 Item Description: TUB LG SUNFLOWER MEAT RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No label on Top, Nutritional Label on Bottom) UPC Number: 094776081738 Lot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 461564 Item Description: TUB PL LG SUNFLOWER SEED RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (Private Label on Top, Nutritional Label on Bottom) UPC Number: 094776081738 Lot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 423622 Item Description: TUB MD MIX CHERRY BERRY Case Pack: 12 Package Size: 12 OZ 2-Piece Clear Plastic Tub ('Cherry' Label on Top, Nutritional Label on Bottom) UPC Number: 094776111404 Lot Number: 16201305 Best By Date: 5/16/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 545303 Item Description: NATURAL GINGER CRYSTALLIZED Case Pack: 12 Package Size: 7 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082940 Lot Number: 09201305 Best By Date: 5/9/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 545603 Item Description: NATURAL ALMONDS DARK CHOC Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082971 Lot Number: 08201304 Best By Date: 4/8/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 545803 Item Description: NATURAL SUNFLOWER KERNEL Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082995 Lot Numbers: 08201304, 22201304, 08201305, 09201305, 23201305, 24201305 Best By Dates: 4/8/2014, 4/22/2014, 5/8/2014, 5/9/2014, 5/23/2014, 5/24/2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Item Number: 631215 Item Description: SUNFLOWER SEED KERNELS RAW Case Pack: 1 Package Size: 50# Brown Bag UPC Number: 079348999086 50# Lot Numbers: PRO-1346, PRO-1349 Best By Date: April 2014 Class I Contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Lipari Foods, Inc.
Food Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed with desired liquid or as directed by a healthcare practitioner. California Proposition 65 warning: this product contains lead, a chemical known to the State of California to cause birth defects or other reproductive harm. UCP 13947-73560 and 13947 73820 formulated exclusively for Allergy Research Group, Alameda, CA 94502. Product number 73560, 53560 - 300 gr. Lot numbers: 11030685, Exp 6/1/13; 11030686, Exp 6/1/13; 11100829, Exp 11/1/13; 11100835, Exp 11/1/13; 12010362, Exp 4/1/14; 12061214, Exp 8/1/14; 12061217, Exp 8/1/14; 13010635, Exp. 2/1/15. Product number 73820, 53820 - 900 gr. Lot numbers: 11030676, Exp Jun 2013; 11030686, Exp 6/1/13; 11100836, Exp 11/1/13; 12010363, Exp 4/25/14; 12061215, Exp 8/1/14; 12061218, Exp 8/1/14; 13010636, Exp 2/1/15; Class II Allergy Research Group received word from their contract manufacturer, ABCO Laboratories, that two of their products have been manufactured with soy based products from CHS Inc. at it Ashdod, Israel facility. Allergy Research Group
Food Eagle Premium, Snack Shoppe, Pistachios, in-shell pistachios, packaged in 2-oz (UPC 4262500705) and 5.25-oz (UPC 42625000604) bags. Distributed by: Genco Marketing, Omaha, NE. 2-oz packages - Best Before: 10/16/13; 10/17/13; 10/18/13; 10/30/13; 11/14/13; 12/15/13; 02/20/14; 03/04/14; 03/18/14; 03/26/14; 04/04/14; 04/16/14; 04/23/14 and 05/16/14 5.25-oz packages - Best Before: 10/16/13; 04/14/14 and 04/24/14 Class I The product may be contaminated with Salmonella. Palmer Candy Co
Devices Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets. Class I Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin Medtronic MiniMed
Devices AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices. Catalog #700-101892, Lot number: 30.12 Class II The RITA Main Cable product contains the incorrect Instructions for Use. Angiodynamics, INC
Food Roasted and Salted In Shell Pistachio Nuts, repackaged into 48 ounce red topped gift jars labeled "Orchard Fresh HINES"; 16 ounce trays labeled "Natural Pistachios, Roasted and Salted"; and 16 ounce bags labeled "Hines Natural Pistachios". No lot number appears on the gift jars; the trays and 1 pound bags have a Hines Nut Company lot number "04396" or "4396". Class I The product recall is being initiated because the product has the potential to be contaminated with Salmonella. Hines Nut Co
Devices Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752 Class I The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. Bryan Medical Inc
Devices REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M619730 , M480920, M656920, M938460, M444630 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M619740, M492940, M444640, M656930, M938470 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M879630 , M584360, M492950, M444650, M656940, M938480 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M879640, M375460, M444660, M886350, M938490 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M375470, M444680 , M886360, M938500 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M561220 M584370 M151880 , M444690, M886370 , M956050, Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M619750 ; M375480; M886380, M956060 , M444700 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M561290, M956070, M444710 6, M136780, M886390 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M375490, M444720 , M886400, M956080 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M375500 ,M886410, M444760, M956090 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M321570, M894590,M619770, M480930, M656950 M444780, M969100 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M321580 , M619780, M492960, M656960, M969120 , M444790 6 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M539400, M619790, M987360 , M444800, M969130, M151150, M987360 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M492970, M598310, M598310, M656980, M969150 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M584380, M754830, M969160, M444820, M987510 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M987290, M035670, 987410, M444830, M920680, M754840 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M598320, M480940, M987300, M444840, M656990 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M300790, M632920, M539410, M444850, M987620, M987310 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M632930 , M539420 , M444860 , M657010, M987630 , M987320 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M561240, M632960 , M136950 M657040 , M722420 , M444890 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M480950 , M657050, M444900 , M030220 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M321600, M539430, M444910, M657070,M722440, M136980, M444910 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M921180, M539440, M444920, M722450, M136990, M657080 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M561250, M657110, M017540, M166880, M920640, M886440 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M480960, M657120, M886450, M166890, M920650 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement. M492980, M657130, M920670, M886460, M166900 Class II Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. Biomet, Inc.
Devices Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03 Class II Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101. Cardio Medical Products
Food Treasured Harvest-Roasted & Salted Pistachios, 5lbs, 12oz, 6oz Lot Codes: 6 oz. size: 123050, 123140, 123320, 123450, 123360, 130150, 130240, 130350; 12 oz. size: 130290; 5 lb. Size: 123550, 130020 Class I Pistachios may be contaminated with Salmonella. Western Mixers Produce & Nuts, Inc.
Food Treasured Harvest-Assorted Nut Trays, 28 oz, 6 per carton Lot Codes: 123100, 122960, 123040 Class I Pistachios may be contaminated with Salmonella. Western Mixers Produce & Nuts, Inc.
Food Treasured Harvest-Raw, Shelled Pistachios, 5lbs & 1lb, 1 per carton Lot Codes: 1lb size: 131540; 5lbs size: 131160, 131200, 131230, 131300, 131400; Class I Pistachios may be contaminated with Salmonella. Western Mixers Produce & Nuts, Inc.
Devices Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography Model number 10140000, serial numbers 3118, 3243 and 3309 Class II Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this issue, and a Siemens Service Engineer has inspected the units and made any adjustments necessary. Siemens Medical Solutions USA, Inc
Drugs Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. Lot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13. Class II Crystallization; crystallized nimopdipine Sun Pharmaceutical Industries Inc.
Devices Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint. The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC. Class II The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. Integra LifeSciences Corp.
Food LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN. Lot code: 28 / JUN / 2013 / 01 Best By Date: 28 / JUN / 2013 / 01 Class II Garden Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan dip containers. Garden-Fresh Foods, Inc.
Food Granna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings Best By dates of 06/20/2013 to 06/20/2014. Class I The product was recalled due to undeclared egg. Granna's, LLC
Devices GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366 Class II DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization. DeRoyal Industries Inc
Food Torn and Glasser Brand Roasted & Salted Natural Pistachios, 8 oz. 24/8oz Case. Labeling reads in part:"TORN & GLASSER***ROASTED & SALTED NATURAL PISTACHIOS***NET WT. 8 OZ***Packed by:Torn & Glasser, Los Angeles, CA***" Best By date:12/05/2012, Julian date 3402 UPC: 0 72488 15002 7 Class I Pistachios have the potential to be contaminated with Salmonella. Torn & Glasser Inc.
Food Roasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various weights. into 12 individual plastic bags with various weights per unit, then packaged into 10 lbs cardboard box. . Sun Harvest Brand Roasted & Salted Pistachios, 12 oz., packaged in plastic bag then packed into cardboard case. 24/12oz. Hilo Brand Roasted & Salted Pistachios, 16 oz., plastic bags, packed into 12/1lb case. Individual 1 lb plastic bag labeling. Outer case #H460-084; 12/1 LB (454g). Sprouts - Best By dates:02/20/2013, 02/25/13; Julian Dates:0513 and 0563; UPC code changes for each package of Sprouts product as it has the price coded, 2 06620 xxxxx x. Sun Harvest - Best By Dates:04/11/2013 & 04/23/2013; Julian Dates:1003 and 1133. Hilo - Best By Date:04/02/2013; Julian Date:0923 Class I Pistachios have the potential to be contaminated with Salmonella. Torn & Glasser Inc.
Food R.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case. Product Code  CFBATTEB, 1464; Lot Code  3-066-133872 Class III Product contains undeclared Red 40. Product does not meet quality specifications for color. R.L. SCHREIBER INC - LEBANON
Devices Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. *** 1) Product Code: 2C1008KP; Lots: 08M036, 08N041, 09A030, 09B044, 09C053, 09D018, 09E019, 09F005; *** 2) Product Code: 2C1009KP; Lots: 08M016, 08M035, 08M066, 09A010, 09A052, 09A065, 09A080, 09B038, 09B048, 09B060, 09B074, 09C03, 09C016, 09C044, 09C060, 09D011, 09D042, 09D049, 09D054, 09E021, 09E043, 09F002; *** 3) Product Code: 2C1063KP; Lots: 08K078, 08M014,  ...
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Class II There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use. Baxter Healthcare Corp.
Devices Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. *** 1) Product Code: 2C1700KP; Lots: 09C013, 09D023; *** 2) Product Code: 2C1702KP; Lots: 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070 Class II There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use. Baxter Healthcare Corp.
Devices Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management. *** 1) Product Code: 2C4700K; Lot: 09A014 Class II There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use. *** Note: This product was not sold in the United States. Baxter Healthcare Corp.
Drugs Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02 a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014; Class II Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials Fresenius Kabi USA, LLC
Devices da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. Part number 380610-15: Serial numbers: 323936 323937 325082 325143 325175 325178 325355 325290 325352 325669 325672 325692 325444 325446 325447 325583 325585 325587 325634 325671 325684 325720 325724 325719 325888 325465 325549 325266 325268 323875 324092 324098 324100 324190 324258 324260 324265 324370 324425 324426 324528 324585 324586 324638 324649 324847 324848 324849 325076 Class II Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Intuitive Surgical, Inc.
Devices da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. Part number 380990-11: Serial numbers: 324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334. Class II Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Intuitive Surgical, Inc.
Devices da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. Part number 372019-01: Serial numbers: 323943 323895 323882 323945 323994 323804 323979 323987 324042 324086. Class II Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Intuitive Surgical, Inc.
Devices da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. Part number 372012-96: Serial numbers: 323986 324198. Class II Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. Intuitive Surgical, Inc.
Food Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries Net Wt. 25 lbs Product of USA Traverse City, MI 49684 Lot 02513 Class II GKI is recalling Dark Chocolate Cherries produced on Jan 25, 2013 because dark chocolate strawberries are mixed with dark chocolate cherries. The strawberries contain sufites which are not declared on the label. GKI Foods, LLC
Food Milagros Green Corn Tamales, packaged in plastic in quantities of one dozen No lot/production codes on the products Class II Los Milagros Tortilleria is recalling Milagros Tortillas Green Corn Tamales because they did not list the sub-ingredient for Monterey Jack Cheese which contains the milk allergen. Los Milagros Tortilleria, LLC
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