Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] Best By code dates between 12MAY2012 - 29MAY2012; 12MAY2012 - 22MAY2012. The code date is located in the upper right hand corner of the bags. [Reason for Recall] 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. [Recalling Firm] River Ranch Fresh Foods LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Plasma Cryoprecipitated Reduced [Code Info] W043210088572 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] W043211094961-A; W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B; W043211025338-B [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Cryoprecipitated AHF, Pooled [Code Info] W043210088572 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] V89413; V26698; W043210088572; W043210075817 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W043210075817 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] V89413 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] V26698 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W043211081138 [Reason for Recall] Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W043211081138 [Reason for Recall] Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. [Recalling Firm] Blood Assurance Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Platelets Leukocytes Reduced [Code Info] W115911013637 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] Central California Blood Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W115911274353; W115911045584 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] Central California Blood Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160057721; 2160058109; 2160060202; 2160073434; 2160078442; [Reason for Recall] Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. [Recalling Firm] Plasmacare Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W037911146400 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] LifeServe Blood Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W037911171995 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] LifeServe Blood Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] 017FR95345 [Reason for Recall] Blood product, incorrectly labeled for Jk(a) red cell antigen, was distributed. [Recalling Firm] American National Red Cross (The) - North Central Region [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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. [Reason for Recall] 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. [Recalling Firm] SCC Soft Computer [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells [Code Info] W071911006426; W071912000837 [Reason for Recall] Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. [Recalling Firm] So Ca Permamente Med Group Blood Donor Cntr [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Blood and Blood Products for Reprocessing [Code Info] W038111302401 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Florida's Blood Centers, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***" [Code Info] Lot # 0464 [Reason for Recall] Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. [Recalling Firm] Altura Food, Inc. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] "***Tres Monjitas***Tropical Splash***Acerola***15 oz***" [Code Info] Lot 0465 [Reason for Recall] Undeclared sub-ingredients considered allergens: hydrogenated coconut oil, sodium caseinate and soy lecithin. [Recalling Firm] Altura Food, Inc. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Drugs [Product Description] Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 [Code Info] Lot number X05011, Exp 08/13 [Reason for Recall] Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. [Recalling Firm] Teva Pharmaceuticals USA, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160080280; 2160063587; 2160083178 [Reason for Recall] Blood products, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160077796 [Reason for Recall] Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160080329; 2160082127 [Reason for Recall] Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. [Recalling Firm] Plasmacare Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 2160076394 [Reason for Recall] Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. [Recalling Firm] Plasmacare Inc [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 12KWIA3540; 12KWIA3311; 12KWIA2924 [Reason for Recall] Blood products, collected from a donor who was previously deferred, were distributed. [Recalling Firm] Interstate Blood Bank, Inc. WI [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] NQ078882 [Reason for Recall] Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. [Recalling Firm] Plasma Biological Services, Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W229812501160 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Center of Northcentral Wisconsin, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] W229812501160 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. [Recalling Firm] Blood Center of Northcentral Wisconsin, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells [Code Info] W038512380006 [Reason for Recall] Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. [Recalling Firm] Walter L. Shepeard Community Blood Center, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot: 564325 [Reason for Recall] AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. [Recalling Firm] Angiodynamics Worldwide Headquarters [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Plasma Frozen within 24 hours (FP24) [Code Info] W047011067810 [Reason for Recall] Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. [Recalling Firm] New York Blood Center, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] W047011067810 [Reason for Recall] Blood products, collected from a donor who was previously deferred for a history of intravenous drug use, were distributed. [Recalling Firm] New York Blood Center, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] W038111305828 [Reason for Recall] Blood product, collected from a therapeutic donor with a history of polycythemia vera, was distributed. [Recalling Firm] Florida's Blood Centers, Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Source Plasma [Code Info] 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, ... More [Reason for Recall] Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. [Recalling Firm] Talecris Plasma Resources, Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells, Irradiated, Leukocytes Reduced, Plasma Reduced [Code Info] W051512035031 [Reason for Recall] Blood product, labeled with an extended expiration date, was distributed. [Recalling Firm] Memorial Blood Centers [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced Irradiated [Code Info] W051512006389 [Reason for Recall] Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. [Recalling Firm] Memorial Blood Centers [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] ***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. [Code Info] Lot Number 2011110798 [Reason for Recall] 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. [Recalling Firm] Biomet 3i, LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot #156920 [Reason for Recall] 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. [Recalling Firm] Linvatec Corp. dba ConMed Linvatec [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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 [Code Info] Version VA11B and all previously released versions. [Reason for Recall] 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. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Plasma Frozen Cryoprecipitated Reduced [Code Info] 2487825 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Cryoprecipitated AHF, Pooled [Code Info] 2424507, 2487825 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Fresh Frozen Plasma [Code Info] 2590622, 2699615, 2522388 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Recovered Plasma [Code Info] 2386094, 2424507, 2459485, 2613407, 2555602 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells Leukocytes Reduced [Code Info] 2386094, 2424507, 2459485, 2487825, 2522388, 2555602, 2590622, 2699615 [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Biologics [Product Description] Red Blood Cells (Apheresis) Leukocytes Reduced [Code Info] 6325565 (2 units) [Reason for Recall] Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. [Recalling Firm] South Texas Blood & Tissue Center [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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 [Reason for Recall] 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. [Recalling Firm] GE OEC Medical Systems, Inc [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510 [Reason for Recall] Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. [Recalling Firm] Stryker Spine [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Drugs [Product Description] 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. [Code Info] Lot: 7212558, Exp 12/12. [Reason for Recall] Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. [Recalling Firm] Apotex Corp. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452. [Reason for Recall] 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. [Recalling Firm] Terumo Cardiovascular Systems Corporation [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. [Reason for Recall] 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. [Recalling Firm] Terumo Cardiovascular Systems Corporation [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Version 5.0 and Version 5.0 Service Pack 1 through 4 [Reason for Recall] 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. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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). [Code Info] 05852170190; Lot P06778 [Reason for Recall] 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. [Recalling Firm] Roche Molecular Systems, Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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: ... More [Reason for Recall] 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. [Recalling Firm] Tango3 LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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 [Code Info] Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842: [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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 [Code Info] Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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 [Code Info] 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 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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 [Code Info] 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 [Reason for Recall] Distal part of the anchor may break on insertion into bone during surgery [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots [Reason for Recall] 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. [Recalling Firm] Abbott Point Of Care Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots [Reason for Recall] 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. [Recalling Firm] Abbott Point Of Care Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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). [Code Info] List number 06F25-01, 06F25-02, 03P92-25, All lots [Reason for Recall] 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. [Recalling Firm] Abbott Point Of Care Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297. [Reason for Recall] 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. [Recalling Firm] Impact Instrumentation, Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 [Reason for Recall] The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. [Recalling Firm] Abbott Point Of Care Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub) [Code Info] Use by code 08/16/12, UPC 89175600037 [Reason for Recall] Product is being recalled due to bloated containers. [Recalling Firm] Two Chefs On A Roll, Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System [Code Info] 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 [Reason for Recall] When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. [Recalling Firm] Philips Healthcare Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Serial Numbers: 12 02 006, 12 02 008, 12 02 013 [Reason for Recall] Battery may become hot and leak [Recalling Firm] FMS, Finapres Medical Systems BV [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Product code 2M8077, all serial numbers [Reason for Recall] 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. [Recalling Firm] Baxter Healthcare Corp. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Product code 2M8075, all serial numbers [Reason for Recall] 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. [Recalling Firm] Baxter Healthcare Corp. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Product codes 2M8286 and 2M8286K, all serial numbers [Reason for Recall] 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. [Recalling Firm] Baxter Healthcare Corp. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Product code 2M8287, all serial numbers [Reason for Recall] 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. [Recalling Firm] Baxter Healthcare Corp. [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair [Code Info] Lot 007A1037, Ref 010-55-25. [Reason for Recall] 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. [Recalling Firm] Encore Medical, Lp [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Serial Numbers/CODES: HIT0535, HIT2953 [Reason for Recall] 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. [Recalling Firm] Varian Medical Systems, Inc. Oncology Systems [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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; [Reason for Recall] Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 [Recalling Firm] Straumann USA, LLC [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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 ... More [Reason for Recall] Some clip applier units may be inadequate to achieve clip closure. [Recalling Firm] Transenterix, Inc [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot #B041206 [Reason for Recall] Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. [Recalling Firm] Greiner Bio-One North America, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] 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, ... More [Reason for Recall] 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. [Recalling Firm] Kimberly-Clark Corporation [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Drugs [Product Description] 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. [Code Info] Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12 [Reason for Recall] Lack of Assurance of Sterility [Recalling Firm] Nephron Pharmaceuticals Corp. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] lot 12095AD, exp 2013-04-04 [Reason for Recall] 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. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Serial numbers 99060001 - 99062554 [Reason for Recall] 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. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Frozen fermented seasoned oysters, bulk packaged 22 lbs per case. [Code Info] no codes [Reason for Recall] 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. [Recalling Firm] Pal-Do Company, Inc d.b.a. Pal-Do World [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot Numbers: 950135R, 950136R, 950137R, 950138R [Reason for Recall] 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. [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R [Reason for Recall] 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. [Recalling Firm] Smith & Nephew, Inc. Endoscopy Division [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot Code: 093309 [Reason for Recall] Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu. [Recalling Firm] Stryker Spine [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg [Code Info] Lot #0215/007/A11 Lot #C308/029/A11 [Reason for Recall] The affected lots were tested and found to contain an unusual high level of selenium. [Recalling Firm] Naturex Inc. [Classification]

Output: Class III

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Devices [Product Description] 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. [Code Info] Lot 318455 [Reason for Recall] 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. [Recalling Firm] Linvatec Corp. dba ConMed Linvatec [Classification]

Output: Class II

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] CRISPY Just Baked Punjabi Cookies 800 g/1.76 lb (28.2 oz): Product of Canada Manufactured by: TWIK Foods Inc. Mississauga, ON, Canada. [Code Info] UPC 6 27265 00152 0 [Reason for Recall] FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Food, Canada, that may not declare milk as an ingredient. [Recalling Firm] Shah Distributors [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Sunrise Indian Corn Candy which is packaged in 16 oz clear plastic tubs/12 tubs per case [Code Info] Best By date of MAR 26 2013 and with Lot # 2321811. This lot had UPC number 0-76500-16651-5. [Reason for Recall] 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. [Recalling Firm] Mount Franklin Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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 [Code Info] 1) Lot Number 0921722, Best By Date March 17, 2013; 2) Lot # 1221802, ... More [Reason for Recall] 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. [Recalling Firm] Mount Franklin Foods LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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. [Code Info] 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. [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Egg Salad Sandwich , 8.5 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. [Code Info] Delish UPC 0 49022 51925 1 All with best if Sold by dates of 7/15/12 to 7/27/12. [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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. [Code Info] 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. [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] Southwestern Snack Bites 5.0 oz, packaged under Delish brand name: Manufactured by GH Foods CA LLC, Rancho Cordova, CA. [Code Info] Delish UPC 0 49022 60220 5 All with best if Sold by dates of 7/19/12 to 7/31/12. [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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. [Code Info] 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 ... More [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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. [Code Info] 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. [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012


Input: [Product Type] Food [Product Description] 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. [Code Info] 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 ... More [Reason for Recall] 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. [Recalling Firm] GH Foods CA LLC [Classification]

Output: Class I

Enforcement Report - Week of August 15, 2012