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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 18, 2011

 

May 18, 2011                                                                                        11-20
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT   
1) Baba Foods Baked Chips Garlic and Parmesan, 32 oz. Recall # F-1106-2011
2) Baba Foods Roma Mozzarella Salad, 8 oz. Recall # F-1107-2011;  
3) Baba Foods Tzatziki Cucumber Yogurt Sauce, 8 oz & 24 oz. Recall # F-1108-2011;
4) Baba Foods Three Layer Dip, 8 oz. Recall # F-1109-2011;
5) Baba Foods Roasted Pepper Tapenade, 8 oz. Recall # F-1110-2011;
6) Baba Foods Spinach Artichoke & Parmesan Dip 8 oz. Recall # F-1111-2011;
7) Baba Foods Spinach & Feta Hummus 8 oz. Recall # F-1112-2011
CODE
1) Exp. Date: 04/15/2011-07/18/2011;
2) Exp. Date: 04/15/2011-05/06/2011;
3) Exp. Date: 04/15/2011-05/15/2011;
4) – 7) Exp. Date: 04/15/2011-05/06/2011;
RECALLING FIRM/MANUFACTURER
Baba Foods, Chula Vista, CA, by telephone and letter on April 15, 2011.  FDA initiated recall is ongoing.
REASON
The recall was initiated because during a routine inspection at Baba Foods it was observed by an FDA Investigator that the firm did not list allergen containing ingredients for the Spinach Artichoke & Parmesan Dip- The firm did not list the sub-ingredients for the ingredient low fat yogurt which contains the allergen of milk.
VOLUME OF PRODUCT IN COMMERCE
1785 units (8oz units)
DISTRIBUTION
CA
___________________________________
PRODUCT
See's Candies; Mayfair with Cherries & Pecans, 4.25 oz (121 gr). Recall # F-1113-2011
CODE
Code 138
RECALLING FIRM/MANUFACTURER
See's Candies Inc., South San Francisco, CA, by press release and telephone on April 19, 2011. Firm initiated recall is ongoing.
REASON
A single code of 4.25 ounce Mayfair eggs with Cherries and Pecans was made with walnuts instead. The label declares pecans as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
597 eggs - e destroyed in testing
DISTRIBUTION
CA, WA, IL, CO, OR, UT, NV, MN
___________________________________
PRODUCT   
Chicken of the Sea Chopped Clams 6.5 oz, Product Codes: a) Y715 6P22UU BMJ1C; b) Y715 6P22UU CCB1C; c) Y715 6P22UU CCC1C; d) Y715 6P22UU CEJ1C; e) Y715 6P22UU CET1C. A Chicken of the Sea Chopped Clam label (4800000073) was put on a can containing shrimp and placed into a Chicken of the Sea Tiny Shrimp case (4800000062). UPC code 04807306. Recall # F-1114-2011
CODE
a) Best By Date 12/18/11; b) Best By Date 3/11/12; c) Best By Date 3/12/12; d) Best By Date 5/18/12; e) Best By Date 5/27/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-Union Seafoods, L.L.C dba Chicken of the Sea, San Diego, CA, by letter and press release on April 7, 2011.    
Manufacturer: Yueh Chyang Canned Food Co., Ben Luc, Vietnam. Firm initiated recall is ongoing.
REASON
The recall was initiated because Chicken of the Sea was alerted that some of the Chicken of the Sea brand 6.5 oz chopped clams have been mislabeled and may contain tiny shrimp. People who have an allergy or severe sensitivity to shellfish run the risk of a serious or life-threatening allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
2,224 cases (12 cans per case)
DISTRIBUTION
PA, NY, VT, VA
__________________________________
PRODUCT   
Chicken salad with cranberries and pecans on whole wheat sandwiches 7.5 oz, wrapped in cellophane. Recall # F-1116-2011
CODE
Expiration date 4/5/2011
RECALLING FIRM/MANUFACTURER
Newberry KOA Campground, Newberry, MI, by visit on March 30, 2011. FDA initiated recall is complete.
REASON
The chicken salad contains mayonnaise but the finished product label does not list egg. The sandwiches also contain yellow pepper rings containing yellow # 5 but the finished product is not labeled with yellow # 5. 
VOLUME OF PRODUCT IN COMMERCE
24 sandwiches
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Skippy Reduced Fat Creamy Peanut Butter Spread, 16.3 oz. plastic jars, Serving size 2 tbsp, Case UPC 10048001006819, Consumer UPC 048001006812. Recall F-1118-2011;
 
2) Skippy Reduced Fat Super Chunk Peanut Butter Spread, 16.3 oz. plastic jars, Serving size 2 tbsp, Case UPC 10048001006789, Consumer UPC 048001006782. Recall #F-1119-2011
CODE
1) and 2) Best-if-used-by Dates MAY 1612LR1, MAY1712LR1, MAY1812LR1, MAY1912LR1, MAY2012LR1, MAY2112LR1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood Cliffs, NJ, by press release and letter dated March 4, 2011.
Manufacturer: Unilever, Little Rock, AR. Firm initiated recall is ongoing.
REASON
Skippy Reduced Fat Peanut Butter, Creamy and Super Chunk varieties are being recalled due to possible salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
64020 (total)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Solaray Dietary Supplement, Organic Tart Cherry, 100% Pure Juice Concentrate, 16 oz, UPC 0 76280 50259 6. Recall # F-1066-2011
CODE
Lot # 686639
RECALLING FIRM/MANUFACTURER
Nutraceutical International Corp., Park City, UT, telephone and emails beginning April 7, 2011.
Manufacturer: Dynamic Health Laboratories, Inc., Brooklyn, NY. Firm initiated recall is ongoing.
REASON
Bottles were reported as bulging or misshaped and in some instances the seals have popped off.
VOLUME OF PRODUCT IN COMMERCE
2,600 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Frankly Fresh Ceviche products labeled as: a) Frankly Fresh Ceviche de Camaron, 10 lbs,  Item Number: 229233, UPC: 826520370191; b) Frankly Fresh Ceviche de Camaron & Pescado, 10 lbs, Item Number: 229243, UPC: 826520370184; c) Frankly Fresh Premium Fish Ceviche, 10 lbs, Item Number: 231981, UPC: N/A; d) Frankly Fresh Shrimp & Scallop Ceviche, 10 lbs, Item Number: 231994, UPC: 826520370221; e) Frankly Fresh Fish Ceviche, 10 lbs, Item Number: 234023, UPC: 826520700233; f) Frankly Fresh Ceviche W/ Pasta Salad, 7 lbs, Item Number: 234033, UPC: 82652030146; g) Frankly Fresh Ceviche, 10 lbs, Item Number: 234052, UPC: 038794348855; h) Frankly Fresh Ceviche Mixto, 10 lbs, Item Number: 234093, UPC: 826520300334; i) Frankly Fresh Ceviche Salad, 16 oz,  Item Number: 234273, UPC: 826520100514. Recall # F-1067-2011;
 
2) Frankly Fresh Agua Chile de Camaron, 10 lbs, Item Number: 229253, UPC: 826520370177. Recall # F-1068-2011;
 
3) Frankly Fresh Cocktail de Camaron con Pulpo, 10 lbs, Item Number: 229263, UPC: 826520370207. Recall # F-1069-2011;
 
4) Frankly Fresh Krab & Shrimp Louie Salad labeled as: a) Frankly Fresh Krab & Shrimp Louie Salad, 14 oz, Item Number: 231322, UPC: 826520100958; b) Frankly Fresh Krab & Shrimp Louie Salad, 10 lb, Item Number: 234072, UPC: 826520300105; c) Frankly Fresh Krab & Shrimp Louie Salad, 16 oz,  Item Number: 234243, UPC: 826520100484; d) Frankly Fresh Krab & Shrimp Louie Salad, 6/12 oz, Item Number: 254364, UPC: 826520104574; e) Frankly Fresh Krab & Shrimp Louie Salad, 6/9.5 oz, Item Number: 254183-1, UPC: 826520103157. Recall # F-1070-2011;
 
5) Frankly Fresh Krab Salad labeled as: a) Frankly Fresh Premium Krab Salad, 10 lb, Item Number: 231993, UPC: 826520370214; b) Frankly Fresh Krab Salad, 16 oz, Item Number: 234253, UPC: 826520100491. Recall # F-1071-2011;
 
6) Frankly Fresh KRAB & SHRIMP, 7 lb, Item Number: 232505-1, UPC: 826520300518. Recall # F-1072-2011;
 
7) Frankly Fresh Tuna labeled as: a) Frankly Fresh Tuna Sandwich Wedge, 5.3 oz, Item Number: 233116, UPC:826520105816; b) Frankly Fresh Wrap Tuna , 10 oz, Item Number: 235032, UPC:8826520100842; c) Frankly Fresh Tuna Salad Wedge, 6.3 oz, Item Number: 262033, UPC:041573103521,; d) Frankly Fresh Tuna Salad w/Pickles, 1/5 lb, Item Number: 252163, UPC:826520300877. Recall # F-1073-2011;
 
8) Frankly Fresh Favorite Krab, 10 lb, Item Number: 234032, UPC: 038794930487. Recall # F-1074-2011;
 
9) Frankly Fresh Seafood Cocktail labeled as: a) Frankly Fresh Seafood Cocktail, 10 lb, Item Number: 234042 & 234-042-2, UPC: 038794348862; b) Frankly Fresh Seafood Cocktail, 8/16 oz, Item Number: 234223, UPC: 826520100507. Recall # F-1075-2011
 
10) Frankly Fresh Seafood Salad, 1/14 oz, Item Number: 254514, UPC: 826520104543. Recall # F-1076-2011
CODE
1) a) Code Dates: 4/02 to 4/16/2011; b) Code Dates: 4/02 to 4/16/2011; c) Code Dates: 3/29 to 4/13/2011; d) Code Dates: 3/29 to 4/13/2011; e) Code Dates: 3/29 to 4/13/2011; f) Code Dates: 3/19 to 4/03/2011; g) Code Dates: 4/08 to 4/23/2011; h) Code Dates: 4/02 to 4/16/2011; i) Code Dates: 3/21 to 4/05/2011;
 
2) Code Dates: 4/02 to 4/16/2011;
 
3) Code Dates: 4/02 to 4/16/2011;
 
4) a) Code Dates: 3/21 to 4/05/2011; b) Code Dates: 3/29 to 4/13/2011; c) Code Dates: 3/21 to 4/05/2011; d) Code Dates: 4/08 to 4/23/2011; e) Code Dates: 4/08 to 4/23/2011;
 
5) a) Code Dates: 3/29 to 4/13/2011; b) Code Dates: 3/21 to 4/05/2011;
 
6) Code Dates: 3/21 to 4/05/2011;
 
7) a) Code Dates: 3/19 to 4/03/2011; b) Code Dates: 3/21 to 4/05/2011; c) Code Dates: 3/19 to 4/03/2011; d) Code Dates:3/21 to 4/05/2011;
 
8) Code Dates: 4/08 to 4/23/2011;
 
9) a) Code Dates: 4/08 to 4/23/2011; b) Code Dates: 4/02 to 4/16/2011;
 
10) Code Dates: 3/ 21 to 4/05/2011
RECALLING FIRM/MANUFACTURER
FranklyFresh, Carson, CA, by letter on March 29, 2011. FDA initiated recall is ongoing.
REASON
The recall was initiated of the seafood line of products, because it has the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
61,694 units
DISTRIBUTION
CA, NV
___________________________________
PRODUCT   
Melomakarona (honey cookies); sold frozen in 6 lb. plastic bags in cardboard boxes, and fresh in 12 count trays. Recall # F-1078-2011
CODE
All lots manufactured between 02/14/2011 and 03/14/2011
RECALLING FIRM/MANUFACTURER
Athenian Foods Co, Melrose Park, IL, by letter dated March 14, 2011 and by telephone on March 14 - 17, 2011. FDA initiated recall is ongoing. 
REASON
The Melomakarona (honey cookies) contain a lemon emulsion and an orange emulsion made with FD&C Yellow #5 and #6, which are not declared on the label of the finished product cookies.
VOLUME OF PRODUCT IN COMMERCE
23 - 6 lb. bulk cases; 6 - 12 x 12 count trays
DISTRIBUTION
IL, SC
___________________________________
PRODUCT
Food Club Moist Classic Chocolate Butter Recipe Deluxe Cake Mix, 18.5 oz. box, 12 boxes per case; UPC 0 36800 13491 1. Recall # F-1079-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilster-Mary Lee Corp., Chester, IL, by letter on April 1, 2011.  
Manufacturer: Gilster-Mary Lee Corp., Steeleville, IL. Firm initiated recall is ongoing.
REASON
The boxes labeled as Food Club Moist Classic Chocolate Butter Recipe Deluxe Cake Mix actually contain bags of yellow cake mix which contains FD&C Yellow #5 and #6 which are not declared in the ingredients statement on the box.
VOLUME OF PRODUCT IN COMMERCE
778 cases
DISTRIBUTION
AL, FL, LA, SC, TX, VA, WI
___________________________________
PRODUCT   
Custom Culinary PanRoast Gravy Low Sodium Chicken Flavored Gravy Mix, item 1740, UPC 0 96248 11740 2, net wt. 16 oz. pouches, 8 pouches per case, which may be labeled as Custom Culinary PanRoast Gravy Low Sodium Brown Gravy Mix, item 1743, UPC 0 96248 11743 8. Recall # F-1080-2011
CODE
Lot # A18856
RECALLING FIRM/MANUFACTURER
Recalling Firm: Custom Culinary, Lombard, IL, by telephone and letters on April 12, 2011.  
Manufacturer: Griffith Labs U.S.A., Alsip, IL. Firm initiated recall is ongoing.
REASON
The chicken flavored gravy mix was mislabeled as brown gravy mix, which does not declare the colors FD&C Yellow #5 and FD&C Yellow #6 on the label.
VOLUME OF PRODUCT IN COMMERCE
482 cases
DISTRIBUTION
AZ, IL
___________________________________
PRODUCT
1) Baguette bread loaf packaged individually in a clear plastic bag with twist tie. Sold individually. No labeling. No UPC code. Recall #F-1081-2011;
 
2) Deli Loaf, one unit in each package. One foot long White loaf bread for use in deli operations packaged individually in a clear plastic bag with twist tie. Sold individually. No labeling and UPC code. Recall #F-1082-2011;
 
3) Focaccia bread loaves packaged individually or sold in a full pan. Individual units packed in a clear plastic bag with twist tie. Full pan products are sold six units per Metal tray, covered with a plastic bag and closed with a twist tie. No labeling and no UPC. Recall #F-1083-2011;
 
4) Garlic Bread. White loaf bread made with fresh Garlic, packaged individually in a clear plastic bag with twist tie. Sold individually, no labeling and no UPC code. Recall #F-1084-2011;
 
5) Wheat Bread Round is in round form, packaged individually in a clear plastic bag with twist tie. Sold individually, no labeling provided and no UPC code. Recall #F-1085-2011;
 
6) White Bread Round is in round form, packaged individually in a clear plastic bag with twist tie. Sold individually, no labeling provided and no UPC code. Recall #F-1086-2011;
 
7) Banana Sweet Bread. Banana flavored white bread, packaged individually in a clear plastic bag with twist tie. Sold individually without any labeling and no UPC. Recall #F-1087-2011;
 
8) White Sub Loaf made from a white bread mix, packaged individually in a clear plastic bag with twist tie. Sold individually, no labeling and no UPC code. Recall #F-1088-2011;
 
9) Wheat Sub Loaf made from a wheat bread mix, packaged individually in a clear plastic bag with twist tie. Sold individually, no labeling provided and no UPC code. Recall #F-1089-2011;
 
10) Artisan White Hoagie made from a white bread mix, packaged individually in a clear plastic bag with twist tie. Sold per half dozen without labeling. No UPC code. Recall #F-1090-2011;
 
11) Artisan Wheat Hoagie roll made from a wheat bread mix packaged individually in a clear plastic bag with twist tie. Sold per half dozen without labeling. No UPC code. Recall #F-1091-2011;
 
12) Green Onion Hoagie roll made from white bread mix with fresh Green Onions, packaged individually in a clear plastic bag with twist tie. Sold per half dozen without any labeling. No UPC code. Recall #F-1092-2011;
 
13) Rye Hoagie rolls made from Rye bread mix packaged individually in a clear plastic bag with twist tie. Sold per half dozen without any labeling. No UPC code. Recall #F-1093-2011;
 
14) Wheat Hoagie roll made from a wheat bread mix, packaged individually in a clear plastic bag with twist tie. Sold per half dozen without any labeling. No UPC code. Recall # F-1094-2011;
 
15) White Hoagie roll made from a white bread mix, packaged individually in a clear plastic bag with twist tie. Sold per half dozen without any labeling. No UPC code. Recall #F-1095-2011;
 
16) Oatmeal Raisin Cookies made with Oatmeal and Raisins, packaged by the dozen in a clear plastic bag with twist tie. Sold per dozen without any labeling. No UPC code. Recall #F-1096-2011;
 
17) Panda Cookies is Brownie-like cookie made from scratch, packaged by the dozen in a clear plastic bag with twist tie. Sold per dozen. No labeling and UPC code. Recall #F-1097-2011;
 
18) Caramel Roll with added nuts on surface made from a white bread mix, packaged per half dozen in a clear plastic bag with twist tie. Sold per half dozen. No labeling provided and no UPC code. Recall #F-1098-2011;
 
19) Caramel Roll without Nuts made from a white bread mix packaged per half dozen in a clear plastic bag with twist tie. Sold per half dozen. No labeling and UPC code. Recall #F-1099-2011;
 
20) Cinnamon Roll made from a white bread mix, packaged per half dozen in a clear plastic bag with twist tie. Sold per half dozen. No labeling and no UPC code. Recall #F-1100-2011;
 
21) Fruit Danishes made from a white bread mix with fruit fillings, packaged by the dozen in a clear plastic bag with twist tie. Sold per dozen. No labeling and no UPC code. Recall #F-1101-2011;
 
22) Various Donuts (Cake and raised) made from dough and frosting, packaged by the dozen in a clear plastic bag with twist tie. Sold per dozen, no labeling and no UPC code. Recall #F-1102-2011;
 
23) Scones made from a white bread mix with Raspberry filling or Blueberry filling, packaged per half dozen in a clear plastic bag with twist tie. No UPC code and no labeling. Recall #F-1103-2011;
 
24) White Chocolate Raspberry Scone made from a white bread mix with White Chocolate Raspberry filling, packaged per half dozen in a clear plastic bag with twist tie. Sold per half dozen, no labeling and no UPC code. Recall #F-1104-2011;
 
25) Pizza Dough Balls made from a white bread mix, packaged per dozen in a clear plastic bag with twist tie. Sold per dozen. There are no labeling and no UPC code. Recall #F-1105-2011
CODE
1) Code is date of manufacture: 5/25/10. All bread products have an expiration of TWO days after manufacture date;
2) Code is date of manufacture: 5/24/10; 5/29/10;
3) Code is date of manufacture: 5/24/10 and 5/25/10;
4) Code is date of manufacture: 5/24/10 and 5/25/10;
5) Code is date of manufacture: 5/24/10; 5/25/10;
6) Code is date of manufacture: 5/24/10; 5/25/10;
7) Code is date of manufacture: 5/28/10;
8) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, and 5/29/10;
9) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, and 5/29/10;
10) Code is date of manufacture: 5/24/10 and 5/25/10;
11) Code is date of manufacture: 5/24/10 and 5/25/10;
12) Code is date of manufacture: 5/25/10;
13) Code is date of manufacture: 5/25/10;
14) Code is date of manufactured: 5/25/10;
15) Code is date of manufacture: 5/25/10;
16) Code is date of manufacture: 5/24/10;
17) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, 5/29/10, and 5/30/10. All pastry products have an expiration of ONE day after manufacture date. All bread products have an expiration of TWO days after manufacture date.
18) Code is date of manufacture: 5/24/10 and 5/25/10;
19) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, 5/29/10, and 5/30/10;
20) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, 5/29/10, and 5/30/10;
21) Code is date of manufacture: 5/24/10 and 5/25/10;
22) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, 5/28/10, 5/29/10, and 5/30/10;
23) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, and 5/28/10;
24) Code is date of manufacture: 5/24/10, 5/25/10, 5/27/10, and 5/28/10;
25) Code is date of manufacture: 5/25/10, 5/27/10, 5/28/10, and 5/29/10.
RECALLING FIRM/MANUFACTURER
Log Cabin Bakery, Billings, MT, by telephone on May 27, 2010. FDA initiated recall is ongoing.
REASON
Products do not have labels and contain undeclared allergen wheat and milk.
VOLUME OF PRODUCT IN COMMERCE
2,943 loaves/units
DISTRIBUTION
MT
___________________________________
PRODUCT   
Italian Sub, net wt. 10 oz. Recall #F-1115-2011
CODE
Expiration date 4/5/2011
RECALLING FIRM/MANUFACTURER
Newberry KOA Campground, Newberry, MI, by visit on March 30, 2011. FDA initiated recall is complete.
REASON
The sandwiches contain yellow pepper rings containing yellow # 5 but the finished product is not labeled with yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
60 sandwiches
DISTRIBUTION
MI
___________________________________
PRODUCT   
Advocare Spark Energy Drink, Cherry, Vitamin and Amino Acid Supplement, Net Wt 1 lb. 5.2 oz., packaged in canisters. Recall # F-1117-2011
CODE
Lot # 1055112
RECALLING FIRM/MANUFACTURER
Recalling Firm: AdvoCare International, LP, Carrollton, TX, by telephone and by e-mail on March 31, 2011. 
Manufacturer: Dymatize Enterprises, Inc., Farmers Branch, TX. Firm initiated recall is ongoing.
REASON
Product manufacturing error resulted in Niacin being substituted for Niacinamide in the formulation.
VOLUME OF PRODUCT IN COMMERCE
1,274 canisters
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Quaker Instant Oatmeal Original; 12 - .98 oz (28 g) packets net wt 11.8 oz (336 g) box; UPC 0 30000 01210 9; The pouches are labeled Original Quaker Instant Oatmeal, Not for resale. 32750121027 M801216, and Peaches & Cream Quaker Instant Oatmeal, Not for resale. Contains Milk & Soy Ingredients, 32750180038 on box, UPC QO01210 on case. Recall # F-1077-2011
CODE
Best Before Date: JUL0412L214
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quaker Foods and Snacks North America, Chicago, IL, by faxed and e-mailed letters on March 22, 2011.
Manufacturer: Pepsico QFS Division, Cedar Rapids, IA. Firm initiated recall is ongoing.
REASON
Some of the boxes of Quaker Instant Oatmeal Original contain pouches incorrectly labeled as Peaches and Cream instead of Original flavor. The oatmeal inside of the pouch is original flavor.
VOLUME OF PRODUCT IN COMMERCE
770 cases
DISTRIBUTION
CA, HI, IL, LA, NV, TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-1261-11
CODE
Unit: 302951795 (3 parts)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 15, 2007.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AZ, ND
___________________________________
PRODUCT
Source Plasma. Recall # B-1262-11
CODE
Units: 06FNCA2590; 06FNCA3409; 06FNCA3967
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fayetteville, NC, by facsimile on August 9, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced Recall # B-1263-11
CODE
Unit: 29FQ27123
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic, Norfolk, VA, by telephone on December 4, 2006. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Recall # B-1264-11
CODE
Units: 309604511; 309604511
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 15, 2007.
Manufacturer: Blood Systems, Inc., Bismarck, ND. Firm initiated recall is complete.
REASON
Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
___________________________________
PRODUCT   
1) Recovered Plasma. Recall # B-1273-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1274-11
CODE
1) Unit: 3815820;
2) Units: 3814557 and 3815820
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on March 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria and CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1287-11
CODE
Unit: 06GF72466
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax on November 6, 2010, follow up letter dated December 16, 2010 and fax on April 9, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced Recall # B-1294-11
CODE
Unit: W04421121339
RECALLING FIRM/MANUFACTURER
Recalling Firm: San Diego Blood Bank, San Diego, CA, by telephone on March 2, 2011 and letter dated April 20, 2011.
Manufacturer: San Diego Blood Bank, El Cajon, CA. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Recall # B-1295-11
CODE
Units: W039711425752Q Part 1; W039711425752Q Part 2
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank Dba Heartland Blood Centers, Aurora, Il, by telephone on March 11, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-1296-11;
2) Fresh Frozen Plasma. Recall # B-1297-11
CODE
1) and 2) Unit: W035211006141A
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by fax on March 25, 2011 and by letter on March 29, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT   
Platelets Pooled Leukocytes Reduced. Recall # B-1315-11
CODE
Unit: W120611180379
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by facsimile on March 15, 2011. Firm initiated recall is complete.
REASON
Blood product, with a platelet concentration that exceeded the maximum specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1316-1 1
CODE
Units: W070511111319, W070510118969
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by facsimile on March 30, 2011 and by letter dated April 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced Recall # B-1330-11
CODE
Units: W03551091893100; W03551091895500; W03551092060200; W03551093089900 Part 1; W03551093089900 Part 2; W03551093093200; W03551093099600 Part 1; W03551093099600 Part 2; W03551093099600 Part 3; W03551093263000 Part 1; W03551093263000 Part 2
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by fax on February 18, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
FL
___________________________________
PRODUCT   
1) Fresh Frozen Plasma. Recall # B-1341-11;
2) Red Blood Cells. Recall # B-1343-11
CODE
1) Unit: 1172849;
2) Units: 1172849; 1116295
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 28, 2011 and by letter on March 15, 2011 and April 20, 2011.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1344-11
CODE
Units: W037710109675 (part 1); W037710109675 (part 2); W037710109675 (part 3)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on January 31, 2011 and by letter on February 9, 2011 and March 29, 2011. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1288-11
CODE
Unit: 06GF72466
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by the logic system on November 6, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1289-11
CODE
Units: 2571518; 2571517
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on January 17, 2007. Firm initiated recall is complete.
REASON
Blood products, out of controlled storage for an undocumented length of time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1293-11
CODE
Units: 305632179; 305632179; 305631869
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on June 26, 2007.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood that lacked the assurance of storage at the correct temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
ND, SD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1298-11
CODE
Unit: W067111021011
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on March 21, 2011. Firm initiated recall is complete.
REASON
Blood product, leukodepleted greater than five days after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1299-11
CODE
Unit: 012KQ84943
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter on March 5, 2011 and April 4, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Source Plasma. Recall # B-1337-11
CODE
Units: 09LWIH0762; 09LWIG9025; 09LWIG8450; 09LWIG6945; 09LWIG6371; 10LWIB7639; 10LWIB6880; 10LWIA2485; 09LWIJ2469; 09LWIJ1391; 09LWIJ0344
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Onalaska, WI, by electronic mail on April 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Austria
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-1342-11
CODE
Unit: 1116295
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 28, 2011 and by letter on March 15, 2011 and April 20, 2011.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, MN
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT   
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a) Catalog Numbers: 270-2415 and b) 270-2417; The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ion�exchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-�throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software. Recall # Z-1932-2011
CODE
a) Lots 70291500 Exp. June 30, 2010; Lot 70292239 Exp. June 30, 2010; and Lot 70292240 Exp. June 30, 2010; b) Lot 70291520 Exp. Dec. 2, 2009; Lot 70292241 Exp.Dec.2, 2009; Lot 70291520R Exp. Jan. 31, 2010; Lot 70292242 Exp.Jan.31, 2010; and Lot 70292318 Exp. Jan. 31, 2010
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated December 1, 2009. Firm initiated recall is ongoing.
REASON
Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.
VOLUME OF PRODUCT IN COMMERCE
1099 units
DISTRIBUTION
Nationwide, and Australia, New Zealand, Taiwan, Singapore, India, China, S. Korea, Hong Kong, France, Sweden, United Kingdom, Italy, Hungary, Germany, Brazil, Mexico and Colombia
___________________________________
PRODUCT   
1) UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1938-2011;
 
2) UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1939-2011;
 
3) UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, DxC860i: A64935, DxC 880i: A59102 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1940-2011
CODE
DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, letter dated January 26, 2011.  
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a "pushed pair." If a pushed pair event occurs, results may be associated with the incorrect patient identification. The association of results with the incorrect patient identification may lead to misdiagnosis, inappropriate testing, inappropriate treatment, and/or delayed treatment.
VOLUME OF PRODUCT IN COMMERCE
2639 units (892 in US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
1) Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray. Recall # Z-1941-2011;
 
2) Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating atomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray. Recall # Z-1942-2011
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated March 1, 2011. Firm initiated recall is ongoing.
REASON
Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
VOLUME OF PRODUCT IN COMMERCE
708 systems
DISTRIBUTION
Nationwide, Canada, China, Denmark, England, France, Germany, Hong Kong, India, Ireland, Italy, Japan, San Salvador, Slovakia, Spain, and Switzerland
___________________________________
PRODUCT   
Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation. Recall # Z-2067-2011
CODE
Lots: Y703 through Y707 and Y709 though Y726 Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015
RECALLING FIRM/MANUFACTURER
Therakos Inc., Raritan, NJ, by letter dated February 1, 2011. Firm initiated recall is ongoing.
REASON
Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
VOLUME OF PRODUCT IN COMMERCE
4,323 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Biomet CC I-Beam Tibial Plate 75mm Interlok 67mm Fixed CR Tibia Plate 67mm REF 141224, Biomet, Interlok 75MM Fixed I-Beam Tibial Plate with Locking Bar, CO-CR-MO/TI 6AL 4V Alloy, qty 1, Sterile R, 2010-09, Expiry Date: 2020-09 I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
Recall #Z-2104-2011
CODE
Lot: 123123
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by electronic communication on March 3, 2011. Firm initiated recall is ongoing.
REASON
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
FL, IN, NC and Japan and the Netherlands
___________________________________
PRODUCT   
1) Clearview� iFOB, Clearview� iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall #  Z-2106-2011;
 
2) Clearview� iFOB, Clearview� - Sample Kit (5 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2107-2011;
 
3) Clearview� iFOB, Clearview� - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8114KCV (25 Test Kit), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2108-2011;
 
4) Clearview� iFOB, Clearview� - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2109-2011;
 
5) Clearview� iFOB, Clearview� - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2110-2011;
 
6) Clearview� iFOB, Clearview� - Clearview iFOB Return Mailer (accessory) Product Part Number: 8117KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices. Recall # Z-2111-2011
CODE
1) Lot Numbers: 0616210 0626710 0818710 1021010;
2) Lot Number: 0630010;
3) Lot Numbers: 0616310 0826110 1024910;
4) Lot Numbers: 0626810 0808110;
5) Lot Numbers: 0626510 0805110;
6) Lot Numbers: 0630110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alere North America, Orlando, FL, by letter dated March 21, 2011.
Manufacturer: Tianjin New Bay Bioresearch Co., Ltd., Tianjin, China. Firm initiated recall is ongoing.
REASON
Potential for false negatives test results and negative/faint positive controls.
VOLUME OF PRODUCT IN COMMERCE
13,227 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-2114-2011
CODE
All serial numbers, SW version 1.1.3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, letter on October 20, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL.  Firm initiated recall is ongoing. 
REASON
For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected and not flagged when there is a WBC Pump Failure. IMPACT: Erroneous RBC and/or HCT could affect the interpretation and management of patients at risk with various types of anemias.
VOLUME OF PRODUCT IN COMMERCE
422 units total (175 in US)
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
___________________________________
PRODUCT   
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall #Z-2119-2011
CODE
Serial Numbers: H510378, H510392, H510712, H510844, H511781, H512506, H512547, H512645, H513143, H513196, H513460, H514034, H514385, H514468, H514759, H514941, H511891
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.
REASON
A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
CA, NV, NJ, GA, IL, TX and Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland and United Kingdom.
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).  
Recall # Z-2121-2011
CODE
All serial numbers, SW version 1.1.3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated. IMPACT: The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact clinical decision making involving reticulocyte percentages or absolute counts
VOLUME OF PRODUCT IN COMMERCE
422 units total (175 in US)
DISTRIBUTION
Nationwide, and Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
___________________________________
PRODUCT
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011
CODE
Versions D.03, E.0, or E.01 of the software
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter on March 16, 2011. Firm initiated recall is ongoing.
REASON
Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.
VOLUME OF PRODUCT IN COMMERCE
387 units
DISTRIBUTION
Nationwide, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom
___________________________________
PRODUCT
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Recall # Z-2177-2011
CODE
Lot numbers BD1008, CD1050, FA1081 and GA1190
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated June 2010. Firm initiated recall is ongoing. 
REASON
Patient results may be falsely depressed or falsely elevated across the assay range.
VOLUME OF PRODUCT IN COMMERCE
860 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System. Recall # Z-2179-2011
CODE
Units: W1F09X2272, W1F0972220, W1F0992260, W1F0992262, W1H1012311, W1F0972219, W1F09Y2281, W1F0972218, W1F09X2270, W1F09X2271, W1F09Y2280, W1F09X2268, W1F09X2273, W1F09Y2282, W1F09Z2296, W1F09Z2297, W1F0992261
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on April 20, 2010.
Manufacturer: Toshiba Medical Systems Corporation, Otawa-Shi, Tochigi, Japan
REASON
There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047. Recall # Z-2181-2011
CODE
NDA Serial numbers: P7-03112, P7-03174, P7-03221.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on April 5, 2011. Firm initiated recall is ongoing.
REASON
Position sensor failure mode may result in an inaccurate position calculation. The error manifests itself in one of two possible ways. 1. The video returned by one of the two cameras inside the Spectra is all white or all black. The consequence of this failure symptom is that the Spectra stops tracking immediately. 2. The video returned by one of the two cameras inside the Spectra is returned but certain video intensities are not available. This results in a video image where transitions from dark to light portions of the image are more abrupt than normal, without the shades of gray that would normally separate the dark and light regions of the image.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Quest MPS and MPS 2 Consoles, Quest Medical, Inc., an Atrion Company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery. Recall #Z-1924-2011
CODE
MPS Serial Numbers: 2022, 2023, 2024, 2297, 2307, 2177, 2258, 2259, 2261, 2263, 2266, 2421, 2422, 1198, 1379, 1385, 1395, 2022, 2023, 2024, 2335, 2336, 2396, 9069, 1407, 1408, 1409, and 2078
RECALLING FIRM/MANUFACTURER
Quest Medical, Inc., Allen, TX, by letter in July 2010. Firm initiated recall is ongoing. 
REASON
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
VOLUME OF PRODUCT IN COMMERCE
771 consoles
DISTRIBUTION
Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
___________________________________
PRODUCT   
Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System. Recall # Z-1969-2011
CODE
Lot 20001814; Exp. February 28, 2012
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated September 8, 2010. Firm initiated recall is ongoing.
REASON
The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.
VOLUME OF PRODUCT IN COMMERCE
23 kits
DISTRIBUTION
PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
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PRODUCT
Testosterone Propionate Micronized USP, In a drum or other suitable container depending on quantity shipped, Active Pharmaceutical Ingredient. Recall # V-126-2011
CODE
Lot TTPMIC10001K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter dated April 11, 2011.
Manufacturer: Pharmacia and Upjohn Company, Div. of Pfizer, Inc., Kalamazoo, MI. Firm initiated recall is ongoing. 
REASON
The firm is recalling shipments of Testosterone Propionate API because it may be contaminated with Testosterone.
VOLUME OF PRODUCT IN COMMERCE
10.1 kg
DISTRIBUTION
AL, AZ, MO
 
END OF ENFORCEMENT REPORT FOR MAY 18, 2011
 
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