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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___" BB Sept 21, 2013 BB Nov 26, 2013 BB Nov 27, 2013 BB Nov 20, 2013 BB Feb 29, 2013 Class III GL Food Wholesale is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms. G.L. Food Wholesale Inc
Food Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___" BB Apr 26, 2013 BB May 24, 2013 Class III Golden Dharma International is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms. Golden Dharma International Corp
Food Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___" BB Mar 16, 2014 BB Mar 17, 2014 BB Mar 20, 2014 BB Aug 14, 2014 BB Sept 11, 2014 BB Sept 12, 2014 Class III Mandalay Trading is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms. Mandalay Trading Corporation
Food Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___" all lots Class III Walong is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms. Walong Marketing, Inc.
Biologics Red Blood Cells LG13666; LG13318 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. LifeServe Blood Center
Biologics Source Plasma 6150025377;6150024781;6150024580;6150021661;6150021487;6150020920;6150025471 Class II Blood products, collected from a donor whose physical was overdue, were distributed. ZLB Bioplasma, Inc.
Biologics Red Blood Cells KW94520; KW92744; KW90445 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. LifeServe Blood Center
Biologics Fresh Frozen Plasma KW88673 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced KW88673 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. LifeServe Blood Center
Biologics Platelets Irradiated KW88673 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 11FR07265 Class II Blood product, which was entered negative in the computer for K, Fya and Fyb antigen when tested turned out to be positive, was distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing LT79278 Class III Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. LifeServe Blood Center
Biologics Red Blood Cells 11KS10932 Class II Blood product, collected from a donor in which hematocrit and hemoglobin was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 09FZ51123; 09FZ51136 Class II Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 6690261 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 2024507 Class II Blood products, collected from a donor who received a MMR vaccine, were distributed. Siouxland Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 011KV10514 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen 011KV10514 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 2046257(Part A); 2046257(Part B) Class III Blood products, collected from a donor without a documented result for body temperature, were distributed. Siouxland Community Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 09GR11089; 09GR11095 Class II Blood products, possibly contaminated with air, were distributed. American National Red Cross (The)
Food Wildcat Creek Farms Country Style Butter Flavored Popcorn Salt, 4.5oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8. 4633 Rd. 94, Payne, OH 45880 All product. 4.5 oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8 Class I Possible undeclared allergens. Milk, eggs, yellow #5, yellow #6 and red 40. WILDCAT CREEK POPCORN
Biologics Red Blood Cells Leukocytes Reduced 21KS76848; 21KS76854; 21KS76857 Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping or storage, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 009FQ38724 Class II Blood products, which were not quarantined subsequent to receiving post donation information, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 009FQ38724 Class II Blood products, which were not quarantined subsequent to receiving post donation information, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42 FZ34322, 42 FZ34323, 42 FZ34325, 42 FZ34328, 42 FY90934, 42 FY90942, 42 FY90943, 42 FY90947, 42 FY90954, 42 FY90990, 42 FY90993, 42 G76618, 42 G76631, 42 G76632, 42G 76644, 42 G 76646, 42 R05856, 42 R05859, 42 R 05863, 42 R05872, 42 R05877, 42 R05880, 42 K06759, 42 K06764,  ...
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Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 42 FY90992, 42 FY90993, 42 R05863, 42 R05877, 42R05880, 42 S41235, 42 S41239, 42 S41247, 42 K06775, 42 K06777, 42 K06794, 42FH67049 Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 25612, 25600,25607, 25634, 25694, 25713, 25731, 25781, 25938, 26009, 26036 Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 21KS81850; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS81947; 21KS82044; 21KS82070; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82142; 21KS82158; 21KS82159; 21KS82162; 21KS82165; 21KS82343; 21KS82344; 21KS82485; 21KS82487; 21KY24230; 21KY24248; 21LG75833; 21LG75842; 21LG75852; 21LG75874; 21LG75890; 21LG75920; 21LG75931; 21LG75963; 21LG75981; 21LG75982; 21LK55444; 21LK55449; 21LK55473; 21LL53586; 21LL53593; 21LL53597; 21LL53612; 21LL53616; 21LL54081; 21LL54095; 21LS04243; 21LS04244. Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 21KS82405; 21KS82409 Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 21KY24238; 21LH71621. Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 21KS81143; 21KS81153; 21KS81169; 21KS81174; 21KS81177; 21KS81182; 21KS81406; 21KS81409; 21KS81418; 21KS81426; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS82044; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82318; 21KS82343; 21KS82344; 21KY24230; 21KY24234; 21KY24238; 21KY24248; 21LG74950; 21LG75874; 21LG75890; 21LG75963; 21LG75981; 21LG75982; 21LH70417; 21LH70423; 21LH70426; 21LH70436; 21LH70451; 21LH70454; 21LH70460; 21LH70462; 21LH70468; 21LH70478; 21LL51972; 21LL52214, 21LL52547; 21LL53593; 21LL53597. Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 21KS82070; 21KS82165; 21KS82485; 21KS82487; 21KW70562; 21KW70564; 21KW70567; 21KW70568; 21KW70571; 21KW70579; 21KY23565; 21KY23579; 21KY23581; 21KY23590; 21KY23592; 21KY23602; 21LG75833; 21LG75852; 21LG75961; 21LH70618; 21LH70637; 21LH70642; 21LH70644; 21LL53612. Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Plasma Frozen Cryoprecipitate Reduced 21KS81418; 21KS81426; 21KY24230; 21LG75006; 21LH70417; 21LH70426; 21LL51972; 21LL52533; 21LL52547. Class II Blood products, possibility sterility compromised and contaminated, were distributed. American National Red Cross (The)
Biologics Source Plasma 79691994, 79688918, 79681117, 79669337, 79665902, 79652131, 79643740, 79638296, 79632287, 79626439, 79620741, 79612906, 79605069, 79601085, 79594257, 79587846, 79577717, 79565332, 79556729, 79552424, 79545914, 79533102, 79525572, 79520171, 79512305, 79507509, 79499057, 79493970, 79466837, 51575007, 51560096, 51555603, 51547356, 51542252, 51532291, 51528041, 51518271, 51513498, 51505011, 51500313, 51490287, 51485825, 51462581, 51457266, 51446741, 51441777. Class III Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. CSL Plasma, Inc.
Drugs Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072. Lot #: 9P367, Exp 12/12 Class II Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone. K C Pharmaceuticals Inc
Biologics Source Plasma 3630073785;3630073518;3630072890;3630072647;3630072205;3630071839;3630071293;3630071007;3630070559;3630070320;3630069898;3630069481;3630069198;3630068539;3630068130;3630067782;3630067388;3630067044;3630066659;3630066336;3630065972;3630065728;3630065190;3630065072;3630064636;3630064397;3630063950;3630063687;3630063267;3630062408;630062257;3630061843;3630061630;3630061193;3630060947;3630059940;3630058945;3630058778;3630056492;3630054774;3630054529;3630054303;3630053267;3630052995;3630052699;3630052510;3630049755;3630049615;3630049412;3630049164;3630049011;3630048782;3630048674;3630048440;3630048288;3630047925;3630047765;3630047517;3630047636;3630047017;3630046878 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Drugs PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 Lot #33250311 Exp. 04/13 Class II Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. A B Nutrition, Inc.
Drugs PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090 Lot # 33280311 Exp. 03/13 Class II Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. A B Nutrition, Inc.
Drugs ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090 Lot # 32000311 Class II Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. A B Nutrition, Inc.
Biologics Source Plasma 11CWYD2770; 11CWYD2350; 11CWYC4816; 11CWYC4486; 11CWYC3904; 11CWYC3580; 11CWYC3052; 11CWYC2727; 11CWYC1908; 11CWYC1363; 11CWYC1017; 11CWYC0112; 11CWYB9556; 11CWYB9227; 11CWYB8692; 11CWYB7810; 11CWYB8359; 11CWYC2252; 09CWYA7624; 09CWYA8110; 09CWYA8874; 09CWYA9397; 09CWYB0181; 09CWYB0702; 09CWYB1521; 09CWYB2032; 09CWYB2858; 09CWYB3354; 09CWYC0658; 09CWYC1200; 09CWYC2126; 09CWYC2665; 09CWY3564; 09CWY4102; 09CWYC4978; 09CWYD3431; 09CWYD4255; 10CWY5744; 10CWYD6006; 10CWYD6456; 10CWYD6716; 11CWYA8273; 11CWYA8597; 11CWYA9130; 11CWYA9455; 11CWYB0013; 11CWYB0319; 11CWYB08113; 11CWYB1113; 11CWYB1698;  ...
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Class III Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. BioLife Plasma Services L.P.
Devices Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. Part Number: 0609-2809-06, Lot: 39AQ Class II Implants were incorrectly laser marked as 23mm instead of 28mm. Spine Smith Partners LP
Food Peanut Butter Power Chews sold as a bulk item through Whole Foods Market self serve bins, PLU 9663 All product sold through the firm's self serve bins between May 1 and September 27th. Class I The bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc. Whole Foods Market
Food Treasure Trove Mix, sold from Whole Foods Market Bulk Bins PLU 6922 All product sold through the firm's self serve bins between May 1 and September 27th. Class I The bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc. Whole Foods Market
Food Chocolate Peanut Butter Cup Gelato. The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and is packaged in clear, plastic One Pint (473ml) containers with UPC code 1 86852 00094 5 printed on the back of the container and "Best By" date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The firm also sold the product in a 5 QT size with UPC code 1-8685200090-7 and best by range 03/21/13 through 03/26/2014. The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and has UPC code 1 86852 00094 5 printed on the back of the container and "Best By" date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The 5  ...
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Class I Talenti Gelato is recalling Talenti Chocolate Peanut Butter Cup Gelato. The peanut butter used in this product has the potential to be contaminated with Salmonella. Consumption of food contaminated with Salmonella 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 being initiated because the peanut butter used in the product is supplied by Sunland, Inc., which has issued a national recall of some of its products. Talenti I, LLC
Food The HINES package is a cello/poly laminated bag, predominately blue, with a yellow label stating "SALTED JUMBO VIRGINIA PEANUTS" packed as 8 oz, 10 oz, 12 oz, 16 oz and 24 oz; Hines also packages three "theme" cello/poly laminated bags that are 5.5oz each. The themes for these bags are: 1) Independence Day - red, white and blue in color with a stylized flag on the front; 2) Football Season - with a football on the front; and Hunting Season - with a camouflage motif on the front of the bag. The Dollar General Clover Valley package is a cello/poly laminated bag, predominately white with red trim and red lettering. These bags are packaged as 8 oz bags. The product will have best by/expiration dates on the packaging from October 12, 2012 through August 27, 2013. The  ...
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Class I Hines Nut Company Inc. recalled its SALTED JUMBO VIRGINIA IN-SHELL PEANUTS. These peanuts were processed in the Sunland, Inc. Peanut Processing Plant and may be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and those 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. Hines Nut Co
Devices Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. Model number 1052; Lots M674180, MAKL170, M674200 Class II Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures. Instratek, Incorporated
Food Raspberry Flavor no code Class III The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40 and Blue #1 Bakery Cash & Carry Inc.
Food Butter Flavor no code Class II The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Yellow#5, Yellow #6 and Red #40 Bakery Cash & Carry Inc.
Food Butter Cream no code Class II The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: The ingredient partially hydrogenated vegetable oil contains soybean oil as a sub-ingredient. Bakery Cash & Carry Inc.
Food Brandy flavor no code Class II The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40, Yellow#5, Yellow #6, Blue#1 and Sulfites. Bakery Cash & Carry Inc.
Biologics Red Blood Cells Leukocytes Reduced W069112124448; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W038112140935; W038112214027; W038112115492; W038112070188; W038112056857; W038112023793; W038112023467; W038112040729; W038111354805; W038111354804; W038111321390; Class II Blood products, leukoreduced more than three days after collection, were distributed. Florida's Blood Centers - Lake Park
Biologics Red Blood Cells Leukocytes Reduced W038111368727; W038111244184; W038111244903; W038111240489; W038111189594; W038111181167; Class II Blood products, leukoreduced more than three days after collection, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 53H35682; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
Biologics Plasma Frozen within 24 hours (FP24) 53H35682; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
Biologics Platelets Pheresis Leukocytes Reduced W227012037073; W227012037073; Class II Blood products, collected from a donor whose eligibility to donate was not adequately determined, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W125612441491; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced W087612049410; Class II Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W051512089599; Class III Blood product, collected in an expired collection bag, was distributed. Memorial Blood Centers
Biologics Red Blood Cells Washed W050912080799; W050912079977; Class III Blood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated Washed W050912082047; W050912079718; W050912067108; Class III Blood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W051512125236; W051512125236; Class II Blood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed. Memorial Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced W056312004293; Class II Blood product, with platelet yield that did not meet the specified minimum requirement, was distributed. St Mary's Hospital and Medical Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115112345094Z; W115112345094Z; W115112345094Z; Class II Blood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115112376125F; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W115112323972Y; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W1151123080944; Class III Blood product, collected from a donor who reported post donation illness, was distributed. LifeSouth Community Blood Centers Inc
Biologics Platelets Pheresis Leukocytes Reduced W115112340698M; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Devices AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207 Diopter 23.5 4759221207 4759821207 4760161207 4759231207 4759831207  ...
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Class II Two production orders of these IOLs that contain mislabeled IOLs. Abbott Medical Optics Inc (AMO)
Drugs PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14 Class III Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. AstraZeneca LP
Drugs PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14 Class III Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. AstraZeneca LP
Devices Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. Siemens Material Number (SMN) 10444944, Catalog number DF84 -- lot numbers BA3016, EXP 2013-01-16; EC3045, EXP 2013-02-14; EA3073, EXP 2013-03-14; DC3102, EXP 2013-04-12; FC3122, EXP 2013-05-02; EA3157, EXP 2013-06-06; BB3184, EXP 2013-07-03; EC3219, EXP 2013-08-07; EC3220, EXP 2013-08-08; GA3248, 2013-09-05; and FB3290, EXP 2013-10-17 Class III The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L). Siemens Healthcare Diagnostics, Inc.
Food Tausi Salted Black Beans, 180 gram (6.34 oz.) can. Ingredient: Black Beans, Water, Iodized salt, sugar and caramel. Distributed by V8 Commercial Co., Inc., San Juan, Metro Manila. Product of the Philippines. UPC 97399 00109 BB:FEB.15, 2013; BB:APR.26, 2013; BB:FEB 15, 2014; BB: APR.11,2013. Class III Reports were received of swollen cans of Tausi Salted Black Beans imported from the Philippines. JMT Trading Company, Inc.
Devices Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Lot Numbers 6602070, 6582333, 6581191, and 6581193 Class II The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. Synthes USA HQ, Inc.
Devices Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process. 151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043,  ...
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Class II The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name. Elekta, Inc.
Devices Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients. Lot Number 7542279 Class II Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm. Synthes USA HQ, Inc.
Devices GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. For use in diagnostic and interventional angiographic procedures of human anatomy. INNOVA 41001Q 00000000609MC8 00000000605MC6 00000000535MC5 00000000225MC3 00000000226MC1 00000000463MC0 00000000223MC8 00000000377MC2 00000000816MC9 00000000841MC7 00000000469MC7 00000000228MC7 00000000830MC0 00000001258MC3 00000000937MC3 00000000485MC3 00000000376MC4 00000000807MC8 00000001078MC5 00000000821MC9 00000000125MC5 00000000123MC0 INNOVA 4100 00000000207MC1 00000000823MC5 00000000814MC4 00000000468MC9 00000000484MC6 00000000465MC5 00000000462MC2 00000000229MC5 00000000606MC4 00000000553MC8 00000000669MC2 00000000212MC1 00000000477MC0 00000000667MC6 INNOVA 31001Q 00000000647MC8 00000000723MC7 00000000620MC5 INNOVA 3100 00000001211MC2 00000000765MC8 INNOVA  ...
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Class II GE Healthcare has recently become aware of a potential safety issue involving a locking nut which might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems. GE Healthcare, LLC
Biologics Level 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V Serial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043 Class II Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. Smiths Medical ASD, Inc.
Devices Level 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V Serial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043 Class II Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. Smiths Medical ASD, Inc.
Biologics Level 1 Fast Flow Fluid Warmer's with and without air detection Reorder Number: H-1200 115V and 230V Serial Numbers: S10000010 S10000758 S10000897 S101A00083 S103A00018 S103A00019 S103A00020 S103A00025 S103A00027 S103A00028 S103A00029 S103A00035 S103A00037 S103A00039 S103A00041 S103A00047 S103A00050 S103A00051 S103A00052 S103A00053 S103A00055 S103A00056 S103A00057 S103A00058 S103A00060 S103A00061 S103A00062 S103A00063 S103A00064 S103A00065 S103A00066 S103A00068 S103A00069 S103A00070 S103A00071 S103A00072 S103A00074 S103A00077 S103A00078 S103A00079 S103A00080 S103A00081 S103A00082 S103A00084 S103A00085 S103A00086 S103A00087 S103A00088 S103A00089 S103A00090 S103A00091 S103A00092 S103A00093 S103A00094 S103A00095 S103A00097 S103A00098 S103A00099 S103A00100 S103A00102 S103A00103 S103A00104 S103A00105 S103A00106 S103A00107 S103A00112 S103A00117 S103A00118 S103A00119 S103A00129 S103A00130 S103A00131 S103A00132 S103A00133 S103A00134 S103A00135 S103A00136 S103A00137 S103A00138 S103A00139 S103A00140 S103A00141 S103A00142 S103A00143 S103A00144 S103A00145 S103A00146 20050458 S10000851 S103B00044 S103B00093 S103B00106 S103B00116 S103B00118 S103B00121 S103B00123 S103B00130 S103B00133 S103B00134 S103B00135 S103B00136 S103B00137 S103B00138 S103B00139 S103B00140 S103B00141 S103B00142 S103B00143 S103B00144 S103B00147 S103B00148 S103B00149 S103B00150 S103B00153 S103B00155 S103B00156 S103B00163 S103B00164 S103B00165 S103B00166 S103B00167 S103B00168 S103B00169 S103B00170 S103B00171 S103B00172 S103B00173 S103B00174 S103B00175 S103B00176 S103B00177 S103B00178 S103B00179 S103B00180 S103B00181 S103B00182 S103B00183 S103B00184 S103B00185 S103B00186 S103B00187 S103B00188 S103B00189 S103B00190 S103B00191 S103B00192 S103B00193 S103B00194 S103B00195 S103B00196 S103B00197 S103B00198 S103B00199 S103B00200 S103B00201 S103B00202 S103B00203 S103B00204 S103B00205 S103B00206 S103B00207 S103B00208 S103B00209 S103B00210 S103B00211 S103B00212 S103B00213 S103B00214 S103B00215 S103B00216 S103B00217 S103B00218 S103B00219 S103B00220 S103B00221 S103B00222 S103B00223 S103B00225 S103B00226 S103B00227 S103B00228 S103B00229 S103B00230 S103B00231 S103B00232 S103B00233 S103B00234 S103B00235 S103B00236 S103B00237 S103B00238 S103B00239 S103B00240 S103B00241 S103B00242 S103B00243 S103B00244 S103B00245 S103B00246 S103B00247 S103B00248 S103B00249 S103B00250 S103B00251 S103B00252 S103B00253 S103B00254 S103B00255 S103B00256 S103B00257 S103B00258 S103B00259 S103B00260 S103B00261 S103B00262 S103B00263 S103B00264 S103B00265 S103B00266 S103B00267 S103B00268 S103B00270 S103B00271 S103B00272 S103B00273 S103B00274 S103B00275 S103B00276 S103B00277 S103B00278 S103B00279 S103B00280 S103B00281 S103B00282 S103B00283 S103B00284 S103B00286 S103B00287 S103B00288 S103B00289 S103B00290 S103B00291 S103B00292 S103B00293 S103B00294 S103B00295 S103B00296 S103B00297 S103B00298 S103B00299 S103B00300 S103B00301 S103B00302 S103B00303 S103B00304 S103B00305 S103B00306 S103B00307 S103B00308 S103B00309 S103B00310 S103B00311 S103B00312 S103B00313 S103B00314 S103B00315 S103B00316 S103B00317 S103B00318 S103B00319 S103B00320 S103B00321 S103B00322 S103B00323 S103B00324 S103B00325 S103B00326 S103B00327 S103B00328 S103B00329 S103B00330 S103B00331 S103B00332 S103B00333 S103B00334 S103B00335 S103B00336 S103B00337 S103B00338 S103B00339 S103B00340 S103B00341 S103B00342 S103B00343 S103B00346 S103B00347 S103B00348 S103B00349 S103B00350 S103B00351 S103B00352 S103B00353 S103B00354 S103B00355 S103B00356 S103B00357 S103B00358 S103B00359 S103B00360 S103B00361 S103B00362 S103B00364 S103B00365 S103B00366 S103B00367 S103B00368 S103B00369 S103B00370 S103B00371 S103B00372 S103B00373 S103B00374 S103B00375 S103B00376 S103B00377 S103B00378 S103B00379 S103B00381 S103B00382 S103B00383 S103B00385 Class II Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. Smiths Medical ASD, Inc.
Biologics Normoflo Irrigation Fluid Warmer Reorder Number: H-1100 230V Serial Numbers: S105B00009, S105B00010, S105B00011, S105B00012, S105B00015, S105B00016, S105B00017, S105B00018, S105B00019, S105B00020, S105B00021, S105B00022, S105B00024, S105B00027, S105B00028, S105B00032, S105B00041 Class II Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed. Smiths Medical ASD, Inc.
Devices ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image. Model number 10042541 - AVBS module. Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012. Class II On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. Siemens Medical Solutions USA, Inc.
Drugs Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. Lot # N03029, Exp 03/14 Class II Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle. Teva Pharmaceuticals USA, Inc.
Devices Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected . Class II Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction Medtronic Navigation, Inc.
Drugs CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10 Lot 6004889, Expiration Date 10/2014 Class III Labeling: Missing label Fresenius Kabi USA LLC (FK USA)
Devices GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy. SERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7 Class II Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected. GE Healthcare, LLC
Food Tausi Brand Salted Black Beans. Net Weight 180g (6.34 oz). Distributed by: V8 Commercial Co., Inc. San Juan, Metro Manila. Product of the Philippines. UPC 897399001097; Best by: BB Sep 21 2010. Class III This recall has been initiated due to suspected but, as of the writing of this letter (1/17/2013), unconfirmed Clostridium botulinum (C. botulinum) contamination. Phil-Am Trading, Inc.
Devices Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. All Lots Class II There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized. Synthes USA HQ, Inc.
Devices Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272922MR6 00000273268MR3 00000273598MR3 00000273631MR2 00000273632MR0 00000274287MR2 00000274288MR0 00000274740MR0 00000274742MR6 00000274886MR1 00000274887MR9 00000275000MR8 00000275001MR6 00000275003MR2 00000275463MR8 00000275464MR6 00000275527MR0 00000275528MR8 00000275533MR8 00000275534MR6 00000275535MR3 00000275536MR1 00000275537MR9 00000275538MR7 00000275539MR5 00000276137MR7 00000276164MR1 00000276184MR9 00000276196MR3 00000276197MR1 00000276241MR7 00000276242MR5 00000276243MR3 00000276244MR1 00000276245MR8 00000276457MR9 00000276458MR7 00000276461MR1 00000276637MR6 00000276656MR6 00000276657MR4 00000276658MR2  ...
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Class II An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. GE Healthcare, LLC
Food Salted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: "***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE CREAMERY***McMINNVILLE***ORE***97128***AA GRADE***KEEP REFRIGERATED***INGREDIENTS: CREAM (MILK), SALT***". CH 024-13. Expiration 10/30/13 Class III Salted Print Butter, Rose Valley brand, is recalled. The Appendix N procedure was not followed and the firm used the milk to process into butter without the confirmation negative antibiotic test result. Farmers Cooperative Creamery
Devices Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306 Class II Stryker® Orthopaedics has received reports from the field indicating handle fracture and subsequent disassociation of cam assembly subcomponents during use. Stryker Howmedica Osteonics Corp.
Food Jamba Multigrain Fruit Chips( Blueberry) 5ozx12 and 1.5ozx55 5ozx12 size: Date code: 7/13/2013 and SKU: 90013 and 90013R. 1.5ozx55 size: Date code: 7/13/2013 and 7/14/2013 and SKU: 90011 and 90012. Class II On 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination. Inventure Foods, Inc.
Food Jamba Multigrain Fruit Chips (Cranberry) 5ozx12 Date code: 7/14/2013 and 10/21/13 SKU: 90014 and 90014R Class II On 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination. Inventure Foods, Inc.
Devices Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently. CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500, 1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710. CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094,  ...
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Class II There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints. Integra LifeSciences Corp.
Devices Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnières sur Seine (France) Coagulation Assay Lot/Unit Numbers : Combination of All STA-R®/ STA-R EVOLUTION® and lots of STA® - LIATEST® VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01 Class II Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. Diagnostica Stago, Inc.
Devices Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage. 005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211 Class II A portion of a silicone wound drain was found to be cracked. Bacterin International, Inc.
Food LYFE Kitchen, Sweet Corn Chowder with Cashew Cream, Yukon Gold Potatoes and Bell Peppers; 28 oz. 680 gr, Keep Refrigerated. UPC 855764003527 Del Monaco Specialty Products, Morgan Hill, CA Expiration date 3/25/13 Orange Carrot Ginger Sleeve UPC 8557640035703, product code 00350; Class II Costco notified firm that some containers of their LYFE Kitchen Sweet Corn Chowder were packaged in a sleeve labeled Orange Carrot Ginger Soup. Individual boxes of the corn chowder are properly labeled and product identity is visible to the consumer. LYFE Kitchen Retail, Inc.
Devices INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. Batch Number 12KM01206 Class II 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. Smith & Nephew Inc
Devices INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. Batch Number 12JM17051 Class II 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. Smith & Nephew Inc
Devices Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13 Class II Isoline defibrillation leads distributed may have internal insulation breach. Sorin C.R.M., srl
Devices ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease. Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011 Class II Multiple incidents of low-reacting assay plates. Innominata Dba Genbio
Food Kellogg's Special K Red Berries, Crunchy Rice & Wheat Flakes with Strawberries 11.2oz; 37 oz; 22.4 ounce Twin Pack 1. 11.2 oz. pkg, UPC Code 38000 59923, Better if Used by DEC 02 2013 KNC 105 00:13 through DEC 02 2013 KNC 105 02:30 2. 37 oz Club Pkg, UPC Code 38000 20940 , Better if Used by NOV 30 2013 KNB 107 17:31 to NOV 30 2013 KNB 107  ...
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Class II A limited amount of Kellogg's Special K, Red Berries is being recalled due to possible glass fragments present in the product, likely from a single batch of one ingredient. Kellogg Company
Devices REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument Catalog Number 5313152 Lot 153880,153930, 415500, 648010 Class II The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes. Biomet, Inc.
Food APPLE DRINK MIX. Yoruk Prens Elma Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of green apple on label. Expiration date 1/04/2013. Class II Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis. Ethnic International Holding Inc
Food ORANGE DRINK MIX. Yoruk Prens Portalcal Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of orange on label. Expiration date 1/04/2013. Class II Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis. Ethnic International Holding Inc
Food POMEGRANATE DRINK MIX. Yoruk Prens Nar Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of pomegranate on label. Expiration date 1/04/2013. Class II Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis. Ethnic International Holding Inc
Food CINNAMON DRINK MIX. Yoruk Prens Tarcin Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of cinnamon sticks on label. Expiration date 1/04/2013. Class II Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis. Ethnic International Holding Inc
Food ROSEHIP DRINK MIX. Yoruk Prens Tarcin Kusburnu Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of flower on label. Expiration date 1/04/2013. Class II Yoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis. Ethnic International Holding Inc
Food 10021 Roman Meal Premium Oat Bran Mix ( Oat Flour, Oats, Oat Bran, white Wheat Bran, Red Wheat Bran, Stabilizi...., Wheat Germ), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 4031205 4181205 5111205 5291205 5301205 6061205 6071205 7051205 7061205 7131205 7161205 8031205 8161205 8221205 8231205 9131205 9261205 10101205 10291205 11131205 11161205 11191205 12071205 12101205 1021305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10021 RM Honey Oat Bran Mixture - Hong Kong / Thailand (oats, oat bran, oat flour), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS. Hong Kong 5111205 8291205 Thailand 5211205 8031205 8221205 8291205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10058-T, RM Multigrain W/Calcium Mixture - Thailand (wheat bran, yellow corn flour, oats, calcium carbonate, millet flour, yellow flax, stabilized wheat germ), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS. 3291205 4241205 5221205 8061206 8271205 8301205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10073, Roman Meal Enhanced Healthy White Mix (sugarcane fiber, whole meal barley flour, white corn, wheat starch, oats, vitamins), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 4021203 4271206 5181206 6131206 6291206 7171205 8101205 8161205 8291205 9101206 9261206 10041206 10221206 11151206 12111206 12211206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10200, Roman Meal Barley Mix (Barley), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 4231205 5091205 6051205 6291205 7171205 7261205 8231205 9251205 10161205 11011205 11131205 12101205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10204, Roman Meal Multi Whole Grain Mix (Millet, White Wheat, Triticale, Oats, Rye, Barely, Buckwheat, Brown Rice), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 3211206 3221206 4181206 4191206 4261206 5091206 5211206 6111206 6211203 6291203 7261205 8101206 8271206 9111206 9211206 9241206 10241206 11051206 11211206 12121206 12201206 12211206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 10209, Roman Meal New 12 Grain Mix (wheat bran, sunflower, wheat germ, wheat, barley, sesame seed, Millet, yellow corn, brown flax, Triticale, Oats, Rye, buckwheat, spelt, Brown Rice, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 2291203 3221203 5081203 5091203 6051203 6061203 6271203 6281203 8031203 9051203 10111203 10121203 11151203 12141203 12161203 12171203 1071303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 13006, Roman Meal Twelve Grain(wheat bran, sunflower seed, stabilized wheat germ, wheat, barley, sesame seed, Millet, yellow corn, flaxseed, Triticale, Oats, Rye, rice flour, black malt, buckwheat flour, spelt, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. 3231206 3261206 5011206 5021206 7181206 7191206 7201206 8291206 8301206 10121206 10151206 11281206 11291206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40048, SPECIALTY VANILLA GRANOLA (...ATS. WHEAT, SUGAR, OAT FLOUR, CANOLA OIL W/TOCOPHEROLS, BROWN SUGAR, VANILLA EXTRACT, HONEY, SI...., SALT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 40 LBS. 2241207 3261207 3271207 3281207 4171207 4181207 6061207 6071207 7101207 8241207 8251207 8271207 11091207 11101207 12051207 12061207 12141207 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40120, CANADIAN OAT BASE (OATS. OAT BRAN, OAT FIBER, RYE, SUNFLOWER, OAT FLOUR, WHEAT, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 4131205 4161205 5301205 5311205 6131205 8041205 8061205 8291205 9101205 9111205 9271205 11191205 11201205 11271205 12151205 12171205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40133, SARA LEE SPECIALTY 8 GRAIN BLEND 100 (SUNFLOWER, WHEAT, OATS, RYE, BARLEY, WHOLE MEAL YELLOW CORN, MILLET, TRITICALE, RYE FLOUR), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 3141203 3151203 5011203 5021203 6201203 6061203 6071203 7181203 7191203 8301203 8311204 9141203 9171203 9271203 9281203 10191203 10221203 11121203 11281203 12131203 1071303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40134, SARA LEE 12 WHOLE GRAIN BLEND 100 ( WHEAT, OATS, RYE, BARLEY, WHOLE GRAIN CORN, SUNFLOWER, BROWN FLAXSEED, MILLET, TRITICALE, BROWN RICE, BUCKWHEAT, WHOLE MEAL AMARANTH FLOUR, SPELT, SORGHUM) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 3201205 4231205 4241205 5161205 6031205 6251205 8141201 10021201 11081201 1071301 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40145, SPECIALTY MULTIGRAIN BASE ( WHEAT BRAN, SUNFLOWER, WHEAT, OAT BRAN, RYE, OATS, OAT FLOUR, FLAXSEED, WHEAT GERM), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 3061203 3151203 4161203 5021203 5101203 6061203 6181203 7181203 8011203 8161203 9251203 10101203 11271203 11281203 12291203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40154, SPECIALTY SG WHOLE WHEAT BLEND ( WHOLE WHEAT FLOUR, WHEAT BRAN, WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 10311203 11011203 11081203 11291203 11301203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40180, SPECIALTY 9 GRAIN BLEND 400 ( OATS, WHITE WHEAT, BARLEY, RYE, TRITICALE, SPELT, BUCKWHEAT, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 4171205 6261205 6271205 7251205 7261205 8171205 11011205 11101205 11121205 11301205 12051205 12211205 1071305 1081305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40450, NORTH DAKOTA MULTI 7 GRAIN BREAD MIX( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, IRON..., RIBOFLAVIN,FOLIC ACID, SUGAR ASCORBIC ACID, NUTRI SOY FLOUR, WHEAT..., BARLEY FLOUR, RYE FLOUR, FLAX MEAL....., OAT BRAN, ROLLED OATS, NONFAT DRY MILK, DRY YEAST), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , Net WT 15.2 OZ. CHECK LABEL 10311202 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40632, SPECIALTY GRANNY GRAINS BLEND ( WHEAT BRAN, WHEAT, OATS , BARLEY, RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 Net WT 40 LBS. 11161203 11191203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40730, SPECIALTY DAKOTA 12 GRAIN BLEND 200( WHEAT, OATS , BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGUR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 3281205 4171205 4181205 5041205 5291205 6221205 7241205 8171205 8301205 8311205 9041205 10011205 10021205 10241205 11211205 11261205 11291205 12281205 1041305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40740, SPECIALTY 11 GRAIN BLEND ( WHEAT,RYE, TRICALE, CORN, BROWN RICE, OATS, BUCKWHEAT, PARLEY, AMARANTH, MILO, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 3011206 5181206 6271206 8021206 9171206 11011206 11301206 12131206 1021306 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41406, MULTI GRAIN WHOLE MEAL FLOUR BLEND 100( WHITE WHEAT, TRITICALE, OATS, RYE, BARLEY, MILLET, BUCKWHEAT, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 2151203 3161203 3191203 4041203 4181203 4191203 5141203 6011203 6031203 7101203 8061203 8281203 9271203 10171203 11051203 11061203 11121203 11131203 12061203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41410, 3 FLOUR BLEND( OATS, BARLEY, MILLET), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS. 1021303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41433, SUN CHIP 6 GRAIN BLEND( WHOLE MEAL: BROWN RICE, BUCKWHEAT AND QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , ----LBS. 2241206 2271206 2281206 2291206 3121206 3131206 3141206 3271206 3281206 4171206 6041206 6051206 6181206 6191206 6251206 6261206 7021206 7061206 8301206 8311206 9041206 12051206 12061206 12071206 12101206 12111206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 90341440, BOULDER 7 WHOLE GRAIN BLEND ( MILO: SORGHUM, MILLET, BROWN RICE, WHOLE GRAIN CORN, TEFF, AMARANTH, QUINOA) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 50. LBS. 7191203 9261203 10091203 11051203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41511, 7 GRAIN BLEND - SOY FREE( WHEAT, WHEAT BRAN, RYE, BARLEY, TRITICALE, RICE FLOUR, OATS, CORN) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50. LBS. 5251205 6221205 7241205 8041205 8201205 9051205 10171205 11081205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41512 and 41512-T, IBC 12 WHOLE GRAIN BLEND( WHEAT, OATS, BARLEY , RYE, TRITICALE, MILLET, BUCKWHEAT, YELLOW CORN, SORGHUM, BROWN RICE, QUINOA, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50. LBS and 1,750 LBS. 41512: 3081201 3181201 3191201 4031201 5031202 5301201 6211201 6221201 7111201 7251201 8071201 8081201 8211201 8221201 9071201 9081201 10101201 10241201 41512-T: 3081201 4021201 4031201 5301201 7101201 7241201 8211201 9071201 10301201 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41631, BLEND DC SOFT MULTIGRAIN BLEND ( WHOLE MEAL OATS, WHOLE MEAL BARLEY. WHOLE MEAL BROWN RICE, WHOLE MEAL CORN, WHOLE FLAXSEED), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 53 NET WT. 50 LBS . 3161203 3311203 4011203 4201203 5101203 5221203 7191203 7201203 8131203 9121203 11061203 11071203 11091203 1031303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41653, MIX 8 GRAIN INSTANTIZED( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, RYE, AMARANTH, FLAXSEED, WHEAT GERM, YELLOW CORN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 2281205 4041205 4231205 5161205 6011205 6131205 6141205 7181205 7191205 8081205 8091205 8231205 8241205 9051205 9061205 10041205 10231205 11081205 11091205 11201205 12111205 1091305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41672, SPECIALTY LIGHT WHITE BLEND 200 ( CELLULOSE FIBER, WHEAT FLOUR, SALT, CELLULOSE GUM, GUAR GUM, CALCIUM PROPIONATE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS . 12171206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41678, NICKLES 12 GRAIN BLEND ( SUNFLOWER, WHEAT, OATS, WHOLE WHEAT FLOUR, SESAME SEEDS, FLAXSEED, BARLEY, RYE, TRICALE, BROWN RICE, MILLET, YELLOW CORN, BUCKWHEAT, BULGUR WHEAT, AMARANTH, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 3191205 3201205 4131205 4261205 4271205 5291205 5301205 7021205 7031205 7301205 7311205 8161205 8171205 9061205 9071205 9101205 10151205 10161205 11091205 11101205 12051205 12061205 12071205 12281205 12291205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41681, NICKLES 9 GRAIN BLEND ( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, BROWN FLAX, RYE, AMARANT, WHEAT GERM, CORN, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 6291205 10031205 10161205 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 41757, SPECIALTY ANCIENT GRAIN FLOUR BLEND ( SPELT, OATS KAMUT, AMARANTH, MILLET, QUINOA, TEFF), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 2211206 3051206 3201206 3211206 5111206 6271206 7031206 8091206 9201206 10181206 11151206 12121206 12131206 1111306 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42203, OCTOBER GRAINS & SEEDS MIX ( OATS, GOLDEN FLAX, SUNFLOWER, SESAME SEED, WHITE WHEAT, OAT FLOUR, BARLEY, WHET BRAN, CORN, MILLET, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 4171205 5161205 6081205 7111205 7301205 10121205 11081205 12181205 1031305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42204, MULTIGRAIN MIX FOR P.S. BREAD ( WHITE WHEAT, OATS, BARLEY, TRICALE, BROWN FLAX, CORN, SESAME SEED, POTATO FLAKES, WHEAT, RYE, WHEAT BRAN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 3011205 4111205 4271205 5041205 5071205 5211205 6151205 7061205 8081205 8131205 9121205 9131205 9251205 10311205 11131205 11291205 12141205 12151205 1021305 1031305 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42207, FIBER PLUS BLEND POLY FREE ( ENRICHED WHEAT FLOUR RIBOFLAVIN, REDUCED IRON, THIAMINE MONONITRATE, NIACIN, FOLIC ACID, OAT BRAN, OAT FIBER, INULIN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS . 12171206 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42208, WHOLE GRAIN FLOUR BLEND( MILLET, TRITICALE, RYE, BROWN RICE, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 2141203 2281203 3021203 4171203 5101203 5231203 7081203 8061203 9101203 9121203 11021203 11291203 12221203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42209, QUADRUPLE WHEAT BLEND( WHITE WHEAT, SPELT, BUCKWHEAT, CALCIUM SULFATE, FERROUS SULFATE-CONTAINS WHEAT STARCH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 3161203 3291203 5151203 5161203 6111203 6121203 7031203 8021203 9041203 9261203 9271203 10311203 11011203 11121203 12071203 12101203 12271203 12281203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 42300, KASHI COARSE 7 GRAIN BLEND ( RYE, WHEAT BRAN, WHOLE WHEAT FLOUR, OATS, BARLEY, YELLOW CORN, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 3261203 3271203 4091203 4101203 5031203 5211203 6121203 6181203 6291203 6301204 7011203 7091203 7301203 7311203 8281203 9131203 10021203 10031203 10121203 10161203 10181203 10261203 10291203 11301203 12271203 1021303 1081303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4050100, ORGANIC WHOLE WHEAT BREAD FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS . 3061203 3141203 3151203 4141203 4151203 4161203 5111203 5131203 5141203 6061203 6071203 7021203 7031203 7051203 7301203 8291203 9211203 9241203 10041203 10051203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060215, OAT FLOUR (OATS), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT. 50 LBS . 2271203 3231203 3261203 4121203 4131203 5041203 5031203 6011203 6281203 7261203 8231203 9181203 9201203 10031203 10251203 10291203 11161203 1119103 12211203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060564, LIGHT RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT. 50 LBS . 3051203 4131203 8091203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060570-T, TOTE - DARK RYE FLOUR, (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT. 1,750 LBS 5091203 5241205 5251203 6141203 6151203 7061203 7101203 7131203 8081203 9061203 10101203 11071203 11271203 12271203 12281203 12291203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060610, SPECIALTY PASTRY FLOUR (SOFT WHITE WHOLE WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. 3291203 5071203 5081203 7301203 8101203 10081203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060625, WHOLE MEAL BARLEY FLOUR (BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT 50 LBS.. 3291203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060685, WHOLE MEAL TRITICALE FLOUR (TRITICALE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. 3021203 6011203 6211203 8011203 8141203 10161203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060800, ORGANIC WHOLE HARD WHITE WHEAT FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. 8091203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060801, ORGANIC HIGH GLUTEN REFINED HARD RED SPRING WHEAT FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. 12041203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060804, ORGANIC ALL PURPOSE FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS.. 8311203 12151712 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060805, ORGANIC HARD WHOLE WHEAT PASTRY FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT 50 LBS.. 8301203 12131203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060567, MEDIUM RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. 4051203 4131203 4201203 4221203 4231203 5181203 5211203 6041203 11081203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060570, DARK RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. 2131203 3021203 3051203 4301203 6141203 6151203 6181203 9191203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 40735, SPECIALTY DAKOTA 12 GRAIN BLEND 100 (WHEAT, OATS, BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGAR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS.. 3231205 4161205 4191203 4251203 4261203 6291203 7021203 9102103 11201303 1031303 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Food 4060573 LOW MICRO. DARK RYE FLOUR (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT 50 LBS. 10291203 12111203 Class II Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter. Dakota Specialty Milling, Inc
Devices Siemens Somatom CT's equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. Model numbers - 7740769, 8098027, 10430603, and 10590000. Class II Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality. Siemens Medical Solutions USA, Inc
Biologics WB corQC 4.5 mL vials Lots 236154, 236154A, Exp. Date 2013-02-07 Class III Immucor WB corQC, associated with complaints of hemolysis, was distributed. Immucor Inc
Devices Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. System Code #728256, Serial #: 3001,3016,3019,3020,3025,3026,3030,3057,3058,3060,3071,3073,3074,3076,3080,3090,3095,3108,3114,3119,3124,3138,3151,3155,3167,3168,3174,3178,3186,3187,3192,3193,3196,3208,3210,3212,3213,3214,3218,3226,3245,3257,3264,3267,3269,3273,3274,3275,3281,3284,3289,3291,3296,3304,3306,3309,3313,3317,3327,3331,3336,3337,3339,3340,3341,3342,3344,3345,3346,3347,3348,3349,3350,3351,3352,3354,3355,3356,3357,3358,3359,3360,3361,3362,3363,3364,3365,3366,3367,3368,3369,3370,3371,3372,3373,3374,3375,3376,3377,3378,3379,3380,3381,3382,3383,3384,3385,3386,3387,3388,3389,3390,3391,3392,3393,3394,3395,3396,3397,3398,3399,3400,3402,3403,3404,3405,3406,3408,3409,3410,3411,3412,3413,3414,3415,3416,3417,3418,3419,3420,3421,3422,3423,3424,3425,3426,3427,3428,3429,3430,3431,3432,3433,3434,3435,3436,3437,3438,3439,3440,3441,3443,3444,3445,3447,3449,3450,3451,3452,3453,3454,3455,3456,3457,3458,3459,3460,3461,3462,3463,3464,3465,3466,3467,3468,3469,3470,3471,3472,3473,3474,3475,3476,3477,3478,3479,3480,3481,3482,3483,3484,3485,3486,3487,3488,3489,3490,3491,3492,3493,3494,3495,3496,3497,3498,3499,3500,3501,3502,3503,3504,3505,3506,3507,3508,3509,3510,3511,3512,3513,3514,3515,3516,3517,3518,3519,3520,3521,3522,3523,3524,3525,3526,3527,3528,3529,3530,3531,3532,3533,3534,3535,3536,3537,3538,3539,3540,3541,3542,3543,3544,3545,3546,3547,3548,3549,3550,3551,3552,3553,3554,3555,3556,3557,3558,3559,3560,3561,3562,3563,3564,3565,3566,3567,3568,3569,3570,3571,3572,3573,3574,3575,3576,3577,3578,3579,3580,3581,3582,3583,3584,3585,3586,3587,3588,3589,3590,3591,3592,3593,3594,3595,3596,3597,3598,3599,3600,3601,3602,3603,3604,3605,3606,3607,3608,3609,3610,3611,3612,3613,3614,3615,3616,3617,3618,3619,3620,3621,3622,3623,3624,3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3636,3637,3638,3639,3640,3641,3642,3643,3644,3645,3646,3647,3648,3649,3650,3651,3652,3653,3654,3655,3656,3657,3658,3659,3660,3661,3663,3664,3665,3666,3667,3668,3669,3670,3671,3672,3673,3674,3675,3676,3677,3678,3679,3680,3681,3682,3683,3684,3685,3686,3687,3688,3689,3690,3691,3692,3693,3694,3695,3696,3697,3698,3699,3700,3701,3702,3703,3704,3705,3706,3707,3708,3709,3710,3711,3712,3713,3714,3715,3716,3717,3718,3719,3720,3721,3722,6039,6040,30003,30004,30006,30007,30008,30009,30012,30013,30015,30016,30021,30026,30028,30029,30030,30031,30036,30037,30038,30039,30046,30047,30050,30053,30054,30057,30060,30062,30065,30066,30072,30073,30075,30078,30079,30082,30083,30089,30090,30094,30100,30101,30103,30105,30109,30110,30111,30117,30118,30120,30122,30124,30125,30126,30128,30129,30130,30131 System Code #728251,  ...
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Class II Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake. Philips Medical Systems (Cleveland) Inc
Food Sunchips 6 Grain Medley Creamy Roasted Garlic, Net WT. 9 oz. (255.1 g), UPC 2840000690 All lot codes with expiration dates prior to May 21, 2013 are impacted. Class II The products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal. Frito-Lay, Inc
Food Sunchips 6 Grain Medley Parmesan & Herb, Net Wts. 9 oz (255.1 g) UPC 2840003963 and 1 3/8 oz (38.9 g) UPC 2840000892 All lot codes with expiration dates prior to May 21, 2013 are impacted. Class II The products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal. Frito-Lay, Inc
Food Case UPC: 144000031944 Carton: Nabisco belVita Chocolate Variety Net Wt. 8.8 oz UPC 0 44000 03194 7 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Chocolate Variety Net Wt. 1.76 oz UPC 0 44000 03192 3 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA 14.08 oz Please note there are mixed shippers, shipper labels are not available: Mixed belVita Shipper UPC 0044000032784 which contains a 14.08 oz 2 pc product- waiting for label for this size. 9618 cases distributed. 21 Jan 13 through 29 Sep 13 Class II belVita breakfast biscuit may contain fragments of flexible metal mesh caused by a faulty screen at a third-party flour supplier. Mondelez Global Llc
Food Carton: Nabisco belVita Apple Cinnamon Net Wt. 8.8 oz UPC 0 44000 02824 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Apple Cinnamon Net Wt. 1.76 oz UPC 0 44000 02825 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Shipper: Mixed "Better For You" Shipper UPC 00044000034023 which also contains product not subject to the recall 590 cases distributed 8 Jan 12 through 2 Sep 13 Class II Mondelez Global LLC is conducting a voluntary recall of belVita Breakfast Biscuit Apple Cinnamon and Chocolate Varieties due to the possible presence of fragments of flexible metal mesh caused by a faulty screen at third party flour supplier. Mondelez Global Llc
Drugs Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco. a) Good Neighbor, Item Number 163792006: Lot #s: 534204, 538468, 540540; b) Quality Choice, Item Number 163792066: Lot #s: 538835, 539431; c) Select Brands, Item Number 163792067: Lot #: 540529; d) Premier Value, Item Number 163792079: Lot #s: 534545 and 535307; e) CVS, Item Number 163791091 (1 oz.): Lot #s  ...
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Class II Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli. Humco Holding Group, Inc
Devices 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine. Part Number: GCSF37512 and Lot Number: 0243 Class II Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery. Genesys Orthopedic Systems, LLC
Devices GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601 Class I Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents. Symbios Medical Products, LLC
Devices Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033 Class II This field change order is being released to update software and customer release notes to the affected installed base. Philips Medical Systems (Cleveland) Inc
Food King Arthur Unbleached All-Purpose Flour, 5-lb. bag UPC 0-71012-01050-9 Best Used By/ Lot Code 12/26/2013 L12A26B; 12/26/2013 L12A26C; 12/27/2013 L12A27A; 01/18/2014 A13A18A; 01/18/2014 A13A18B; 01/21/2014 A13A21A; 01/22/2014 A13A22B; 01/30/2014 A13A30A; 01/31/2014 A13A31A. Class II Foreign material The King Arthur Flour Company, Inc.
Food King Arthur Unbleached Bread Flour, 5-lb. bag UPC 0-71012-04105-3 Best Used By/ ot Code 12/26/2013 L12A26A; 12/26/2013 L12A26B; 01/03/2014 A13A03A; 01/03/2014 A13A03B; 01/16/2014 A13A16B; 01/17/2014 A13A17A; 01/23/2014 A13A23A; 01/28/2014 A13A28A; 01/31/2014 A13A31A. Class II Foreign material The King Arthur Flour Company, Inc.
Devices Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Class II The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed. Draeger Medical, Inc.
Devices Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015. Class II Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. Vygon Corporation
Devices Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. Lot Number: 2376 Exp Date: 09/2013 Class II Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, Keystone Dental Inc
Devices Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. Lot Number: 2385 Exp Date: 09/2013 Class II Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment Keystone Dental Inc
Devices Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system. C110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019 C110318006 C110318013 C110519022 C110519021 C110323024 C110323039 C110323037 C110323034 C110519003 C110323011 C110323007 C110815003 C110323040 C110815030 C110815015 C110517040 C110815026 C110519031 C110519030 C110513015 C110519035 C110318009 C110815020 C110519023 C110519023 C110815001 C110519010 C110519017 C110318018 61855 C110519002 C110323006 38249 C110815007 C110323036 C110519007 C110519012 C110519027 C110318008 C110318016 C110318026 C110318027 C110519008 C110519009 C110815023 C110815013 C110519034 C110519029 C110323050 C110118018 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C110318016 C110318002 C110815016 C110815012 RC110125M C110323018 C110815024 A4312 & A4314 C110318014 C110318011 C110318015 34902 C110815011 C110309001 C110519002 A42A0 C110318025 C110519036 C110519028 C110519024 C110519013 C110318005 Class II Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn. Natus Neurology Incorporated
Food Mochiko Blue Star Sweet Rice Flour, Net Wt 50 lb. or packaged in 1 lb bags. Koda Farms Milling, Inc. South Dos Palos, CA. 93665 Lot numbers F307, F308, F309, F311, F314, F315, F317, F322, F323. 50 Lb bag UPC 0 74823-00023-3; 1 lb gab UPC-0-74823-00021-9. Class II Koda Farms received a report from a customer that a hard yellow material was found in dough made with rice flour from Koda Farms. This is an expansion of the recall of two lots of rice flour that commenced on February 15, 2013 to include additional lots after a report of the same material found in an earlier lot of rice flour. Koda Farms Inc
Food Publix 7 inch Chocolate Cookies n Cream Cake Scale ID Number * 002-13584-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Cookies Cream Layer Cake Scale ID Number * 002-16466-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch W/T Iced Chocolate Layer cake Scale ID Number * 002-16467-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Dec. Butter cream w/Filling Cake Scale ID Number * 002-19722-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Dec. Whip Topping with filling cake Scale ID Number * 002-19734-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Dec. Fudge iced w/filling cake Scale ID Number * 002-19748-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Dec. Cream Cheese Iced W/F cake Scale ID Number * 002-19759-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Cream Cheese VAN DEC cake Scale ID Number * 002-92096-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Cream Cheese CHOC DEC cake Scale ID Number * 002-92097-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Cream Cheese 1/2 & 1/2 DEC cake Scale ID Number * 002-92099-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Chocolate Ganache cake Scale ID Number * 002-94078-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Dulce de Leche Bon Bon cake Scale ID Number * 002-94003-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Chocolate Ganache Supreme cake Scale ID Number * 002-94085-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Chocolate Ganache Bon Bon cake Scale ID Number * 002-94098-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate Ganache Grandeur cake Scale ID Number * 002-94130-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Buttercream Choc Dec cake Scale ID Number * 002-943330-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Raspberry Sacher Torte Scale ID Number * 002-94132-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Latte Blast cake Scale ID Number * 002-94162-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Whipped Topping Choc Dec cake Scale ID Number * 002-94396-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Whipped Topping 1/2 & 1/2 cake Scale ID Number * 002-94420-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Fudge iced Choc DEC cake Scale ID Number * 002-94432-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Ice Cream Choc Dec cake Scale ID Number * 002-94468-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Ice Cream 1/2 & 1/2 DEC cake Scale ID Number * 002-94490-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Buttercream 1/2-1/2 cake Scale ID Number * 002-94502-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix W/T Blackout layer cake Scale ID Number * 002-95322-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Chocolate Shadow cake Scale ID Number * 002-95323-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7inch Checkerboard Whole cake Scale ID Number * 002-95325-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch German Chocolate Layer cake Scale ID Number * 002-95353-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Peanut Butter Fudge Fix cake Scale ID Number * 002-95628-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate w Pistachio layer cake Scale ID Number * 002-95657-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Ripple layer cake Scale ID Number * 002-95658-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Mocha layer cake Scale ID Number * 002-95697-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Fudge layer cake Scale ID Number * 002-95663-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Buttercream layer cake Scale ID Number * 002-95664-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Cherry Buttercream layer cake Scale ID Number * 002-95767-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Chocolate with Cheesecake torte 6" whole Scale ID Number * 002-95770-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Chocolate butter cream layer cake Scale ID Number * 002-95954-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Chocolate with Mint butter cream layer cake Scale ID Number * 002-95955-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch German Chocolate cake Scale ID Number * 002-95958-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inch Black Forest cake Scale ID Number * 002-95970-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Caramel Pecan Crunch cake Scale ID Number * 002-94301-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Midnight Fudge Fantasy cake Scale ID Number * 002-94254-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix Peanut Butter Fudge Fix cake Scale ID Number * 002-94599-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food Publix 7 inchW/T Black Forest layer cake Scale ID Number * 002-95334-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. Recalled products were distributed from November 11, 2012 through November 15, 2012. Class I Maplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012. Publix Super Markets, Inc.
Food 365 Organic Orzo, 16oz, 20 carton/case UPC Code: 0 99482 43112 9; Lot Code: Lot 142251 Class II This product (one specific lot code) was being held at the manufacturers' request in distribution centers upon receiving. The vendor had an initial positive result for egg protein in one of their regularly scheduled tests, but it occurred after the product had shipped. The manufacturer tested again when they received a second positive result. At this time the manufacturer authorized Whole Foods Market and distribution centers to destroy the product on hand. Whole Foods Market learned from the distribution centers that two distribution centers had released the product by mistake, sending it from their York, Pa. and Atlanta, Ga. Distribution Centers to Whole Foods Market stores on Sunday November 18th,2012. Whole Foods Market
Food See's Candies, Divinity with Walnuts; Net Wt. 1.7 oz, (48 gr). See's Candies, South San Francisco, CA. L.A.D. 102/13 Class I One code of 1.7 oz Divinity Easter Eggs with Walnuts may actually contain Peanut Butter Eggs. See's Candies Inc.
Food Ezekiel 4:9 Sprouted Grain Cereal- Original, 16 oz. Packaging label reads in part:"***Food FOR Life*** Ezekiel 4:9 SPROUTED WHOLE GRAIN CEREAL ORIGINAL NET WT. 16 OZ (454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***". UPC 07347200255 1 LOT numbers: M3232, M3313, M3512, M3565 Best by dates: NOV. 21, 2013 NOV. 30, 2013 DEC. 19, 2013 DEC. 27, 2013 Class II The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond. Food For Life Baking Company Inc.
Food Ezekiel 4:9 Sprouted Grain Cereal- Golden Flax, 16 oz. Packaging label reads in part:" Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL GOLDEN FLAX***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***". UPC 07347200256 8 LOT numbers: M3253, M3309, M3414, M3439, M3523, N0068, N0165 Best by dates: NOV. 24, 2013 DEC. 5, 2013 DEC. 11, 2013 DEC. 18, 2013 DEC. 21, 2013 JAN. 14, 2014 JAN. 15, 2014 Class II The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond. Food For Life Baking Company Inc.
Food Ezekiel 4:9 Sprouted Grain Cereal- Cinnamon Raison, 16 oz. Packaging label reads in part:" Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL Cinnamon Raison***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***". UPC 07347200257 2 LOT numbers: M3232, M3313, M3328, M3425, M3512, M3527, M3537, N0045, N0132 Best by dates: JAN. 21, 2014 JAN. 30, 2014 FEB. 6, 2014 FEB. 13, 2014 FEB. 23, 2014 FEB. 25, 2014 FEB. 26,2014 MAR. 9, 2014 MAR. 15, 2014 Class II The firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond. Food For Life Baking Company Inc.
Drugs Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13 Class II CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. RX South LLC DBA RX3 Pharmacy
Food Glory Foods Mixed Greens, Verduras Mixtas 16 oz Lot 171853 UPC 3639320605 Use By 3/5/13 Class II Product has the potential to be contaminated 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. Routine testing by the Michigan Department of Agriculture revealed the presence of Listeria Monocytogenes in a single 16 ounce package of "Mixed Blend" Greens. Riggio Dist Co
Devices TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT® 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. S/N between N230AM1358 & O023AM3687. Class II In certain situations a software problem with the TotalCare SpO2RT® 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested, and will be released within thirty (30) days. Hill-Rom, Inc.
Food 55613210946 Western Family, Easy Sides, Herb & Butter Pene, Net WT 5.5 oz (156 g), UPC "0 15400 12655 7", Proudly Distributed by Western Family Foods, Inc., P.O. Box 4057, Portland OR, 97208 77A03192, 77A04262, 77B08042, 77B09252. Class II Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement. Bay Valley Foods LLC/ TreeHouse Foods, Inc
Food 556132100582 Meijer, Angel Hair Pasta with Herbs Angel Hair Pasta with Creamy Herb Sauce Mix , Net WT 4.8 oz ( 136g), UPC 7 19283 73636 95, Dist. by Meijer Distribution Inc., Grand Rapids, MI 49544. 77A02032, 77A02222, 77A03092, 77A07192. Class II Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement. Bay Valley Foods LLC/ TreeHouse Foods, Inc
Food 55613130643 Our Specialty Linguini & Parmesan, Linguini pasta with naturally flavored Parmesan & Romano Cheese Sauce Mix, Net WT 5.8 oz ( 164g), UPC 0 55049 00602 5, Distributed by S.T. Specialty Foods, Inc, Brooklyn Park, MN 55455. Batch 77A02072, 77A04232, 77A04242, 77A04252, 77A07222, 77A08072, 77A09172, 77A09262, 77A09272, 77A09282, 77A10161, 77A10162. Class II Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement. Bay Valley Foods LLC/ TreeHouse Foods, Inc
Food 55613205218 Pasta on the Side,  Angel Hair Pasta with Herbs, Net WT 4.8 oz ( 136g), UPC 0 51933 08275 5, Distributed by Save- A- Lot Food Stores LTD, Earth City, MO 63045. 77A01023, 77A01173, 77A02022, 77A02053, 77A02102, 77A02162, 77A03142, 77A03282, 77A04182, 77A06062, 77A06232, 77A07072, 77A07182, 77A08132, 77A08202, 77A09132, 77A09222, 77A09242, 77A10052, 77A10082, 77A10312, 77A11012. Class II Bay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement. Bay Valley Foods LLC/ TreeHouse Foods, Inc
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