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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells W045004052739;W045004113287 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045005058349; W045005058368 Class III Blood products, which may have been exposed to unacceptable storage temperatures, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045005053221 Class III Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045005075084 Class III Blood product, which did not have the preservative solution added but labeled with a 42 day expiration date, was distributed. Community Blood Center of Greater Kansas City
Biologics Platelets Pheresis Leukocytes Reduced W045005910246 Class II Blood product, which did not meet acceptable product specifications, was distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced W045005055407; W045005074435 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed Community Blood Center of Greater Kansas City
Biologics Source Plasma 4210035209;4210034732;4210033969;4210033556; 4210032838;4210032339;4210031541;4210031077; 4210030338;4210029885;4210029191;4210028901; 4210051188;4210050153;4210049932;4210048992; 4210044186;4210043671;4210042848;4210042402; 4210041503;4210041005;4210040192;4210039709; 4210039056;4210038579;4210037747;4210037271 4210036475;4210035991 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. CSL Plasma Inc
Biologics Red Blood Cells Leukocytes Reduced 50E41930; 50LJ90522; 50LW38383; 50LH71894; 50LC19120; 50LC19119; 50LC18780; 50LC18883; 50LC18941; 50LW38261; 50LW38273; 50LH71767; 50LH71774; 50LC19079; 50LC19100; 50LC19118; 50LW38267 Class II Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed. American National Red Cross (The)
Biologics Source Plasma 4030064251; 4030063654; 4030063261; 4030062710; 4030062320; 4030061734; 4030061410; 4030060712; 4030060289; 4030059562; 4030059145; 4030058428; 4030057176; 4030056764; 4030056135; 4030055633; 4030054832; 4030054000; 4030053605 Class II Blood products, collected from a donor who had been incarcerated, were distributed. ZLB Bioplasma, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 24FY08611; 24FY08614; 24FY08615 Class II Blood products, collected using equipment that had not been validated, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 24FY08618; 24FY08617; 24FY08608; 24FY08609; 24FY08611; 24FY08612; 24FY08612; 24FY08613; 24FY08613; 24FY08614; 24FY08615; 24FY08616; 24FY08616 Class II Blood products, collected using equipment that had not been validated, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 24FH48890 Class II Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed. American National Red Cross (The)
Biologics Red Blood Cells 1279445 Class II Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced 2816618 Class II Blood products, collected from a donor who lived in a country at risk for HIV Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 2816618 Class II Blood products, collected from a donor who lived in a country at risk for HIV Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 383019214;383018948;383036249;383036056; 383035479;383035354;383034064;383033640; 383033452;383033117;383032912;383030664; 383029720;383029305;383029137;383026151; 383019723;383019597;383024769;383024567; 383024292;383023250;383023217 Class II Blood products, collected from a donor who was previously deferred, were distributed. Talecris Plasma Resources, Inc.
Food Designer Whey Chocolate, 2lbs, item#10200131, 4 units/case. UPC 8-44334-00131-5. Lot code: 201306 Class II The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. Designer Protein LLC
Food Designer Whey French Vanilla, 2lbs, item # 10200133, 4 units/case. UPC 8-44334-00133-9. Designer Whey French Vanilla, 3lbs, Item#10200134, 5 units/case. UPC 8-4434-00133-10. Lot code: 201306, 201305. Class II The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. Designer Protein LLC
Food Designer Whey Strawberry, 2lbs, Item#10200137, 4 units/case. UPC 8-44334-00137-7. Lot code: 201305 Class II The recall was initiated because Designer Protein has confirmed that Designer Whey 2lb Protein Powder products claim gluten free, and lab results from the Canadian Food Inspection Agency (CFIA) found the products to contain gluten. Designer Protein LLC
Food Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages. 2-lb package: Lots #93059, #93124, #93584, #93150, #93023 and #93048. 5-lb package: Lot #93061 Class II Southwind is recalling cooked shrimp meat because it contains undeclared red #40 and yellow #6 colors. Southwind Foods LLC dba Great American Seafood Imports Co.
Biologics Source Plasma 09KWIB8731;09KWIB8443;09KWIB8100;09KWIB7843;09KWIB7470; 09KWIB7195;09KWIB6849;09KWIB6580;09KWIB6077;09KWIB5968; 09KWIB5382;09KWIB5036;09KWIB4770;09KWIB4406;09KWIB4112; 09KWIB3709;09KWIB3470;09KWIB2886 09KWIB2560, 09KWIB2195, 09KWIB1875, 09KWIA9619, 09KWIA9398, 09KWIA8733, 09KWIA8432, 09KWIA8104, 09KWIA7796, 09KWIA7464, 09KWIA7064, 09KWIA6883, 09KWIA6200, 09KWIA6025, 09KWIA5673, 09KWIA5460, 09KWIA5113, 09KWIA4568, 09KWIA4076, 09KWIA3992, 09KWIA3528, 09KWIA3471, 09KWIA3011, 09KWIA2921, 09KWIA2498, 09KWIA1879, 09KWIA1814, 09KWIA1330, 09KWIA0918, 09KWIA0677, 09KWIA0395, 09KWIA0135, 08KWIC0511, 08KWIC0219, 08KWIC0086, 08KWIB9715, 08KWIB9465, 08KWIB9234, 08KWIB8883, 08KWIB8716, 08KWIB8327, 08KWIB8255, 08KWIB7830, 08KWIB7450, 08KWIB7308, 08KWIB6949, 08KWIB6785, 08KWIB6469, 08KWIB6340, 08KWIB5993, 08KWIB5812, 08KWIB5546, 08KWIB4949, 08KWIB4676, 08KWIB4559, 08KWIB4295, 08KWIB4083, 08KWIB3904, 08KWIB3666, 08KWIB3520, 08KWIB3327, 08KWIB3134, 08KWIB2802, 08KWIB2677, 08KWIB2474 Class II Blood products, collected from a donor who was previously deferred, were distributed. Interstate Blood Bank Inc
Biologics Source Plasma 6130388170,6130386936,6130386073,6130385314, 6130381439,6130378266,6130376520,6130375438, 6130374544,6130373548,6130373236,6130372194, 6130371735,6130370734,6130370156,6130369427, 6130368822,6130366953,6130362858,6130361897, 6130357900,6130356107,6130355771,6130354109 Class II Blood products, collected from a previously deferred donor, were distributed. CSL Plasma, Inc.
Food Diced Yellow Onions, 7oz, UPC 643550000405, Gills Onions Label; Diced Yellow onions, 5lb bag, UPC 898634001018, True Leaf label; Diced Yellow onions, 8oz, UPC 643550000498, clear plastic containers sold in Wegmans stores; Diced Yellow Onions, Oignons jaunes frais, en des, 198 grams, UPC 643550000443, Gills Onions Label. Diced Yellow Onions, 5lbs, "Gills Onions" label, no UPC. USA Lot code: 22YAA1A2184 for 7oz, and Canada Lot code: 22YAA1A2184 for 198g. Recall expanded on July 25, 2012 with the following codes: USA Lot code: all for 7oz, 8oz, and 5lbs on or before August 3, 2012. Canada Lot code: all for 198 g on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Diced Red Onions, 7oz, UPC 643550000412; Diced Red Onions, Oignons rouge frais, en des, 198 grams, UPC 643550000450. Diced Red Onions, 5lbs., "Gills Onions" Label, no UPC; Diced Red Onions, 5lbs, "Crossvalley" label, no UPC. Diced Red Onions, 5lbs, "Markon" label, no UPC. Diced Red Oninos, 5lbs, "Cisco" label, no UPC. USA Lot code: 22RAA1A2184 for 7oz., and Canada Lot code: 22RAA1A2184 for 198g. Recall expanded to include following lots: USA lot code: All lots on or before August 3, 2012. Canada Lot code: all lot codes on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Slivered Yellow Sweet Onions, 5 oz, UPC 643550000092. Slivered Yellow Onions, 5lbs, "Gills Onions" label, no UPC. Slivered Yellow Onions, 5lbs, "Crossvalley" label, no UPC; Slivered Yellow Onions, 5lbs, "Sysco" label, no UPC. Slivered Yellow Onions, 5lbs, "Markon" label, no UPC. Slivered Yellow Onions, 5lbs, "Nourish & Delight" label, no UPC. USA Lot code: 22YAA1A2184, Recall expanded to include following lots: USA lot code: All lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Slivered Red Onions, 5 oz, UPC 643550000009. Slivered Red Onions, 5lbs, "Gills Onions" label, no UPC; Slivered Red Onions, 5lbs, "Markon" label, no UPC. Slivered Red Onions, 5lbs, "Sysco" label, no UPC; Slivered Red Onions, 5lbs, "Crossvalley", no UPC. USA Lot code: 22RAA1A2184, Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Diced Celery and Onion, 7 oz, UPC 643550000429; Diced Celery and Onion, 19 oz, UPC 643550000351; Diced Celery and Onions, 8oz, UPC 643550000504, clear plastic containers sold in Wegmans; Diced Celery & Onions, Celeri et oignons frais, en des, 198g, UPC 643550000467. Diced Celery and Onions, 5lbs, "Crossvalley" label, no UPC. USA Lot code: 22YAA1A2184 for 7oz and 19oz., Canada Lot code: 22YAA1A2184 for 198 g. Expanded on July 25, 2012 to include: USA Lot code: All lots for 7oz, 8oz, and 19 oz on or before August 3, 2012. Canada Lot Code: All lots for 198 g on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Whole peeled Yellow onions, 30 lbs, UPC 02060042553, "Western Onion" label; Whole peeled yellow onions, 1400lbs and 1200 bins, "Gills Onions" label, no UPC Whole peeled Yellow onions, 20lbs, "Gills Onions" label; 25lbs, "Crossvalley" label; 30lbs, "Sysco" label; 30lbs, "Crossvalley" label; 30lbs, "Markon" label. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Diced Organic Yellow Onions, 5lbs, "Gills Onions" label, no UPC. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food 4 Piece Wedge Cutted Onions, 28lbs, "Gills Onions" label, no UPC. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Diced Red Tomatoes, 5lbs tray, "Nourish & Delight", no UPC. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Yellow Onion Puree, 38lbs, "Gills Onions" label, no UPC. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Food Red Onion Puree, 38lbs, "Gills Onions" label, no UPC. USA Lot code: all lots on or before August 3, 2012. Class I Gills Onions is recalling diced and slivered red and yellow onions and diced celery and onion mix because they may be contaminated by Listeria monocytogenes. Gills Onions, LLC
Veterinary Kaytee exact Hand Feeding Formula, formulated for All Baby Birds. with DHA Omega-3 For Growth and Development. Packaged into the following sizes with Product Code/SKU/Material # and UPC codes: 1. Net Wt. 7.5 oz (213g) 100032326, UPC 71859-47510; 2. Net Wt. 18 oz (510g), 100032328, UPC 71859-47511; 3. Net Wt 5 lb (2.27kg) 100032330 and 100034332, UPC 71859-47512; 4. Net Wt 22 lb (9.98kg) 100032336, UPC 71859-47518. Manufactured by Kaytee Products, Inc., Chilton, WI 53014 USA. Best Before 9 Mar 2013, 14 Mar 2013, 21 Mar 2013, 30 Mar 2013, 30 March 2013, 13 Apr 2012, 19 Apr 2013, 20 Apr 2013, and 16 May 2013. Class I Kaytee exact Hand Feeding Formula Baby Bird and Kaytee exact hand Feeding Formula Baby Macaw food may contain an elevated amount of Vitamin D. Central Garden & Pet Company
Veterinary Kaytee exact Hand Feeding Formula, Specifically Formulated for Baby Macaws. with DHA Omega-3 For Growth and Development. Net Wt 5 lb (2.27kg), Product Code/SKU/Material # 100032337, UPC 71859-47515. Manufactured by Kaytee Products, Inc., Chilton, WI 53014 USA. Best Before 1 Mar 2013, 14 Mar 2013, and 19 Apr 2013. Class I Kaytee exact Hand Feeding Formula Baby Bird and Kaytee exact hand Feeding Formula Baby Macaw food may contain an elevated amount of Vitamin D. Central Garden & Pet Company
Veterinary Bulk Honor Show Chow Showlamb Creep Pellet, DX Medicated, containing 0.0029% (13.6 MG/LB) Decoquinate. The firm name on the label is Purina Mills, LLC, St. Louis, MO. date of manufacture: 4/19/2012 Class I Lamb feed was contaminated with cattle feed containing monensin sodium. Land O Lakes Purina LLC
Drugs HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). Lot #07547LL, Exp 07/01/13 Class I Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. Hospira Inc.
Food River Ranch brand Three-Color Cole Slaw Mix, 16 oz bag, UPC: 45388-10046; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Angel Hair, 10 oz bag, UPC: 45388-10031;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Creamy Homestyle Cole Slaw Kit, 11.5oz bag, UPC: 45388-10037;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg & Romaine European, 12 oz bag, UPC: 45388-60019;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg & Romaine American, 12 oz bag, UPC: 45388-60042;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Greener Garden, 12 oz bag, UPC: 45388-60040;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Classic Garden, 6 oz, 16 oz bags, UPCs: 45388-60001, 45388-60002; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Chopped Romaine, 10 oz bag, UPC: 45388-88030;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Complete Caesar Salad Kit, 10 oz bag, UPC: 45388-60043;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Italian Salad, 10 oz bag, UPC: 45388-60020;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Romaine Garden, 10 oz bag, UPC: 45388-60044;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg Shreds, 8 oz bag, UPC: 45388-60045; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Restaurant-Style Cole Slaw, 16 oz bag, UPC: 45388-10024; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Spring Mix, 24 oz bag, 48 oz bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Heritage Blend, 16 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Farm Stand brand Iceberg Garden Salad, 16 oz bag, 24 oz bag, UPCs: 41163-45452, 41163-45453; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Cole Slaw, 16 oz bag, UPC: 75450-12051; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand European Blend, 12 oz bag, UPC: 75450-12049; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand American Blend, 12 oz bag, UPC: 75450-12047; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Garden Supreme ,12 oz bag, UPC: 75450-12046; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Garden Salad, 16 oz, 48 oz bag, UPC: 75450-12052, 75450-12065;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Italian Blend, 10 oz bag, UPC: 75450-12048; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Shredded Lettuce, 8 oz bag, UPC: 75450-12053; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Caesar Salad Kit, 10 oz bag, UPC: 75450-12050; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Chopped Romaine, 10 oz bag, UPC: 75450-12055; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Hy Vee brand Romaine Garden Blend, 12 oz bag, UPC: 75450-12058; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Shurfresh brand Greener Garden Salad, 12 oz bag, UPC: 11161-40133; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Shurfresh brand Romaine Garden Salad, 10 oz bag, UPC: 11161-40134; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Shurfresh brand Iceberg Garden Salad, 16 oz bag, UPC: 11161-49092; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Shurfresh brand Cole Slaw, 16 oz bag, UPC: 11161-49088; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Spring Mix, 48 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Cole Slaw, 16 oz bag, UPC: 30034-30013; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand American Salad Blend, 12 oz bag, UPC: 30034-30105; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Italian Salad Blend, 10 oz bag, UPC: 30034-30115; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Romaine Garden Salad Blend, 12 oz bag, UPC: 30034-30220; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Romaine Chopped, 10 oz bag, UPC: 30034-30141; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Garden Supreme, 12 oz bag, UPC: 30034-30146; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Parisian Salad Blend, 7 oz bag, UPC: 30034-30259; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Angel Hair Cole Slaw, 10 oz bag, UPC: 30034-30266; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand European Salad Blend, 12 oz bag, UPC: 30034-30125; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Leafy Romaine Blend, 9 oz bag, UPC: 30034-30364; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Garden Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 30034-30012, 30034-30400, 30034-30363; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand ColeSlaw Kit, 11 oz bag, UPC: 30034-99829; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food The Farmers Market brand Iceberg Shredded, 8 oz, 16 oz bags, UPCs: 30034-30195, 30034-99888; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Classic Garden, 32 oz bag, UPC: 45388-60011; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Marketside brand Classic Iceberg Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 81131-32893, 81131-32894, 81131-32895; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Marketside brand Shredded Iceberg Lettuce, 8 oz bag, 16 oz bag, UPC: 81131-32896, 81131-53209; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Diced Grn Cabbage w/Color, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Salinas, CA Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Shred Grn Cabbage w/Color, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Shred Grn Cabb w/Carr, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Diced Green Cabb w/Carrot, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Shredded Red Cabbage, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Carrot Shreds, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Valley Blend, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand California Blend, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg Salad Mix, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg/Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg & Romaine 50/50, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Iceberg & Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Shredded Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food River Ranch brand Chopped Romaine w/ Liner, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Iceberg Salad Mix, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Chopped Iceberg w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Iceberg / Romaine w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Cross Valley brand Shredded Icebreg (1/4"), (1/8") 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Fresh n Easy brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Fresh n Easy brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Fresh n Easy brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Fresh n Easy brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Fresh n Easy brand Shredded Icebreg (1/4"), (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Promark brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Promark brand Shredded Icebreg (1/8"), 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Shred Grn Cabbage w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Chopped Iceberg, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Iceberg Salad Mix, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Chopped Iceberg w/ Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Shredded Iceberg (1/4"), (1/8") 4 x 5 lb bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Chopped Romaine, 6 x 2 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class I River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Food Sysco brand Spring Mix, 3 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. Class II River Ranch was notified that two separate samples of products pulled by the FDA which were produced by River Ranch, tested positive for Listeria monocytogenes. River Ranch Fresh Foods LLC
Biologics Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572; W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing V89413 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043211081138 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211081138 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Leukocytes Reduced W115911013637 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115911274353; W115911045584 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. Central California Blood Center
Biologics Source Plasma 2160057721; 2160058109; 2160060202; 2160073434; 2160078442; Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Plasma Frozen within 24 hours (FP24) W037911146400 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing W037911171995 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced 017FR95345 Class II Blood product, incorrectly labeled for Jk(a) red cell antigen, was distributed. American National Red Cross (The) - North Central Region
Devices SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Class II On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu. SCC Soft Computer
Biologics Red Blood Cells W071911006426; W071912000837 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. So Ca Permamente Med Group Blood Donor Cntr
Biologics Blood and Blood Products for Reprocessing W038111302401 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Florida's Blood Centers, Inc.
Food "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***" Lot # 0464 Class I Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. Altura Food, Inc.
Food "***Tres Monjitas***Tropical Splash***Acerola***15 oz***" Lot 0465 Class I Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. Altura Food, Inc.
Drugs Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 Lot number X05011, Exp 08/13 Class II Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. Teva Pharmaceuticals USA, Inc.
Biologics Source Plasma 2160080280; 2160063587; 2160083178 Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160077796 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 2160080329; 2160082127 Class III Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. Plasmacare Inc
Biologics Source Plasma 2160076394 Class III Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Plasmacare Inc
Biologics Source Plasma 12KWIA3540; 12KWIA3311; 12KWIA2924 Class III Blood products, collected from a donor who was previously deferred, were distributed. Interstate Blood Bank, Inc. WI
Biologics Source Plasma NQ078882 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Plasma Biological Services, Inc
Biologics Red Blood Cells Leukocytes Reduced W229812501160 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Center of Northcentral Wisconsin, Inc.
Biologics Fresh Frozen Plasma W229812501160 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Center of Northcentral Wisconsin, Inc.
Biologics Red Blood Cells W038512380006 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Walter L. Shepeard Community Blood Center, Inc.
Devices AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis. Lot: 564325 Class II AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. Angiodynamics Worldwide Headquarters
Biologics Plasma Frozen within 24 hours (FP24) W047011067810 Class II Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W047011067810 Class II Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038111305828 Class III Blood product, collected from a therapeutic donor with a history of polycythemia vera, was distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 3270188347, 3270187833, 3270186174, 3270185904, 3270184947, 3270209668, 3270209101, 3270208775, 3270208200, 3270207880, 3270207303, 3270206968, 3270206410, 3270206106, 3270205543, 3270205233, 3270204604, 3270204322, 3270203751, 3270203417, 3270202882, 3270202560, 3270202006, 3270201709, 3270201150, 3270200829, 3270200273, 3270199969, 3270199389, 3270199089, 3270198499, 3270198181, 3270197543, 3270197188, 3270196532, 3270196114, 3270195019, 3270194450, 3270193990, 3270193500, 3270191564, 3270190082, 3270188723, 3270187148, 3270185258, 3270192964, 3270192093, 3270191039, 3270190592, 3270189609, 3270189148 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells, Irradiated, Leukocytes Reduced, Plasma Reduced W051512035031 Class III Blood product, labeled with an extended expiration date, was distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced Irradiated W051512006389 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Memorial Blood Centers
Devices ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures. Lot Number 2011110798 Class II Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. Biomet 3i, LLC
Devices CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. Lot #156920 Class II ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. Linvatec Corp. dba ConMed Linvatec
Devices Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments Version VA11B and all previously released versions. Class II The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex(R) CA-7000 or CA-1500 coagulation analyzer does not match the syngo LDM settings. Siemens Healthcare Diagnostics, Inc.
Biologics Plasma Frozen Cryoprecipitated Reduced 2487825 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Cryoprecipitated AHF, Pooled 2424507, 2487825 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Fresh Frozen Plasma 2590622, 2699615, 2522388 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Recovered Plasma 2386094, 2424507, 2459485, 2613407, 2555602 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Red Blood Cells Leukocytes Reduced 2386094, 2424507, 2459485, 2487825, 2522388, 2555602, 2590622, 2699615 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 6325565 (2 units) Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. South Texas Blood & Tissue Center
Devices Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray. E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G Class I The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image. GE OEC Medical Systems, Inc
Devices Stryker Reliance AL Implant Blocker (Various sizes) Manufactured by: Stryker Spine SAS Z1 Marticot-33610-Cestas-France +33 ()) 5.57.97.08.30 http://www.stryker.com Distributed in the USA by: STryker Spine 2 Pearl Court Allendale NJ 07401-1677 USA +1-201-760-8000 The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position. Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510 Class II Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. Stryker Spine
Drugs Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. Lot: 7212558, Exp 12/12. Class II Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. Apotex Corp.
Devices System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452. Class II Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. Terumo Cardiovascular Systems Corporation
Devices System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. Class II Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. Terumo Cardiovascular Systems Corporation
Devices EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. Version 5.0 and Version 5.0 Service Pack 1 through 4 Class II There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following page. Siemens Healthcare Diagnostics, Inc.
Devices cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC). 05852170190; Lot P06778 Class III During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled for 9 months shelf life stability. The data shows that the commercial kits are degrading at an accelerated rate when compared to pilot lots. The degradation will lead to an increased rate of invalid results but will not cause incorrect calls. Roche Molecular Systems, Inc.
Devices TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. Model WOZ -250-PE, Serial #s: 1031, 1032, 1033, 1035, 1036, 1038, 1039, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076 & 1077. Model WOZ-180-SS, Serial #s: 1034, 1037, 1040 & 1064. Model WOZ-240-SS, Serial #s: 1041 & 1052. Class II During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone. Tango3 LLC
Devices Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618 Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842: Class II Distal part of the anchor may break on insertion into bone during surgery Smith & Nephew, Inc. Endoscopy Division
Devices Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555 Class II Distal part of the anchor may break on insertion into bone during surgery Smith & Nephew, Inc. Endoscopy Division
Devices Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone Lot Numbers: 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50413407, 50414970, 50412647, 50415864, 50416801, 50418088, 50420654, 50421030, 50421495 Class II Distal part of the anchor may break on insertion into bone during surgery Smith & Nephew, Inc. Endoscopy Division
Devices Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 50400184, 50402082, 50403278, 50405085, 50406197, 50406805, 50408994, 50410001, 50412043, 50412967, 50414260, 50415224, 50416542, 50415681, 50417216, 50418491, 50420660, 50421624 Class II Distal part of the anchor may break on insertion into bone during surgery Smith & Nephew, Inc. Endoscopy Division
Devices i-Stat cTnl cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures. List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots Class II Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Abbott Point Of Care Inc.
Devices i-Stat BNP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuertic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots Class II Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Abbott Point Of Care Inc.
Devices i-Stat CK-MP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). List number 06F25-01, 06F25-02, 03P92-25, All lots Class II Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Abbott Point Of Care Inc.
Devices Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. Class III Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. Impact Instrumentation, Inc.
Devices I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 Class II The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. Abbott Point Of Care Inc.
Food Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub) Use by code 08/16/12, UPC 89175600037 Class II Product is being recalled due to bloated containers. Two Chefs On A Roll, Inc
Devices Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278 Class II When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. Philips Healthcare Inc.
Devices Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. Serial Numbers: 12 02 006, 12 02 008, 12 02 013 Class II Battery may become hot and leak FMS, Finapres Medical Systems BV
Devices AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Product code 2M8077, all serial numbers Class I After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. Baxter Healthcare Corp.
Devices AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Product code 2M8075, all serial numbers Class I After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. Baxter Healthcare Corp.
Devices AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Product codes 2M8286 and 2M8286K, all serial numbers Class I After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. Baxter Healthcare Corp.
Devices AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Product code 2M8287, all serial numbers Class I After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. Baxter Healthcare Corp.
Devices djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair Lot 007A1037, Ref 010-55-25. Class II One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. Encore Medical, Lp
Devices Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. Serial Numbers/CODES: HIT0535, HIT2953 Class II A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. Varian Medical Systems, Inc. Oncology Systems
Devices Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. 26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 25143US_ 10215_00_ b01; 25267US_10278- 00_ b01; 25267US _10280_ 00_b01; 25267US_ 1280_ 00_b03; 25310US_10342_03_b01; 25310US_10342_03_b03; 25310US_10342_03_b05; 25310US_10345_00_b01; 26249US_10019_00_b01; Class II Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 Straumann USA, LLC
Devices SPIDER Surgical Instrument: Flexible Clip Applier The SPIDERĀ® Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization. Model Number: 9000029, Lot #DC301112, Exp. Date: Oct 2013; Lot #DC313111, Exp. Date: Nov 2013; Lot #DC061121, Exp. Date: Mar 2013; Lot #DC082122, Exp. Date: Feb 2014; Lot #DC168112, Exp. Date: Jun 2013; Lot #DC265111 Exp. Date: Sept 2013; Lot #DC341111, Exp. Date: Dec 2013; Lot #DC019125, Exp. Date: Jan 2014; Lot #DC061122, Exp. Date: Mar 2014; Lot #DC082121, Exp. Date: Feb 2014; Lot #DC102122, Exp. Date: Apr 2014; Lot #DC102123, Exp. Date: Apr 2014 and Lot #DC144121, Exp. Date: May 2014. Class II Some clip applier units may be inadequate to achieve clip closure. Transenterix, Inc
Devices 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. Lot #B041206 Class II Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. Greiner Bio-One North America, Inc.
Devices Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature. Catalogue #01000-01 and 01000-01R, Units with 4-Digit Serial Numbers: Lot #4297, 4324, 4332, 4519, 4559, 4572; Units with 10 Character Serial Numbers: SA08017027, SA08017028, SA08017029, SA08017030, SA08017031, SA08017032, SA08017033, SA08017034, SA08017035, SA08017036, SA08017037, SA08017038, SA08017039, SA08017040, SA08017041, SA08017042, SA08017043, SA08017044, SA08017045, SA08017046, SA08017047, SA08017048, SA08017049, SA08343100, SA11137004, SA11137005, SA11137006, SA11137007, SA11137008, SA08094124, SA08094125, SA08094126, SA08094127, SA08094128, SA08094129, SA08094130, SA08094131, SA08094132, SA08094133, SA08094134, SA08094135, SA08094136, SA08094137, SA08094138, SA08094139, SA08094140, SA08094141, SA08094142, SA08094143, SA08094144, SA08094145, SA08094146, SA08094147, SA08094148, SA08094149, SA08094150, SA08094151, SA08094152, SA08094153, SA09020004, SA09020005, SA09020007, SA09020008, SA09020010, SA09020013, SA11298011, SA11298012, SA11298013, SA11298014, SA11298015, SA11298016, SA11298017, SA11298018, SA11298019, SA08136001, SA08136002, SA08136003, SA08136004, SA08136005, SA08136006, SA08136007, SA08136008, SA08136009, SA08136010, SA09043001, SA09043002, SA09043003, SA09043004, SA09043007, SA09043008, SA09043009, SA09043010, SA09043010, SA09043011, SA09043012, SA09043013, SA09043014, SA09043015, SA09043016, SA09043017, SA09043018, SA09043019, SA09043020, SA08343061, SA08343082, SA08343083, SA08343084, SA08343085, SA08343086, SA08343087, SA08343088, SA08343089, SA08343090, SA08343091, SA08343092, SA08343093, SA08343094, SA08343095, SA08343096, SA10337006, SA10337007, SA10337008, SA10337009 and SA10337010. Class II A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. Kimberly-Clark Corporation
Drugs Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12 Class II Lack of Assurance of Sterility Nephron Pharmaceuticals Corp.
Devices Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. lot 12095AD, exp 2013-04-04 Class III Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System. Siemens Healthcare Diagnostics, Inc.
Devices Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids. Serial numbers 99060001 - 99062554 Class II Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected. Siemens Healthcare Diagnostics, Inc.
Food Frozen fermented seasoned oysters, bulk packaged 22 lbs per case. no codes Class II Korean frozen fermented seasoned oysters being recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Pal-Do Company, Inc d.b.a. Pal-Do World
Devices Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. Lot Numbers: 950135R, 950136R, 950137R, 950138R Class II Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. Smith & Nephew, Inc. Endoscopy Division
Devices Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R Class II Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. Smith & Nephew, Inc. Endoscopy Division
Devices LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision. Lot Code: 093309 Class II Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu. Stryker Spine
Food Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg Lot #0215/007/A11 Lot #C308/029/A11 Class III The affected lots were tested and found to contain an unusual high level of selenium. Naturex Inc.
Devices PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch. Lot 318455 Class II ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. Linvatec Corp. dba ConMed Linvatec
Food CRISPY Just Baked Punjabi Cookies 800 g/1.76 lb (28.2 oz): Product of Canada Manufactured by: TWIK Foods Inc. Mississauga, ON, Canada. UPC 6 27265 00152 0 Class I FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Food, Canada, that may not declare milk as an ingredient. Shah Distributors
Food Sunrise Indian Corn Candy which is packaged in 16 oz clear plastic tubs/12 tubs per case Best By date of MAR 26 2013 and with Lot # 2321811. This lot had UPC number 0-76500-16651-5. Class I Mount Franklin Foods, LLC. is voluntarily recalling Safeway Autumn Mix, Sunrise Autumn Mix, and Sunrise Indian Corn because the candy contains undeclared milk and sulfites. People with an allergy or severe sensitivity to milk can run the risk of serious or life-threatening allergic reactions if they consume this product. Mount Franklin Foods LLC
Food Autumn Mix sold under the following name brands: 1) Sunrise Autumn Mix which is packaged in 8 oz bags/36 bags per case; 2) Safeway Autum Mix which is packages in 10 oz bags/24 bags per case 1) Lot Number 0921722, Best By Date March 17, 2013; 2) Lot # 1221802, Best By Date March 25, 2013; Lot # 1221811, Best By Date March 25, 2013; Lot # 0821812, Best By Date March 26, 2013; Lot # 0821822, Best By Date March 27, 2013; Lot # 0821831, Best By Date March 28, 2013; Lot # 0821832, Best By Date March 28, 2013; and Lot # 0821852, Best By Date March 30, 2013 Class I Mount Franklin Foods, LLC. is voluntarily recalling Safeway Autumn Mix, Sunrise Autumn Mix, and Sunrise Indian Corn because the candy contains undeclared milk and sulfites. People with an allergy or severe sensitivity to milk can run the risk of serious or life-threatening allergic reactions if they consume this product. Mount Franklin Foods LLC
Food Asian Stir Fry, packaged under the following labels and sizes: Delish, 8.5 oz. Albertson's Generic Label, 10 oz, Chef Essentials - 10 oz. Raley's, 10 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Delish UPC 0 4902255868 7; Albertsons UPC 8 26766 79000 5; Chef Essentials UPC: 8 26766 71600 5; Raley;s UPC 0 46567 71759 3. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Egg Salad Sandwich , 8.5 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Delish UPC 0 49022 51925 1 All with best if Sold by dates of 7/15/12 to 7/27/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Southwest Crimini Mushrooms, 8.0 oz, packaged under Delish brand name: and 7 oz package under Chef Essentials Brand name. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Delish UPC 0 49022 59602.3; Chef Essentials UPC: 8 26766 71632 6. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Southwestern Snack Bites 5.0 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Delish UPC 0 49022 60220 5 All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Stuffed mushrooms, packaged under the following brand names: Delish - 7 oz package; Garden Highway Chef Essentials - 7 oz package; Pacific Coast Directions; 7 oz and 8 oz package Raleys - 7 oz package; Safeway - 7 oz package; Sprouts - 7 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Delish UPC 0 49022 55872 4; Garden Highway Chef Essentials UPC 8 26766 71121 5; Pacific Coast: 7 oz UPC: 0 98447 10131 0 8 oz UPC: 0 98487 20361 8; Raley's UPC: 0 46567 71753 1; Safeway Farms UPC: 0 21130 28410 8 Sprouts UPC: 8 26766 89325 6. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Fajita Mix, 9.5 oz package; packaged under the following brand names: Albertsons, Garden Highway Chef Essentials, Raley's, Safeway , Marketside and Sprouts Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Albertson's UPC: 9 26766 79002 9; Chef Essentials UPC: 8 26766 71604 3 Raley's UPC: 0 46567 02011 2; Safeway Farms UPC: 0 21130 28404 7 Sprouts UPC: 8 26766 89372 0; Marketside UPC: 6 81131 03747 1. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Fresh Pico de Gallo packaged under the following brand names and sizes: Albertson's - 12 oz container; Garden Highway - 7 oz; 1 lb containers and Fresh Party Favorites 1 lb and 7 oz; Natural Directions - 1 lb; Pacific Coast Directions - 7 oz and 1 lb; Raley's 7 oz and 1 lb Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Albertson's UPC: 8 26766 41725 4; Garden Highway UPC's; 7 oz. 8 26766 41700 1 and 8 26766 77088 5; 1 lb 8 26766 41710 0 and 8 26766 77089 2; Garden Highway Frash Party Favorites UPC: 7 oz. 8 26766 41710 1 1 lb: 8 26766 77089.2. Natural Directions UPC: 1 lb - 0 15400 19446 4; Pacific Coast Directions UPC: 7 oz 0 98487 20449 3 1 lb 0 98487 20448 6 Raley's UPC: 7 oz: 0 46567 71724 1; 1 lb 0 46567 71725 8. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Seasoned Squash, Onion & Dill sold under the following brand names and package sizes: Albertson's - 10.5 oz Chefs Essentials - 10.5 oz; Raley's - 10.5 oz. Safeway Farms - 10. 5 oz and Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Albertson's UPC: 8 26766 7900607; Garden Highway UPC's; 7 oz. 8 26766 71120 8; Raley's UPC: 7 oz: 0 46567 71752.4 All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Tuna Sandwich under Delish brand name; 8.5 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 0 49022 51928 2. All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Stir Fry Vegetables, 10 oz package. Packaged under the brand names of Albertson's;s Garden Highway Chef Essentials, and Sprouts. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Albertson's UPC: 8 26766 79007 4 Garden Highway Chef Essentials UPC: 8 26766 71155 0. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Bean Dip Bowl, 20 oz, packaged under Garden Highway label. Bean Dip snack tray, packaged under the brand names of Garden Highway (24 oz) and Garden Highway Fresh Party Favorites 20 oz); Bean Dip Tray under brand name of Pacific Coast Directions, 52 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC Bean Dip bowl: 8 26766 41775 9; Garden Highway UPC Bean Dip Snack Tray; 8 26766 41780 3; Fresh Party Favorites Bean Dip snack Tray UPC: 8 26766 41775 9; Garden Highway Bean Dip Tray UPC 8 26766 41758 2 Pacific Coast Bean Dip Tray UPC: 0 98487 20341 0 All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Bean Dip Tray NO Salsa, 52 oz. packaged under Garden Highway label. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 8 26766 41785 8; All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Bean Dip Tray w/Salsa, 52 oz. packaged under Garden Highway label; Fresh Bean Dip with Salsa, 40 oz under Garden Highway Label and Pacific Coast Directions Label Manufactured by GH Foods CA LLC, Rancho Cordova, CA. 52 oz UPC: 8 26766 41750 6; 40 oz. Garden Highway UPC 8 26766 41752 0; Pacific Coast Highway UPC: 0 98487 20450 9 All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Fiesta Bean Dip Tray 20 oz. packaged under Garden Highway and Pacific Coast Highway labels. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 41793 3; Pacific Coast Highway UPC: 0 98477 20358 8 All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway brand Caldo mix, 48 oz.; Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 30710 4; All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Cacciatore Mix under the brand name of Garden Highway Chef Essentials, Safeway Farms, 11 oz packages. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71603 6; Safeway Farms UPC 0 21130 09336 6. All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway Chef Essentials Carrots, Celery, Onions, diced: 5 oz Natural Directions Carrots, Celery, onions deli cup , 5 oz; Safeway Farms Carrots, Celery, onions. , 5 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 77050 2; Natural Coast Directions UPC: 0 15400 19454 9; Safeway Farms UPC 0 21130 28421 4. All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway Chef Essentials Celery, Onions, diced: 5 oz Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 77000 7; All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Mushroom & Bleu Cheese Steak Topper: 7.5 oz packaged under the following brand names: Garden Highway Chef Essentials , Raley's, Sprouts Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71024 9; Raley's UPC: 0 46567 02008 2; Sprouts UPC: 8 26766 89379 9. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Mushroom Garlic Herb Steak Topper: 7.5 oz packaged under the following brand names: Garden Highway Chef Essentials, Safeway Farms. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71623 4; Safeway Farms UPC: 0 21130 09352 6 All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway Chef Essentials Pizza Crimini Mushrooms: 7.0 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71630 2; All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway Chef Essentials Pizza Style Portabella Mushrooms: 8.0 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71619 7; All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Southwest Style Portabella Mushrooms: 8.0 oz . Packaged under the brand names of Garden Highway Chef Essentials, Raley's and Sprouts. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71620 3; Raley's UPC: 0 46567 02006 8; Sprouts UPC: 8 26766 89368 3. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Sweet and Sour Stir Fry packaged under the following brand names and sizes: Garden Highway Chef Essentials 10.5 oz; Raley's 10.5 oz Safeway Farms 10.5 oz . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71155 0; Raley's UPC: 0 46567 02002 0; Safeway Farms UPC 0 21130 09335 9. All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Traditional Gourmet Portabella Mushrooms Garden Highway Chef Essentials brand, 8 oz package . Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 8 26766 71621 0; All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Diced yellow onions, 5 oz cup packaged under the brand names of Garden Highway Chef Essentials, Natural Directions, Raley's. 5 lb under Garden highway label. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 5 oz. 8 26766 77015 1; 5 lb. 10 826766 85045 4 Natural Direction UPC: 0 15400 19451 8; Raley's UPC: 0 46567 71730 2. All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway Green Peppers & Yellow Onion sliced 3/8" 2 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Garden Highway UPC: 2 lb. 20 826766 85344 5 All with best if Sold by dates of 7/17/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Trader Joe's Diced Onions, Garlic & Shallots; 2 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 0093 0277. All with best if Sold by dates of 7/19/12 to 7/31/12. Class II GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway brand Spicy Corn Salsa, 7 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 8 26766 42283 8. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Garden Highway brand Traditional Guacamole Kit, 3 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 10 826766 00491 8. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Pacific Coast brand Pizza Stuffed Mushrooms, 8 oz package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 0 98487 20359 5. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Raley's Mirepoix, 5 oz package.. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. UPC: 0 46567 71749 4. All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Signature Cafe Sandwich Philly Cheesesteak hot and cold;regular and large sizes. All Signature Cafe Made to order sandwiches for which customers asked for optional green Pepper and yellow onion mix. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. Reg hot UPC: 21012800000; Reg cold UPC: 21009100000; Large hot UPC: 21012700000; Large cold UPC: 2109900000 All with best if Sold by dates of 7/19/12 to 7/31/12. Class I GH Foods CA received notification from Gills onions of a recall of onions due to Listeria Monocytogenes. GH Foods used the recalled onions in numerous product. GH Foods CA LLC
Food Tartar Sauce sold under the following brand names: 1) Golden Corral Tartar Sauce, 1 gallon,refrigerated Product Code: GD2517; 2) Fatz Tartar Sauce, 1 gallon cases, refrigerated, Product Code FD0666; 3) Ken's Tartar Sauce, 1 gallon cases refrigerated, Product Code: KE0666, 1.5 oz. cups, Product Code: KE066A5 1) Date Code:MFG: 17/JUL/12; 2) Date Code: MFG:23J/UL/12; 3) 1 gallon Date Code: MFG:009/JUL/12, 1.5 oz. cups: Date Code: EXP:011313 Class I Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes Ken's Foods, Inc.
Food Dickey's BBQ Bean Sauce, 48oz pouches, refrigerated Product Code: DI2063 Date Code: USE BY: 11MAR13 Class I Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes Ken's Foods, Inc.
Food Lee's Cole Slaw Dressing 40oz pouches Product Code: FQ2103 Date Code: MFG: 23/JUL/12 Class I Products manufactured with Gills Onions recalled due to potential for Listeria monocytogenes Ken's Foods, Inc.
Devices Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures. Serial numbers: 350111-S10017, 350111-S10018, 350111-S10019, 350111-S10020, 350111-S10021, 350111-S10022, 350111-S10023, 350111-S10024, 350111-S10025, 350111-S10026, 350111-S10027, 350111-S10028, 350111-S10030, 350111-S10031, 350111-S10032, 350111-S10033, 350111-S10034, 350111-S10035, 350111-S10036, 350111-S10037, 350111-S10038, 350111-S10039, 350111-S10040, 350111-S10041, 350111-S10043, 350111-S10044, 350111-S10045, 350111-S10046, 350111-S10047, 350111-S10048, 350111-S10049, 350111-S10050, 350111-S10051, 350111-S10052, 350111-S10053, 350111-S10054, 350111-S10055, 350111-S10056, 350111-S10060, 350111-S10061, 350111-S10062, 350111-S10063, 350111-S10064, 350111-S10065, 350111-S10066, 350111-S10067, 350111-S10068, 350111-S10069, 350111-S10070, 350111-S10071, 350111-S10072, 350111-S10073, 350111-S10074, 350111-S10075, 350111-S10076, 350111-S10077, 350111-S10078, 350111-S10079, 350111-S10080, 350111-S10081, 350111-S10082, 350111-S10083, 350111-S10084, 350111-S10085, 350111-S10086, 350111-S10087, 350111-S10088, 350111-S10089, 350111-S10090, 350111-S10091, 350111-S10092, 350111-S10093, 350111-S10094, 350111-S10095, 350111-S10096, 350111-S10097, 350111-S10098, 350111-S10099, 350111-S10100, 350111-S10101, 350111-S10102, 350111-S10103, 350111-S10104, 350111-S10105, 350111-S10106, 350111-S10107, 350111-S10108, 350111-S10109, 350111-S10110, 350111-S10111, 350111-S10112, 350111-S10113, 350111-S10114, 350111-S10115, 350111-S10116, 350111-S10117, 350111-S10118, 350111-S10119, 350111-S10120, 350111-S10121, 350111-S10122, 350111-S10123, 350111-S10124, 350111-S10125, 350111-S10126, 350111-S10127, 350111-S10128, 350111-S10129, 350111-S10130, 350111-S10131, 350111-S10132, 350111-S10133, 350111-S10134, 350111-S10135, 350111-S10136, 350111-S10137, 350111-S10138, 350111-S10139, 350111-S10140, 350111-S10141, 350111-S10142, 350111-S10143, 350111-S10144, 350111-S10145, 350111-S10146, 350111-S10147, 350111-S10148, 350111-S10149, 350111-S10150, 350111-S10151, 350111-S10152, 350111-S10153, 350111-S10154, 350111-S10155, 350111-S10156, 350111-S10157, 350111-S10158, 350111-S10159, 350111-S10160, 350111-S10161, 350111-S10162, 350111-S10164, 350111-S10165, 350111-S10166, 350111-S10167, 350111-S10168, 350111-S10169, 350111-S10170, 350111-S10171, 350111-S10172, 350111-S10173, 350111-S10176, 350111-S10177, 350111-S10178, 350111-S10179, 350111-S10180, 350111-S10181, 350111-S10192, 350111-S10193, 350111-S10194, 350111-S10195, 350111-S10196, 350111-S10197, 350111-S10198, 350111-S10199, 350111-S10200, 350111-S10201, 350111-S10202, 350111-S10203, 350111-S10204, 350111-S10205, 350111-S10206, 350111-S10207, 350111-S10208, 350111-S10209, 350111-S10210, 350111-S10211, 350111-S10212, 350111-S10213, 350111-S10215, 350111-S10216, 350111-S10218, 350111-S10219, 350111-S10220, 350111-S10221, 350111-S10222, 350111-S10223, 350111-S10224, 350111-S10225, 350111-S10226, 350111-S10227, 350111-S10228, 350111-S10229, 350111-S10230, 350111-S10231, 350111-S10232, 350111-S10233, 350111-S10234, 350111-S10235, 350111-S10236, 350111-S10237, 350111-S10238, 350111-S10239, 350111-S10248, 350111-S10249, 350111-S10250, 350111-S10251, 350111-S10252, 350111-S10253, 350111-S10254, 350111-S10255, 350111-S10256, 350111-S10257, 350111-S10258, 350111-S10259, 350111-S10260, 350111-S10261, 350111-S10262, 350111-S10263, 350111-S10265, 350111-S10266, 350111-S10267, 350111-S10268, 350111-S10269, 350111-S10270, 350111-S10273, 350111-S10274, 350111-S10276, 350111-S10277, 350111-S10278, 350111-S10279, 350111-S10280, 350111-S10281, 350111-S10282, 350111-S10283, 350111-S10284, 350111-S10285, 350111-S10286, 350111-S10287, 350111-S10288, 350111-S10289, 350111-S10290, 350111-S10291, 350111-S10292, 350111-S10293, 350111-S10295, 350111-S10296, 350111-S10297, 350111-S10298, 350111-S10300, 350111-S10301, 350111-S10302, 350111-S10303, 350111-S10305, 350111-S10306, 350111-S10307, 350111-S10309 and 350111-S10310. Class III Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. Berchtold Corp.
Food Crispy By TWI Foods Punjabi Cookies Just Baked Product of Canada 2600 Drew Road, Mississauga, ON Canada L4T 3M5 Net Wt. 800g/1.76 lb Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate. UPC 6 27265 00152 0. The recall is for all codes that do not declare milk on the ingredient statement. Class I Undeclared milk. Fahman Enterprises, Inc
Drugs OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK All lots distributed January 1, 2011 - October 18, 2011. Class II CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation Oklahoma Respiratory Care Inc
Food Onions Diced. Products are labeled in part: "***Onions Yellow Diced***Ready To Eat Product***4/5 LB***Slot Location***". "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW DICED***4/5#***RT # FC***" Item # 599104 ONIONS, FC YEL DICED 1/4" CORONADO 4/5# bags; Item # 599645 ONIONS, FC YELLOW DICED 1/2" 4/5# bags; Item # 514524 ONIONS, FC YELLOW DICED 1/4" FC 4/5# bags; Item # 481258 ONIONS, FC YELLOW DICED 1/4" FL HO 4/5# bags; Item # 481271 ONIONS, FC YELLOW DICED 1/4" FW 4/5# bags; Item # 599997 ONIONS, FC YELLOW DICED 3/4" 4/5# bags; Item # 514007 ONIONS, FC YELLOW DICED 3/8" 4/5# bags; Item # 514012 ONIONS, FC YELLOW DICED 1/4" 1# BA 10/1#. Item #: 599104; 599645; 514524; 481258; 481271; 514012; 599997; 514007. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onions Julienne Sliced. Products are labeled in part: "***Onions Yellow Julienne Sliced***Ready To Eat Product***4/5 LB***" "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW JUL SLICED 1/4"***4/5 #***RT # FC***" Item # 514098 ONIONS, FC YELLOW JUL SLICED 1/4" 4/5 #. Item #: 514098. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onions Peeled. Products are labeled in part: "***Onions ***Yellow Whole Peeled***Read To Eat Product***4/5 LB***". "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW COLOSSAL PEELED***4/5#***RT # FC***" Item # 515670 ONIONS, FC YELLOW COLOSSAL PEELED 4/5#; Item # 514003 ONIONS, FC YELLOW WHOLE PEELED FC 4/5#; Item # 480142 ONIONS, FC YELLOW WHOLE PLD UNIVER 1 1/5# Item # 514035 ONIONS, FC YELLOW WHOLE PEELED 2/10#. Item #: 515670; 514003; 514035 ; 480142. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onions Cubed. Products are labeled in part: "***Onions Yellow Cubed 1"***Ready To Eat Product***LB***". FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW CUBED 1"***2/5#***RT # FC***" Item # 514061 ONIONS, FC YELLOW CUBED 1" 2/5# . Item #: 514061. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onion Rings. Products are labeled in part: "***FP CENTRAL FL. FRESHCUTS***ONIONS FC YELLOW COLOSSAL RINGS 1/2 IN***LB***". Item # 481253 ONIONS, FC YELLOW COLOSSAL RIN 4/5#. Item #: 481253. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onion Slab Cut. Products are labeled in part: "***Onions Yellow Slab***Ready To Eat Product***LB***" "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW SLAB***RT # FC***" Item # 514064 ONIONS, FC YELLOW SLAB 1/16" 2/5# Item # 514058 ONIONS, FC YELLOW SLAB 1/4" 4/5#; Item # 514034 ONIONS, FC YELLOW SLAB 3/8" NO 4/5#; Item # 481155 ONIONS, FC YELLOW SLAB CUT 1/8 2/5#. Item #: 514064; 514058; 514034; 481155. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Onions Yellow Fajita. Products are labeled in part: "***Onions Yellow Slab*** "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW FAJITA***LB***" Item # 513996 ONIONS, FC YELLOW FAJITA Item #: 513996. Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***FP CENTRAL FL. FRESHCUTS MIXES, FC BLACK BEAN/CORN SALSA***2/5#***RT # FC***". Item # 511536 MIXES, FC BLACK BEAN/CORN SALS Item # 511536 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***LSG Pico De Gallo***Ready To Eat Product***2/5LB***" Item # 481744 MIXES, FC LSG PICO. Item # 481744 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Pico De Gallo***Ready To Eat Product***2/5 LB***" Item # 512514 MIXES, FC PICO DE GALLO Item # 512514 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: 1) "***Pico De Gallo 3/8" Cut***Ready To Eat Product***2/5 LB***", "***FP CENTRAL FL. FRESHCUTS MIXES, FC PICO DE GALLO 3/8#***2/5#***RT # FC***", Item # 511511 MIXES, FC PICO DE GALLO 3/8" 2) "***FP CENTRAL FL. FRESHCUTS MIXES, FC T.G.I. PICO 3/8" SMALL PACK***4/2.5LB***RT # FC***", Item # 481603 MIXES, FC T.G.I. PICO 3/8" SMA 1) Item # 511511; 2) Item #481603 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Mixes***RP, Cel, YO Diced 1/4:***Ready To Eat Product***2/5 LB***" "***FP CENTRAL FL. FRESHCUTS MIXES, FC RP, CEL, YO DICED 1/4"***2/5 LB***RT # FC***" Item # 481240 MIXES, FC RP,CEL,YO DICED 1/4" Item # 481240 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***FP CENTRAL FL. FRESHCUTS***MIXES, FC SHEPPARD PIE MIX RR***2/5#***RT # FC***" Item # 481273 MIXES, FC SHEPPARD PIE MIX RR Item # 481273 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Stir Fry Mix D***Ready To Eat Product***4/5 LB***" Item # 513450 MIXES, FC STIR FRY"D" Item # 513450 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food MIX w/yellow onions used as an ingredient. Product may be labeled in part: "***Mixes Tropical Salsa***Ready To Eat Product 2/5 LB***" "***FP CENTRAL FL. FRESHCUTS MIXES, FC TROPICAL SALSA***2/5#***RT # FC***" Item # 597778 MIXES, FC TROPICAL SALSA Item # 597778 Class I FreshPoint Central Florida is recalling multiple onion products and mixes. The products were prepared using onions sourced from Gills Onions LLC which may be adulterated with Listeria monocytogenes. FreshPoint Central Florida
Food Fishery Products International (FPI) Brand : Frozen Breaded Raw Oysters, Net Wt. 10 lbs (4.54 kg) Manufactured by: High Liner Foods, Portsmouth, NH 03801 SKU#: 89695 All lot codes from May 2010 Class II The product was manufactured with Korean Molluscan Shellfish which are considered adulterated as they may have been harvested from polluted waters. FDA revoked approval status for all Molluscan shellfish shippers from South Korea as of May 1, 2012. High Liner Foods Inc.
Food Cut N Clean Greens Comfort Greens Kit, Ready-to-Cook Kit, 24 oz. Packaged in 24 oz plastic clamshell at 6 per case. This product is sold as a 24oz clamshell (plastic container with lid) cooking greens kit. Product is identifiable by the UPC Number 028764000616 this is located on the back label of the product. Product labeling reads in part:" Cut N Clean Greens COMFORT GREENS KIT Complete with collard, mustard and turnip greens, bacon, red cabbage, sweet onion and seasoning Ready-to-Cook Kit NET WT 680g 24 oz***Produce of U.S.A.***SAN MIGUEL PRODUCE, INC. Grown in Ventura County, California U.S.A.***". UPC Number 028764000616. The run numbers with its best used by dates are below: 20260-07/25/12 20651-08/03/12 20260-07/26/12 20756-08/06/12 20340-07/27/12 20756-08/07/12 20437-07/30/12 20546-08/02/12 Class I The firm initiated the recall because the product contain onions from Gills Onions, which has the potential to be contaminated with Listeria monocytogenes. San Miguel Produce, Inc.
Food CRISPY Just Baked Punjabi Cookies by TWI Foods, Net Wt 800 gr, (1.76 lbs, 28.2 oz). Product of Canada Manufactured by TWI Foods, Mississauga, Ontario, Canada. UPC 6 27265 00152 0 Class I FDA was notified by CFIA of a recall of Punjabi cookies manufactured by TWI Foods, Mississauga, Ontario, Canada due to the potential for undeclared milk. Nuts and Spice Co., Inc.
Devices Medstream 81" (206cm) 20 Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set LOT NUMBER: 20111115 Class II Devices leaking at the Y-site Medical Specialties Distributors, Inc.
Food Diced Yellow Onion. 1) Product is labeled in part: "***Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 159280 Onion Yellow Diced 1/4" 4/5#. Item # 301540 FC ONION YELLOW DICED 1/2" 4/5#. Item # 301560 FC ONION YELLOW DICED 1/4" 2/7#. Item # 301580 FC ONION YELLOW DICED 3/4" #. 2) Yellow Onion. Product is labeled in part: "***FC Onion Diced 1/4" EVB***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301565 FC ONION DICED 1/4" EVB. 1) Item # 159280, 301540, 301560, 301580. 2) 301565 Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***Onion Yellow Julienne***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Julienne***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301570 FC ONION YELLOW JULIENNE 3/8" 2/5#. Item # 301590 FC ONION YELLOW JULIENNE 1/4" 4/5#. Item # 301570, 301590. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***Onion Yellow Ring***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Ring***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301586 FC ONION YELLOW RING 1/4" TRAY. Item # 301587 FC ONION YELLOW RING 3/16" . Item # 301586, 301587. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***Onion Yellow Whole***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 159760 ONION YELLOW WHOLE PEELED 4/5#. Item # 159760. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Mix Fajita (Jul Mix Pep/Yo)***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 301255 FC MIX FAJITA (JUL MIX PEP/YO) 4/5#. Product is rinsed to reduce microbial load, dried and vacuum sealed. Item # 301255. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Mix Stir Fry "D"***Refrigerate at 34 F***" Item # 301280 FC MIX STIR FRY "D" 4/5#. Fresh Made - Ready To Eat. Item # 301280. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Salsa Chunky Tomato"***Refrigerate at 34 F***" Item # 302920 FC SALSA CHUNKY TOMATO 2/5#. Fresh made - Ready to Eat.. Item # 302920. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Salsa Mango"***Refrigerate at 34 F***" Item # 302940 FC SALSA MANGO 2/5#. Product is fresh made - Ready To Eat. Item # 302940. Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Salsa Pico de Gallo"***Refrigerate at 34 F***" Item # 302945 FC SALSA PICO DE GALLO 2/5#. Product is fresh made - Ready To Eat. Item # 302945 Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Yellow Onion. Product is labeled in part: "***FC Salsa Pineapple & Papaya"***Refrigerate at 34 F***" Item # 302950 FC SALSA PINEAPPLE 2/5#. Product is fresh made - Ready To Eat. Item # 302950 Class I FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes. FreshPoint South Florida
Food Conch Salad w/onions. Product is labeled in part: "***KEYS FISHERIES CONCH SALAD***Ingredients Ground Conch, Fresh tomatoes, Fresh Cucmber, Mojo (grapefruit juice, lime juice, orange juice, extra virgin olive oil, garlic, onion, sugar, spices, cumin) Tomatoe juice, Line juice, Parsley, Black pepper, Salt, Spices, Paprika.***FRESH PRODUCT KEEP REFRIGERATED***" CODE: 07294144950 Product was packaged in 5 lb plastic containers with 4 per case. Onions used in the manufacture of the above item is subject to recall for Listeria monocytogenes. CODE: 07294144950 Class I Keys Fisheries, Inc. is recalling Keys Fisheries Conch Salad. The Conch Salad was prepared with onions sourced from Gills Onions, LLC being recalled for possible Listeria monocytogenes. Keys Fisheries, Inc.
Food Frozen Fermented Salted and Seasoned Oyster, 39.7 lbs, 2 packs/container. not available. Class II Charm Han Enterprise Inc. is recalling seasoned oyster because it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. SJBW Corp
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