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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | "***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/Cosmetics | "***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/Cosmetics | 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 SPIDER® 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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/Cosmetics | 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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