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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Class I Food Event

Event ID62707
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGarden-Fresh Foods, Inc.
CityMilwaukee
StateWI
CountryUS
Distribution PatternAZ CA FL IA IL IN MA MI MN MO OH PA TX WI
 

Associated Products

Product DescriptionFinest Traditions Smokey Baked Beans, 8 lbs.,10 733147 10456 6, 16 oz., 7 33147 00161 5, 8 lbs., 10 733147 10231 9;
Code InfoFinest Tradiitons Smokey Baked Beans, 38698, 8/15/12-8/20/12, 38854, 08/15/12-08/22/12 & 38700, 8/15/12-8/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2168-2012
Product DescriptionGarden-Fresh Anti Pasto Salad Base, Net Wt. 4 lbs., UPC 0 11596 65634 2
Code InfoProduct Code 5634B with Date codes 8/17/2012-8/20/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity820 LBS
Recall NumberF-2169-2012
Product DescriptionGarden-Fresh Pickled Beet And Onion Salad, Net Wt. 5 lbs., UPC 0 11596 52051 3
Code InfoProduct Code 2051 with Date codes 08/14/12-08/17/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity740 LBS
Recall NumberF-2170-2012
Product DescriptionAcme Creamed Cabbage, Net Wt. 16 oz., UPC 0 11596 14025 1
Code InfoProduct Code 4025 with Date codes 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity756 LBS
Recall NumberF-2171-2012
Product DescriptionCreamy Cole Slaw packaged under the following brand, salad name, container size, and UPC number: 1) Garden-Fresh Creamy Cole Slaw Kit , 6 lbs., 0 11596 63039 7; 2) Spartan Creamy Shredded Cole Slaw, 16 oz., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 3) Garden-Fresh Creamy Shredded Cole Slaw, 16 oz., 0 11596 1402 3, 2 lb., 011596 24203 3, 5 lb., 0 11596 93014 5, 8 lb., 0 11596 53005 5; 4) Weis Creamy Cole Slaw, 16 oz., 0 41497 05837 2 , 3 lb., 0 41497 059906 5, 5 lb., 0 1596 53101 4
Code Info1) Garden-Fresh Creamy Cole Slaw Kit , 3039, 07/27/12-07/31/12; 2) Spartan Creamy Shredded Cole Slaw, 4072, 8/16/2012 & 4372, 8/16/2012; 3) 4022, 08/14/12-08/20/12, 4203, 8/15/2012, 3014, 8/15/2012-8/17/2012, 3005, 8/72012; 4) 05837, 8/14/12-8/16/12, 05906, 8/13/12-8/14/12, 3101, 8/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2172-2012
Product DescriptionRogges Sour Cream Cuke Salad, 5 lbs., UPC 0 11596 52057 5
Code Info Rogges Sour Cream Cuke Salad, 2057, 8/7/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity410 LBS
Recall NumberF-2173-2012
Product DescriptionArcher Farms Layered Taco Dip Kits - Taco Dip, kit, 0 11 11596 36300 4
Code InfoArcher Farms Layered Taco Dip Kits - Taco Dip, Kits, 8/24/2012.
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity686.32 LBS
Recall NumberF-2174-2012
Product DescriptionChef's Kitchen Deluxe Egg Salad, 5 lbs., 0 11596 52044 5
Code InfoChef's Kitchen Deluxe Egg Salad, 2044, 8/8/2012-8/15/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity4760 LBS
Recall NumberF-2175-2012
Product DescriptionGerman Potato Salads packaged under the following brand, dip name, container size, and UPC number: 1. Copperwood Kitchens German Potato Salad, 5 lbs., 8 11839 01033 3; 2. Garden-Fresh German Potato Salad, 16 oz., 0 11596 14017 9 ,3 lbs., 0 11596 34319 8 , 5 lbs., 0 11596 91020 8 3. Grandpa's German Potato Salad, 5 lbs., 0 11596 91023 9
Code Info1. Copperwood Kitchens German Potato Salad, 810333, 8/16/2012 2. Garden-Fresh German Potato Salad, 4017, 8/13/2012-8/15/2012, 4319, 8/13/2012 & 1020, 8/13/2012-8/20/2012 3. 1023, 08/13/12-08/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2176-2012
Product Description DF Homemade macaroni Salad, 5 lbs., 0 70163 89080 0 ;
Code InfoDF Homemade macaroni Salad, 401140, 8/22/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity610 LBS
Recall NumberF-2177-2012
Product DescriptionGarden-Fresh Potato Pancakes 4 lbs. 0 11596 40425 5
Code InfoGarden-Fresh Potato Pancakes 0425 08/10/12-08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1324 LBS
Recall NumberF-2178-2012
Product DescriptionWeis Spiral Pasta Salad, 5 lbs, 0 11596 52107 7
Code InfoWeis Spiral Pasta Salad, 2107, 8/15/2012 - 8/16/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1865 LBS
Recall NumberF-2179-2012
Product DescriptionGarden-Fresh Bacon Mac & Cheddar Salad Kit 5.75 lbs. 0 11596 62209 5
Code InfoGarden-Fresh Bacon Mac & Cheddar Salad base 2209B 08/14/12-08/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1300 LBS
Recall NumberF-2180-2012
Product DescriptionGarden-Fresh Tomato Mozzarella Salad Kit 4 lbs. 0 11596 55163 0
Code InfoBrand, Product name, Product Code and Date Code: Garden-Fresh Tomato Mozzarella Salad Kit 5163 08/04/12-08/10/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity916 LBS
Recall NumberF-2181-2012
Product DescriptionFinest Traditions Smoked Imitation Salmon, 12 oz., 7 33147 00127 1; 8 lbs., 10 733147 10120 6
Code Info38954, 08/15/12-08/22/12; 38736, 08/15/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1222.5 LBS
Recall NumberF-2182-2012
Product DescriptionGarden-Fresh Fresh Salsa, 15 oz., 0 11596 06137 5; 5 lbs.,0 11596 59010 3; 5 lbs., Roundys Fresh Salsa, 0 11596 59011 0; 15 oz., 0 11596 06117 7
Code Info6137, 8/20/2012; 9010, 8/24/2012-8/27/2012; 9011, 8/25/2012-8/26/2012; Roundys Fresh Salsa, 6117, 8/25/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity2605.625 LBS
Recall NumberF-2183-2012
Product DescriptionFinest Traditions Spinach Dip, 8 oz., 7 33147 10538 2
Code Info38992, 08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity792 LBS
Recall NumberF-2184-2012
Product DescriptionTuna Salad packaged under the following brand name, container size, UPC code: Finest Traditions Tuna Salad Spread 12 oz. 7 33147 10487 3 Finest Traditions Tuna Salad Spread 4 lbs. 10 733147 10186 2 Garden-Fresh Premium Tuna Salad 5 lbs. 0 11596 55101 2 Market Pantry Tuna Salad 12 oz. 0 85239 24108 0 Weis Tuna Salad 8 oz. 0 41497 05345 2
Code InfoBrand, Product name, Product Code and Date Code: Finest Traditions Tuna Salad Spread 38622 08/20/12-08/25/12 Finest Traditions Tuna Salad Spread 38620 08/25/12 Garden-Fresh Premium Tuna Salad 5101 08/18/12-08/25/12 Market Pantry Tuna Salad 24108 8/18/2012-8/25/2012 Weis Tuna Salad 5345 8/18/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity6383 LBS
Recall NumberF-2185-2012
Product DescriptionFinest Traditions Garden Vegetable Spaghetti 8 lbs., 10 733147 10196 1
Code Info38612, 08/15/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity664 LBS
Recall NumberF-2186-2012
Product DescriptionFinest Traditions Wild Rice Salad Base, 8 lbs., 10 733147 10183 7
Code Info38668, 08/15/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity968 LBS
Recall NumberF-2187-2012
Product DescriptionGarden-Fresh Family Style Creamy Tuna Salad 5 lbs. 0 11596 55108 1
Code InfoBrand, Product name, Product Code and Date Code: Garden-Fresh Family Style Creamy Tuna Salad 5108 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity640 LBS
Recall NumberF-2188-2012
Product DescriptionGarden-Fresh Fresh Mango Salsa 5 lbs. 0 11596 59025 3
Code InfoGarden-Fresh Fresh Mango Salsa 9025 8/26/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity80 lbs
Recall NumberF-2189-2012
Product DescriptionGarden-Fresh Black Bean Salsa, 15 oz., 0 11596 06118 4 Garden-Fresh Black Bean Salsa, 5 lbs., 0 11596 52587 7
Code InfoGarden-Fresh Black Bean Salsa, 6118, 08/25/12; Garden-Fresh Black Bean Salsa, 52587, 8/24/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity560 lbs
Recall NumberF-2190-2012
Product DescriptionFinest Traditions Fat Free Black Bean Salsa, 8 lb., 10 733147 10181 7
Code InfoFinest Traditions Fat Free Black Bean Salsa, 38694, 08/15/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity360 lbs
Recall NumberF-2191-2012
Product DescriptionGarden-Fresh Baked Potato Salad Kit, 5 lb., 0 11596 61071 9
Code InfoGarden-Fresh Baked Potato Salad Kit, 1071B, 08/13/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity6930 lbs
Recall NumberF-2192-2012
Product DescriptionKnowlan's Club Salad Base, 8 lb.,10 733147 10201 5
Code InfoKnowlan's Club Salad Base, 39076, 08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity376 lbs
Recall NumberF-2193-2012
Product DescriptionCopperwood Kitchens Greek Style Pasta Salad 5 lbs. 8 11839 01032 6 Garden-Fresh Greek Style Pasta Salad 5 lbs. 0 11596 52035 3
Code InfoCopperwood Kitchens Greek Style Pasta Salad, 8103, 8/16/2012 Garden-Fresh Greek Style Pasta Salad 2035 8/13/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity595 lbs
Recall NumberF-2194-2012
Product DescriptionBow Tie Pastas: 1) Copperwood Kitchens Venetian Bow Tie Pasta, 5 lbs., 8 11839 01031 9; 2) Garden-Fresh Venetian Bowtie Pasta, 5 lbs., 0 11596 520278
Code Info1) 81031908/14/12-08/20/12; 2) 2027, 08/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity540 lbs
Recall NumberF-2195-2012
Product DescriptionFinest Traditions Pea & Cheese Pasta Salad, 8 lb., 10 733147 10146 6
Code InfoFinest Traditions Pea & Cheese Pasta Salad, 38688, 08/15/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity4328 lbs
Recall NumberF-2196-2012
Product DescriptionFinest Traditions Rigatoni Pasta Salad, 8 lb., 10 733147 10148 0
Code InfoFinest Traditions Rigatoni Pasta Salad, 38666, 08/15/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity416 lbs
Recall NumberF-2197-2012
Product DescriptionGarden-Fresh California Pasta Salad, 5 lbs, 0 11596 82068 2 Garden-Fresh California Pasta Salad, 5 lbs., 0 11596 52115 2
Code Info2068, 8/11/2012-8/15/2012; 2115, 08/10/12-08/11/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1840 lbs
Recall NumberF-2198-2012
Product DescriptionItalian Pasta Salad: 1) Garden-Fresh Italian Pasta Salad, 8 lbs., 0 11596 92012 4; 2) Market Pantry Italian Pasta Salad 14 oz., 0 85239 20119 0
Code Info1) 2012, 8/17/12 - 8/20/12; 8/14/12-8/21/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity3777.25 lbs
Recall NumberF-2199-2012
Product DescriptionGarden-Fresh Ranch Pasta Salad, 5 lb., 0 11596 52202 9
Code InfoGarden-Fresh Ranch Pasta Salad, 2202, 8/13/2012-8/15/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity2240 lbs
Recall NumberF-2200-2012
Product DescriptionGarden-Fresh Seafood Pasta Salad, 5 lb., 0 11596 55007 7
Code InfoGarden-Fresh Seafood Pasta Salad, 5007, 08/14/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity320 lbs
Recall NumberF-2201-2012
Product DescriptionGarden-Fresh Southwestern Pasta Salad, 5 lb., 0 11596 52046 9
Code InfoGarden-Fresh Southwestern Pasta Salad, 2046, 08/13/12-08/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity600 lbs
Recall NumberF-2202-2012
Product DescriptionTaco Pasta Salad: 1) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52076 6; 2) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52065 0
Code Info1) 2076, 08/14/12-08/20/12; 2) 2065, 08/13/12-08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity2325 lbs
Recall NumberF-2203-2012
Product DescriptionOur Own Fettuccine Pasta Salad, lb., 0 11596 52150
Code InfoOur Own Fettuccine Pasta Salad, 2150, 8/15/2012- 8/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity915 lbs
Recall NumberF-2204-2012
Product DescriptionDF Special Recipe Macaroni Salad, 16 oz., 0 70163 98110 2
Code InfoDF Special Recipe Macaroni Salad, 98110, 8/25/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity324 lbs
Recall NumberF-2205-2012
Product DescriptionFinest Traditions Creamy Cheddar Macaroni , 8 lbs., 10 733147 10156 5
Code InfoFinest Traditions Creamy Cheddar Macaroni , 38888, 08/13/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity968 lbs
Recall NumberF-2206-2012
Product DescriptionFinest Traditions Macaroni Salad, 16 oz., 7 33147 00018 2, 3 lbs., 7 33147 00032 8 & 8 lbs., 10 733147 10140 4;
Code InfoFinest Traditions Macaroni Salad, 38856, 08/08/12-08/15/12, 38982, 08/13/12 & 38552, 08/08/12-08/13/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1204 lbs
Recall NumberF-2207-2012
Product DescriptionGarden-Fresh Amish Country macaroni Salad, 2010, 5 lbs, 011596520100 Weis Amish Macaroni Salad: 05844, 16 oz, 41497058440. 2105, 5 lbs, 11596521053 05905, 3 lbs, 41497059058
Code InfoGarden-Fresh Amish Country Macaroni Salad: 2010 08/15/12 Weis Amish Macaroni Salad : 05844 8/16/2012 2105 8/14/2012 - 8/16/2012 05905 8/14/2012 - 8/16/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity14680 lbs
Recall NumberF-2208-2012
Product DescriptionGarden-Fresh Family Style Macaroni Salad 2060 5 lbs 0 11596 52060 5
Code InfoGarden-Fresh Family Style Macaroni Salad 2060 8/15/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity3120 lbs
Recall NumberF-2209-2012
Product DescriptionMacaroni Salads: 1) Garden-Fresh Macaroni Salad, 0 11596 14018 6, 16 oz., 4018, 0 11596 52005 6, 5 lbs., 20050 11596 34305 1, 3 lbs., 4305, 0 11596 24210 1, 2 lbs., 4210 2) Spartan Macaroni Salad 11213903262 3 lbs 4373 11213903217 16 oz 4073 3) Finest Traditions Macaroni Salad, 16 oz., 7 33147 00018 2, 3 lb., 7 33147 00032 8 , 8 lb., 10 733147 10140 4 4) Market Pantry Macaroni Salad, 216240101, 3 lb., 4101 216240105, 16 oz., 24105
Code Info1) Garden-Fresh Macaroni Salad 4018 8/14/2012 - 8/20/2012 Garden-Fresh Macaroni Salad 2005 8/15/2012 - 8/16/2012 Garden-Fresh Macaroni Salad 4305 8/20/2012 Garden-Fresh Macaroni Salad 4210 8/15/2012 2) Spartan Macaroni Salad 4373 8/16/2012 - 8/20/2012 Spartan Macaroni Salad 4073 8/14/2012 3) 38856, 08/0812-08/15/12, 38982, 08/13/12, 38552, 08/08/12-08/13/12 4) 24101, 8/22/2012; 24105, 8/20/2012-8/26/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity13070 lbs
Recall NumberF-2210-2012
Product DescriptionCopperwood Kitchens Deviled Egg Potato Salad, 00295, 8/15/2012-8/20/2012
Code InfoCopperwood Kitchens Deviled Egg Potato Salad, 00295, 8/15/2012-8/20/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1350 lbs
Recall NumberF-2211-2012
Product DescriptionGarden-Fresh Deluxe Egg Salad, 5 lbs., 0 11596 52043 8 & 5 lbs., 0 11596 52122 0;
Code InfoGarden-Fresh Deluxe Egg Salad, 2043, 8/8/2012-8/15/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1570 lbs
Recall NumberF-2212-2012
Product Description Garden-Fresh Deviled Egg Salad, 5 lbs, 0 11596 521220
Code InfoGarden-Fresh Deviled Egg Salad , 2122, 8/12/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity75 lbs
Recall NumberF-2213-2012
Product DescriptionEgg Salads: Garden-Fresh Egg Salad, 5 lbs., 0 11596 52022 3 & 5 lbs., 0 11596 52053 Weis Egg Salad, 8 oz., 0 41497 05365 0 & 5 lbs., 0 11596 55221 7
Code InfoGarden-Fresh Egg Salad, 2022, 8/2/2012-8/4/2012 & 2053, 8/11/2012 Weis Egg Salad, 05365, 8/9/2012-8/16/2012 & 5221, 8/11/2012-8/15/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity4204.5 lbs
Recall NumberF-2214-2012
Product DescriptionEgg Salad Spreads: 1) Garden-Fresh Egg Salad Spread, 5 lbs., 0 11596 52053 7; 2) Finest Traditions Egg Salad Spread, 12 oz., 7 33147 10491 0 & 4 lbs., 10 733147 10189
Code Info1) Garden-Fresh Egg Salad Spread, 5168, 8/10/2012-8/17/2012 2) 5168, 8/10/12-8/17/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1316 lbs
Recall NumberF-2215-2012
Product DescriptionRoundy's Old Fashioned Cream Dill Dip, 12 oz., 0 11150 52603 6
Code InfoBrand, Product name, Product Code and Date Code: Roundy's Old Fashioned Cream Dill Dip, 52603, 09/09/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity112.5 lbs
Recall NumberF-2216-2012
Product DescriptionGarden-Fresh Sweet and Sour cucumber, 5 lbs., UPC 0 11596 52014 8;
Code InfoBrand, Product name, Product Code and Date Code: Garden-Fresh Sweet and Sour cucumber, 2014, 08/06/12-08/10/12,
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1180 lbs
Recall NumberF-2217-2012
Product DescriptionGrandpas Sour Cream Cucumbers Salad, 5 lbs., UPC 0 11596 52080 3;
Code InfoGrandpas Sour Cream Cucumbers Salad, 2080, 8/5/2012-8/10/2012 &
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity900 lbs
Recall NumberF-2218-2012
Product DescriptionGarden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 8 lbs., 0 11596 83028 5;
Code InfoGarden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 3028B, 08/16/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1304 lbs
Recall NumberF-2219-2012
Product DescriptionGarden-Fresh Creamy Cole Slaw Dressing , 2 lbs., 0 11596 43200 7
Code InfoGarden-Fresh Creamy Cole Slaw Dressing , 3200, 09/09/12-09/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity64 lbs
Recall NumberF-2220-2012
Product DescriptionCole Slaws: 1) Spartan Cole Slaw, 1 lb., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 2) Market Pantry Cole Slaw, 15 oz., 0 85329 24106 6, & 44 oz., 0 85239 24114; 3) Spoon River Cole Slaw, 3 lb., 0 11596 34238 2
Code Info1) Spartan Cole Slaw, 4072, 08/14/12-08/20/12 & 4372, 08/16/12-08/20/12; 2) Market Pantry Cole Slaw, 24106, 8/19/2012 & 24106, 8/20/2012-8/25/2012; 3) 44238, 8/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity17082 lbs
Recall NumberF-2221-2012
Product DescriptionDixie Cole Slaws:1) Garden-Fresh Dixie Cole Slaw, 5 lbs., 0 11596 93007 7 ; 2) DF Special Recipe Dixie Cole Slaw, 16 oz. 0 70163 98115 7
Code Info1) Garden-Fresh Dixie Cole Slaw, 3007, 8/16/2012-8/17/2012 ; 2) DF Special Recipe Dixie Cole Slaw, 98115, 8/25/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity9759.25 lbs
Recall NumberF-2222-2012
Product DescriptionGarden-Fresh Amish Country Cole Slaw, 5 lbs., 0 11596 53010 9;
Code InfoGarden-Fresh Amish Country Cole Slaw, 3010, 08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity360 lbs
Recall NumberF-2223-2012
Product DescriptionFinest Traditions Homemade-Style Cole Slaw, 8 lbs., 10 733147 10170 1; Finest Traditions Homemade Style Cole Slaw, 16 oz., 7 33147 00025 0;
Code InfoFinest Traditions Homemade-Style Cole Slaw, 38562, 08/13/12-08/20/12 Finest Traditions Homemade Style Cole Slaw, 38858, 08/13/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity552 lbs
Recall NumberF-2224-201
Product DescriptionFinest Traditions XTRA Creamy Cole Slaw, 8 lbs., 10 733147 10017 9;
Code InfoFinest Traditions XTRA Creamy Cole Slaw, 39000, 8/20/2012-8/22/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity136 lbs
Recall NumberF-2226-2012
Product DescriptionFinest Traditions Creamy Country Cole Slaw, 8 lbs., 10 733147 10172 5;
Code InfoFinest Traditions Creamy Country Cole Slaw, 38554, 08/13/12-08/22/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity880 lbs
Recall NumberF-2227-2012
Product DescriptionGarden-Fresh Black Bean Couscous, 5 lbs., 0 11596 55620 8
Code InfoGarden-Fresh Black Bean Couscous, 5620, 08/06/12-08/13/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity320 lbs
Recall NumberF-2228-2012
Product DescriptionGarden-Fresh Kidney Bean Salad , 5 lbs., 0 11596 52016
Code InfoGarden-Fresh Kidney Bean Salad , 2016, 8/14/2012 - 8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity2950 lbs
Recall NumberF-2229-2012
Product DescriptionArcher Farms Four Bean Salad, 14 oz., 0 85239 24207 0
Code InfoArcher Farms Four Bean Salad, 242070, 8/23/2012-8/30/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity136.5 lbs
Recall NumberF-2230-2012
Product DescriptionFinest Traditions Fat Free Bean Salad, 8 lbs., 10 733147 10180 0
Code InfoFinest Traditions Fat Free Bean Salad, 38644, 08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity200 lbs
Recall NumberF-2231-2012
Product DescriptionAcme Classic Potato Salad 16 oz. 0 11596 14030 5
Code InfoAcme Classic Potato Salad, 4030, 8/14/2012 - 8/20/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1128 lbs
Recall NumberF-2232-2012
Product DescriptionPotato Salad with Egg: 1) Acme Homestyle Egg Potato Salad, 16 oz. 0 11596 14005 3; 2) Weis Potato w/ Egg Salad, 16 oz., 0 41497 05841 9, 3 lb., 0 41497 05902 7, 5 lb., 0 11596 51101 6
Code Info 1) Acme Homestyle Egg Potato Salad , 4005, 8/17/2012 ; 2) Weis Potato w/ Egg Salad, 05841, 8/15/2012-8/16/2012, 05902, 8/14/2012-8/16/2012 & 1101, 8/13/2012-8/16/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity1836 lbs
Recall NumberF-2233-2012
Product DescriptionHomestyle Potato Salads: 1) Acme Homestyle Potato Salad, 2 lbs. 0 11596 34209 2 ; 2) Finest Traditions Homestyle Potato Salad, 16 oz., 7 33147 00019 9, 3 lb., 7 33147 00031 1 , 8 lb., 10 733147 10134 3
Code Info1) Acme, 4209, 8/14/2012-8/17/2012; 2) Finest Tradition, 38860, 08/15/12, 38980, 08/13/12-08/20/12, 38640, 08/15/12-08/20/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity3680 lbs
Recall NumberF-2234-2012
Product DescriptionMustard Potato Salads: 1) Copperwood Premium Mustard Potato Salad, 2 lbs., 8 11839 01001 2, 5 lbs.; 2) Dairy Fresh Mustard Potato Salad, 0 070163 89090 9, 5 lbs.; 3) Garden Fresh Mustard Potato Salad, l lb., 0 11596 14010 0, 2 lb. 0 11596 24215 6; 4) Market Pantry Mustard Potato Salad, 16 oz., 0 85239 24104 2, 3 lb., 0 85239 24100 4; 5) Spartan Mustard Potato Salad, 1 lb., 0 11213 90319 4, 3 lb., 0 11213 90324; 6) Spoon River Mustard Potato Salad, 3 lb., 0 11596 24207 8; 7) Rogges Mustard American Potato Salad, 5 lb., 0 11596 51053 3
Code Info1) Copperwood, 01001, 8/15/2012, 01029, 8/15/2012-08/17/12; 2) Dairy Fresh, 401536, 8/20/2012; 3) Garden Fresh, 4010, 8/14/2012, 4215, 8/15/2012; 4) Market Pantry, 24104, 8/19/20128/25/2012, 24100, 8/21/2012; 5) Spartan, 4071, 8/7/20128/14/2012, 4371, 8/13/2012-8/20/2012 ;6) Spoon River, 4207, 8/14/2012; 7) Rogges, 1053, 8/11/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2235-2012
Product DescriptionSteakhouse Potato Salads: 1) Copperwood Steakhouse Potato Salad, 5 lbs., 8 11839 01001 7, 5 lb.; 2) Grandpas Steakhouse Potato Salad, 5 lb., 0 11596 55604 8; 3) Finest Traditions Steak House Potato Salad, 8 lb., 10 733147 10773 4
Code Info1) Copperwood, 01014, 8/15/2012; 2) 5604, 08/13/12-08/20/12; 3) Finest Traditions, 38292, 08/15/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2236-2012
Product DescriptionDairy Fresh Special Recipe Potato Salad, 5 lbs., 0 70163 40659 7, 5 lbs.
Code Info98135, 8/22/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2237-2012
Product DescriptionPremium Potato Salads: 1) Copperwood Premium Potato Salad, 2 lb., 8 11839 01000 5, 5 lb., 8 11839 01016 6; 2) Our Own Premium Potato Salad, 5 lb., 0 11596 91045 1
Code Info1) Copperwood, 01000, 8/15/2012-08/17/12, 0106, 8/15/2012 ; 2) Our Own, 1045, 8/10/2012-8/12/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2238-2012
Product DescriptionDairy Fresh Baked Potato Salad, 5 lb., 0 70163 40659
Code Info406599, 8/22/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2239-2012
Product DescriptionDairy Fresh Special Recipe Mustard Potato Salad, 16 oz.., 0 70163 98105 8
Code Info98105, 8/22/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2240-2012
Product DescriptionDairy Fresh Special Recipe Potato Salad, 16 oz.., 0 70163 98135 5
Code Info98135, 8/22/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2241-2012
Product DescriptionFinest Traditions Blue Cheese Potato Salad, 8 lb., 10 733147 10137 4
Code Info38760, 08/01/12-08/08/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2242-2012
Product DescriptionFinest Traditions Deluxe Potato Salad, 16 oz., 7 33147 00007 6, 3 lb., 7 33147 00030 4, 8 lb., 10 733147 10130 5, 8 lb., 10 733147 10450 4
Code Info38768, 08/15/12-08/20/12, 38568, 08/20/12, 38978, 08/15/12-08/20/12, 38536, 08/15/12-08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2243-2012
Product DescriptionFinest Traditions Roasted Garlic Potato Salad, 8 lb., 10 7 33147 10159 6
Code Info38580, 08/15/12-08/22/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2244-2012
Product DescriptionAmerican Potato Salads: 1) Garden-Fresh American Potato Salad, 1 lb., 0 11596 14015 5, 2 lb., 0 11596 24200 2; 2) Market Pantry American Potato Salad, l lb., 0 85293 24107 3, 3 lb., 0 85239 24102 8; 3) Spartan American Potato Salad, 3 lb., 0 11213 90325 5
Code Info1) Garden-Fresh, 4015, 08/17/12, 4200, 08/15/12; 2) Market Pantry, 24107, 9/19/2012-8/25/2012; 3) Spartan, 4370, 8/16/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2245-2012
Product DescriptionAmish Potato Salads: 1) Garden-Fresh Amish Country Potato Salad, 5 lb., 0 11596 51005 7; 2) Weis Amish Potato Salad, 16 oz., 0 41497 05845 7, 3 lb., 0 41497 05901 0, 5 lb., 0 11596 51103 0
Code Info1) Garden-Fresh, 1005, 8/17/12; 2) Weis, 1103, 8/14/2012-8/16/2012, 05845, 8/14/2012-8/16/2012, 05901, 8/14/2012-8/16/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2246-2012
Product DescriptionGarden-Fresh Country Style Potato Salad, 5 lb., 0 11596 51075 0
Code Info1075, 08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2247-2012
Product DescriptionGarden-Fresh Family Style Potato Salad, 5 lb., 0 11596 51061 3
Code Info1061, 8/14/2012-8/15/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2248-2012
Product DescriptionGarden-Fresh Gourmet Dill Potato Salad, 5 lb., 0 11596 55137 1
Code Info5137, 8/7/2012-8/9/2012, 5132, 8/15/2012-8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2249-2012
Product DescriptionGarden-Fresh Large Diced American Potato Salad, 5 lb., 0 11596 91018 5
Code Info1018, 8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2250-2012
Product DescriptionRed Potato Salads: 1) Garden-Fresh Red Potato Salad, 2 lb., 0 11596 24205 7; 2) Weis Red Potato Salad, 16 oz., 0 41497 05848, 5 lb., 0 11596 51105 4
Code Info1) Garden-Fresh, 4205, 08/16/12; 2) Weis, 05848, 8/14/2012-8/16/2012, 1105, 8/14/2012-8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2251-2012
Product DescriptionGarden-Fresh Reduced Fat American Potato Salad, 5 lb., 0 11596 51201 2
Code Info1201, 08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2252-2012
Product DescriptionReduced Fat Mustard Potato Salads: 1) Garden Fresh Reduced Fat Mustard Potato Salad, 5 lb., 0 11596 51202 0; 2) Market Pantry Reduced Fat Mustard Potato Salad, 16 oz., 0 85239 20016 2
Code Info1) Garden-Fresh, , 1202, 08/14/12; 2) Market Pantry, 200162, 08/14/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2253-2012
Product DescriptionDeviled Egg Potato Salads: ) Grandpas Deviled Egg Potato Salad, 1 lb., 0 11596 14012 4; 5 lb., 0 11596 51065 1; 3.5 oz., 0 11596 08005 5; 2) Copperwood Kitchens Deviled Egg Potato Salad, 00295
Code Info1) ; 2) 8/15/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2254-2012
Product DescriptionGrandpas Potato Salad, 16 oz., 0 11596 14027 8; 8.2 lb., 0 11596 24227 9; 3 lb., 0 11596 34326 6; 5 lb., 0 11596 91026 0
Code Info4027, 8/14/2012-8/17/2012, 4227, 08/17/12, 4326, 8/15/2012-8/20/2012, 8005, 08/20/12, 1026, 8/15/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2255-2012
Product DescriptionGrandpas Red Skin Potato Salad, 5 lb., 0 11596 51080 4
Code Info1080, 08/17/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2256-2012
Product DescriptionSpoon River Potato Salad, 5 lb., 0 11596 51032 3
Code Info1032, 8/14/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2257-2012
Product DescriptionMarsh's Signature Potato Salad, 5 lb., 0 11596 51085 9
Code Info1085, 8/13/2012-8/15/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2258-2012
Product DescriptionRogges White Potato Salad, 5 lb., 0 11596 51052 1
Code Info1052, 8/11/2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2259-2012
Product DescriptionWeis Original Potato Salad, 16 oz., 0 41497 05838 9, 3 lb., 0 41497 05900 3, 5 lb., 0 11596 51102 3
Code Info05838, 8/14/2012-8/16/2012, 05900, 8/14/2012-8/16/2012, 1102, 8/14/2012-8/20-2012
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2260-2012
Product DescriptionAcme Homestyle Cole Slaw, 16 oz., 0 11596 14304 3
Code Info4034, 8/5/12-8/17/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2261-2012
Product DescriptionGarden-Fresh Family Style Cole Slaw, 5 lb., 0 11596 53060 4
Code Info3060, 8/16/12
ClassificationClass I
Reason for RecallRecalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination.
Product Quantity
Recall NumberF-2262-2012

Class I Food Event

Event ID62734
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmRon Stockman Whole Foods
CityFt Lauderdale
StateFL
CountryUS
Distribution PatternProducts were sold directly to the consumers though our Whole Foods Market Retail stores in the state of Florida.
 

Associated Products

Product DescriptionThe product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BABY SHRIMP SALAD
Code InfoThese products were sold by the pound.
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2134-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BEET & GOAT CHEESE SALAD WITH RASPBERRY VINAIGRETTE
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2135-2012
Product DescriptionBeet Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***BEET DRESSING***RED BEETS, HONEY, GARLIC, ONIONS, CANOLA MAYONNAISE (CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER) CONTAINS: EGGS***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2136-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. CHUNKY RANCH VEGETABLE SALAD NO OIL ADDED
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2137-2012
Product DescriptionCranberry Tuna Salad Roll sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***CRANBERRY TUNA SALAD ROLL 2 FOR 5***BREAD (UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), TUNA (TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS, SUN-DRIED CRANBERRIES (CRANBERRIES, EVAPORATED CANE SUGAR), CANOLA MAYONNAISE (CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), LEMONS, TOMATO, LETTUCE CONTAINS: WHEAT, EGGS, MILK, SOY, FISH***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2138-2012
Product DescriptionGills Onions were used in this product. The Thousand Island Potato Salad is sold at the chef's case, self serve counter, or packaged.It is also sold as "Family Sized Savings Thousand Island Potato Salad". Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND POTATO SALAD***POTATOES, CAGE-FREE HARD COOKED EGGS (EGGS, WATER, CITRIC ACID), THOUSAND ISLAND DRESSING....***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2139-2012
Product DescriptionMiso Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***MISODRESSING***WHITE MISO (WATER, RICE, WHOLE SOYBEAN, SEA SALT, KOJI STARTER), TOFU (FILTERED WATER, (NON-GMO) SOYBEANS, NATURAL COAGULANTS (CALCIUM CHLORIDE (NIGARI), CALCIUM SULFATE), EXTRA VIRGIN OLIVE OIL, WATER, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), ONIONS, TAMARI (WATER, SOYBEANS, SALT, ALCOHOL (TO PRESERVE FRESHNESS)), PARSLEY CONTAINS: SOY***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2140-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. MISO KISSED CUKES
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2141-2012
Product DescriptionNew York City Corned Beef on Rye sold at the chef's case, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***FANCY REUBEN SANDWICH WITH PASTRAMI OR CORNED BEEF***PASTRAMI OR CORNED BEEF (BEEF, WATER, SEA SALT, SUGAR, BEET POWDER, GARLIC POWDER, SPICES, GARLIC, BAY LEAF, MUSTARD SEED, ALLSPICE) HONEY MUSTARD COLESLAW ( GREEN & RED CABBAGE, CARROTS), HONEY MUSTARD DRESSING ( DIJON MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), WHOLEGRAIN MUSTARD ( WATER, GRAIN VINEGAR, MUSTARD SEED, SALT, SPICES), LEMON JUICE, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), HONEY), OR CLASSIC COLESLAW ( GREEN & RED CABBAGE, CARROTS, CANOLA MAYONNAISE, HORSERADISH ( HORSERADISH, WATER, VINEGAR, SALT, NATURAL FLAVORINGS), SUGAR, FENNEL, LEMON PEPPER, CELERY SEED, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), SWISS CHEESE ( PART SKIM MILK, CHEESE CULTURE, SALT, ENZYMES), BREAD CIABATTA (ENRICHED WHEAT FLOUR ( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, CANOLA OIL, EXTRA VIRGIN OLIVE OIL, RYE SOURDOUGH FLAVOR, SALT, YEAST). CONTAINS: MILK, EGGS, SOY, WHEAT.***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2142-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. PASTA WITH LONG BEANS & ARAME IN CREAMY BEET VINAIGRETTE
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2143-2012
Product DescriptionRanch Dressing No Oil Added sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***RANCH DRESSING NO OIL ADDED***TOFU ( WATER, SOYBEANS, ISOLATED SOY PROTEIN, GLUCONOLACTONE & CALCIUM CHLORIDE), OAT MILK, LEMON JUICE, ONION, WHITE VINEGAR, DIJON MUSTARD ( DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), NUTRITIONAL YEAST, BASIL, GARLIC, CILANTRO, GREEN ONION, DILL, PARSLEY, PEPPER, CRUSHED RED PEPPER. CONTAINS : SOY***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2144-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RANCH ICEBERG SALAD WEDGE NO OIL ADDED
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2145-2012
Product DescriptionRussian Coleslaw is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***RUSSIAN COLESLAW***CABBAGE, CARROTS, THOUSAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( SUGAR, WATER, CHILI, VINEGAR, GARLIC, SALT, GUAR GUM, CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES). CONTAINS: EGG, SOY***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2146-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RUSSIAN SALAD
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2147-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SEASONAL SUCCOTASH
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2149-2012
Product DescriptionThe Shrimp Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***SHRIMP SALAD SANDWICH***SHRIMP, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), CELERY, ONIONS, CARROTS, PARSLEY, KOSHER SALT, PEPPER, SPINACH WRAP ( UNBLEACHED UNBROMATED ENRICHED WHEAT FLOUR ( WHEAT FLOUR, NIACIN (VITAMIN B3), REDUCED IRON, THIAMINE MONONITRATE (VITAMIN B1), RIBOFLAVIN (VITAMIN B2), FOLIC ACID ( VITAMIN B 9), MALTED BARLEY FLOUR), WATER, SUNFLOWER OIL, CONTAINS: 2% OR LESS OF: CULTURED WHEAT FLOUR ADDED WITH VINEGAR, SALT, LECITHIN, DRIED SPINACH POWDER, YEAST, GUAR GUM, LEAVENINGS ( SODIUM ACID PYROPHOSPHATE, SODIUM BICARBONATE, CORN STARCH, MONOCALCIUM PHOSPHATE), CITRIC ACID), GREENLEAF LETTUCE, TOMATO. CONTAINS: EGGS, SHELLFISH, WHEAT.***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2150-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SHRIMP WITH SNOW PEAS
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2151-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SOY & THE SEA
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2152-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TEMPEH SALAD
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2153-2012
Product DescriptionThe Thousand Island Chicken Salad Roll is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***1000 ISLAND CHICKEN SALAD ROLL 2 FOR 5***BREAD ( UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), CHICKEN ( CHICKEN, WATER, RICE STARCH, SALT), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE, CUCUMBERS, CRYSTALIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES (CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID, ONION, AGED CAYENNE RED PEPPERS, GARLIC POWDER, LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES), CAPERS ( CAPERS, VINEGAR SALT), GARLIC, EXTRA VIRGIN OLIVE OIL, DILL, CABBAGE, CARROTS, SUGAR, CHILI, SALT, GUAR GUM, CITRIC ACID), AGED CAYENNE RED PEPPERS, PAPRIKA CONTAINS: WHEAT, EGGS, MILK, SOY.***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2155-2012
Product DescriptionGills Onions were used in this product. The Thousand Island Chicken Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND CHICKEN SALAD SANDWICH***CHICKEN ( CHICKEN, SEASONING ( SALT, GRANULATED ONIONS & GARLIC, WHITE PEPPER, BLACK PEPPER), THYME), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CABBAGE, CARROTS, THOUSAND ISLAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( CUCUMBERS, SUGAR, VINEGAR, SEA SALT, XANTHAN GUM, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES ( CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE RED PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), ....***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2156-2012
Product DescriptionConch Salad is labeled as listed below: "***SALAD CONCH***INGREDIENTS: GROUND CONCH, MOJO (GARLIC, ONION, GRAPEFRUIT JUICE (100% SQUEEZE D), OANGE JUICE (100% SQUEEZED) , LIME JUICE (100% PASTEURIZED ), ONION, EXTRA VIRGIN OLIVE OIL, CUMIN), BLACKENING SEASONING (SALT, SPICES, PAPRIKA, GARLIC, ONION POWDER ( CALCIUM STERATE ), SUGAR, CHILI POWDER ( CHILI PEPPER, SPICES, SALT, SILICON DIOXIDE, SOYBEAN OIL) , SUGAR, 100% PASTEURIZED LIME JUICE, FLORIDA BAY SEASONING ( SALT, SPICES, PAPRIKA ), SALT, TOMATO JUICE ( TOMATO CONCENTRATE (WATER, TOMATO PASTE ), SALT, VITAMIN C ( ASCORBIC ACID ), CUCUMBER, TOMATO, ONION, GREEN PEPPER, BLACK PEPPER, PARSLEY. CONTAINS: SHELLFISH, SOY.*** SELL BY: 08/08/12***NET WT 0.95 LB***550 BOWIE ST. AUSTIN, TX 78703***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2157-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THOUSAND ISLAND SHRIMP SALAD
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2158-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2159-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi Crab Salad Roll
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2160-2012
Product DescriptionGills Onions were used in this product. The Thousand Island Surimi Salad is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND SURIMI SALAD***SURIMI ( FISH, PROTEIN ( POLLOCK AND/OR PACIFIC WHITING), WATER, SUGAR, WHEAT STARCH, EGG WHITE, POTATO STARCH....***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2161-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THREE BEAN SALAD
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2162-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TOFU JAPONAISE
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2163-2012
Product DescriptionGills Onions were used in this product. The Tuna With Cranberries Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***TUNA SALAD WITH CRANBERRIES (TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2164-2012
Product DescriptionGills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Tuna with Sun-Dried Cranberries
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2165-2012
Product DescriptionGills Onions were used in this product. The Tuna With Sun-Dried Cranberries & Lemon is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***TUNA WITH SUN-DRIED CRANBERRIES AND LEMON*** TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***"
Code InfoNone
ClassificationClass I
Reason for RecallWhole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.
Product QuantityUnknown
Recall NumberF-2166-2012

Class I Food Event

Event ID62794
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMissa Bay, LLC
CitySwedesboro
StateNJ
CountryUS
Distribution PatternAlabama, Arkansas, Connecticut, Delaware, DC, Florida, Georgia, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carlina, South Dakota, Tennessee, Vermont, Virginia, Wisconsin, and West Virginia.
 

Associated Products

Product DescriptionCrown Program BK Fresh Apple Slices, 2 oz On or before August 13; no upc code
Code InfoOn or before August 13; no upc code
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2263-2012
Product DescriptionHannaford Apples & Caramel Snack Pack Net Wt. 4 oz (113g) Distributed By: Hannaford Bros. Co., Scarborough, ME 04074 1-800-213-9040. www.hannaford.com On or before August 18 UPC 4126817191
Code InfoOn or before August 18 UPC 4126817191
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2264-2012
Product DescriptionHannaford Apple, Granola, & Yogurt Snack Pac, Net Wt. 4.3 oz (122g), Distributed by Hannaford Bros. Co., Scarborough, ME 04074 10-800-213-9040 www.hannaford.com. On or before August 18 UPC 4126817195
Code InfoOn or before August 18 UPC 4126817195
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2265-2012
Product DescriptionMcDonalds M Apple Slices Net Wt 1.2 oz (34g) On or before August 19; no upc code
Code InfoOn or before August 19; no upc code
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2266-2012
Product DescriptionMcDonalds M Diced Apples Net Wt. 0.02 oz (26g) On or before August 19; no upc code
Code InfoOn or before August 19; no upc code
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2267-2012
Product DescriptionMcDonalds M fruit & walnut snack with vanilla lowfat yogurt Net Wt 5.75 OZ (163g) On or before August 20; no upc code
Code InfoOn or before August 20; no upc code
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2268-2012
Product DescriptionReady Pac Bistro Apple Bleu Pecan Salad Net Wt. 4.75 OZ (135g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 12; UPC 7774529497
Code InfoOn or before August 12; UPC 7774529497
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2269-2012
Product DescriptionReady Pac fruit frenzy Net Wt. 32 OZ (2 LB) 907 g Distributed by Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-782 www.readypac.com On or before August 18; UPC 7774523086
Code InfoOn or before August 18; UPC 7774523086
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2270-2012
Product DescriptionReady Pac fruit tray bien Net Wt. 32 OZ (2 LB) 907 g Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774521606
Code InfoOn or before August 18; UPC 7774521606
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2271-2012
Product DescriptionReady Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pac Net Wt. 4 OZ (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 readypac.com On or before August 18; UPC 7774523896
Code InfoOn or before August 18; UPC 7774523896
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2272-2012
Product DescriptionReady Pac Ready Snax Apples, Celery, Raisins with Peanut Butter Snack Pac Net Wt 4 oz (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523897
Code InfoOn or before August 18; UPC 7774523897
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2273-2012
Product DescriptionReady Pac Ready Snax Apples, Granola, & Yogurt Snack Pac Net Wt 4.3 OZ. Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523089
Code InfoOn or before August 18; UPC 7774523089
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2274-2012
Product DescriptionReady Pac super fruit blend Net Wt 6 oz (170g) Distributed By Ready Pac Foods Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 17; UPC 7774523076
Code InfoOn or before August 17; UPC 7774523076
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2275-2012
Product DescriptionReady Pac super fruit medley Net Wt 10.5 OZ (298g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774523746
Code InfoOn or before August 16; UPC 7774523746
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2276-2012
Product DescriptionReady Pac Sweet Sunshine Platter Net Wt 37 OZ )2 LB 5 OZ) 1.05 Kg Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774524204
Code InfoOn or before August 16; UPC 7774524204
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2277-2012
Product DescriptionSafeway farms Complete Apple, Blue Cheese & Pecan Total Net Wt. 8.75 OZ (248g) Salad & Toppings 6.75 OZ (191g) Dressing 2 OZ (!.83 FL OZ) 54 mL Distributed by Safeway Inc. PO Box 90 Pleasonton, CA 94506-0009 1-800-SAFEWAY/www.safeway.com On or before August 18; UPC 2113033680
Code InfoOn or before August 16; UPC 7774524204
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2278-2012
Product DescriptionWawa apple caramel dipper Net Wt 6.7 OZ (191g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261900394
Code InfoOn or before August 16; UPC 261900394
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2279-2012
Product DescriptionWawa apple peanut butter dipper Net Wt. 6.5 OZ (183g) Distributed by: Wawa, Inc Wawa, PA 19063 wawa.com On or before August 15; UPC 261900268
Code InfoOn or before August 15; UPC 261900268
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2280-2012
Product DescriptionWawa apple slices Net Wt 3.5 OZ (99g) Distributed by: Wawa Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261902232
Code InfoOn or before August 16; UPC 261902232
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2281-2012
Product Description Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517
Code Info1) Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity7887 cases
Recall NumberF-2282-2012
Product DescriptionWawa Chicken salad Snack Net Wt. 6.7 oz Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 12; UPC 261902760
Code InfoOn or before August 12; UPC 261902760
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2283-2012
Product Description21) Wawa Chicken salad sandwich Net Wt. 7.8 OZ (221g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905670
Code InfoOn or before August 10; UPC 261905670
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2284-2012
Product Description) Wawa fruit & cheese Net Wt 6 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902567
Code InfoOn or before August 11; UPC 261902567
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2285-2012
Product DescriptionWawa protein power pack Net Wt 7.8 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902565
Code InfoOn or before August 11; UPC 261902565
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2286-2012
Product DescriptionWawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518
Code InfoWawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity11846 cases
Recall NumberF-2287-2012
Product DescriptionWawa turkey & cheese sandwich Net Wt 7.7 OZ (219g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905622
Code InfoOn or before August 10; UPC 261905622
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2288-2012
Product DescriptionWegmans Apples, Celery, Raisins, & Peanut Butter Net Wt 4 oz. (113g) Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026744
Code InfoOn or before August 18; UPC 7789026744
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2289-2012
Product DescriptionWegmans Apples, Cheese & Caramel Dip, 4 OZ (113g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 15; UPC 7789026743
Code InfoOn or before August 15; UPC 7789026743
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2290-2012
Product DescriptionWegmans Apples, Granola, & Low Fat Vanilla Yogurt, 4.3 OZ (122g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026737
Code InfoOn or before August 18; UPC 7789026737
ClassificationClass I
Reason for RecallThe products are contaminated with Listeria monocytogenes.
Product Quantity264,662 cases and 296,224 individually distributed units (total)
Recall NumberF-2291-2012

Class II Biologics Event

Event ID32594
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-04
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMicro Typing Systems Inc.
CityPompano Beach
StateFL
CountryUS
Distribution PatternThe product was distributed to 79 consignees throughout the USA and Canada.
 

Associated Products

Product DescriptionORTHO-ProVue (TM) A modular, microprocessor-controled instrument.
Code InfoMTS213784
ClassificationClass II
Reason for RecallORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed.
Product Quantity1 unit
Recall NumberB-2373-12

Class II Devices Event

Event ID54659
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Nov-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiosense Webster, Inc.
CityIrwindale
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.
 

Associated Products

Product DescriptionCARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO· XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.
Code InfoFG-5400-00
ClassificationClass II
Reason for RecallThe recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.
Product Quantity71 units total (30 units in US)
Recall NumberZ-2369-2012

Class II Biologics Event

Event ID61526
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLife Technologies, Inc.
CityBrown Deer
StateWI
CountryUS
Distribution PatternNationwide; CANADA, BRAZIL, GERMANY, ALGERIA, ESTONIA, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ISRAEL, ITALY, JAPAN, POLAND, ROMANIA, SAUDI ARABIA, SWEDEN, SINGAPORE, TUNISIA, TAIWAN, URUGUAY, SOUTH AFRICA.
 

Associated Products

Product DescriptionLife Technologies": BRAND NAME: ABC SSP UniTray® Kit, A Locus SSP UniTray® Kit, ABDR SSP UniTray® Kit, ABDRDQ SSP UniTray® Kit, AllSet+" Gold SSP HLA-A Locus Low Res Kit, AllSet+" Gold SSP HLA-ABC Low Res Kit, AllSet+" Gold SSP HLA-ABDR Low Res Kit, AllSet+" Gold SSP HLA-ABDRDQ Low Res Kit Invitrogen" , 9099 North Deerbrook Trail, Brown Deer, Wisconsin 53223 USA.
Code InfoAllSetGoldSSPHLA-ALowResKit 54310D 021709367 021791391 021858141 021916872 021944913 0211076053; AllSetGoldSSPHLA ABCLowResKit 54340D 037736548 037791458 037841437 037887231 037912911 037981112 0371011633 0371099919; AllSetGoldSSPHLA ABDRLowResKit 54350D 035735485 035757726 035791451 035832512 035866507 035911311 035951701 0351008471 0351073440 0351103719; AllSetGoldSSPHLA ABDRDQLowResKit 54360D 027736541 027778991 028835924 028861758 028911312 028984379 0281073439 0281103699; ABCSSPUniTrayKit 7800010 037712454 037757729 037796665 037851612 037902242 037920508 037979628 0371092252; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037712454752859 037712454758394 037712454760790 037712454764016 037712454766991 037712454770869 037712454771629 037712454772789 037712454774287 037712454778484 037712454778956 037712454781733 037712454788029 037712454789359 037712454790178 037757729798591 037757729797983 037757729801400 037757729804912 037757729808045 037757729812168 037757729814418 037757729815958 037757729819705 037757729821059 037757729825396 037757729827308 037757729828024 037757729830803 037796665832713 037796665834166 037796665838009 037796665838890 037796665844722 037796665847106; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037796665849099 037796665850875 037796665851181 037796665852860 037796665851949 037796665857262 037796665858683 037796665865627 037796665866156 037796665869762 037796665871196 037796665874253 037796665874943 037851612880429 037851612881201 037851612883129 037851612890428 037851612895476 037851612899445 037851612900035 037851612904079 037851612904692 037851612905849 037851612907021 037851612907856 037851612910035 037851612910577 037851612914817 037851612917475 037851612919222 037851612924833 037902242932770 037902242933984 037902242935517 037902242938190 037902242940463 037902242942846 037902242943935 037902242946600 037902242977061 037920508978727 037920508985066 037920508988899; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037920508991179 037920508998068 0379205081007233 0379205081008777 0379205081009666 0379205081012119 0379205081016105 0379205081017791 0379205081022104 0379205081021177 0379205081022614 0379205081025411 0379205081028018 0379205081028598 0379205081030883 0379796281034872 0379796281039558 0379796281041841 0379796281043290 0379796281044774 0379796281047614 0379796281048266 0379796281070125 0379796281073455 0379796281077182 0379796281083262 0379796281084640 0379796281092860 0379796281093721 0379796281097467 0379796281098059 0379796281099188 0379796281101573 0379796281104591 03710922521111533 03710922521113863 03710922521114554 03710922521116675 03710922521123330 03710922521124844; ABDRSSPUniTrayKit 7810010 035709363 035757737 035841438; ABDRSSPUniTrayKit 7810010 035912902 035999103 0351091909; ABDRSSPUniTrayKitwithTaqPolymerase 7810110 035709363752340 035709363757045 035709363764325 035709363770868 035709363771628 035709363784352 035709363792242 035709363794386 035757737795098 035757737801401 035757737812169 035757737820236 035757737833338 035757737835069 035757737838145 035757737851950 035757737864234 035841438883648 035841438897030 035841438900036 035841438924835 035912902946416 0359129021025412 0359991031079276 0359991031096908; ABDRDQSSPUniTrayKit 7850010 027711596 027749793 027785475 028848815 028912903 0281017323; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027711596757044 027711596758147 027711596764014 027711596764678 027749793799826 027749793826676 027785475834613; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027785475866155 027785475869047 028848815905848 028848815912398 028848815942043 028848815947403 028848815978967 028848815979292 028848815984697 0289129031022118 0289129031036927 02810173231045578 02810173231076646 02810173231090097; ALocusSSPUniTrayKit7860010 021751563 021825655 021912905 021999106; ALocusSSPUniTrayKitwithTaqPolymerase7860110 021751563824723 021825655924846 021825655926945 021825655928179 021825655932194 021825655935516 021912905948130 021912905951091 0219991061082229 ALocusSSPUniTrayKit7860010021751563 2010-032011-10 0218256552010-082012-04 0219129052011-032012-11 0219991062011-082013-03 ALocusSSPUniTrayKitwithTaq Polymerase 78601100217515638247232010-072011-10 0218256559248462011-022012-04 0218256559269452011-022012-04 0218256559281792011-022012-04 0218256559321942011-032012-04 0218256559355162011-032012-04 0219129059481302011-042012-11 0219129059510912011-042012-11 02199910610822292011-102013-03
ClassificationClass II
Reason for RecallHLA typing assay, associated with false negative results, were distributed.
Product Quantity12 units
Recall NumberB-1713-12

Class II Devices Event

Event ID61869
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmJK Products & Services, Inc
CityJonesboro
StateAR
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Canada
 

Associated Products

Product DescriptionSUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
Code InfoPN 8000809705; Serial numbers 248-1298
ClassificationClass II
Reason for RecallThe firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
Product Quantity1948 units
Recall NumberZ-2334-2012

Class II Veterinary Event

Event ID61880
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jan-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmProcess Managers LLC
CityWinchester
StateKY
CountryUS
Distribution PatternNationwide distribution: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA, WA & WV. No shipments were made to foreign countries including Canada.
 

Associated Products

Product DescriptionCalDensity Black Label, CalDensity White Label with HA, packaged in white plastic 5, 15, 25, 40, 60 lb pails with plastic liner and white plastic lid.
Code Info042009, 051009, 061209, 071509, 091009, 011510, 030310, 031610, 052610, 092410, 120110, 011211, 020111, 030911, 050111, 071111 & 090111.
ClassificationClass II
Reason for RecallDuring an FDA inspection it was found that the CalDensity Black label and CalDensity White Label with HA product containers did not include the precautionary statement DO NOT FEED TO CATTLE OR OTHER RUMINANTS
Product Quantity50,935 lbs
Recall NumberV-209-2012

Class II Biologics Event

Event ID62028
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityMelbourne
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW038111183305
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-2272-12

Class II Devices Event

Event ID62140
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmExactech, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternNationwide distribution: USA state of: Arkansas only
 

Associated Products

Product DescriptionREF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number 101-05-20; Serial Numbers: 2179820 and 2216759.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2361-2012
Product DescriptionREF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number: 101-05-30. Serial Numbers:2218601 and 2218603.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2362-2012
Product DescriptionREF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number: 101-05-40. Serial Numbers:2193123 and 2193124.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2363-2012
Product DescriptionREF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number: 101-45-20. Serial Numbers:2138948 and 2138950.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2364-2012
Product DescriptionREF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2365-2012
Product DescriptionREF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code InfoCatalog Number: 101-45-20. Serial Numbers:2139099 and 2139100.
ClassificationClass II
Reason for RecallExactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
Product Quantity2
Recall NumberZ-2366-2012

Class II Biologics Event

Event ID62304
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSouth Dakota Lions Eye and Tissue Bank, Inc.
CitySioux Falls
StateSD
CountryUS
Distribution PatternNC, Egypt
 

Associated Products

Product DescriptionSouth Dakota Lions Eye Bank, Cornea, SD11-079, For single use only, Not considered sterile, Culturing Recommended.
Code InfoSD11079OD; SD11079OS
ClassificationClass II
Reason for RecallHuman Corneas, recovered from a donor who had not been properly evaluated, were distributed.
Product Quantity2
Recall NumberB-2313-12

Class II Devices Event

Event ID62321
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Aug-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide distribution: International only-country of: Terumo Dubai, UAE
 

Associated Products

Product DescriptionSafety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
Code Infocatalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations have been adjusted to avoid mix-ups of different current rated circuit breaker. Terumo CVS implemented a requirement to ensure that assembly associates verify the values of electrical components in process to avoid such mix ups. At the time the problem was discovered, an NCR was opened to document that all remaining inventory at Terumo CVS had the correct circuit breaker installed. All Safety Monitors at Terumo CVS were verified to have the correct circuit breaker. Terumo CVS received complaints in 2009, at which time corrective action was completed for devices in the field. These corrections were not reported to the agency at that time.
Product Quantity8
Recall NumberZ-2348-2012

Class II Devices Event

Event ID62328
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and the countries of : AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN
 

Associated Products

Product DescriptionPhilips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Code InfoPhilips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide
ClassificationClass II
Reason for RecallTherapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
Product Quantity58,701 units
Recall NumberZ-2347-2012

Class II Biologics Event

Event ID62466
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmIndiana Blood Center
CityIndianapolis
StateIN
CountryUS
Distribution PatternIndiana
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW040712445641;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-2315-12

Class II Biologics Event

Event ID62467
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Bank of Erie County
CityErie
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045611821798;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2316-12

Class II Biologics Event

Event ID62474
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151121920149;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-2317-12

Class II Biologics Event

Event ID62475
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityEl Paso
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW041111083987D;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-2318-12

Class II Food Event

Event ID62480
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSunny Seafoods Inc
CityParamus
StateNJ
CountryUS
Distribution PatternMassachusetts to Georgia.
 

Associated Products

Product DescriptionAquaRoyale Oyster IQF Packed By Dai One Food.Co., LTD. Packed For: Sunny Seafoods, Inc. 11 Sunflower Avenue, Paramus, NJ 07652. USA NET WT.: 20 LBS (40/8oz) ICSSL No. KR-8-SP
Code InfoAll Lots between 1/01/2010 and 3/01/2012.
ClassificationClass II
Reason for RecallThis recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated.
Product Quantity80,000 pounds.
Recall NumberF-2293-2012
Product DescriptionFrozen Cooked Oyster: 1) Cooked Oyster 40-90 CT/LB IQF Packed By: Dai One Food.Co., LTD. Country of Origin: Republic of Korea. NET WT.: 40 LBS with 8 LBS Glaze; ICSSL No. KR-8-SP 2) AquaRoyale FROZEN COOKED OYSTER IQF PACKED FOR: SUNNY SEAFOODS INC. 11 SUNFLOWER AVENUE, PARAMUS, NJ 07652 U.S.A. NET WT.: 4 LBS (1/40 LBS) PACKED BY DAI ONE FOOD CO., LTD. ICSSL NO. KR-8-SP.
Code Info1 & 2: All Lots between 1/01/2010 and 3/01/2012
ClassificationClass II
Reason for RecallThis recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated.
Product Quantity1) 80,000 pounds; 2) 84,520 pounds
Recall NumberF-2294-2012
Product DescriptionHalf Shell Oyster Imported By: KORYEO INT'L CORP 200 STEWART AVENUE, BROOKLYN, NY 11237; SPEC 72PCS; COUNTRY OF ORIGIN: REPUBLIC OF KOREA; METHOD OF PRODUCTION: FARM RAISED; ICSSL No. KR-8-SP
Code InfoAll Lots between 1/01/2010 and 3/01/2012.
ClassificationClass II
Reason for RecallThis recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated.
Product Quantity150,000 pounds
Recall NumberF-2295-2012

Class II Biologics Event

Event ID62482
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityEl Paso
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW041112035793X;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-2314-12

Class II Biologics Event

Event ID62483
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityEl Paso
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW041112032780H;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-2319-12

Class II Biologics Event

Event ID62484
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternAustria; Florida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW038111208369; W038110158215;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-2320-12

Class II Biologics Event

Event ID62485
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDci Biologicals Llc
CitySan Angelo
StateTX
CountryUS
Distribution PatternIsrael
 

Associated Products

Product DescriptionSource Plasma
Code InfoSA0006509; SA0007428; SA0008238; SA0009496; SA0009707;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity5
Recall NumberB-2321-12

Class II Biologics Event

Event ID62487
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMeek Blood Center
CityAbilene
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW141412016763;
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-2325-12

Class II Biologics Event

Event ID62488
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityMelbourne
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW038111183306;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2330-12

Class II Biologics Event

Event ID62489
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151121360646;
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1
Recall NumberB-2331-12

Class II Biologics Event

Event ID62506
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWisconsin
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036312000290;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2332-12

Class II Biologics Event

Event ID62545
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmArup Laboratories, Inc.
CitySandy
StateUT
CountryUS
Distribution PatternUtah
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW158011201964;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed
Product Quantity1
Recall NumberB-2333-12

Class II Biologics Event

Event ID62547
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045010076930; W045010092946; W045010092946; W045011029587; W045011012156; W045011012156; W045012002820; W045012002820;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity8
Recall NumberB-2334-12

Class II Veterinary Event

Event ID62700
StatusTerminated
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNutra Blend LLC
CityNeosho
StateMO
CountryUS
Distribution PatternThe product was distributed in MO.
 

Associated Products

Product DescriptionBLN Fescue Forage Blend CTC NB-0451, Type B Medicated Feed For Beef Cattle, containing 1.4 g/lb. chlortetracycline, packaged in 50-lb. bags. The tag is labeled Manufactured by: Nutra Blend, LLC, Neosho, MO. The bag lists the firm name as Bass Livestock Nutrition, LLC, Rogersville, MO.
Code InfoLot 0525264
ClassificationClass II
Reason for RecallThe feed contains excessive levels of selenium
Product Quantity81/50-lb. bags
Recall NumberV-211-2012

Class II Devices Event

Event ID62760
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAÚDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN.
 

Associated Products

Product DescriptionGE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Code InfoSystem ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOVA2 HSRINNOVA1 82416070010 82416150007 82416210022 82416040046 CS1006VA05 EG1000VA01 M4198064 N4192939 M4166990 M4212443 HC1819XR10 HC5284XR39 542120XR02 HC5284XR38 83016862100448 835160028 IQ1165VA02 IE1100VA03 A5632421 A5102694 A5379605 A5320145 B5114298 A5360408 YV0370 YV0365 YV0364 YV0166 YV0369 YV0473 YV0480 YV0478 YV0475 YV0362 YV0510 YV0474 YV0481 YV0367 YV0477 YV0388 YV0466 YV0500 YV0463 YV0476 YV0464 YV0462 YV0400 YV0366 YV0501 YV0520 YV0363 YV0555 YV0472 YV0471 YV0470 YV0469 YV0468 YV0467 KW1098VA01 KW1098VA02 KW1011VA02 LB1331VA01 LY1086VA01 834160006 834160005 834160004 INNOVA2948687 PL1804VA01 PER18124 RO1095VA01 RU3427VA01 RU2741VA04 RU3847VA01 RU3883VA01 NA SA2253VA01 SA2236VA01 847160005 847160006 850060744 850060739 MEX68922 853060209 853060201 853060200 853060198 853060202 856160010 AE1225VA01 00234VAS02 00095VAS08 05448VAS01 00440VAS04 10086VAS07 10307VAS01 00243VAS02 00026VAS01 256HHCIB1 205877CCL3 480512BP 8184093131 6263973131 415206IBP1X53 3108252121A 3108252121B 909LLUMC2121 661949INNOVA3 650493BIPL 510428BIPL 619543INNOVABP CHLDRNCL1 303436LCLP 303425CL2 2036882121 FHORLEP4 561548BIP 561495DLBIP FHORLEP5 FHORL3131 904202WCL1 561881BP1 561881BP2 808547QCV4 319272EP 208227INNOVA31 630856H3131 630933INVLAB4 309655FSP4A 773RES3131BP 309655FSP2B 219326EP1 812238UNBPL 317338PV4 317338CL4BP 2197383131 2192632121 2198362121 913541OP3131 316268BIPLANE 504842OMC3131 504842OMCEP2 504842OMCEP1 504897INNOVA2 985867INNOVA31 617636IN2121 857307IN12121 857307IN22121 617525IN13131 857307IN32121 410614CV2 410614CV1 4105502121 410740CV 3018912121 202782LABA 301295EP 301295CATH 616392BP 507385INN3131 612273INNOVA3 816698CP3131 816932SL3131 704355RM7 704355P2121 603650EP1 973971EP3 973972LAB3 7327762121 7323213131 505887CL1 7028533131 718579INNOVABP 516562INNOVA1 718226BP1 COR373252 COR373301 COR373295 ORMCIR2 518262BP1 5135843131 541743CL5 503OHSUCV4 503OHSUCV3 541743CL2 541382BP 570824BP1 215576INNOVA2 LVINOV6 610526LAB3 814877BP 215662INNOVA3 412623H 610954BP1 864512EPBP 843692GSBPEP 615284ANG2 615222BIH 615222BIG 615769SP1 956632INN3131 281637SL3131 832522MW3131 903CSM2121 817465AR3131 361857CATH2 VAD2121 BMANGIO 936539CL4 936WH2121 214590EP2121 BMEP 713794LAB8 832355LAB4 713794LAB11 281440BP31 210617VACATH1 MCDEP 801532LCA 540776LGVAS2 276258INV3131 434654CATH2121 253627INNOVA5 206598UWBP 253403CL4 509474BIP 509473RM1 4146492121 4144473131 ECXV1402B 304526INNOVABP YE1002VA01
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Product Quantity240 (133 US and 107 OUS)
Recall NumberZ-2376-2012

Class II Devices Event

Event ID62768
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.
 

Associated Products

Product DescriptionSunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.
Code InfoVersion versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1
ClassificationClass II
Reason for RecallSunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event merge across patients may be formatted exactly the same as the patient-to-patient merge trigger. This may also occur if the application interfacing code has not been modified to process the event merge across patients trigger.
Product Quantity126 sites
Recall NumberZ-2332-2012

Class II Devices Event

Event ID62774
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jun-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmC.R. Bard, Inc., Urological Division
CityCovington
StateGA
CountryUS
Distribution PatternNationwide distribution: USA
 

Associated Products

Product DescriptionBard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Code InfoCatalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)
ClassificationClass II
Reason for RecallIncomplete seal on sterile packages of product.
Product Quantity56,694 units
Recall NumberZ-2327-2012

Class II Devices Event

Event ID62807
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
 

Associated Products

Product DescriptionTip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO).
Code InfoModel No. 400180-12 Lot No: M10120601 M10120430 M10120329 M10120312 M10111214 M10120516 M10120426 M10120321 M10120208 M10111208 M10120510 M10120419 M10120317 M10120207 M10111201 M10120507 M10120413 M10120315 M10120130 M10111028
ClassificationClass II
Reason for RecallThere is potential for the sterility of the product to be compromised.
Product Quantity11,121 Boxes
Recall NumberZ-2339-2012

Class II Devices Event

Event ID62842
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAesculap Implant Systems LLC
CityCenter Valley
StatePA
CountryUS
Distribution PatternNationwide Distribution-including the states of IL, MN, NV, OK, and TX.
 

Associated Products

Product DescriptionAesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.
Code InfoAll distributed lots and serial numbers
ClassificationClass II
Reason for RecallThere is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
Product Quantity5
Recall NumberZ-2333-2012

Class II Devices Event

Event ID62844
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCapsule Tech Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Denmark, France, Germany, Netherlands and UK.
 

Associated Products

Product DescriptionCapsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.
Code InfoSerial Numbers TS9801371 -TS9801650; TS9900670 - TS9900679; TS9B00413 - TS9B00722; TS9B01753 - TS9B02041; TSA301587 - TSA302186; TSA600246 - TSA600845 TSA801222 - TSA801821; TSAB00031 - TSAB00629; TSB300410 - TSB300912; TSB302698 - TSB303201; TSB401570 - TSB402012; TSB500633 - TSB501136; TSB502359 - TSB502861; TSB600767 - TSB601270; TSB700368 - TSB700871; TSB801147 - TSB803555; TSB902081 - TSB902585; TSBA03569 - TSBA03595; TSBB00027 - TSBB00537; TSBC00200 - TSBC01321; TSC100319 - TSC101318; TSC101972 - TSC103113; TSC301294 - TSC301299; TSC301389 - TSC303425; TSC401639 - TSC401995; TSC402020 - TSC402087; TSC402136 - TSC402346
ClassificationClass II
Reason for RecallCapsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron
Product Quantity12,448 units
Recall NumberZ-2377-2012

Class II Devices Event

Event ID62875
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Sep-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCustom Medical Specialties, Inc.
CityPine Level
StateNC
CountryUS
Distribution PatternNationwide Distribution including GA, MI, NY, and PA.
 

Associated Products

Product DescriptionCMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Code Info19207-1004
ClassificationClass II
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity3 cases
Recall NumberZ-2328-2012
Product DescriptionCMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Code Info16480-0908, 20976-1008, 21283-1009
ClassificationClass II
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity16 cases
Recall NumberZ-2329-2012
Product DescriptionCMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Code Info20179-1006
ClassificationClass II
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity4 cases
Recall NumberZ-2330-2012
Product DescriptionCMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Code Info14327-0902, 19929-1006
ClassificationClass II
Reason for RecallThe firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Product Quantity15 cases
Recall NumberZ-2331-2012

Class II Devices Event

Event ID62895
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
 

Associated Products

Product DescriptionThe SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Code InfoModel #: P6500, S/N 400000 through 406294
ClassificationClass II
Reason for RecallThe firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Product Quantity6,051 units
Recall NumberZ-2335-2012

Class II Devices Event

Event ID62909
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira, Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.
 

Associated Products

Product DescriptionSterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Code InfoThe letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.
ClassificationClass II
Reason for RecallReports of leaking during filling and administration.
Product Quantityunknown
Recall NumberZ-2346-2012

Class II Devices Event

Event ID62912
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOmni Life Science
CityEast Taunton
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
 

Associated Products

Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity312 units
Recall NumberZ-2370-2012
Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity286 units
Recall NumberZ-2371-2012
Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity310 units
Recall NumberZ-2372-2012
Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity270 units
Recall NumberZ-2373-2012
Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity182 units
Recall NumberZ-2374-2012
Product DescriptionOmnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Code InfoLot Numbers: 10723, 10763, 10824
ClassificationClass II
Reason for RecallThe Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product Quantity36 units
Recall NumberZ-2375-2012

Class II Veterinary Event

Event ID62914
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSteve Pritchett Farms LLC
CityHenderson
StateKY
CountryUS
Distribution PatternThe firm distributed to one firm in Indiana.
 

Associated Products

Product DescriptionFrozen mice in ziplock bags
Code InfoThere is no code information. The package shows the type of mice and the quantity.
ClassificationClass II
Reason for RecallThe firm initiated a voluntary recall of frozen mice because of possible human exposure to Lymphocytic Choriomenengitis Virus from handling the mice.
Product QuantityUnknown
Recall NumberV-210-2012

Class II Devices Event

Event ID62915
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmElekta, Inc.
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide Distribution including DC & MD
 

Associated Products

Product DescriptionMultileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Code Info152599 and 152678
ClassificationClass II
Reason for RecallInformation released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Product Quantity2
Recall NumberZ-2340-2012

Class II Food Event

Event ID62920
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmT.F. Foods Incorporated
CityParamount
StateCA
CountryUS
Distribution PatternFirm distributed to 6 direct consignees located in CA and NY.
 

Associated Products

Product DescriptionThai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:"***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***".
Code InfoProduct not coded. Production date is May 2, 2011.
ClassificationClass II
Reason for RecallProducts recalled due to undeclared FD&C Yellow # 6.
Product Quantityunknown
Recall NumberF-2225-2012

Class II Veterinary Event

Event ID62922
StatusTerminated
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBreadfarm
CityBow
StateWA
CountryUS
Distribution PatternRetail sales at firm only.
 

Associated Products

Product Description"Sirius Dog Treats". Bone-shaped treats packaged 10 each in a cellophane package
Code Info"126", "136", "143" and "150". These are the julian dates that the dough was made, baked and packaged.
ClassificationClass II
Reason for RecallThe wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 0.5mm in diameter and 3-15mm in length. The contamination occurred at the raw ingredient manufacturer.
Product Quantity144 packages each containing 10 treats
Recall NumberV-208-2012

Class II Devices Event

Event ID62926
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLucero Medical LLC
CityIndependence
StateOH
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionEnduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Code InfoPart #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018.
ClassificationClass II
Reason for RecallThe firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Product Quantity169
Recall NumberZ-2368-2012

Class II Devices Event

Event ID62946
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution -- USA (nationwide) Distribution
 

Associated Products

Product DescriptionOptima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Code InfoPart Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
ClassificationClass II
Reason for RecallSoftware issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Product Quantity254 total in the US
Recall NumberZ-2255-2012
Product DescriptionOptima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Code InfoPart Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
ClassificationClass II
Reason for RecallSoftware issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Product Quantity254 total in the US
Recall NumberZ-2256-2012

Class II Food Event

Event ID62960
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAtlas Operations, Inc.
CityPompano Beach
StateFL
CountryUS
Distribution PatternDistributed to one direct account in Florida who further distributed the entire shipment to one account in Dallas, TX.
 

Associated Products

Product DescriptionMeal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the best, and none of the rest, in amounts that are the right balance for you.***More than just the best ingredients, The perfect Shake supplement is made from the optimal ratio of the right ingredients, scientifically designed to supplement a healthy diet and use along with your weight management program.**The Perfect Shake supplement is as much about what it doesn't contain as what it does. There are no animal proteins (it's vegan). No whey, soy or casein. No ingredients produced using biotechnology. No glutens. No artificial sweeteners like sucralose or aspartame.***Maintaining your ideal energy levels and supporting your weight management goals shouldn't be a challenge; it should be easy, natural, and something anyone can do.***Try The Perfect Shake Supplement for 30 days. If you don't love it, return the empty container for a full refund.***All of the Best***Ancient Grain Blend***Amaranth, Sorghum and Brown Rice***Richest sources of nutrients among grains***Metabolic Support Blend***Use as part of your diet to help promote healthy blood sugar levels***Promotes healthy metabolism* ***SuperFood Blend***With superfoods like spinach and carrot powders***Lycopene - the powerful anti-oxidant***Digestive Blend***Dietary fiber to support your digestive system***Guar gum to provide a gentle laxative***Beneficial bacteria to promote digestive health* ***Natural Flavoring and Sweeteners***NuStevia - sweeter than sugar without the unwanted effects***Natural vanilla flavor***None of the Rest***whole milk***gluten***lactose***processed sugar***fructose***casein protein***processed sugar***fructose***casein protein***synthetics***food dyes***artificial coloring***ingredients produced using biotechnology***artificial sweeteners***artificial flavorings***Directions for use: For adults 18 years and older, mix one full scoop with water or skim milk. Not for use by individuals under the age of 18.***Supplement Facts Serving Size 1oz***Servings Per Container: 30***Ancient Grain Blend 10g***Brown Rice, Amaranth, Sorghum***Metabolic Support Blend 346mg***Irvingia Gabonesis 4:1, Guarana PE 12% Chromium Picolinate, Slippery Elm Bark Spirulina Powder, Vita Choline, Mucuana Pruiens 25% To 40%, Noni PE 4:1, PPQ***SuperFood Blend 195mg***Spinach Powder, Carrot Powder, Pascalite Powder Horsetail Powder Ext. 7%, Lycopene 5%***Digestive Blend 5g***Fibers (Maltodextrin), UltraSmooth (Tic Gum) Guar Gun, Fungal Protease 100,000HUTG Lactobacillus Acidophilus 10 Billion***Other Ingredients: Natural Vanilla Flavor, NuStevia***This product is derived from natural ingredients and therefore color may vary from lot to lot, and some ingredients may not dissolve as rapidly as other natural ingredients.***Keep lid tightly closed and in a dark, cool place. Keep out of reach of children. This product is sold by weight, not by volume. Settling of contents may occur during shipping and handling.***Questions? 1-888-488-9493***Manufactured for foru international, inc. 1231 Greenway Drive, Ste. 200 Irving Texas 75038***" The product is in white plastic bottles with Black Top. Product is packaged 12 bottles per case. Product Form: Powder. Dosage: 1 Scoop (16.6g) Product Description: Cream color powder blend, somewhat vanilla scent. Product use: Intended use as meal replacement.
Code InfoLot R2-981-12. Exp 07/14
ClassificationClass II
Reason for RecallAtlas Operations, Inc is recalling Meal Replacement foru Dietary Supplement, Lot R2-981-12, Exp. Date: 7/14 for possible microbial contamination.
Product Quantity425 bottles
Recall NumberF-2292-2012

Class II Devices Event

Event ID62988
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide distribution: USA including states of: IN, MI, MS, TN and TX.
 

Associated Products

Product DescriptionSiemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Code InfoModel number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.
ClassificationClass II
Reason for RecallSiemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
Product Quantity5
Recall NumberZ-2341-2012

Class II Devices Event

Event ID62989
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUS Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
 

Associated Products

Product DescriptionSiemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Code InfoModel number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054
ClassificationClass II
Reason for RecallDuring regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt to the floor on one side.
Product Quantity9
Recall NumberZ-2367-2012

Class II Devices Event

Event ID63008
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Xomed, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
 

Associated Products

Product DescriptionInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Code InfoAll serial numbers.
ClassificationClass II
Reason for RecallIn January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally.
Product Quantity464
Recall NumberZ-2342-2012
Product DescriptionInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Code Info8253410 (Neuro). All Serial Numbers.
ClassificationClass II
Reason for RecallIn January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally.
Product Quantity53
Recall NumberZ-2343-2012
Product DescriptionInterfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Code Info8253210 (Pulse). Serial Numbers 00004, 00009, 00010, 00013, 00014, 00015, 00017 (International Consignees only)
ClassificationClass II
Reason for RecallIn January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally.
Product Quantity7
Recall NumberZ-2344-2012

Class II Devices Event

Event ID63102
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVolcano Corporation
CityRancho Cordova
StateCA
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionVolcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
Code InfoAll units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
ClassificationClass II
Reason for RecallThe display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Product Quantity1020 units
Recall NumberZ-2345-2012

Class III Biologics Event

Event ID61619
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Nov-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmD. D. Eisenhower Army Med. Ctr. - Blood Bank
CityFort Gordon
StateGA
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW010711011931; W010711011963; W010711011962; W010711011951; W010711011946; W010711011939; W010711011922; W010711011929; W010711011947; W010711011957; W010711011957; W010711011943;
ClassificationClass III
Reason for RecallBlood products, labeled with an incorrect expiration date, were distributed.
Product Quantity12 units
Recall NumberB-1410-12

Class III Biologics Event

Event ID62026
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Apr-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityLubbock
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW0415120158940
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1492-12

Class III Biologics Event

Event ID62030
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160062845; 2160063872; 2160065445; 2160068908; 2160071590
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity5 units
Recall NumberB-2097-12

Class III Biologics Event

Event ID62031
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160069348
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2096-12

Class III Biologics Event

Event ID62032
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160078505; 2160079641
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2095-12

Class III Biologics Event

Event ID62037
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160063807
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2090-12

Class III Biologics Event

Event ID62039
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077885; 2160078198
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2100-12

Class III Biologics Event

Event ID62040
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077908
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2099-12

Class III Biologics Event

Event ID62041
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info2160070522; 2160080254
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Product Quantity2 units
Recall NumberB-2098-12

Class III Biologics Event

Event ID62045
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160062561; 2160067517
ClassificationClass III
Reason for RecallBlood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2088-12

Class III Biologics Event

Event ID62046
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160079251
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2089-12

Class III Biologics Event

Event ID62047
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160077780
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2094-12

Class III Biologics Event

Event ID62048
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160078077
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2093-12

Class III Biologics Event

Event ID62049
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160067549; 2160074048
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2092-12

Class III Biologics Event

Event ID62050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160065452
ClassificationClass III
Reason for RecallBlood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2091-12

Class III Biologics Event

Event ID62262
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160075750; 2160076155; 2160058983; 2160063549; 2160065677; 2160067374; 2160068963; 2160080530
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity8 units
Recall NumberB-2079-12

Class III Biologics Event

Event ID62263
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160058856; 2160059304; 2160062919
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2074-12

Class III Biologics Event

Event ID62264
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160082868; 2160083407; 2160084296
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2076-12

Class III Biologics Event

Event ID62265
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160066915; 2160067545; 2160076395
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2075-12

Class III Biologics Event

Event ID62268
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160066934; 2160068103; 2160069088; 2160071419; 2160072603;
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity5 units
Recall NumberB-2078-12

Class III Biologics Event

Event ID62269
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPlasmacare Inc
CityCleveland
StateOH
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info2160065002; 2160071557; 2160072847; 2160084133
ClassificationClass III
Reason for RecallBlood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-2077-12

Class III Biologics Event

Event ID62286
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican Red Cross Blood Services
CityBirmingham
StateAL
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info041LS92218
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2280-12

Class III Food Event

Event ID62890
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMeijer Distribution, Inc
CityGrand Rapids
StateMI
CountryUS
Distribution PatternThe 4 oz. product was distributed to 25 stores and the. 8 oz. product was distributed to 197 stores. Stores are located in Illinois, Indiana, Kentucky, Michigan, and Ohio. Product was distributed from Meijer's distribution centers located in lansing, Michigan; Newport, Michigan; and Tipp City, Ohio.
 

Associated Products

Product DescriptionMeijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3
Code InfoAll lots
ClassificationClass III
Reason for RecallThe sodium in the product is above the declared value of the sodium stated on the label.
Product Quantity74,667 units of 4-oz and 159,349 units of 8-oz
Recall NumberF-2296-2012

Class III Devices Event

Event ID62925
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Sterilization Products
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionSTERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Code InfoProduct Code: 10113
ClassificationClass III
Reason for RecallAdvanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Product Quantity7,495 units
Recall NumberZ-2337-2012
Product DescriptionSTERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Code InfoProduct Code: 10133
ClassificationClass III
Reason for RecallAdvanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Product Quantity7,550 units
Recall NumberZ-2338-2012

Class III Veterinary Event

Event ID62944
StatusTerminated
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGreer Laboratories Inc
CityLenoir
StateNC
CountryUS
Distribution PatternFL, IL, KS, MS, NJ, NY, OH, VA & Australia
 

Associated Products

Product DescriptionProduct is an aqueous Black/Carpenter Ant, veterinary allergenic extract in liquid form. Product is viled in 10 mL Type 1 glass vials, stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap.
Code InfoLot # 200794
ClassificationClass III
Reason for RecallMislabeled vials
Product Quantity11 vials
Recall NumberV-212-2012

Class III Devices Event

Event ID62970
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHelix Medical LLC
CityCarpinteria
StateCA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
 

Associated Products

Product DescriptionBLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Code InfoLot#1008419
ClassificationClass III
Reason for RecallHelix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Product Quantity2 devices
Recall NumberZ-2336-2012

Mixed Classification Biologics Event

Event ID62297
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternSwitzerland; FL
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info2721483
ClassificationClass III
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2283-12
Product DescriptionRed Blood Cells
Code Info2721483
ClassificationClass II
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2284-12

Mixed Classification Biologics Event

Event ID62299
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternSwitzerland; FL, NY
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info2564980
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2286-12
Product DescriptionFresh Frozen Plasma
Code Info2625072
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2287-12
Product DescriptionRed Blood Cells
Code Info2564980; 2625072
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity2 units
Recall NumberB-2288-12
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